ASCP MLT, B.S.
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Jovona PowelsonASCP‐MLT, B.S.
Implementation and Utilization of the Sysmex pocH‐100i Analyzers in a
Blood Donor Center
• I have no disclosures
• Established 1958 at the current location
• Service nearly 70 hospitals,
• A consistent program for testing; helping ensure the safety and purity of the blood supply;
• A research program; designed to bring new tests and treatment options to the community;
• Reference laboratory services; allowing physicians and hospitals immediate information on tests utilizing state‐of‐the‐art technology;
• Educational programs offering the latest findings to the medical, technical and nursing communities, as well as the general public.
• Convenient donation sites– Six neighborhood sites
– More than 1,800 annual bloodmobiles.
• 145,000 collections each year, approximately 65% are given through mobiles.
• Currently all platelets are collected using apheresis methods.
• CBC also utilizes apheresis instruments to collect Red Cells.
• Implementation Steps
– Develop procedures
• Operational Concerns
– Analyzer oversight
– Validation practices
– Calibration and Quality Control
• Impact on product split rates
• Do your research– Review Operator and Installation Manuals as soon as possible– Discuss proposed change with your Quality (QA) Department– Talk to other blood centers about their implementation, etc– Determine who will develop and own procedures– Budget needs (analyzers and reagents to purchase, staffing needs,
etc)– Evaluate requirements or expectations to be met through the use
of the pocH‐100i
• Determine who will over see the analyzers and associated data which includes:– Maintenance,– Quality control, and– Calibration data
• Determine who will operate the analyzers
Research• What are the number of donor center?
• What is the average volume of platelet donors on a daily basis for each center?
• How many analyzers are needed in each donor center?– More analyzers may be needed for centers with higher donor volumes
• Is space available in each center and is there room for the analyzer?– Are there space limitations?– Can the analyzer specifications for clearance space be met?
• Does the center have environmental issues to fix prior to placing the analyzer into service?– Direct air drafts– Humidity problems, etc.
– Correct number of analyzers
– Amount of reagents
– Quality control and calibration materials
– CAP survey /CLIA fees
– Staffing to dedicate to the installation and validation
– Remodeling costs, if needed
Number of Analyzers / Donor Center
After evaluating our donor centers, it was determined that:
• 2 analyzers for centers with higher volumes
• 1 analyzer for centers with lower volumes
• Training department would receive 2 analyzers to allow for easier training access
Analyzer Requirements• Environmental Requirements:
– Humidity operating range: 30 – 85%– Ideal operating temperature: 15 – 30 degrees Celsius
• Other requirements:– 6 inch clearance space on all sides of the analyzer – Away from direct sunlight. – Away from direct heat or cooled air outlet, and– Away from other analyzers or equipment that can interfere with its operation.
– Power source is available.– Data connection is available, if applicable.
Expectations• Ask the following questions:
– Why do we want to change or add a new analyzer?
• Better reagent pricing?
• Is it easier for staff to use?
• Do we need different specimen requirements?
• Do we need improved TAT for donor Pre‐counts?
• Are we looking for minimal maintenance?
• Do we expect to see improved split rates?
• Do we need portability?
Community Blood Center
• Aging analyzers:
– Numerous maintenance problems
– Higher volume of reagents
– Expensive maintenance/service agreements
• pocH‐100i offered:– Minimal maintenance
– Lower volume of reagents
– Simple, less expensive maintenance/service agreements
• The Sysmex Implementation Manual states that preferred specimen is whole blood anticoagulated with EDTA‐K2.
• Optimal draw is a tube drawn to capacity. The collection tube should be filled to a minimum of one‐half full for acceptable
results.• EXCEPTION: a 2.5 ml EDTA tube filled less than one‐half
full is unacceptable
Maintenance• LCD Screen will initiate communication when certain maintenance is needed.
• Other as needed maintenance is done accordingly:
Bi-weekly or every 150 cycles Clean transducer
Quarterly or every 1500 cycles Clean waste chamber
As needed Cleaning instrument surfaceAuto Rinse procedureDisposal of waste fluidCleaning the sample tube adapterRemoving a clog from the apertureCalibrating the LCD panelReplacing thermal printer paperAdjusting date/timePerforming deprime sequencePerforming instrument setup
Oversight of Analyzers
• Trained laboratory personnel who are either:– Medical Technologists,
– Medical Laboratory Technicians
– Trained Lab Technicians / Bachelor Degree in Science
• Product Testing Laboratory or Quality Control Laboratory:– Personnel fall under the CLIA guidelines for performing moderate to high complexity testing
CMS Guidelines (CLIA)D6066
• §493.1423 Standard; Testing personnel qualifications.
• (b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens.
• §493.1423 Standard; Testing personnel qualifications.
Such training must ensure that the individual has‐‐
– (b)(4)(ii)(A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens;
– (b)(4)(ii)(B) The skills required for implementing all standard laboratory procedures;
– (b)(4)(ii)(C) The skills required for performing each test method and for proper instrument use;
– (b)(4)(ii)(D) The skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed;
– (b)(4)(ii)(E) A working knowledge of reagent stability and storage;
– (b)(4)(ii)(F) The skills required to implement the quality control policies and procedures of the laboratory;
– (b)(4)(ii)(G) An awareness of the factors that influence test results; and
– (b)(4)(ii)(H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results.
Product Testing Laboratory
• Review the quality control data on a daily basis.– Notify sites of Shifts, Trends, etc. in quality control data, and
– Instruct sites to perform minor corrective actions as needed.
• Monitor, schedule, and perform calibrations.
• Monitor, schedule, and review comparison data.
