HIV, TB requirements in latest accreditation checklist edition

Dr. Anderson explains: “We have specified that testing be ‘available’ so that all laboratories can adopt this as a best practice without having to institute molecular testing, which would require levels of expertise and instrumentation that not every lab has access to. ‘Available’ means labs may either perform the testing on site or have a system set up so they can send it to a reference lab. One might argue that sending to a reference lab could diminish the turnaround-time benefit. But sending to a reference lab for molecular testing will still be quicker than growing a Mycobacterium tuberculosis. Culture still has great sensitivity, but this is all about getting an answer quicker and being able to make a positive impact by preventing spread. It’s all about speed.”

In no way, he says, should this lead to labs no longer doing mycobacterial testing because they can’t do PCR in-house. “That is not the intention here. We don’t want to limit anyone’s practice; we want to expand it when possible.”

Dr. Campbell, too, says the requirement was written so as not to be “draconian but to encourage laboratories to be part of the solution, not to be just a pass-through for providers.”

The CAP’s position on avoiding overuse of NAAT is part of the equation, Dr. Anderson says. “PCR is very, very expensive. There are laboratories, particularly in the U.S., performing a lot of cultures for mycobacteria, for more than just tuberculosis. For instance, a laboratory may end up having 30 of these cultures in a single day, and the vast majority might be from patients who have other mycobacterial infections and for whom tuberculosis is very low in the differential. If we were to require a laboratory to run PCR on every single specimen that came through, it would be a huge waste of resources.”

The required evidence of compliance for U.S.-regulated labs is a written policy for availability of M. tuberculosis complex NAAT and patient reports/worksheets with NAAT results or referral laboratory reports with results.

“Some labs might not have a written policy for availability of testing yet,” Dr. Anderson says. “But this could be as simple as a lab making this available on its test menu based on send-out tests and having a policy that allows for physicians to order NAAT when it’s clinically desired.” He poses a possible question inspectors might ask laboratories: “If a physician suspects tuberculosis in a patient, how would they go about getting molecular testing and what are the policies in place for molecular testing?”

“That’s the way I’d ask it on an inspection,” Dr. Anderson says.

MIC.32170 “Rapid Detection of Mycobacterium tuberculosis Complex—Laboratories Not Subject to US Regulations” differs from MIC.32150 in that it provides more flexibility. It says appropriate testing is available, in the laboratory or by referral laboratory, for the rapid detection of Mycobacterium tuberculosis complex on at least one respiratory specimen submitted to the laboratory (preferably the first diagnostic specimen) for mycobacterial culture that includes a nucleic acid amplification test or follows an established testing algorithm for that country or region.

Bharati Suketu Jhaveri, MD, immediate past chair of the CAP Council on Accreditation and a member now of the CAP International Accreditation Committee, has inspected many international labs and has extensive experience in helping to create requirements suited to international laboratories. Although best practices are clear here in the U.S., she says, barriers exist for some labs in other countries. “If we make our best practices a requirement for laboratories that do not have access to high-end molecular tests, they would not be able to be in compliance and could not be accredited,” explains Dr. Jhaveri.

Having consulted with TB experts in the laboratory field, particularly in India where TB is endemic, Dr. Jhaveri says she learned they wanted the CAP to permit each country to work with its own health commissioner and health department, have access to guidelines that each country can use in its own hospitals, and use that country’s own algorithms and best practices. “So the checklist requirement stipulates labs follow the guidelines they are subject to in their region for patients suspected of having pulmonary TB,” she says. “Again, it is aimed at rapid detection. So with the first diagnostic specimen, labs preferably will do a nucleic acid amplification test or follow an established testing algorithm for that country or region.”

Dr. Jhaveri says algorithms do not vary widely from country to country because they are largely based on WHO guidelines. “However, labs in these countries have worked for years to find the best testing for them in their own environment and to utilize what is widely available and inexpensive. If all these laboratories had to send specimens to referral laboratories for NAATs, it could be a prohibitive expense to people who cannot even afford their medication.”

There is also disease prevalence to consider, Dr. Anderson says. “In some areas of the world where there is a lot of tuberculosis, the pretest probability is very high” and the benefit of PCR testing is lower. “If the physician is convinced that a patient has tuberculosis and is in a region where TB prevalence is high, it makes more sense to assume the patient has TB and treat. While the requirement says it might be a good idea to offer nucleic acid amplification testing, by allowing laboratories to alternatively choose to follow an established testing algorithm for that locale, we’re giving them an out. This flexibility makes the requirement more portable to other countries around the globe.”

Dr. Campbell advises international labs to drill down on the public health record requirements in their regions and to be responsive to them. He says labs will need to be able to tell inspectors what the policy, which may or may not involve a PCR test, is. They will have to maintain documentation of that policy and have records to show it is being adhered to.

Two other checklist requirements, one revised and one new, address TB exposure and blood culture contamination.

GEN.74900 “Tuberculosis Exposure Plan” addresses employee screening and safety. This revised requirement says, in part: The laboratory follows a written tuberculosis exposure control plan that includes TB exposure screening at defined intervals for all personnel who have occupational exposure to tuberculosis, and use of engineering and practice controls for hazardous activities that may potentially aerosolize Mycobacterium tuberculosis.

The plan must define when exposure screening will be performed and who may have occupational exposure to tuberculosis.

Dr. Campbell says the requirement, though now more specific about what must be included in a laboratory’s exposure control plan and about exposure screening intervals, also allows labs greater flexibility in terms of how often they test personnel. “The newest TB exposure recommendations from the CDC allow facilities with a very low incidence of tuberculosis to decrease the frequency. So people don’t have to get tested every year for latent tuberculosis when their risk is very low and when the risk of a false-positive test starts to generate problems in terms of excessive follow-up testing,” he says.

MIC.22635 “Blood Culture Contamination” is a new requirement in the microbiology checklist. It is largely broken out of an existing requirement and has been changed from a best practice activity to a requirement.

The requirement calls for the laboratory to monitor blood culture contamination rates and establish an acceptable threshold. A note in the requirement says the laboratory must determine and regularly review the number of contaminated cultures. Tracking the contamination rate and providing feedback to units and persons drawing cultures is one method, it says, that has been shown to reduce contamination rates. Other measures for consideration in monitoring blood culture contamination include the types of skin disinfection used and line draws. The requirement says the threshold may be established in collaboration with other relevant institutional groups, and the laboratory must perform and record corrective action if the threshold is exceeded.

“What we’re describing is best practice,” Dr. Anderson explains. “It demonstrates that we are collecting this important quality assurance data, using it, and feeding it back to make sure that we are improving practices.”

Dr. Campbell says these practices have always been important. “But we wanted to make it clearer to laboratories that we need to monitor and work to reduce contamination rates. This is also part of antimicrobial stewardship,” he says. “Patients with contaminated blood cultures usually get put on empiric antibiotics until the nature of the contaminant is clear. We’re trying to reduce the use of empiric antibiotics by asking laboratories to be more active in the preanalytic realm, to monitor and reduce blood culture contamination rates.”

Valerie Neff Newitt is a writer in Audubon, Pa.