Dodging point-of-care testing potholes in PT, IQCP

He noted that planning for point-of-care inspections is more difficult than it is for lab inspections because the inspection information packet doesn’t always reveal which tests are performed at which site. “As a point-of-care inspector, I wait until I’m on site to talk to a coordinator.”

A few of Dr. Karon’s tips for inspectors: Ask the POC coordinator to direct you to testing sites, but “don’t let the coordinator select the sites for you. They’ll take you to sites they know are very compliant.” At each site, ask a nurse to run through procedures for the testing performed at that site, “but again, don’t allow the coordinator to bring you the charge nurse who’s a trainer for the test method. The trainer always knows the answers. Talk to the nurses who are doing testing but are not in charge of the platform. Jot down the names of nurses you talk to in order to look up their competency and training materials, especially for nonwaived testing.” Ask what-if questions from the SOP: When do you need to confirm the INR? What do you do if capillary glucose results are greater than 400 mg/dL? Ask testing personnel to locate the procedure for you.

Visit sites where POC instruments aren’t interfaced and data are entered manually. “What we care about is that the results get in the electronic medical record,” Dr. Karon said. Typically, he asks to see results in the EMR from the three most recent tests performed at the site.

Observe testing, if possible. “I’ve had success getting time from the cath lab nurse to walk me through the steps of testing,” Dr. Karon said, and he’s had the same success in the ED. It’s busy but “be patient. Find a nurse to take you to an empty trauma pod and walk you through the test.”

“How do you know if a new device for your point-of-care program is eligible for an IQCP?” Dr. Perry asked, in her presentation on individualized QC plans. “First of all, if it’s a waived test, you don’t need it,” she said, advising directors to find waived tests for point of care, if possible, because the requirements are easier. Any nonwaived testing that employs an internal QC system is eligible for an IQCP. “And even if you do your own internal study,” the number and frequency of controls tested cannot be less than indicated by the manufacturer’s QC instructions, Dr. Perry said. Laboratories that don’t write IQCPs for nonwaived instruments are responsible for two levels of QC per day. “In point of care, we know that’s a lot of money and a lot of wasted cartridges.”

Most laboratorians are familiar with the three-part basics of IQCPs—risk assessment, quality control plan, quality assessment. But point of care has unique considerations. Dr. Perry presented this scenario: A 200-bed community hospital in California offers POC testing in the ED and ICU, which is performed by nursing staff. EPOC and bedside glucose testing are performed. A CAP on-site inspection cited no deficiencies related to POC testing, but a follow-up CMS validation inspection identified two POC testing-related citations: The technical consultant performing the competency assessment was not qualified, and the risk assessment portion of the IQCP was incomplete.

The laboratory had written an IQCP for the nonwaived EPOC, but the CMS was concerned because the lab had written only one IQCP for two testing locations—the ED and the ICU. “Each lab with a separate CAP/CLIA number must do its own risk assessment,” Dr. Perry said. “If there are multiple sites with the same instrument and device within one CAP/CLIA number, you have a couple of options.”

One is to write a single risk assessment but account for all variations. “You’re certainly going to have different people performing testing in the OR than in the ED or ICU. The environment will also be different. You can either write different IQCPs for each location,” or write one large IQCP, documenting the differences in location and personnel in the risk assessment portion.

The CMS cited the laboratory in the preceding scenario for failing to have all five components of testing in its risk assessment. Risk assessments are “very prescriptive,” and must include the preanalytic, analytic, and postanalytic testing phases and the five components of testing: reagent, environment, specimen, test system, and testing personnel. “If you miss even one of the five,” Dr. Perry said, “the risk assessment portion will be considered inadequate.”

Developing risk assessments for new POC devices poses an additional challenge when “there isn’t any equivalent testing in the lab to compare it to,” she said. Laboratories can use the data gathered during the test method verification process. “And sometimes you have to use the default QC for a period of 20 to 30 days to collect enough data to implement an IQCP.”

An IQCP’s quality control plan should “define all aspects of everything you’re going to do,” Dr. Perry said. “So the number of QC, the type of QC, whether it’s external or internal, the frequency of your controls, your acceptability criteria. Sometimes in point of care we forget to write whether a test is qual or quant, and what exactly will be acceptable QC. As we know, point of care is often not in the lab,” so it’s critical to document a plan for monitoring the testing environment and reagents. “Make sure those reagents are in the fridge if they need to be and that the fridge is monitored.”

For quality assessment monitoring, the laboratory medical director or a designee should review QC, instrument maintenance, and function check records at least monthly. “Any complaints from clinicians or other health care providers regarding the quality of testing also must be reviewed monthly,” she said.

In addition, reevaluate the quality control plan. If there are changes in the environment or with specimen testing, “document those in your IQCP and note the change to your quality control plan.”

Quality assessment monitoring “is sometimes not well documented and not well done,” Dr. Perry said. The most common IQCP citations— “evaluation of errors relating to all phases of the testing process” and “evaluation of corrective actions taken if problems are identified”—are related to quality assessment monitoring (COM.50600). “If you do those things correctly,” she said, “you won’t get citations. And, more importantly, the patients will be taken care of right. That’s our ultimate goal.”

Charna Albert is CAP TODAY associate contributing editor.