Sometimes it’s hard to estimate the impact of shifting healthcare policies until providers actually begin putting them into practice. That seems to be the case with two significant shifts in federal policy that are now working their way toward implementation in clinical laboratories throughout the United States.
The intent of the Center for Medicare and Medicaid Services individualized quality control plan (IQCP) program is to provide clinical laboratories with flexibility in customizing their quality control policies and procedures. Choosing to adopt an IQCP approach will make it possible for labs to streamline their operations while also promoting patient safety and meeting the regulatory requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
The IQCP program builds upon quality systems principles familiar to many laboratorians, and adds the framework of a risk management approach to guide the application of quality control activities in the lab. According to interpretive guidelines issued by CMS last August, a laboratory’s IQCP must include risk assessment, a quality control plan, and quality assessment.
While laboratorians have long conducted a variety of activities for quality control, they may be less familiar with the principles and practices of risk assessment, which CMS defines as “the identification and evaluation of potential failure and sources of errors in a testing process.”
To conduct an IQCP risk assessment, a laboratory must identify the sources of potential failures and errors for a testing process, and evaluate the frequency and impact of those failures and sources of error. The scope of the risk assessment must encompass the entire testing process—preanalytic, analytic, and postanalytic phases—and include, at a minimum, an evaluation of five components: specimen, environment, reagent, test system, and testing personnel.
With a two-year transition period at their disposal, laboratory staff will no doubt rapidly gain proficiency in risk assessment methodologies. But the devil, as always, will be in the details.
CMS reminds laboratories that risk assessment must be conducted for each location where testing is performed, including some circumstances that could fall between the cracks: multiple lab or testing locations within a single CLIA number; point-of-care devices throughout healthcare or laboratory systems; or multiple identical devices or kits in a single location. How labs implement such aspects of their IQCP program will ultimately determine their effectiveness.
“There is a great deal of anxiety on the part of laboratories, not knowing exactly where to begin as they develop their IQCP,” says Rose Mary Casados, president of COLA Resources Inc, a provider of educational and consultative programs for laboratory professionals. “As educators, our goal is to drive awareness about the new regulations, and provide tools for labs to begin their education process now.”
Labs will have less time to figure out how to comply with new rules issued in mid February to amend CLIA and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Jointly issued by CMS, the Centers for Disease Control and Prevention, and the HHS Office for Civil Rights, the new rules require laboratories to give patients or their designates direct access to the patients’ completed pathology and laboratory test reports upon request.
The new rules pre-empt many state laws that previously prohibited laboratories from releasing test results directly to patients. They become effective on April 7.
In the background section for the new rules, HHS explained that many health system stakeholders believe previous CLIA regulations impeded individuals’ access to their own health records, thereby preventing patients from playing a more active role in their personal healthcare decisions.
“We believe these concerns, as well as the advent of certain health reform concepts (for example, personalized medicine, an individual’s active involvement in his or her own healthcare, and the department’s work toward the widespread adoption of EHRs), call for revisiting barriers or challenges to individuals’ gaining access to their health information,” HHS wrote.
You can read more about the impact of these shifting policies in this issue’s feature on “Individualizing Quality” (page 12) and the Inside Track column on “New Rules, New Tools” (page 34).
Steve Halasey
Chief Editor, CLP
[email protected]
(626) 219-0199
