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February 21, 2007 1 Laboratory Accreditation Program COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP ©2007 COLLEGE OF AMERICAN PATHOLOGISTS College of American Pathologists 1 College of American Pathologists Update on Unannounced Inspections Laboratory Accreditation Program Copyright © 2007 College of American Pathologists (CAP). All rights are reserved. Participants are permitted to duplicate the materials for educational use only within their own institution. These materials may not be used for commercial purposes or altered in any way. Francis E. Sharkey, MD, FCAP Chair, Accreditation Education Committee February 21, 2007 College of American Pathologists 2 LAP Update Audioconference Objectives 1. Explain the new reapplication and inspector assignment processes 2. Identify changes to the on-site inspection process 3. Describe how laboratories can prepare for unannounced inspections College of American Pathologists 3 Why Unannounced? Need for continuous compliance Agreement with JCAHO Public perception of accreditation process Common in industry
Transcript of College of American...
February 21, 2007
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
College of American Pathologists
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College of American Pathologists
Update on Unannounced Inspections
Laboratory Accreditation Program
Copyright © 2007 College of American Pathologists (CAP). All rights are reserved. Participants are permitted to duplicate the materials for educational use only within their own institution. These materials may not be used for commercial purposes or altered in any way.
Francis E. Sharkey, MD, FCAPChair, Accreditation Education Committee
February 21, 2007
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LAP UpdateAudioconference Objectives1. Explain the new reapplication
and inspector assignment processes
2. Identify changes to the on-site inspection process
3. Describe how laboratories can prepare for unannounced inspections
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Why Unannounced?
Need for continuous complianceAgreement with JCAHOPublic perception of accreditation processCommon in industry
February 21, 2007
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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What Does “Unannounced” Really Mean?
Lab not notified of inspectors’ identitiesNo contact between inspector and lab• All communication through CAP
Inspector chooses date• Notifies CAP but does not notify lab
Coordinated inspections (e.g., AABB) also unannounced
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Which Labs Are Affected?
All laboratories in the US, Canada and Puerto Rico• Exception: Initial inspections
Announced inspections continue at:• International laboratories• Reproductive laboratories• Forensic drug testing laboratories
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How Does It Work?
Inspector assignments ~1 year prior to Anniversary DateReapplication 9 months prior to ADInspection “window” begins 6 months prior to anniversary dateLab declares up to 10 “blackout” dates• Same dates for labs inspected together• May not be changed
February 21, 2007
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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Scenario #1
Three inspectors arrive unannounced to inspect a small lab. The Medical Director and the Lab Manager are on vacation, leaving only 2 technicians, neither of whom is familiar with the location of lab documentation.
How could the lab have prevented this situation?
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What We’ve LearnedInspection day impact on the lab similar to an announced inspectionMajor anticipated issues not a problem• Availability of staff• Access to documentation• Conference/work rooms• Meal planning
Back-up lab staff essentialChecklist “notebooks” very helpful
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Scenario #2
In planning the inspection, the team leader notes that the lab is similar in size and scope to the last lab she inspected, but she’s worried that an unannounced inspection will take longer.
Should she bring an additional inspector?
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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What We’ve Learned
Team needs an extra 30-60 minutes to complete the inspection• Getting through security• Lab needs to organize at beginning
No increase in number of inspectorsInspection team preparation is key!
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What We’ve LearnedNo increase in number of deficiencies• But, housekeeping and safety issues
Advantages: Less stress/pressure• No last minute push to prepare• Increased communication within lab• Increased pride for showing continuous
complianceMajor request: Advance notification
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Things That Haven’t Changed
One-day inspection (most labs)Inspectors as peers• Volunteer inspectors• Active laboratorians
Primary goals of CAP program:• Laboratory improvement• Regulatory compliance• Education
February 21, 2007
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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Things That Haven’t Changed
Inspectors will:Use checklistsReview documentation, observe testing, and interview staffCite deficiencies observedMake recommendationsProvide a verbal and written report
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Inspection AssignmentAssignment made by CAP central office• Automated process• Performed one year in advance• Reviewed by State Commissioner
Assignment criteria include:• Size and scope of respective laboratories• Geographic distance• Known conflicts of interest• Training
Will improve peer review
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Scenario #3
A Team Leader’s inspection is assigned 11 months in advance of the anniversary date of the lab to be inspected.
