Point of Care Testing

BACKGROUND

Point of care testing (POCT) refers to conducting laboratory tests outside the traditional laboratory setting that occurs near the client with the result leading to possible changes in care  for those clients. The Nova Scotia College of Medical Laboratory Technologists (NSCMLT) has a mandate to regulate the practice of medical laboratory technology and govern its members in accordance with the Medical Laboratory Act and the regulations. Since POCT can be performed by other health professionals, it is necessary that there is laboratory guidance and oversight by a licensed MLT of all POCT programs and activities. 

 

Point of Care Testing must be prescribed by an authorized practitioner and all results must be included into the client record. The innovation, apparent simplicity and functionality of POCT provide many challenges, in particular, the ability to determine the quality of the result and the value which POCT may bring to the client care process. POCT has the potential to improve treatment if undertaken within a comprehensive quality management system. It is expected that accuracy and reproducibility of the POCT result is comparable to that in an accredited hospital laboratory. In order to recognize the proper functioning of equipment and to provide reliable results, the operator must have education and training in the quality control procedures and knowledge of the analytical concept.

POSITION

The NSCMLT endorses the use of point of care testing when it enhances client care and when it is under laboratory supervision and jurisdiction as supported by accreditation and legislative guidelines. POCT offers a unique opportunity for Medical Laboratory Technologists (MLT’s) to work collaboratively with a broad scope of health care professionals by providing strong clinical laboratory expertise and leadership.

 

The NSCMLT endorses POCT programs which require: 

  1. The organization to have a policy that clearly defines reporting and contractual relationships and roles and responsibilities for POCT.
  2. POCT has laboratory guidance, management and oversight by a licensed MLT.
  3. An organizational interdisciplinary professional committee to define the scope of services and oversee the delivery of POCT.
  4. The organization has a standard operating procedure (SOP) that clearly defines the roles and responsibilities of all health care professionals delivering POCT.
  5. Nova Scotia’s labs are accredited by Accreditation Canada; personnel performing POCT must meet Accreditation Canada’s definition of Health Care Professional delivering POCT.
  6. All POCT users have formal educational and training and a competence assessment initially and periodically thereafter.
  7. There are written organizational POCT policies requiring:
    • A documented order for the tests from an authorized prescriber.
    • A documented record of the client test results, operator name, date and time of the test and a clear indication that it is a POCT result
    • Licensed MLT’s in collaboration with other relevant health professionals to be responsible for: 
    • Evaluation and selection of instruments and test materials
    • Development of the training and competence program
    • Regular quality checks on all instruments, reagents and strips
    • Selection and provision of standards and quality control material to operators and for the operation of a quality control program involving periodic simultaneous determinations by the laboratory 
    • A quality assurance program
    • Review of any risks or potential adverse events or non-conformances
  8. It is recognized that due to the nature of POCT that testing may be performed by non laboratory personnel in settings such as ,nursing homes, pharmacies, doctors’ offices or other areas where no laboratory exists within the organization. In these circumstance, it is strongly recommended that expert advice be sought from an appropriate licensed medical laboraotry technologist. 
    If there is no laboratory within an organization or practice to provide oversight, the organization has a documented POCT program that demonstrates the following:
    • The organization provides management and technical requirements concerning POCT

Management requirements

  • Defines, documents and implements processes and procedures for POCT throughout the organization
  • Manages Quality control and monitoring of all POCT processes and systems including maintenance records
  • Implements a process that prevents the use of POCT results when the performance of the device does not conform to pre determined quality requirements
  • Documents corrective action to determine the cause and prevent recurrence of quality non-conformance
  • Provides resources to support POCT
  • Ensures POCT results are entered into health records and are specified as a POCT result
  • Appoints appropriately trained and experienced person to oversee POCT and reports to management on POCT operations within the organization
  • Reviews POCT performance with changes to procedures and processes as recommended a POCT advisory committee or equivalent
  • Investigates adverse incidents and implements corrective actions to prevent further occurrences
  • There is adequate quality assurance program that includes quality control, calibration checks, inventory control, maintenance schedules and is open to audits by the NSCMLT.
  •  
  • Technical Requirement
    • Maintains an inventory of all POCT testing equipment that is licensed by Health Canada and CSA approved
    • Records of all materials and reagents purchased for POCT to allow for audit or trial in case of an adverse incident
    • Ensures all POCT results are recorded into the clients’ health record and the name of the person who performed the test is known
    • Defines ,implements and monitors quality control procedures for each system
    • Trains, certifies and re-certifies the operators of POCT devices
    • Maintains a competency based roster of all POCT operators
    • Provides procedural instructions for each POCT system to the operator
    • Ensures that only certified operators carry out POCT
    • Appoints and appropriately trains an experienced person as the manager responsible for training and competency
    •  
  • The training manager must
      • Develops, implements and maintains a training and competency assessment program for all POCT personnel
      • Health professionals performing POCT have adequate education and training. 
      • Ensures the program covers pre-analytical requirements and appropriate use of the device or system including; preparation of the client, sample collection, use of device, reagent storage,quality control,limitations of device,clinical implications of results and required records
      • Documents training provided and keep records of person trained or re-trained
      • Monitors POCT operator performance as a basis for re-training

A point of care service has the potential of providing improved client care; however, there is the risk of harm if it is not introduced and maintained properly. The laboratory or organization must be responsible for the oversight of the service to ensure all quality standards are met. Any liability will be assumed by the employer, health care professional who performed the POCT and may include the licensed MLT who was involved in the training and competency assessment of the health care professional performing POCT and/or the licensed MLT that has oversight of POCT.

 

It should be noted that any POCT must be handled in a manner consistent with the NS Medical Laboratory Act and Regulations and meets accreditation Canada’s guidelines for POCT. All licensed MLTs have an obligation to ensure that POCT is done in a manner consistent with the NS Medical Laboratory Act and Regulations.

REFERENCES

 

CSA Standards Z22870-07, Point-of-care testing - requirements for quality and competence, CSA, 2007

 

Ministry of Health and Long-Term Care Ontario, Revised Point-of-Care Testing Policy and Guideline for Hospitals with a Licensed Laboratory, April 12, 2007

 

MOHLTC Point-of-Care Testing Policy and Guideline for Hospitals with a Licensed Laboratory, Ministry of Health and Long Term Care, April 2007

 

NBSMLT Position Statement, Internet Access May 2012, 

 

NS Medical Laboratory Technology Act and Regulations, Bill#29, Chapter 8 of the Acts of 2000, June 2000

Plus 15189 The ISO 15189:2003 Essentials, A practical Handbook for implementing ISO 15189:2003 Standard for medical laboratories, CSA 2007.

 

Qmentum Program Point of Care Testing Standards, Accreditation Canada, October 2011

 

Oct 12, 2012

Revised  Jan 2016