S02 - Attachment 9 - Ancillary Testing Policy and Provider-Performed Microscopy (PPM) Testing Policy.docx

Attachment 9 VA Medical Center Numbered Memorandum 113-02-17 Spokane, WA July 19, 2017

ANCILLARY TESTING POLICY AND PROVIDER-PERFORMED MICROSCOPY (PPM) TESTING POLICY

1. PURPOSE:

a. To establish the policies, procedures, and requirements for performing the program in compliance with The Joint Commission standards, College of American Pathologists (CAP) standards, and Department of Veterans Affairs (VA), Veterans Health Administration (VHA) Handbook 1106.1, Chapters 7 and 8.

b. Ancillary Testing is defined as laboratory testing or services performed within a VA Medical Center or its outreach functions (clinics, et.al.), but outside the facilities of the main clinical laboratory. It is often referred to as Point-of-Care Testing (POCT).

2. POLICY:

a. Ancillary testing is defined as diagnostic laboratory testing performed outside the physical facilities of the clinical laboratory by non-laboratory personnel.

b. Only approved ancillary tests and procedures are to be employed.

c. This policy does not apply to tests approved by the Food & Drug Administration (FDA) for home use only and not used for professional purposes. For example, glucose meters cleared for home use only are not used in a hospital setting by nursing staff except as patient education.

d. FDA enacted labeling changes specific to use of multi-patient waived whole blood glucose devices. Under the section of “Intended Use” in the 510(k) Summary the limitation clause “the performance of this system has not been evaluated on the critically ill” has been added. Use of such devices on the critically ill patients constitutes an off-label use. Mann-Grandstaff Veterans Affairs Medical Center (MGVAMC) Critical Care Committee defined “critically ill” as those in diabetic coma. Those critically ill patients will have glucose testing performed by traditional laboratory methodology approved for use on critically ill patients.

e. Provider-Performed Microscopy (PPM) is a testing modality that requires the use of a microscope and must be performed personally by a clinical provider during a patient encounter. Specimens utilized are considered labile, or delay in performing the PPM test could compromise the accuracy of the test result. PPM testing permits providers to render a rapid diagnosis that can, in turn, facilitate the rapid initiation of treatment.

f. Since the Veterans Administration Pathology and Laboratory Medicine is accredited by CAP, PPM is held to the same inspection as the main laboratory and other point-of-care. The same regulations apply regardless of where the testing is done or the level of complexity. All Licensed Independent Providers (LIP) must participate in annual competency. Proficiency testing for PPM category is no longer optional under the new Code of Federal Regulations (CFR) (Title 42, Volume 3, Parts 430 to End, Revised October 1st 1999) quoting VA National Enforcement Office.

3. PROCEDURES:

a. Authorization:

(1) Authorization to perform ancillary testing at MGVAMC will be limited to those individuals who have satisfied the authorization requirements. These requirements will include participation in an approved training program, including completion of an electronic test, and demonstration of clinical competency. Ancillary testing competency is reassessed annually.

(2) Continued authorization will be dependent upon a satisfactory Quality Control (QC) record and satisfactory performance on proficiency challenges along with adherence to procedures.

(3) Authorization will be renewed annually unless otherwise indicated by performance on routine QC, performance on proficiency challenges, or lack of procedure compliance. Laboratory will notify area trainers and nurse managers that staff authorization will expire one month before their expiration date so staff will have time to complete proficiencies before they are locked out of testing equipment.

(4) Individuals not complying with the stated policy, Ancillary Testing Manual, or incorrectly performing tests will be will be notified, along with their supervisors, of each offense that may lead to removal from the list of authorized personnel. Offending violations include failure to repeat any critical values, failure to document provider notification of critical values, failure of proper patient identification (incorrect Social Security Number (SSN) given), improper entry of required i-STAT fields, and failure to repeat out of range i-STAT results.

(a) Non-compliance first offense: Document all first violations of policy and procedure, however minor, and corrective action taken (counseling, retraining etc), emphasizing the risk to patient safety if procedures are not followed, and notify the employee’s supervisor.

(b) Non-compliance second offense: If there is a second violation, revoke privileges, notify employee and manager by email, and do not allow this employee to carry out patient testing until retraining occurs.

(5) Reinstatement will occur only after participation in additional training program and after clinical competency is demonstrated.

b. Verification of new methods and/or instrumentation:

(1) Initial Verification: Performance criteria for the selected method and/or instruments, including precision, accuracy, linearity within assay range, and sensitivity specified by the manufacturer or supplier must be verified by the Ancillary Testing Coordinator (ATC), according to Clinical & Laboratory Standards Institute (CLSI) guidelines. Documentation of this procedure will be retained for two years beyond the life of the instrument or two years longer than method is in use.

(2) Verification of additional instruments: When the initial verification has been completed, subsequent instruments of the same type may be evaluated with an abbreviated procedure, e.g., comparison to initial instrument with a limited number of controls or patient specimens.

(3) Requests for new POCT/Instruments are to be sent to the ATC. Requests will be reviewed through the Laboratory Quality Assurance (QA) Manager. Under no circumstances will new POCT be brought into MGVAMC without ATC or Laboratory Manager’s knowledge. POCT vendors should be directed to Lab.

c. QC: All individuals who are authorized to perform ancillary tests must participate in the QC program.

(1) Different levels of commercial control are required. Each level will have an assigned, acceptable range provided by the manufacturer. Such range will be verified by the ATC prior to placing reagents, strips, and test cartridges into use. Control results will be reviewed by the ancillary testing coordinator. Quantitative tests are reviewed for actual mean, standard deviation (SD), and coefficient of variation (CV) on a monthly basis. Methods for performing QC are detailed in the specific procedures. Minimum standards for each parameter will be set to evaluate performance of instrument and operator.

