Everyday QA: A case study. . Health Department Laboratory - Lab Management - the Wayne County NC - quality assurance

Medical Laboratory Observer, March, 2003 by Ann McKenzie, Lisa Ballance

Ever feel like there's not enough time to develop a good quality assurance (QA) program for your laboratory? Have inspectors ever cited your laboratory for lack of documentation of ongoing QA activities? Don't dismay--remedying this situation may not be as difficult as you think. During a recent CLIA inspection, the Wayne County (NC) Health Department Laboratory received high marks from the surveyor regarding our laboratory quality assurance program. (1)

The secret to our successful QA program includes staff participation in data collection, review and report generation. In addition, the development of standardized computer templates for routine QA monitors has taken much of the effort out of the process by providing models for employees to follow. As a result, documenting quality assurance has become integrated into our everyday laboratory activities, rather than being viewed as an arduous task ever looming at the bottom of the lab manager's "to-do" list.

Why document? The benefit of having an effective QA program is that it can serve a multitude of purposes when used as the primary method of documentation of instrument and reagent problems, complaint investigations, personnel assessments and routine monitoring. It streamlines required documentation through the elimination of various problem logs by recording the information into one standard format. In regard to CLIA noncompliance, having no quality assurance program has consistently ranked in the top three of the most frequent survey deficiencies cited. (2)

As seen in Figure 1, 26 percent of all labs inspected in the first survey were cited for no QA program. This percentage fell to 12 percent and 7 percent respectively, in the subsequent inspection cycles. In physicians' office labs (POLs), no QA program was cited as a deficiency in 28 percent of these labs during the first inspection cycle. An identical decrease in POL QA-related deficiencies was also observed in the following inspection cycles. In light of this data, you can conclude that the majority of laboratories inspected now have a quality assurance program in place. It is, however, one thing to develop a comprehensive QA plan on paper and quite another to effectively "monitor and evaluate the ongoing and overall quality of the total testing process." (3)

Table 1 (3) outlines what components a comprehensive QA program must include.

All significant lab-related occurrences are recorded as QA studies. (Quality assurance - 493.1701). This approach incorporates into the laboratory's workflow review of the areas defined in the CLIA Standards listed under Subpart-P. This has been accomplished with minimal effort through the development of standardized templates, which are used by all laboratory personnel.

Patient test management assessment (493.1703) is a routine activity in our laboratory. All laboratory results reported on a randomly selected workday are reviewed each month. In addition, all specimens submitted for reference testing are tracked on a monthly basis to assure laboratory reports are received in a timely manner.

Another preanalytic monitor our lab regularly employs is assuring that specimens are processed and/or stored appropriately until testing. In one instance, an out-of-range incubator temperature was discovered. The incident was documented, including the corrective action taken (verifying proper operation and temperature of the incubator and clinic notification) and subsequent follow up (consisting of recollection dates for the microbiological cultures affected).

One way that quality control (QC) assessments (493.1705) are conducted in our lab is by recording instrument or reagent problems via the QA template. It has been our experience that a quicker vendor response and a $1,300 reimbursement resulted by documenting a concise history of the various problems encountered with our chemistry analyzer. By including in our QA studies the detailed resolution to a particular instrument problem (i.e., a recurrent paper jam), this type of QA study dually serves as a record of the event and as a quick reference for laboratory personnel should problems of this nature recur.

Another example of a QC assessment documented by our lab involved a noted increase in faulty urine pregnancy test cassettes. As part of our investigation, the supplier was contacted regarding our observations. When questioned, the supplier stated that there was a change in the pipettes provided in the kit. To compensate for this problem, the manufacturer's instructions had been amended to increase the amount of urine added to the test. However, our supplier could not give a sufficient answer as to why our laboratory was not alerted to this change. As corrective action, our facility began ordering pregnancy test packs directly from the manufacturer, which required a change in the contract agreement between the manufacturer and supplier. This assured us of prior notification by the manufacturer in the event of any future changes. Our follow up has verified that we have had no additional problems since making this change.