American Proficiency Innovative Solutions. - api-pt.com
Transcript of American Proficiency Innovative Solutions. - api-pt.com
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CONTACT US
HOURS
Monday thru Friday – 8:00am to 5:00pm EST
International: [email protected]
PHONE
Toll Free: 800-333-0958
International: +1-231-941-5887
FAX
855-900-6119
REMITTANCE ADDRESS
American Proficiency Institute Department 9526
PO Box 30516 Lansing, MI 48909-8016
ADDRESS
American Proficiency Institute 1159 Business Park Drive Traverse City, MI 49686
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Table of Contents
Highlights and Features 4-6Program Overview 7Enrollment Information 8-92020 Order Form 10-112020 Shipment Calendar 12Treatment of Proficiency Testing Samples 13Confidentiality Provisions 13
Confidentiality 13Policy for Use of Reports by Individuals and Organizations 13
Activities Subcontracted by API 14Sample Homogeneity and Stability 14
Homogeneity Testing 14Stability Testing 14
Grading Standards 15-18CLIA ’88 and Grading 15 Evaluation Reports 15-17Metrological Traceability and Measurement Uncertainty of Assigned Values 17 Advice on Interpretation of Statistics 17-18“Results Not Graded” – What’s Next? 18
Program Analysis 19-132Chemistry 19-43Urine Chemistry and Body Fluid Analysis 44-49Hematology 50-59Miscellaneous Hematology 60-66Andrology 67-69Coagulation 70-79Urinalysis, PPM, and Misc. Tests 80-87Microbiology 88-113Immunology 114-125Immunohematology 126-132
Paperless Proficiency Testing Instructions 133-158Entering Results 133-138Managing Sub-Users 139-145Viewing Evaluation Reports 146-151DataDashboard 152-158
Continuing Education 159-163Appendix A: Cell Count/Hematology/Sedimentation Rate Instrument List 164-165Appendix B: Analytes Included in Molecular Multiplex Panels 166-168Glossary of Abbreviations and Terms 169-170Index 171-174
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Highlights and Features
Accepted by All Major U.S-Based Regulatory Agencies!
CAP – College of American Pathologists – Please refer to individual programs to confirm CAP acceptance.
CMS – Centers for Medicare and Medicaid Services and all State Regulatory Agencies (e.g. New York State, New Jersey, Texas)
COLA
The Joint Commission
HFAP/AOA – Healthcare Facilities Accreditation Program
ISO Accredited!
API is accredited as a proficiency testing provider to the requirements of ISO/IEC 17043:2010. We are accredited by the American Association for Laboratory Accreditation (A2LA) under certificate number 3094.01 (www.A2LA.org). A2LA is a signatory to all existing International Accreditation Forum (IAF) international recognition agreements. Programs included under the scope of this accreditation are marked with a in this user guide.
Outstanding Features and Services!
API offers outstanding features and services that can help you easily manage your proficiency testing!
Enter, review, submit, and print your results online.
Receive email notifications about upcoming shipments, tracking information, due date reminders, andmore!
Set-up and manage sub-user accounts for your staff, with the option to assign specific sample sets andgrant permissions on an individual basis.
View and print evaluation reports, grading criteria, and participant data summaries.
Utilize API ImageViewer for all virtual images including Blood Cell Identification, Provider-PerformedMicroscopy, and more!
Create free Continuing Education accounts for you and your staff and earn up to 18 free credits per year!
Track your Proficiency Testing performance using the new API DataDashboard – Easily view PTperformance over the six most recent test events using customizable graphs. See pages 152-158 for more information on API DataDashboard, including how to access it.
API DataDirect – Proficiency Testing Reporting Made Easier!
Using their laboratory information system (LIS) or middleware, laboratories may now transmit proficiency testing results directly to API using API DataDirect, a process that revolutionizes proficiency testing for clinical laboratories. No more manual data entry, no more clerical errors, no new technology systems to purchase, and no additional fees! DataDirect is easy to use and saves time!
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API currently works with the following LIS and middleware companies:
Contact our DataDirect Specialists for more information or to request a demonstration at [email protected] or 800-333-0958.
Free Continuing Education!
Physicians, Medical Laboratory Scientists (MLS), and Medical Laboratory Technicians (MLT) can earn up to 18 free CME or CMLE credits per year through an arrangement between API and the American Society for Clinical Pathology (ASCP). Multiple credits are offered each year in Chemistry, Microbiology, Hematology, and Immunology. Credits are also occasionally offered in Blood Banking, Coagulation, Microscopy, and Laboratory Management. Each educational exercise is available for between three and four months. The number of exercises available at any one time will vary and the number of earned credits depends on individual participation. See pages 159-163 for more information on how to set up CE accounts for your laboratory staff.
The acceptability of the credits provided by API is up to the organization requiring you to earn continuing education credits. Please check with the organization setting your requirements to determine if these credits will be accepted.
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Verification Programs
CLIA regulations state that laboratories are not to test proficiency testing samples during the proficiency testing event with more than one method unless that is how they test patient specimens. This restriction applies to both regulated and non-regulated analytes.
If a laboratory uses multiple methods to test an analyte, then they must designate one of the methods as “primary” and test the proficiency samples using that method. After the proficiency testing due date has passed, laboratories may test proficiency testing samples using multiple methods.
API’s Verification Programs (programs that begin with a letter) offer laboratories the convenience of using PT samples and statistics to verify back-up methods, while still remaining compliant with CLIA regulations. Verification programs are to be tested and resulted during the noted verification testing period, which is printed on the packaging for each set of verification samples.
Where available, verification programs are listed in the main body of this user guide along with regular PT programs. Scores from verification programs are not reported to regulatory agencies (e.g. CAP, CMS, or The Joint Commission). However, API will provide online evaluations for verification programs when evaluations for primary programs are released.
Off-Schedule Testing
Remedial Proficiency Testing
API offers remedial proficiency testing to laboratories who need specimens for additional testing, beyond their regular proficiency testing. This is generally required by an accrediting/regulatory agency when a laboratory has had poor performance on a particular analyte in two of three test events.
Remedial proficiency testing includes blind samples, customized instruction forms, and worksheets. API will grade the results and provides a letter to the laboratory evaluating the performance. It is the laboratory’s responsibility to forward the letter of evaluation on to the accrediting/regulatory agency.
Troubleshooting Samples
API offers troubleshooting samples at a nominal charge. Troubleshooting samples are generally ordered when a customer has had one failed event and would like to obtain a new, identical set of samples to retest in order to help determine the cause of the failure. This is often documented as part of their corrective action process.
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Program Overview
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Enrollment Information
Design and Implementation of API Proficiency Testing
API’s proficiency testing program was developed in the early 1990s to meet CLIA’s proficiency testing requirements for physician office laboratories. Since then, API has expanded to cover all areas of laboratory medicine and now services over 20,000 laboratories. Our program is open to testing facilities around the world who are interested in a proficiency testing format that is sent 2-3 times per year, with 2-5 samples per testing event.
How to Order
Enrolling in API Proficiency Testing is easy! The current API Catalog and Order Form are located on the API website. Simply click the “Catalog” link, located at the top of our homepage, and download the PDF versions of the Catalog and the Order Form. They can also be found in the “Getting Started/Ordering” section of the Knowledge Base.
The Order Form file also contains information that may be helpful in program selection for Hematology and Coagulation instruments, as well as a credit card form for transmitting payment information.
Our Customer Service Representatives and Technical Specialists are available to answer any questions regarding program selection and order placement. Once you’ve determined which programs you wish to order, complete the Order Form and email or fax it to API Customer Service.
Renewal Orders (Current Customers Only)
Renewal reminder notifications will be sent to all current customers, usually beginning in August. Once notifications are sent, customers should review the generated renewal form for accuracy. If necessary, customers can request revisions to the renewal order form. Customers may renew online (which includes an option to request changes), by phone, by fax, or by mail. API recommends that renewal orders be placed no later than November 15th to guarantee product availability.
International customers working with a distributor will be contacted by their distributor to make renewal arrangements.
Partial Year Orders
API will gladly accept new orders and order changes throughout the year and will make every effort to accommodate them, based on sample availability. Prices (excluding fees and binders) will be prorated for orders received after the first shipment(s) have closed.
Order Additions & Cancellations
Current customers can request additional programs by contacting API Customer Service via telephone, email, or live chat. Requests can also be made by submitting a completed order form to Customer Service by email or fax. Ordering additional programs may require additional shipping charges for international and non-continental U.S. locations.
Cancellation requests can be made by email, telephone, and live chat. API will credit the facility for the cost of the unshipped specimens if notification is received four or more weeks prior to the next scheduled shipment. In accordance with our cancellation policy, all credits expire within 120 days of the issuance date of the credit
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memo. Please note: Additional shipping and handling charges, including the shipping and processing fee, are nonrefundable.
Price Estimates
If you are currently ordering proficiency testing with another provider, we would be happy to create a customized price and product comparison for your facility. To take advantage of this service, please email the order confirmation for your current proficiency testing order to [email protected]. Be sure to include the facility name, shipping address, phone number, and your contact information (email address and direct phone number, if applicable).
International and Non-Continental U.S. Customers
API is able to service international locations and non-continental U.S. customers. Some locations, including the state of Hawaii, U.S. territories and commonwealths, as well as international locations, may require import permits for API shipments. Local authorities can assist you in determining if any permits are required for your location. Please note: It is the responsibility of the testing facility to obtain any required import permits.
Additional shipping charges for international and non-continental U.S. locations may apply. Please contact Customer Service at [email protected] for more information.
2020 Order Form Innovative Solutions. Technical Excellence.
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Product and prices apply to domestic orders only. Contact API for product availability and pricing for international requests.
To Order: a. Complete the order form in its entirety.b. Ensure the “Total” includes the $103 Shipping and Processing fee.c. Select from the following choices to submit your order:
Email your order to [email protected] Fax the order form to us at 855-900-6119 Mail orders with payment to:
American Proficiency InstituteDepartment 9526P.O. Box 30516Lansing, MI 48909-8016
d. Call us at 800-333-0958 and speak with a Customer Service Representative if you have any questions.
Accrediting Information
CLIA # TJC # CAP/LAP ID# State ID# COLA ID# API# (existing)
Laboratory Type (Please select one)
Air Force Hospital / Clinic Hospital Laboratory ≤ 100 Beds Hospital Laboratory 301 - 400 Beds Manufacturer
Army Hospital / Clinic Hospital Laboratory 101 - 200 Beds Hospital Laboratory > 400 Beds Navy Hospital / Clinic
Clinic / Physician Office Lab Hospital Laboratory 201 - 300 Beds Independent Laboratory VA Hospital / Clinic
Laboratory Information System (LIS) (Please select one)
Allscripts Epic McKesson Horizon Meditech Sunquest
Cerner Healthland McKesson Paragon Orchard Other:
ClinLab LabDAQ-CompuGroup Medhost (HMS) SCC Soft YES! I would like to learn more about uploading PT results using my LIS.CPSI Labtrak Medicus Schuyler House - SchuyLab
Shipping Information (If shipping by department, please use additional copies)
Shipping Contact
Facility Name
Department
Street Address (No P.O. Boxes)
Address 2
City State Zip Code
Phone (required) Fax
Contact Email Address
Billing Information
Billing Contact
Facility Name
Mailing Address
Address 2
City State Zip Code
Phone (required) Fax
Billing Email Address
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Additional Report Copies (To an additional person at a different location than the shipping address)
Current Consultant/Management IDs to Receive Report Copies
Please set up a new consultant/management account for the following person. They will be overseeing multiple API accounts.
Contact Name
Facility Name
Mailing Address
Address 2
City State Zip Code
Phone Fax
Email Address
Order Information
Catalog # Program Description Quantity * Unit Price Total
Purchase Order #: Sub-Total $
Authorized Signature: Shipping & Processing $ $103.00 Date: Additional Shipping Charges ** $
Please complete the following Credit Card Payment Form to pay by credit card. Order Total $
* Quantity refers to the number of sets of samples, not the number of events being ordered. Due to CLIA regulations, quantity should be 1 for PT programs. Ordering multiple Verificationprograms is allowed. For questions, please contact API.
** Contact API at [email protected] for International requests or Additional Shipping Charges for Alaska and Puerto Rico.
API Use Only
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Treatment of Proficiency Testing Samples
Proficiency testing samples should be treated in the same manner as patient samples. According to CMS, “this means testing the PT [proficiency testing] samples the same number of times you would patient specimens, by the same personnel that routinely test the patient specimens, and using the same test system, including analyzer and reagents, that is routinely used for the patient specimens. PT samples should be rotated among the testing personnel in your laboratory.”1
Please note: For CMS/CLIA-regulated laboratories, do not refer any of your proficiency testing samples to another laboratory, even in cases where you would normally do so with a patient specimen.
Confidentiality Provisions
Confidentiality
Information on the identity, enrollment, and performance of individual participants is considered confidential by API and is not disclosed to third parties without explicit authorization from the customer. Once issued, reports become the property of the laboratory and may be distributed as needed. API will, however, vigorously defend our copyright on the layout and terminology of our evaluation reports and the content of our data summaries. Reports are to be used for the purpose of laboratory improvement and/or by persons providing similar services. Any use outside of those listed is considered unauthorized and is prohibited. In addition, microorganisms used in API PT programs are licensed for our use; retention or further subculturing of these organisms is unauthorized.
It is mandatory for U.S. PT providers to provide reports on U.S. laboratories to the Centers for Medicare and Medicaid Services (CMS), as well as some state Department of Health offices. A list of agencies and/or persons receiving reports, including those requested by the participant, appears on every evaluation’s report cover and on order confirmations for individual participants. Contact API Customer Service to request changes to agencies and/or persons receiving copies of your evaluation reports.
Policy for Use of Reports by Individuals and Organizations
Results from a single event of proficiency testing or results from a single analyte should not be used as the only method of judging laboratory or analyst performance. Proficiency testing is best regarded as one component of a laboratory’s efforts to ensure quality. All proficiency testing failures should be thoroughly investigated and a course of corrective action pursued. However, individual proficiency results may be affected by variables not involved in the laboratory’s routine testing, such as pre-analytical preparation of the proficiency sample and the matrix of the sample itself. These deviations from a laboratory’s normal procedures, required by the nature of proficiency testing, rarely affect long-term proficiency performance but may occasionally affect individual proficiency results.
Eurachem published a document on this topic in 2011, titled Selection, Use and Interpretation of Proficiency Testing (PT) Schemes by Laboratories. It is applicable to many types of laboratories and was developed for use with ISO standards.
1 Additional information can be obtained from the CMS website at: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html. The CMS brochure regarding proficiency testing and PT referrals can be downloaded at https://www.cms.gov/Regulations-and-guidance/Legislation/CLIA/downloads//CLIAbrochure8.pdf.
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Activities Subcontracted by API
API subcontracts the manufacture of all physical samples as well as sample homogeneity and stability testing. All other activities related to this PT program are performed by API staff.
Sample Homogeneity and Stability
Homogeneity Testing
The homogeneity testing that is performed on the proficiency testing samples is based on recommendations found in ISO/IEC 17043:2010, ISO 13528:2015, and referenced documents. These techniques have been developed and refined by scientific and statistical experts and are designed for samples used in proficiency testing programs.
Quantitative Analytes
Homogeneity testing is performed on each new material proposed for use in accredited PT programs. The type of homogeneity study varies depending on the sample manufacturer, the number of samples being produced, and any anticipated source of inhomogeneity in the type of material being used. Testing is performed either on analytes which may be more likely to exhibit inhomogeneity or on analytes representative of the quality of the entire sample. Multiple levels of these analytes are tested to ensure that the material performs well regardless of the level of various analytes in the sample.
After samples have reached their final packaged form, a set quantity of samples is chosen randomly from the samples produced. Where possible, each sample is tested twice. Analysis of variance is used to measure the difference between the samples and between the replicate tests. The difference attributed only to the samples is compared to the difference typically seen in participant testing, and must meet statistical tests described in ISO 13528:2015 and referenced documents for the material to be approved.
Once a material is approved, overall participant statistics for each sample are monitored against statistics for previous samples to ensure that the material continues to perform well and the original homogeneity comparison remains valid. Participant results are evaluated using robust participant statistics rather than a reference value, so any occasional inhomogeneity between PT items is included in the evaluation criteria for each sample.
Qualitative Analytes
Homogeneity testing is performed on each new sample type proposed for use in accredited PT programs. After samples have reached their final packaged form, two or more samples are chosen randomly from the samples produced. Where possible, positive samples are tested twice; negative samples are tested only once. All results must match the targeted absence, presence, and/or identification for that sample type to be approved. Stability Testing
Stability testing is based on recommendations found in ISO/IEC 17043:2010, ISO 13528:2015, and referenced documents. It generally consists of repeating the homogeneity analyses on a smaller number of samples and verifying that there will be no significant change in samples during distribution and testing, as long as recommended storage temperatures are maintained once samples are received. When samples are stable for only a portion of the proficiency testing period, this is printed on sample packaging.
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Grading Standards
CLIA ’88 and Grading
The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) were established by the U.S. federal government and administered by the Centers for Medicare & Medicaid Services (CMS) to regulate U.S. clinical laboratories and proficiency test providers like API.
One of the subjects regulated by CLIA '88 is the way proficiency test results are graded. The method by which an analyte is graded depends on whether the test is quantitative (e.g., the amount of Cholesterol in a blood sample) or qualitative (e.g., a blood sample Positive/Negative for Infectious Mononucleosis). The range of results considered acceptable and the way that range is calculated is also specified by CLIA ’88 for “regulated” analytes (listed in CLIA regulations). See the Program Analysis section of this user guide or the API Grading Criteria webpage for individual analyte details.
Evaluation Reports
Evaluation reports consist of four parts: a Report Cover, Performance Summary, Comparative Evaluation, and Participant Data Summary. Full reports and individual components can be viewed, downloaded, or printed by logging into the API website and selecting “Evaluation Reports.”
Report Cover The report cover lists overall information about the evaluation report, such as other entities receiving copies of the report. It also includes the contact information for the program coordinators, the correction policy, and the details of any corrections that may have been made to a report.
Performance Summary This part of your report is a summary of your performance on individual analytes for a period of time up to the three most recent test events. It is divided into sections according to specialty/sub-specialty.
For each test event, the scores for individual analytes are calculated as the ratio of acceptable responses to the total number of samples tested, expressed as a percentage.
Analyte score = Acceptable responses
Total number of samples tested
Unsatisfactory performance (denoted by a red checkmark) is indicated for any analyte with less than 80% (100% for ABO Group, D (Rh), Typing, and Compatibility Testing). Analytes that are regulated under CLIA and will have scores sent to CMS are designated by (**).
Microbiology scores are regulated and reported to CMS by sub-specialty, not by individual analyte. Microbiology scores are grouped by sub-specialty (Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology) on your report. In the heading for each sub-specialty section is a combined score for the regulated challenges (indicated by **) in that section. This is the score that is reported to CMS. It is the ratio of acceptable responses for all regulated challenges in the sub-specialty to the total number of regulated responses, expressed as a percentage. Additional scores without double asterisks (**) may appear in each section and were not used in the calculation of the regulated sub-specialty score.
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Sub-specialty score = Acceptable responses
Total number of responses
Unsuccessful long-term performance, where indicated, is based on unsatisfactory scores (less than 80%) for two of three test events.
Comparative Evaluation This part of your report shows a detailed breakdown of your performance and statistics for each test performed, including:
Analyte Tested Test Method Used Samples Tested (Sample IDs) Reported Result: The result that your facility reported to API. Expected Result Mean Standard Deviation (SD) Standard Deviation Interval (SDI) Performance: Your performance on the individual sample for the given test, shown as either “Acceptable”
or “Unacceptable.”
Qualitative Tests
The Expected Result is often “Positive” or “Negative,” a category or interpretation such as “Moderate,” or an identification of a bacteria, cell, or other element. It is normally determined by consensus of participating laboratories and supported by an independent reference value. Consensus is defined as at least 80% of participating laboratories agreeing on one answer or a small group of clinically correct answers. Immunohematology analytes, as defined by the CLIA regulations, require 95% consensus. If consensus is not achieved between participating laboratories, the expected result is based on the results of a small group of expert laboratories (“referees”) with successful PT performance for the past three events.
The Performance is determined by comparing the reported result to this expected result and is generally listed as “Acceptable” or “Unacceptable.” If “Not Graded” appears in the Performance column, please refer to the Participant Data Summary section of the website for technical commentary.
Quantitative Tests
The Expected Result for a quantitative test is a range of results based on a target value (mean) ± a fixed amount. This fixed amount is determined by CLIA '88 for each analyte and is expressed as a percentage, a specific quantity, or a number of standard deviations. The grading criteria are listed in the Program Analysis section of this manual.
The target value is the Mean (average) of the results for your comparison group. A comparison group, also known as a peer group, may consist of laboratories that use the same instrument or reagent as you or it may consist of laboratories that use the same method principle. A comparison group of "All Participants" (all facilities performing that test) may also be used, as well as a group of referee laboratories. The comparison group must contain at least 10 laboratories. In cases where an appropriate comparison group cannot be found, no grading criteria is applied. In addition, only samples with a minimum of 80% consensus are graded.
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The Standard Deviation (SD) is calculated from the results for your comparison group. Both the mean and SD are robust statistics, calculated in such a way as to reduce the effect of any outlying results. The SD is listed for all quantitative analytes, whether or not it is the basis for the grading criteria for that analyte. It is also used to calculate the Standard Deviation Interval (SDI) described below. The SDI is not used to determine performance.
Performance is determined by comparing the reported result to the range of expected results calculated above. It is generally listed as “Acceptable” or “Unacceptable.” If “Not Graded” appears in the Performance column, please refer to the Participant Data Summary section of the website for technical commentary.
Participant Data Summary This part of your report is the statistical summaries and graphical representation of participant data, available on the API website.
The Participant Data Summary is a summary of the collected results of all laboratories that participated in each proficiency testing event. The information shown for qualitative tests includes the number of laboratories reporting each response, organized by the methods used. The information shown for quantitative tests includes the number of laboratories reporting, the mean, SD, range of acceptable results, and uncertainty for each comparison group, so long as it consists of 5 or more participants. In addition, "All Participant" statistics are shown for both qualitative and quantitative tests.
Metrological Traceability and Measurement Uncertainty of Assigned Values
Consensus values derived from participant results are not metrologically traceable to a single reference value or standard. They are traceable only to the laboratories submitting results for analysis. However, using a robust mean of participant results as an estimate of the true value of a test material is a reliable and accepted practice which has many benefits, including allowing for peer group comparisons among laboratories using similar or equivalent methods. The measurement uncertainty of consensus values used for grading is reviewed to ensure that it is reasonable in comparison to the grading intervals used. It is also reported along with each consensus value in the participant data summary.
The qualitative statistics are based on the results reported by participants but are compared to the known or reference results established by the sample manufacturer before being used for grading. Qualitative result s of this type do not require a calculated estimate of measurement uncertainty.
Advice on Interpretation of Statistics
The SDI is determined using the following calculation:
Your Result - Comparison Group Mean Comparison Group Standard Deviation
The SDI describes how far a proficiency result is from the comparison group mean. The closer the SDI is to “0”, the closer the result is to the group mean. For example, an SDI of -1.0 means that your laboratory's reported result is one standard deviation below the mean of the group and an SDI of +2.0 means that your reported result is two standard deviations above the mean.
