An inspection-ready laboratory is one that uses a variety of tools to maximize the chances of a successful inspection. In order for that to occur, the laboratory must be able to ensure that: 1) any previous inspectional issues have been addressed; 2) the laboratory is current with regard to changes or anticipated changes in the rules, recommendations, and expectations of inspectional organizations; and 3) the laboratory is compliant with the expectations of federal, state/local and/or professional organizations. These organizations can include, but are not limited to, federal (e.g., FDA, CMS/CLIA, OSHA), state (e.g., laboratory, public health, medical waste management), and professional (e.g., CAP and AABB).
Laboratory leaders should begin by reviewing previous inspectional issues that they encountered. At a minimum, laboratories should review and assess their previous inspectional observations and “close calls” over a period of several inspection cycles, to ensure that corrective actions were taken, that follow-up was done to demonstrate the effectiveness of the action, that there was no negative impact on other processes, and that the remedies have remained in effect.
Other sources for inspectional issues are published by the organizations discussed in this article. Such publications can be used to identify observation trends and/or new observation types that you may want to assess in your laboratory. There are a variety of sources to obtain information on changes or anticipated changes. Some of these are described in the following sections.
Additional inspectional preparation tools include using inspection forms (when available) as checklists to conduct a mock inspection. Another option is to prepare “an inspectional checklist” from inspection criteria, utilizing known essential requirements (i.e., CLIA regulations; state requirements).
In the following sections, checklist information is integrated into the discussion of each given organization. That is, the sections on each organization include information about changes, and information about checklists (inspectional assessment tools), where applicable.
FDA
Health professionals may obtain FDA updates on the website at www.fda.gov, and by further selecting the appropriate center. They may also sign up for FDA updates to be sent by email. These notices include, but are not limited to, FDA-proposed and final regulations and guidance documents; new clearance and approvals; changes in medical device classifications; and warning letters. You may select only the information you are interested in receiving, and you may select notification by FDA Center. The link is http://www.fda.gov/ForHealthProfessionals/default.htm.
FDA has several inspection program documents that may be utilized as checklists. These include documents for blood banks and reference laboratories; source plasma centers and testing labs; tissue establishments; and human cells, tissues and cellular and tissue-based products. They are located at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/CompliancePrograms.
CMS/CLIA
CLIA regulatory citations and decisions provide insight into items cited during inspections that have resulted in hearings. This information can assist you in ensuring that your lab is compliant in similar areas. The URL is http://www.cms.gov/Regulations-and- Guidance/Legislation/CLIA/CLIA_Related_Hearing_Decisions_and_Compliance_Topics.html. One of the recent examples is intentional Proficiency Testing referrals. In this case, a laboratory may want to review its Proficiency Testing procedures and practices for CLIA compliance.
Changes to CMS/CLIA regulations are published in the Federal Register. CMS provides help in searching the Federal Register at http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html.
The CMS/CLIA website also provides links to different topics where additional information may be obtained. One example is the link Individualized Quality Control Plan (IQCP). This link provides an additional link to CMS1256877, which is a memo regarding Implementing the IQCP, and its incorporation into the Interpretive Guidelines as an alternative to the CLIA QC policy. The bottom of this page identifies when it was last modified.
The CDC/CLIA website provides the “Latest News” and related publications. “Latest News” is located at http://wwwn.cdc.gov/clia/default.aspx. An example is the “Good Laboratory Practices for Biomedical Genetic Testing and Newborn Screening for Inherited Metabolic Disorders,” April 2012. This publication includes recommendations for ensuring quality biochemical genetic testing and newborn screening based on Clinical Laboratory Improvement Advisor Committee (CLIAC) recommendations.
You may also enroll for email updates for CLIAC meetings at http://wwwn.cdc.gov/cliac/default.aspx. These meetings provide insight into issues under consideration by CLIA. As an example, the March 2013 agenda included CDC, CMS, and FDA updates, as well as presentations and discussions related to forthcoming FDA infection prevention guidance for the use of fingerstick and point-of-care blood testing devices, especially glucose meters. Other topics included the harmonization of clinical laboratory test results, and assuring the quality of new DNA sequencing technologies in the clinical laboratory.
