Increasing numbers of providers rely on laboratory testing, in the words of the Mayo School of Health Sciences, “in the detection, diagnosis and treatment of disease in patients.”1 Studies show that “an estimated 60 percent to 70 percent of all decisions regarding a patient’s diagnosis and treatment, hospital admission, and discharge are based on laboratory test results.”1 Labs are one of the most highly regulated departments in a hospital, and numerous agencies can or will inspect them. Fundamentally, this is because, as has been pointed out before in the pages of this magazine,2 the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88), enforced by the Department of Health and Human Services (DHHS), requires biennial inspections for clinical laboratories performing non-waived tests. Further, the College of American Pathologists (CAP) conducts “unannounced inspection[s] within a three-month window of time” on more than 20,000 laboratories worldwide.3 Clinical labs also prepare for inspection by the United States Food and Drug Administration (FDA), The Joint Commission on Accreditation of Healthcare Organizations (TJC), and other organizations related to the business the laboratory is attached to or affects. Regardless of continuous improvement and coordinated quality efforts in laboratories around the world, when an inspection approaches, most lab managers and supervisors feel the crunch of preparing for the impending inspection.
Preparation for one inspection almost always starts with looking at the last one. Labs should conduct a re-evaluation of deficiencies and corrections made, and revisit notes from a “close call” or additional observations made by previous inspectors. Anything that previously was graded as a deficiency is always an area of concern for regulatory agencies. They want to see if a policy was updated appropriately, and whether a laboratory repeated the same mistakes or deviations. When preparing for an inspection (such as a CAP inspection), it is important to keep abreast of the most common deficiencies found in laboratories as well as upcoming topics that are “hot” for a closer scrutiny during the inspectors’ visit.
One deficiency that is commonly noted nowadays involves CAP proficiency testing (PT) surveys. A proficiency survey program can be used to assess quality of a testing menu, reviewing all testing performed in a laboratory without scrutinizing all patient results. When surveys are graded, all codes must be addressed. Some laboratories do not mark or acknowledge that these codes, such as the educational challenges, are reviewed. In addition, an increasingly common deficiency with PT is the failure to have an authorized person sign the attestation page at the end of a CAP survey. Inspectors will scrutinize surveys to see if they have all been signed and will issue deficiencies for surveys that have not been signed by an authorized designee.
Another common deficiency deals with compliance with standard operating procedures (SOPs). CAP will hold a laboratory accountable to the procedures or standards it sets for itself, even if they are more stringent than what CAP requires. For example, CAP requires that pipettes be checked for accuracy every year. If a laboratory’s SOP states that it conducts accuracy checks every six months, but then, for whatever reason, conducts a check only once a year, CAP will cite a deficiency for failing to adhere to SOPs. Further, with regard to SOPs, inspectors will cite a deficiency if laboratory staff are not knowledgeable of SOPs (current version) or if pen and ink changes have not been reviewed by staff. In addition, competency training issues can trip up a lab, especially one with a sizeable workforce. CAP requires that six methods of evaluation be assessed throughout a time period (such as annually). All six task methods must be assessed if possible. These issues are considered traditional expectations of CAP inspectors; however, an emerging compliance issue rests with individualized quality control plans (IQCPs).
The IQCP has been a hot-button topic since this option became available to labs at the beginning of 2016. IQCP participation is voluntary, and it is an option only for non-waived tests.4 Non-participating sites will revert to CLIA’s default quality control (QC) policy of two levels of external controls analyzed once per day for each test or more frequently for blood gas testing. CAP will cite numerous deficiencies in different checklists if laboratories have not adjusted to the Centers for Medicare & Medicaid Services’ edict for daily QC or the option of creating IQCPs. If laboratories do elect to establish IQCPs, they must have a designation letter from the Medical Director stating who can design and implement the IQCP. Also, laboratories must assess pre-analytic, analytic, and post-analytic processes for Specimen, Testing Personnel, Test System, Reagent, and Test Environment. IQCPs also must have a Risk Acceptability Matrix, a Quality Control Plan, and Quality Assessment. Finally, IQCPs must be reviewed at least annually.
IQCPs represent an “internal” laboratory function. Laboratories must also contend with “external” laboratory issues, such as point-of-care testing (POCT), which remains a mainstay in most medical facilities. Laboratory management shoulders the responsibility to make POCT sites successful for CAP inspections and those of other inspection agencies (such as TJC). Moreover, laboratories frequently face challenges in maintaining regulatory compliance at POCT sites. By fostering inter-departmental relationships, spearheading laboratory-conducted inspections,5 and reviewing IQCP protocol,6 deficiencies can easily be mitigated if not averted. A common hurdle associated with POCT is that nurses and laboratorians do not think alike, so it is vital to build relationships between these patient-care teammates.
In fact, encouraging face-to-face communication between the principals goes a long way toward improving effort and performance in meeting regulatory requirements. The “do it because I say so” mandate rarely wins hearts and minds: it is more effective for lab leaders to explain the stringent accreditation requirements in-person to build rapport around a common goal. Some labs have a facility POCT committee that will help maintain compliance and gear-up for inspection.
A sad truth: Some POCT participants in medical facilities do not have much sensitivity to CAP’s requirements; CAP is a laboratory agency, and it is not in the forefront for them. They don’t think much about the laboratory’s need for compliance with CAP inspection. It can be difficult, though not impossible, to make them care. BUT—they do care about TJC, which accredits hospitals. And TJC is very keenly interested in POCT programs, and will want to see compliance with their regulations as well as other agencies’ regulations (such as CAP). This is something that can be gently pointed out to the POCT people, if necessary.
One aid to growing relationships is to conduct regular inspections at POCT sites. Facilitating inspections serves a dual purpose: face-to-face communication and an on-site review of compliance. In one study, a medical center instituted an annual POCT inspection and increased deficient-free sites by 9.3 percent.5 In addition, for sites that had deficiencies during the annual inspections, reports were sent to the department leadership requiring mandatory corrective-action plans. Utilizing training and competency records, environment of care, safety, reagent storage and labeling, documentation of results, and correct/current procedures6 is highly beneficial.
Inspections and credibility
It is not surprising that laboratories, as key components in patient health, are under high scrutiny to ensure quality test results and appropriate training. Some laboratories fail to achieve accreditation, putting the quality of that laboratory into question. Laboratories strive to provide outstanding care every day. By preparing for successful inspections, laboratory professionals maintain a high level of excellence, assuring the public that laboratorians provide superior care.
- Mayo School of Health Sciences. Medical Laboratory Sciences. http://www.mayo.edu/mshs/careers/laboratory-sciences.
- Bachman MA. How to make your laboratory inspection-ready. MLO. 2012;44(1):30-32.
College of American Pathologists. Frequently asked questions about three-month window of unannounced inspections. http://www.cap.org/apps/portlets/contentViewer/show.do?printFriendly=true&contentReference=laboratory_accreditation%2Fbuild%2Fthree_month_window_faq.html.
- College of American Pathologists. CAP accreditation programs instructions for responding to deficiencies. http://www.cap.org/apps/docs/laboratory_accreditation/def_res_general_information.pdf.
- Gregory K, Tse JY, Wu R, Lewandrowski K. Implementation of an expanded point-of-care testing (POCT) site inspection checklist in a large academic medical center: implications for the management of a POCT program. Clinica Chimica Acta. 2012 Dec 24;414:27-33.
- Mardis C, Gundler DC. Is your POCT program inspection-ready? MLO. 2015;47(12):28-29.