A review of SDIs can assist with detection of random or systemic errors before they are large enough to be detected by quality control results. Random errors are caused by unknown and unpredictable events and occur
18 | 800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
without any real pattern. Systemic errors are continuous and affect all results equally. Systemic errors are indicated by a trend or shift, and are commonly due to mis-calibration.
In a broad sense, when looking at the SDIs for a group of five proficiency samples the numbers should be both positive and negative. Systematic errors are indicated by trends in the data. If the SDIs are all positive numbers (e.g. your proficiency results are all above the group mean) your instrument's calibration could be drifting to the high side. Conversely, if your SDIs are all negative numbers your calibration could be drifting to the low side. Significant systematic error must also be considered if two or more SDIs exceed the same limit and the average of the five SDIs exceeds +1.5 or -1.5.
“Results Not Graded” – What’s Next?
Whenever a result is not graded, you should perform a self-evaluation. To do this, you would compare your result to the expected result(s). If your result falls within the expected range, you may conclude that your lab obtained the correct response. If your result does not fall within the expected range, you may want to troubleshoot to determine the cause.
In most cases, the expected result is printed on your evaluation next to your reported result for each sample. If the expected result is not printed on your evaluation, to find the result or range of results that is the most appropriate for you to use for comparison:
On the API website, click "Participant Data Summaries," located on the left-hand side of the screen. Choose the appropriate test event. You will see three drop-down menus, which will allow you to select the analyte, the peer group, and
sample number.
The Participant Data Summary includes descriptions of qualitative analytes (such as blood cell identification or organisms contained in culture samples) and other information that may help you with your documentation.
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 19 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Basic ChemistryProgram Description
5.0 mL – Serum – Cholestech users see Catalog #176/976 – Lipid Plus on page 38. For quantitative HCG, see Catalog #409 – Serum HCG on page 40.
Program Information
121 – Basic Chemistry 141 – Additional Sample Volume A21 – Basic Chemistry – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean ALT (SGPT) U/L U/L ± 20% AST (SGOT) U/L U/L ± 20%
Bilirubin, direct µmol/L mg/dL ± 2 SD or ± 0.4 mg/dL,
whichever is greater
Bilirubin, total µmol/L mg/dL ± 0.4 mg/dL or ± 20%, whichever is greater
Calcium mmol/L mg/dL ± 1 mg/dL Chloride mmol/L mmol/L ± 5% Cholesterol mmol/L mg/dL ± 10% CO2 mmol/L mmol/L ± 3 SD
Creatinine µmol/L mg/dL ± .3 mg/dL or ± 15%, whichever is greater
Glucose mmol/L mg/dL ± 6 mg/dL or ± 10%, whichever is greater
HDL Cholesterol mmol/L mg/dL ± 30% LDL, calculated & measured
mmol/L mg/dL ± 2 SD
Potassium mmol/L mmol/L ± 0.5 mmol/L Sodium mmol/L mmol/L ± 4 mmol/L Triglycerides mmol/L mg/dL ± 25%
Urea Nitrogen (BUN) - mg/dL ± 2 mg/dL or ± 9%, whichever is greater
Uric Acid µmol/L mg/dL ± 17%
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 20 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Chemistry – EndocrinologyProgram Description
5.0 mL – Serum – OCD Vitros labs performing thyroid tests, see Catalog #175 –Thyroid Special on page 42. For quantitative HCG, see Catalog #409 – Serum HCG on page 40.
Program Information
125 – Chemistry – Endocrinology
Analytes Standard Units Conventional Units AV from Consensus Mean
Alpha-fetoprotein IU/mL ng/mL ± 3 SD Cortisol nmol/L µg/dL ± 25% Free T3 pmol/L pg/mL ± 2 SD Free T4 pmol/L ng/dL ± 3 SD
T Uptake N/A %
± 3 SD Uptakeunit
Thyroxine (T4) nmol/L µg/dL ± 1 µg/dL or ± 20%, whichever is greater
Triiodothyronine nmol/L ng/mL ± 3 SD TSH mIU/L uU/mL ± 3 SD
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th
Comprehensive ChemistryProgram Description
5.0 mL – Serum – OCD Vitros labs performing thyroid tests, see Catalog #175 –Thyroid Special on page 42. Cholestech users see Catalog #176/976 – Lipid Plus on page 38. For quantitative HCG, see Catalog #409 – Serum HCG on page 40.
Program Information
122 – Comprehensive Chemistry 141 – Additional Sample Volume A22 – Comprehensive Chemistry – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean Albumin g/L g/dL ± 10% Alkaline Phosphatase U/L U/L ± 30%
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 21 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Comprehensive Chemistry continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
Alpha-fetoprotein IU/mL ng/mL ± 3 SD ALT (SGPT) U/L U/L ± 20% Amylase U/L U/L ± 30% AST (SGOT) U/L U/L ± 20%
Bilirubin, direct µmol/L mg/dL ± 2 SD or ± 0.4 mg/dL,
whichever is greater
Bilirubin, total µmol/L mg/dL ± 0.4 mg/dL or ± 20%, whichever is greater
Calcium mmol/L mg/dL ± 1 mg/dL
Calcium, ionized mmol/L mmol/L ± 3 SD or ± 0.05
mmol/L, whichever is greater
Chloride mmol/L mmol/L ± 5% Cholesterol mmol/L mg/dL ± 10% CO2 mmol/L mmol/L ± 3 SD Cortisol nmol/L µg/dL ± 25% Creatine Kinase (CK) U/L U/L ± 30%
Creatinine µmol/L mg/dL ± .3 mg/dL or ± 15%, whichever is greater
GGT U/L U/L ± 20%
Glucose mmol/L mg/dL ± 6 mg/dL or ± 10%, whichever is greater
HDL Cholesterol mmol/L mg/dL ± 30% Iron µmol/L µg/dL ± 20%
Lactic Acid mmol/L mmol/L ± 3 SD or ± 0.4 mmol/L,
whichever is greater LDH U/L U/L ± 20% LDL, calculated and measured
mmol/L mg/dL ± 2 SD
Lipase U/L U/L ± 2 SD or ± 30 U/L, whichever is greater
Magnesium mmol/L mg/dL
± 25% mEq/L
Osmolality mOsm/kg mOSm/kg ± 3 SD Phosphorus mmol/L mg/dL ± 2 SD Potassium mmol/L mmol/L ± 0.5 mmol/L
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 22 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Comprehensive Chemistry continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
Sodium mmol/L mmol/L ± 4 mmol/L
T Uptake N/A %
± 3 SD Uptakeunit
Thyroxine (T4) nmol/L µg/dL ± 1 µg/dL or ± 20%, whichever is greater
TIBC (iron based
calculation)♦µmol/L µg/dL ± 20%
TIBC, measured µmol/L µg/dL ± 2 SD Free T3 pmol/L pg/mL ± 2 SD Free T4 pmol/L ng/dL ± 3 SD Total Protein g/L g/dL ± 10% Triglycerides mmol/L mg/dL ± 25% Triiodothyronine nmol/L ng/mL ± 3 SD TSH mIU/L uU/mL ± 3 SD UIBC, measured µmol/L µg/dL ± 2 SD
Urea Nitrogen (BUN) - mg/dL ± 2 mg/dL or ± 9%, whichever is greater
Uric Acid µmol/L mg/dL ± 17%
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th ♦ See Catalog #133/180 – Immunoassay for TIBC (transferrin based calculation) on page 34.
Chemistry – WaivedProgram Description
5.0 mL – Serum – For waived methods, Cholestech users see Catalog #976 – Lipid Plus – 2 samples on page 38.
Program Information
144 – Chemistry – Waived A44 – Chemistry – Waived – Verification Program
Analytes Standard Units Conventional
Units AV from Consensus
Mean Albumin g/L g/dL ± 10%
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 23 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Chemistry - Waived continued…
Analytes Standard Units Conventional
Units
AV from Consensus Mean
Alkaline Phosphatase U/L U/L ± 30% ALT (SGPT) U/L U/L ± 20% Amylase U/L U/L ± 30% AST (SGOT) U/L U/L ± 20%
Bilirubin, direct µmol/L mg/dL ± 2 SD or ± 0.4 mg/dL,
whichever is greater
Bilirubin, total µmol/L mg/dL ± 0.4 mg/dL or ± 20%,
whichever is greater Calcium mmol/L mg/dL ± 1 mg/dL Chloride mmol/L mmol/L ± 5% Cholesterol mmol/L mg/dL ± 10% CO2 mmol/L mmol/L ± 3 SD Creatine Kinase (CK) U/L U/L ± 30%
Creatinine µmol/L mg/dL ± .3 mg/dL or ± 15%, whichever is greater
GGT U/L U/L ± 20%
Glucose mmol/L mg/dL ± 6 mg/dL or ± 10%, whichever is greater
HDL Cholesterol mmol/L mg/dL ± 30% LDL, calculated & measured
mmol/L mg/dL ± 2 SD
Phosphorus mmol/L mg/dL ± 2 SD Potassium mmol/L mmol/L ± 0.5 mmol/L Sodium mmol/L mmol/L ± 4 mmol/L Total Protein g/L g/dL ± 10% Triglycerides mmol/L mg/dL ± 25%
Urea Nitrogen (BUN) - mg/dL ± 2 mg/dL or ± 9%, whichever is greater
Uric Acid µmol/L mg/dL ± 17%
Format Shipping Dates
2 samples x 3 shipments January 14th, May 20th, August 26th
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 24 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Alcohol Program Description 2.0 mL – Serum – For quantitative alcohol and qualitative acetone (ketone) testing, such as Bayer Acetest. For quantitative Beta-hydroxybutyrate testing, see Catalog #174 – B-Ketone on page 26.
Program Information
137 – Alcohol A37 – Alcohol – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Acetone (qualitative) - - -
Alcohol mmol/L mg/dL ± 10 mg/dL or ± 25%, whichever is greater
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th
Ammonia
Program Description 2.0 mL – Serum
Program Information
138 – Ammonia A38 – Ammonia – Verification Program
Analytes Standard Units Conventional Units AV from
Consensus Mean
Ammonia µmol/L µmol/L ± 2 SD or ± 10 µmol/L,
whichever is greater
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 25 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Amniotic Fluid pH
Program Description 0.5 mL – Simulated Amniotic Fluid – For Nitrazine methods.
Program Information
166 – Amniotic Fluid pH
Analytes pH (nitrazine) pH (interpretation)
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
Apolipoproteins
Program Description 3.0 mL – Lyophilized Serum
Program Information
130 – Apolipoproteins
Analytes Standard Units Conventional Units AV from Consensus
Mean
Apolipoprotein A1 g/L mg/dL ± 2 SD Apolipoprotein B g/L mg/dL ± 2 SD Lipoprotein (a) nmol/L mg/dL ± 2 SD
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 26 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
B-Ketone
Program Description 1.0 mL – Serum – For quantitative Beta-hydroxybutyrate testing performed on chemistry analyzers or whole blood glucometers. For qualitative testing using Bayer Acetest, see Catalog #137 – Alcohol on page 24.
Program Information
174 – B-Ketone
Analytes Standard Units Conventional Units AV from Consensus
Mean
Beta-hydroxybutyrate mmol/L mmol/L ± 3 SD or ± 0.2 mmol/L,
whichever is greater
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
Blood Gas
Program Description 3.0 mL ampule – For blood gas testing on i-Stat analyzers, see Catalog #145 – i-Stat Chemistry on pages 36-37.
Program Information
111 – Blood Gas A11 – Blood Gas – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
pCO2 mmHg mmHg ± 5 mmHg or ± 8%, whichever is greater
pH - - ± 0.04 pO2 mmHg mmHg ± 3 SD
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 27 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Blood Gas Plus
Program Description 3.0 mL ampule – For combination blood gas/electrolyte analyzers with or without hematocrit option. For blood gas testing on i-Stat analyzers, see Catalog #145 – i-Stat Chemistry on pages 36-37.
Program Information
112 – Blood Gas Plus A12 – Blood Gas Plus – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
pCO2 mmHg mmHg ± 5 mmHg or ± 8%, whichever is greater
pH - - ± 0.04 pO2 mmHg mmHg ± 3 SD
Urea Nitrogen (BUN) - mg/dL ± 2 mg/dL or ± 9%, whichever is greater
Calcium, ionized mmol/L mmol/L ± 3 SD or ± 0.05
mmol/L, whichever is greater
Chloride mmol/L mmol/L ± 5%
Creatinine µmol/L mg/dL ± .3 mg/dL or ± 15%, whichever is greater
Glucose mmol/L mg/dL ± 6 mg/dL or ± 10%, whichever is greater
Hematocrit Fraction % ± 6% Hemoglobin, calculated g/L g/dL ± 7%
Lactate mmol/L mmol/L ± 3 SD or ± 0.4 mmol/L, whichever is greater
►Magnesium, ionized mmol/L mmol/L ± 3 SD or ± 0.1 mmol/L, whichever is greater
Potassium mmol/L mmol/L ± 0.5 mmol/L Sodium mmol/L mmol/L ± 4 mmol/L tCO2 mmol/L mmol/L ± 3 SD
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 28 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Blood Lead – 5 Samples
Program Description 1.0 mL – Hemolysate – Designed for LeadCare I, Plus, and Ultra.
Program Information
172 – Blood Lead – 5 Samples
Analytes Standard Units Conventional Units AV from Consensus
Mean
Lead µmol/L µg/dL ± 4 µg/dL or ± 10%, whichever is greater
Format Shipping Dates
5 Samples x 3 shipments January 14th, May 20th, August 26th
Blood Lead - Waived
Program Description 1.0 mL – Hemolysate – Designed for LeadCare II.
Program Information
173 – Blood Lead – Waived
Analytes Standard Units Conventional Units AV from Consensus
Mean
Lead µmol/L µg/dL ± 4 µg/dL or ± 10%, whichever is greater
Format Shipping Dates
2 samples x 3 shipments January 14th, May 20th, August 26th
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 29 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Blood Oximetry
Program Description 2.0 mL ampule – Hemoglobin source is bovine.
Program Information
114 – Blood Oximetry A14 – Blood Oximetry – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Carboxyhemoglobin Fraction % ± 3 SD or ± 3, whichever is greater
Hematocrit, calculated Fraction % ± 6% Hemoglobin, total g/L g/dL ± 7% Methemoglobin Fraction % ± 2
Oxyhemoglobin Fraction % ± 3 SD or ± 3, whichever is greater
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th
Cardiac Markers – 5 Samples
Program Description 1.5 mL – Liquid – CAP accredited labs must test 5 samples for all Cardiac Markers, except D-dimer, Myoglobin, and waived BNP.
Program Information
140 – Cardiac Markers – 5 Samples 165 – Additional Sample Volume A40 – Cardiac Markers – 5 Samples – Verification Program
Analytes Standard Units Conventional Units AV from
Consensus Mean
BNP pmol/L pg/mL ± 3 SD or ± 10 pg/mL,
whichever is greater
CK-MB ng/mL ng/mL ± 3 SD or ± 3,
whichever is greater U/L U/L CK, total U/L U/L ± 30%
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 30 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Cardiac Markers continued…
Analytes Standard Units Conventional Units AV from
Consensus Mean
D-dimer ugFEU/mL ugFEU/mL
± 3 SD µg/L µg/L
Myoglobin ng/mL ng/mL ± 2 SD or ± 15 ng/mL,
whichever is greater
NT pro-BNP pmol/L pg/mL ± 2 SD or ± 10 pg/mL,
whichever is greater
Troponin I ng/mL ng/mL ± 3 SD or ± 0.3 ng/mL, whichever is greater
Troponin T (►qualitative)
ng/mL ng/mL ± 2 SD or ± 0.1 ng/mL, whichever is greater
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th
Cardiac Markers – 2 Samples
Program Description 1.5 mL – Liquid – CAP accredited labs must test 5 samples for all Cardiac Markers, except D-dimer, Myoglobin, and waived BNP.
Program Information
920 – Cardiac Markers – 2 Samples J20 – Cardiac Markers – 2 Samples – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
►BNP pmol/L pg/mL ± 3 SD or ± 10 pg/mL,
whichever is greater
D-dimer ugFEU/mL ugFEU/mL
± 3 SD µg/L µg/L
Myoglobin ng/mL ng/mL ± 2 SD or ± 15 ng/mL,
whichever is greater
►NT pro-BNP pmol/L pg/mL ± 2 SD or ± 10 pg/mL,
whichever is greater
►Troponin I ng/mL ng/mL ± 3 SD or ± 0.3 ng/mL, whichever is greater
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 31 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Cardiac Markers continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
►Troponin T ng/mL ng/mL ± 2 SD or ± 0.1 ng/mL, whichever is greater
Format Shipping Dates
2 samples x 3 shipments January 14th, May 20th, August 26th
Cystatin C
Program Description 1.0 mL – Serum
Program Information
170 – Cystatin C
Analytes Standard Units Conventional Units AV from Consensus
Mean
Cystatin C mg/L mg/L ± 3 SD
Format Shipping Dates
2 samples x 2 shipments April 22nd and October 14th
Fetal Fibronectin
Program Description 1.0 mL – Liquid
Program Information
142 – Fetal Fibronectin
Analytes
Fetal Fibronectin
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 32 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Fetal ROMProgram Description
0.5 mL – Simulated Amniotic Fluid – Compatible with Actim Prom, AmniSure ROM, and Clinical Innovations ROM Plus.
Program Information
131 – Fetal ROM
Analytes
Fetal Membranes Rupture Test
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
FructosamineProgram Description
1.0 mL – Serum
Program Information
135 - Fructosamine
Analytes Standard Units Conventional Units AV from Consensus
Mean
Fructosamine µmol/L µmol/L ± 2 SD
mmol/L ± 2 SD or ± 0.2 mmol/L,
whichever is greater
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 33 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Glycohemoglobin
Program Description 0.7 mL – Hemolysate – CAP accredited labs using a non-waived method must test 5 samples for Glycohemoglobin. For Afinion analyzers, see Catalog #134 – Glycohemoglobin – Whole Blood.
Program Information
126 – Glycohemoglobin – 5 Samples 179 – Additional Sample Volume – 5 Samples 127 – Glycohemoglobin – 2 Samples 167 – Additional Sample Volume – 2 Samples A27 – Glycohemoglobin – 2 Samples – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Glycohemoglobin (as HbA1c)
% % ± 3 SD or ± 20%, whichever is greater
Format Shipping Dates
3 shipments January 14th, May 20th, August 26th
Glycohemoglobin – Whole Blood
Program Description 0.5 mL – Liquid – For laboratories using Afinion analyzers for HbA1c testing.
Program Information
134 – Glycohemoglobin – Whole Blood
Analytes Standard Units Conventional Units AV from Consensus
Mean
Glycohemoglobin (as HbA1c)
% % ± 3 SD or ± 20%, whichever is greater
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 34 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
HemoCue
Program Description 2.5 mL – Whole Blood
Program Information
128 – HemoCue – 5 Samples 928 – HemoCue – 2 Samples J28 – HemoCue – 2 Samples – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Glucose mmol/L mg/dL ± 10 mg/dL or ± 20% whichever is greater
Hemoglobin g/L g/dL ± 7%
Format Shipping Dates
3 Shipments January 14th, May 20th, August 26th
Immunoassay
Program Description 5.0 mL – Serum
Program Information
180 – Immunoassay – 5 133 – Immunoassay – 3 A33 – Immunoassay – 3 – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
CEA ng/mL ng/mL ± 3 SD DHEA-S µmol/L µg/dL ± 2 SD Estradiol pmol/L pg/mL ± 2 SD
►Estriol nmol/L ng/mL ± 2 SD or ± 0.5 ng/mL,
whichever is greater FSH IU/L mIU/mL ± 3 SD Ferritin ng/mL ng/mL ± 3 SD Folate nmol/L ng/mL ± 3 SD
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 35 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Immunoassay continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
Homocysteine µmol/L µmol/L ± 3 SD LH U/L mIU/mL ± 3 SD
PAP ng/mL ng/mL ± 2 SD or ± 30%,
whichever is greater
PSA, total ng/mL ng/mL ± 3 SD or ± 0.4 ng/mL,
whichever is greater Prolactin ng/mL ng/mL ± 3 SD
Prealbumin g/L mg/dL ± 5 mg/dL or ± 25%, whichever is greater
Progesterone nmol/L ng/mL ± 3 SD Testosterone nmol/L ng/mL ± 3 SD TIBC (transferrin based
calc)♦ µmol/L µg/dL ± 20%
Transferrin g/L mg/dL ± 20% Vitamin B12 pmol/L pg/mL ± 3 SD
Format Shipping Dates
2 shipments April 22nd and October 14th ♦ See Catalog #122 - Comprehensive Chemistry for TIBC (iron based calculation) on pages 20-22.
Immunoassay – Special Program Description 2.0 mL – Lyophilized
Program Information
160 – Immunoassay – Special A60 – Immunoassay – Special – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean C-peptide nmol/L ng/mL ± 2 SD Insulin uU/mL uIU/mL ± 3 SD
►Gastrin ng/L
pg/mL ± 2 SD pmol/L
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 36 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Immunoassay – Special continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
PTH pmol/L pg/mL ± 2 SD 25-OH Vitamin D nmol/L ng/mL ± 2 SD
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
i-Stat Chemistry
Program Description 3.0 mL ampule – For ACT testing, see Catalog #215 – i-Stat ACT on page 76. For BNP, CK-MB, and Troponin I testing, see Catalog #140/920 - Cardiac Markers on page 29-31. For quantitative HCG testing, see Catalog #409 – Serum HCG on page 40.
Program Information
145 – i-Stat Chemistry A45 – i-Stat Chemistry – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
pH - - ± 0.04
pCO2 mmHg mmHg ± 5 mmHg or ± 8%, whichever is greater
pO2 mmHg mmHg ± 3 SD
Calcium, ionized mmol/L mmol/L ± 3 SD or ± 0.05 mmol/L, whichever is greater
Chloride mmol/L mmol/L ± 5%
Creatinine µmol/L mg/dL ± .3 mg/dL or ± 15%, whichever is greater
Glucose mmol/L mg/dL ± 6 mg/dL or ± 10%, whichever is greater
Hematocrit Fraction % ± 6% Hemoglobin g/L g/dL ± 7%
Lactate mmol/L mmol/L ± 3 SD or ± 0.4 mmol/L, whichever is greater
Potassium mmol/L mmol/L ± 0.5 mmol/L Sodium mmol/L mmol/L ± 4 mmol/L tCO2 mmol/L mmol/L ± 3 SD
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 37 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
i-Stat Chemistry continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
Urea Nitrogen (BUN) - mg/dL ± 2 mg/dL or ± 9%, whichever is greater
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th
i-Stat Chemistry – Waived
Program Description 3.0 mL ampule – For non-scored analytes or waived testing on i-Stat analyzers.
Program Information
945 - i-STAT Chemistry – Waived J45 - i-STAT Chemistry – Waived – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Calcium, ionized mmol/L mmol/L ± 3 SD or ± 0.05 mmol/L, whichever is greater
Chloride mmol/L mmol/L ± 5%
Creatinine µmol/L mg/dL ± .3 mg/dL or ± 15%, whichever is greater
Glucose mmol/L mg/dL ± 6 mg/dL or ± 10%, whichever is greater
Hematocrit Fraction % ± 6% Hemoglobin g/L g/dL ± 7%
Lactate mmol/L mmol/L ± 3 SD or ± 0.4 mmol/L, whichever is greater
Potassium mmol/L mmol/L ± 0.5 mmol/L Sodium mmol/L mmol/L ± 4 mmol/L tCO2 mmol/L mmol/L ± 3 SD
Urea Nitrogen (BUN) - mg/dL ± 2 mg/dL or ± 9%, whichever is greater
Format Shipping Dates
2 samples x 3 shipments January 14th, May 20th, August 26th
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 38 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Lamellar Body CountProgram Description
3.0 mL – Liquid – For lamellar body counts performed on Hematology analyzers.