Is there anything to do at this point?
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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Assignment Notification
Letter from CAP central office• Directions for “what to do now”• Laboratory testing and demographics• Training status of known inspectors• Team Leader Inspection Planner• Team Member Inspection Planner• Inspector Acceptance of Assignment
and Disclosure StatementSome State Commissioners will continue to assign
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Reapplication Process
Reapplication sent 9 months in advance of Anniversary DateAdditional data collected:• Operating days and hours• Blackout dates• Security procedures (if any)• Airport and hotel recommendations
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Security Clearance
If inspectors need security clearance:Lab returns forms with reapplicationForm completed by each team member, returned to CAPCAP sends completed forms to Lab Director 2-3 days prior to inspectionLab Director not permitted to tell lab staffBadges available when inspectors arrive
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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Tips for Getting the Lab Ready
NotificationsPersonnelDocumentationContinuous complianceAdditional tips
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Scenario #4
On inspection day, the CEO is declared to be in meetings all day and unavailable for an interview with the Team Leader.
Is there any alternative?
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Lab PreparationNotifications
Laboratory personnel• Inspection window and blackout dates
Laboratory Director/Hospital administrator/CEO/CMO• Backups for when absent• Blackout dates
CateringRoom scheduling• Working space for inspectors• Summation Conference
February 21, 2007
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
College of American Pathologists
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Lab PreparationPersonnel
Identify & train backups for each area:• How to work with inspectors• Location of procedures, records, key docs• Fill-ins for benchwork, as needed
Phone tree to notify key personnel when team arrivesResponsibility for “when they arrive”(See Attachment A)
Show CAP video/DVD
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Scenario #5
During an unannounced inspection, the Chemistry inspector requests the validation records for a Chemistry analyzer. When told that the records are stored off-site and cannot be retrieved that day, she cites several deficiencies as if the records didn’t exist.Should the lab protest these deficiencies?
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Lab PreparationDocumentation
Timely retrieval of off-site records• QC, PT, validation studies
Annotated checklist notebook:• Policy/procedure• Examples of implementation• Location of additional info/documents
Centralized records easier to retrieve
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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Lab PreparationContinuous Compliance
Spread periodic tasks throughout year• Procedure manual update/review• Equipment & lab maintenance• Competency and evaluations
Ensure that continuous tasks do not become periodic• QC & PT evaluations• Quality monitors & corrective action
Implement new processes/instruments when needed
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Scenario #6
During the Anatomic Pathology QM inspection, the inspector is shown records of monthly peer review. There is no evaluation or corrective action for the last 6 months, and the inspector is told that they “got a little bit behind.”
Should a deficiency be cited?
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Lab PreparationAdditional Tips
Use self-inspection as a continuous compliance tool• Try an “unannounced” self-inspection
Transport of inspectors off-site• Vehicles, maps, guides
Do NOT:• Reschedule vacations• Skip meetings or outside conferences• Delay needed renovation/implementation
February 21, 2007
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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When the inspectors arrive…Activate phone treeDetermine who is available• Adjust workflow to free up supervisors• Additional personnel as needed
Delivery of off-site recordsSchedule interviews with CEO & CMOSchedule rooms - working, SummationLunch arrangements
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Scenario #7
During a conversation with the Lab Director at a meeting of the State Pathology Society, the Team Leader inadvertently mentions that he will be inspecting the Director’s lab in two months.
What should the Team Leader do?
