Section D.11 - Memorandum 113-007 Ancillary Testing Waived Testing and Provider-Performed Microscopy.pdf

Department of Veterans Affairs (VA) Memorandum 113-007 Central Texas Veterans Health Care System (CTVHCS) November 15, 2018 Austin-Temple-Waco Community-Based Outpatient Clinics (CBOCs)

ANCILLARY TESTING, WAIVED TESTING, AND PROVIDER-PERFORMED

MICROSCOPY

1. CHANGES: Added 5. d.; Updated Policy and Procedures.

2. RESCISSION: Memorandum 113-007, dated August 7, 2015.

3. NEXT REVIEW DATE: November 2021.

4. AFFECTED SERVICES: Dental, Medical, Nursing, Pathology and Laboratory Medicine (P&LMS), Pharmacy, Ambulatory Care, Surgical, and Information Technology Services.

5. POLICY:

a. All testing in CTVHCS will be in full compliance with Veterans Health Administration (VHA), Joint Commission, College of American Pathologists (CAP), and Clinical Laboratory Improvement Act (CLIA) '88 regulations.

b. Competency and training of individuals using ancillary testing instruments or test procedures will be assessed on an ongoing basis and additionally on an annual basis.

Demonstration of competency will be ongoing through successful participation in established quality control procedures, routine maintenance, and successful performance in a proficiency testing program, document review, result reporting, and direct observation of the test procedure.

c. If an individual uses more than one type of instrument and test procedure, e.g., whole blood glucose, occult blood, and urine dipstick, competency must be demonstrated for each instrument and each test procedure.

d. Glucose meter manufacturers have limitations on the use of their glucose meters in critically ill patient populations. CTVHCS defines “critically ill patient” as “a patient on mechanical ventilator with a mean arterial pressure less than 60 mmHg despite the use of pressors.” Capillary blood samples from critically ill patients should not be tested using the glucose meter. Venous or arterial blood collected by venipuncture or from indwelling catheters are acceptable alternatives for use with glucose meters.

e. The results of all ancillary testing must be entered in Veterans Integrated System Technology Architecture (VistA) in accordance with VHA Handbook 1106. There are no exceptions.

CTVHCS Memorandum 113-007 November 15, 2018

f. All ancillary testing sites are under the quality management oversight of Pathology and Laboratory Medicine Service. Inspection of those sites will be performed during accreditation inspection of P&LMS by the College of American Pathologists (CAP).

g. When patients are in a VA inpatient or ambulatory care setting, they may not perform self-testing, except when required as part of their education program or the patient admitted to the domiciliary or similar setting and adjusting their own medication.

h. Appropriate CLIA certificates of accreditation will be obtained for each testing location with a unique physical address prior to patient testing.

i. Testing personnel are expected to follow good laboratory practices in terms of quality control, quality assurance, proficiency testing, and patient safety.

j. Test procedures must be performed strictly in accordance the manufacturer’s instructions.

6. RESPONSIBILITY:

a. Chief, Pathology and Laboratory Medicine Service (P&LMS):

(1) Responsible for quality management oversight of all ancillary testing within

CTVHCS.

(2) Distributes the policy memorandum within the service or section; ensures that all affected personnel are notified of policy memorandum changes and additions on a timely basis.

b. P&LMS Ancillary Testing Coordinator (ATC): Responsible for documenting training, authorization, and annual competence for all persons in the medical center who perform ancillary testing and/or operator training (train-the-trainer). The competency review method suitable for each test will be determined by the Ancillary Testing Coordinator in accordance with regulatory requirements.

(1) Periodically surveys other services to identify and monitor any ancillary, waived, and/or Provider-Performed Microscopy (PPM) testing that is being performed for compliance with the following: appropriate policy and procedure in place; qualified and trained staff; maintenance logs; and ongoing competency assessment.

(2) Provides technical oversight supervision for testing methods and ensures appropriate method validation as needed.

