PURPOSE WAIVED TESTING Policy No. 2-047 To define the organization's compliance with waived testing criteria and the need for a certificate of laboratory services. POLICY The Clinical Laboratory Improvement Act (CLIA) of 1988 requires all clinical laboratories to possess a CLIA certificate in order to perform testing on human specimens. Certain tests are exempted on a waived list. Organizations that collect human specimens but do not perform tests are excluded from this act. When a patient performs a test on himself or herself, such as blood glucose testing on the patient s own glucose meter, the action is not regulated by CLIA. PROCEDURE 1. Carter Healthcare will perform permitted laboratory tests in the home. 2. Carter Healthcare will apply for and maintain a CLIA waiver on file. 3. Waived tests that produce a result measured as a number are called quantitative and are usually instrument-based (rely on use of instrument to produce result.) Qualitative tests, such as occult bloods, are those that produce a negative or positive result. A. Quantitative test result reports documented in the clinical record are accompanied by reference intervals specific to the test method used and are appropriate to the patient population. B. Criteria for confirmatory testing for each test whether qualitative or quantitative, is specified in written procedure as dictated by clinical usage and methodology limitations. C. Actual test result usage is consistent with the organization s policies and the manufacturer s recommendations for the specific waived test. 4. Patients who require laboratory tests performed that are not within the scope of tests offered will have their specimens transported to a CLIA-certified laboratory for testing. 5. Policies and procedures will be developed and implemented for each waived test performed by organization personnel. 6. Policies and procedures for each type of waived test performed will include, at a minimum: A. Indications and purpose of the test B. Personnel responsible for performing and supervising waived testing C. Training of staff in performing waived tests and current competence D. Parameters for requiring follow-up or referral E. Mechanism used to ensure accuracy of testing instruments used 7. Appropriate quality control and test records are maintained which includes a functional audit trail that allows retrieval of results and associated quality control values for a minimum of two years 8. Waived testing may be performed by licensed clinical staff and will be supervised by the Director of Nurses. 05/2011 05/2011 Policy No. 2-047 Section 02 Page 76
PURPOSE To provide guidelines for the safe use of home glucose monitoring devices. POLICY HOME GLUCOSE MONITORING Nurses will utilize home glucose monitoring (HGM) devices, in accordance with manufacturer's guidelines, in order to ensure the quality and accuracy of blood glucose values. Home glucose monitoring performed in the patient s home for purposes of care and diagnosis will be considered definitive. Blood glucose monitoring utilized as a screening tool will be followed with confirmation testing, as ordered by the physician (or other authorized licensed independent practitioner), prior to care or treatment decisions. All nurses utilizing HGM devices will have evidence of: 1. Specific training on the HGM device 2. Orientation to the organization s process for monitoring 3. Current competency PROCEDURE 1. Assignment of HGM equipment A. All nursing personnel who use an HGM device provided through the Agency will be informed of and acknowledge responsibility for care, calibration and return of the item to the Agency. (See Patient Care Equipment Checkout Log Form). B. While in use, the nurse will be responsible for maintaining the HGM device in optimal operating condition, according to the manufacturer's instructions, including cleaning, use of appropriate accessory equipment, proper operating procedure, and protection from damage. C. When the nurse s function no longer requires the use of an HGM device, the device will be returned to the appropriate Clinical Coordinator/ Supervising Nurse or designee with associated stock items and the Quality Control Log (See Addendum following). 2. Training of Personnel A. All nurses will receive training in the HGM devices in use by the Agency. Training will include instruction and return demonstration of the following procedures, according to the manufacturer's directions. All of the procedures listed below are to be conducted in accordance with standard precautions. (See Standard Precautions Policy, Section 7.) 1. Calibration performance and recording 2. Control solution checks and recording 3. Obtaining an adequate blood specimen 4. Blood testing procedure 5. Cleaning the machine 6. Storage of the machine 7. How to change a battery 8. Actions to take if a machine malfunction is suspected B. Return demonstration of the procedures (listed above) by full-time, per diem, and contract nursing personnel using HGM devices will be performed at least annually in the presence of staff members personnel file. Section 02 Page 77
