Issues in the practical implementation of POCT: overcoming challenges

ABSTRACT

There are many challenges in implementing a successful point-of-care testing (POCT) program. When compared to traditional testing, POCT results are faster and allow for rapid patient treatment. Unfortunately, the excitement of this technology is often lost due to an assortment of practical obstacles. Implementation of POCT requires consideration of the regulatory complexity and amount of documentation to be compliant. As more tests move to the site of patient care, the number of operators that need to be trained and assessed will grow. An effective POCT program rests solely on the foundation of education and training of each operator, but assuring regular competency updates for a large number of staff can be a management issue. Discussed in this article are several of the key obstacles to implementing a POCT program including laboratory quality regulations, compliance documentation and operational management challenges.

KEY WORDS:

• Point of Care
• Regulations
• Training
• Challenges
• Quality Control

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Key issues

• The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulate all laboratory tests conducted for patient care on humans, including tests performed at the point of care.

• Waived-, moderate-, or high-complexity POCT regulations differ based on the difficulty of performing and interpreting the test, maintaining and troubleshooting the analyzer, and conducting other steps required for testing.

• The continued advancement of POCT connectivity and computerized data management will lead to less manual documentation.

• Annual competency fairs, monthly training meetings and one-on-one sessions with POCT training staff are crucial to reaching the number of operators involved with POCT and meet federal and accreditation organization requirements.

• Managing reagent expiration dates, storage conditions, and open container expirations can be challenging to non-laboratory staff.

• Attention to the frequency and proper documentation of QC for POCT can prevent result errors and ensure regulatory compliance.

• Cleaning and disinfection of high-touch and multiuse medical devices is necessary in preventing harmful transmission of infectious diseases.

• Lack of harmonization and agreement between POCT and central laboratory results are a major area for clinical confusion and topic for emphasis with staff training.

• Understanding the limitations and preventing inappropriate use of POCT can enhance result reliability.