S02 Attachment Sixteen 16 Medical Care Memorandum Number 548 113 97 Pathology and Laboratory Medicine Service.pdf

VETERANS AFFAIRS MEDICAL CENTER MEMORANDUM

MEDICAL CENTER NUMBER 548-113-97

WEST PALM BEACH, FLORIDA June 17, 2019

PATHOLOG Y AND LABORATORY MEDICINE SERVICE

1. PURPOSE: The Pathology & Laboratory Medicine Service (P&LMS) of the Medical Center will assist, support, and guide the Medical Center staff by providing the diagnostic services of anatomic and clinical pathology and the therapeutic resources of the blood bank.

A. P&LMS will contribute to appropriate medical care by supporting the following goals:

Detect and quantify the risk of future disease Detect subclinical disease Establish and exclude diagnoses Assess disease severity and establish prognoses Assist in selecting appropriate therapy Assist in monitoring disease progress and therapeutic effect Use of autopsy as an educational and Quality Assurance tool for Medical staff

B. The subsets of Anatomic Pathology are Autopsy Pathology, Surgical Pathology and Cytopathology. The Autopsy subset of the Pathology & Laboratory Medicine Service is addressed with a separate Medical Center Memorandum.

Educational, developmental and research aspects of medical practice will be supported to the limit of available resources.

C. Point of Care Testing, also known as Ancillary Testing, includes all testing performed outside of the laboratory spaces.

This testing remains under the quality oversight and technical direction of the Chief, Pathology & Laboratory Medicine and is addressed with a separate Medical Center Memorandum.

2. POLICY :

A. This service shall be under the professional and administrative guidance of the Chief, Pathology and Laboratory

Attachment Sixteen (16)

36C24821R0092

Medicine Service, who is a qualified pathologist, certified in Anatomic and Clinical Pathology.

B. Development of offered diagnostic modalities will actively involve all major stakeholders including Laboratory staff, Medical staff, Patient Care Services and Medical Center Administration.

C. Scope of testing will be governed by the needs of the patient population and availability of resources to acquire appropriate instrumentation and personnel.

D. Quality of patient care is our highest priority and diagnostic and therapeutic procedures will only be undertaken where there is a decided patient benefit without the introduction or augmentation of clinically significant errors in the testing process.

E. The service will support patient care by providing information in the following areas:

Assess organ function status and metabolic activity Assess nutritional status Detection and quantification of tissue injury Detection and monitoring of neoplastic conditions Detection and identification of infectious agents, toxins and antibiotic sensitivity patterns of identified infectious agents

Therapeutic drug monitoring

F. The service will embrace the standards of good laboratory medicine including quality control and assurance, proficiency testing and all components of Quality Management system.

G. Regulations of the VHA, College of American Pathologists, the Joint Commission, and other accrediting agencies shall be held in strict accord.

3. PROCESS:

A. The Pathology & Laboratory Medicine Service operates 24 hours a day, 7 days a week, with Medical Technologists (Clinical Laboratory Scientists) on station at all times. Staff pathologists will be on station during normal duty hours on week days with at least one pathologist on call at other times. The Pathology staff is available for consultation and guidance.

B. Test ordering will be restricted to the Medical and Dental staff and other disciplines granted this responsibility by Medical Center policy and VHA regulation.

C. Component transfusion therapy will be available (24/7) for type specific blood. The availability of more labile components, such as platelets, will be governed by the speed with which they can be obtained from the blood banking community.

D. An optimal number of testing procedures will be made available on a 24 hour a day basis to help ensure that necessary procedures are readily available to promote rapid and appropriate diagnosis and therapy. The list of such procedures will be periodically evaluated depending upon the variable constraints, such as availability of resources, instrumentation, commercial test modalities, and appropriateness of the requested procedure.

E. The Laboratory Director will be responsible for assuring the selection of reference laboratories following federal acquisition guidelines. Selection will be made primarily based on the specific needs of the department, quality of performance and CLIA certification. Preference will be given to federal institutions when the turnaround time is acceptable.

F. Patient results will be promptly recorded in VISTA Laboratory package by the individuals performing the testing.

These individuals will be identified by name and/or an identification number in the computer record. Results reported in VISTA are immediately available in the electronic Medical Record.

G. The Medical Center laboratory and all Point of Care test sites are accredited by the College of American Pathologists (CAP) and the Joint Commission (TJC).

H. Turnaround times will be established for each test or type of test performed by Pathology & Laboratory Medicine Service. This information will be included in the Laboratory Reference Manual. If instances of significant delays in reporting occur, communication of the delay will be made to Medical staff via the use of electronic mail or phone call as appropriate.

I. A list of current test methods, including performance specifications, will be made available to clinical staff upon request. When changes to current tests are made that result in significant changes in results or interpretations, these changes will be communicated with a memorandum or comments in the computer result report.

4. RESPONSIBILITY :

A. The Chief, Pathology & Laboratory Medicine Service is responsible for the philosophical and technical direction of the service. The Chief, with the assistance of Staff Pathologists and Laboratory Manager, actively oversees laboratory aspects of transfusion medicine, quality control and quality assurance within the service, maintenance of appropriate record keeping systems, and active support of the infection control program.

He/she is also involved in the interdepartmental and hospital-wide quality assurance and educational activities as they relate to the Laboratory Service.

B. Laboratory Manager will oversee technical performance of laboratory technical personnel, supply and equipment procurement, development of contracts for laboratory and blood services, and coordinate development of new procedures.

C. Laboratory Section supervisors will be responsible for insuring performance of quality control protocols, the input of patient results, supply inventory for their section, time and leave requests, scheduling of section personnel, and the maintenance of equipment within their section.

D. The Ancillary Testing Coordinator will monitor performance and accuracy of quality control values, proficiency testing, and oversee documentation of equipment maintenance at all alternate testing sites, and will maintain training and performance documentation of individual participants.

5. REPORTING STRUCTURE: Clinical Executive Board, Performance Improvement Board

6. REFERENCES:

College of American Pathologists, Laboratory Accreditation Program, Laboratory General Checklist, Northfield, IL;

Current Version

College of American Pathologists. Laboratory Accreditation Program, Laboratory Accreditation Manual, Northfield, IL;

Current Version

College of American Pathologists. Laboratory Accreditation Program, Standards for Laboratory Accreditation, Northfield, IL; Current Version.

VHA Handbook 1106, Pathology & Laboratory Medicine Service Procedures, January 29, 2016.

6. FOLLOW-UP RESPONSIBILITY : Chief, Pathology & Laboratory Medicine Service

7. RESCISSION: Pathology & Laboratory Medicine MCM 548-113-097 dated June 17, 2016.

8. RECERTIFICATION DATE: June 17, 2022

Donna Katen-Bahensky, MSPH Medical Center Director

Attachment: Organization Structure Distribution: A

VETERANS AFFAIRS MEDICAL CENTER MEMORANDUM

MEDICAL CENTER NUMBER 548-113-97

WEST PALM BEACH, FLORIDA June 17, 2019