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Inspector PreparationDirect contact with lab forbidden• All questions through CAP• (Send security clearance forms to CAP)
Scheduling the inspection• Wait for inspection packet to arrive• Avoid blackout dates & holidays• Lab should be in active operation
Conflict of Interest form for inspectorsMandatory training requirements
February 21, 2007
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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Inspector PreparationMandatory Inspector Training
Training required for both Team Leaders and Team Members Training options• Inspector Training Seminar• Comprehensive On-line Self-Study• Team Leader workshops
Inspection assignment letterReassignment if not trained
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Team Leader PreparationOpen Inspector’s Packet immediately and begin planningSet inspection date• Choose a date convenient for team• Report to CAP Central Office
Communicate with CAP Central Office to coordinate inspectionDistribute inspection materialsMeet with your team
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Team Member PreparationReview materials well in advance• Test menu, instrumentation, PT failures• Avoid the procrastination bug
Review Laboratory Accreditation ManualRefer questions to Team Leader or CAPCAP technical assistance:• Email: [email protected]• Phone: 1-800-323-4040, x6065• Web site: http://www.cap.org
February 21, 2007
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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On the Day…
Eat breakfast before arrivingArrive together, 30-60 minutes earlier than usualBring picture IDBe patient; lab needs time to organizeSee Attachment B
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Beginning the Inspection
Present letter of introduction from CAP• Lab may request picture ID’s• Lab may verify team by calling CAP
Introduce teamMatch inspectors with supervisorsSchedule interviews, lunch, Summation Conference
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Scenario #8
Arriving at the lab on Tuesday morning, the team discovers that the Molecular Pathology section is open only on Mondays, Wednesdays and Fridays.
What should the team do?
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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Scenario #9
At the beginning of the inspection, the Team Leader is told that the Lab Director is 4 hours distant, and that this is not the day for his weekly visit.
How will the Team Leader conduct the Team Leader Checklist inspection?
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Team Leader’s InspectionTeam Leader Assessment of Director and Quality checklistEvaluate Laboratory Director’s:• Qualifications• Role and authority in the lab• Effectiveness
Work with the Laboratory DirectorInterview CEO and CMOInspect with only one other checklist
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Team Leader’s InspectionSample Questions
How is the QM plan is put together?What is the worst incident suffered by
the laboratory last year?How does the laboratory satisfy the
CAP patient safety goals?What is the most useful hospital
committee that you serve on?What is the process for obtaining new
instrumentation?
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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Scenario #10
The inspection packet for a complex University hospital inspection containsnine Team Leader checklists (one for each laboratory).
Does the Team Leader need to conduct all nine inspections?
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7:30 - 8:00 am Team arrives at lab8:00 - 8:30 am Introductions, tour8:30 - Noon Inspect larger sectionNoon - 1:00 Working lunch; review
progress with team leader1:00 - 3:00 pm Inspect smaller section3:00 - 4:00 pm Presummation conf.4:00 - 4:30/5 pm Summation conference
Typical Inspection Schedule
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Scenario #11
A Microbiology inspector is presented a notebook that contains each checklist question, with each “Yes” response circled, along with the related policy/procedure.
Does the inspector need to see anything else?
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
College of American Pathologists
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Conducting the Inspection
Read - Observe - Ask• Inspection instructions in checklist• 1 hr. reading, 2 hrs. observing/interviewing
Review all deficiencies with supervisor at conclusion of section inspectionMaintain contact with Team Leader• Review interpretation issues• Report when finished with each section
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Deficiencies and Recommendations
When to cite a Deficiency• No or inadequate policy/procedure• Policy/procedure not followed• Incomplete documentation
When to cite a Recommendation• Improvement in policy or process, but
compliance is not an issue• Need not cite a checklist item
Write the finding, not the question!
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Finishing the InspectionPresummation ConferenceSummation Conference• Review all deficiencies• Exchange views / Avoid arguments
Leave copy of Deficiencies and RecommendationsComplete Inspector’s CommentsReturn ISR to CAP central office• General Summary (Part A)• Deficiencies and Recommendations
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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Advantages for Inspectors
Earlier assignment - more time to prepare for inspectionEasier for inspector to choose a convenient inspection dateCurrent knowledge of inspection process still appropriate
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Advantages for Labs
Lab focuses on continuous compliance• Avoids “once-every-two-years” syndrome• Less stressful for lab personnel• More consistent with best lab practices
Lab ready for inspection by any agency at any time
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CAP Web Resources for Unannounced Inspections
http://www.cap.org• Search “Unannounced Inspections”
FAQsOn-line audioconference (Fall 2005)Tips for laboratories*Tips for inspectors*
* Supplied as handouts for this audioconference
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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Questions?
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Scenario #1 – Answer
Use blackout dates for absences of key personnel.Have backups for personnel who willhave the most contact with inspectors.
