New Checklists Includes Many Changes

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Overview

According to CAP, Point of Care Testing refers to those analytical patient tests provided within the institution, but performed outside the physical facilities of the clinical laboratories.  The central criterion of POCT is that it does not require permanent dedicated space.  This type of testing is performed by a large number of different non-laboratory healthcare personnel who have other patient care responsibilities in addition to POCT.  Another key aspect that distinguishes POCT from main laboratory testing is that it utilizes instruments and kits that are hand-carried or otherwise transported to the vicinity of the patient for immediate testing at that site.  POCT does not include limited service satellite laboratories with fixed dedicated testing space; these are covered under the Limited Service Laboratory Checklist.  

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The Inspection Process

When records are maintained centrally by a designated coordinator or POCT Director, only one copy of this Point of Care Testing Checklist need be completed.  The Inspector will review all centrally maintained records and visit at least a sampling of the testing sites in order to evaluate compliance with the standards.  If records are not maintained centrally, the Inspector must visit each POCT site, and a separate checklist must be completed for each location.  In the latter case, each POCT site will be billed as an additional laboratory section.

To be accredited, all analytes being measured under the POCT program/site must be included in the on-site inspection and comply with the CAP Standards for Laboratory Accreditation.  POCT programs may be inspected as sections of the central laboratory if they are registered under the same CLIA-88 number.  In this circumstance, they are included in the Laboratory General Checklist used for the central laboratory.  If the POCT sites are registered under separate CLIA numbers, a separate Laboratory General Checklist must be completed for each POCT program.  

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Quality Control

Quality control samples are samples that act as surrogates for patient specimens.  They are to be periodically processed like a patient sample to monitor the ongoing performance of the entire analytic process, and must be judged acceptable prior to reporting patient results.  They must be evaluated and organized such that they can be used daily by the testing personnel or supervisory technical staff to detect problems, trends, etc.  It is implicit that quality control specimens be tested in the same manner as patient specimens.  Moreover, QC specimens must be analyzed by personnel who routinely perform patient testing-this does not imply that each operator must perform QC daily, so long as each instrument/test system has QC performed at required frequencies.  

Most quantitative tests are traditionally monitored with two levels of liquid QC.  This is to be done at a frequency within which the accuracy and precision of the measuring system is expected to be stable, but at least each day that patient testing is performed.  The daily use of two levels of liquid QC may not be required for certain test systems where the daily use of electronic controls is demonstrably sufficient.  

For hematology, coagulation, and blood gas tests, two different levels of control material are required during each eight hour period of patient testing and each time there is a change of reagents. 

For qualitative tests, a positive and negative control must be included with each run of patient specimens.  As an exception to this general practice, the specific frequency of such testing for multiparameter urine chemistry dipsticks may vary according to workload and testing location, and may not occur with each run.  However, the frequency must be defined and followed by the laboratory. 

For direct bacterial or viral antigen tests that include internal positive and negative controls, a positive and negative external control must be tested with each new kit lot number or separate shipments of a given lot number.  Internal quality control tests can be used for subsequent testing, based upon the manufacturers’ recommendations. 

Oversight review of quality control must occur at least monthly by the Laboratory Director or designee.  Beyond the specific CAP requirements, a laboratory may perform more frequent review at intervals that it determines appropriate for its setting and the assays involved.  Because of the many variables, CAP makes no specific recommendations on the frequency of any additional assessment/review of QC.

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Proficiency Testing

POCT programs must participate in a CAP-approved proficiency program of interlaboratory comparison testing appropriate to the scope of their program.  Proficiency testing is required for all analytes regardless of their CLIA classification.  When possible, the proficiency testing samples must be processed as patient samples, and analyzed by personnel who routinely test patient samples, using the same method.  Further, these samples should be periodically rotated among all analyzers used for testing, and among all testing personnel.     

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Reagents

In the POCT setting, it is very important to verify reagent performance because reagents may be stored under a variety of uncontrolled conditions.  This verification is required by CAP.  Any of several methods may be used.  Such as direct analysis with reference materials, parallel testing of old vs. new reagents, and checking against routine controls.  The intent of the CAP requirements is for new reagents to be checked by an appropriate method and the results recorded before being placed in service.   Where individually packaged reagents/kits are used, there should be criteria established for monitoring reagent quality and stability.  Running “wet controls” is a typical way of validating the reagent quality and operator technique.  

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Procedure Manuals

Procedures should be written in substantial compliance and meet the intent of the NCCLS GP2-A3 document without having to precisely copy it.  Procedures should be available to all testing personnel.  Electronic manuals are acceptable, so long as the electronic versions are readily available to all personnel.  There is no requirement for paper copies to be available for the routine operation of the laboratory.  It is suggested, however, that current paper copies of electronically stored procedures be available at the time of the CAP inspection, or rapidly generated at the request of the inspector. 

Manufacturer inserts or procedure manuals for an instrument or reagent system may not be used as a replacement for a department procedure.  It may be used as part of the procedure description if the insert accurately describes the procedure performed in the laboratory.  Any modification to, or deviation from the procedure must be clearly explained and documented.

The Director of the POCT program is responsible for ensuring that the collection of policies and procedures is complete, current, and has been thoroughly reviewed by a knowledgeable person.  Therefore, there must be documentation of at least annual review of all policies and procedures for POCT by the current Director or designee.  Signature review must be at the level of each procedure, or as multiple signatures on a listing of named procedures.  A single signature on a Title Page or Index of all procedures is not sufficient documentation that each procedure has been carefully reviewed.  In addition, a signature on each page of a procedure is not required.   

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Testing Personnel

It is required that each facility performing POCT have a documented program to ensure that each person performing point-of-care testing maintains satisfactory levels of competence.  The records must clarify what skills are assessed and how those skills are measured.  The laboratory must have a system documenting that all personnel are knowledgeable about the contents of the procedures in which they perform.  This does not specifically require annual procedure sign-off by testing personnel.  However, the form of this system should be defined by the POCT Laboratory Director and followed.

References:

College of American Pathologists; Commission on Laboratory Accreditation, Laboratory Accreditation Program, Point of Care Testing Checklist, October 2001.