Confidentiality of Healthcare Quality Assurance Reviews

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AG01

Confidentiality of Healthcare Quality Assurance Reviews

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Department of Veterans Affairs (VA) is amending its

regulations which govern the confidentiality of documents produced in

VA healthcare quality assurance programs. These regulations specify and

provide for the limited disclosure of those quality assurance documents

which are confidential under the provisions of the Dept. of Veterans

Affairs Confidentiality of Medical Quality Assurance Records Act of

1980, 38 U.S.C. 5705.

EFFECTIVE DATE: This amendment is effective January 23, 1995.

FOR FURTHER INFORMATION CONTACT: Galen L. Barbour, M.D. Associate CMD

for Quality Management (15), 810 Vermont Avenue N.W., Washington, D.C.

20420.

SUPPLEMENTARY INFORMATION: VA published a proposal to amend 38 CFR part

17 in the Federal Register of August 20, 1993 (58 FR 44313). Interested

persons were invited to submit written comments, suggestions or

objections on or before September 20, 1993. We received one comment

from the American Psychiatric Association.

The commenter noted that the standards for disclosure of medical

quality assurance records protected by section 5705 do not mirror the

standards recently proposed by the VA regarding the confidentiality of

patient records related to drug abuse, alcoholism or alcohol abuse,

infection with the human immunodeficiency virus (HIV) and sickle cell

anemia. The commenter asked that VA articulate any statutory or public

policy difference regarding the protection of these two categories of

records.

Each category of records is protected by a statute which

specifically provides that records subject to it may be released

outside the agency only as authorized by that particular section of

title 38. Section 5705 applies to medical quality assurance records,

and section 7332 applies to drug abuse, alcoholism or alcohol abuse,

HIV infection and sickle cell anemia. The VA regulations in each case

reflect the protection and the disclosure authority specified by

Congress in each statute.

This revision of the regulations in 38 CFR part 17 applies to

healthcare quality assurance records and documents created after the

date on which the revision becomes effective. The previous regulations

are still applicable to records and documents created prior to that

date and remain protected by 38 U.S.C. 5705 (formerly 38 U.S.C. 3305),

Confidentiality of Medical Quality-Assurance Records. Records generated

for reviews which are initiated prior to the effective date of this

revision and are in accordance with the previous regulations are

protected by the previous regulations even if the records are completed

after the effective date of this revision.

This revision is necessary to update the previous regulations which

were published in 1982. Much of the language in those regulations no

longer reflects the practice and terminology of quality assurance.

These revised regulations describe the conditions determining the

confidentiality of documents produced in quality assurance programs.

They do not specify the quality assurance program requirements for

VA medical facilities; the rapidly changing environment to which

quality assurance programs respond requires that policy guidance on

this subject be presented in a more flexible and readily modifiable

format. Consequently, the Veterans Health Administration (VHA) is

simultaneously publishing a directive delineating the specific quality

assurance requirements for VA medical facilities and the oversight

responsibilities of VHA regarding these requirements.

To be confidential and privileged under 38 U.S.C. 5705 and these

regulations, a document or part of a document must meet all four of the

following criteria:

1. The quality assurance activity which generated the document must

fall under one of the four classes listed in 17.501(a).

2. In accordance with 17.501(b), the activity which generated the

document must have been previously designated in writing as an activity

which produces confidential quality assurance documents.

3. The document or part of document must meet one of the five

conditions described in 17.501(c).

4. The document or part of document must not meet any of the

conditions in 17.501(g).

The revised regulations allow confidential information concerning a

provider to be seen by that provider for educational and quality

improvement purposes. To protect the integrity of the peer review

process, the identities of the peer reviewers involved in the creation

of the data will not be disclosed to the provider, to the extent

practicable. We believe these changes will permit a flow of information

conducive to continuous quality improvement by making information on

their practice readily available to clinicians.

Information concerning the number of cases treated and procedures

performed by individual providers will no longer be confidential and

protected by 38 U.S.C. 5705 and these regulations. Consequently, 38

U.S.C. 5705 no longer constitutes a bar to VA facilities placing this

information in a practitioner's credentialing and privileging folder.

Since this information is important to the evaluation of a

practitioner's request for renewal of clinical privileges, making it

more readily available should increase the effectiveness of that

process.

The specific examples of programs and activities cited in 17.501(a)

are included to provide guidance to VA facilities in classifying their

review documents to simplify coverage under these regulations.