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Scenario #2 – Answer
Be sure Team Members are well-prepared.Arrive 30-60 minutes earlier than usual.Wait for lab to organize its activities.An extra inspector is not needed.
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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Scenario #3 – AnswerReview lab demographics to determine team size and expertiseCheck training status of self and team members; begin training processDistribute copies of inspection plannerReturn Accept/Disclosure form to CAPHold setting inspection date until packet arrives
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Scenario #4 – Answer
Another person should be assigned to cover for the CEO during vacations, etc. The interview should be conducted with that person or with the administrator in charge of the laboratory. The CAP should be notified in the Inspector’s Comments section of Part A of the Inspector’s Summation Report.
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Scenario #5 – Answer
Appropriate deficiencies should be cited as if the records did not exist. In preparing for unannounced inspections, the lab is responsible for developing a process for timely retrieval of off-site records on inspection day. The deficiency will stand even if the lab produces the needed records after the inspection.
February 21, 2007
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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Scenario #6 – Answer
The laboratory is not in continuous compliance, and appropriate deficiencies in Quality Management should be cited. See GEN.20208 and GEN.20316.
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Scenario #7 – Answer
The CAP must be notified of all premature disclosures, and will evaluate whether or not a reassignment or a new inspection date is needed.
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Scenario #8 – Answer
The Team Leader should have noted the operating days that the Molecular Pathology declared in its reapplication. The CAP will have to send in an inspector on a different day, at additional cost to the accreditation program.
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Laboratory Accreditation Program
COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES UPDATE ON UNANNOUNCED INSPECTIONS – CREATED AND PRESENTED BY FRANCIS E. SHARKEY, MD, FCAP
©2007 COLLEGE OF AMERICAN PATHOLOGISTS
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Scenario #9 – Answer
The Team Leader may conduct a phone interview with the Lab Director. However, the Team Leader should carefully evaluate whether a once-per-week schedule is appropriate for this laboratory, and cite deficiencies as appropriate. The CAP should be notified of the nature of this part of the inspection in the ISR.
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Scenario #10 – Answer
Another pathologist on the team who has been trained as a Team Leader may help with the interviews.
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Scenario #11 – Answer
The inspector must verify that the lab’spractices match its policies and procedures. Appropriate samples of PT, QC, maintenance and other records should be examined, and lab personnel should be watched duringtesting and interviewed.
Attachment A
CAP UNANNOUNCED INSPECTION TIPS FOR LABS Prior to the Inspection 1. Notify relevant hospital medical and administrative personnel of the change to unannounced inspections. Ask
for their support as well as contact information for primary and backup individuals who need to be notified on the day of the inspection and who would be available for interviews by the inspection team.
2. Identify primary and back-up staff for each area of the lab who will have knowledge of procedures, policies and
location of key documents (e.g., QC, PT, QM, training and competency, instrument validation, AMR records). 3. Identify inspection day tasks and assign primary and backup staff for each task (see sample task list). 4. Develop a phone list of primary and backup staff to contact upon the arrival of the inspection team. List should
include CEO, medical chief-of-staff, medical director, lab director, lab manager and section head supervisors. If the lab needs additional FTEs on the day of the inspection, a list of staff who have previously indicated the ability to work on short notice should also be available.
5. For each Checklist question, note the location of documents or records that demonstrate compliance to the
requirement. This may be a good opportunity to have department staff review the questions and attach samples of records or forms as appropriate.
6. Develop a process for timely retrieval of off-site records, such as personnel training records and initial
instrument/method validation studies. Store onsite documents and records in a central location so that they are easily accessible during the inspection. Ensure that relevant staff knows how to locate or retrieve the documents and records.
7. Identify options for workspace that can be used by the team. Space can either be in the laboratory, in an area
designated for clerical/administrative services, or elsewhere in the institution that is convenient to the lab. 8. If the inspection team has to travel from site to site, develop maps and identify possible modes of transportation
in case the team has not previously made travel arrangements. 9. Train all staff so that they are familiar with the Checklists and the inspection process. Show the video that is
included with the reapplication process to reinforce the general CAP approach to inspections and familiarize staff on what to expect. Unannounced inspections could be an on-going agenda item at lab meetings to increase communication and provide preparedness updates.
