Attachment 12 - 113-02 ANCILLARY TESTING.pdf

1. PURPOSE: To establish policy for ancillary testing for laboratory tests used for patient care purposes in the VA Medical Center and outreach functions.

a. A laboratory test is defined as a diagnostic or monitoring procedure on a human specimen to determine specific information for patient care, prevention of disease, and to detect the impairment of health status or assess the health of human beings.

b. Ancillary testing is defined as laboratory testing or services within the VA Medical Center or its outreach functions (clinic, etc.) that is performed by VAMC employees outside the physical facilities of the main clinical laboratory.

c. Laboratory tests performed in the VA Medical Center and its outreach functions are of waived and moderate complexity levels regardless of the time required, method or analyzer used to perform the test. Physician Performed Testing (PPT) is completed in accordance with Attachment A.

2. POLICY:

a. All ancillary testing sites within the medical center and its outreach functions are mandated to comply with current Standards for Laboratory Accreditation of The Joint Commission and College of American Pathologists (CAP) regardless of scope of testing activity. Coordination of all ancillary testing in the VA Medical Center is through the Ancillary Testing Coordinator.

b. All ancillary testing sites are required to be inspected and fully accredited by the College of American Pathologists and The Joint Commission. The inspection will be performed during the same inspection visit for the main clinical laboratory.

(1) Ancillary testing sites that perform testing must be under the quality management oversight responsibility of the qualified Laboratory Director appointed by the Chief, Pathology and Laboratory Medicine Service. Laboratory Directors are responsible for maintaining CLIA licensure and full accreditation for their assigned ancillary testing sites.

(2) Quality management records for all ancillary testing must be maintained by the Ancillary Testing Coordinator in the main laboratory. The Ancillary Testing Coordinator and the Laboratory Director(s) should review these records on a monthly basis. Regulatory and performance indicators tracked in the Quality Management records will be reported to the Chief of Pathology and Laboratory Medicine Service at the Department’s Quality Management Meeting each month.

POLICY MEMORANDUM

VA Medical Center 1030 Jefferson Avenue Memphis, TN 38104

Number: 113-02

Dated: March 21, 2016

Expires: March 20, 2019

Title: ANCILLARY TESTING

36C24920R0114 - Attachment 12

(3) The testing standards require written records and requirements for tests performed, including identification of personnel performing testing, quality control tests, and certification of current competency of testing personnel.

3. RESPONSIBILITY:

a. The Ancillary Testing Coordinator acts as a technical oversight supervisor for all ancillary testing under the direction of the Laboratory Directors and the Chief, Pathology and Laboratory Medicine Service, and is responsible for:

(1) Selection of test methodologies appropriate for clinical use of test results.

This is critically important to ensure that there is consistency of patient test results, normal values, critical values and standardization of reporting of test results in CPRS.

(2) Verification of methods and test procedures performed and the establishment of the laboratory’s test performance characteristics, including the precision and accuracy of each test and test system.

(3) Enrollment and participation in a proficiency-testing program commensurate with the testing services offered.

(4) Establishing a quality control program appropriate for testing performed.

(5) Establishing acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results.

(6) Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications.

(7) Ensuring that all testing personnel know that patient test results are not to be reported until all corrective actions have been taken and the test system is functioning properly.

(8) Identifying training needs.

(9) Ensuring that each individual performing test receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed.

(10) Evaluating the competency of all testing personnel and assuring that the staff maintains their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include:

(a) Direct observations of routine patient test performance, including patient preparation, specimen collection, handling, processing and testing.

(b) Monitoring the recording and the reporting of test results.

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

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

(e) Assessment of test performance through testing previously tested samples, blind testing samples or proficiency testing samples.

(f) Assessment of problem solving skills.

(g) Evaluating and documenting the performance of individuals responsible for testing.

b. Testing personnel are VA employees who are authorized by the Ancillary Testing Coordinator to perform patient testing. Their training and experience must be appropriate for testing and meet accrediting agency (The Joint Commission, CAP, etc.), CLIA 88 and VHA Handbook 1106.1 requirements for testing personnel. The supervisor must request the Ancillary Testing Coordinator or designee to evaluate the employees’ qualifications before training begins. They are responsible for the following:

(1) For attending in-services and any additional training required for test performance.

(2) For following procedures in manuals, policies, videos, etc.

(3) In situations where solutions to problems must be related to personnel in a timely and efficient manner, the testing personnel will be responsible for reading memos and mailman messages.

4. PROCEDURE:

a. Ancillary testing authorization must be requested in order to initiate testing in ancillary sites. Service chiefs must request evaluation of testing methods, instruments, and personnel qualifications. The request should be through the Chief, Pathology and Laboratory Medicine Service or designee, and the Ancillary Testing Coordinator.

b. The service must also agree to follow all standards of practice for ancillary testing including, but not limited to, quality control, quality management, test performance, training, and accrediting standards.

c. The Chief, Pathology and Laboratory Medicine Service may terminate ancillary testing if patient care and Clinical Laboratory Standards are not met. Personnel may lose authorization for testing if levels of competency are not met.

d. Each service is responsible for instrument purchases, costs of reagents, supplies, maintenance and other expenses necessary for quality control, quality improvement, etc.

5. REPORTING REQUIREMENTS: The Ancillary Testing Coordinator will send a report to the service chiefs of any deficiencies in their service.

6. RESPONSIBLE OFFICE: Chief, Pathology and Laboratory Medicine Service and Laboratory Directors (113).

7. REFERENCES: VHA Handbook 1106.1 (2015), College of American Pathologists Checklist (www.cap.org; CAP Number: 1587601; 2014). The Joint Commission Manual http://www.cap.org/ http://www.cap.org/ for Pathology and Clinical Laboratory Services (www.jointcommission.org; 2008- 2014).8. RESCISSION: Medical Center Policy Memorandum 113-02, dated July 2, 2008.

Medical Staff Concurrence: Date: March 18, 2016

/s/

CHRISTOPHER MARINO, M.D.

Chief of Staff

/s/

WILLIAM H. MILLS

Interim Medical Center Director http://www.jointcommission.org/ http://www.jointcommission.org/

Attachment A Policy Memorandum 113-02 Date: March 10, 2016

Physician Performed Testing

Physician-performed testing (PPT) is defined by the “College of American Pathologists” as testing that is personally performed by a physician in conjunction with the physical examination or treatment of a patient. The PPT category is NOT the same as the U.S.

CLIA-88 term “provider performed microscopy” (PPM), which allows certain tests to be performed by non-physicians. Rather, it includes both waived tests under CLIA-88 and PPM, but only when either is performed by a licensed physician.

Typically, includes the following tests:

1. Occult blood, fecal;

2. Potassium Hydroxide (KOH) preparations, microscopy fungus;

3. Synovial fluid for crystals; and

4. Vaginal wet mount microscopy.

Services that facilitate patient management by having the physician perform some laboratory tests at the time of a patient encounter will add the test to the privileging documents for their service.

Training and competency assessment of physicians in the performance of specific tests must be documented, as required by accrediting agencies. .

Patient results must be entered into the progress notes on the patient chart. Notes must include:

1. Test performed;

2. Name of physician performing test;

3. Date and time of specimen collection; and

4. Control performance (for Occult Blood).