(2) Instruments that use electronic simulated controls will be monitored and documented at least monthly by the ATC.

(3) QC data must be recorded. Specific procedures outline how to document control data.

(4) If the results are not within the expected range, corrective action must be taken. All corrective action must be documented.

(5) QC for PPM: Standard quality control processes are limited with miscellaneous microscope examinations, thus the main focus becomes “the microscope”. Microscopes have various attributes and should be carefully maintained. Bio Medical Engineering will provide incoming inspections and place microscope equipment on the annual preventive maintenance program, but operational maintenance must be carried out by the providers as the main users. Proficiency testing and control procedures may not be available for all microscopic examinations. Therefore, analyzing specimens with the microscope requires training in microscopic techniques, knowledge of standard precautions, and an understanding of the capabilities, use and care of the microscope.

d. Proficiency Testing:

(1) Each site performing ancillary testing must participate in proficiency testing.

(2) Authorized individuals must participate in in-house proficiency studies, which will determine the individual’s ability to continue ancillary testing. Instrument operation, documentation and repeat testing of critical results, meter maintenance and QC will be included in the training program.

(3) If available, a commercially prepared survey specimen (CAP) will be received by the laboratory three times per year and distributed to all sites for analysis. These results are then evaluated by an external agency who determines the acceptability of results based on results received by other users of the same method. Communication about proficiency testing samples between employees is prohibited until after the deadline for submission of the proficiency testing data. Referral of proficiency testing samples to another laboratory is prohibited.

e. Maintenance of instruments will be performed as required and in accordance with the manufacturer’s guidelines. Procedures will be written according to CLSI guidelines. All maintenance and repair work will be documented.

f. Definitive/screening Tests:

(1) The hospital defines whether the results of POCT will be considered definitive for purposes of care and diagnosis or regarded as a screening tool, in which cases they may be followed by confirmation testing.

(2) The following POCT are listed as definitive:

(a) Bedside glucose monitoring for non-critically ill patients only

(b) i-STAT blood gases and chemistries

(c) PPM

(3) The following POCT are listed as screening:

(a) Fecal Occult Blood tests (Hemoccult SENSA)

(b) Clinitek urine panels

g. Ancillary testing will be done in the following areas of the hospital:

(1) Urgent Care Center/Emergency Department (UCC/ED) – glucose, i-Stat, Occult Blood.

(2) Out-Patient Clinics – glucose, Clinitek.

(3) In-Patient – glucose.

(4) Acute Care Unit and Intensive Care Unit - i-Stat, glucose.

(5) PPM is performed at the KOH (Potassium Hydroxide) microscope location.

4. RESPONSIBILITIES:

a. The Laboratory Director is responsible for the overall management of ancillary testing and must appoint an ATC to provide oversight to the program. The Laboratory Director will approve all new POCT/PPM methods.

b. The Laboratory Manager and/or ATC will monitor the test procedures, QC, QA, proficiency testing, records control, documentation of training, authorization, and annual competency evaluation for all persons who perform ancillary testing.

c. Laboratory Designee: The ATC acts as a technical oversight supervisor for all ancillary testing sites. The ATC is responsible for the routine monitoring of the QC, QA, maintenance review and training of authorized individuals. The ATC notifies areas that are not in compliance to the ancillary testing site director or supervisor. A copy of all procedures, QC, QA, maintenance, and information related to the authorization of individuals will be kept in the Pathology and Laboratory Medicine Service.

d. The Laboratory Manager and ATC are responsible for the overall policy, standards development, and operational quality management of ancillary testing, and approve which tests may be performed outside the main laboratory. The Laboratory Manager and ATC will advise and have input on the evaluation of instruments, develop procedures for testing, quality control, and action to be taken when problems arise.

e. The ATC is responsible for seeing that all requirements are carried out in accordance with applicable VA, regulatory, and accreditation regulations. He/she is responsible for testing procedures written according to CLSI, training and documentation of clinical competency of authorized individuals on the policies and procedures of the ancillary tests. The ATC is also responsible for the performance of calibration, monitoring of quality control, and routine instrument maintenance, and maintaining of documentation of such.

f. Each ancillary testing site will have at least one area trainer who is responsible for initial and continued training, and evaluation for individuals performing the test.

g. Authorized Individuals: Those individuals who have successfully participated in the authorization program will be responsible for the performance of ancillary tests as described in the contained policy and procedures.

h. The ATC may be contacted in the lab at Extension 7563.

5. REFERENCES:

· Clinical and Laboratory Standards Institute (CLSI) (formerly NCCLS) CLSI Document C30-A2, Volume 22 Number 17, Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities;Approved Guideline – Second Edition

· Clinical and Laboratory Standards institute (CLSI) Document POCT 4-A2, Volume 26, Number 30, Point-of-Care Testing In Vitro Diagnostic (IVD) Testing; Approved Guideline – Second Edition VHA Handbook 1106.1, Chapter 8, October 2008

· CFR 42 Part 493.16 Physician Performed Microscopy

· CFR 42 Part 493.1359 Director of PPM Responsibilities

· Comprehensive Accreditation Manual for Hospitals (JCAHO) 2007

· FDA Labeling Change on Point of Care (POC) Glucose Devices (Glucose Meters) January 23, 2014

6. RESCISSION: Numbered Memorandum 113-02-14, Ancillary Testing Policy And Provider-Performed Microscopy (PPM) Testing Policy, dated May 16, 2014

7. FOLLOW-UP RESPONSIBILITY: Chief of Staff (011), Chief, Laboratory (113)

//s// Tracye B. Davis, FACHE Interim Medical Center Director

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