Inspection Day 1. Activate the inspection day task list and refer to it as necessary during the day. Post-Inspection 1. Identify successes and develop an action plan for what you might do differently for your next inspection. 2. Make appropriate changes as soon as feasible. 3. Use the self-evaluation period to refine your inspection day processes. Have a group of staff (preferably your
designated inspection back-up staff) conduct an unannounced inspection of the lab or section of the lab. This will help you spot areas that you may have overlooked or that need better clarification, and will give your back-up staff the experience of having primary staff explain how the laboratory is in compliance.
4. Continue to communicate with staff, conduct drills and evaluate the process throughout the two years. © 2007 College of American Pathologists. All rights reserved. LAP Audioconference: Update on Unannounced Inspections, February 21, 2007
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Attachment A
SAMPLE INSPECTION DAY TASKS
Task/Role Primary Staff/ Extension #
Backup Staff/ Extension #
Designated central contact for the inspection
1. Secure workspace for the inspection team
2. Greet the inspection team at the reception desk and lead them into the lab or to the workspace
3. Assess workflow/FTE situation; make appropriate modifications as necessary
4. Make appropriate phone calls to notify that inspection team has arrived
5. Schedule interviews with CEO and Chief-of-Staff
6. Arrange for food and beverages –coffee/water/drinks and lunch
7. Arrange for off-site records to be delivered
ADDITIONAL INFORMATION
Please note that the Checklist edition sent with your reapplication will be the edition used for your inspection. The Checklists will be customized. For answers to other Frequently Asked Questions, visit the CAP Web site.
Taped audioconferences provide more information about unannounced inspections and are available on the
CAP Web site.
www.cap.org“What’s New” section of the “Accreditation and Laboratory Improvement” tab
© 2007 College of American Pathologists. All rights reserved. LAP Audioconference: Update on Unannounced Inspections, February 21, 2007
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Attachment B
CAP UNANNOUNCED INSPECTOR TIPS
Prior to the Inspection 1. Communicate with the CAP Central Office to coordinate the inspection. The Central Office can help clarify
any questions that you may have about the inspection and can also help identify additional team members if needed, particularly if a specialty inspector is required for the inspection.
2. Review the Inspector’s Packet and plan the inspection – allow sufficient time for the inspection especially in
light of the new unannounced inspection process. Consider planning to arrive one hour earlier than usual to allow the laboratory a little extra time.
3. When scheduling the inspection day, consider the laboratory’s operating hours and any other applicable
holidays (like Federal or Canadian). Choose a day when the lab is operating at its fullest capacity, typically on a weekday. By doing so, you will be able to assess most, if not all, aspects of lab operations and will likely encounter the appropriate staff that you will need to interview and observe. Be sure to schedule around the laboratory’s indicated black out dates.
4. If the laboratory that you are inspecting requires security clearance, allow for an extra ½ hour in the morning for
any clearance details to be worked out on-site. 5. Meet with your team:
Distribute appropriate lab information to each inspector on the team. Inform team members to bring identification. Remind team members to be flexible and to keep the inspection moving; if a document is not readily
available, an inspector should move to another part of the Checklist until the lab has located the appropriate documentation.
Remind team members to interview lab staff and observe testing to make sure written policies and procedures match actual practice.
6. Ensure that your team members are trained; web-based sessions are available at www.cap.org under the
Education tab. Inspection Day 1. Meet team members at a central location away from the laboratory. Arrive at the laboratory as a group. 2. Assume that breakfast will not be provided by the lab because they are not expecting you. Make your own
plans for this meal and arrive at the lab ready to inspect. 3. Present the letter that identifies your team as a group representing the CAP to the lab; wait until the lab verifies
the information. Ensure that all team members can provide personal identification if asked. 4. Be courteous and patient as the lab organizes its day – it may take them a while to institute their action plan. 5. Meet with your team members throughout the day; keep lines of communication open to ensure that the
inspection is proceeding according to plan. Ensure that any deficiencies are discussed with the laboratory as identified throughout the day.
Post-Inspection 1. Identify successes and develop an action plan for what you might do differently for the next inspection. 2. Make appropriate changes and evaluate the process with your team members.
© 2007 College of American Pathologists. All rights reserved. LAP Audioconference: Update on Unannounced Inspections, February 21, 2007
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