36C24419R0052-005.pdf

Department of Veterans Affairs POLICY 113-18-57 Medical Center March 21, 2018

Wilkes-Barre Pennsylvania 18711

ANCILLARY TESTING POLICY

I. SCOPE/EFFECT: This Medical Center Policy affects the following Services and Sections: Pathology and Laboratory Medicine; Nursing; Logistics / Prosthetics;

Pharmacy; Social Work; Imaging; Mental Health and Behavioral Medicine; Surgery ;

Geriatrics and Extended Care, and Women Veterans Program and all VA Medical Center staff who have an active role in performing, monitoring, ordering and controlling

Ancillary Testing.

II. PURPOSE: To establish policies, procedures and requirements for performing and maintaining the Ancillary Testing program.

III. POLICY:

A. Ancillary Testing is defined as diagnostic laboratory testing performed outside the physical facilities of the clinical laboratory by non-laboratory personnel. See Attachment A.

B. Only approved ancillary tests are to be performed and these tests must be validated by a laboratory method.

C. Ancillary testing will be monitored by the Chief, Pathology and Laboratory

Medicine Service or designee as mandated by VA Central Office. The Ancillary Testing Coordinator will monitor the Quality control (QC), Quality Assurance (QA), Quality Management (QM), and maintenance documentation for all glucose meters and/or other instruments and/or methods used in ancillary testing. This program will ensure quality throughout the pre-analytic, analytic, and post-analytic phases of testing, including patient identification and preparations, specimen collections, identification, and processing, and accurate result reporting. The program is capable of detecting problems and identifying opportunities for system improvement.

The Ancillary Testing program will be able to develop plans of corrective/preventive actions based on data from its QM system.

D. Pathology and Laboratory Medicine will be responsible for the training and certification/authorization process for all individuals who will be performing Ancillary Testing.

E. Chiefs of the appropriate Services or Nurse Mangers will be the contact point for any incidents of lack of compliance with policy and procedure.

IV. PROCEDURE/FUNCTION:

A. GENERAL:

1. Authorization to perform ancillary tests in this institution will be limited to those individuals who have satisfied the certification requirements. These requirements include participation in a training program and demonstration of clinical competency. Clinical Competency will be measured on the successful performance of:

a. Direct observation of routine test performance, including patient preparation, if applicable, specimen handling, processing and testing.

b. Monitoring the recording and reporting of test results.

c. Review of intermediate test results, quality control records and proficiency testing results.

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

e. Assessment of test performance through testing previously analyzed specimens or external proficiency testing sample.

f. Evaluation of problem-solving skills.

2. Continued certification will be contingent upon a satisfactory QC and proficiency testing as well as adherence to policy and procedures.

3. Certification will be renewed annually unless otherwise indicated by performance of inadequate QC, proficiency testing or lack of compliance with procedure.

4. Individuals not complying with the stated policy or performing inaccurate patient testing will be counseled by site supervisor, retrained and recertified.

Documentation of corrective action will be kept on site and in the laboratory by the Ancillary Testing Coordinator (ATC).

5. The Chief of the appropriate service or Nurse Manager will be notified of the lack of compliance by an individual or unit so that administrative action can be taken.

6. Any interpretation of results and therapeutic decision based on tests performed by patients themselves are the direct responsibility of the attending physician.

B. QUALITY MANAGEMENT QM: QM will cover four basic areas: quality assurance logs, quality control, proficiency testing, and maintenance.

1. Quality Assurance Logs: Each meter will have its own log that will be kept for the life of the meter and will be located in the laboratory. This log will contain the following information:

Initial instrument verification to include accuracy, precision, and linearity checks.

2. Completed QC log with daily QC data from each unit will be evaluated on a monthly basis by the laboratory.

2. Maintenance/service records will be maintained on each meter ( kept electronically in the RALS system).

4. Records of proficiency testing from each unit will be kept in the laboratory.

5. The training documentation along with a list of current certified individuals will be maintained in the laboratory.

C. QUALITY CONTROL:

1. All operators who are certified to perform ancillary testing must participate in the QC program.

2 A High and Low control is provided for all instruments performing Ancillary Testing. Each level has an assigned acceptable range established by the manufacturer. On a monthly basis, all results will be reviewed by the Ancillary Testing Coordinator for actual mean, standard deviation, and % coefficient of variation. A lock-out feature prevents the use of the meter if the quality control test fails. A wet control must be performed at least daily for the Accuchek Meters, monthly for the INR meters and each day of testing for the i-Stat meters. The wet control for all testing will be performed by testing personnel. All testing sites will adhere to the manufacturers recommended quality control program.

3. Each instrument will have a QC check run using the two levels of control material. Obtained control values are stored in each individual monitor with the following information: Date, time, operator initials, lot number and expiration date of reagent strip in use, code number of reagent strip, control lot number, and expiration date for each level of control.

4. Each control value must be evaluated for acceptability. The expected control range for each level is stored in the monitor. If results are within acceptable limits, patient testing can proceed. If the results are not within the expected range, corrective action must be taken. All corrective action must be documented by entering the appropriate comment codes or documented on the maintenance log.

