Subject: Quality Assurance of the NASA Medical Care (Revalidated w/change 1)

Responsible Office: Office of the Chief Health & Medical Officer

Chapter 3. Confidentiality of Medical Quality Assurance Records

3.1 Introduction

3.1.1 NASA medical operations shall maintain a system of records for physician credentialing information and medical quality assurance activities. The records include, but are not limited to, records associated with activities conducted by civil servants, detailees to NASA, contractors, or consultants related to the provision of medical, dental, or psychological care, and any committees or other review bodies responsible for medical quality assurance.

3.1.2 The records associated with these activities should include: patient care, assessment, and medical and behavioral health records; health-care provider credentialing and privileging records of health-care providers; and information collected and compiled for quality assurance reviews and assessments.

3.1.3 The records will include the clinical and health-care provider instructions, clinical and medical procedure records, and records of all ancillary medical activities required to prescribe quality assurance activities, including closely related specifications such as required qualifications of personnel, procedures, and equipment.

a. The records will include the instructions or procedures that establish a records retention program consistent with applicable regulations and NASA policy requirements and designate factors such as duration, location, and assigned responsibility.

3.1.4 Medical Quality Assurance (QA) records created by or for NASA, as part of a medical QA program, will be confidential and privileged. They may not be made available to any person, except in those cases described in sections 3.2 and 3.3, under the "Freedom of Information Act" (Section 552) and the "Privacy Act" (Section 552a) of Title 5, United States Code.

3.1.5 As a system of records, QA records are within the purview of the "Privacy Act" of 1974, as amended and, therefore, the health-care provider who is the subject of a QA action may be entitled access to the records. With the exception of such a provider, the identities of third parties in the record (i.e., any person receiving health-care services from NASA or any other person associated with the NASA QA program) will be redacted from the record before any disclosure of the record is made outside the Agency. No part of any medical QA record may be subject to disclosure, except pursuant to applicable law.

3.1.6 No part of any medical QA record will be subject to discovery or admitted into evidence in any judicial or administrative proceeding, except in those cases described in sections 3.2 and 3.3, under the "Freedom of Information Act," or under applicable law.

3.1.7 A person who reviews or creates medical QA records for NASA or who participates in any proceeding that reviews or creates such records will not testify in any judicial or administrative proceeding on such records or on any finding, recommendation, evaluation, opinion, or action taken by such person or body for such records, except in those cases described in sections 3.2 and 3.3, under the "Freedom of Information Act," or under applicable law.

3.1.8 A person or entity having possession of medical QA records, or access to medical QA records or testimony, will not disclose the contents of such record or testimony in any manner or for any purpose, except in those cases described in sections 3.2 and 3.3, under the "Freedom of Information Act," or under applicable law.

3.2 Access to Quality Assurance Records and Documents Within the Agency

3.2.1 Access to confidential and privileged quality assurance records and documents will be restricted to NASA employees (including detailees, consultants, and contractors) who have a need for such information to perform their government duties or contractual responsibilities and who have been granted authorized access by the Chief Health and Medical Officer (CHMO).

3.2.2 To foster continuous quality improvement, NASA medical personnel may have access to confidential and privileged quality assurance records and documents relating to evaluation of the care they provide.

3.2.3 Any quality assurance record or document, or the information contained within them, whether confidential and privileged or not, should be provided to the NASA Inspector General upon request. A written request is not required (a written record of the request will be maintained by the Office of the Chief Health and Medical Officer).

3.3 Non-NASA Disclosure of Quality Assurance Records and Documents

3.3.1 For any disclosure made for the purposes described in this section, and not necessary to achieve those purposes, the name of, and other identifying information regarding any individual patient, employee, or other individual associated with NASA shall be redacted from any confidential and privileged quality assurance record or document before any disclosure is made. NASA medical QA records may be authorized for disclosure or testimony to the following:

a. Any survey teams, national accreditation agencies or boards, and other organizations requested by NASA to assess the effectiveness of quality assurance program activities or to consult regarding these programs;

b. Any committees, panels, or boards convened by NASA to review Agency policy and practices. Any Federal executive agency or private organization, which will, if necessary, license, accredit, or monitor NASA health-care facilities;

c. Any proceeding commenced concerning the termination, suspension, or limitation of their clinical privileges for a present or former NASA civil servant or NASA assigned detailee, contractor, or consultant care provider;

d. A governmental board or agency or a professional health-care society or organization, if necessary, to perform licensing, or privileging, or to monitor professional standards for a health-care provider who is or was an employee of NASA, detailed to NASA, or a NASA contractor, or consultant assigned to NASA;

e. Other Federal agencies, upon their written request, to permit NASA's participation in health-care programs including health-care delivery, research, planning, and related activities with the requesting agencies. If NASA decides to participate in the health-care program with the requestor, the requesting agency must enter into an agreement with NASA to ensure that the Agency and its staff maintain the confidentiality of any quality assurance records or documents shared with the Agency;

f. Civil or criminal law enforcement governmental agencies or instrumentalities charged under applicable law with the protection of public health or safety, including state licensing and disciplinary agencies, if a written request for such records or documents is submitted by an official of the organization, if the request states the purpose for which the records will be used, and if the purpose for the records is authorized by law;

g. Federal agencies charged with protecting the public health and welfare, Federal, state, and private agencies which engage in various monitoring and quality control activities, agencies responsible for licensure of health-care facilities or programs, and similar organizations, if a written request for such records or documents is received from an official of the organization and the request states the purpose for which the records will be used;

h. A hospital, medical center, or other institution that provides health-care services, if needed by such institution to assess the professional qualifications of any health-care provider who is, or was, an employee or contractor of NASA and who has applied for, or has been granted, authority or employment to provide health-care services in or on behalf of such institution; and

i. The General Accounting Office or committee of Congress if such records or documents pertain to any matter within their jurisdiction.

j. A court of competence jurisdiction, pursuant to a protective order.

3.4 Responsibilities

3.4.1 The CHMO shall be responsible for ensuring that each NASA clinic has developed policies and procedures for:

(a) Monitoring of QA recordkeeping processes and practices to assure appropriate implementation of this policy and issuing any additional requirements necessary for its implementation, and

(b) Maintaining a record of requests for access to NASA medical QA records as described in this policy.

3.4.2 Center Chief Medical Officers/Medical Directors, in collaboration with NASA Center Occupational Health Program Managers, and in the case of the Johnson Space Center, the Director of the Flight Medicine Clinic, shall be responsible for:

a. Maintaining medical QA records and assuring such records meet privacy requirements as described in this policy;

b. Reporting to the CHMO in writing (e.g., letter and/or e-mail) any requests for disclosure of medical QA records; and

c. Providing medical QA records only to approved recipients as described in this NPR.

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