LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP...
Transcript of LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP...
![Page 1: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/1.jpg)
LAP Audioconference
Unannounced Inspections:A Guide for Continual Readiness
April 15, 2009
Amy S. Gewirtz, MD, FCAPMedical Director
The Ohio State University Medical Center
© 2008 College of American Pathologists. Materials are used with the permission of the faculty.
![Page 2: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/2.jpg)
2
Learning Objectives
• After participating in this audioconferenceyou will be able to:– Establish an approach to document control that
will ease the retrieval of information during an unannounced inspection
– Establish a step wise itemized protocol to more efficiently and effectively facilitate the entire unannounced inspection process
– Develop your own laboratory’s action plan to better achieve continued readiness for the unannounced inspection
![Page 3: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/3.jpg)
3
Certification and Accreditation• CLIA 1988 established quality standards and
on-site inspections for laboratory testing to ensure– accuracy– reliability – timeliness of patient test results
• Under CLIA CMS has responsibility for regulating laboratories
• 195,000 labs are certified under CLIA– >6,000 labs accredited by CAP
![Page 4: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/4.jpg)
4
Certification and Accreditation
• Moderate and high complexity laboratories must undergo onsite surveys at least every two years.
• CMS utilizes an outcome oriented survey protocol – ensure quality test results – identifies problems that could cause actual
or potential harm to patients.
![Page 5: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/5.jpg)
5
US Government Accountability Office June 2006 Report
• Standardization of surveys across organizations
• Balancing educational and enforcement efforts to maximize laboratory quality
• Creating an environment that encourages complaint reporting by laboratory personnel
• Emphasizing CMS’s responsibilities and authority, validation surveys– enforcement of accrediting standards
![Page 6: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/6.jpg)
6
Other CMS Quality Initiatives For Clinical Labs
• Improved Quality Control Requirements • Cytology Proficiency Testing (2005)• Complaint Tracking System • Performance Standards for State Survey
Agencies• Performance Measures for Accrediting
Organizations• Accrediting Organization Response &
Improvement
![Page 7: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/7.jpg)
7
Impact to the Clinical Laboratory
• Shift of focus from educating staff and document preparation to improvement of laboratory operations by identifying and reducing errors and ensuring patient safety
• Tracer methodology• Unannounced Inspections
– enhance the credibility of the accreditation process
– perception that unannounced inspections are more rigorous and better able to expose poor quality
![Page 8: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/8.jpg)
8
Changes in CAP Accreditation Process
• Window of opportunity• Inspector Training• New Team Leader Checklist• Focus on CAP patient safety goals
![Page 9: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/9.jpg)
9
Patient Safety Goals• CAP (9/27/2007 Lab Gen)• Improve patient and sample
identification– at the time of specimen
collection, analysis and results delivery
• Improve communication of life threatening or life altering information
– malignancies, HIV and other infections, cytogenetic abnormalities and critical results
• Identification, communication and correction of errors
• Improve coordination of the laboratory patient safety role within healthcare organizations (nursing, administration, POCT personnel, providers)
• TJC 2008 (Goals 1,2,7,13)• Improve the accuracy of patient
identification. – two patient identifiers
• Improve the effectiveness of communication among caregivers.
– readback of verbal order or critical values
– standardize a list of abbreviations, acronyms, symbols, and dose designations that are not to be used
– measure, assess, improve the timeliness of reporting, and receipt by the responsible licensed caregiver, of critical values and critical test results
– standardized approach to “hand off”communications,
• Reduce the risk of health care-associated infections
– hand hygiene guidelines– sentinal events resulting from
infection• Encourage patients’ active
involvement in their own care as a patient safety strategy
![Page 10: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/10.jpg)
10
Quality Management System
• Requisitions, specimen collection, accessioning
• Computer functions• Technical policies / procedures
– quality control– instrument maintenance and calibration– carryover studies, AMR, reagent validation
![Page 11: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/11.jpg)
11
Quality Management System
• Inventory control• Proficiency testing• Safety policies/procedures• Quality assurance/improvement• Personnel
– training and competency
![Page 12: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/12.jpg)
12
Continual Readiness
• Pre-Inspection• Inspection• Post-Inspection
![Page 13: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/13.jpg)
13
Pre-Inspection
• Ongoing monitoring of accreditation standards and governmental regulations– dedicated compliance staff
![Page 14: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/14.jpg)
14
Review Procedures
• Current for testing performed• Match manufacturer instructions• Specifications for specimen
requirements, QC, reagents, calibrations, temperature logs, testing procedure, results reporting
![Page 15: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/15.jpg)
15
Continual Inspection Readiness
• Documentation is key: if a process, result, etc. is not written or recorded and available for review, it didn’t happen!
