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Title: Physician Directed Laboratory Point of Care Testing
Manual: Point of Care Testing / Section: Laboratory
Document Number:POCT.GEN.1000 / Issuing Authority: Medical Director, Laboratory Services
Date Issued: Mar 2001

1.0Purpose

  • To ensure accurate patient results, it shall be the policy of the Laboratory to establish protocols, procedures, a quality assurance program, operator training guidelines, and certification of operators performing analysis for all Point of Care Testing (POCT)

2.0Scope

  • MAC in consultation with the laboratory director shall be responsible for defining the scope of POCT
  • POCT testing is made available, taking into consideration of cost impact and technological feasibility to patient care areas including critical care, emergency, medical, surgical, rehab, pediatric, neonates, maternal, dialysis and off-site clinics
  • MAC approved POCT includes the use of glucose meters (BGH and Willett site), urine pregnancy tests (Willett site only), urinalysis strip test (Willett site only), and HbA1C (BGH only).

3.0Definitions

  • POCT: Point of Care Testing
  • MAC: Medical Advisory Committee
  • BCHS: Brant Community Healthcare System

4.0Responsibility and Accountability

  • The ultimate responsibility for POCT lies with the hospital board to ensure that quality care is provided. POCT issues shall be communicated to the Board through MAC.
  • Primary responsibilty for the management of POCT resides with the Laboratory Medical Director at the Brant Community Healthcare System (Brantford General site and Willett Hospital site) who is knowledgeable in all aspects of the program including clinical implications, instrumentation, troubleshooting, quality assurance, analysis and documentation. The Director may delegate the responsibility of reviewing the Quality Assurance program to a Technical Specialist or their designate at the Brantford General
  • The ordering physician shall take responsibility for the test results produced. With respect to glucose testing, if the ordering physician does not wish to follow the established repeat / verification criteria, they may override this by means of a written order and a comment shall be entered into the meter.
  • The accountablity for ensuring that equipment maintenance, quality control and patient testing are appropriately performed and documented rests with the individual performing those functions
  • The individual performing the collection and/or POCT shall be accountable to their professional college for insuring that they are competent
  • A Registered Nurse, Registered Practical Nurse or Nursing Pre-Grad Student who has demonstrated competency by successfully completing a formal training program including a written quiz and a practical demonstration may perform Point of Care Testing
  • POCT may be removed from service at the discretion of the Medical Director based on information identified in the monthly Quality Assurance reports or in the event of serious proficiency problems. Refer to POCT.GEN.3005 Non Compliance and POCT.GEN.4800 Non-Compliance Notification

5.0Related Policies / Procedures

  • BCHS Patient Services Manual N-IV-150 Glucose Meters
  • BCHS Medical Directive N-IV-324 Initiation of Capillary Blood Glucose Meter testing
  • BCHS Medical Directive N-IV-1550 Pre-op Prep Day of Surgery
  • BCHS Patient Services Manual N-IV-320
  • BCHS Patient Services Manual N-OBS-IV-1307 Newborn Capillary Blood Sampling
  • BCHS Patient Services Manual N-OBS-IV-715 Hypoglycemia protocol – Neonates
  • POCT.GEN.3001 Bedside Ancillary Blood Glucose Testing
  • POCT.GEN.4700 Operator Non Compliant Notification

6.0Policy Statement

6.1 Selection and Verification of Point of Care Instrumentation

  • It is the responsibility of the Laboratory Director or a designated co-ordinator to facilate a multi-disciplinary advisory management group for POCT evaluations and implementations to include multi-disciplinary representation from Nursing, Laboratory, Materiel Management, Nurse Educators, and Information Techonology personel. The selection and verification of a method and POCT device will be based on a review of performance, cost, and clinical trials with the potential users.

6.2 Personnel Training and Certification

  • The training program shall be included in Nursing Orientation sessions and shall be established under the direction and authority of the laboratory director. A Medical Laboratory Technologist or Technical Specialist will ensure that all training is conducted and documented in accordance with the training program to establish that personnel have adequate training and proficiency for the test they are performing
  • The Medical Laboratory Technologist or Technical Specialist in conjunction with the nurse educator will oversee and be responsible for the development, implementation and maintenance of the training program
  • Only operators who have successfully completed the training program and demonstrate competency shall be authorized to perform POCT
  • A written examination will be completed by the trainee , and graded acceptable (60%) or nonacceptable by the Laboratory. If the trainee is unacceptable, further instruction/demonstration will be provided by the laboratory and a re-test completed.
  • Records of trainers, trained operators, retraining and date of completion shall be maintained
  • Training program shall include:

a)principles of standard/universal precautions for the collection and disposal of specimens

b)limitations of the testing system, including sources of error

c)instruction and demonstrations of quality control handling, testing and documentation

d)instruction on critical high and/or low values with appropriate follow-up actions

e)instruction and demonstrations on procedures for obtaining proper specimens

f)instruction and demonstrations on operational procedures of the testing device

g)instruction on infection control with regards to hospital policy

h)instruction on documentation of test results

i)procedures for instrument maintenance and troubleshooting

  • The Technical Specialist or designate will be communicated to all certified operators as the resource person for troubleshooting assistance if required
  • Training sessions shall be held monthly
  • Re-certifications shall be required yearly which shall include a successful completion of a re-certification quiz (60%) and/or practical component
  • Additional re-certification of an operator shall be at the discretion of the Medical Director of the Laboratory based on information identified in the monthly Quality Assurance reports and audits performed by the Laboratory.