3. Calibration and Control Tests (see manufacturer's guidelines for specific procedures) A. Calibration of the HGM machine assigned to the nurse will be checked prior to every use with a patient. The calibration procedure of the HGM device will be performed when a new bottle of strips is opened for use and at other times, as indicated by the manufacturer's guidelines. B. Control testing using control solution will be performed by a nurse each day that a HGM machine will be used, according to the manufacturer's directions, prior to use with a patient. C. Calibration and control test results will be recorded on a log form for quality control for home glucose monitoring devices per the manufacturer. The nurse will maintain this log with the device. Completed logs will be turned in to and reviewed by the Clinical Coordinator/ Supervising Nurse or designee and will be retained by the organization. 4. Blood Testing Procedure A. Supplies needed 1. HGM device 2. Test strips 3. Lancet 4. Optional lancet device 5. Tissue or cotton ball 6. Alcohol wipes 7. Non-sterile gloves 8. Bio-hazardous sharps container 9. Disposable towel or similar material to cover surface where testing with the machine will take place 10. One (1) 6-volt photographic alkaline battery B. Before the Test: 1. Verify that proper equipment is available. a. If the nurse is using an HGM device owned by the patient to test blood care according to the plan of care, the nurse must ensure that the machine is in proper operating condition. Calibration performance control solution checks are required when nurses use patient-owned HGM devices. Recording of calibration and control tests will be recorded in the nurse s notes. Calibration and control tests will be performed per manufacturer instructions for the patient-owned meter. b. If the machine is not in acceptable operating condition, the nurse must use the HGM device issued by the organization for testing. 2. Verify orders as needed. 3. Inform patient of the purpose and procedure. 4. Verify if a new vial of strips will be used. a. Wash hands. b. Assemble equipment on a clean towel, on a safe, flat surface with bio-hazardous sharps disposal unit available. c. Don non-sterile gloves. C. Testing 1. This entire procedure will be performed in accordance with standard precautions. (See Standard Precautions Policy, Section 7.) 2. Blood glucose testing will be conducted in accordance with the procedure outlined by the manufacturer. 3. Blood glucose results will be recorded on the skilled nursing note. 5. HGM Device Malfunctions A. If a device fails a control test or otherwise malfunctions, the nurse should consider performing the following procedures: 1. Check the battery (replace if necessary and available). Section 02 Page 78
2. Recheck using fresh control solution and/or a fresh bottle or strips (if available). 3. Check the cleanliness of the machine, and clean according to manufacturer s instructions. If necessary, allowing drying time. 4. Ensure that the size and location of the blood specimen was adequate. 5. Ensure that the testing procedure was followed properly. 6. Ensure that the machine was calibrated properly. 7. Inspect the machine for any damaged parts that can be detected visually. 8. Refer to the troubleshooting guide in the HGM Manual. 9. Call the manufacturer's toll-free number for further instructions. B. If the machine continues to malfunction despite attempts to isolate the problem, the following procedure is to be followed: 1. The machine will be placed out of use. 2. The patient s physician will be contacted to ascertain if a venipuncture for a blood sugar value is required. 3. If provided by the Agency, the HGM device will be returned to the office for return to the manufacturer, and a replacement will be obtained. 4. If the HGM device is owned by the patient, he/she will be instructed to get a replacement, or if patient s device is outdated and/or cannot be replaced, the Agency can provide one. Section 02 Page 79
ADDENDUM 2-048 Section 02 Page 80
QUALITY CONTROL LOG FOR GLUCOSE MONITORING DEVICES FORM Section 02 Page 81
PURPOSE HOME PROTHROMBIN TIME/INTERNATIONAL RATIO (PT/INR) MONITORING Policy No. 2-049 To provide guidelines for the safe use of the CoaguChek System device. POLICY Nurses will utilize the CoaguChek System devices in accordance with manufacturer's guidelines in order to ensure the quality and accuracy of Prothrombin and INR (international ratio) values. The use of CoaguChek devices will be used as a treatment screening method only and does not require follow-up confirmation testing, unless specifically ordered by the physician. PROCEDURE 1. Assignment of CoaguChek Equipment A. The nurse will be responsible for maintaining the CoaguChek device in optimal operating condition according to the manufacturer's instructions including cleaning, use of appropriate accessory equipment, proper operating procedure and protection from damage. The clinician will complete the Patient Care Equipment Check-Out Log form. C. After use and calibration, the CoaguChek device will be returned to the Carter Healthcare, Inc., office and the device signed back in (dated) on the Check-Out Log form. 2. Training of Personnel A. All nurses will demonstrate correct use of the CoaguChek device. When knowledge deficits are identified, training will be done. ** All procedures listed below are to be conducted in accordance with Standard Precautions and manufacturer s directions. 1. Calibration performance and recording 2. Control checks and recording 3. Obtaining an adequate blood specimen 4. Blood testing procedure 5. Cleaning the machine 6. Storage of the machine 7. How to change a battery 8. Actions to take if a machine malfunction is suspected B. Return demonstration of the procedures (listed above) by full time, per diem and contract nursing Agency personnel using HGM devices will be performed annually in the presence of the Clinical Coordinator/ Supervising Nurse and/or designee. This process will be documented and retained in the Agency personnel's personnel file. 3. Calibration and Control Tests (see Manufacturer's Guidelines for specific procedures) CoaguChek runs self-controls; the clinician should check to see that has been done prior to each use. 4. CoaguChek Device Malfunctions A. If a device fails a control test or otherwise malfunctions, see Manufacturing Guidelines for specified procedure. B. If the machine continues to malfunction despite attempts to isolate the problem, the following procedure is to be followed: 1. The client s physician is contacted to ascertain if venipuncture for PT/INR is required. 2 The CoaguChek device will be returned to the office for return to the manufacturer. 03/2000 12/2010 01/2011 Policy No. 2-049 Section 02 Page 82