36C25718R0247-024.pdf

DEPARTMENT OF VETERANS AFFAIRS Policy Memorandum 113-14-02 South Texas Veterans Health Care System San Antonio, Texas 78229-4404 September 11, 2014

ANCILLARY TESTING POLICY

1. PURPOSE: The purpose of this memorandum is to establish policies for conducting ancillary testing procedures( waived, non-waived, and provider performance microscopy), and requirements for performing and maintaining the Ancillary Testing Program in the South Texas Veterans Health Care System (STVHCS).

2. POLICY: Except where separate College of American Pathologists (CAP) certificates have been obtained, testing performed in the STVHCS and in clinics are included under the CAP/Joint Commission accreditation of the Audie L. Murphy Pathology and Laboratory Medicine Service, are hereby are required to comply as mandated in Veterans Health Administration (VHA) Directive 1106.01, and The Code of Federal Regulations (42 CFR part 493). Failure to comply with CAP/Joint Commission and VHA handbook 1106.1, Department of Veterans Affairs Central Office (VACO), and Clinical Laboratory Improvement Act of 1988 (CLIA 88) requirements can lead to suspension, revocation, or limitation of testing. The STVHCS Ancillary Testing and Laboratory Utilization Review Committee (AT/LUR) will work cooperatively with testing areas to assure regulatory compliance. Testing sites must meet requirements for inspection by accrediting agencies (The Joint Commission and College of American Pathologist) and will be held accountable for the following documentation where applicable: Continuous quality improvement instrument maintenance; training /competency; annual certification;

recertification; and, procedural manual.

3. ACTION:

a. Definitions:

(1) Ancillary testing: Ancillary testing is defined as those diagnostic, monitoring, follow-up and initial laboratory testing procedures used /performed outside of the laboratory by non-laboratory personnel for the evaluation and treatment of patients. Only ancillary tests approved by the Ancillary Testing Committee will be performed in the STVHCS. All ancillary test procedures must be validated by a laboratory method as appropriate.

(2) Waived tests: Tests that must meet the specific descriptive criteria and must be test systems that are simple laboratory examinations and procedures which are cleared by FDA, employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible, or pose no reasonable risk of harm to the patient if the test is performed incorrectly. Waived tests performed at STVHCS are: bedside glucose, fecal occult, urine pregnancy, and activated clotting time (ACT).

(3) Non-Waived testing: Non-waived testing is the term used to refer collectively to moderate complexity and high complexity testing. Laboratory or sites that perform these tests need to have a CLIA certificate, be inspected, and must meet the CLIA quality standards described in 42 CFR Subpart H, J, K, and M. Nonwaived tests performed as ancillary tests at STVHCS are: Tzanck, Arterial blood gas, Blood oximetry, and Thromboelastometry.

(4) Provider-performed Microscopy procedures (PPM): Provider-performed Microscopy procedures must meet the following criteria and specifications:

POLICY MEMORANDUM 113-14-02

(a) The examination must be personally performed by one of the following practioners: A physician during the patient’s visit on a specimen obtained from his or her own patient or from a patient of a group medical practice of which the physician is a member or an employee.

(b) The procedure must be categorized as moderately complex, the primary instrument for performing the test is the microscope, limited to bright-field or phase-contrast microscopy, the specimen is labile or delay in performing the test could compromise the accuracy of the test result, control materials are not available to monitor the entire testing process, and limited specimen handling or processing is required.

PPM tests performed are: Scabies and KOH.