(3) Ensures CLIA certificates are obtained and maintained for the scope of ancillary or laboratory testing at each site.

(4) Ensures there is a documented system in operation to detect and correct significant clerical and analytical errors, and unusual or unexpected test results, in a timely manner.

d. Ancillary Site Educators: Provide record of initial training to the ATC.

e. Providers: Request additional privileges through their Service’s Chief to perform simple manual (waived) tests and/or PPM appropriate for their area of expertise and to contact the ATC. All staff that perform testing, including all physicians, dentists and mid-level practitioners as defined by CLIA 493.2 performing PPM must participate in competence demonstrations.

f. Chief of each service desiring to perform ancillary and/or waived testing:

(1) Contact the Chief, Pathology and Laboratory Medicine Service with test information and define the extent to which it will be used for diagnosis, monitoring, or screening.

(2) Identify staff responsible for testing activity and identify a supervisor or other responsible individual(s) who will be the ATC’s primary contact for each testing location.

(3) Ensure mechanisms/processes are in place to provide verification of competencies, remedial training, and provision of required documentation to the ATC.

g. Testing Personnel: Perform quality control checks and document patient test results to follow established procedure and policy.

7. PROCEDURES:

a. Test Definitions:

(1) Waived testing is usually a simple manual test performed at the point of care Test status must be considered “waived” by the Centers for Disease Control (CDC).

Examples include, but are not limited to, fecal occult blood and urine dipstick (visual) for diagnostic, treatment, or screening purposes.

(2) Provider Performed Microscopy (PPM) is a category of testing performed outside the laboratory but separate from waived testing. It includes the following tests, which may be performed by privileged providers: wet mounts, KOH, and urine sediment exam for definitive or screening purposes.

(3) Ancillary Testing is any laboratory test performed outside the laboratory by non-laboratory personnel (other than privileged providers) within CTVHCS, regardless of CDC test status. Testing may be used for definitive, monitoring, or screening purposes.

b. Competency Assessment:

(1) Waived Testing: Depending on the instrument or test method, designated trainers (approved by the ATC) or Clinical Education will provide initial training. Original documentation of training will be filed in the office of the Ancillary Testing Coordinator.

Performance guidelines will specifically list criteria for competency for each ancillary test. All operators must attend an initial training for the particular instrument or test procedure. Annual competency assessment (recertification) of each operator/user must include at least two of the following:

(a) Direct observation of routine work, i.e. patient test or instrument maintenance, by the supervisor or qualified designee.

(b) Monitoring of each user’s quality control performance.

(c) Use of an electronic or written test specific to each test assessed.

(2) Non-waived Testing: Annual competency assessment (recertification) of each operator/user must include all of the following elements for each test system:

(a) Direct observation of routine patient test performance, including, as applicable, patient identification and preparation; and specimen collection, handling, processing and testing.

(b) Monitoring the recording and reporting of tests results, including, as applicable, reporting of critical results

(c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records

(d) Direct observation of performance of instrument maintenance and function checks

(e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.

(f) Evaluation of problem-solving skills

c. Re-training:

(1) Two consecutive unsuccessful review periods (especially the same deficiency) identifies a need for retraining or remedial action. Remedial action for most deficiencies encountered during a review period can be accomplished by simple reminders to the testing personnel.

(2) Individuals who do not complete adequate control checks, patient test information, or reports inaccurate patient tests, or fails to follow established procedure may be required to attend additional training. The individual must cease ancillary testing and may not resume testing activity until competency can be demonstrated. The ATC or supervisor will set up the training. The designated trainer will ensure that the training covers the individual's ability to run quality control and patient tests according to procedure.

d. Proficiency Testing Program:

(1) The ATC enroll each site in the appropriate proficiency testing program to ensure full compliance with CAP, Joint Commission, and CLIA requirements.

(2) ATC will review all proficiency testing evaluation reports as they are received.