Program Information
208 – Lamellar Body Count
Analytes Standard Units Conventional Units AV from Consensus
Mean
Lamellar Body Count x103/uL x103/uL ± 25%
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
Lipid PlusProgram Description
1.0 mL – Serum – For laboratories using the Cholestech analyzer for lipid testing.
Program Information
176 – Lipid Plus – 5 Samples 976 – Lipid Plus – 2 Samples
Analytes Standard Units Conventional Units AV from Consensus
Mean
Cholesterol mmol/L mg/dL ± 10%
Glucose mmol/L mg/dL ± 6 mg/dL or ± 10%, whichever is greater
HDL Cholesterol mmol/L mg/dL ± 30% LDL Cholesterol, calculated
mmol/L mg/dL ± 2 SD
Triglycerides mmol/L mg/dL ± 25%
Format Shipping Dates
3 shipments January 14th, May 20th, August 26th
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 39 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Neonatal Bilirubin
Program Description 1.0 mL – Serum – Bilirubin levels targeted to be representative of those seen in newborns.
Program Information
147 – Neonatal Bilirubin – 5 Samples 129 – Neonatal Bilirubin – 2 Samples A29 – Neonatal Bilirubin – 2 Samples – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Bilirubin, direct µmol/L mg/dL ± 2 SD or ± 0.4 mg/dL, whichever is greater
Bilirubin, total µmol/L mg/dL ± 0.4 mg/dL or ± 20%, whichever is greater
Format Shipping Dates
3 shipments January 14th, May 20th, August 26th
Procalcitonin
Program Description 1.0 mL – Lyophilized Serum
Program Information
169 – Procalcitonin
Analytes Standard Units Conventional Units AV from Consensus
Mean
Procalcitonin ug/L ng/mL ± 3 SD
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 40 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Serum HCG
Program Description 1.0 mL – Serum – For quantitative and qualitative serum HCG methods. Laboratories testing quantitative and qualitative Serum HCG should order Catalog #409 and #D09 in order to report results for both.
Program Information
409 – Serum HCG D09 – Serum HCG – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
HCG IU/L mIU/mL ± 3 SD or ± 10 mIU/mL,
whichever is greater
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th
SHBG and Testosterone
Program Description 2.0 mL – Lyophilized Serum
Program Information
171 – SHBG and Testosterone
Analytes Standard Units Conventional Units AV from Consensus
Mean Sex Hormone Binding Globulin
nmol/L nmol/L ± 3 SD
Testosterone, Bioavailable
nmol/L ng/dL ± 3 SD
Testosterone, Total♦ nmol/L ng/mL ± 3 SD
Testosterone, Free (►measured)
pmol/L pg/mL ± 3 SD
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th ♦ If testing Total Testosterone only, see Catalog #133/180 – Immunoassay on pages 34-35.
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 41 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Therapeutic Drugs
Program Description 5.0 mL – Serum
Program Information
132 – Therapeutic Drugs 136 – Therapeutic Drugs – Add-on option to Catalog #121 or #122 A36 – Therapeutic Drugs – Verification Program – Add-on option to Catalog #A22
Analytes Standard Units Conventional Units AV from Consensus
Mean
Acetaminophen µmol/L µg/mL ± 3 SD or ± 2.5 µg/mL,
whichever is greater Amikacin µmol/L µg/mL ± 2 SD Carbamazepine µmol/L µg/mL ± 25%
Digoxin nmol/L ng/mL ± 0.2 ng/mL or ± 20%,
whichever is greater ►Ethosuximide µmol/L µg/mL ± 20% Gentamicin µmol/L µg/mL ± 25%
►Lidocaine µmol/L µg/mL ± 3 SD or ± 10%, whichever is greater
Lithium mmol/L mmol/L ± 0.3 mmol/L or ± 20%, whichever is greater
N-acetylprocainamide µmol/L µg/mL ± 25% Phenobarbital µmol/L µg/mL ± 20% Phenytoin µmol/L µg/mL ± 25% ►Primidone µmol/L µg/mL ± 25% Procainamide µmol/L µg/mL ± 25% Quinidine µmol/L µg/mL ± 25%
Salicylates mmol/L mg/dL ± 3 SD or ± 2.8 mg/dL, whichever is greater
Theophylline µmol/L µg/mL ± 25% Tobramycin µmol/L µg/mL ± 25% Valproic Acid µmol/L µg/mL ± 25%
Vancomycin µmol/L µg/mL ± 2 µg/mL or ± 20%, whichever is greater
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 42 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Thyroid Special Program Description 5.0 mL – Serum – Designed for the Ortho Clinical Diagnostics Vitros analyzers.
Program Information
175 – Thyroid Special
Analytes Standard Units Conventional Units AV from Consensus
Mean
Free T3 pmol/L pg/mL ± 2 SD
Thyroxine (T4) nmol/L µg/dL ± 1 µg/dL or ± 20%, whichever is greater
Triiodothyronine nmol/L ng/mL ± 3 SD Free T4 pmol/L ng/dL ± 3 SD TSH mIU/L uU/mL ± 3 SD
T Uptake N/A %
± 3 SD Uptakeunit
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th
Tumor Markers
Program Description 2.0 mL – Serum
Program Information
150 – Tumor Markers
Analytes Standard Units Conventional Units AV from Consensus
Mean
Beta-2 Microglobulin mg/L mg/L ± 2 SD CA 27.29 U/mL IU/L ± 2 SD CA 125 U/mL IU/mL ± 2 SD CA 15-3 U/mL IU/mL ± 2 SD CA 19-9 U/mL IU/mL ± 2 SD CEA ng/mL ng/mL ± 3 SD
PROGRAM ANALYSIS – CHEMISTRY
► Analyte is not CAP accepted. 43 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Tumor Markers continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
PSA, total♦ ng/mL ng/mL ± 3 SD or ± 0.4 ng/mL, whichever is greater
PSA, free ng/mL ng/mL ± 3 SD or ± 0.4 ng/mL,
whichever is greater ►PSA, complexed ng/mL ng/mL ± 2 SD Thyroglobulin ng/mL ng/mL ± 2 SD
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th ♦ If testing Total PSA only, see Catalog #133/180 – Immunoassay on pages 34-35.
Whole Blood Glucose
Program Description 2mL – Whole Blood – For waived blood glucose meters. Per CMS, only one set of proficiency results may be reported during the regular testing period. Facilities using more than one meter should also enroll in Catalog #X23, #A23, #X18, or #J18.
Program Information
123 – Whole Blood Glucose – 5 Samples X23 – Extra Results for WBG – Verification Program – Report up to 20 additional meters using samples from #123. A23 – Whole Blood Glucose – 5 Samples – Verification Program 918 – Whole Blood Glucose – 3 Samples X18 – Extra Results for WBG – Verification Program – Report up to 20 additional meters using samples from #918. J18 – Whole Blood Glucose – 3 Samples – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Glucose mmol/L mg/dL ± 10 mg/dL or ± 20%, whichever is greater
Format Shipping Dates
2 shipments April 22nd and October 14th
PROGRAM ANALYSIS – URINE CHEMISTRY & BODY FLUID ANALYSIS
► Analyte is not CAP accepted. 44 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
CSF & Body Fluid Chemistry
Program Description For manual cell count and body fluid crystals, see Catalog #277 – Cell Count and Body Fluid Crystals on page 61.
Program Information
177 – CSF & Body Fluid Chemistry
Analytes Standard Units Conventional Units AV from Consensus
Mean
CSF Chemistry – 2.0 mL – Simulated CSF ►Albumin g/L mg/dL ± 2 SD Chloride mmol/L mmol/L ± 2 SD
Glucose mmol/L mg/dL ± 6 mg/dL or ± 10%, whichever is greater
►IgG g/L mg/dL ± 2 SD
Lactic Acid mmol/L mmol/L 3 SD or ± 0.4 mmol/L, whichever is greater
LDH U/L U/L ± 2 SD Sodium mmol/L mmol/L ± 2 SD
Total Protein g/L mg/dL ± 3 SD or ± 20%,
whichever is greater Body Fluid Chemistry – 3.0 mL – Simulated Body Fluid
Albumin g/L g/dL ± 3 SD or ± 10%,
whichever is greater Alkaline Phosphatase U/L U/L ± 30% Amylase U/L U/L ± 30%
Bilirubin, total µmol/L mg/dL ± 0.4 mg/dL or ± 20%, whichever is greater
Calcium mmol/L mg/dL ± 1 mg/dL
Chloride mmol/L mmol/L ± 2 SD or ± 5%, whichever is greater
Cholesterol mmol/L mg/dL ± 3 SD
Creatinine µmol/L mg/dL ± 0.3 mg/dL or ± 15%, whichever is greater
Glucose mmol/L mg/dL ± 6 mg/dL or ± 10%, whichever is greater
LDH U/L U/L ± 20%
Lipase U/L U/L ± 2 SD or ± 30 U/L, whichever is greater
PROGRAM ANALYSIS – URINE CHEMISTRY & BODY FLUID ANALYSIS
► Analyte is not CAP accepted. 45 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
CSF & Body Fluid Analysis continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean pH - - ± 2 SD Potassium mmol/L mmol/L ± 0.5% Sodium mmol/L mmol/L ± 4%
Total Protein g/L g/dL ± 3 SD or ± 10%, whichever is greater
Triglycerides mmol/L mg/dL ± 3 SD or ± 10 mg/dL, whichever is greater
Urea Nitrogen mmol/L mg/dL ± 2 mg/dL or ± 9%, whichever is greater
Uric Acid mmol/L mg/dL ± 0.17%
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
Ethyl Glucuronide
Program Description 5.0 mL – Urine – For qualitative testing.
Program Information
148 – Ethyl Glucuronide
Analytes
Ethyl glucuronide (EtG)
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
Microalbumin
Program Description 3.0 mL – Urine – For semi-quantitative dipstick testing or quantitative analysis. Recommended for Afinion users. For facilities performing other urine chemistry testing, see Catalog #143 – Urine Chemistry on pages 47-48.
Program Information
236 – Microalbumin
PROGRAM ANALYSIS – URINE CHEMISTRY & BODY FLUID ANALYSIS
► Analyte is not CAP accepted. 46 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Microalbumin continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
Microalbumin mg/L mg/L ± 3 SD or ± 30%,
whichever is greater Urine Creatinine mmol/L mg/dL ± 20%
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
Sweat Analysis
Program Description 5.0 mL – Liquid
Program Information
163 – Sweat Analysis
Analytes Standard Units Conventional Units AV from Consensus
Mean
Chloride (qualitative) - - - ►Chloride (quantitative) mmol/L mmol/L ± 2 SD Conductivity mmol/L mmol/L ± 3 SD Osmolality mOSm/kg mOSm/kg ± 2 SD Sodium mmol/L mmol/L ± 2 SD
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
Urine Adulteration
Program Description 10.0 mL – Urine – For urine drug screen (toxicology) testing, see Catalog #139 – Urine Drug Screen on page 48-49.
Program Information
146 – Urine Adulteration
PROGRAM ANALYSIS – URINE CHEMISTRY & BODY FLUID ANALYSIS
► Analyte is not CAP accepted. 47 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Urine Adulteration continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
Creatinine mg/dL mg/dL ± 2 SD or ± 20%,
whichever is greater
Oxidants µg/mL µg/mL ± 2 SD or ± 30 µg/mL,
whichever is greater pH - - ± 2 SD
Nitrite µg/mL µg/mL ± 2 SD or ± 30 µg/mL,
whichever is greater Specific Gravity - - ± 2 SD
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
Urine Chemistry
Program Description 10.0 mL – Urine – If testing urine creatinine and/or microalbumin only or for facilities using the Afinion, see Catalog #236 – Microalbumin on pages 45-46.
Program Information
143 – Urine Chemistry
Analytes Standard Units Conventional Units AV from Consensus
Mean
Amylase U/l U/L ± 3 SD Calcium mmol/L mg/dL ± 3 SD Chloride mmol/L mmol/L ± 3 SD Creatinine mmol/L mg/dL ± 20% Glucose mmol/L mg/dL ± 3 SD Magnesium mmol/L mg/dL ± 25%
Microalbumin mg/L mg/L ± 3 SD or ± 30%,
whichever is greater Osmolality mOsm/kg mOSm/kg ± 3 SD Phosphorus mmol/L mg/dL ± 3 SD Potassium mmol/L mmol/L ± 3 SD Sodium mmol/L mmol/L ± 3 SD Total Protein g/L mg/dL ± 3 SD
PROGRAM ANALYSIS – URINE CHEMISTRY & BODY FLUID ANALYSIS
► Analyte is not CAP accepted. 48 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Urine Chemistry continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean Urea mmol/L mg/dL ± 3 SD Uric Acid mmol/L mg/dL ± 3 SD
Format Shipping Dates
3 samples x 2 shipments April 22nd and October 14th
Urine Drug Screen
Program Description 10.0 mL – Urine – Qualitative or quantitative testing for urine drug screen.
Program Information
139 – Urine Drug Screen ( qualitative only) A39 – Urine Drug Screen – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Acetaminophen µg/mL µg/mL ± 2 SD 6-Acetylmorphine ng/mL ng/mL ± 2 SD Alcohol mg/dL mg/dL ± 2 SD Amphetamines ng/mL ng/mL ± 2 SD Barbiturates ng/mL ng/mL ± 2 SD Benzodiazepines ng/mL ng/mL ± 2 SD Buprenorphine ng/mL ng/mL ± 2 SD Cannabinoids ng/mL ng/mL ± 2 SD Carisoprodol ng/mL ng/mL ± 2 SD Cocaine Metabolites ng/mL ng/mL ± 2 SD Cotinine ng/mL ng/mL ± 2 SD EDDP ng/mL ng/mL ± 2 SD Fentanyl ng/mL ng/mL ± 2 SD Hydrocodone ng/mL ng/mL ± 2 SD LSD ng/mL ng/mL ± 2 SD MDMA ng/mL ng/mL ± 2 SD Meperidine ng/mL ng/mL ± 2 SD Methadone ng/mL ng/mL ± 2 SD Methamphetamines ng/mL ng/mL ± 2 SD
PROGRAM ANALYSIS – URINE CHEMISTRY & BODY FLUID ANALYSIS
► Analyte is not CAP accepted. 49 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Urine Drug Screen continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
Methaqualone ng/mL ng/mL ± 2 SD Opiates ng/mL ng/mL ± 2 SD Oxycodone ng/mL ng/mL ± 2 SD Phencyclidine ng/mL ng/mL ± 2 SD Propoxyphene ng/mL ng/mL ± 2 SD Tramadol ng/mL ng/mL ± 2 SD Tricyclic Antidepressants ng/mL ng/mL ± 2 SD Zolpidem ng/mL ng/mL ± 2 SD
Format Shipping Dates
3 samples – 2 shipments April 22rd and October 14th
PROGRAM ANALYSIS – HEMATOLOGY
► Analyte is not CAP accepted. 50 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Hematology 3
Program Description 2.0 mL – Simulated Whole Blood – For automated techniques, including 2 and 3-part differentials or manual techniques for hematocrit, WBC (ammonium oxalate only), and platelet count.
Program Information
221 – Hematology 3 B21 – Hematology 3 – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Automated Differential x109/L % ± 3 SD or ± 1, whichever
is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD Platelet Count x109/L x109/L ± 25% RBC x1012 /L x1012/L ± 6% RDW % % ± 3 SD WBC 109 /L x109/L ± 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
Hematology – 3S
Program Description 2.0 mL – Simulated Whole Blood – For the CDS Medonic M Series, Sysmex KX Series, pocH-100i, and XP-300.
Program Information
227 – Hematology – 3S B27 – Hematology – 3S – Verification Program
PROGRAM ANALYSIS – HEMATOLOGY
► Analyte is not CAP accepted. 51 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Hematology – 3S continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
Automated Differential x109/L % ± 3 SD or ± 1, whichever
is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD Platelet Count x109/L x109/L ± 25% RBC x1012 /L x1012/L ± 6% RDW-CV % % ± 3 SD RDW-SD fL fL ± 3 SD WBC x109/L x109/L ± 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
QBC HematologyProgram Description
1.4 mL – Simulated Whole Blood – For use with QBC analyzers.
Program Information
222 – QBC Hematology
Analytes Standard Units Conventional Units AV from Consensus
Mean
Granulocytes x109/L % ± 3 SD or ± 1, whichever
is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7%
Lymph/Mono x109/L % ± 3 SD or ± 1, whichever
is greater Platelet Count x109/L x109/L ± 25% WBC x109/L x109/L ± 15%
PROGRAM ANALYSIS – HEMATOLOGY
► Analyte is not CAP accepted. 52 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
QBC Hematology continued…
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
Hematology – 5A
Program Description 2.5 mL – Simulated Whole Blood – For the Horiba Pentra 60, 60+, 80, 120 and the Coulter AcT 5-Diff.
Program Information
231 – Hematology – 5A B31 – Hematology – 5A – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Automated Differential x109/L % ± 3 SD or ± 1, whichever
is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD Platelet Count x109/L x109/L ± 25% RBC x1012 /L x1012/L ± 6% RDW % % ± 3 SD WBC 109 /L x109/L ± 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
PROGRAM ANALYSIS – HEMATOLOGY
► Analyte is not CAP accepted. 53 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Hematology – 5B
Program Description 4.0 mL – Simulated Whole Blood – For the Siemens Advia 120, 2120, and 2120i.
Program Information
240 – Hematology – 5B B40 – Hematology – 5B – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Automated Differential x109/L % ± 3 SD or ± 1, whichever
is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD Platelet Count x109/L x109/L ± 25% RBC x1012 /L x1012/L ± 6% RDW % % ± 3 SD WBC 109 /L x109/L ± 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
Hematology – 5C
Program Description 2.0 mL – Simulated Whole Blood – For the Coulter UniCel DxH600, DxH800, and LH750, LH755, LH780, LH785.
Program Information
230 – Hematology – 5C B30 – Hematology – 5C – Verification Program
PROGRAM ANALYSIS – HEMATOLOGY
► Analyte is not CAP accepted. 54 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Hematology – 5C continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
Automated Differential x109/L % ± 3 SD or ± 1, whichever
is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% IRF % % ± 3 SD MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD
nRBC x103/µL % ± 3 SD or ± 1, whichever
is greater Platelet Count x109/L x109/L ± 25% RBC x1012/L x1012/L ± 6% RDW-CV % % ± 3 SD RDW-SD fL fL ± 3 SD Reticulocyte Count % % ± 3 SD WBC x109/L x109/L ± 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
Hematology – 5C2
Program Description 2.0 mL – Simulated Whole Blood – For the Coulter LH500, HmX, MAXM, and STKS.
Program Information
220 – Hematology – 5C2 B20 – Hematology – 5C2 – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Automated Differential x109/L % ± 3 SD or ± 1, whichever
is greater Hematocrit L/L % ± 6%
PROGRAM ANALYSIS – HEMATOLOGY
► Analyte is not CAP accepted. 55 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Hematology – 5C2 continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean Hemoglobin g/L g/dL ± 7% MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD Platelet Count x109/L x109/L ± 25% RBC x1012/L x1012/L ± 6% RDW-CV % % ± 3 SD WBC x109/L x109/L ± 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
Hematology – 5D
Program Description 3.0 mL – Simulated Whole Blood – For the Abbot Cell-Dyn 3000-3700, 4000, Ruby, and Sapphire.
Program Information
242 – Hematology – 5D B42 – Hematology – 5D – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Automated Differential x109/L % ± 3 SD or ± 1, whichever
is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% IRF - - ± 3 SD MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD nRBC x109/L ± 3 SD Platelet Count x109/L x109/L ± 25% RBC x1012/L x1012/L ± 6%
PROGRAM ANALYSIS – HEMATOLOGY
► Analyte is not CAP accepted. 56 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Hematology – 5D continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
RDW % % ± 3 SD Reticulocyte Count % % ± 3 SD WBC x109/L x109/L ± 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
Hematology – 5H
Program Description 2.5 mL – Simulated Whole Blood – For the Beckman Coulter DXH500.
Program Information
279 – Hematology – 5H
Analytes Standard Units Conventional Units AV from Consensus
Mean
Automated Differential x109/L % ± 3 SD or ± 1, whichever
is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD Platelet Count x109/L x109/L ± 25% RBC x1012 /L x1012/L ± 6% RDW TBD TBD TBD WBC x109/L x109/L ± 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
PROGRAM ANALYSIS – HEMATOLOGY
► Analyte is not CAP accepted. 57 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Hematology – 5M
Program Description 3.0 mL – Simulated Whole Blood – For the Mindray 5000 series analyzers.
Program Information
226 – Hematology – 5M
Analytes Standard Units Conventional Units AV from Consensus
Mean
Automated Differential x109/L % ± 3 SD or ± 1, whichever
is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD Platelet Count x109/L x109/L ± 25% RBC x1012 /L x1012/L ± 6% RDW-CV % % ± 3 SD RDW-SD fL fL ± 3 SD WBC x109/L x109/L ± 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
Hematology – 5S
Program Description 2.0 mL – Simulated Whole Blood – For all Sysmex XE, XN, XS, and XT analyzers.
Program Information
238 – Hematology – 5S B38 – Hematology – 5S – Verification Program
PROGRAM ANALYSIS – HEMATOLOGY
► Analyte is not CAP accepted. 58 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Hematology – 5S continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
Automated Differential x109/L % ± 3 SD or ± 1, whichever
is greater Hematocrit L/L % ± 6% Hemoglobin g/L g/dL ± 7% IG Absolute (#) x109/L x109/L ± 3 SD IG Percent (%) % % ± 3 SD IPF % % ± 3 SD IRF % % ± 3 SD MCH pg pg ± 3 SD MCHC g/L g/dL ± 3 SD MCV fL fL ± 3 SD MPV fL fL ± 3 SD
nRBC x103/µL x109/L ± 3 SD or ± 0.01 x
10E9/L, whichever is greater
Platelet Count x109/L x109/L ± 25% RBC x1012/L x1012/L ± 6% RDW-CV % % ± 3 SD RDW-SD fL fL ± 3 SD RET-He pg pg ± 3 SD Reticulocyte Count % % ± 3 SD WBC x109/L x109/L ± 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
Blood Cell Identification
For laboratories that perform both Blood Cell Identification and Automated Differentials:
CMS allows for the transmission of only one of these scores each test event. Results from both tests are graded and will appear on your evaluation but only one score is sent to CMS.
If you would like your score for Blood Cell ID to be sent to CMS, enroll in Catalog #224 – Blood Cell ID – CMS Scored.
If you would like your score for your automated differential to be sent to CMS, enroll in Catalog #225 – Blood Cell ID – Not CMS Scored.
Detailed program information is located on the following page…
PROGRAM ANALYSIS – HEMATOLOGY
► Analyte is not CAP accepted. 59 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Blood Cell Identification
Program Description Virtual Images – Two virtual Wright stained peripheral blood smears for blood cell identification. One case study will include five annotated cells/objects for identification and will be graded. The second case study is educational and will include five annotated cell/objects for identification and a manual 100 WBC differential. This is a virtual program only and will not include printed photographs. If facilities would like to receive printed photographs, add Catalog #286 – Add-on Blood Cell ID Photographs.
