Memorandum of Understanding
Between The Health Care Financing Administration
and The Food and Drug Administration

 

SUBJECT:  MOU with Health Care Financing Administration Concerning Blood-Banking and Transfusion Programs (FDA 225-80-4000)

 

I. Purpose and Background:

 

Since 1966, hospitals and independent laboratories participating in the program of Health Insurance for the Aged and Disabled established by Title XVIII of the Social Security Act (Medicare), have been surveyed by HHS, most recently including the Health Care Financing Administration (HCFA), for compliance with the applicable provisions of the Medicare statute and regulations.  These regulations include requirements affecting the blood banking and transfusion services of hospitals and independent laboratories.  (Hospitals accredited by the Joint Commission on the Accreditation of Hospitals (JCAH) or the American Osteopathic Association (AOA) are deemed under the Medicare Act and regulations to meet most of the Medicare requirements.)

 

Since 1973, the Food and Drug Administration (FDA) has concurrently conducted administrative inspections of blood banks and transfusion services engaged in the collection, processing, storage, compatibility testing, or distribution of blood and blood components under the drug provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the biological products provision of the Public Health Service Act (42 U.S.C. 262).

Most nongovernmental hospitals and independent laboratories with blood-banking or transfusion service capabilities approved by the Medicare program are also subject to inspection by the FDA.  In early 1979, HCFA and FDA proposed to coordinate all Federally authorized inspections of hospital blood banks and transfusion services in order to minimize duplication of effort and to reduce the burden on affected facilities.  This Memorandum of Understanding finalizes the consolidation within HCFA of all responsibilities for the inspection and surveying of approximately 3,000 transfusion services.  However, other blood establishments, as defined below, will remain subject to inspection under the Public Health Service (PHS)/FDA program, and will also be subject to HCFA requirements if they choose to participate in the Medicare Program.

 

PHS/FDA and HCFA shall continue to act under existing delegations of authority, and no transfer of statutory functions or authority is made here.  HCFA shall, however, conform many of its program requirements for the survey of blood banks and transfusion services to those issued by PHS/FDA.  This includes the adoption of certain of the PHS/FDA regulations applicable to blood and blood component products set forth at 21 CFR Part 606.

 

Additionally, PHS/FDA shall no longer inspect on a routine basis clinical laboratories or portions thereof which perform tests such as hepatitis tests, serum protein electrophoresis, or quantitative immunoglobulin determinations in support of the preparation of biological products by a firm registered with PHS/FDA, if the clinical laboratory is approved under the HCFA program.

 

II. Substance of Agreement:

 

A. Definitions

For the purpose of this agreement, the following definitions apply:

1. A “transfusion service” is a facility, which is part of either a hospital or an independent clinical laboratory, and which performs compatibility tests for, but is not engaged in the routine collection or processing of, blood or plasma (except recovered plasma or red blood cells) except for therapeutic collections, and the hospital or the independent testing laboratory is approved by HCFA for participation in the Medicare program.

2. A “blood establishment” is any other facility or portions of a facility registered as such with FDA pursuant to 21 U.S.C. Part 510 and 21 CFR Part 607.  Blood establishments include hospital and non-hospital blood banks, plasmapheresis centers, and the clinical laboratories performing required testing for these establishments.

 

B. Transfusion service survey and approval

HCFA shall be responsible for:

1. Surveying hospitals and independent laboratories, including the transfusion service, and applying the Medicare conditions of participation and conditions for coverage through the Medicare survey, certification, and facility approval process, including the utilization of HCFA’s system of Medicare State survey agency agreements;

2. Approving and dispproving hospitals and independent laboratories for purposes of Medicare.

3. Surveying the transfusion service of hospitals and independent laboratories in conjunction with PHS/FDA, when such a survey is appropriate to certify and document any alleged significant deficiency or deficiencies, which would, if confirmed to be present, adversely affect the health and safety of patients.

4. Conducting special surveys of the transfusion services of hospitals and independent laboratories concerning administrative, procedural, licensure, technical certification or related matters as needed, or when required by PHS/FDA or others, as appropriate.

5. Conducting enforcement activities, such as the investigation and referral of cases to the Inspector General of the Department of Health and Human Services for further action.

6. Negotiating, approving, and administering agreements with the Medicare State survey agencies; and

7. Applying the administrative review and hearing provisions applicable to hospitals and independent laboratories under Medicare.

 

C. Survey of good manufacturing practices in facilities performing emergency blood collections only

HCFA shall survey the procedures related to the collection and processing (including labeling) of blood and blood components for transfusion at transfusion services in hospitals and independent clinical laboratories participating in the Medicare program.  These facilities will not be register as blood establishments with PHS/FDA.

 

D. Development of technical and scientific standards

PHS/FDA shall be responsible for the promulgation and interpretation of technical and scientific standards relating to transfusion services and blood establishments and for responding to inquiries concerning these standards except as indicated in paragraph E below.  HCFA shall undertake to adopt these standards for use in the Medicare program.