![Page 16: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/16.jpg)
16
Document Control
• Electronic availability of all procedures• Only one hard copy at a single location
if at all possible• Index
![Page 17: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/17.jpg)
17
Document Control
![Page 18: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/18.jpg)
18
Document Control
![Page 19: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/19.jpg)
19
Document Control
![Page 20: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/20.jpg)
20
Document Control
![Page 21: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/21.jpg)
21
Document Control
![Page 22: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/22.jpg)
22
Document Control
![Page 23: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/23.jpg)
23
Document Control
![Page 24: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/24.jpg)
24
Document Control
![Page 25: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/25.jpg)
25
Document Control
![Page 26: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/26.jpg)
26
Document Control
![Page 27: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/27.jpg)
27
Document Control
![Page 28: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/28.jpg)
28
Document Control
![Page 29: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/29.jpg)
29
Document Control
![Page 30: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/30.jpg)
30
Document Control
![Page 31: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/31.jpg)
31
Document Control
![Page 32: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/32.jpg)
32
Monthly Readiness Activities
• Review of annotated checklist• Tracer methodology
![Page 33: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/33.jpg)
33
Review of Annotated Checklist
See Attachment A
![Page 34: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/34.jpg)
34
Monthly Tracer
See Attachment B See Attachment C
![Page 35: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/35.jpg)
Documentation of New and Current Testing
![Page 36: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/36.jpg)
36
Testing Requirements
See Attachment D
![Page 37: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/37.jpg)
37
Request for New Test
See Attachment E
![Page 38: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/38.jpg)
38
Continual Inspection Readiness
• Documentation of test validation for new tests implemented since previous inspection
![Page 39: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/39.jpg)
39
Test Menu and PT
![Page 40: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/40.jpg)
40
AMR Chart
See Attachment F
![Page 41: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/41.jpg)
41
Continual Inspection Readiness
• Prepare a list of “key activities” to document compliance with programs’regulations, standards, guidelines, integration with your health system
![Page 42: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/42.jpg)
42
Key Activities
![Page 43: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/43.jpg)
43
Service Occurrence Form
See Attachment G
![Page 44: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/44.jpg)
44
PT Discrepancies
See Attachment H
![Page 45: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/45.jpg)
45
Proficiency Testing Rotation Among Critical Care Lab Staff
Name ACL API AQ BFC/CRS BNP BP* CZ2X CARI CGEX CGL
Day ShiftAbdulkadr, Zeynab
Aldridge, Kimberly
Barnett, Pam CGE-B
Berihun, Mizanu
Bicking, Bill CARI-C
Buening, Tom
Dalmar, Abdi CARI-C
Failla, Lori CRS-A/B BP-B
Griffin, Jarrod BNP-A C-A
Heineike, Linda C-B/C CARI-A
![Page 46: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/46.jpg)
46
Medical Director Site Visit
See Attachment I
![Page 47: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/47.jpg)
47
Continual Inspection Readiness
Unannounced Inspection Tips• Train all staff
– Regulations / Checklists / Standards– Daily Activities– Resources for use during inspection
![Page 48: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/48.jpg)
48
Inspection Day Preparedness
• Unannounced inspection resource folder and staff education – folder on the desktop
• Identification of key staff and alternative individuals
![Page 49: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/49.jpg)
49
Unannounced Inspection Resource Folder
• Arrival notification procedures– call tree– identification of managers, directors, key staff and
alternates– inspection day checklist
• Inspection team welcome materials• Team Leader Interviews• Health System Quality and Safety Plans• Updated annotated checklists
![Page 50: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/50.jpg)
50
Continual Inspection Readiness
• Perform mock inspections• Walk through the laboratory with a
critical eye• Again and again and again
![Page 51: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/51.jpg)
51
Inspection Day
![Page 52: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/52.jpg)
52
They’re Here…….
![Page 53: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/53.jpg)
53
Inspection – Home Team• Initiate division and director notification
• Inspection day checklist
![Page 54: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/54.jpg)
54
Inspection Day
• Welcoming Conference• Provide Inspector Packet
– organizational structure– scope of care– list of laboratory contacts by checklist– list of on and off site laboratories with directions
and maps and scope of care• Team Leader Packet
– list of Clinical Laboratories participation in OSUMC Health System Committees
![Page 55: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/55.jpg)
55
Inspection – Home Team
• Arrange for meeting room/workplace– Determine how the visiting team wants to conduct
the inspection• Who needs to go where, when and with whom• coordinate inspectors with key techs and various
locations
• Arrange for lunches, breakfasts• Begin discussions to identify approximate
time and location for summation conference
![Page 56: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/56.jpg)
56
Inspection – Home Team
• Assess workload staffing• Information gathering
– review procedures– talk to staff– meet with medical staff– review logs, charts, reports– examine procedures, slides, testing
![Page 57: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/57.jpg)
57
Inspection – Home Team
• Print/provide annotated Checklists• Locate key documentation and
examples notebook/folder and move to inspector’s workplace
![Page 58: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/58.jpg)
58
Inspection – Home Team
• Schedule meetings with medical staff, direct health care providers, hospital administration and medical laboratory director
![Page 59: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/59.jpg)
59
Inspection – Visiting Team
• Provide frequent updates regarding areas still needed to be reviewed and additional documentation needed
![Page 60: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/60.jpg)
60
Inspection
• For documents requested to share with inspecting team– review with your medical director the
release of the information– remove any patient identification is
applicable– make a copy and stamp confidential
![Page 61: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/61.jpg)
61
Inspection
• Exit Conference– allow adequate time for the team leader
and medical director of the laboratory to review findings and sign off on paperwork
![Page 62: LAP Audioconferencewebapps.cap.org/apps/docs/education/lapaudio/pdf/041509... · LAP Audioconference Unannounced Inspections: A Guide for Continual Readiness April 15, 2009 Amy S.](https://reader030.fdocuments.us/reader030/viewer/2022040522/5e807fb7faee827d3d444683/html5/thumbnails/62.jpg)
62
Post-Inspection
• Plan of corrective action• Respond to deficiencies within allowed
time period• Summarize inspection process and
opportunities for improved outcomes