College of American Pathologists
1
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
College of American Pathologists
2
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
College of American Pathologists
3
Why Unannounced?Why Unannounced?
Need for continuous complianceAgreement with JCAHOPublic perception of accreditation processCommon in industry
College of American Pathologists
4
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
College of American Pathologists
5
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
College of American Pathologists
6
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
College of American Pathologists
7
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?
College of American Pathologists
8
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
College of American Pathologists
9
Scenario #2Scenario #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?
College of American Pathologists
10
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!
College of American Pathologists
11
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
College of American Pathologists
12
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
College of American Pathologists
13
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
College of American Pathologists
14
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
College of American Pathologists
15
Scenario #3Scenario #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?
College of American Pathologists
16
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
College of American Pathologists
17
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
College of American Pathologists
18
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
College of American Pathologists
19
Tips for Getting the Lab ReadyTips for Getting the Lab Ready
NotificationsPersonnelDocumentationContinuous complianceAdditional tips
College of American Pathologists
20
Scenario #4Scenario #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?
College of American Pathologists
21
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
College of American Pathologists
22
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
College of American Pathologists
23
Scenario #5Scenario #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?
College of American Pathologists
24
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
College of American Pathologists
25
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
College of American Pathologists
26
Scenario #6Scenario #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?
College of American Pathologists
27
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
College of American Pathologists
28
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
College of American Pathologists
29
Scenario #7Scenario #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?
College of American Pathologists
30
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
College of American Pathologists
31
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
College of American Pathologists
32
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
College of American Pathologists
33
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
College of American Pathologists
34
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
College of American Pathologists
35
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
College of American Pathologists
36
Scenario #8Scenario #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?
College of American Pathologists
37
Scenario #9Scenario #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?
College of American Pathologists
38
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
College of American Pathologists
39
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?
College of American Pathologists
40
Scenario #10Scenario #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?
College of American Pathologists
41
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
College of American Pathologists
42
Scenario #11Scenario #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?
College of American Pathologists
43
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
College of American Pathologists
44
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!
College of American Pathologists
45
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
College of American Pathologists
46
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
College of American Pathologists
47
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
College of American Pathologists
48
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
College of American Pathologists
50
Scenario #1 – AnswerScenario #1 – Answer
Use blackout dates for absences of key personnel.Have backups for personnel who willhave the most contact with inspectors.
College of American Pathologists
51
Scenario #2 – AnswerScenario #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.
College of American Pathologists
52
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
College of American Pathologists
53
Scenario #4 – AnswerScenario #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.
College of American Pathologists
54
Scenario #5 – AnswerScenario #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.
College of American Pathologists
55
Scenario #6 – AnswerScenario #6 – Answer
The laboratory is not in continuous compliance, and appropriate deficiencies in Quality Management should be cited. See GEN.20208 and GEN.20316.
College of American Pathologists
56
Scenario #7 – AnswerScenario #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.
College of American Pathologists
57
Scenario #8 – AnswerScenario #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.
College of American Pathologists
58
Scenario #9 – AnswerScenario #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.
College of American Pathologists
59
Scenario #10 – AnswerScenario #10 – Answer
Another pathologist on the team who has been trained as a Team Leader may help with the interviews.
College of American Pathologists
60
Scenario #11 – AnswerScenario #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.