CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Dr. Perry
Under COM.50200 in the 2017 checklist, labs need only have the IQCP list form ready for the inspection team’s review when inspectors are on site. Since the Centers for Medicare and Medicaid Services does not require the use of specific forms, clearance from the CMS was unnecessary. “It was an ease-of-operations change that is effective immediately,” Dr. Perry says.
This change, in fact, was already announced with an e-alert from the CAP on May 17 and took effect right away. “Some labs already had both forms filled out because they were using the electronic versions available from the College at that time,” Dr. West says. “The e-alert said you no longer have to fill out the summary form, but if you’ve already completed both forms, they’re still good. In the next inspection cycle you’re not going to be dinged. But from that point on, just the IQCP list form will be available on the College’s website.”
As of mid-August, the information previously requested on the IQCP summary form for processes to control risk is no longer included on a CAP form; inspectors are instructed to review the laboratory’s risk assessment and quality control plan for this information. Laboratories will still need to do risk assessment, Dr. West emphasizes. “That’s still a very important part of an IQCP and inspectors will look at their documentation, but they no longer have to put that on a separate form.”
The other IQCP change due to have the most impact is the removal from COM.50500 the requirement that external QC be performed every 31 days, Dr. Perry says. That update has been considered ever since IQCP was introduced two years ago—“partially because a lot of the IQCPs are used for point-of-care devices. Thirty-one days is a bit limiting with some of the point-of-care tests.”
The prospect of cost savings was part of the motivation here. “Labs were using a lot of QC material on POC devices that don’t analytically probably need it. And the fact that most POC tests have a cartridge, and much testing is done internally, means you probably don’t need as much external QC as years ago,” Dr. Perry says.
Two years of using IQCP, she adds, have helped people see that the data support a potentially longer interval between external QCs. “People are able to document that, yes, using it every 31 days has shown we could safely extend it and have no compromise in the quality of the testing.” The time interval would still vary based on the laboratories’ risk assessments, so some will make the time interval 35 days, or 45 days. “But there is still the requirement that you can’t do it less frequently than the manufacturers’ instructions. If the manufacturer mandates 28 days, you can’t go less than that.”
Dr. West
Compiling historical data is one of the five elements required for laboratories’ risk assessment, in addition to following manufacturers’ instructions. Under the changed COM.50300, laboratories must include their own lab-specific data to show that performance is acceptable. “If you’re saying you only need to run external QC at a certain frequency, basically you need to show that the testing in your lab is stable enough to allow that extended frequency,” Dr. West says. “If you’re saying you only have to run external QC once every two weeks but you only have five days’ worth of data, that doesn’t show that the test is stable for a two-week period.”
A new section makes its debut with this edition of the laboratory general checklist: chain-of-custody specimen collection and handling, which is intended to ensure that laboratories have good documentation when legal or forensic testing specimens change hands. The chain-of-custody checklist requirements were originally in the legal testing section of the chemistry and toxicology checklist. That section was created for in-house blood alcohol testing, says Richard M. Scanlan, MD, chair of the Commission on Laboratory Accreditation and a professor and vice chair of laboratory medicine, OHSU School of Medicine. “We moved the chain-of-custody checklist items out of the chemistry checklist and put them into a laboratory general section so they wouldn’t be tied to testing.”
This move originated with a proposal to eliminate the entire legal testing section in the chemistry and toxicology checklist. Every year, the CAP’s scientific resource committees are asked to look at the checklist content appropriate to their expertise, Dr. West says. This year, the Toxicology Resource Committee said the legal testing section of the chemistry and toxicology checklist was a problem because in essence it suggested that labs can do limited forensic testing without going through the full Forensic Drug Testing Accreditation Program. But feedback from laboratories was clear: “They needed something for specimen handling in potential legal cases,” Dr. West says. The Commission on Laboratory Accreditation suggested the needed requirements be added to the laboratory general checklist.
The new section is aimed not at labs that perform the testing in-house, but at those that collect samples to be tested by other labs for legal purposes. It “defines how the lab maintains the chain of custody from the patient’s arm to the laboratory that’s going to test it,” Dr. Scanlan says. “Legal samples have to be under very tight control, and the additional requirements are things that might draw legal criticism if they weren’t followed to the letter of the law.” Such items include keeping records as needed for pending legal action, securing specimens while they are in the laboratory, who can touch specimens, and where they can be kept.
Dr. Scanlan
There are six new requirements related to the use of a chain-of-custody process. “The crucial thing is to have a policy for how to handle these samples until they get to the lab ultimately doing the testing, typically a toxicology lab. The testing lab may define its own chain-of-custody procedures, and the originating lab needs to follow that protocol,” Dr. Scanlan says.
Labs that aren’t doing legal testing under their scope of service—that would be the majority of labs—won’t see these requirements. Labs that check off the activity for chain-of-custody collection (No. 6468) for services such as pre-employment testing and workplace drug testing will see the requirements. “If they tell us they’re doing this work in their activity menu, that will prompt the six requirements to show up on their checklist. We’ve tried to keep the requirements under control. So when an inspector comes through, they’ll know to look for those things even if the lab is not doing in-house legal testing.”
The overlap between Laboratory Accreditation and the Forensic Drug Testing (FDT) programs generated extensive discussion, Dr. Scanlan says. “The legal section was originally put in years ago for blood alcohol; then people were using it for other forensic testing like drug screening for cause. And it just got to be too concerning. It was being handled as ‘FDT Lite’ and it was a little too ‘lite’ to be viable. We want people doing on-site forensic drug testing to be in the FDT program.”
Most labs are not going to move to an FDT program, Dr. West believes. “I don’t think very many small facilities that just do an occasional specimen will have an interest in becoming FDT-accredited, so they will have to decide what testing they want to do. It wouldn’t make a lot of sense for the smaller facilities to become FDT-accredited because it adds significant expense. However, the new chain-of-custody section will help them understand how they have to handle specimens for potential legal testing or forensic testing to ensure the handling is sufficient for those purposes.”
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Anne Paxton is a writer and attorney in Seattle.