(5) Privileged provider: Privileged providers are members of the medical staff and licenced practitioners priviledged through the medical staff credentialing process.

b. When a service wishes to perform testing outside of the main laboratory, a request to perform Waived/ Point-of-Care Testing must submitted to the Ancillary Testing and Laboratory Utilization Committee in Pathology & Laboratory Medicine Section (P&LMS) (See Attachment B). The committee will review the request and the Chief of P&LMS will either approve or disapprove the testing.

c. The Ancillary Testing Coordinator/Pathology & Laboratory Medicine Section (ATC/P&LMS) will contact the requesting service and assist them to ensure the appropriate instrument/reagent is obtained. The ATC/P&LMS will assure that the instrument(s) is validated and all users are trained before patient testing commences.

d. The ATC/P&LMS will monitor for compliance with the following:

(1) appropriate policy and procedures in place;

(2) qualified and trained staff;

(3) documentation or test data and quality controls;

(4) Equipment maintenance logs;

(5) and ongoing competency assessments for designated staff.

e. The ATC/P&LMS will determine the proficiency testing needs, where appropriate, to ensure full compliance with The Joint Commission, CAP and CLIA, and VHA Handbook

1106.01 requirements. The ATC/P&LMS will distribute proficiency testing surveys in a timely manner to the test sites upon receipt in P&LMS. The ATC/P&LMS will review proficiency testing results as they are received, and communicate these results to the testing sites, as well as to ensure appropriate corrective actions are initiated and documented for instances of unacceptable performance.

f. Each person performing Point of Care Testing must complete training and submit competency assessment before performing patient testing. Thereafter, competency must be assessed annually. Retraining and reassessment of employee competency must occur when problems are identified with employee performance. Elements of competency assessment include, but are not limited to:

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

(2) Monitoring the recording and reporting of test results, including, as applicable, reporting critical results.

(3) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.

(4) Direct observation of performance of instrument maintenance and function checks, as applicable.

(5) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples of external proficiency testing samples; and

(6) Evaluation of problem solving skills.

g. Categories of Ancillary tests in the STVHCS:

(1) Provider Performed Testing (PPT) is limited to: Scabies, and KOH preparations. The performing provider must document the patient results with the quality control results in VistA (electronic medical record and/or patient's hardcopy medical record). P&LMS will provide technical assistance where requested. Only physicians, mid-level practitioners such as nurse practitioners, and physician's assistants are qualified to perform PPT. Initial credentialing with documentation is required with subsequent annual recertification for competency is necessary as per VA Laboratory Accreditation Guidelines.

(a) Personnel performing these procedures are expected to follow good laboratory practices in terms of quality control, quality assurance, and proficiency testing whenever possible.

(b) The procedure must be performed strictly in accordance with the manufacturer's instructions.

(c) Written policies and procedures must be in place for performing the test.

(d) Patient and quality control test results must be documented. For patient tests performed by privileged providers (such as occult blood test), the quality control, the patient test results, and the date the test was performed may be documented in the patient chart; the test lot number used on that patient must be tracked in some manner. All other procedures require appropriate logs for recording this information, as well as entry of results into the VHA computer system.

(e) Any one performing such testing must participate in a formal proficiency-testing program (CAP) or have a system in place that verifies, at least twice a year, the accuracy of test results.

(f) All testing must be carried out in accordance with applicable accreditation standards. 3

(2) Non-waived Testing: P&LMS and ancillary testing sites that perform Non-Waived testing such as Tzank, and Scabies testing in Dermatology, and blood oximetry, Thromboelastometry, and Arterial Blood Gas testing in Anesthesia and Cath Laboratory, must follow the Code of Federal Regulations 42 (CFR) Part 493.

(3) Waived: P&LMS and all testing sites that perform Bedside glucose, Fecal Occults, Urine pregnancy testing, and Activated Clotting Time (ACT) must follow the guidelines in 42 CFR part 493, CLIA88; and VACO Directive 1106.01.

Note: If waived tests are used as screening tests, confirmatory testing is specified in the written procedure if it is required and/or applicable.

h. Limited Service Laboratories: Ancillary Tests approved by the Ancillary Testing and Laboratory Utilization Review Committee are either Waived, PPT and/or Non-waived and are used in the following table:

Locations performed (as medically required)

Timed defined

Performed by staff providers or staff

Complexity

Bedside blood glucose

STVHCS,

Kerrville, All CBOPCs

Monitoring Approved staff Waived

Fecal Occults STVHCS (Urgent care only)