5. All levels of controls must be run any time a new lot number of reagent is put into use, a new package of reagent strips is opened, or if the meter’s performance is in question.

D. PROFICIENCY TESTING:

1. Each unit which performs ancillary testing must participate in proficiency testing.

Proficiency testing material will be mailed directly to each of the Outpatient Clinics.

2. Certified operators must participate quarterly in a proficiency study.

Performance of these surveys will determine the individual’s ability to continue

Ancillary Testing. For proficiency studies, each operator will analyze both levels of control material and/or unknown samples provided for proficiency testing.

The ATC, Nurse Managers at the Outpatient Clinics or designee will sign as the designee for the Director on the Attestation form.

3. If unacceptable results are reported, the operator(s) will be required to repeat the procedure. If these results are acceptable, no further action will be taken. If the results are not acceptable, then the technique of the operator will be reviewed and a third set of two controls will be run. If these results are still unacceptable, the operator in question will be retrained.

4. If any unit shows a high degree of reporting unacceptable results on routine

QC and/or proficiency testing, the meter(s) assigned there will be thoroughly checked and/or replaced if needed. All reagent strips and control material will be examined and replaced if necessary, and the individuals involved will be retrained, if indicated. If the reporting of unacceptable results continues, that unit will have testing privileges revoked.

5. Three times a year, commercially prepared survey specimens will be received by the laboratory and distributed to all for an analysis on each meter or other ancillary test performed in this facility. These results are then evaluated by the provider of proficiency materials. This agency will evaluate the acceptability of the results based on comparison with other institutions using the same method.

Acceptable performance on these surveys is required by accreditation standards to continue Ancillary Testing.

6. Maintenance will be performed as specified in the manufacturer’s guidelines.

These procedures will be outlined in the method procedure and documented on the maintenance log sheet. See Quality Control Flow Chart, Attachment B for finger stick glucose.

7. Infection Control will be included in the approved training program. Authorized individuals must be familiar with Universal precautions. Hospital Safety Policies must be observed, when dealing with patient specimens and proficiency materials.

Procedures will be followed pertaining to Reusable Medical Equipment.

E. SUPPLY ACQUISITION:

1. Test strips for finger stick glucose testing will be distributed through Logistics.

Controls for finger stick glucose testing as well as strips and controls for INR testing will be distributed through the Laboratory. All other reagents for ancillary testing will be provided by Primary Care, Medical Service and Pathology and Laboratory Medicine Service.

2. Finger-stick lancets and batteries may be obtained from Logistics.

3. Replacement meters for finger stick glucose testing, INR testing, and I-STAT may be obtained from the ATC.

F. REPORTING OF RESULTS:

1. Ancillary testing results will be downloaded into a server on a daily basis. This data will be auto-accessioned into VISTA and all data that do not meet all criteria for auto-accessioning will be monitored and handled by the Ancillary Testing Coordinator.

Reference range for normal healthy adults:

Fasting Glucose: 65-99 mg/dl

Therapeutic INR: 2.0-3.5

2. Diabetic patient glucose results will vary depending on the physicians recommended choice of therapy, i.e. diet control or insulin control. Therefore, the therapeutic whole blood glucose range for diabetic patients is at the discretion of his/her physician and will not be recorded with the patient result.

3.Critical values:

a. If a patients’ finger-stick glucose result is less than 50 mg/dl or greater than

400mg/dl, the test must be repeated and the physician must be notified and documented with physician’s read back of results using the Lab Finger-Stick Glucose Critical Value Template. The physician will determine the necessity of a confirmatory laboratory glucose test. For Critical Low Glucose results, in an emergency situation it will be at the discretion of the operator to intervene without repeat or physician notification, however, it has to be repeated after intervention and called to the provider explaining the situation.

b. INR tests are reported to Pharm Ds who address critical results immediately.

Any INR greater than 5.0 should be repeated and follow-up determined by the

Pharm D.

4. Ordering Protocol: For finger-stick glucose: Tests are only to be performed on written order from the physician or if the patient is presenting with symptoms of

Hypo/Hyperglycemia. For other ancillary tests, the need for testing will be determined by the physician who will adhere to the ordering protocol set up in the testing procedure.

a. For INR results the Clinical Pharmacist will order and document test results in the Anticoagulation template. Testing by RNs, LPNs, and Medical Technologists at the Outpatient Clinics will be reported to the Pharm D in real time via Tele Health.

b. For Rapid HIV results – testing will be performed by the Clinical Pharmacist and results entered using the bypass entry by the Clinical Pharmacist.

c. Testing on the i-Stat will be performed by certified staff and results will be given to the Physician during the Cardiac Catherization procedure. Results will download into the patients chart.

d. For Urine Pregnancy, testing will be performed by RNs, LPNs and

Medical Technologists. Results will be entered using the Accuchek Inform Meters under Other Test Entry or bypass entry.

e. For Point of Care HCV – testing will be performed by the Clinical Pharmacists. Results will be entered using the fast bypass entry by the individual performing the test.

