36C24419R0074-008.pdf

DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTER

Erie, Pennsylvania

Medical Center Memorandum No. 113-10 May 26, 2016

ANCILLARY (WAIVED) BLOOD GLUCOSE BEDSIDE TESTING

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

II. POLICY: All ancillary testing sites that perform patient blood glucose testing for diagnostic or monitoring 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 Blood Glucose 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 Blood Glucose 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 blood glucose 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 F

MCM 113-10, Ancillary (Waived) Blood Glucose Bedside 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: Are responsible for appropriate ordering of ancillary blood glucose testing.

E. Supervisor(s) or designee of all approved ancillary blood glucose testing sites will be the contact person for any issues or noncompliance of staff with established policies or procedures related to bedside blood glucose monitoring. The individual 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: Will perform tests in compliance with established guidelines and participate in training and certification.

G. Authorized Personnel: Those individuals who have participated in the authorization program will be responsible for the performance of ancillary glucose 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 blood glucose testing sites will designate those individuals who will be authorized to perform ancillary blood glucose testing. Authorization to perform ancillary blood glucose testing will be limited to those individuals who have satisfied training requirements by attending the training session during New Employee Orientation. As instructed by Ancillary Testing Coordinator, policies and procedures will be introduced followed by a 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 on a patient during their orientation, or in an 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. Ordering of Ancillary Blood Glucose Testing

1. The provider should specify the frequency of monitoring Bedside Glucose

Testing at the time of ordering. In general, at approved sites, bedside glucose testing should be reserved for those patients whose clinical situation warrants close supervision of their blood glucose levels.

2. Fingerstick glucose determinations should be done 30 to 60 minutes before meals unless otherwise ordered by a provider. The regular insulin should be given 15 to 20 minutes before meals.

3. The provider should verify the patient’s hematocrit to assure glucose test results are accurate. When the patient(s) clinically are having loss of blood or a condition that elevates hematocrit, the provider should be aware of the hematocrit levels when interpreting glucometer test results.

Note: Inform II glucometers give accurate glucose results when a patient’s hematocrit is between 10-65%.

4. Lipemic samples (triglycerides) in excess of 1800 mg/dl may produce elevated results.

5. The system should NOT be used to monitor patients that are critically ill.

The critically ill patient(s) is defined as follows:

a. A patient on mechanical ventilation with a mean arterial pressure

<60 mmHg despite the use of pressors.

b. Any patient with decreased peripheral blood flow; examples might be an individual with severe dehydration, hypotension, shock, decompensated heart failure, or peripheral arterial occlusive disease.

6. If the clinical picture is inconsistent with the fingerstick glucometer value, testing should be confirmed by a venous blood draw glucose level in the laboratory.

7. The general guidelines for Appropriateness of Ancillary Blood Glucose

Testing are as follows:

a. Continuous management of blood glucose concentrations of patients with diabetes.

b. Rapid detection of extreme glucose concentrations with patients whose symptoms suggest hypoglycemia or severe hyperglycemia.

c. Intra-operative and peri-operative management of blood glucose concentrations on surgical patients.

d. Rapid identification of extreme blood glucose concentrations in patients who present with a coma of unknown origin, especially in the emergency department.

e. Monitoring of patients receiving parenteral nutrition or medication likely to affect their blood glucose concentrations.

NOTE: All test orders should be reviewed at 48-72 hour intervals.

C. Quality Control (QC)

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

2. Each instrument must have a QC check using two levels of control performed once every 24 hours on each day of use. Control values will automatically be stored in the instrument.

3. Each control value must be evaluated for acceptability. The expected range for each level will be programmed into the instrument. If results are not within the acceptable range, corrective action must be taken. This action most commonly includes repeating QC testing with either a new vial of strips, controls, or both.

4. All levels of control MUST be run:

a. Daily (every 24 hours) on each day of use.

b. When the patient’s blood glucose results are in question.

c. When a new vial of test strips are opened.

d. When the instrument readings are in question.

e. If the meter is dropped or damaged.

f. If the cap is left off the vial of strips.

5. On a weekly basis, the Ancillary Testing Coordinator will review all QC results. The Program Leader/Supervisors or designee of the approved testing site will be notified if corrective measures are warranted.

