At MetroHealth, a county-wide healthcare system based in Cuyahoga County, Ohio, the volume and complexity of our point-of-care testing (POCT) have increased rapidly. In the past, we had a decentralized POCT system in which individual testing centers held independent CLIA licenses.

While this was a reasonable strategy when POCT was available only at a few sites, the mushrooming dissemination of this modality led to a situation in which our POCT coordinators could provide only initial training and guidance with technical issues but were not involved in overseeing individual testing areas.

Though qualified medical staff were designated as directors, oversight was lacking at some sites. The limitations of this decentralized system came into sharp focus during an accreditation visit that found significant shortcomings, primarily due to the fragmented nature of the POCT program.

We subsequently reorganized our POCT program under the pathology department, with 27 CLIA certificates consolidated into four. Given the still rising number of sites performing POCT and testing at experimental sites utilizing novel models of healthcare delivery, we now perform all POCT under eight CLIA certificates.

To accommodate this new responsibility, we doubled the pathology-based POCT staff to four, which made it possible for them to perform monthly audits. These audits, which include on-site inspections, ensure that MetroHealth staff at all sites perform testing appropriately and in compliance with all regulatory requirements.

Performance Requirements

Our on-site inspections follow The Joint Commission requirements and include audits for each site under the following categories:

  • Quality Control (QC) performance and documentation;
  • QC and reagent storage and labeling;
  • Specimen labeling;
  • Adherence to personal protective equipment guidelines;
  • Procedure manual review and availability;
  • Result documentation per protocol;
  • Preventive maintenance performed and documented; and
  • Competency testing successfully completed.

Our policies require that sites be notified when they fail any category. A second consecutive failure or three failures in a 5-month period in the same category results in a warning notice, and a third consecutive failure or four failures within 6 months can cost a site its testing privileges. We implemented this strike-out policy in 2016.

Tracking Results

In analyzing the effects of consolidating POCT under pathology and in performing monthly audits with on-site inspections, we found a total of 605 infractions across all sites between August 2015 and May 2018. Of these, 38% were associated with QC performance and documentation and 19% with QC and reagent storage and labeling.

The other major categories were preventive maintenance (23%) and result documentation (10%). Over time we’ve seen a significant decrease in the average number of infractions per month (about 50%) along with a marked drop in the number of repeat infractions (approximately 90%).

Of the top sources of infractions detailed above, QC-related problems decreased by more than 60%. Infractions associated with preventive maintenance have remained steady, while those associated with results reporting have increased.

At sites offering moderate-complexity testing, the average number of infractions per month decreased by about 80% at the same time the number of testing sites declined by 8%. In this nearly 3-year period, even as provider-performed microscopy procedures grew at both waived (110%) and nonwaived (27%) testing sites, the number of infractions declined by 36% and 50%, respectively.

Striking-Out: A Hard Place

In reviewing our strike-out policy, data from 2015 indicated that 11 sites would have had to shut down testing, as these centers failed our criteria on 28 occasions. Since 2016, just three sites reached strike-out level on nine occasions. One center had three consecutive failures before receiving a warning, so was not penalized. The other two had repeated failures.

These sites operated under a new healthcare model wherein some waived testing was offered at novel non-traditional healthcare settings at non-MetroHealth locations. Due to contractual obligations, testing at these sites continued during our study period. Our root cause analysis showed that individuals at these locations were failing to document QC performance.

We subsequently implemented at the sites in question and at other MetroHealth sites a software-based solution that locks out individuals and prevents testing when QC has not been documented. We also modified our policy to clarify that one of the consequences of repeated failures would include cessation of specific tests.

Reorganizing POCT and implementing audits has enabled us to ensure that our testing is performed appropriately in compliance with all regulatory requirements, an achievement reflected in our last accreditation visit. We’ve found that our monthly audits help us identify problem sites and tests. They’ve enabled us to home in readily on the particular sites and tests that are causing most of the errors, in turn facilitating focused solutions to remedy these problems.

POCT testing at MetroHealth continues to expand rapidly and is offered more and more at non-traditional sites, bringing new challenges to ensuring compliance. Audits have enabled us to identify specific risks and problem sites despite this growth.

Vikram Palamalai, PhD, is a senior chemist and director of point-of-care testing at MetroHealth Medical Center in Cleveland, Ohio, and an assistant professor at Case Western Reserve Uni-versity School of Medicine. E-Mail: vpalamalai[a]