6.3Purchasing and Inventory Supplies

  • A record shall be retained electronically of reagent and control lot numbers along with expiry dates
  • The inventory of supplies shall be controlled, ordered and sequestered by the Materiel Management department. All contracts shall be negotiated between Material Management and the vendor. All supplies shall be cost directed to the origin of use. New lot numbers shall be pre-approved and validated by the laboratory for acceptability before distribution to patient care areas. The stores department shall be responsible for maintaining and distributing adequate operating supplies to the patient care areas.

6.4Equipment

  • An inventory record shall be maintained for all point of care equipment to include a name of the manufacturer, date received, serial number and unique identification and date if out of service
  • All point of care equipment shall be controlled by the use of unique patient identification numbers and operator numbers
  • Periodic and episodic maintenance of the equipment shall be performed, monitored and documented
  • All point of care equipment shall be validated and/or calibrated prior to distribution, with new lot number changes, and as a troubleshooting tool.

6.5Pre-Analytical

  • Specimen collection procedures shall be documented to ensure good sample integrity, safe collection practices for POCT. Refer POCT.GEN.3001 and Newborn Blood Capillary Sampling N-OBS-IV-1307
  • All POCT shall have a documented order by a physician on the patient’s chart
  • POCT for Glucose meters may be initiated at the discretion of certified personnel (Medical Directive N-IV-324)

6.6Analytical

  • Standard operating procedures (SOP) shall be developed by the Laboratory Technical Specialist, and Nurse Clinician. SOP’s shall be reviewed or deemed acceptable by appropriate care teams. All SOP’s shall be available to certified personnel and reviewed annually
  • All POCT SOP’s shall include the principle of the operation, the purpose of the test, specimen collection and handling, preparation of reagents, calibration procedures if required, quality control procedures including corrective actions, step by step instructions to perform the test, critical values, limitations of the procedure, repeat testing criteria, reference intervals, trouble shooting references if test system is inoperable, safety and infection control processes, and method references
  • Only strips and meter approved by the Medical Director of Laboratory will be utilized unless patient’s meter is to be used as ordered by a physician. A qualified practitioner must check patient’s technique for patients using their own meters
  • Patients (adult and child) may perform their own blood glucose test using their own equipment providing all of the following criteria are met

-A Physician’s order is written

-The meter, strips and patient’s technique are checked by a qualified practitioner and documented as being done

-Patient results MUST be correlated with laboratory results before deemed acceptable for glucose monitoring.

-Every reading obtained by patients using own meters will be documented in the Medication Administration Record (MAR) including indication “done by patient”; meter type and model; strip name, lot number and expiry date and results of meter compared with laboratory

6.7Quality Assurance

  • A list of certified operators will be maintained. This list will include the person’s name, credentials, signature, initials, date, trainer and the date recertification is due.

Recertification must be completed within one month of this date.

  • Quality control data shall be generated and recorded every time a control is tested
  • Unless electronically generated, the person performing the POCT must sign and date the control test
  • Patient data must be signed and dated
  • Quality control material lot numbers and expiry dates will be checked monthly at time of review.
  • Quality control data shall be reviewed by the Technical Specialist or designate on a monthly basis or earlier if required to verify the system and/or operator is meeting established standards. The review will identify trends allowing for remedial action such as operator retraining, device maintenance, or device, control and/or test troubleshooting
  • New lot numbers of reagents will be validated prior to distribution. Validations will vary depending on the POC test.
  • Monthly evaluation reports shall be sent to each nursing unit manager for review
  • All complaints and resolutions shall be entered into RiskPro. The POCT Coordinators shall respond to open files by completing severities and root cause analysis. If appropriate initiated the Quality Improvement Initiatives and Tracking procedure Laboratory General\Procedure\Quality Improvement Initiatives & Tracking.doc
  • The Laboratory shall on an on-going basis provide any technical assistance necessary to a certified operator or physician
  • Where available, participation in external quality control programs shall be initiated and shared with the management group and/or care teams and nurse managers
  • Records shall be retained for 2 years of the performance of each POCT location and/or meter

6.8Non-Compliance

  • Patient data shall be reviewed for policy compliency with respect to

Patient identification

Operator identification

Lot number verifications

Critical high and low concentration limits with course of action comments where applicable to the POC test

Confirmation testing policy; if applicable

  • If compliance is not met, the following shall occur

The operator shall be notified of Non-compliance event(s) POCT.GEN.4800 “Operator Non Compliant Notification” and privilages to perform the identified POC test removed

Nursing Manager will be notified

Laboratory Director will be notifed

Corrective actions must be initiated and documented to include possible re-training before access to POC test re-instated

If non-compliance re-occurring, the device may be removed from that specific patient testing area or operator will no longer be able to perform POC testing.

6.9Post Analytical

  • POCT results shall be recorded in the patient’s medical record to include date and time of testing, operator name, and shall be clearly distinguishable as a POCT test
  • There shall be a procedure for critical value reporting and actions taken
  • All patient information and POCT results shall be treated as confidential
  • The Willett site’s Point of Care Hard Copy manual is considered a controlled document and resides at the Willett Urgent Care.

7.0References

  • Ministry of Health and Long Term Care; Point of Care
  • Ontario Laboratory Accreditation 2003

8.0 Developed in Consultation with

  • Medical Director, Laboratory Services
  • Clinical Nurse Educators, BCHS
  • BCHS Care Teams
  • Technical Specialist, Laboratory Services
  • Quality Coordinator, Laboratory Services
  • Medical Laboratory Technologist, Laboratory Services

DISCLAIMER: This is a CONTROLLED document. The most current version is in electronic format on the BCHS intranet site. Any documents appearing in paper form are NOT controlled