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TRANSCRIPT
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.
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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
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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
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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.
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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
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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
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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
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Changes in CAP Accreditation Process
• Window of opportunity• Inspector Training• New Team Leader Checklist• Focus on CAP patient safety goals
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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
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Quality Management System
• Requisitions, specimen collection, accessioning
• Computer functions• Technical policies / procedures
– quality control– instrument maintenance and calibration– carryover studies, AMR, reagent validation
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Quality Management System
• Inventory control• Proficiency testing• Safety policies/procedures• Quality assurance/improvement• Personnel
– training and competency
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Continual Readiness
• Pre-Inspection• Inspection• Post-Inspection
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Pre-Inspection
• Ongoing monitoring of accreditation standards and governmental regulations– dedicated compliance staff
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Review Procedures
• Current for testing performed• Match manufacturer instructions• Specifications for specimen
requirements, QC, reagents, calibrations, temperature logs, testing procedure, results reporting
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Continual Inspection Readiness
• Documentation is key: if a process, result, etc. is not written or recorded and available for review, it didn’t happen!
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Document Control
• Electronic availability of all procedures• Only one hard copy at a single location
if at all possible• Index
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Document Control
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Document Control
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Document Control
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Document Control
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Document Control
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Document Control
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Document Control
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Document Control
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Document Control
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Document Control
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Document Control
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Document Control
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Document Control
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Document Control
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Document Control
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Monthly Readiness Activities
• Review of annotated checklist• Tracer methodology
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Review of Annotated Checklist
See Attachment A
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Monthly Tracer
See Attachment B See Attachment C
Documentation of New and Current Testing
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Testing Requirements
See Attachment D
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Request for New Test
See Attachment E
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Continual Inspection Readiness
• Documentation of test validation for new tests implemented since previous inspection
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Test Menu and PT
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AMR Chart
See Attachment F
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Continual Inspection Readiness
• Prepare a list of “key activities” to document compliance with programs’regulations, standards, guidelines, integration with your health system
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Key Activities
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Service Occurrence Form
See Attachment G
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PT Discrepancies
See Attachment H
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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
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Medical Director Site Visit
See Attachment I
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Continual Inspection Readiness
Unannounced Inspection Tips• Train all staff
– Regulations / Checklists / Standards– Daily Activities– Resources for use during inspection
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Inspection Day Preparedness
• Unannounced inspection resource folder and staff education – folder on the desktop
• Identification of key staff and alternative individuals
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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
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Continual Inspection Readiness
• Perform mock inspections• Walk through the laboratory with a
critical eye• Again and again and again
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Inspection Day
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They’re Here…….
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Inspection – Home Team• Initiate division and director notification
• Inspection day checklist
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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
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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
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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
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Inspection – Home Team
• Print/provide annotated Checklists• Locate key documentation and
examples notebook/folder and move to inspector’s workplace
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Inspection – Home Team
• Schedule meetings with medical staff, direct health care providers, hospital administration and medical laboratory director
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Inspection – Visiting Team
• Provide frequent updates regarding areas still needed to be reviewed and additional documentation needed
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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
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Inspection
• Exit Conference– allow adequate time for the team leader
and medical director of the laboratory to review findings and sign off on paperwork
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Post-Inspection
• Plan of corrective action• Respond to deficiencies within allowed
time period• Summarize inspection process and
opportunities for improved outcomes
