Update on Unannounced Inspections - Presentationwebapps.cap.org/apps/docs/education/lapaudio/pdf/022107_presentation.pdfLab Preparation PersonnelPersonnel Identify & train backups

College of American Pathologists

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College of American PathologistsCollege 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 Objectives

LAP UpdateAudioconference ObjectivesAudioconference 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?Why Unannounced?

Need for continuous complianceAgreement with JCAHOPublic perception of accreditation processCommon in industry


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What Does “Unannounced” Really Mean?

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 labbut does not notify lab

Coordinated inspections (e.g., AABB) also unannounced


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Which Labs Are Affected?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?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


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Scenario #1Scenario #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 LearnedWhat 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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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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What We’ve LearnedWhat 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 LearnedWhat 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 ChangedThings 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


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Things That Haven’t ChangedThings 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 AssignmentInspection 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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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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Assignment NotificationAssignment 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 ProcessReapplication Process

Reapplication sent 99 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 ClearanceSecurity 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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Tips for Getting the Lab ReadyTips for Getting the Lab Ready

NotificationsPersonnelDocumentationContinuous complianceAdditional tips


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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

Lab PreparationNotificationsNotifications

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


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Lab PreparationPersonnel

Lab PreparationPersonnelPersonnel

Identify & traintrain 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)(See Attachment A)

Show CAP video/DVD


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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

Lab PreparationDocumentationDocumentation

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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Lab PreparationContinuous Compliance

Lab PreparationContinuous ComplianceContinuous 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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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

Lab PreparationAdditional TipsAdditional 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


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When the inspectors arrive…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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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 PreparationInspector 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


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Inspector PreparationMandatory Inspector Training

Inspector PreparationMandatory Inspector TrainingMandatory 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 PreparationTeam 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 PreparationTeam 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


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On the Day…On the Day…

Eat breakfast before arrivingArrive together, 30-60 minutes earlier than usualBring picture IDBe patient; lab needs time to organizeSee Attachment BSee Attachment B


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Beginning the InspectionBeginning 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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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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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’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

Team Leader’s InspectionSample QuestionsSample 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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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 ScheduleTypical Inspection Schedule


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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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Conducting the InspectionConducting 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 RecommendationsDeficiencies and

RecommendationsWhen 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 itemWrite the finding, not the question!Write the finding, not the question!


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Finishing the InspectionFinishing 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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Advantages for InspectorsAdvantages 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 LabsAdvantages 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 timeat any time


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CAP Web Resources for Unannounced InspectionsCAP Web Resources for

Unannounced Inspectionshttp://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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Questions?Questions?


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Scenario #1 – AnswerScenario #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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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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Scenario #3 – AnswerScenario #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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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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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.


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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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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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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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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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Another pathologist on the team who has been trained as a Team Leader may help with the interviews.


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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.

Documents

Update on Unannounced Inspections - Presentationwebapps.cap.org/apps/docs/education/lapaudio/pdf/022107_presentation.pdfLab Preparation PersonnelPersonnel Identify & train backups