Program Information
224 – Blood Cell ID – CMS Scored 225 – Blood Cell ID – Not CMS Scored 286 – Add-on Blood Cell ID Photographs
Analytes
Blood Cell Identification
Format Shipping Dates
10 images x 3 shipments March 11th, July 8th, November 11th
Advanced Blood Cell ID Program Description Virtual Images – A virtual Wright stained peripheral blood smears for blood cell identification. The case study will include seven cells/objects chosen for ID and an educational commentary. This option is designed to offer cases studies that are more challenging and complex.
Program Information
259 – Advanced Blood Cell ID
Analytes
Blood Cell Identification
Format Shipping Dates
7 images x 3 shipments March 11th, July 8th, November 11th
PROGRAM ANALYSIS – MISCELLANEOUS HEMATOLOGY
► Analyte is not CAP accepted. 60 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Body Fluid Cell Count – C Program Description 3.0 mL – Liquid – For Abbott, Coulter, Sysmex, and Advia analyzers. For manual cell counts, see Catalog #277 – Cell Count and Body Fluid Crystals on page 61.
Program Information
206 – Body Fluid Cell Count – C
Analytes Standard Units Conventional Units AV from Consensus
Mean
RBC x1012/L x1012/L
± 3 SD cells/uL cells/uL
WBC x109/L x109/L
± 3 SD cells/uL cells/uL
Format Shipping Dates
1 sample x 3 shipments March 11th, July 8th, November 11th
Body Fluid Cell Count – I Program Description 4.0 mL – Liquid – For Iris IQ®. For manual cell counts, see Catalog #277 – Cell Count and Body Fluid Crystals on page 61.
Program Information
207 – Body Fluid Cell Count – I
Analytes Standard Units Conventional Units AV from Consensus
Mean
RBC cells/uL cells/uL ± 3 SD Nucleated Cells cells/uL cells/uL ± 3 SD
Format Shipping Dates
1 sample x 3 shipments March 11th, July 8th, November 11th
PROGRAM ANALYSIS – MISCELLANEOUS HEMATOLOGY
► Analyte is not CAP accepted. 61 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Body Fluid Microscopy Program Description Virtual Images – Three online images for the identification of crystals and other formed elements/cells in various body fluids. This program includes 2 shipments per year. This is a virtual program only and will not include printed photographs. If facilities would like to receive printed photographs, add Catalog #181 – Add-on Body Fluid Microscopy Photographs.
Program Information
168 – Body Fluid Microscopy 181 – Add-on Body Fluid Microscopy Photographs
Analytes
Identification of formed elements
Format Shipping Dates
3 images x 2 shipments March 11th and November 11th
Cell Count and Body Fluid Crystals
Program Description Number of challenges per event, sample volume and sample type are shown in the table below. For CSF and Body Fluid Chemistry, see Catalog #177 – CSF & Body Fluid Chemistry on pages 44-45.
Program Information
277 – Cell Count and Body Fluid Crystals
Analytes Standard Units Conventional Units AV from Consensus
Mean
Cell Count (2) – 2mL – Liquid RBC cells/uL cells/uL ± 3 SD WBC cells/uL cells/uL ± 3 SD WBC Differential % % ± 3 SD
Body Fluid Crystals (2) – 1.5 mL – Body Fluid Crystals - - -
Format Shipping Dates
4 samples x 2 shipments March 11th and November 11th
PROGRAM ANALYSIS – MISCELLANEOUS HEMATOLOGY
► Analyte is not CAP accepted. 62 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Fetal Hemoglobin
Program Description 1.2 mL – Simulated Gastric Fluid – For qualitative fetal hemoglobin. For Whole Blood Fetal Screen, see Catalog #515 – Fetal RBC on pages 131-132.
Program Information
210 – Fetal Hemoglobin
Analytes
Fetal Hemoglobin (gastric fluid)
Format Shipping Dates
2 samples x 2 shipments March 11th and November 11th
Flow Cytometry Program Description 2.5 mL – Simulated Whole Blood – Lymphocyte phenotyping.
Program Information
229 – Flow Cytometry
Analytes Standard Units Conventional Units AV from Consensus
Mean
►CD3 (T Cells) % Positive % Positive
± 2 SD cells/uL cells/uL
►CD4 (T Helper) % Positive % Positive
± 2 SD cells/uL cells/uL
►CD8 (T Cytotoxic) % Positive % Positive
± 2 SD cells/uL cells/uL
►CD19 (B Cells) % Positive % Positive
± 2 SD cells/uL cells/uL
►CD45 (Leukocytes) % Positive % Positive
± 2 SD cells/uL cells/uL
►CD56/CD16+56 (NK Cells)
% Positive % Positive ± 2 SD
cells/uL cells/uL
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
PROGRAM ANALYSIS – MISCELLANEOUS HEMATOLOGY
► Analyte is not CAP accepted. 63 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
HemoCue White Blood Cell Count Program Description 2.0 mL – Simulated Whole Blood – For HemoCue WBC System.
Program Information
209 – HemoCue White Blood Cell Count
Analytes Standard Units Conventional Units AV from Consensus
Mean
WBC x109/L x109/L ± 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
Reticulocyte Count
Program Description 1.0 mL – Simulated Whole Blood – Manual (new methylene blue stain only) and automated reticulocyte techniques. An automated reticulocyte count can be reported in Catalog #230, #238, and #242.
Program Information
223 – Reticulocyte Count
Analytes Standard Units Conventional Units AV from Consensus
Mean Reticulocyte Count x106/uL or X103/uL % ± 3 SD
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
Sedimentation Rate – A
Program Description 5.0 mL – Simulated Whole Blood – For manual methods and most automated methods.
Program Information
228 – Sedimentation Rate – A
PROGRAM ANALYSIS – MISCELLANEOUS HEMATOLOGY
► Analyte is not CAP accepted. 64 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Sedimentation Rate - A continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
Sedimentation Rate mm/hr mm/hr ± 2 SD or ± 3 mm/hr, whichever is greater
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
Sedimentation Rate – B
Program Description 6.0 mL – Simulated Whole Blood – For Polymedco Sedimat 15 and 15 Plus.
Program Information
201 – Sedimentation Rate – B
Analytes Standard Units Conventional Units AV from Consensus
Mean
Sedimentation Rate mm/hr mm/hr ± 2 SD or ± 3 mm/hr, whichever is greater
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
Sedimentation Rate – C
Program Description 6.0 mL – Simulated Whole Blood – For HemaTechnologies ESR Stat Plus and ESR Stat 180.
Program Information
202 – Sedimentation Rate – C
Analytes Standard Units Conventional Units AV from Consensus
Mean
Sedimentation Rate mm/hr mm/hr ± 2 SD or ± 3 mm/hr, whichever is greater
PROGRAM ANALYSIS – MISCELLANEOUS HEMATOLOGY
► Analyte is not CAP accepted. 65 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Sedimentation Rate - C continued…
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
Sedimentation Rate – D
Program Description 4.5 mL – Simulated Whole Blood – For Alcor i-SED.
Program Information
203 – Sedimentation Rate – D
Analytes Standard Units Conventional Units AV from Consensus
Mean
Sedimentation Rate mm/hr mm/hr ± 2 SD or ± 3 mm/hr, whichever is greater
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
Sedimentation Rate – E
Program Description 3.0 mL – Simulated Whole Blood – For Alifax ESR analyzers.
Program Information
280 – Sedimentation Rate – E
Analytes Standard Units Conventional Units AV from Consensus
Mean
Sedimentation Rate mm/hr mm/hr ± 2 SD or ± 3 mm/hr, whichever is greater
Format Shipping Dates
3 samples x 2 shipments March 11th and November 11th
PROGRAM ANALYSIS – MISCELLANEOUS HEMATOLOGY
► Analyte is not CAP accepted. 66 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Sickle Cell Screen
Program Description 2.5 mL – Simulated Whole Blood – For screening kits and electrophoresis screening methods.
Program Information
237 – Sickle Cell Screen
Analytes Sickle Cell Screen
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
PROGRAM ANALYSIS – ANDROLOGY
► Analyte is not CAP accepted. 67 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Antisperm Antibody
Program Description 500 uL – Serum – For screening kits and electrophoresis screening methods.
Program Information
154 – Antisperm Antibody
Analytes ►Antisperm Antibody
Format Shipping Dates
2 samples x 2 shipments March 11th and November 11th
Post-Vasectomy Sperm Analysis
Program Description 0.3 mL – Stabilized Sperm Sample
Program Information
162 – Post-Vasectomy Sperm Analysis
Analytes Standard Units Conventional Units AV from Consensus
Mean
►Sperm Count million/mL million/mL ± 3 SD Sperm, presence/absence
- - -
Format Shipping Dates
2 samples x 2 shipments March 11th and November 11th
Sperm Count
Program Description 0.3 mL – Stabilized Sperm Sample
Program Information
151 – Sperm Count
PROGRAM ANALYSIS – ANDROLOGY
► Analyte is not CAP accepted. 68 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Sperm Count continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean Sperm Count million/mL million/mL ± 3 SD
Format Shipping Dates
2 samples x 2 shipments March 11th and November 11th
Sperm Morphology
Program Description 1 Unstained Semen Smear and 1 Virtual Image – For specific sperm morphology.
Program Information
152 – Sperm Morphology
Analytes Standard Units Conventional Units AV from Consensus
Mean
Sperm Morphology % normal % normal ± 20% normal
Format Shipping Dates
2 samples x 2 shipments March 11th and November 11th
Sperm Motility
Program Description Web-Based Video – For sperm motility and progressive motility.
Program Information
161 – Sperm Motility
Analytes Standard Units Conventional Units AV from Consensus
Mean Sperm Motility % % ± 2 SD Sperm Progressive Motility
% % ± 2 SD
Format Shipping Dates
2 samples x 2 shipments March 11th and November 11th
PROGRAM ANALYSIS – ANDROLOGY
► Analyte is not CAP accepted. 69 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Sperm Viability
Program Description Glass Slides – Two Eosin-Nigrosin stained smears.
Program Information
153 – Sperm Viability
Analytes Standard Units Conventional Units AV from Consensus
Mean
Sperm Viability % viable % viable ± 2 SD or ± 2% viable,
whichever is greater
Format Shipping Dates
2 samples x 2 shipments March 11th and November 11th
PROGRAM ANALYSIS – COAGULATION
► Analyte is not CAP accepted. 70 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Activated Clotting Time – Hemochron/Helena
Program Description 3.0 mL – Lyophilized – For the Hemochron Response, 801, Helena Laboratories Actalyke, and Cascade POC.
Program Information
211 – Activated Clotting Time – 5 Samples 916 – Activated Clotting Time – 2 Samples J16 – Activated Clotting Time – 2 Samples – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Activated Clotting Time seconds seconds ± 3 SD
Format Shipping Dates
3 shipments March 11th, July 8th, November 11th
Activated Clotting Time – Medtronic
Program Description 3.0 mL – Lyophilized – For the Medtronic ACT and HMS Plus.
Program Information
212 – Activated Clotting Time – 5 Samples 917 – Activated Clotting Time – 2 Samples J17 – Activated Clotting Time – 2 Samples – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean Activated Clotting Time seconds seconds ± 3 SD
Format Shipping Dates
3 shipments March 11th, July 8th, November 11th
PROGRAM ANALYSIS – COAGULATION
► Analyte is not CAP accepted. 71 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Coagulation
Program Description 1.0 mL – Lyophilized Plasma – For plasma-based coagulation analyzers.
Program Information
217 – Coagulation B17 – Coagulation – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
APTT seconds seconds ± 15% Fibrinogen g/L mg/dL ± 20% INR - - ± 3 SD Prothrombin Time seconds seconds ± 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
Coagulation, Supplemental Program Description 1.0 mL – Lyophilized Plasma – 2 samples, each in duplicate.
Program Information
281 – Coagulation, Supplemental 282 – Additional Sample Volume – Coagulation, Supplemental
Analytes Standard Units Conventional Units AV from Consensus
Mean
Antithrombin III Activity % Activity % Activity TBD Factor II Activity % Normal % Normal TBD Factor V Activity % Normal % Normal TBD Factor VII Activity % Normal % Normal TBD ►Factor VIII Activity % % TBD Factor IX Activity TBD TBD TBD Factor X Activity % Normal % Normal TBD Factor XI Activity % Normal % Normal TBD Factor XII Activity % Normal % Normal TBD
PROGRAM ANALYSIS – COAGULATION
► Analyte is not CAP accepted. 72 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Coagulation, Supplemental continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean Plasminogen % Normal % Normal TBD Protein C % Normal % Normal TBD Protein S % Normal % Normal TBD Thrombin Time sec sec TBD
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
D-dimer – Qualitative
Program Description 0.5 mL – Plasma – For qualitative D-dimer methods.
Program Information
245 – D-Dimer – Qualitative
Analytes
D-dimer
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
D-dimer – Quantitative
Program Description 0.5 mL – Plasma – For quantitative D-dimer methods. Quantitative D-dimer can also be reported in Catalog #140/920 – Cardiac Markers - see pages 29-30.
Program Information
246 – D-Dimer – Quantitative B46 – D-dimer – Quantitative – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
D-dimer µg/L µg/L ± 3 SD or ± 10 µg/L,
whichever is greater ugFEU/mL ugFEU/mL ± 3 SD
PROGRAM ANALYSIS – COAGULATION
► Analyte is not CAP accepted. 73 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
D-dimer - Quantitative continued…
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
Hemochron Jr. ACT +
Program Description 0.7 mL – Lyophilized – For the Hemochron Jr., Signature, Signature +, Signature Elite, and IL Gem PCL. For use with the ACT-LR cuvette.
Program Information
248 – Hemochron Jr. ACT + B48 – Hemochron Jr. ACT + – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Activated Clotting Time seconds seconds ± 3 SD
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
Hemochron Jr. ACT – LR
Program Description 0.7 mL – Lyophilized – For the Hemochron Jr., Signature, Signature +, Signature Elite, and IL Gem PCL. For use with the ACT-LR cuvette.
Program Information
247 – Hemochron Jr. ACT – LR B47 – Hemochron Jr. ACT – LR – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Activated Clotting Time seconds seconds ± 3 SD
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
PROGRAM ANALYSIS – COAGULATION
► Analyte is not CAP accepted. 74 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Hemochron Jr. Citrate APTT
Program Description 0.7 mL – Lyophilized – For the Hemochron Jr. II, Signature, Signature +, and Signature Elite. For use with the Citrate cuvette.
Program Information
252 – Hemochron Jr. Citrate APTT
Analytes Standard Units Conventional Units AV from Consensus
Mean ►APTT seconds seconds ± 3 SD
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
Hemochron Jr. Citrate PT
Program Description 0.7 mL – Lyophilized – For the Hemochron Jr. II, Signature, Signature +, and Signature Elite. For use with the Citrate cuvette.
Program Information
249 – Hemochron Jr. Citrate PT
Analytes Standard Units Conventional Units AV from Consensus
Mean
INR - - ± 3 SD Prothrombin Time seconds seconds 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
PROGRAM ANALYSIS – COAGULATION
► Analyte is not CAP accepted. 75 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Hemochron Jr. PT
Program Description 0.7 mL – Lyophilized – For the Hemochron Jr. II, Signature, Signature +, Signature Elite, IL Gem PCL, and Gem PCL Plus. For use with whole blood.
Program Information
250 – Hemochron Jr. PT
Analytes Standard Units Conventional Units AV from Consensus
Mean
INR - - ± 3 SD Prothrombin Time seconds seconds 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
Heparin Assay
Program Description 1.0 mL – Lyophilized – For testing Low Molecular Weight Heparin (LMWH) and Unfractionated Heparin (UFH) levels. Not CMS scored or reported to CAP.
Program Information
278 – Heparin Assay
Analytes Standard Units Conventional Units AV from Consensus
Mean
Anti-Xa U/mL U/mL ± 3 SD APTT seconds seconds ± 15% INR - - ± 3 SD Prothrombin Time seconds seconds ± 15% Thrombin Time seconds seconds ± 3 SD
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
PROGRAM ANALYSIS – COAGULATION
► Analyte is not CAP accepted. 76 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
i-Stat ACT
Program Description 1.0 mL – Lyophilized – For the i-Stat analyzer.
Program Information
215 – i-STAT ACT B15 – i-STAT ACT – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean
Activated Clotting Time seconds seconds ± 3 SD
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
Platelet Function – Aspirin Test
Program Description Pellet – For aspirin-induced inhibition. Designed for use with the Accumetrics VerifyNow System.
Program Information
255 – Platelet Function – Aspirin Test
Analytes Standard Units Conventional Units AV from Consensus
Mean
Aspirin induced inhibition ARU ARU ± 3 SD or ± 50 ARU, whichever is greater
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
Platelet Function – PRU Test
Program Description Pellet – For P2Y12 inhibition (Plavix® and Effient®). Designed for use with the Accumetrics VerifyNow System.
Program Information
256 – Platelet Function – PRU Test
PROGRAM ANALYSIS – COAGULATION
► Analyte is not CAP accepted. 77 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Platelet Function – PRU Test continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
P2Y12 inhibition PRU PRU ± 3 SD or ± 30 PRU, whichever is greater
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
POC Coagulation A
Program Description Lyophilized Plasma – Point of Care Coagulation for CoaguChek XS, XS Plus, and XS Pro.
Program Information
214 – POC Coagulation A – 5 Samples B14 – POC Coagulation A – 5 Samples – Verification Program 914 – POC Coagulation A – 2 Samples J14 – POC Coagulation A – 2 Samples – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean INR - - ± 3 SD Prothrombin Time seconds seconds ± 15%
Format Shipping Dates
3 shipments March 11th, July 8th, November 11th
POC Coagulation B
Program Description 1.0 mL – Lyophilized – For the i-STAT PCA, i-STAT I, and CoaguSense.
Program Information
216 – POC Coagulation B B16 – POC Coagulation B – Verification Program
PROGRAM ANALYSIS – COAGULATION
► Analyte is not CAP accepted. 78 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
POC Coagulation B continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean INR - - ± 3 SD Prothrombin Time seconds seconds 15%
Format Shipping Dates
5 samples x 3 shipments March 11th, July 8th, November 11th
Thromboelastogram
Program Description 1.0 mL – Lyophilized – For the Haemonetics Thromboelastograph® and TEM International ROTEM® analyzers.
Program Information
244 - Thromboelastogram
Analytes Standard Units Conventional Units AV from Consensus
Mean
TEG® 5000 R-Time (R) minutes minutes ± 3 SD
K-Time (K) minutes minutes ± 3 SD or ± 0.1 minutes,
whichever is greater Max Amplitude (MA) mm mm ± 3 SD Angle degrees degrees ± 3 SD
ROTEM® CT seconds seconds ± 3 SD CFT seconds seconds ± 3 SD MCF mm mm ± 3 SD Alpha angles degrees degrees ± 3 SD
TEG 6s CK R-Time (R) minutes minutes ± 3 SD CK K-Time (K) minutes minutes ± 3 SD CK Max Amplitude (MA)
mm mm ± 3 SD
CK Alpha (a) angles degrees degrees ± 3 SD CRT Max Amplitude (MA)
mm mm ± 3 SD
CKH R-Time (R) minutes minutes ± 3 SD
PROGRAM ANALYSIS – COAGULATION
► Analyte is not CAP accepted. 79 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Thromboelastogram continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
CFF Max Amplitude (MA)
mm mm ± 3 SD
CFF FLEV mg/dL mg/dL ± 3 SD
Format Shipping Dates
3 samples x 3 shipments March 11th, July 8th, November 11th
PROGRAM ANALYSIS – URINALYSIS, PPM, AND MISC. TESTS
► Analyte is not CAP accepted. 80 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Automated Urine Microscopy – I Program Description 10.0 mL – Urine – Designed for IRIS instruments.
Program Information
270 – Automated Urine Microscopy – I
Analytes Standard Units Conventional Units AV from Consensus
Mean
Crystals - - ± 10 Non-Squamous Epithelial Cells
- - ± 10
RBC - - ± 3 SD WBC - - ± 3 SD
Format Shipping Dates
1 sample x 3 shipments March 11th, July 8th, November 11th
Automated Urine Microscopy – S
Program Description 10.0 mL – Urine – Designed for Sysmex and the Arkray Aution AU-4050.
Program Information
271 – Automated Urine Microscopy – S
Analytes Standard Units Conventional Units AV from Consensus
Mean
Bacteria cells/uL cells/uL ± 3 SD or ± 5 cells/uL, whichever is greater
Casts casts/uL casts/uL ± 3 SD or ± 1 /uL, whichever is greater
Crystals - - -
Epithelial Cells cells/uL cells/uL ± 3 SD or ± 1 cell/uL, whichever is greater
RBC cells/uL cells/uL ± 3 SD or ± 2 cells/uL, whichever is greater
WBC cells/uL cells/uL ± 3 SD or ± 3 cells/uL, whichever is greater
PROGRAM ANALYSIS – URINALYSIS, PPM, AND MISC. TESTS
► Analyte is not CAP accepted. 81 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Automated Urine Microscopy - S continued…
Format Shipping Dates
1 sample x 3 shipments March 11th, July 8th, November 11th
Fecal Lactoferrin
Program Description 0.5 mL – Simulated Stool Samples – For qualitative detection of fecal lactoferrin.
Program Information
261 – Fecal Lactoferrin
Analytes
Fecal Lactoferrin
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
Fecal Occult Blood
Program Description 1.5 mL – Simulated Stool Samples – For Guaiac or Immunoassay methods.
Program Information
284 – Fecal Occult Blood B84 – Fecal Occult Blood – Verification Program 285 – Fecal Occult Blood – Add-on to Catalog #232 or #272
Analytes
Fecal Occult Blood
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
PROGRAM ANALYSIS – URINALYSIS, PPM, AND MISC. TESTS
► Analyte is not CAP accepted. 82 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Gastric Occult Blood
Program Description 2.0 mL – Simulated Gastric Samples – For gastric occult blood and pH.
Program Information
239 – Gastric Occult Blood B39 – Gastric Occult Blood – Verification Program
Analytes
Gastric Occult Blood
pH
Format Shipping Dates
2 samples x 3 shipments March 12th, July 8th, and November 12th
Provider-Performed Microscopy
Program Description Virtual Images – Online images for provider-performed microscopy. For KOH preparations of skin, hair, or nails, see Catalog #333 – KOH Slides on pages 104-105. This program includes two challenges for urine sediment and one challenge for all others. This is a virtual program only and does not include printed photographs. If facilities would like to receive printed photographs, add on Catalog #287 – Add-on PPM Photographs.
Program Information
233 – Provider-Performed Microscopy B33 – Provider-Performed Microscopy – Verification Program 287 – Add-on PPM Photographs
Analytes
Fecal WBC (1)
Fern Test (1)
Nasal Smear (1)
Pinworm Preparation (1)
Sperm, presence/absence (1)
Urine Sediment (2)
Vaginal Wet Prep (1)
Vaginal Wet Prep-KOH (1)
PROGRAM ANALYSIS – URINALYSIS, PPM, AND MISC. TESTS
► Analyte is not CAP accepted. 83 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Provider-Performed Microscopy continued…
Format Shipping Dates
9 images x 3 shipments March 11th, July 8th, November 11th
Rapid Urease
Program Description 0.5 mL – Simulated gastric biopsy samples for CLOtest, PyloriTek, or similar methods.