The ATC will initiate appropriate corrective action if indicated and document unacceptable performance.

(3) Privileged providers must participate in the laboratory’s Proficiency Testing program for waived testing or microscopy as appropriate.

e. Documentation:

(1) A detailed procedure manual, applicable policies, and appropriate test or maintenance logs will be available at the testing site. The ATC will provide assistance in the preparation of these documents, as needed.

(2) Current policies and procedures are available on the P&LMS department web page on SharePoint.

(3) Patient test logs and maintenance logs will be submitted monthly to the office of the ATC for review and retained in Pathology and Laboratory Medicine Service for two years.

(4) For qualitative test results of patient tests performed by a privileged provider (such as occult blood), test results and the date the test was performed, will be documented in the provider’s note in the patient’s medical record. The associated quality control results may be documented in the patient chart or on a separate log. All other ancillary testing results (qualitative or quantitative) require entry into the VISTA system.

f. Test Centralization:

(1) Approval for ancillary testing at the point of care may be revoked immediately by Pathology and Laboratory Medicine Service if at any time evidence of noncompliance is discovered at the testing site.

(2) The Clinical Executive Committee removes approval for waived testing procedures if the laboratory can perform the proposed test procedure in a more cost-effective manner or for performance improvement activity.

g. Waived to non-Waived Status Change:

(1) VA regulations, CLIA regulations, and Joint Commission Standards for moderately and highly complex testing are considerably more stringent than waived testing. Personnel requirements are more rigid to ensure accuracy of these more complex tests.

(2) Non-waived status testing cannot be part of the whole facility Joint Commission accreditation. Laboratory accreditation by a deemed status accrediting organization is required every two years. In the case of a CBOC, this means a separate on-site accreditation inspection. The CBOC cannot be accredited as part of the main laboratory accreditation unless the clinic is located at the same address as the main laboratory.

8. REFERENCES:

VHA Handbook 1106.1, 29 January 2016; College of American Pathologists Point of Care and All Common Checklists, 21 August 2017; current Joint Commission Hospital Accreditation Standards(HAS); Code of Federal Regulations: 42 CFR Part 493, 1997.

/s/ Christopher R. Sandles, MBA, FACHE

Director

Attachment:

A. Approved tests and methods for point-of-care testing:

CEC Approved: 10/2/18

Attachment

APPROVED TESTS AND METHODS FOR POINT-OF-CARE TESTING:

Test Name Definition Authorized Testing Personnel

1. TEMPLE

Glucose (whole blood) Screen Nurse, Nursing Assistant, Technicians, lab personnel Fecal Occult Blood Screen Privileged Provider only (Emergency Dept. only) Urine Dipstick Screen GU Technicians Microscopy Screen Privileged Provider only (GU Clinic, (urine sediment) Nephrology) (presence/absence of sperm) Screen Privileged Provider Only (GU Clinic) (KOH, scabies) Screen Privileged Provider only (Dermatology) 8+ Profile Definitive Anesthesia staff, lab personnel Activated Clotting Time Definitive Anesthesia/Surgery Arterial Blood Gases Definitive Respiratory Therapist/Anesthesia Staff

2. WACO

Glucose (whole blood) Screen Nurse, Nursing Assistant, Technician Arterial Blood Gas Definitive Respiratory Therapist

3. AUSTIN

Arterial Blood Gas Definitive Respiratory Therapist Glucose (whole blood) Screen Nurse, Nursing Assistant Microscopy (KOH, scabies) Screen Privileged Provider only (Dermatology)

4. COMMUNITY BASED OUTPATIENT CLINICS

Glucose (whole blood) Screen Nurse, Nursing Assistant Fecal Occult Blood Screen Nurse, Privileged Provider, Nursing Assistant Urine Dipstick Screen Nurse, Nursing Assistant Urine Pregnancy Test Screen Nurse, Nursing Assistant