Tuesday, 26 May 2015 22:03

Ensuring Quality in the Laboratory: Tapping the CDC for Tips and Training

Written by Robin Zweifel

r zweifelThose who work in a laboratory do not have to be reminded about the importance of the tests they perform. As American Clinical Laboratory Association (ACLA) president Alan Mertz wrote to members of Congress in a Jan. 29 letter:

"...lab services make up less than 2 percent of Medicare spending, but (what some) fail to take into account (is) the critical role clinical laboratory testing plays in reducing Medicare spending. Clinical lab services provide clinicians with the critical data necessary to diagnose and treat acute and chronic conditions, which saves the program and the nation's healthcare system overall from unnecessary downstream costs.

Given the importance of laboratory test results, the Centers for Disease Control and Prevention (CDC) includes many divisions related to laboratory services, and following guidelines for achieving quality is one of its main goals.

For example, the National Center for Environmental Health (http://www.cdc.gov/nceh/) offers programs related to laboratory sciences and identifies ways to help ensure data quality so that patients, healthcare providers, researchers, and public health officials can be confident that laboratory test results they receive are accurate. This division also addresses the hottest topic in the Medicare program right now: ensuring quality assurance and rewarding providers when certain parameters are met.

Quality Assurance

An article recently posted on the CDC website defines quality assurance (QA) as a management system designed to:

  • Achieve an acceptable level of quality services;
  • Prevent poor quality; and
  • Ensure reliability of laboratory test results.

This comprehensive system includes controlling the quality of procedures at each and every step:

  • Pre-analytical (specimen collection and transport);
  • Analytical (specimen processing in the lab); and
  • Post-analytical (reporting and interpretation of results).

CDC researchers also address total quality management (TQM), which they believe represents a much higher level of QA procedures. This includes but is not limited to:

  • Technical accuracy and precision
  • Equipment and supplies
  • Staff training and skill
  • Financial management (cost effectiveness)
  • Lab safety
  • Communication

TQM also entails the "continuous inspection and refinement of processes to ensure the efficient delivery of services that meet the needs and expectations of those who use them," the agency has said.

Steps toward Efficiency

According to the CDC, a good QA system does these four things:

  • Establishes standard operating procedures (SOPs) for each step of the laboratory testing process, ranging from specimen handling to instrument performance validation;
  • Defines administrative requirements, such as mandatory recordkeeping, data evaluation, and internal audits to monitor adherence to SOPs;
  • Specifies corrective actions, documentation, and the persons responsible for carrying out corrective actions when problems are identified; and
  • Sustains high-quality employee performance.

It also includes laboratory standardization, which is achieved when "test results with the same high levels of accuracy and precision can be reproduced across measurement systems, laboratories, and over time." Standardization depends on a "rigorous process" using:

  • Reference material: A sample with a precisely known composition, which can be used to calibrate laboratory instruments and validate test protocols;
  • A reference measurement procedure (RMP): The "gold standard" measurement system for a particular substance to be analyzed; and
  • Secondary measurement procedures: These are validated using reference material and RMP, which may be less sophisticated than the RMP, but usually more easily implemented by a larger number of laboratories.

Well-executed standardization of programs greatly improves the quality of laboratory measurements that are used to detect signs of illnesses and to guide interventions to prevent or treat illnesses.

Communicating with Physicians

The CDC's Division of Laboratory Science and Standards (DLSS) established the Clinical Laboratory Integration into Healthcare Collaborative (CLIHC™) to develop solutions to optimize the effective use of laboratory services for better patient care.

Toward that end, the group has been exploring the challenges clinicians face in relation to appropriate laboratory test selection and result interpretation. Providing solutions to these "will improve utilization of laboratory services and reduce diagnostic and treatment errors and delays," the CDC says.
Here's a partial list of the challenges that the CLIHC found in a 2012 national survey of 1,700 internal and family medicine physicians

  • Multiple or confusing test names for the same test
  • Diverse testing panels with the same name
  • Differing practice guidelines
  • Communicating with laboratory professionals
  • Result interpretation, including:
    • Variation in laboratory normal values and reporting format
    • Previous results not readily available
    • Lack of timely reporting
    • Results inconsistent with patient's symptoms

Suggested solutions include:

  • Computerized physician order entry (CPOE) with electronic suggestions for appropriate test-ordering
  • Clinical algorithms/pathways to guide test selection
  • Interpretive comments
  • Reflex testing

The physicians surveyed were particularly concerned about communication with laboratory professionals because it was not as frequent as they liked. However, when clinicians did consult with laboratory professionals, the majority found it useful.

The CLIHC group believes that "overuse, underuse, and misuse of laboratory tests may be reduced and patient care improved if the methods deemed 'useful' by the survey respondents can be available to more physicians."

An overview of topics relating to clinical labs can be found at the website of the CDC Division of Laboratory Programs, Standards, and Services (DLPSS) at http://www.cdc.gov/ophss/csels/dlpss/index.html

About the Author:

Robin Miller Zweifel, BS, MT(ASCP), is Senior Vice President of Revenue Capture at Panacea Healthcare Solutions. She possesses 25-plus years of healthcare industry experience, including 16 years in the clinical setting. At Panacea, Ms. Zweifel's duties include conducting procedure coding and chargemaster assessments, reviewing operations for regulatory compliance, and assisting in the implementation of facility compliance programs. Among her responsibilities are coding and compliance audits for outpatient medical oncology and pharmacy, specific to drug administration service lines. In addition, Ms. Zweifel is a contributor to MedLearn Publishing infusion services publications. She leads the development of Panacea's CDMAuditor CDM Coding & Compliance module and contributes to a number of publications and web-based products that help providers maintain regulatory compliance, while ensuring positive revenue outcomes.

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Last modified on Wednesday, 27 May 2015 14:16