Laboratory Accreditation Program Update on Unannounced Inspections Francis E. Sharkey, MD, FCAP Chair, Accreditation Education Committee February 21, 2007 Copyright 2007 (CAP). All rights are reserved. Participants are permitted to duplicate the materials for 1 educational use only within their own institution. These materials may not be used for commercial purposes or altered in any way.
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 2
Why Unannounced? Need for continuous compliance Agreement with JCAHO Public perception of accreditation process Common in industry 3
What Does Unannounced Really Mean? Lab not notified of inspectors identities No 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 4
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 5
How Does It Work? Inspector assignments ~1 year prior to Anniversary Date Reapplication 9 months prior to AD Inspection window begins 6 months prior to anniversary date Lab declares up to 10 blackout dates Same dates for labs inspected together May not be changed 6
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? 7
What We ve Learned Inspection day impact on the lab similar to an announced inspection Major anticipated issues not a problem Availability of staff Access to documentation Conference/work rooms Meal planning Back-up lab staff essential Checklist notebooks very helpful 8
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? 9
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 inspectors Inspection team preparation is key! 10
What We ve Learned No 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 compliance Major request: Advance notification 11
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 12
Things That Haven t Changed Inspectors will: Use checklists Review documentation, observe testing, and interview staff Cite deficiencies observed Make recommendations Provide a verbal and written report 13
Inspection Assignment Assignment 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 14
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? 15
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 Statement Some State Commissioners will continue to assign 16
Reapplication Process Reapplication sent 9 months in advance of Anniversary Date Additional data collected: Operating days and hours Blackout dates Security procedures (if any) Airport and hotel recommendations 17
Security Clearance If inspectors need security clearance: Lab returns forms with reapplication Form completed by each team member, returned to CAP CAP sends completed forms to Lab Director 2-3 days prior to inspection Lab Director not permitted to tell lab staff Badges available when inspectors arrive 18
Tips for Getting the Lab Ready Notifications Personnel Documentation Continuous compliance Additional tips 19
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? 20
Lab Preparation Notifications Laboratory personnel Inspection window and blackout dates Laboratory Director/Hospital administrator/ceo/cmo Backups for when absent Blackout dates Catering Room scheduling Working space for inspectors Summation Conference 21
Lab Preparation Personnel 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 arrives Responsibility for when they arrive (See Attachment A) Show CAP video/dvd 22
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? 23
Lab Preparation Documentation 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 24
Lab Preparation Continuous 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 25
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? 26
Lab Preparation Additional 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 27
When the inspectors arrive Activate phone tree Determine who is available Adjust workflow to free up supervisors Additional personnel as needed Delivery of off-site records Schedule interviews with CEO & CMO Schedule rooms - working, Summation Lunch arrangements 28
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? 29
Inspector Preparation Direct 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 inspectors Mandatory training requirements 30
Inspector Preparation Mandatory 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 letter Reassignment if not trained 31
Team Leader Preparation Open Inspector s Packet immediately and begin planning Set inspection date Choose a date convenient for team Report to CAP Central Office Communicate with CAP Central Office to coordinate inspection Distribute inspection materials Meet with your team 32
Team Member Preparation Review materials well in advance Test menu, instrumentation, PT failures Avoid the procrastination bug Review Laboratory Accreditation Manual Refer questions to Team Leader or CAP CAP technical assistance: Email: accred@cap.org Phone: 1-800-323-4040, x6065 Web site: http://www.cap.org 33
On the Day Eat breakfast before arriving Arrive together, 30-60 minutes earlier than usual Bring picture ID Be patient; lab needs time to organize See Attachment B 34
Beginning the Inspection Present letter of introduction from CAP Lab may request picture ID s Lab may verify team by calling CAP Introduce team Match inspectors with supervisors Schedule interviews, lunch, Summation Conference 35
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? 36
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? 37
Team Leader s Inspection Team Leader Assessment of Director and Quality checklist Evaluate Laboratory Director s: Qualifications Role and authority in the lab Effectiveness Work with the Laboratory Director Interview CEO and CMO Inspect with only one other checklist 38
Team Leader s Inspection Sample 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? 39
Scenario #10 The inspection packet for a complex University hospital inspection contains nine Team Leader checklists (one for each laboratory). Does the Team Leader need to conduct all nine inspections? 40
Typical Inspection Schedule 7:30-8:00 am Team arrives at lab 8:00-8:30 am Introductions, tour 8:30 - Noon Inspect larger section Noon - 1:00 Working lunch; review progress with team leader 1:00-3:00 pm Inspect smaller section 3:00-4:00 pm Presummation conf. 4:00-4:30/5 pm Summation conference 41
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? 42
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 inspection Maintain contact with Team Leader Review interpretation issues Report when finished with each section 43
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! 44
Finishing the Inspection Presummation Conference Summation Conference Review all deficiencies Exchange views / Avoid arguments Leave copy of Deficiencies and Recommendations Complete Inspector s Comments Return ISR to CAP central office General Summary (Part A) Deficiencies and Recommendations 45
Advantages for Inspectors Earlier assignment - more time to prepare for inspection Easier for inspector to choose a convenient inspection date Current knowledge of inspection process still appropriate 46
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 47
CAP Web Resources for Unannounced Inspections http://www.cap.org Search Unannounced Inspections FAQs On-line audioconference (Fall 2005) Tips for laboratories* Tips for inspectors* * Supplied as handouts for this audioconference 48
Questions? 49
Scenario #1 Answer Use blackout dates for absences of key personnel. Have backups for personnel who will have the most contact with inspectors. 50
Scenario #2 Answer Be sure Team Members are wellprepared. Arrive 30-60 minutes earlier than usual. Wait for lab to organize its activities. An extra inspector is not needed. 51
Scenario #3 Answer Review lab demographics to determine team size and expertise Check training status of self and team members; begin training process Distribute copies of inspection planner Return Accept/Disclosure form to CAP Hold setting inspection date until packet arrives 52
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. 53
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. 54
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. 55
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. 56
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. 57
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-perweek 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. 58
Scenario #10 Answer Another pathologist on the team who has been trained as a Team Leader may help with the interviews. 59
Scenario #11 Answer The inspector must verify that the lab s practices match its policies and procedures. Appropriate samples of PT, QC, maintenance and other records should be examined, and lab personnel should be watched during testing and interviewed. 60