CLIA Corner, a quarterly publication from the State Hygienic Laboratory at the University of Iowa, covers topical news and subjects for the clinical laboratory. Obtaining this publication can assist in remaining current with CLIA requirements. The most recent example is the First Quarter 2013 Issue, which covers CLIA Regulations for Antimicrobial Susceptibility Testing; General Quality Control (QC) for Antimicrobial Suspectibility Testing; Minimum Inhibitory Concentration (MIC) QC; and Antimicrobial Disk Diffusion Susceptibility Testing QC. The URL is http://www.shl.uiowa.edu/publications/index.xml.
A reference that describes CLIA inspector criteria and may be used as a checklist is Appendix C Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services at http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/apcpolicy.pdf. This is an older document which would require review to ensure it is up-to-date. The CLIA regulations themselves can be put into a checklist for self-use.
There are several websites that provide CLIA self-inspection checklists. These may be used as a starting point for development of personalized checklists. Examples can be located by searching for CLIA Inspection Checklists.
Joint Commission—Laboratory Services
New information related to Laboratory Services is located at http://www.jointcommission.org/accreditation/laboratory.aspx. Two examples are: “What’s New and Improved for 2013,” which includes information and revised standards that go into effect July 1, 2013; and “5 Sure-Fire Methods for Complying with WT.03.01.0,” which applies to ambulatory healthcare, behavioral healthcare, home care, hospitals, laboratories, long-term care, and office-based surgery, and states that staff and licensed independent practitioners performing waived tests are competent.
OSHA
The latest news from OSHA may be obtained on its homepage at http://www.osha.gov. OSHA regulatory update information is located at http://www.osha.gov/law-regs.html.
OSHA provides a Safety Management System (SMS) Audit checklist on its website at http://www.oshatrain.org/pdf/audit1.pdf. There are also many other checklists available on the web by searching “OSHA safety inspection checklist.”
College of American Pathologists (CAP)
New CAP information may be obtained through eNews and eAlerts, which may be accessed at http://www.cap.org/apps/cap.portal?_nfpb=true&_pageLabel=accreditation (Note: access to some documents requires membership.) For example, a recent eNews edition provides information on the 2013 Competency Assessment Program; a recent eAlert provides a link for the 2012 CAP Accreditation Checklist.
Another source of information is the CAP Media Center at http://www.cap.org/apps/cap.portal?_nfpb=true&_pageLabel=media. This link includes News Releases, CAP Public Statements and other information.
CAP provides checklists that specify the detailed requirements used by inspectors during an inspection and provides up-to-date information. The URL is http://www.cap.org/apps/cap.portal?_nfpb=true&_pageLabel=accreditation; select Custom Accreditation Checklist LOG IN.
Clinical Laboratory Standards Institute (CLSI)
CLSI provides laboratory performance standards that are intended to assist laboratories in ensuring quality results and continually advancing laboratory practices. While not an inspectional organization, CLSI standards are considered best practices and recognized by most inspectional organizations. New information may be obtained at http://www.clsi.org/news-and-events. A recent example is the release of the New Version of Quality Management System: Development and Management of Laboratory Documents (QMS02-A6—Quality Management System: Development and Management of Laboratory Documents; Approved Guideline—Sixth Edition.) This guideline, which replaces GP02-A5, provides direction for document development, control, and management in paper and electronic environments using a process-based approach that supports the laboratory’s entire quality management system and includes four new features.
AABB
AABB provides members with the latest news and updates in its AABB Weekly Report and AABB News. These may be received via email or accessed at http://www.aabb.org/Pages/Homepage.aspx. An example in the AABB News is “Updates to the DHQ Materials for HPC, Apheresis and HPC, Marrow.”
AABB provides members with checklists and audit forms. The link is http://www.aabb.org/searchcenter/pages/results.aspx?k=audit%20checklist.
State/local
Obtaining state and local updates requires accessing the websites for information, and/or contacting the agency for the appropriate way to receive information.
For laboratories that also have state-specific requirements and inspections (including waste management inspections), the state laboratory/health department or waste management organization may be contacted and a request made for checklists or for a list of specific benchmarks targeted during inspection.
There are many resources available to assist you in making your laboratory inspection-ready. Obtaining and/or developing inspectional tools and implementing processes to ensure that your laboratory has up-to-date information on rules, recommendations, and expectations takes some time to “start up,” but the endeavor is worthwhile—in order to ensure inspectional success.
Sharyn Orton, MT(ASCP)SBB, MPSH, PhD, is Senior Consultant for Massachusetts-based MEDIcept, Inc.