 

E. Application of personnel and proficiency testing standards

For purposes of the Medicare program, the HCFA standards for personnel (42 CFR 405.1028(d), (g), and (i) for hospitals and 42 CFR 405.1310 through 405.1315 for independent clinical laboratories) and proficiency testing (42 CFR 405.1314(a)) shall apply.  For purposes of the PHS/FDA program, the PHS/FDA standards for personnel (21 CFR 600.10 for licensed establishments and 21 CFR 606.20 of registered blood establishments) shall apply to registered licensed and unlicensed blood establishments.

 

F. Special investigations of clinical laboratories

PHS/FDA shall no longer routinely inspect clinical laboratories or portions thereof which perform hepatitis tests or other laboratory procedures for registered blood establishments when the laboratory is surveyed by and meets the requirements of the HCFA program.  When a special investigation is required by PHS/FDA to document the presence of any alleged significant deficiency or deficiencies which would, if confirmed, adversely affect the safety or efficacy of products, or the safety or health of donors, the investigation by FDA will be coordinated with regional HCFA personnel.

 

G. Adverse transfusion reaction reporting

The provisions of 21 CFR 606.170(b) require that fatal transfusion reactions related to the administration of blood or blood components be reported as soon as possible to PHS/FDA.  PHS/FDA evaluates these reports and, when indicate, may undertake special investigations to determine whether remedial action has been or needs to be undertaken by the blood establishment.

PHS/FDA shall continue to receive these reports from blood banks and transfusion services in hospitals and independent laboratories participating in the Medicare program.  Those reports received by FDA from transfusion services will be transmitted to HCFA for evaluation and followup under that program.  In addition PHS/FDA shall transit to HCFA those reports which involve fatalities resulting from errors and accidents in areas of a hospital unrelated to the collection or processing of blood or blood components.

 

H. Research and development

1. PHS/FDA shall be responsible for conducting studies related to the technical and scientific aspects of the administration and regulation of transfusion services and blood establishments, including studies for standards’ development, improved quality control practices and testing, and evaluation methodologies.

2. HCFA shall be responsible for conducting studies pertaining to the Medicare coverage and amount of reimbursement to hospitals and independent laboratories stemming from the activities of their transfusion services and blood banks, the survey and approval of such services, the appropriate utilization of services, and the related administrative processes.

 

I. Training

1. PHS/FDA shall furnish technical assistance to HCFA for the training of laboratory surveyors of the Medicare State survey agencies and other HCFA survey personnel with respect to the technical and scientific standards applicable to transfusion services and blood banks.

2. HCFA, in conjunction with PHS/FDA, shall be responsible for training laboratory surveyors of the Medicare State survey agencies and HCFA personnel concerning blood banking administration and procedure.

 

J. Amendments

This agreement may be modified at any time in writing by the Assistant Secretary for Health, the Commissioner of Food and Drugs, and the Administrator of the Health Care Financing Administration, or their authorized delegates.  PHS/FDA and HCFA shall review this memorandum of understanding within 2 years after its effective date.  Either party in the interim has a right to an earlier review of this agreement or any of its provisions.

 

K. Resolution of difference

In any case in which PHS/FDA and HCFA find that the resolution of significant differences with respect to this agreement cannot be achieved, that matter will be referred by the Assistant Secretary for Health, the Commissioner of Food and Drugs, and the Administrator, HCFA, to the Undersecretary or the Secretary for decision.

 

Amendment:

Section II.A.1. and II.C. have been amended and all references to Department of Health, Education and Welfare and HEW changed to Health and Human Services and HHS, respectively as provided in approvals shown below:

 

Approved and Accepted
for the Public Health Service
Signed by: Assistant Secretary for Health
Public Health Service
Date: October 15, 1979

Approved and Accepted
for the Public Health Service
Signed by: Assistant Secretary for Health
Public Health Service
Date: May 4, 1983

Approved and Accepted
for the Health Care Financing Administration
Signed by: Administrator, Health Care Financing Administration
Date: January 5, 1980

Approved and Accepted
for the Health Care Financing Administration
Signed by: Acting Deputy Director, Health Standards & Quality Bureau, HCFA
Date: February 3, 1983

Approved and Accepted
for the Department of Health, Education, and Welfare
Signed by: Secretary of the Department of Health, Education and Welfare
Date: January 21, 1980

Approved and Accepted
for the Department of Health, Education, and Welfare
Signed by: Secretary of the Department of Health, Education and Welfare
Date: June 6, 1983

Approved and Accepted
for the Food and Drug Administration
Signed by: Joseph P. Hile
Associate Commissioner for Regulatory Affairs
Date:

Approved and Accepted
for the Food and Drug Administration
Signed by: Joseph P. Hile
Associate Commissioner for Regulatory Affairs
Date: March 14, 1983