Screening Approved staff Waived

Urine Pregnancy FTOPC, SBOPC, BHOPCs, SPOPC, VOPC

Screening Approved staff Waived

Arterial blood gas STVHCS, Kerrville

Definitive Approved staff Non-waived

Activated clotting time (ACT)

Cath Lab, OR Perfusionist, Anesthesia Lab

Definitive Approved staff Non-waived

Blood oximetry Anesthesia lab/Cath lab

Screening Approved staff Non-waived

KOH, Scabies, Tzanck

Dermatology clinic

Definitive Staff providers PPM

Thromboelastometry Anesthesia Lab Definitive Approved staff Non-waived

i. Continued Joint Commission and College of American Pathologists certification will be contingent upon satisfactory quality control, proficiency testing, and accreditation review guidelines, as well as adherence to policy and procedures.

j. The end users will perform proficiency-testing surveys. Those testing sites with a different

CLIA certificate number must report the proficiency results back to the College of American Pathologists.

k. Individuals not complying with the stated policy or performing inaccurate testing will be counseled, retrained, and recertified as appropriate, and on continued non-compliance will not be allowed to perform testing.

l. The respective Service Chief will be notified of the lack of compliance by an individual or unit and administrative action can be taken as deemed appropriate. Methods used to assess current skills include at least one of the following: Performing a test on an unknown specimen (i.e., patient sample or College of American Proficiency Survey Sample), having a supervisor or site manager observe routine work, or monitoring each user's quality control performance.

m. Maintenance will be performed as specified in the manufacturer's guidelines. These procedures will be outlined in the methodology procedure and documented.

n. Infection Control will be included in the approved training program. Authorized individuals must be familiar with universal precautions. System safety policies must be observed. Personnel must wear gloves for all test procedures and for all finger stick specimen collections.

o. Reporting of Results are to be maintained in the patient's electronic medical record and identified by the date, time, test performed, quality control data, instrument identification number and name of person performing the test.

4. ACCOUNTABILITY:

(1) The Chief Pathology & Laboratory Medicine Service (P&LMS 113) will be responsible for routine monitoring and overall management of all ancillary tests. The Chief, P&LMS, with the approval of the Chief of Staff, has the responsibility and authority to discontinue any ancillary testing when quality assurance guidelines are not in compliance. VACO Directive 1106, Handbook 1106.1 dated October 6, 2008, states: "All testing, regardless of complexity level or where it is performed...is under the direct or indirect oversight of the Chief or Director, Pathology & Laboratory Medicine Service..." as it relates to the organization's Quality Control policies, procedures and processes for waived testing and pertaining to ancillary testing sites.

(2) Ancillary Testing Coordinator will be responsible for:

(a) Routine monitoring of the quality control, maintenance records, review and training records of authorized individuals,

(b) Reporting any non-compliance to the Chief, P&LMS, and Chief, Nursing Service or the appropriate service chief. Copies of all quality control maintenance records will be kept in the testing service or be immediately available upon request.

(c) Acting as technical advisor to all ancillary sites. The Ancillary Testing Coordinator will perform periodic data validation of results utilizing the VistA/Remote Automated Laboratory System (RALs) review.

(3) The Ancillary Testing and Laboratory Utilization Review Committee AT/LUR will be responsible for the overall policy, standard development, and operational quality management of ancillary and point of care testing. The committee will be responsible for monitoring cost and request patterns of tests sent to a referral laboratory for testing. The committee will serve as the board where medical center services or providers may submit a request new test methodologies or new point of care testing services (attachment B). The Committee will on a periodic basis, review the costs and appropriateness of high volume or high cost referral laboratory testing; serve as the forum to receive requests from STVHCS providers for new laboratory tests or change in test methodologies needed to meet current standards of medical care; decide which point of care tests may be performed outside the main laboratory, and whether the tests are used as screening or diagnostic; develop protocols and standards for individuals performing ancillary testing; define protocols for immediate evaluation of results and actions by non-laboratory testing personnel should test results fall outside specified ranges; develop/recommend/implement appropriate continuous monitors as specific concerns are identified; define the clinical limits of acceptable variability for each type of test performed outside the main clinical laboratory; and, establish under the guidance of the Chief, P&LMS, critical values ("panic values"), which will be used throughout the STVHCS for notification of the patient's Health Care Provider in an emergency or when unexpected life-threatening value is obtained in a testing site.