D. Quality Assurance (QA)

1. Only one brand of meter will be utilized for in-house testing. Each meter will have its own permanent log that will be kept for the life of the instrument, which will be located in Pathology & Laboratory Medicine (P&LM). This log will consist of the following information:

a. Initial instrument verification to include accuracy, precision, and linearity checks performed by (P&LM).

b. Completed Quality Control records.

c. Maintenance/service records will be kept by the Ancillary Testing

Coordinator in P&LM.

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

E. Proficiency Testing

1. Each ancillary test site that has a meter issued to it must participate in proficiency testing.

2. Three times a year, a commercially prepared CAP survey specimen will be received by P&LM and distributed 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, P&LM and 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 instruments/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.

F. Maintenance

1. Routine daily maintenance will be performed by the ancillary test site as specified by the manufacturers' guidelines. These procedures will be outlined in the method procedure and documented on the maintenance log sheet.

2. Any in-depth maintenance, trouble shooting, or repair will be referred to the Ancillary Testing Coordinator and/or the manufacturer for replacement/repair.

G. Acquisition of Supplies

1. Warehouse will be responsible for supplying reagent test strips to each ancillary testing site for the blood glucose. NOTE: Strips are kept in Pyxis machine.

2. Pathology & Laboratory Medicine will be responsible for supplying the control material.

3. Logistics/Warehouse will be responsible for supplying lancets and batteries.

H. Reporting Results

1. All ABGT results within the meters reportable range are entered automatically into the patient’s electronic record.

2. Any ABGT results outside the meters reportable range (10-600 mg/dl) are flagged as “LO” or “HI”. These results must be confirmed immediately by Laboratory testing to ensure test accuracy. In case an operator error is suspected cause for a LO/HI flag, a repeat chemstick may be performed prior to laboratory confirmation.

3. 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.

4. In the event the Rals Web program (used to automatically transfer patient’s results) is not working, paper documentation is to be maintained at all sites to record all patient test results until the interface is working properly. Manual (VistA) computer entry may be needed as a backup plan. If any problems are identified, contact P&LM for assistance.

I. Critical Values for ABGT. For ABGT critical values less than 50 or greater than 400 mg/dL the following procedure must be followed:

1. Repeat the chemstik glucose testing meter immediately (within 10 minutes) unless patient requires immediate treatment. . Low (<50 mg/dl) criticals must repeat ± 10 mg/dl. High (>400 mg/dl) criticals must repeat ± 50 mg/dl. If there is any discrepancy in the test results confirm the results by laboratory testing.

NOTE: In case an operator suspects a testing error due to technique, a third chemstick may be performed prior to laboratory confirmation.

2. Initiate appropriate treatment, notification, and documentation for confirmed criticals. (A confirmed critical is a result that is critical with a repeat that is critical.)

3. The patient’s health care provider must be notified of confirmed critical results with read-back confirmation. The date, time, individual notified, notifying personnel and action taken/treatment given by the provider (physician, nurse practitioner or approved clinical personnel) should be documented in the patient’s electronic record. The Critical Fingerstick Notification template is the preferred template in CPRS for all confirmed results (see Attachment).

4. Repeat fingerstick glucose as clinically indicated.

5. Follow-up treatment or additional laboratory testing is at the discretion of the provider.

J. Infection Control

1. Test performance and disposal of reagent strips and lancets must follow the guidelines of the hospital infection control policy.

2. Meters taken into the rooms of isolation patients must be placed inside a clear plastic transport bag as a barrier while performing testing.

Immediate decontamination with a hospital approved disinfectant will be done upon exiting the room. Accessory cases are not to be carried into an isolation room.

V. REFERENCES:

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

Procedures, January 29, 2016

B. The Joint Commission Comprehensive Accreditation Manual for Laboratory &

Point-of-Care Testing, (current edition)

C. FDA labeling change on point-of-care (POC) glucose devices (glucose meters)

VHA Pathology & Laboratory Medicine, January 23, 2014

D. MCM 00Q-107, Infection Control Precautions

E. MCM 113-05, Communication of Critical Results for Laboratory Tests

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 115-10, Ancillary (Waived) Blood Glucose Bedside Testing, dated April 3, 2015.

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

Attachment: Critical Fingerstick Notification

ATTACHMENT