Program Information
260 – Rapid Urease
Analytes
Urease
Format Shipping Dates
3 samples x 2 shipments February 11th and September 23rd
Urinalysis and HCG
Program Description 10.0 mL – Urine – HCG is intended for waived methods. For automated urine microscopy, see Catalog #271 – Automated Urine Microscopy – S on pages 80-81. For urine testing using Iris iChem, Velocity, and vChem, see Catalog #272 – Urinalysis & HCG – I on pages 84-85 and Catalog #270 – Automated Urine Microscopy – I on page 80. For Fecal Occult Blood testing, see Catalog #285 – Fecal Occult Blood on page 81.
Program Information
232 – Urinalysis and HCG B32 – Urinalysis and HCG – Verification Program
Analytes Standard Units Conventional Units AV from Consensus
Mean Bilirubin - - - Bilirubin, confirmatory - - - Blood/Hemoglobin - Ery/mL - Creatinine - mg/dL - Glucose - mg/dL - HCG - - - Ketones - mg/dL -
PROGRAM ANALYSIS – URINALYSIS, PPM, AND MISC. TESTS
► Analyte is not CAP accepted. 84 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Urinalysis and HCG continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
Leukocyte Esterase - - - Nitrite - - - pH - - - Protein - mg/dL - Protein, confirmatory - - - Reducing Substance - - - Specific Gravity - - ± 0.01 Urobilinogen - mg/dL -
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
Urinalysis and HCG - I Program Description 10.0 mL – Urine – HCG is intended for waived methods. For use with Iris iChem, Velocity, and vChem. For automated urine microscopy, see Catalog #270 – Automated Urine Microscopy – I on page 80. For urine testing on non-Iris methods, see Catalog #232 – Urinalysis, HCG, and FOB on pages 83-84 and Catalog #271 – Automated Urine Microscopy – S on pages 80-81. For Fecal Occult Blood testing, see Catalog #285 – Fecal Occult Blood on page 81.
Program Information
272 – Urinalysis, HCG – I
Analytes Standard Units Conventional Units AV from Consensus
Mean
Bilirubin - - - Bilirubin, confirmatory - - - Blood/Hemoglobin - Ery/uL - Glucose - - - HCG - - - Ketones - mg/dL - Leukocyte Esterase - WBC/uL - Nitrite - - - pH - - - Protein - mg/dL -
PROGRAM ANALYSIS – URINALYSIS, PPM, AND MISC. TESTS
► Analyte is not CAP accepted. 85 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Urinalysis and HCG – I continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
Protein, confirmatory - mg/dL - Reducing Substance - - - Specific Gravity - - ± 0.01 Urobilinogen - mg/dL -
Format Shipping Dates
2 samples x 3 shipments March 11th, July 8th, November 11th
Urine Crystals
Program Description 1.5 mL – Urine – For identification of urine crystals.
Program Information
273 – Urine Crystals
Analytes
Urine Crystal Identification
Format Shipping Dates
2 samples x 2 shipments March 11th and November 11th
Urine Eosinophils
Program Description Virtual Images – An online image for the presence or absence of urine eosinophils. This is a virtual program only and will not include printed photographs. If facilities would like to receive printed photographs, add Catalog #289 – Add-on Urine Eosinophils Photographs.
Program Information
258 – Urine Eosinophils 289 – Add-on Urine Eosinophils Photographs
Analytes
Urine Eosinophils
PROGRAM ANALYSIS – URINALYSIS, PPM, AND MISC. TESTS
► Analyte is not CAP accepted. 86 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Urine Eosinophils continued…
Format Shipping Dates
1 image x 3 shipments March 11th, July 8th, November 11th
Urine HCG – Qualitative
Program Description 1.0 mL – Urine – For non-waived methods such as latex agglutination or FIA. Also may be ordered by laboratories with waived methods who wish to test 5 samples.
Program Information
235 – Urine HCG – Qualitative B35 – Urine HCG – Qualitative – Verification Program
Analytes
HCG
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th
Urine Sediment
Program Description Virtual Images – Two online images for identification of formed elements in urine sediment. This is a virtual program only and will not include printed photographs. If facilities would like to receive printed photographs, add Catalog #288 – Add-on Urine Sediment Photographs.
Program Information
234 – Urine Sediment 288 – Add-on Urine Sediment Photographs
Analytes
Formed elements such as RBC, WBC, bacteria, casts, crystals, epithelial cells, etc.
Format Shipping Dates
2 images x 3 shipments March 11th, July 8th, November 11th
PROGRAM ANALYSIS – URINALYSIS, PPM, AND MISC. TESTS
► Analyte is not CAP accepted. 87 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Waived & PPM Package
Program Description Number of challenges per event, sample volume, and sample type are shown in the table below, to the right of each sample name. For waived methods and procedures commonly performed in a physician’s office.
Program Information
251 – Waived and PPM Package B51 – Waived and PPM Package – Verification Program X51 – Extra Results for WBG in the Waived and PPM Package – 2 Samples
Analytes Standard Units Conventional Units AV from Consensus
Mean Fecal Occult Blood (1) – 1.5 mL – Simulated Stool Sample
- - -
Group A Strep Antigen (2)♦ – Swab
- - -
Hematocrit & Hemoglobin (2) – 1.5 mL – Whole Blood
Hematocrit L/L % ± 6%
Hemoglobin g/L g/dL ± 7% Urinalysis (1) – 10.0 mL – Urine♦♦
- - -
Urine Sediment (2) – Photograph - - -
Vaginal Wet Prep (1) – Photograph
- - -
Vaginal Wet Prep–KOH (1) – Photograph - - -
Whole Blood Glucose (2) – 2.0 mL – Whole Blood♦♦♦
Whole Blood Glucose mmol/L mg/dL ± 10 mg/dL or ± 20%, whichever is greater
Format Shipping Dates
12 samples x 3 shipments March 11th, July 8th, November 11th ♦ If using a molecular method for Group A Strep, see Catalog #364/964 – Strep pharyngeal (molecular) on page 99.
♦♦ See analyte breakdown for urinalysis on pages 83-84 under Catalog #232. ♦♦♦ If using HemoCue, see Catalog #128/928 – HemoCue on page 34.
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 88 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Microbiology Enrollment Requirements CLIA requires laboratories performing microbiology tests that are regulated for proficiency testing to test five regulated challenges per test event in each sub-specialty where regulated testing is performed. The five sub-specialties are Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology. All non-waived tests in a sub-specialty can be combined to meet the five-challenge requirement. For molecular testing of direct specimens, CMS considers only bacteriology, virology, and yeast in blood cultures to be regulated tests. Regulated tests are indicated in bold type.
Challenges tested with waived methods (e.g., Rapid Group A Strep) cannot be included in the five regulated challenges. Furthermore, if one of your methods becomes waived or you change to a waived method mid-year, you are responsible for ensuring you maintain five challenges per test event for the remaining non-waived tests in that sub-specialty.
Programs listed that have fewer than five samples are to be used as add-on options to other programs in the same sub-specialty.
Susceptibility testing counts as one challenge regardless of the number of drugs reported.
Urine colony count is not a regulated test and cannot be included as one of the five challenges.
BACTERIOLOGY
Affirm VP
Program Description Swab – For the BD Affirm VP III.
Program Information
324 – Affirm VP
Analytes
Candida sp.
Trichomonas vaginalis
Gardnerella vaginalis
Format Shipping Dates
5 samples x 3 shipments February 11th, June 17th, September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 89 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Basic Bacteriology Package
Program Description Number of challenges per event, sample volume, and sample type are shown in the table below, to the right of each sample name. For laboratories performing non-waived Group A Strep Antigen testing, Throat Cultures, and Urine Cultures. For strep testing for molecular methods, see Catalog #364/#964 – Strep pharyngeal (molecular) on page 99.
Program Information
321 – Basic Bacteriology Package
Analytes
Group A Strep Antigen (2) – Swab
Throat Culture (2) – Inocu-Swab II
Urine Colony Count (1) – Quantitated Pellet + Dilution Fluid
Urine Culture (1) – Quantitated Pellet + Dilution Fluid
Susceptibility Testing (1) – Tested on Urine Sample
Format Shipping Dates
5 samples x 3 shipments February 11th, June 17th, September 23rd
Bacterial Vaginosis
Program Description 1.0 mL – Liquid – For OSOM BVBlue.
Program Information
359 – Bacterial Vaginosis
Analytes
Bacterial Vaginosis Screen
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 90 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Blood Culture
Program Description 12.0 mL – Pellet + Rehydration Fluid – For aerobic and anaerobic Blood Cultures. For use as an add-on to other Bacteriology programs.
Program Information
361 – Blood Culture
Analytes
Blood Culture
Susceptibility Testing
Format Shipping Dates
2 samples x 2 shipments February 11th and September 23rd
Bordetella pertussis/parapertussis (molecular) Program Description 1.0 mL – Liquid – For molecular methods for Bordetella pertussis and Bordetella parapertussis. For use as an add-on to other Bacteriology programs.
Program Information
363 – Bordetella pertussis/parapertussis
Analytes
Bordetella pertussis
Bordetella parapertussis
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 91 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
C. difficile Toxin/Antigen
Program Description 1.0 mL – Liquid – For C. difficile antigen and toxin test kits. Also compatible with molecular methods.
Program Information
350 – C. difficile Toxin/Antigen – 5 Samples 347 – C. difficile Toxin/Antigen – 2 Samples – Add-on Option C47 – C. difficile Toxin/Antigen – 2 Samples – Verification Program
Analytes
C. difficile Antigen
C. difficile Toxin
Format Shipping Dates
3 shipments February 11th, June 17th, September 23rd
Campylobacter
Program Description Inocu-Swab II – For detection of Campylobacter sp. using antigen or culture. For use as an add-on to other Bacteriology programs.
Program Information
360 – Campylobacter
Analytes
Campylobacter sp.
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
Chlamydia/GC (molecular) Program Description 1.0 mL – Liquid – For nucleic acid probe or amplification methods.
Program Information
311 – Chlamydia/GC (molecular)
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 92 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Chlamydia/GC (molecular) continued…
Analytes
Chlamydia trachomatis
Neisseria gonorrhoeae
Format Shipping Dates
5 samples x 3 shipments February 11th, June 17th, September 23rd
Chlamydia AntigenProgram Description
1.0 mL – Liquid – For Chlamydia antigen detection kits.
Program Information
316 – Chlamydia Antigen – 5 Samples 930 – Chlamydia Antigen – 2 Samples – Add-on Option
Analytes
Chlamydia Antigen
Format Shipping Dates
3 shipments February 11th, June 17th, September 23rd
Comprehensive BacteriologyProgram Description
Number of challenges per year, sample volume, and sample type are shown in the table below, to the right of each sample name. For facilities performing a variety of bacteriology procedures. Not compatible with molecular methods.
Program Information
328 – Comprehensive Bacteriology
Analytes
Blood Culture (1) – Pellet + Rehydration Fluid
CSF Culture (1) – Pellet + Rehydration Fluid
Campy Antigen (2) – Allowed on Stool Culture Samples
Ear/Eye Culture (1) – Inocu-Swab II
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 93 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Comprehensive Bacteriology continued…
Analytes
Gram Stain (15) – Glass Slides
Group A Strep Antigen (3) – Swab
GC/Group B Strep Culture (2) – Inocu-Swab II
Educational Culture and Susceptibility (3) – Inocu-Swab II
Sputum Culture (2) – Inocu-Swab II
Stool Culture (2) – Inocu-Swab II
Urine Culture and Susceptibility Testing (3) – Quantitated Pellet + Dilution Fluid
Throat Culture (1) – Inocu-Swab II
Urine Colony Count (3) – Quantitated Pellet + Dilution Fluid
Wound Culture – Aerobic and Anaerobic (2) – Inocu-Swab II
Format Shipping Dates
3 shipments February 11th, June 17th, September 23rd
Gram Stain
Program Description Glass Slide – Fixed unstained glass slides for Gram stain and morphology.
Program Information
320 – Gram Stain 330 – Additional Gram Stain Slides
Analytes
Gram Stain
Gram Stain Morphology
Format Shipping Dates
5 samples x 3 shipments February 11th, June 17th, September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 94 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Gram Stain – Direct Smears
Program Description Virtual Images – Gram stained direct smears from various sources including blood, sputum, CSF, and wound. Not CMS Scored or reported to CAP.
Program Information
329 – Gram Stain – Direct Smears
Analytes
Gram Stain
Leukocytes
Sputum Quality
Stain Quality
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
Gram Stain – Vaginitis
Program Description Virtual Images – Gram stained vaginal smears for the detection of bacterial vaginosis. Not CMS Scored or reported to CAP.
Program Information
319 – Gram Stain – Vaginitis
Analytes
Bacterial Vaginosis (Gram Stain)
Nugent Score
Format Shipping Dates
3 samples x 2 shipments February 11th and September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 95 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Group A Strep Antigen
Program Description Swab – For rapid Group A Strep antigen detection.
Program Information
312 – Group A Strep Antigen – 5 Samples 912 – Group A Strep Antigen – 3 Samples – Add-on Option 912 – Group A Strep Antigen – 2 Samples – Add-on Option or for Waived Methods J12 – Group A Strep Antigen – 2 Samples – Verification Program
Analytes
Group A Strep Antigen
Format Shipping Dates
3 shipments February 11th, June 17th, September 23rd
Group B Strep (molecular) Program Description Swab – For molecular Group B Strep testing.
Program Information
365 – Group B Strep (molecular) – 5 Samples 965 – Group B Strep (molecular) – 2 Samples – Add-on Option
Analytes
Group B Strep
Format Shipping Dates
3 shipments February 11th, June 17th, September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 96 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
GC/Group B Strep Culture
Program Description Inocu-Swab II – Culture for N. gonorrhoeae and Group B Strep. For molecular methods, see Catalog #365/#965 – Group B Strep (molecular).
Program Information
315 – GC/Group B Strep Culture – 5 Samples 929 – GC/Group B Strep Culture – 2 Samples – Add-on Option
Analytes
Neisseria gonorrhoeae Culture
Group B Strep Culture
Format Shipping Dates
3 shipments February 11th, June 17th, September 23rd
H. pylori Antigen, Stool Program Description 0.5 mL – Fecal Suspension – For detection of H. pylori antigen. For use as an add-on to other Bacteriology programs.
Program Information
351 – H. pylori Antigen, Stool
Analytes
Helicobacter pylori Antigen
Format Shipping Dates
2 samples x 2 shipments February 11th and September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 97 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Legionella AntigenProgram Description
0.5 mL – Liquid – For Legionella antigen detection methods in urine. For use as an add-on to other Bacteriology programs.
Program Information
340 – Legionella Antigen
Analytes
Legionella Antigen
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
MRSA CultureProgram Description
Inocu-Swab II – For laboratories using culture methods for MRSA. For use as an add-on to other Bacteriology programs.
Program Information
356 – MRSA Culture
Analytes
Methicillin Resistant Staphylococcus aureus
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
MRSA/Staph aureus (molecular)Program Description
Swab – For molecular methods that detect MRSA and Staph aureus. For use as an add-on to other Bacteriology programs.
Program Information
366 – MRSA/Staph aureus (molecular)
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 98 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
MRSA/Staph aureus (molecular) continued…
Analytes
Methicillin Resistant Staphylococcus aureus
Staphylococcus aureus
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
Mycoplasma pneumoniae (molecular) Program Description 1.0 mL – Liquid – For molecular methods that detect Mycoplasma pneumoniae. For use as an add-on to other Bacteriology programs.
Program Information
374 – Mycoplasma pneumonia (molecular)
Analytes
Mycoplasma pneumoniae
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
Shiga Toxin
Program Description 1.0 mL – Liquid – For methods that detect Shiga Toxins 1 and 2.
Program Information
343 – Shiga Toxin
Analytes
Shiga Toxin 1
Shiga Toxin 2
Shiga Toxin 1 and 2
Format Shipping Dates
2 samples x 2 shipments February 11th and September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 99 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
S. pneumoniae Antigen
Program Description 0.5 mL – Liquid – For antigen detection methods in urine. For use as an add-on to other Bacteriology programs.
Program Information
341 – S. pneumoniae Antigen
Analytes
S. pneumoniae Antigen
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
Strep Pharyngeal (molecular) Program Description Swab – For detection of Group A and Group C/G Strep by molecular methods
Program Information
364 – Strep Pharyngeal (molecular) – 5 Samples 964 – Strep Pharyngeal (molecular) – 2 Samples – Add-on Option
Analytes
Group A Strep
Group C/G Strep
Format Shipping Dates
3 shipments February 11th, June 17th, September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 100 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Throat Culture
Program Description Inocu-Swab II – For culture methods detecting Group A Strep only. For molecular testing, see Catalog #364/#964 – Strep pharyngeal (molecular) on page 99.
Program Information
313 – Throat Culture – 5 Samples 953 – Throat Culture – 3 Samples – Add-on Option 952 – Throat Culture – 2 Samples – Add-on Option
Analytes
Throat Culture
Format Shipping Dates
3 shipments February 11th, June 17th, September 23rd
Urine Culture
Program Description Quantitated Pellet + Dilution Fluid – Culture (including screening tubes, paddles, and agar plates) for bacterial colony count and/or identification. One sample per event for susceptibility testing.
Program Information
314 – Urine Culture – 5 Samples 924 – Urine Culture – 2 Samples – Add-on Option
Analytes
Susceptibility Testing
Urine Colony Count
Urine Culture
Format Shipping Dates
3 shipments February 11th, June 17th, September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 101 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
VRE Culture
Program Description Inocu-Swab II – For culture methods. For use as an add-on to other Bacteriology programs. For molecular methods, see Catalog #367 – VRE (molecular).
Program Information
357 – VRE Culture
Analytes
Vancomycin Resistant Enterococci
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
VRE (molecular) Program Description Swab – For molecular methods. For use as an add-on to other Bacteriology programs. For culture methods, see Catalog #357 – VRE Culture.
Program Information
367 – VRE (molecular)
Analytes
Vancomycin Resistant Enterococci
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 102 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
MYCOBACTERIOLOGY
Acid Fast Smears
Program Description Glass Slide – Fixed unstained glass slides.
Program Information
335 – Acid Fast Smears
Analytes
Acid Fast Smears
Format Shipping Dates
5 samples x 2 shipments March 4th and August 19th
M. tuberculosis (molecular) Program Description 1.0 mL – Liquid – For detection of M. tuberculosis and rifampin resistance using molecular methods.
Program Information
372 – M. tuberculosis (molecular)
Analytes
M. tuberculosis
Rifampin resistance screen
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
Mycobacteriology Culture
Program Description Liquid and Lyophilized – For culture and identification of mycobacteria.
Program Information
344 – Mycobacteriology Culture
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 103 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Mycobacteriology Culture continued…
Analytes
Mycobacteriology Identification
►Mycobacterial Susceptibility Testing
Format Shipping Dates
5 samples x 2 shipments March 4th and August 19th
MYCOLOGY
Candida Culture
Program Description Inocu-Swab II – For Candida culture.
Program Information
317 – Candida Culture
Analytes
Candida Culture
Format Shipping Dates
5 samples x 3 shipments February 11th, June 17th, September 23rd
Cryptococcal Antigen
Program Description 1.0 mL – Liquid – For Cryptococcal antigen detection.
Program Information
345 – Cryptococcal Antigen
Analytes
Cryptococcal Antigen
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 104 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Dermatophyte Culture
Program Description Inocu-Swab II – For culture methods for dermatophytes.
Program Information
332 – Dermatophyte Culture
Analytes
Dermatophyte Culture
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th
India Ink
Program Description 1.0 mL – Liquid – For presence or absence of encapsulated yeast using India Ink methods.
Program Information
339 – India Ink
Analytes
India Ink
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
KOH Slides
Program Description Glass Slides – For KOH examination of skin, hair, or nails.
Program Information
333 – KOH Slides
Analytes
KOH Preparation
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 105 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
KOH Slides continued…
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
Mycology Culture
Program Description Inocu-Swab II – For culture and identification of yeasts, molds, and aerobic actinomycetes.
Program Information
331 – Mycology Culture
Analytes
Mycology Culture
Format Shipping Dates
5 samples x 3 shipments January 14th, May 20th, August 26th
PARASITOLOGY
Blood Parasites
Program Description Two virtual blood smears and three Giemsa-stained thick and/or thin blood smears for the detection and identification of blood parasites.
Program Information
336 – Blood Parasites
Analytes
Blood Parasite Identification
Format Shipping Dates
5 samples – 3 times per year February 11th, June 17th, September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 106 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Giardia & Cryptosporidium AntigenProgram Description
1.0 mL – Liquid – For EIA & DFA test methods.
Program Information
342 – Giardia & Cryptosporidium Antigens – 5 Samples 932 – Giardia & Cryptosporidium Antigens – 2 Samples – Add-on Option
Analytes
Cryptosporidium Antigen
Giardia Antigen
Format Shipping Dates
3 shipments February 11th, June 17th, September 23rd
ParasitologyProgram Description
Number of challenges per event, sample volume, and sample type are shown in the table below, to the right of each sample name. For Cryptosporidium antigen, see Catalog #342/#932 – Giardia and Cryptosporidium Antigens. For Blood Parasites, see Catalog #336 – Blood Parasites on page 105.
Program Information
334 – Parasitology
Analytes
Blood Smear (1) – Photo
Formalin Concentrates (2) – 0.5 mL – Fecal Suspension
Modified Acid-fast Stain (2)
PVA (1) – Glass Slide
Stool Prep (1) – Photo
Format Shipping Dates
3 shipments February 11th, June 17th, September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 107 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Trichomonas
Program Description 2.0 mL – Liquid – For molecular methods and for Sekisui OSOM Rapid Trichomonas test.
Program Information
362 – Trichomonas
Analytes
Trichomonas vaginalis
Format Shipping Dates
5 samples x 3 shipments February 11th, June 17th, September 23rd
VIROLOGY
HPV (molecular) - 5
Program Description 1.0 mL – Liquid – For detection of High-Risk HPV using molecular methods.
Program Information
375 – HPV (molecular) – 5 Samples
Analytes
HPV
HPV genotyping (16, 18, and 18/45)
Format Shipping Dates
5 samples x 3 shipments February 11th, June 17th, September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 108 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
HPV (molecular) - 2Program Description
1.0 mL – Liquid – For detection of High-Risk HPV using molecular methods. For use as an add-on option to other Virology programs.
Program Information
975 – HPV (molecular) – 2 Samples
Analytes
HPV
HPV genotyping (16, 18, and 18/45)
Format Shipping Dates
2 samples x 2 shipments February 11th and September 23rd
HSV 1 & 2 (molecular)Program Description
1.0 mL – Liquid – For detection of HSV 1 & 2 using molecular methods.
Program Information
373 – HSV 1 & 2 (molecular)
Analytes
Herpes Simplex Virus Type 1
Herpes Simplex Virus Type 2
Format Shipping Dates
5 samples x 3 shipments February 11th, June 17th, September 23rd
Influenza A & B (Silaris) - 5Program Description
Swab – For Silaris Influenza A & B Test kits. For other methods, see Catalog #322/942 – Virology Package on page 110.