• Maintain all related records.
according to CLIA
Donor Services Apheresis Operators
• Trained on the:
– Operation of the pocH‐100i
• Trained through:
– Sysmex online training course
– Departmental trainers
• Renovation needed?
• CAP Survey changes?
• CLIA notification?
• Training documentation?
• Planned date of implementation?
– Allow enough time to adequately validate analyzers and train staff
• Quality Control
• Comparison Studies
• Shipping and Relocation validation procedures
Validation• Installation Qualification
– Create test cases in order to document all installation steps
• Follow instructions in the Sysmex Implementation Manual.
– Obtain and complete Sysmex installation verification forms.
– Test cases should outline steps in Implementation
» Completing installation checklist
• Confirming all equipment is present
» Verifying and documenting analyzer settings
» Obtaining original set up documentation (includes Sysmex pocH‐100i Instrument Data Sheet to show certification, pocH‐100i Data Verification Sheet to show all items included with analyzer, and ISC Pre Certification form)
• Operational Qualification– Demonstrate operation and functionality of the analyzer after installation.
• Perform the precision check
• Analysis for calibration – Using Sysmex SCS‐1000 calibrators
» Refer to Sysmex Installation documents in installation manual
» You may use their form or create one
• Perform Quality Control testing on analyzer in replicates of 11 (parallel testing) to demonstrate performance
• Set control limits suggested by Sysmex during initial installation/set up
• Perform linearity studies using Range Check material. – Document all results into “Linearity.xls” file from implementation manual CD– Print report and send to Sysmex for review
• Compare results to expected limits outlined in package insert and Sysmex Instructions for Use manual.
• Perform carryover study to determine if high cell counts influence subsequent samples with lower cell counts.– Sysmex provides instructions and carry over acceptability limits.
• Test the analyzer alerts/ error flags.
• Set up the analyzer for your specified reporting criteria:– White Blood Cells, and Platelets
Note(s):1.)The implementation CD ROM provides working tables and forms.2.) Ensure appropriate validation numbers are determined and used according to the applicable FDA guidance
Determine if the analyzer performs as
manufacturer and blood center intends.• Perform all maintenance and daily quality control.
• Perform Correlation Study: run sample on your current analyzer and pocH‐100i, if applicable.– Document comparison results on Correlation Study
Spreadsheet (include graphs) which is supplied by Sysmex.
1.)The implementation CD ROM provides working tables and forms.
2.) Ensure appropriate validation numbers are determined and used according to the applicable FDA guidance document.
• Verify result transmission for all results above to your BECS, if applicable.Note: Some analyzers have functionality that may interference with your BECS, such as:
‐ Auto increment of unit numbers cause duplicate test results.‐ Disabling the auto increment feature solved this problem
• Document humidity or other environmental characteristics while performing all validation test cases.
Note: Ensure you choose the appropriate validation numbers according tothe applicable FDA guidance document related to validation sample size.
Summary of Initial Validation
• pocH‐100i validations were staggered over the course of 4 months
– 12 total pocH‐100i analyzers
– Approximately 2 weeks were spent on each analyzer
• Sysmex provides necessary spreadsheets or examples for your use in validation or form development.
• Using examples from implementation manual, examples from other blood centers, CBC created our version of the forms to suit our facility needs.
• Most of our original forms required manual documentation.
• Precision Check
• Quality Control Ranges
• Quality Control forms were designed with space for adhering result tape to the form.
• Calibration forms were further enhanced to working excel forms and validated for accuracy. – Results are directly entered for immediate calculations for related data (Means, 3 SD, Hist. CV, limits, etc.) for following:
• Calibrator development• Precision Check• pocH‐100i Calibration with new calibrator value• Calibration verification• Comparison Study between XE‐2100 D and the pocH‐100i
CalibrationAll pocH‐100i analyzers are calibrated to XE‐2100D within 30 days of XE‐2100D calibration.• Develop calibrator means on XE‐2100D• Perform pre‐calibration procedures • Perform the precision check on the pocH‐100i• Develop calibration means on the pocH‐100i• Perform pocH‐100i Calibration, calculate calibration values and
enter values into the pocH‐100i• Print calibration history from pocH‐100i• Perform calibration verification,• Perform final calibration verification by running all levels of
controls, and• Perform pocH‐100i to XE‐2100D comparison study.
5 EDTA tubes ran on XE‐2100D (total of 15 runs)
Verify precision of pocH‐100i
Develop pocH‐100i Means
Calculate Calib. Values and enter into pocH‐100i
Run the same 5 samples 3 times each
Calculate Calib. Means and 3 SD
Post Calibration pocH‐100i/XE‐2100 D Comparison
pocH‐100i to XE‐2100D Comparison
1 2 3 4 5
A9166 PLT Comparison
Quality Control Record ‐ 1
Quality Control Record ‐2
Control Failure Record
Summary of pocH‐100i Oversight
• Product Testing Lab provides oversight
– Approximately 4 staff trained as pocH‐100i reviewers.
• Set QC limits
• Review QC data
• Maintenance logs
• Perform calibrations and comparisons
• Abbreviated version of initial validation.
– IQ, OQ, PQ
• Procedure and form developed to provide instructions for relocation of pocH‐100ianalyzers
• Criteria to use the Relocation Validation:
– Must be an analyzer that has an approved full validation
• What’s the key to increasing split rates?
– Difficult to determine
• implemented pocH‐100i and triple platelets within 6 to 8 months of each other
– Actual platelet count instead of an average
Summary of Our pocH‐100iProgram
• 6 Donor Centers
– Approximately 4 staff trained as operators per center.
• Donors arrive for donation
– A donor pre‐count is collected
• If the donor qualifies, result is entered into Apheresis instrument to determine the collection type.
• Having a pre‐count prior to collection reduces product waste.