VI. RESPONSIBILITY:

A. Chief of Pathology and Laboratory Medicine Service: Will be responsible for the routine monitoring of overall management of all ancillary tests.

B. Coordinator: ATC or laboratory designee. The coordinator will be responsible for routine monitoring of the Quality Control, Quality Assurance, Maintenance Records, Review and Training of authorized individuals. This information will be kept by the ATC. The coordinator will act as technical advisor to all ancillary testing sites. Documentation of validation of each machine will be kept by the ATC for two years.

C. Ancillary Testing Supervisor: (Nurse Manager) Each site supervisor will be responsible to assure that routine calibration, daily quality controls and routine maintenance are being performed by operators. The site supervisor will provide documentation of corrective action taken for deficiencies noted on monthly summary report. The Nurse Manager will be responsible to assure that all proficiency testing is completed and submitted to CAP in a timely manner.

D. Certified Operators: Those individuals who have participated in the certification program will be responsible for the performance of ancillary tests as described in the contained policy and procedures. The operator will be responsible to assure that routine calibration, daily quality controls and routine maintenance is performed and that infection control standards are maintained. The operator will document patient results and critical values of ancillary tests in the progress notes upload results into the VISTA. Glucometer, Coaguchek, and i-Stat results will be downloaded into a server and auto-accessioned. The operator will be responsible for validation of the testing systems, using coordinated ancillary test and laboratory results at least semiannually. Documentation of validation will be kept on site or in the laboratory for a period of two years. The operator will notify physician of any ancillary test values that are in established critical range and document utilizing the Critical Glucose Template.

VII. CUSTOMER SATISFACTION: Patient/family satisfaction issues were considered in the development of this policy.

VIII. REFERENCES: Department of Veterans Affairs

Veterans Health Administration Handbook 1106.01

- January 29, 2016 , Chapter 13

College of American Pathologists (CAP), Commission on Laboratory Accreditation, Point of Care Testing:

Section 30

Joint Commission, Chapter 6: Waived Testing

IX. RESCISSION: Medical Center Policy 114-16-57, dated September 15, 2016, Subject: Ancillary Testing Policy.

X. DISTRIBUTION: Electronic Access to All Employees

XI. ATTACHMENTS: A & B

X Russell E. Lloyd

Medical Center Director

POLICY 113-18-57 ATTACHMENT A

LIST OF POINT OF CARE TESTS AND LOCATIONS

TEST METHOD EXTENT OF USE

PERFORMED

BY

Finger stick glucose

Accu- Check

Inform meters

Whole blood glucose monitors to assist in treatment of diabetic patients.

Certified RNs and LPNs

Finger-stick

INR

Roche Coaguchek

XS Plus

Monitor to assist in the treatment for patients on coumadin.

Pharm D., Certified RNs, LPNs And Certified

Medical Technologists

Rapid HIV

1.2

Orasure Screen used by Clinical Pharmacists in Infectious

Disease Clinic

CG8+

ACT-K

I-STAT

Monitor of Saturated 02

ACT Testing

Certified RNs, Certified

Radiology Tech and Certified

Medical

Instrument:

Technicians

POC Urine Pregnancy

Manual Screen used to detect HCG and confirm pregnancy

Certified RNs

Certified LPNs And Certified Medical

Technologists

Rapid HCV Manual Screen Used for screening of

Hepatitis C

Revised: 2/27/2018 Linda Stubb

Ward 9, Respiratory Therapy, Hemodialysis, 4ICU, 4 East , 2 CLC, 3CLC, SPU, Physical Therapy, Primary Care Clinic 1st and 2nd floor, Primary Care Specialty Clinic, Emergency Room, PACU, Mental Hygiene Clinic, Pet Scan, HBPC, Allentown

Outpatient Clinic, Sayre Outpatient Clinic, Williamsport Outpatient Clinic, Northampton Outpatient Clinic, Honesdale Outpatient Clinic , Berwick Outpatient Clinic, Tobyhanna

Outpatient Clinic, Anticoagulation Clinic, Cardiac Catherization Lab.

POLICY 113-18-57 ATTACHMENT B

Flow Chart for Glucometer Testing

Sequential tests with both high and low level control solutions

Both tests within limits: Proceed with patient tests.

One or both tests exceed limits:

Check expiration date of strips and control solutions.

Compare 3-digit code number of calibration strip & chemstrip bG vial to insure identical match.

Check cleanliness of test strip adaptor.

Incorrect Technique:

Supervisor should evaluate technique.

Repeat tests

One or both exceed limits.

Discontinue use of instrument and contact Nurse Manager

Correct Technique:

Repeat tests in duplicate with new vial of control.

One or both tests exceed limits.

Repeat test with new vial of strips

Both tests within limits:

1. Examine storage of strips.

2. Discard the first vile.

3. Proceed with patient testing.

Within limits proceed testing

Review technique (if strips are read visually, confirm by second person)