Program Information
377 – Influenza A & B (Silaris) – 5 Samples
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 109 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Influenza A & B (Silaris) continued…
Analytes
► Influenza A
► Influenza B
Format Shipping Dates
5 samples x 3 shipments February 11th, June 17th, September 23rd
Influenza A & B (Silaris) - 3
Program Description Swab – For Silaris Influenza A & B Test kits. For other methods, see Catalog #933 – Virology Package – waived on pages 110-111.
Program Information
977 – Influenza A & B (Silaris) – 3 Samples
Analytes
► Influenza A
► Influenza B
Format Shipping Dates
3 samples x 2 shipments February 11th and September 23rd
Rotavirus
Program Description 1.0 mL – Liquid – For the detection of rotavirus antigen.
Program Information
348 – Rotavirus – 5 Samples 349 – Rotavirus – 3 Samples – Add-on Option
Analytes
Rotavirus Antigen
Format Shipping Dates
3 shipments February 11th, June 17th, September 23rd
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 110 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Virology Package
Program Description 1.0 mL – Liquid – For Influenza A, Influenza B, RSV, and Adenovirus. Compatible with antigen detection kits and molecular methods. For Influenza testing on Silaris, see Catalog #377/977 – Influenza A & B (Silaris) on pages 108-109.
Program Information
322 – Virology Package – 5 Samples C22 – Virology Package – 5 Samples – Verification Program 942 – Virology Package – 2 Samples – Add-on Option
Analytes
Adenovirus
Influenza A
Influenza B
Influenza A or B
RSV
Format Shipping Dates
3 shipments February 11th, June 17th, September 23rd
Virology Package - Waived
Program Description 1.0 mL – Liquid – For Influenza A, Influenza B, RSV, and Adenovirus. Compatible with antigen detection kits and molecular methods. For Influenza testing on Silaris, see Catalog #377/977 – Influenza A & B (Silaris) on pages 108-109.
Program Information
933 – Virology Package – Waived J33 – Virology Package – Waived – Verification Program
Analytes
Adenovirus
Influenza A
Influenza B
Influenza A or B
RSV
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 111 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Virology Package - Waived continued…
Format Shipping Dates
2 shipments February 11th and September 23rd
Molecular Multiplex Programs
For molecular testing of direct specimens, CMS considers bacteriology, virology, and yeast in blood cultures to be regulated tests. If the only regulated bacteriology, virology, or mycology testing you perform is using a multiplex analyzer, you are required to participate in five challenges, three times a year for compliance with CLIA.
Blood Pathogen Panel Program Description 1.0 mL – Liquid – For molecular multiplex panels. For a full list of reportable analytes, see table on page 166.
Program Information
368 – Blood Pathogen Panel
Analytes
Identification of Bacteria
Identification of Yeasts
Resistance Genes
Format Shipping Dates
5 samples x 3 shipments February 11th, June 17th, September 23rd
GI Panel Program Description 1.0 mL – Liquid – For molecular multiplex panels. For a full list of reportable analytes, see table on page 167.
Program Information
369 – GI Panel
Analytes
Identification of Bacteria
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 112 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
GI Panel continued…
Analytes
Identification of Parasites
Identification of Viruses
Format Shipping Dates
5 samples x 3 shipments February 11th, June 17th, September 23rd
Meningitis PanelProgram Description
1.0 mL – Liquid – For molecular multiplex panels. For a full list of reportable analytes, see table on pages 168.
Program Information
371 – Meningitis Panel
Analytes
Identification of Bacteria
Identification of Viruses
Identification of Yeasts
Format Shipping Dates
5 samples x 3 shipments February 11th, June 17th, September 23rd
Pneumonia PanelProgram Description
0.5 mL – Liquid – For molecular multiplex panels. For a full list of reportable analytes, see table on page 168.
Program Information
378 – Pneumonia Panel
Analytes
Identification of Bacteria
Identification of Viruses
PROGRAM ANALYSIS – MICROBIOLOGY
► Analyte is not CAP accepted. 113 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Pneumonia Panel continued…
Analytes
Resistance Genes
Format Shipping Dates
2 samples x 3 shipments June 17th and September 23rd
Respiratory PanelProgram Description
1.0 mL – Liquid – For molecular multiplex panels. For a full list of reportable analytes, see table on page 167.
Program Information
370 – Respiratory Panel
Analytes
Identification of Bacteria
Identification of Viruses
Format Shipping Dates
5 samples x 3 shipments February 11th, June 17th, September 23rd
Vaginal PanelProgram Description
0.5 mL – Liquid – For the detection of vaginitis/vaginosis using molecular multiplex panels. For use as an add-on to other Bacteriology programs. For a full list of reportable analytes, see table on page 168.
Program Information
376 – Vaginal Panel
Analytes
Identification of Bacteria
Identification of Candida
Identification of Trichomonas
Format Shipping Dates
2 samples x 3 shipments February 11th, June 17th, September 23rd
PROGRAM ANALYSIS – IMMUNOLOGY
► Analyte is not CAP accepted. 114 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
ANA
Program Description 0.6 mL – Serum – Qualitative reporting only. Not compatible with latex agglutination methods. See Catalog #429 – ANA (Latex Kits) for latex agglutination methods.
Program Information
421 – ANA
Analytes ANA Anti-DNA (ds, ss) Anti-Sm Anti-RNP Anti-SSA Anti-SSB
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
ANA (Latex Kits) Program Description 0.6 mL – Serum – Qualitative reporting only. Designed for latex agglutination methods only.
Program Information
429 – ANA (Latex Kits)
Analytes ANA
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
PROGRAM ANALYSIS – IMMUNOLOGY
► Analyte is not CAP accepted. 115 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Anti-CCPProgram Description
1.0 mL – Serum – May be reported as qualitative, quantitative, or semi-quantitative.
Program Information
423 – Anti-CCP
Analytes Standard Units Conventional Units AV from Consensus
Mean
Anti-Cyclic Citrullinated Peptide
U/mL U/mL ± 3 SD or ± 5 U/mL, whichever is greater
Format Shipping Dates
2 samples x 3 shipments April 1st, August 5th, December 2nd
ASOProgram Description
1.0 mL – Serum – May be reported as qualitative, quantitative, or as a titer.
Program Information
424 – ASO
Analytes Standard Units Conventional Units AV from Consensus
Mean
Anti-Streptolysin O IU/mL IU/mL ± 2 SD or ± 25 IU/mL, whichever is greater
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
BRCA1/2 SequencingProgram Description
10-µg – Extracted DNA specimens
Program Information
441 – BRCA1/2 Sequencing
PROGRAM ANALYSIS – IMMUNOLOGY
► Analyte is not CAP accepted. 116 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
BRCA1/2 Sequencing continued…
Analytes ►BRCA1/2 DNA sequencing and variant interpretation BRCA1/2 duplication/deletion analysis
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
C-Reactive Protein
Program Description 0.5 mL – Serum – For qualitative and quantitative CRP procedures that measure levels >1.0 mg/dL.
Program Information
431 – C-Reactive Protein
Analytes Standard Units Conventional Units AV from Consensus
Mean
C-Reactive Protein mg/L mg/dL ± 2 SD
Format Shipping Dates
2 samples x 3 shipments April 1st, August 5th, December 2nd
Diagnostic Allergy
Program Description 2.0 mL – Serum – For quantitative IgE. Specific allergens may be reported qualitatively or quantitatively.
Program Information
419 – Diagnostic Allergy 437 – Additional Sample Volume
Analytes Standard Units Conventional Units AV from Consensus
Mean Total IgE IU/mL IU/mL ± 3 SD Specific Allergens kUA/L kUA/L ± 3 SD
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
PROGRAM ANALYSIS – IMMUNOLOGY
► Analyte is not CAP accepted. 117 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
H. pylori Antibody
Program Description 0.5 mL – Serum – For kits that detect the Helicobacter pylori antibody. For antigen testing, see Catalog #351 – H. pylori – Antigen, Stool on page 96.
Program Information
420 – H. pylori Antibody
Analytes
H. pylori Antibody
Format Shipping Dates
2 samples x 3 shipments April 1st, August 5th, December 2nd
HBV Viral Load
Program Description 1.5 mL – Plasma – For molecular quantification of HBV DNA.
Program Information
442 – HBV Viral Load
Analytes Standard Units Conventional Units AV from Consensus
Mean
►HBV Viral Load IU/mL (log10 transformed)
IU/mL ± 3 SD
Format Shipping Dates
2 samples x 3 shipments April 1st, August 5th, December 2nd
HCV Viral Load
Program Description 1.5 mL – Plasma
Program Information
439 – HCV Viral Load
PROGRAM ANALYSIS – IMMUNOLOGY
► Analyte is not CAP accepted. 118 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
HCV Viral Load continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
►HCV Viral Load IU/mL (log10 transformed)
IU/mL ± 3 SD
►HCV, qualitative - - - ►HCV genotyping - - -
Format Shipping Dates
2 samples x 3 shipments April 1st, August 5th, December 2nd
High Sensitivity CRP
Program Description 0.5 mL – Serum – For high sensitivity CRP procedures that measure levels between 0-1.5 mg/dL
Program Information
425 – High Sensitivity CRP
Analytes Standard Units Conventional Units AV from Consensus
Mean
C-Reactive Protein (hs) mg/L mg/dL ± 2 SD
Format Shipping Dates
2 samples x 3 shipments April 1st, August 5th, December 2nd
HIV Viral Load
Program Description 1.5 mL – Plasma
Program Information
440 – HIV Viral Load
Analytes Standard Units Conventional Units AV from Consensus
Mean
►HIV-1 RNA Viral Load IU/mL (log10 transformed)
IU/mL ± 3 SD
PROGRAM ANALYSIS – IMMUNOLOGY
► Analyte is not CAP accepted. 119 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
HIV Viral Load continued…
Format Shipping Dates
2 samples x 3 shipments April 1st, August 5th, December 2nd
HSV-2 Antibody
Program Description 0.5 mL – Serum – For the Biokit HSV-2 rapid test.
Program Information
430 – HSV-2 Antibody
Analytes
HSV-2 Antibody
Format Shipping Dates
2 samples x 3 shipments April 1st, August 5th, December 2nd
Immunology Package
Program Description Serum – Number of challenges per event and sample volume are shown in the table below, to the right of each sample name. Cost savings package for facilities that perform all of the included tests. ASO, Rubella, and Rheumatoid Factor may be reported as qualitative, quantitative, or as a titer.
Program Information
407 – Immunology Package
Analytes Standard Units Conventional Units AV from Consensus
Mean Anti-Streptolysin O (5) – 1.0 mL
IU/mL IU/mL ± 2 SD or ± 25 IU/mL, whichever is greater
Infectious Mononucleosis (5) – 0.65 mL
- - -
Rheumatoid Factor (5) – 1.0 mL
IU/mL IU/mL ± 3 SD or ± 20 IU/mL, whichever is greater
Rubella (5) – 1.0 mL IU/mL IU/mL ± 3 SD or ± 10 IU/mL, whichever is greater
PROGRAM ANALYSIS – IMMUNOLOGY
► Analyte is not CAP accepted. 120 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Immunology Package continued…
Format Shipping Dates
3 shipments April 1st, August 5th, December 2nd
Immunoproteins/C3 & C4
Program Description 1.0 mL – Serum
Program Information
436 – Immunoproteins/C3 & C4
Analytes Standard Units Conventional Units AV from Consensus
Mean Alpha-1-Antitrypsin g/L mg/dL ± 3 SD Complement C3 g/L mg/dL ± 3 SD
Complement C4 g/L mg/dL ± 3 SD Haptoglobin g/L mg/dL ± 3 SD
IgA g/L mg/dL ± 3 SD
IgE IU/mL IU/mL ± 3 SD IgG g/L mg/dL ± 25%
IgM g/L mg/dL ± 3 SD
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
Infectious Disease Serology
Program Description 0.5 mL – Lyophilized defibrinated plasma – 1 sample provided for each analyte (CMV IgG and IgM are included in the same sample - Toxoplasma gondii IgG and IgM are included in the same sample).
Program Information
438 – Infectious Disease Serology
Analytes
►CMV (IgG & IgM) Mumps Virus IgG
PROGRAM ANALYSIS – IMMUNOLOGY
► Analyte is not CAP accepted. 121 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Infectious Disease Serology continued…
Analytes ►Rubella IgG ►Rubeola Virus IgG ►Toxoplasma gondii (IgG & IgM) ►Varicella Zoster Virus (VZV) IgG
Format Shipping Dates
6 samples x 2 shipments April 1st and December 2nd
Infectious Mononucleosis
Program Description 0.65 mL – Serum
Program Information
410 – Infectious Mononucleosis – 5 Samples 910 – Infectious Mononucleosis – 2 Samples – For waived methods
Analytes Infectious Mononucleosis
Format Shipping Dates
3 shipments April 1st, August 5th, December 2nd
Infectious Mononucleosis & Rheumatoid Factor
Program Description Serum – Number of challenges per event and sample volume are shown in the table below, to the right of each sample name. Cost savings package for laboratories that perform both tests. Rheumatoid Factor may be reported as qualitative, quantitative, or as a titer.
Program Information
411 – Infectious Mononucleosis & Rheumatoid Factor
Analytes Standard Units Conventional Units AV from Consensus
Mean
Infectious Mononucleosis (5) – 0.65 mL
- - -
PROGRAM ANALYSIS – IMMUNOLOGY
► Analyte is not CAP accepted. 122 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Infectious Mononucleosis & Rheumatoid Factor continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean
Rheumatoid Factor (5) – 1.0 mL
IU/mL IU/mL ± 3 SD or ± 20 IU/mL, whichever is greater
Format Shipping Dates
3 shipments April 1st, August 5th, December 2nd
Lyme Disease
Program Description 0.6 mL – Serum – For IgG and IgM antibody detection to Borrelia burgdorferi.
Program Information
418 – Lyme Disease
Analytes
Lyme Disease Antibody
Format Shipping Dates
2 samples x 3 shipments April 1st, August 5th, December 2nd
Mycoplasma Antibody
Program Description 0.5 mL – Serum – For kits that detect Mycoplasma pneumoniae antibody.
Program Information
428 – Mycoplasma Antibody
Analytes
Mycoplasma Antibody
Format Shipping Dates
2 samples x 3 shipments April 1st, August 5th, December 2nd
PROGRAM ANALYSIS – IMMUNOLOGY
► Analyte is not CAP accepted. 123 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Rapid HIV
Program Description 1.0 mL – Serum – For laboratories using a rapid method for anti-HIV and/or HIV-1 p24 antigen. For other antigen and antibody methods, see Catalog #417 – Viral Markers on page 125.
Program Information
432 – Rapid HIV – 5 Samples 433 – Rapid HIV – 2 Samples D33 – Rapid HIV – 2 Samples – Verification Program
Analytes
Anti-HIV-1/2
HIV-1 p24 Antigen
Format Shipping Dates
3 shipments April 1st, August 5th, December 2nd
Rheumatoid Factor
Program Description 1.0 mL – Serum – For qualitative, quantitative, and semi-quantitative (titer) methods.
Program Information
408 – Rheumatoid Factor
Analytes Standard Units Conventional Units AV from Consensus
Mean
Rheumatoid Factor IU/mL IU/mL ± 3 SD or ± 20 IU/mL, whichever is greater
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
PROGRAM ANALYSIS – IMMUNOLOGY
► Analyte is not CAP accepted. 124 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Rubella
Program Description 1.0 mL – Serum – For qualitative, quantitative, and semi-quantitative (titer) methods.
Program Information
415 – Rubella
Analytes Standard Units Conventional Units AV from Consensus
Mean
Rubella IU/mL IU/mL ± 3 SD or ± 10 IU/mL, whichever is greater
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
Syphilis Serology
Program Description 1.0 mL – Serum – For qualitative and semi-quantitative (titer) methods for serum and CSF. Designed for RPR, VDRL, FTA, and Treponemal Antibody methods.
Program Information
416 – Syphilis Serology
Analytes Standard Units Conventional Units AV from Consensus
Mean Syphilis IU/mL IU/mL -
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
Thyroid Antibodies
Program Description 0.5 mL – Serum
Program Information
164 – Thyroid Antibodies
PROGRAM ANALYSIS – IMMUNOLOGY
► Analyte is not CAP accepted. 125 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Thyroid Antibodies continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean Thyroglobulin antibody (Anti-TG)
kU/L IU/mL ± 2 SD or ± 20 IU/mL, whichever is greater
Thyroid microsomal antibody (Anti-TPO)
kU/L IU/mL ± 2 SD or ± 20 IU/mL, whichever is greater
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
Viral Markers
Program Description 3.0 mL – Plasma – For Anti-HIV, HIV antigen, and/or Hepatitis testing. Anti-HIV and HIV-1 p24 antigen is for standard or confirmatory methods only. For rapid HIV antibody and antigen methods, see Catalog #432/#433 – Rapid HIV on page 123.
Program Information
417 – Viral Markers
Analytes
Anti-HAV (total and IgM) ►Anti-HAV (IgG) Anti-HBc (total and IgM) Anti-HBs, qualitative and quantitative Anti-HCV Anti-HIV-1 Anti-HIV-2 Anti-HIV-1/2 Anti-HIV-1/2 Confirmatory Anti-HIV-1/2, p24 Antigen HBsAg HBsAg Confirmatory
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
PROGRAM ANALYSIS – IMMUNOHEMATOLOGY
► Analyte is not CAP accepted. 126 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
ABO/Rh
Program Description 3.0 mL – 4% Cell Suspension – For ABO/Rh testing.
Program Information
511 – ABO/Rh
Analytes
ABO Group D (Rho) Type
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
Antibody Elution
Program Description 2.0 mL – 50% Cell Suspension – For antibody elution testing on non-ABO antibodies.
Program Information
516 – Antibody Elution
Analytes
Antibody Elution
Format Shipping Dates
2 samples x 2 shipments April 1st and December 2nd
Antibody Titer – A
Program Description 2.0 mL – Serum – One serum sample for anti-A titer and one red cell sample (4% suspension) to be used as titer cell.
Program Information
519 – Antibody Titer – A
PROGRAM ANALYSIS – IMMUNOHEMATOLOGY
► Analyte is not CAP accepted. 127 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Antibody Titer - A continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean Anti-A (IgM and IgG) titer - - -
Format Shipping Dates
1 sample x 2 shipments April 1st and December 2nd
Antibody Titer – D
Program Description 2.0 mL – Serum – One serum sample for anti-D titer and one red cell sample (4% suspension) to be used as titer cell.
Program Information
520 – Antibody Titer – D
Analytes Standard Units Conventional Units AV from Consensus
Mean
Anti-D titer - - -
Format Shipping Dates
1 sample x 2 shipments April 1st and December 2nd
Antibody Titer – AD
Program Description 2.0 mL – Serum – One serum sample for anti-A titer, one serum sample for anti-D titer, and one red cell sample (4% suspension) to be used as titer cell.
Program Information
521 – Antibody Titer – AD
Analytes Standard Units Conventional Units AV from Consensus
Mean Anti-A (IgM and IgG) titer - - - Anti-D titer - - -
PROGRAM ANALYSIS – IMMUNOHEMATOLOGY
► Analyte is not CAP accepted. 128 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Antibody Titer - AD continued…
Format Shipping Dates
2 samples x 2 shipments April 1st and December 2nd
Automated Blood Bank
Program Description Includes five samples of CPD anticoagulated whole blood (4.0 mL each) and one donor red cell suspension (2.0 mL) for compatibility testing and antigen typing. Compatible with Bio-Rad, Grifols, Immucor, and Ortho blood bank analyzers. For manual methods, see Catalog #512 – Blood Bank on page 129.
Program Information
517 – Automated Blood Bank E17 – Automated Blood Bank – Verification Program
Analytes ABO Group ABO Subgroup Antibody Identification Antibody Screen Antigen Typing Compatibility Testing D (Rho) Type
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
Automated Blood Bank with Electronic Crossmatch
Program Description Includes five samples of CPD anticoagulated whole blood (4.0 mL each) and one donor red cell suspension (2.0 mL) for compatibility testing and antigen typing. Two donor red cell suspensions (2.0 mL each) with corresponding simulated ISBT donor unit labels are included for electronic crossmatch. Compatible with Bio-Rad, Grifols, Immucor, and Ortho blood bank analyzers. For manual methods, see Catalog #532 – Blood Bank with Electronic Crossmatch on page 130.
Program Information
537 – Automated Blood Bank with Electronic Crossmatch
PROGRAM ANALYSIS – IMMUNOHEMATOLOGY
► Analyte is not CAP accepted. 129 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Automated Blood Bank with Electronic Crossmatch continued…
Analytes
ABO Group ABO Subgroup Antibody Identification Antibody Screen Antigen Typing Compatibility Testing Electronic Crossmatch D (Rho) Type
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
Blood Bank
Program Description Includes five samples (2.0 mL each) of a 4% red cell suspension and five samples of corresponding serum (3.0 mL each). One donor red cell suspension (2.0 mL) is also included for compatibility testing and antigen typing. For automated blood bank methods, see Catalog #517 – Automated Blood Bank on page 128.
Program Information
512 – Blood Bank E12 – Blood Bank – Verification Program
Analytes
ABO Group ABO Subgroup Antibody Identification Antibody Screen Antigen Typing Compatibility Testing D (Rho) Type
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
PROGRAM ANALYSIS – IMMUNOHEMATOLOGY
► Analyte is not CAP accepted. 130 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Blood Bank with Electronic Crossmatch
Program Description Includes five samples (2.0 mL each) of a 4% red cell suspension and five samples of corresponding serum (3.0 mL each). One donor red cell suspension (2.0 mL) is also included for compatibility testing and antigen typing. Two donor red cell suspensions (2.0 mL each) with corresponding simulated ISBT donor unit labels are also included for electronic crossmatch. For automated blood bank methods, with electronic crossmatch, see Catalog #537 – Automated Blood Bank with Electronic Crossmatch on pages 128-129.
Program Information
532 – Blood Bank with Electronic Crossmatch
Analytes
ABO Group ABO Subgroup Antibody Identification Antibody Screen Antigen Typing Compatibility Testing Electronic Crossmatch D (Rho) Type
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
DAT
Program Description 1.0 mL – 4% Cell Suspension – For DAT testing.
Program Information
514 – DAT E14 – DAT – Verification Program
Analytes Direct Antiglobulin Testing
Format Shipping Dates
2 samples x 3 shipments April 1st, August 5th, December 2nd
PROGRAM ANALYSIS – IMMUNOHEMATOLOGY
► Analyte is not CAP accepted. 131 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
DAT – Automated
Program Description 4.0 mL – 15% Cell Suspension – For automated DAT testing methods.
Program Information
534 – DAT – Automated
Analytes Direct Antiglobulin Testing
Format Shipping Dates
2 samples x 3 shipments April 1st, August 5th, December 2nd
Educational Blood Bank
Program Description Sample volume varies by event. 1-2 serum samples and/or 1-2 red cell samples for special challenges in antibody detection and identification.
Program Information
518 – Educational Blood Bank
Analytes
Antibody Identification
Format Shipping Dates
3 shipments April 1st, August 5th, December 2nd
Fetal RBC
Program Description 2.0 mL – Whole Blood – For fetal screen, Kleihauer-Betke, and flow cytometry.
Program Information
515 – Fetal RBC
PROGRAM ANALYSIS – IMMUNOHEMATOLOGY
► Analyte is not CAP accepted. 132 | Program is included in our A2LA scope of accreditation.