(4) Ancillary Testing Site Manager - Each service performing ancillary testing will designate an Ancillary Testing Site Manager. The site manager is responsible for the following:

(a) Adherence to Joint Commission, College of American Pathologists and applicable VA requirements at ancillary testing sites;

(b) Assist in the training of operators and will be responsible for their authorization, evaluation, and documentation of their annual clinical competency. For waived tests to be performed properly, the operator performing them must be qualified to do so. Operators must have specific training in the tests. This training may be acquired through hospital or other training programs with proper documentation, such as those provided by other health care hospitals or manufacturers;

(c) Supervision of routine testing and assurance that routine calibration, quality control, performance of routine maintenance, and applicable infection control measures are followed;

and,

(d) Maintain documentation of compliance and forward a copy to the Ancillary Testing Coordinator, P&LMS. Nursing Education, Nursing Service, will assist in the training of the operators and will be responsible for authorization, evaluation, and documentation of the clinical competency of nursing service personnel. The operator will be responsible to assure that routine calibration, quality control, and maintenance are performed, and that infection control standards are maintained.

(5) Certified Operators: Those health care personnel (administered by the Ancillary Testing Office) who have participated in the certification program and will be responsible for the performance of ancillary tests as described in the contained policy and procedures. Any interpretation of results and therapeutic decisions based on tests performed by patients themselves are the direct responsibility of the attending physician. The certification program assessments include the following:

(a) Frequency that staff members perform tests,

(b) Technical background of staff,

(c) Complexity of test methodology and the consequences of an inaccurate result,

(d) Emphasized for individuals who perform infrequent testing.

(e) Competency Assessments: Formal competency assessment of all new Nursing staff are required following initial training at the testing site, competency, and annually thereafter. This competency assessment must include each of the following elements, as applicable to the employee’s duties:

1. Direct observations of routine patient test performance, including, as applicable, patient identification and preparation; and specimen collection, handling, processing and testing.

2. Monitoring the recording and reporting of test results, including, as applicable, reporting critical results.

3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.

4. Direct observation of performance of instrument maintenance and function checks.

5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and

6. Evaluation of problem-solving skills.

5. REFERENCES:

a. Department of Veterans Affairs Veterans Health Administration Directive 1106, Pathology and Laboratory Medicine Service Chapter 7 "Ancillary Testing" Verification of Proficiency of Blood Glucose Monitoring

b. VHA Handbook 1106.1.

c. CAP Checklist. HospitalAccreditation Standards, The Joint Commission, Code of Federal

Regulations: 42 CFR, Part 493

6. RESPONSIBILITY: Chief, Pathology & Laboratory medicine Service (113)

7. RESCISSION: STVHCS Policy Memorandum 113-12-02 dated December 17, 2012;

STVHCS Policy Memorandum 113-12-13 dated February 6, 2012

8. RECERTIFICATION: September 2019

(Signature on file)

MARIE L. WELDON, FACHE

Director

Attachment

DISTRIBUTION: A

South Texas Veterans Health Care System

Request for Point-of-Care/PPM Testing

Service/Care Line: _____________________________________________________________ Location of Testing Site: ________________________________________________________ Site Supervisor: _______________________________________________________________ Test/s Performed and Instrument and/or Reagents to be used: ________________________ Reason for Testing _____________________________________________________________ Will this test be a screening or definitive test? ___________________ If it is a screening test, what follow-up procedures will be performed? __________________ Testing Personnel: _____________________________________________________________ How will personnel be certified? _________________________________________________ How will competency be checked? __________________________________________ Who will purchase equipment/reagents/supplies? ___________________________________ Will results be documented in Vista? Yes/No Will appropriate Quality Control records be kept and be available for review? Yes/No Signature of Service Chief Date

________________________________ Approved/Disapproved __________________ Chief, P&LMS Date

Attachment