Advance and contingency preparations meet changed inspection system.

On one of my vacation mornings in January 2006, I received the call from the hospital. The College of American Pathologist's (CAP's) inspection team had just arrived, unannounced, to perform our biennial laboratory inspection--without me present! Several weeks earlier, I had been invited by CAP to voluntarily enroll our laboratory to become the first laboratory inspected under a trial program. Their goal for the trial was to assess problems that might arise from operating unannounced inspections. Planning and thorough preparation in our 220-bed teaching hospital for this inspection would make the difference between our laboratory's success or failure.

All CAP had told me was that the inspection would take place after the first of the year, so the laboratory had to be fully prepared by January 3--just a few weeks away and likely months ahead of what would have been a routinely scheduled inspection. Although our county hospital struggles with extreme California clinical laboratory scientist shortages and chronic budgetary restrictions that permit only the most basic of needs, we reasonably manage to keep current with policies, documentation, and compliance standards. Of course, laboratories always struggle with the typical last-minute rush to get final details in place. Are all of the policies up-to-date and signed? Are all of the reagents dated? Are expired supplies off the shelves? Was the last fire drill required by standards performed and documented? Pleasantly enough, that sense of last-minute urgency was largely missing because we had recently been doing what we should have been doing all along--continuous preparedness.

Many months earlier CAP's Washington staff was abuzz with scandalous articles pumping from The Baltimore Sun following its expose article in 2004. Maryland General Hospital, immediately post-satisfactory CAP inspection, was being inspected by the Maryland Department of Health for fraudulent laboratory practices involving HIV and hepatitis testing. Congress was launching hearings into accreditation by Centers for Medicare and Medicaid Services-deemed organizations that had been entrusted to assure healthcare standards and patient safety. CAP was distraught. Barry Ziman, director of CAP State Affairs, was heavily involved in CAP mitigation efforts and received heated attacks from the Maryland State Health Secretary, Nelson Sabatini, who accused CAP, The Joint Commission on Accreditation of Hospital Organizations, and other accrediting organizations of promoting lax compliance--and who vowed to reassert state control of standards compliance.

Established order undergoes transformation

Lost among the public uproar was the fact that fraudulent activity was hidden from CAP, and state officials failed to communicate important knowledge about concerns to CAP prior to its inspection. CAP leaders fought desperately to preserve the old accreditation practices, worrying that the program itself might be a casualty of politics. Meanwhile, outside viewers could not understand how deemed organizations such as CAP and The Joint Commission could assure meaningful compliance when hospitals were told beforehand that they were about to be inspected. After all, a defining aspect of unquestionable ethical conduct is the appearance of complete propriety at all times. "How could advance notice of accreditation inspection be trusted and in the best public interest?" wondered outsiders.

W. Edwards Deming taught "change comes from outside the system." Now the established order of CAP inspections was about to undergo a seismic transformation. The Joint Commission had just launched unannounced inspections. The time-honored CAP inspection process was also to change, from the collegial-peer improvement process to a critical review and scrutiny of actual laboratory practices. Inspectors and inspections were about to get much tougher. But how could laboratories possibly prepare for unannounced inspections? It was not possible to have all key staff present all the time for a possible inspection that could occur any unscheduled day. This was impractical and absurd, declared many senior pathologists.

Preparing for the unknown

This is how our laboratory successfully prepared for this eventuality: advanced preparedness and contingency scheduling. Foremost, laboratories must now do what they should always have done--keep current on all administrative functions. Directors must develop and maintain a rigorous system of administrative control and update. Gone are the days of sitting back 22 months between servicing deficiencies during the month following the last inspection and preparing for inspection one month before the next inspection. Directors and managers need to maintain a disciplined approach to laboratory management that ensures continuous compliance with accreditation standards and governmental regulations.

Contingency scheduling is the key to a smooth inspection process when the day of the unannounced inspection occurs. During the tentative inspection period--the period within which an inspection team could show up any day--contingency arrangements must be made for coverage in the event of a key staff absence. This means having a contingency schedule for administration, nursing, medical-staff leadership, laboratory director, and lab supervisors. This is not as onerous as it may first appear. Directors must identify scheduled absences, assign alternates, ensure that alternates are fully knowledgeable about policies and procedures, and make sure that an alert system is developed to inform and activate key staff and alternates when the inspection does occur.

Another good practice includes attaching flags referencing standards to actual policies, procedures, and performance documents in the event that a key member is absent when the inspection occurs. The benefit of this measure is well worth the effort. Rapid and organized laboratory response to surveyor questions about standards conveys confidence that the laboratory is orderly and well managed, and will greatly shorten the inspection process. Cross-referencing laboratory documents with laboratory standards also facilitates staff practice and preparedness for the inspection process.

Learn the 'tracer' methodology

Finally, be aware of CAP's use of tracer methodology during the inspection process. The tracer methodology is patterned after The Joint Commission's Continuum of Care focus, which was implemented during January 2006. Continuum of Care is a focus method to better assess the patient's hospital course, as documented in the medical record, looking for appropriateness and timeliness of patient care in relation to hospital accreditation standards. CAP tracer methodology was similarly adopted during the same time as The Joint Commission's Continuum of Care. Tracer methodology is designed to assess the appropriateness and timeliness of laboratory-specimen handling by tracking the movement of one or more samples in real-time through pre-analytic, analytic, and post-analytic phases of the testing process. In this process, an inspector will ask persons handling the specimen to recite their knowledge of standards and practices in an effort to evaluate how adequately staff functions.

Such preparedness will go a long way in eliminating the anxiety that often accompanies the laboratory inspection process. And who knows? You may avoid anxiety altogether if you are as fortunate as I was to be on vacation when the unannounced inspection occurs! To receive other useful preparatory suggestions for meeting the challenge of an unannounced accreditation inspection, contact the CAP laboratory-accreditation program.

David F. Jadwin, DO, FCAP is president of Columbia Healthcare Analytics, an international informatics company that reduces hospital blood usage thorough external utilization review via the Internet. He is former chair of pathology at Kern Medical Center in Bakersfield, CA.