All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com
Fetal RBC continued…
Analytes Standard Units Conventional Units AV from Consensus
Mean ►F Cell Value (by flow cytometry)
- - -
Fetal Screen - - - Hemoglobin F, quantitative
% % ± 2 SD or ± 0.6,
whichever is greater
Format Shipping Dates
2 samples x 3 shipments April 1st, August 5th, December 2nd
Rh Slide Test
Program Description 0.5 mL – 35-45% Cell Suspension – For laboratories using slide methodology or Eldoncards for Rh typing.
Program Information
513 – Rh Slide Test
Analytes
D (Rho) Type
Format Shipping Dates
5 samples x 3 shipments April 1st, August 5th, December 2nd
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com 133 |
Paperless Proficiency Testing Entering Results Online
1) Log in to Paperless Proficiency Testing.
a. When you open your browser window, type the web address into the address bar [www.api-pt.com]. A link, bookmark, or search engine may not load the most recent version of the website.
b. Once on the API homepage, click the “Login” button in the teal section, directly underneath “Paperless Proficiency Testing.”
c. Enter your User ID in the designated field. When entering the password, turn the Caps Lock button off and use the Shift key for any capital letters.
d. If you need to reset your password, click “Lost your password?” and follow the instructions on the screen.
1
1d
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com 134 |
2) Once you are logged in, move the cursor over “Enter Results” in the teal section, located on the left-hand side of the screen.
3) Click on “Current Events.”
4) Click on the current event (i.e. “Hematology – 1st Event (Kit 1)”).
a. Current events are events that have kits shipping out that day or kits that have already shipped.
b. Upcoming events are events that will be shipping out within the next two weeks. Early method entry is available by clicking the icon to the right of the event name.
c. If you need to print copies of worksheets and/or instructions, click on “Instructions & Worksheets” in the “View” column and select the desired option.
2 3
4a
4b
4c
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com 135 |
5) On the “Enter or Review Test Results” page, you should see a list of the tests that your facility is enrolled in for the current event, as well as the corresponding sample IDs for each test.
6) Click on the test name (i.e. “Hematology – 5S”).
New Test Enrollment: If your facility does not have a history of reporting for this test, you will see a list of all available analytes, with no method identified. If you enter results for an analyte, you must select a method or the system will not allow you to transmit results to API.
5
6
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com 136 |
Continued Test Enrollment: If your facility has a history of reporting for this test, you will see a list of the analytes that your facility reported during the previous test event. Beneath each analyte, the last reported method will also be listed.
a. Any additional, reportable, analytes can be selected from the “Additional Analytes” section at the bottom of the screen.
7) Input your results.
a. Depending on the nature of the test, you may need to enter numerical values, select a result from a drop-down menu, or click-to-highlight an option from a list.
8) Once you are finished entering your results, click “Save Results” at the bottom of the screen.
6a
7 7
8
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com 137 |
9) When you have finished entering results for a test, a will appear to the left of the test name. If you have not selected a test method for all analytes where results have been entered or, if you have not entered all expected results, an will appear to the left of the test name.
a. There may be situations where a test name will not have a or an after you have entered results. For example, if a facility is enrolled in the 277-Cell Count and Body Fluid Crystals program and only performs a manual cell count, the “Manual Cell Count” test name will have a but it will remain blank next to the Body Fluid Crystal test name.
In cases like this one, you will be able to submit without the green check mark. Please be sure that your lab does not perform the test before you submit. If you have questions about this type of situation, please contact API Customer Service.
10) Once you have entered all results for the event (and verified that they have been transcribed correctly), click “Results Complete, Go to Next Step,” located beneath the Samples section.
9
10
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com 138 |
11) On the “Attestation Statement” page, you have the ability to enter and/or update the “Lab Director (or Designee),” as well as the “Person or persons performing the test.”
12) When everything is complete, click “Transmit to API.”
a. After you transmit your results to API, you have two hours during which you are able to unsubmit the results and make corrections. After that two hour window, you will need to contact API Customer Service to discuss whether or not a correction can be made. The two hour window is only in effect if it is still prior to the deadline time on the due date.
11
12
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com 139 |
Paperless Proficiency Testing Sub-User Accounts
Because there can only be one primary accountholder, API offers the Sub-User Account feature, which allows you to create sub-accounts with special permissions for other lab personnel. There are two types of Sub-User Accounts that can be created: a Sub-User with Supervisory Rights and a non-supervisory Sub-User.
• Sub‐Users with Supervisory Rights have the ability to review and submit results for all sample sets. They will receive the same reminder emails as the primary accountholder, excluding tracking number emails. They will receive due date reminders if that option is selected during account creation. They are also able to create other Sub-User accounts, as well as delete and edit non-supervisory Sub‐User accounts.
• Non-Supervisory Sub‐Users are only able to enter and save results for sample sets that have been assigned to them by the primary accountholder or a Sub-User with Supervisory Rights. Once a Non-Supervisory Sub-User enters and saves results, they are considered “locked” and can only be unlocked by the primary user or a Sub-User with Supervisory Rights. They will receive limited email notifications regarding the account and will only receive due date reminders if that option was selected during the account set‐up. They cannot edit their own accounts or any other Sub‐User accounts. Non-Supervisory Sub-Users cannot submit any results, even if the test is assigned to them.
Creating a Sub-User with Supervisory Rights:
1) Log in to Paperless Proficiency Testing.
a. See login tips on page 133.
1
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com 140 |
2) Once you are logged in, move the cursor to “My Account” in the teal section, located on the left-hand side of the screen.
3) Click on “Manage Sub-Users.”
4) On the “My Account – Manage Sub-Users” page, click on “click to Add User.”
5) On the “Account Settings – Advanced Options – Add User” page:
2
3
4
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com 141 |
a. Enter the name of the new Sub-User in the “Name” field.
b. Enter the Sub-User’s email address in the “Email field.
c. Under “Options,” check the box next to “Check to allow this person to review all results and to submit results to API (‘Supervisory Rights’).”
i. Please note: The list of tests in the “Sample Sets Available to Assign” section will become disabled and analytes cannot be selected because a Sub-User with Supervisory Rights has access to all tests.
d. Under “Options,” check the box next to “Check if this person should receive due date reminder emails,” if desired.
6) When all information is complete, click “Save and email password link to new user.”
a b
c
d
6
5
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com 142 |
7) The new sub-user will receive an email with his/her newly created User ID and a link to set up a password. They will be able to log in to the API website immediately after the account has been created and the password has been set up.
Creating a Non-Supervisory Sub-User:
• Follow Steps 1-4 from “Creating a Supervisory Sub-User.”
5) On the “Account Settings – Advanced Options – Add User” page:
a. Enter the name of the new Sub-User in the “Name” field.
b. Enter the Sub-User’s email address in the “Email field.
c. Do not check the box under “Options” next to “Check to allow this person to review all results and to submit results to API (‘Supervisory Rights’).
d. Under “Options,” check the box next to “Check if this person should receive due date reminder emails,” if desired.
a b
c
d
8
5
6 a x
7
800-333-0958 (toll free) +1-231-941-5887 (international) www.api-pt.com 143 |
6) Under “Sample Sets Available to Assign,” select the tests that should be assigned to this sub-user. To select more than one sample set at a time, hold the CTRL button down while clicking on the name of the test.
a. Please note: You may assign the same sample set to multiple users. To do this, check the box next to “Show All” under “Sample Sets Available to Assign.” Once that has been done, you will see the entire list of sample sets ordered for your facility and you may assign them as you usually would.
7) Once the tests are selected, click the arrow button that points toward the “Sample Sets Assigned to This Person” section on the right-hand side. The selected tests should move to the “Sample Sets Assigned to This Person” section.
8) When the selected tests show in the “Sample Sets Assigned to This Person” section and all other information is complete, click “Save and email password link to new user.”
9) The new sub-user will receive an email with his/her newly created User ID and a link to create his/her password. They will be able to log in to the API website immediately after the account has been created.
10) Once a Non-Supervisory Sub-User enters results and saves them, only the primary accountholder or a Sub-User with Supervisory Rights can “unlock” the results for editing by double-clicking on the padlock next to the locked sample set.
Editing a Sub-User:
• Only the primary user on an account may edit a sub-user account. A supervisory sub-user can create another sub-user account but cannot edit or delete any type of sub-user account.
• Follow Steps 1-3 from “Creating a Supervisory Sub-User.”
4) Locate the Sub-User account that you wish to edit and the click “Edit” button, located at the right end of the row.
5) On the “Account Settings – Advanced Options – Edit User” page, all of the current information for the selected sub-user will appear.
6) Make the necessary changes.
7) Click “Save” at the bottom of the page.
a. Please note: If you are changing the email address for an existing Sub-User, an email with the User ID and a link to reset the password will not be sent. If you need to have the password reset, click the “Login” button underneath “Paperless Proficiency Testing,” then click “Lost your password?” Enter the User ID and the new email address and click “Send Reset Instructions.”
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Deleting a Sub-User:
• Repeat Steps 1-3 from “Creating a Supervisory Sub-User.”
4) Locate the Sub-User account that you wish to delete and click the “Edit” button, located on the right side of the row.
5) On the “Account Settings – Advanced Options – Edit User” page, all of the current information for the selected sub-user will appear.
6) Click the “Delete User” button, located to the right of the displayed User ID.
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7) Click “Confirm Delete” at the bottom of the page.
8) On the “My Account – Manage Sub-Users” page, you should see that the sub-user is no longer listed.
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Paperless Proficiency Testing Viewing Evaluation Reports
1) Log in to Paperless Proficiency Testing
2) Once you are logged in, select “Evaluation Reports” in the teal section, on the left-hand side of the screen.
3) Each Evaluation Report consists of four components:
a. Cover Page: This is the cover sheet for your proficiency testing evaluation. It contains information about the laboratory, including the shipping contact information, the API#, CLIA#, which agencies and/or managers receive report copies, shipping reminders, and a section for Performance Review and Corrective Action. This can be accessed by downloading a PDF of the full evaluation.
b. Performance Summary: This is a summary of your proficiency testing performance for the last three test events. It is divided into sections according to specialty/sub-specialty. The scores for individual analytes are expressed as a percentage (ratio of acceptable responses to the number of samples tested).
c. Comparative Evaluation: This report shows the analyte tested, test method used, samples tested (Sample IDs), reported result, expected result, mean, Standard Deviation (SD), Standard Deviation Interval (SDI), and Performance.
d. Participant Data Summary (PDS): This is a summary of all of the proficiency testing data for the given event. It contains drop-down menus that allow you to select a specific analyte, peer group, and sample number, for which you can then view statistical information including the number of labs reporting, the mean, the Standard Deviation, the Range (for quantitative analytes) or the correct response, the reported responses, and the number of labs reporting for each response (qualitative analytes). The PDS can be accessed by clicking on “Participant Data Summaries” on the left-hand side of the screen.
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4) On the “Evaluation Reports” page, there are a few options for how to view and print your Evaluation Reports.
To View or Print a PDF - Full Evaluation:
a. Locate the year, program, and event number you wish to view.
b. Under the “Full Eval” column, click on the PDF icon for the selected event.
c. Follow the prompts generated by your Internet Browser (i.e. Explorer, Chrome, Firefox) to open the PDF.
d. View or print, as desired.
To View or Print Performance Summary Only:
a. Locate the year, program, and event number you wish to view.
b. Under the “Test Event Performance” column, click “Review” or “Failures,” as shown.
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c. You may print using “Print This Screen” or “Print Report (PDF),” as desired.
To View or Print Comparative Evaluation Only:
a. Locate the year, program, and event number you wish to view.
b. Under the “Comparative Evaluation” column, click the program name, event number, and kit number you wish to view.
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c. You may print using two options: Print This Screen or Print Report (PDF), as desired.
Viewing Grading Criteria
1) On the “Evaluation Reports” page, under the “Comparative Evaluation” column, click the program name, event number, and kit number you wish to view.
2) Click “View Grading Criteria”
3) A new window will open with a complete list of the grading criteria.
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Viewing Statistics
1) On the “Evaluation Reports” page, under the “Comparative Evaluation” column, click the program name, event number, and kit number you wish to view.
2) Locate the analyte and sample number for which you wish to view statistics.
3) Click “View” in the “Statistics” column, located on the right side of the screen.
4) A new internet window will open. If desired, you may print the statistics information by clicking “Print” in the top, right-hand corner.
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Corrective Action
In the event of failures, API offers blank forms that can be used for documentation of Corrective Action. The two different forms available are listed below, followed by instructions on how to access them.
• Checklist for Corrective Action: This form is designed to offer assistance to laboratories with investigating and troubleshooting proficiency testing failures.
• Corrective Action Form: This form allows laboratory personnel to document the corrective action taken for each failed analyte. The form can then be printed and retained for the laboratory’s records, along with the evaluation report.
1) Log in to Paperless Proficiency Testing.
2) Once you are logged in, select “Evaluation Reports” in the teal section, on the left-hand side of the screen.
For the “Checklist for Corrective Action”:
a. On the “Evaluation Reports” page, click on “Checklist for Corrective Action.” This will allow you to open the form and view or print it, as desired.
For the Corrective Action Form:
b. On the “Evaluation Reports” page, locate the year, program, and event number for which you want a Corrective Action Form.
c. Under the “Corrective Action” column, click on the PDF icon for the selected event.
d. Follow the prompts generated by your Internet Browser (i.e. Explorer, Chrome, Firefox) to open the fillable PDF.
e. View or print, as necessary.
i. Please note: It is possible to generate a Corrective Action Form for all events, regardless of whether or not failures occurred.
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Paperless Proficiency Testing DataDashboard Information and Instructions
With DataDashboard you can quickly and easily view proficiency performance over the most recent six test events, including:
• Trending data by analyte • Percentage of acceptable results compared to all API labs • Failure count by test event • Analytes with unsatisfactory, unsuccessful, and repeat unsuccessful performance
How to Access the API DataDashboard:
1) Log in to Paperless Proficiency Testing.
2) Select “API DataDashboard” on the left-hand side of the page.
3) From the drop down menu, select the Discipline you wish to view (e.g. “Chemistry”).
a. Please note: Chemistry Core and Chemistry Miscellaneous are included in “Chemistry.” Mycobacteriology, Mycology, and Dermatophyte are included in “Microbiology.”
The Basics:
• For each graph, you have the ability to “Reset” the view, click the “Help” button for more information, or “Collapse” the window.
• For each performance panel, you have the ability to “Expand” the group, click the “Help” button for more information or “Collapse” the window
• If you would like to customize your view, you can move the windows by clicking on the heading and dragging it to the desired area (see example on the following page).
Collapse
Help Reset
Collapse
Help
Expand
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o Please note: If you move a graph to the right-hand side of the page, it will automatically resize.
• Zoom In/Zoom Out: It is possible to zoom in and out on the graphs using the scroll wheel on your mouse or a trackpad.
• Print: You may print your screen by clicking the “Print” button, located at the top right hand corner of the page.
How to Navigate the Performance Dashboard:
• Once you have selected a Discipline, seven panels will appear on the screen.
• On the left-hand side, there are two graphs:
1) Failure Count by Event
o This graph shows the total number of failures over the past six events, for the selected Discipline.
o If you click on a data point, it will open the Failures Summary for that test event.
o Please note: For the Chemistry and Microbiology Disciplines, you may see a bar chart when you click on a data point. This will show you the number of failures in each category (e.g. Chemistry Core and Chemistry Miscellaneous).
o If you click on the column, it will open your lab’s Failures Summary for the selected test event.
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2) Acceptable % by Event
o This graph shows the percentage of your results that were acceptable over the past six events compared to the average of all API labs, for the selected Discipline.
o If you click on a data point, it will open your lab’s Comparative Evaluation.
o Please note: For the Chemistry and Microbiology Disciplines, you may see a bar chart when you click on a data point. If you click on the column, it will open your lab’s Comparative Evaluation for the selected test event.
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• On the right-hand side, there are five expandable sections that will show:
1) Analytes with unsatisfactory performance
o Analytes listed as Unsatisfactory have had only one test event with a score below 80% (100% for ABO Group, D (Rh) Typing, and Compatibility). If another failure for this analyte occurs in either of the next two consecutive events, this analyte will transition to the unsuccessful performance section.
o If you wish to see more information on the “unsatisfactory” analyte, you can expand the panel to view the analyte name, the reported method, and the specific event.
o If you click on the Analyte Name, it will open your Failures Summary for that test event.
2) Analytes with unsuccessful performance
o Analytes listed as Unsuccessful have had two or more test events with scores below 80% (100% for ABO Group, D (Rh) Typing, and Compatibility), in the last three events.
Collapse
Expand
Analyte Name Reported Method Specific Event
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o If you wish to see more information on the “unsuccessful” analyte, you can expand the panel to view the analyte name, the reported method, and the most recent event with a failure (see example on following page).
o If you click on the Analyte Name, it will open your Failures Summary for that test event.
3) Analytes with repeat unsuccessful performance
o Analytes listed as Repeat Unsuccessful have had scores below 80% (100% for ABO Group, D (Rh) Typing, and Compatibility) for two test events, twice in the last six test events.
o If you wish to see more information on the “repeat unsuccessful” analyte, you can expand the panel to view the analyte name, the reported method, and the most recent event with a failure.
o If you click on the Analyte Name, it will open your Failures Summary for that test event.
Analyte Name Reported Method Most Recent Event with a Failure
Collapse
Expand
Analyte Name Reported Method Most Recent Event with a Failure
Collapse
Expand
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4) SDI Performance and Trending Analysis
o The graphs represent lab performance on quantitative tests for the most recent three test events. The dots represent the SDI of results (number of Standard Deviations from the Comparison Group Mean) on each sample tested. Please note that grading for many analytes is not based on SD so these graphs do not represent grading of results. Instead they show results in relation to other labs in the peer group.
o To view the trending data, click the “Load Graphs” button.
o Once the line graphs have loaded, click on any data point to view the statistics for the peer group.
5) Export Evaluation Data
o This export feature allows you to download your evaluation data for the selected Discipline in a CSV file format.
o The Analyte Detail option exports individual result data, including mean and SDI.
When you select the Year and Event from the drop-down menus, click “Export Data” and the file will download.
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o The Performance Summary option exports performance and score information.
When you select the Year, Event, Scored for CMS, and Performance that you wish to view, click “Export Data” and the file will download.
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Continuing Education
Physicians, Medical Laboratory Scientists (MLS), and Medical Laboratory Technicians (MLT) can earn up to 18 free CME or CMLE credits per year through an arrangement between API and the American Society for Clinical Pathology (ASCP). Multiple credits are offered each year in Chemistry, Microbiology, Hematology, and Immunology. Credits are also occasionally offered in Blood Banking, Coagulation, Microscopy, and Laboratory Management. Each educational exercise is available for between three and four months. The number of exercises available at any one time will vary and the number of earned credits depends on individual participation.
The acceptability of the credits provided by API is up to the organization requiring you to earn continuing education credits. Please check with the organization setting your requirements to determine if these credits will be accepted.
To Enroll in a Free Continuing Education Account:
1) Log in to Paperless Proficiency Testing (like you would if you were going to enter PT results).
2) Once you are logged in, click “Enroll” in the blue section, under “Continuing Education,” on the left-hand side of the screen.
3) Complete the fields with the requested information then click “Enroll.”
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4) If the enrollment is successful, the information in the fields will disappear and you will receive a message that says, “The enrollment is complete and an email has been sent to the designated person.”
5) Additional staff members can be signed up at any time.
To Log in to a Continuing Education Account – Already Enrolled:
1) When the account is created, the User ID and a link to set up a password will be sent to the email address on the account.
a. If the user has forgotten his/her User ID and password, click on “Login” under
“Continuing Education.” Then click “Lost Your Password?” and enter the correct email address. An email with the login information will be resent.
2) Click the link and follow the instructions to set up your password.
3) Once the password has been created, click the “Login” button in the blue section, directly underneath “Continuing Education.”
4) Enter your User ID in the appropriate field. When entering the password, turn the Caps Lock button off and use the Shift key for all capital letters.
5) Once logged in, you will be prompted to enter additional information. Read the paragraph on Identifying Information and then either fill out the section with your birthdate and ASCP BOC Certification Category & Number or check the box that says “I decline to have my transcripts sent electronically to any organization.”
6) If the account is activated successfully, you will now see a button that will allow you to change your password, if you choose. Account settings can be updated at any time, when logged in, by clicking on “My Account.”
How to Earn CE Credits:
1) Log in to Continuing Education.
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2) Select “Earn CE Credits” in the blue section. Available exercises will be listed under their respective categories.
3) Click on the name of the exercise.
a. “Step 1” provides a link to the ASCP educational commentary that is related to the questions. The commentary is in a PDF format and should open when you follow your browser’s prompts.
b. “Step 2” provides instructions to answer the multiple-choice questions shown on the screen and an option to print the questions. Please note: If you print the questions, the answers still need to be submitted on the website to earn credit.
4) Once you’ve answered all of the questions, click “Submit for Credit” at the bottom of the screen.
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5) Correct answers will be highlighted in green. Incorrect answers will be highlighted in red. All answers must be correct for credit to be awarded.
6) Once all answers are correct, you will be able to continue to the next screen and you will be asked to participate in an optional survey that will allow you to provide feedback on the exercise.
7) Repeat Steps 2-6 to earn additional credits for other available exercises.
To View Credits
1) Log in to Continuing Education
2) Select “Credits Awarded” in the blue section, under the “Continuing Education” heading.
3) Click on the name of the exercise. Follow your browser’s prompts to open the certificate as a PDF.
4) Repeat Steps 2-3 for different activities to print additional certificates.
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Please note: New courses are posted around the same time that evaluations are available online (or approximately one week after another exercise’s posted expiration date). Credits are transmitted to ASCP electronically two times per month.
These instructions may not cover all of the issues and/or questions that you may encounter. If, at any time, you have a question about Continuing Education accounts, please contact API Customer Service. We will be happy to answer your questions or help walk you through any of these process!
