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POINT-OF-CARE TESTING

Point of Care testing may seem, on its face, simple and 'fool proof', but in a study conducted by the Health Care Financing Administration (HCFA - now referred to as CMS)  in Colorado and Ohio, quality problems were identified in more than 50% of Certificate of Waiver labs surveyed nationwide. 

This study revealed "glaring quality control problems" and urged the FDA to provide more governmental oversight of these laboratories. The HCFA study noted problems in 50% of the laboratories surveyed and specifically cited the following performance problems:

o        Obsolete instructions
o        Lack of instructions
o        Incorrect instructions
o        Failing to perform quality control as required by the manufacturer.
     

 The NJ HIV program is designed to assist personnel engaged in Rapid HIV Point of Care testing to achieve the following goals:

  • To provide quality care to clients;
  • To meet the standards of quality review organizations;
  • To insure compliance with state and federal regulations regarding laboratory oversight;
  • To provide consistency of test offerings within the NJ HIV program;
  • To achieve economies of scale in the acquisition of reagents and instrumentation;
  • To insure the highest quality of test performance

 Under this program a standard package of Point of Care services are available at each clinical facility, so long as the required training, proficiency testing, quality control procedures and validation procedures are performed by the clinical staff in the facility. The Robert Wood Johnson Department of Pathology and Clinical Laboratory Medicine oversees this program and provides Bioanalytical Laboratory Directorship (BLD) and all necessary state and federal licensing for each site. 

This program is responsible for:

  • Submission and maintenance of clinical laboratory licensure
  • Providing written procedures, a training program, a competency assessment program, a proficiency testing program, a quality control program and an internal laboratory inspection program.
  • Testing reagents will be provided through the program and lot to lot variability minimized by centralized bulk purchasing and central validation of reagents
  • Troubleshooting support will be provided to insure testing quality along with standardized procedure for reporting testing exceptions and problem resolution
  • A team of clinical laboratory specialists will periodically inspect facilities to insure continued compliance with state and federal regulations at least semi-annually and more frequently, if necessary.

To participate in Point of Care Testing involves three simple steps:

  1. Completion of a facility survey. The purpose of the facility survey is to ascertain all clinical laboratory testing being conducted on premises. The Department of Pathology and Laboratory Medicine will then arrange for a site  inspection and submit a NJ clinical license on behalf of the facility.
  2. Arrange for appropriate insurance coverage. Each institution has its own unique set of insurance requirements. All facilities in which faculty of the UMDNJ - Robert Wood Johnson Medical School are serving as Directors/Supervisors or Consultants will need to establish a Professional Service Agreement. This can be arranged at the time of the initial site visit. It is designed to insure that appropriate insurance is available for all participants in the program.
  3. Receipt of procedures and subsequent training. Upon completion of laboratory licensure, the Department will arrange to provide training. The Department will:
    • Provide procedure manuals and forms. The most current procedure and forms will be available on this website
    • Provide staff training. Efforts will be made to provide training at convenient locations in the State of New Jersey.
    • Provide competency assessment of newly trained staff including 'Hands On' testing of unknown specimens
    • Provide ongoing review with your staff and resolution of problematic issues.
    • Arrange for site participation in on-going proficiency testing under an appropriate program, and/or additional assessments as deemed necessary by the Bioanalytical Laboratory Director
  4.  Adhere to Point of Care Procedures. Continued participation in the program requires that Point-of-Care Testing be performed in accordance with procedures described in our manuals and include those related to quality control, recordkeeping, proficiency testing and competency assessment. Periodic inspections of all sites will occur and the results will determine continued participation in the program.

Obtaining necessary supplies. Supplies, including test and control reagents, may be requested by forwarding a POCT supply request to our Central Administrative Offices in Somerset via fax (732) 235-8113 or by email to corbojo@rwjms.rutgers.edu.  Testing devices will be provided at no charge to a site. Charges for other supplies will be distributed to the facility periodically. Testing devices and control reagents will be validated prior to distribution. If supplies are obtained in any other way it is obligatory that they be validated by the site prior to use.

 If a facility wishes to perform any other procedure aside from those listed above, additional clinical laboratory licensure under the University Diagnostic Laboratories auspices would be required. 

The responsibility for successful participation in proficiency testing is ultimately the clinical sites’. The Department will provide assistance in troubleshooting of a limited nature. More extensive troubleshooting activities will be provided on an hourly basis to provide more complex troubleshooting of procedures on a unit specific basis.