36C24419R0074-009.pdf

DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTER

Erie, Pennsylvania

Medical Center Memorandum No. 113-25 May 26, 2016

ANCILLARY (WAIVED) URINE PREGNANCY TESTING

I. PURPOSE: To establish policies, procedures, and requirements for performing the Ancillary (Waived) Urine Pregnancy Testing Program in compliance with Joint Commission and directive from Department of Veterans Affairs.

II. POLICY: All ancillary testing sites that perform urine pregnancy testing for diagnostic purposes must comply with established test procedures and participate in proficiency testing program.

III. RESPONSIBILITY:

A. Pathology and Laboratory Medicine: The Medical Director, Pathology & Laboratory Medicine (P&LM), will provide oversight for the Ancillary Urine Pregnancy Testing Program.

B. Ancillary Testing Program Review Team: The Ancillary Testing Program Review Team will be responsible for the overall policy, standards development, operational quality management and medical appropriateness for Ancillary Urine Pregnancy Testing. The Team will advise and have input on the evaluation of instruments, development of procedures for testing and quality, and action to be taken when problems arise.

C. Ancillary Testing Coordinator: The Ancillary Testing Coordinator acts as a technical quality oversight supervisor for all ancillary urine pregnancy testing.

The coordinator will advise and assist in:

1. Selections of test methodologies appropriate for the use of the test results.

2. Verification of methods and test procedures and the establishment of performance characteristics including precision and accuracy of each test system.

3. Enrollment and participation in a proficiency testing program commensurate with the testing services.

4. Establishing a quality control and management program appropriate for the testing.

Attachment G

MCM 113-25, Ancillary (Waived) Urine Pregnancy Testing

5. Documents orientation, training, authorization and annual competence evaluation for all persons who perform ancillary testing.

6. The Ancillary Testing Coordinator will report to the Medical Director, P&LM, and the designated Supervisor(s) of any areas that are not in compliance.

D. Providers: Providers are responsible for appropriate ordering of ancillary urine pregnancy testing.

E. Supervisor(s) (or designee of all approved urine pregnancy testing sites):

Supervisor(s) will be the contact person for any issues of noncompliance of staff with established policies or procedures related to testing. The supervisor or designee will identify the staff members who perform testing, assist in training of site personnel on policy and procedure, ensure that routine maintenance is being performed, that testing records are maintained and informs Ancillary Testing Coordinator of any identified problems.

F. Nursing personnel: Nursing personnel will perform tests in compliance with established guidelines and participate in training and certification.

G. Authorized Personnel: Authorized personnel are those individuals who have participated in the authorization program. They will be responsible for the performance of ancillary urine pregnancy testing as described in the contained policy and procedure, including maintenance of supplies at the ancillary testing site(s).

IV. PROCEDURES:

A. Authorization of Testing Personnel.

1. The Program Leader/Supervisors or designee of all approved ancillary testing sites will designate those individuals who will be authorized to perform ancillary urine pregnancy testing. Authorization to perform ancillary testing will be limited to those individuals who have satisfied training requirements by attending an initial training session. As instructed by Ancillary Testing Coordinator, policies and procedures will be introduced followed by written exam. Clinical competence will be measured by the successful recovery of a control material to include documentation and interpretation of that control data. In addition, the testing site supervisor or designee will observe the individual perform the test procedure in the event of identified problems.

2. Authorization will be granted at time of orientation. During the first year, competency will be assessed at the discretion of the ancillary testing coordinator depending on test volume, number of operators and difficulty of testing, etc. It will be renewed annually thereafter, unless otherwise indicated by performance on routine QC, proficiency testing, or lack of compliance. Competence assessment will include at least two of the following methods: testing an “unknown” specimen, periodic direct observation of testing, monitoring operators’ quality control performance or written testing specific to the method used.

3. Individuals not showing satisfactory QC and proficiency records, following the stated policies and procedures or failing to complete the annual recertification will be removed from the list of authorized personnel. Reinstatement will occur only after additional training and clinical competency are demonstrated.

4. Documentation of staff training, certification, and recertification will be maintained by the Ancillary Testing Coordinator in Pathology & Laboratory Medicine.

B. Quality Control (QC).

1. All individuals who are authorized to perform ancillary urine pregnancy testing must participate in the QC program.

2. Each control value must be evaluated for acceptability. If results are not acceptable, corrective action must be taken. This action most commonly includes repeating QC testing.

3. Two out of 3 levels of QC must be run each day of testing.

4. On a monthly basis, each site will fax the specimen/QC log sheets to the

Ancillary Testing Coordinator for review. The Program Leader/ Supervisors or designee of the approved testing site will be notified if corrective measures are warranted.

C. Quality Assurance (QA).

1. Only one brand of kit will be utilized for testing. Each testing area will have its own log that will be kept in Pathology & Laboratory Medicine (P&LM). This log will consist of the following information:

a. Quality Control records.

b. Maintenance records

2. The training documentation along with the list of current authorized individuals will be maintained in P&LM.

D. Proficiency Testing.

1. Each ancillary test site that performs urine pregnancy testing must participate in proficiency testing.

2. Three times a year, a commercially prepared CAP survey specimen will be mailed to all ancillary test sites for analysis. These results are then evaluated by an external agency that determines the acceptability of the results. The Medical Director, and the Supervisor P&LM, along with the Ancillary Testing Coordinator will review the final analysis. A proficiency testing investigation review form will be initiated for all unacceptable results.

3. If unacceptable results are reported, the individual(s) involved will be notified and asked to perform testing on blind samples made up by the Ancillary Testing Coordinator. If the results are not acceptable, then the individual(s) will have their technique reviewed. The individual(s) in question will no longer be allowed to perform testing until retraining and competency are demonstrated.

4. If any ancillary test site shows a high degree of reporting unacceptable results on routine QC and/or proficiency testing, then the site in question will have their test systems thoroughly checked and corrective action taken if needed. If reporting of unacceptable results continues, the ancillary test site may have their testing removed.

E. Maintenance. Room and refrigerator temperatures will be taken by the ancillary test site. These procedures will be outlined in the method procedure and documented on the maintenance log sheet.

F. Acquisition of Supplies. Pathology & Laboratory Medicine will be responsible for supplying the test kits and quality control material.

G. Reporting Results.

1. Patient test results will include: Patient identification, date and time of specimen collection, name of test performed, reference (normal) values, test result, name of analyte, name of ordering physician, and location where testing was performed.

2. Patient test results will be manually entered in the patient's electronic record through VistA.

NOTE: If the urine pregnancy test result is not consistent with the clinical presentation of the patient, the provider may repeat a quantitative serum hCG.

H. Infection Control. Test performance and disposal of testing pipettes and testing devices must follow the guidelines of the hospital infection control policy.

V. REFERENCES:

A. VHA Handbook 1106.01, Pathology and Laboratory Medicine Service (PALMS)

Procedures, Section 13, Ancillary Testing

B. The Joint Commission Comprehensive Accreditation Manual for Laboratory and

Point-of-Care Testing (current edition)

C. MCM 00Q-107, Infection Control Precautions

VI. FOLLOW UP RESPONSIBILITY: Medical Director, Pathology & Laboratory Medicine/Ancillary Testing Coordinator

VII. REPORTING REQUIREMENTS: To the Ancillary Testing Program Review Team

VIII. RESCISSION: MCM 113-25, Ancillary (Waived) Urine Pregnancy Testing, dated April

10, 2015.

(Original Signed 5/26/16) Melissa A. Sundin Interim Medical Center Director