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Appendix A
Cell Count/Hematology/Sedimentation Rate Instrument List
Body Fluid Cell Count Methods and Programs
Instrument/Method Program Abbott Cell-Dyn (all models) 206 Coulter (all models) 206 Iris iQ®200 207 Siemens Advia 120/2120 206 Sysmex (all models) 206 Manual Count 277
Hematology Analyzers and Programs
Instrument/Method Program Abbott Cell-Dyn (1400 thru 1800) 221 Abbott Cell-Dyn (3000 thru 5000) 242 Abbott Cell-Dyn Emerald 221 Abbott Cell-Dyn Emerald 22 242 Abbott Cell-Dyn Ruby, Sapphire 242 CDS Medonic CA 221 CDS Medonic M-Series 227 Coulter AcT-5 231 Coulter Ac-T (all 3-part differential models) 221 Coulter HmX 220 Coulter LH500, MAXM, STKS 220 Coulter LH 750, 755, 780, 785 230 Coulter Micro Diff (all models) 221 Coulter UniCel DxH 300 221 Coulter UniCel DxH 500 279 Coulter UniCel DxH 600, 800, 900 230 Diatron Abacus 3CP 221 Diatron Abacus 5 242 Drew (Danam) Excell 16 221 Drew D3, Evolution 221 HemoCue - for WBC only (all models) 209 Horiba ABX Micros (all models) 221 Horiba ABX Pentra (all models) 231 Mindray 5000 Series 226 Mindray BC (all models) 221 QBC Autoread, Autoread Plus 222 QBC Manual Reader 222 Siemens Advia 120, 2120 240
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Siemens Advia 60 221 Siemens Advia 560 242 Sysmex KX Series, pocH-100i, and XP-300 227 Sysmex XW-100 Not available Sysmex XE, XN, XN-L, XS, XT (all models) 238
Sedimentation Rate Methods and Programs
Instrument/Method Program Alcor i-Sed 203 Alifax ESR 280 Chase Westergren 830 SO 228 Diesse Mini-Cube 228 Dispette, Dispette 2 228 Globe Scientific (all methods) 228 HemaTech ESR STAT PLUS, STAT 180 202 MiniVes 228 Polymedco Sedimat 15, 15 Plus 201 Polymedco Sedimat/Sediplast 228 Sedifast, Sediplast, Sediten, Seditube 228 Streck/Analys ESR, Auto ESR Plus (all methods) 228 Ves Matic (all models) 228 Vital Diagnostic Excyte (all models) 228 Winpette 228
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Appendix B
Analytes Included in Molecular Multiplex Panels
368 - Blood Pathogen Panel Molecular Bacti – Blood
Acinetobacter sp. Listeria monocytogenes Acinetobacter baumannii Neisseria meningitidis Citrobacter sp. Proteus sp. Enterobacteriaceae Pseudomonas aeruginosa Enterobacter sp. Serratia marcescens Enterobacter cloacae complex Staphylococcus sp. Enterococcus sp. Staphylococcus aureus Enterococcus faecalis Staphylococcus epidermidis Enterococcus faecium Staphylococcus lugdunensis Escherichia coli Streptococcus sp. Haemophilus influenzae Streptococcus agalactiae Klebsiella oxytoca Streptococcus anginosus group Klebsiella pneumoniae Streptococcus pneumoniae Listeria sp. Streptococcus pyogenes
Molecular Mycology – Blood Candida albicans Candida parapsilosis Candida glabrata Candida tropicalis Candida krusei
Molecular Resistance Genes - Blood Resistance Gene: mecA Resistance Gene: CTX-M Resistance Gene: vanA/B Resistance Gene: IMP Resistance Gene: vanA Resistance Gene: NDM Resistance Gene: vanB Resistance Gene: OXA Resistance Gene: KPC Resistance Gene: VIM
369 – GI Panel Molecular Bacti – GI
Campylobacter sp. Shigella EAEC Shigella / EIEC EPEC Vibrio E. coli O157 Vibrio cholerae Plesiomonas shigelloides Yersinia enterocolitica Salmonella
Molecular Parasite – GI Cryptosporidium Entamoeba histolytica Cyclospora cayetanensis Giardia lamblia
Molecular Toxin - GI C. difficile Toxin A/B Shiga Toxin 1 ETEC lt/st Shiga Toxin 2 STEC stx1/stx2
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369 – GI Panel continued… Molecular Virology - GI
Adenovirus F 40/41 Rotavirus A Astrovirus Sapovirus Norovirus GI/GII
370 – Respiratory Panel Molecular Bacti – Respiratory
Bordetella holmesii B. parapertussis/bronchiseptica Bordetella pertussis Chlamydophila pneumoniae Bordetella parapertussis Mycoplasma pneumoniae
Molecular Virology – Respiratory Adenovirus Influenza A / H1-2009 Coronavirus 229E Influenza B Coronavirus Parainfluenza 1 Coronavirus HKU1 Parainfluenza 2 Coronavirus NL63 Parainfluenza 3 Coronavirus OC43 Parainfluenza 4 Human Metapneumovirus (hMPV) Respiratory Syncytial Virus Human Rhinovirus / Enterovirus RSV A Influenza A RSV B Influenza A H1 Rhinovirus Influenza A H3
371 – Meningitis Panel Molecular Bacti – Meningitis
Escherichia coli K1 Neisseria meningitidis Haemophilus influenzae Streptococcus agalactiae Listeria monocytogenes Streptococcus pneumoniae
Molecular Virology – Meningitis Cytomegalovirus Human herpesvirus 6 Enterovirus Human parechovirus Herpes simplex virus 1 Varicella zoster virus Herpes simplex virus 2
Molecular Mycology - Meningitis Cryptococcus neoformans/gatti
376 – Vaginal Panel Molecular Bacti – Vaginitis
Bacterial Vaginosis Molecular Parasite – Vaginitis
Trichomonas vaginalis
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369 – Vaginal Panel continued… Molecular Mycology – Vaginitis
Candida Group Candida krusei Candida glabrata
378 – Pneumonia Panel Molecular Bacti – Pneumonia
Acinetobacter calcoaceticus- baumannii (ACB) complex
Moraxella catarrhalis Mycoplasma pneumonia
Chlamydia pneumoniae Proteus sp. Enterobacter cloacae Pseudomonas aeruginosa Escherichia coli Serratia marcescens Haemophilus influenza Staphylococcus aureus Klebsiella aerogenes Streptococcus agalactiae Klebsiella oxytoca Streptococcus pneumoniae Klebsiella pneumonia group Streptococcus pyogenes Legionella pneumophila
Molecular Resistance Genes – Pneumonia Resistance Gene: CTX-M Resistance Gene: NDM Resistance Gene: IMP Resistance Gene: OXA-48-like Resistance Gene: KPC Resistance Gene: VIM Resistance Gene: mecA/C & MREJ
Molecular Virology – Pneumonia Adenovirus Influenza A Coronavirus Influenza B Human Metapneumovirus Parainfluenza virus Human Rhinovirus/Enterovirus Respiratory Syncytial Virus
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Glossary of Terms and Abbreviations
A2LA: American Association for Laboratory Accreditation
AOA: American Osteopathic Association
API DataDashboard: Performance analysis dashboard that allows API customers to view trend data by analyte, percentage of acceptable results compared to all API labs, failure count by test event, and analytes with unsatisfactory performance.
API DataDirect: Feature that allows API customers to use their LIS or middleware to upload proficiency testing results directly to the API website.
API ImageViewer: Feature that allows API customers to view virtual images while logged into their Paperless Proficiency Testing account. While using the ImageViewer, customers are able to scan the slide to view other cells (in addition to the cells selected for identification) and can utilize other features like measurement and magnification tools.
CMS: Centers for Medicare and Medicaid Services
CLIA ’88: Clinical Laboratory Improvement Amendments of 1988
CAP: College of American Pathologists
CE/CME: Continuing Education/Continuing Medical Education
Corrective Action: Action taken by the testing facility to identify and correct any deficiency resulting in a proficiency testing failure.
Evaluation Report: Detailed report indicating a testing facility’s performance during an event. Includes Performance Summary Report and Comparative Evaluation.
HFAP: Healthcare Facilities Accreditation Program
Homogeneity: In the context of proficiency testing, homogeneity refers to the extent that all PT samples of the same sample ID (e.g. CH-01) are of the same state and quality, meaning the expectation is that they will return the same results.
LAP: CAP’s Laboratory Accreditation Program
Paperless Proficiency Testing (PPT): Feature that allows API customers to manually enter, review, and submit their PT results on the API website. PPT also allows API customers to review evaluation reports, utilize the API ImageViewer and API DataDashboard, and customize several aspects of their API account.
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Participant Data Summary (PDS): Section of the API website that contains the quantitative and qualitative statistical data from participant and referee test results, along with selected interpretive information.
PT: Proficiency Testing
Qualitative: Describing the quality of something in size, appearance, value etc. In the context of PT, qualitative testing refers to testing where the result is either “positive” or “negative” or where it is a categorization, interpretation, or identification (e.g. “moderate,” “yeast seen,” or “monocyte”).
Quantitative: Measuring or relating to something in regards to quantity, rather than quality. In the context of PT, quantitative testing refers to a test where the result is a number, usually with a specific unit of measure attached.
Standard Deviation (SD): A calculation used to indicate the extent of deviation for a group of data.
Standard Deviation Interval (SDI): Describes how far a PT result is from the comparison group mean. Determined by the following calculation:
Your Result - Comparison Group Mean Comparison Group Standard Deviation
TJC: The Joint Commission
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O CAP Accepted ◊ CAP – Accepted PT not required ► Not CAP Accepted
This list is not intended to replace CAP guidelines on required analytes. See the current, online API catalog index for the most up-to-date information on CAP accepted analytes.
Index
Analyte Page
#O 25-OH Vitamin D 36 O 6-Acetylmorphine 48
AO ABO Group 126, 128-130 ◊ ABO Subgroup 128-130O Acetaminophen (TDM) 41O Acetaminophen (UDS) 48◊ Acetone 24O Acid Fast Smears 102O Activated Clotting Time (ACT) 70, 73, 76O Adenovirus 110O Albumin (◊ body fluid, ►CSF Chemistry) 20, 22, 44-47O Alcohol 24, 26O Alcohol (UDS) 48O Alkaline Phosphatase (◊ body fluid) 20, 23, 44O Alpha-1-Antitrypsin 120O Alpha-fetoprotein 20-21O ALT (SGPT) 19, 21, 23 O Amikacin 41 ◊ Ammonia 24 ◊ Amniotic Fluid pH 25 O Amphetamines 48 O Amylase (◊ body fluid) 21, 23, 44, 47 O ANA 141 ◊ Antibody Elution 126 O Antibody Identification and Screen 128-131◊ Antibody Titer – A 126-128◊ Antibody Titer – D 126-128◊ Anti-CCP 115O Anti-DNA (ds, ss) 114◊ Antigen Typing 128-130O Anti-HAV (◊ total) 125► Anti-HAV, IgG 125O Anti-HBc (total and IgM) 125O Anti-HBs 125O Anti-HCV 125O Anti-HIV Confirmatory 125O Anti-HIV-1 and 2 125O Anti-HIV-1/2 123O Anti-RNP 114O Anti-Sm 114► Antisperm Antibody 67O Anti-SSA and SSB 114O Anti-Streptolysin O (◊ titer) 115, 11◊ Anti-TG 125◊ Antithrombin III Activity 71◊ Anti-TPO 125◊ Anti-Xa 75O Apolipoprotein A1, B 25O APTT (►Hemochron Jr. Citrate) 71, 74◊ APTT (Heparin Assay) 75O AST (SGOT) 19, 21, 23O Automated Differential (CBC) 50-58
B◊ Bacterial Vaginosis 89 O Barbiturates 48 O Benzodiazepines 48 O Beta-2 Microglobulin 42 O Beta-hydroxybutyrate (B-Ketone) 26
Analyte Page ◊ Bilirubin, body fluid 44 O Bilirubin, direct and total, serum 19, 21, 23, 39 O Bilirubin, urine (◊ confirmatory) 83-84O Blood Cell Identification 58-59O Blood Culture 90, 92O Blood Parasite 105O Blood/hemoglobin (urine) 83-84
O BNP (► Cat. #920 – only accepted for wvd. methods)
29-30
◊ Body Fluid Cell Count 60 ◊ Body Fluid Chemistry 44 ◊ Body Fluid Crystals 61 ◊ Body Fluid Differential 61 ◊ Body Fluid Microscopy 61 O Bordetella pertussis/parapertussis 90 ► BRCA1/2 DNA Sequencing 115-116O Buprenorphine 48
CO C. difficile Antigen (◊ toxin) 91 O CA 125 42 O CA 15-3 42 O CA 19-9 42 O CA 27.29 42 O Calcium (◊ body fluid) 19, 21, 23, 44, 47 O Calcium, ionized 21, 27, 36-37 O Campylobacter sp. 91-92O Candida (◊ Cat. #376 – Vaginal Panel) 103-116O Cannabinoids 48O Carbamazepine 41O Carboxyhemoglobin 29◊ Carisoprodol 48► CD19 (B Cells) 62► CD3 (T Cells) 62► CD4 (T Helper) 62► CD45 (Leukocytes) 62► CD56/CD16+56 (NK Cells) 62► CD8 (T Cytotoxic) 62O CEA 34, 42O Chlamydia Antigen 92O Chlamydia trachomatis 91-92
O Chloride (◊ CSF, body fluid) 19, 21, 23, 27, 36-37, 44, 47
O Chloride, sweat (►quantitative) 46O Cholesterol (◊ body fluid) 19, 21, 23, 38, 44O CK-MB 29► CMV IgG 120► CMV IgM 120
O CO2 19, 21, 23, 26-27, 36-37
O Cocaine Metabolites 48
O Compatibility Testing (◊ Electronic Crossmatch)
128-130
O Complement C3 & C4 120 O Conductivity, sweat 46 O Cortisol 20-21O Cotinine 48O C-peptide 35O C-Reactive Protein (hs) 118O C-Reactive Protein (quant., qual.) 116O Creatine Kinase (CK) 21, 23, 29O Creatinine (◊ body fluid, urine adult.) 36-37, 44, 46-47, 83
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O CAP Accepted ◊ CAP – Accepted PT not required ► Not CAP Accepted
This list is not intended to replace CAP guidelines on required analytes. See the current, online API catalog index for the most up-to-date information on CAP accepted analytes.
Analyte Page O Cryptococcal Antigen 103 O Cryptosporidium 106 O CSF Culture 92 ◊ Cystatin C 31
D
O D (Rho) Type 126, 128-130, 132 O D-dimer (◊ qualitative) 29-30, 72-73 O Dermatophyte Culture 104 O DHEA-S 34 O Digoxin 41 O Direct Antiglobulin Testing (◊ automated) 130-131
E
O Ear/Eye Culture 92 O EDDP 48 ◊ Electronic Crossmatch 128-130 O Estradiol 34 ► Estriol 34 ► Ethosuximide 41 ◊ Ethyl glucuronide (EtG) 45
F ► F Cell Value (by flow cytometry) 132 ◊ Factor Activity (► Factor VIII) 71-72 ◊ Fecal Lactoferrin 81 ◊ Fecal Occult Blood 81 O Fecal WBC 82 O Fentanyl 48 O Fern Test 82 O Ferritin 34 O Fetal Fibronectin 31 ◊ Fetal Hemoglobin (gastric fluid) 62 ◊ Fetal Membranes Rupture Test 32 O Fetal Screen 515 O Fibrinogen 71 O Folate 34 O Free T3 20, 22, 42 O Free T4 20, 22, 42 ◊ Fructosamine 32 O FSH 34
G
◊ Gastric Occult Blood 82 ► Gastrin 35 O GC Culture 93, 96 O Gentamicin 41 O GGT 21, 23 O Giardia 106
O Glucose (◊ body fluid) 19, 21, 23, 27, 36-38, 44, 47, 83-84
◊ Glucose, Whole Blood (O HemoCue) 34, 43 O Glycohemoglobin (as HbA1c) 33 O Gram Stain (◊ morphology) 92-93 ◊ Gram Stain, Direct 94 ◊ Gram Stain, Vaginitis 94 O Granulocytes (◊ IG#, IG%) 51 O Group A Strep Antigen 87, 89, 93, 95 O Group A Strep (molecular) 99 O Group B Strep (molecular) 95 O Group B Strep Culture 93, 96 O Group C/G Strep (molecular) 99
H
O H. pylori Antibody 117 O H. pylori Antigen, Stool 96 O Haptoglobin 120 O HBsAg & HBsAg Confirmatory 125
Analyte Page ► HBV Viral Load 117 O HCG, serum 40 O HCG, urine (qual.) 83-86 ► HCV genotyping 117-118 ► HCV Viral Load 117-118 ► HCV, qualitative 117-118 O HDL Cholesterol 19, 21, 23, 38
O Hematocrit 27, 29, 36-37, 50-58, 87
O Hemoglobin 27, 29, 34, 36-37, 50-58, 87
O Hemoglobin F, quantitative 132 ◊ Heparin Assay 75 ► HIV-1 RNA Viral Load 118 O Homocysteine 34 O HPV (◊ genotyping) 107-108 O HSV 1 & 2 108 O HSV-2 Antibody 119 ◊ Hydrocodone 48
I O IgA 120 O IgE 116, 120 O IgG (►CSF Chemistry) 44, 120 O IgM, total 120 ◊ India Ink 104 O Infectious Mononucleosis 191, 121-122 O Influenza A (►Silaris) 108-110 O Influenza B (►Silaris) 108-110
O INR (◊ waived, Cat. #278 – Heparin Assay)
71, 74-75, 77-78
O Insulin 35 ◊ IRF 54-55, 58 O Iron 21-22, 35
K
O Ketones (◊ serum qual.) 24 O KOH Preparation 104
L
O Lactate 27, 36-37 O Lactic Acid 21, 44 ◊ Lamellar Body Count 38 O LDH (◊ body fluid) 21, 44 O LDL (◊ calculated) 19, 21, 23, 38 O Lead 28 O Legionella Antigen 97 O Leukocyte Esterase 83-84 O LH 34-35 ► Lidocaine 41 O Lipase (◊ body fluid) 21, 44 O Lipoprotein (a) 25 O Lithium 41 ◊ LSD 48 ◊ Lyme Disease Antibody 122 O Lymph/Mono 51
M
O Magnesium 21, 47 ► Magnesium, ionized (blood gas) 27 ◊ MCH, MCHC, MCV, MPV 50-58 O MDMA 48 O Meningitis Panel (◊ yeast) 112 ◊ Meperidine 48 O Methadone 48 O Methamphetamines 48 O Methaqualone 48 O Methemoglobin 29
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O CAP Accepted ◊ CAP – Accepted PT not required ► Not CAP Accepted
This list is not intended to replace CAP guidelines on required analytes. See the current, online API catalog index for the most up-to-date information on CAP accepted analytes.
Analyte Page O Microalbumin (urine) 45-46
O Molecular Multiplex Panels (bacteria, ◊ parasites, ◊ resistance genes, viruses, ◊ yeast)
111-113
Blood Pathogen Panel 111 GI Panel 111-112 Meningitis Panel 112 ◊ Pneumonia Panel 112-113 Respiratory Panel 113 ◊ Vaginal Panel 113 O MRSA 97-98 ◊ Mumps Virus IgG 120-121 O Mycobacteriology Identification 102-103 ► Mycobacteriology Susceptibility Testing 102-103 ◊ Mycobacterium tuberculosis (molecular) 102 O Mycology Culture 105 ◊ Mycoplasma Antibody 122 O Mycoplasma pneumoniae 98 O Myoglobin (quant., qual.) 29-30
N
O N. gonorrhoeae 92, 93, 96 O N-acetylprocainamide 41 O Nasal Smear 82 O Nitrite (◊ urine adulteration) 47, 84 ◊ nRBC 54-55, 58
O NT pro-BNP (►Cat. #920 – CAP requires 5 sample program)
29-30
O
O Opiates 48 O Osmolality (◊ sweat) 21, 46-47 ◊ Oxidants 47 O Oxycodone 48 O Oxyhemoglobin 29
P
O p24 antigen 123, 125 O PAP 34-35 O Parasitology 106 O Parathyroid Hormone (PTH) 36 O pCO2 26-27, 26
O pH (◊ gastric, body, amniotic fluid, urine adulteration)
26-27, 36-37, 44-45, 47, 82
O Phencyclidine 49 O Phenobarbital 41 O Phenytoin 41 O Phosphorus 21, 23, 47 O Pinworm Preparation 82 ◊ Plasminogen 72 O Platelet Count (◊ IPF) 50-58 ◊ Platelet Function 76-77 O pO2 26-27, 36 O Potassium (◊ body fluid) 27, 36-37, 45, 47 O Prealbumin 35 ► Primidone 41 O Procainamide 41 O Procalcitonin 39 O Progesterone 35 O Prolactin 35 O Propoxyphene 49 ◊ Protein C 71-72 ◊ Protein S 71-72 O Protein, urine (◊ confirmatory) 47, 83-84
O Prothrombin Time (◊ waived, Cat. #278 – Heparin Assay)
71, 74-75, 77-78
O PSA (total, free) 35, 43
Analyte Page ► PSA, complexed 43
Q
O Quinidine 41
R
O RBC (◊ automated body fluid and urine) 50-58, 60-62, 80, 86, 131-132
◊ RDW 50-58 O Reducing Substance 84-85 O Reticulocyte Count (◊ RET He, IRF) 54, 56, 58, 63 O Rheumatoid Factor (◊ titer) 119, 121-123 O Rotavirus Antigen 109 O RSV 110 O Rubella Antigen (◊ titer) 119, 124 ► Rubella IgG 120-121 ► Rubeola Virus IgG 120-121
S
O S. pneumoniae Antigen 99 O Salicylates 41 ◊ Sedimentation Rate 63-65 O Sex Hormone Binding Globulin (SHBG) 40 ◊ Shiga Toxin 98 O Sickle Cell Screen 66
O Sodium (◊ CSF, body fluid, sweat) 19, 22-23, 27, 36-37, 44-47
◊ Specific Allergens 116 O Specific Gravity (◊ urine adulteration) 47, 84-85 O Sperm Count (► post-vasectomy) 67-68 ◊ Sperm Morphology 68 ◊ Sperm Motility 68 ◊ Sperm, presence/absence 67, 82 O Sperm Viability 69 O Sputum Culture 93 O Stool Culture 93 O Susceptibility Testing (►TB) 88-90, 93, 100-103
O Sweat Analysis (► chloride, quant.; ◊ osmolality, sodium)
46
O Syphilis Serology (◊ CSF titer) 124
T
O T Uptake 20, 22, 42 ◊ tCO2 27, 36, 37 ◊ Testosterone, Bioavailable 40 ◊ Testosterone, Free (►directly measured) 40 O Testosterone, Total 35, 40 O Theophylline 41 O Throat Culture 89, 93, 100 ◊ Thrombin Time 71-72, 75 ◊ Thromboelastogram 78-79 O Thyroglobulin 48 O Thyroxine (T4) 20, 22, 42 O TIBC (◊ calculated) 22, 35 O Tobramycin 41 O Total Protein (◊ body fluid) 22-23, 44-45, 47 ► Toxoplasma gondii IgG 120-121 ► Toxoplasma gondii IgM 120-121 O Tramadol 49 O Transferrin 35
O Trichomonas (◊ Cat. #376 – Vaginal Panel)
88, 107, 113
O Tricyclic Antidepressants 49 O Triglycerides (◊ body fluid) 19, 22-23, 38, 45 O Triiodothyronine 20, 22, 42
O Troponin I (►Cat. #920 – CAP requires 5 sample program)
29-31
► Troponin T, qual. 29-31
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O CAP Accepted ◊ CAP – Accepted PT not required ► Not CAP Accepted
This list is not intended to replace CAP guidelines on required analytes. See the current, online API catalog index for the most up-to-date information on CAP accepted analytes.
Analyte Page
O Troponin T, quant (►Cat. #920 – CAP requires 5 sample program)
29-31
O TSH 20, 22, 42
U
O UIBC, measured 22 O Urea 48 O Urea Nitrogen (BUN) (◊ body fluid) 19, 22-23, 27, 37, 45 O Urease 83 O Uric Acid (◊ body fluid) 19, 22-23, 45, 48 O Urinalysis 83-85 ◊ Urine Adulteration 46-47 O Urine Chemistry 47-48 O Urine Colony Count 89, 93, 100 ◊ Urine Crystals 85 O Urine Culture 89, 93, 100 ◊ Urine Eosinophils 85-86 ◊ Urine Microscopy, automated 80-81 O Urine Sediment 82, 86-87 O Urobilinogen 84-85
V
◊ Vaginal Panel 113 O Vaginal Wet Preparation 82-83 O Valproic Acid 41 O Vancomycin 41 ► Varicella Zoster Virus (VZV) IgG 121 O Vitamin B12 35 O VRE 101
W
◊ WBC (auto CSF/BF, body fluid diff., urine)
60, 80
O WBC Count (blood, manual CSF/BF) 61 O Wound Culture 93
Z
◊ Zolpidem 49