Documents from other systematic healthcare quality assurance reviews

which meet the criteria in 17.501 are also confidential.

It is expected that VA facilities will indicate on all confidential

review documents created after the publication of these regulations

that the document is confidential under 38 U.S.C. 5705 and these

regulations and also will designate the specific program or activity

within which the review is included. The program and activity names

used should be from the policy documents referred to in 17.501(b).

However, it is not necessary for the facility to have taken these steps

for a document which meets the criteria in 17.501 to be confidential

and privileged.

These regulations recognize that there are two types of external

reviews of care conducted by VA Central Office and the Regions. One

type generates documents which are made confidential and privileged by

38 U.S.C. 5705 while the documents resulting from the second type of

external review are not protected by that statute. Sections

17.501(a)(2), 17.501(a)(3) and 17.501(g)(9) clarify existing agency

procedures in this respect.

This revision does not address the filing of confidential quality

assurance documents by individual identifiers. This change from the

previous regulations does not mean that it is now legal to file

documents in this manner. Guidelines will be provided to the field when

this issue is resolved.

The revised regulations no longer specify the manner in which VA

facilities will maintain and protect records containing information

protected by 38 U.S.C. 5705. However, all VA facilities are expected to

provide the level of protection reasonably necessary to ensure that

access to and disclosure of all records containing information

protected by 38 U.S.C. 5705 will occur only as authorized by the

statute and implementing regulations.

Under these regulations, quality assurance investigations may be

initiated as needed by facilities as focused reviews. Focused reviews

can be used to study both specific incidents and specific issues.

Records and documents relating to focused reviews will be confidential

and privileged if they meet the criteria in 17.501.

As in the past, information and records derived from patient

medical records or facility administrative records, which are not

protected by 38 U.S.C. 5705 and these regulations, may be sent or

communicated to a third party payor who has asked for this information

in response to a VA request for reimbursement based on Public Law 99-

272 and Public Law 101-508. Reviews conducted at the request of the

third party payor do not generate records protected by 38 U.S.C. 5705

and these regulations since the reviews are not undertaken as part of

the VA's quality assurance program. Compliance with applicable patient

record confidentiality statutes is, of course, necessary.

The Secretary hereby certifies that this proposed regulatory

amendment will not, if promulgated, have a significant economic impact

on a substantial number of small entities as they are defined in the

Regulatory Flexibility Act, 5 U.S.C. SS 601-612. The reasons for this

certification are that the proposed regulatory amendment is for the

express purpose of implementing 38 U.S.C. 5705 which protects

particular records generated by the VA medical quality assurance

program; affects only confidential VA records; and imposes no

regulatory burdens on small entities. Pursuant to 5 U.S.C. S 605(b),

this proposed regulatory amendment is therefore exempt from the initial

and final regulatory-flexibility analyses requirements of sections 603

and 604.

There is no Catalog of Federal Domestic Assistant Number.

List of Subjects in 38 CFR Part 17

Alcoholism, Claims, Dental health, Drug abuse, Foreign relations,

Government contracts, Grant programs-health, Health care, Health

facilities, Health professions, Medical devices, Medical research,

Mental health programs, Nursing homes, Philippines, Veterans.

Approved: October 4, 1994.

Jesse Brown,

Secretary of Veterans Affairs.

For the reasons set forth in the preamble, VA amends 38 CFR Part 17

as follows:

PART 17--MEDICAL

1. The authority citation for Part 17 is revised to read as

follows:

Authority: 38 U.S.C. 501, 5705.

2. Sections 17.500 and 17.501 and the undesignated centerheading

preceding Sec. 17.500 are revised; Sec. 17.502 is added; Secs. 17.503

through 17.510 are revised; Sec. 17.511 is added; and Secs. 17.512

through 17.541 are removed as follows:

Confidentiality of Healthcare Quality Assurance Review Records

Sec. 17.500 General.

(a) Section 5705, title 38, United States Code was enacted to

protect the integrity of the VA's medical quality assurance program by

making confidential and privileged certain records and documents

generated by this program and information contained therein. Disclosure

of quality assurance records and documents made confidential and

privileged by 38 U.S.C. 5705 and the regulations in Secs. 17.500

through 17.511 may only be made in accordance with the provisions of 38

U.S.C. 5705 and those regulations.

(b) The purpose of the regulations in Secs. 17.500 through 17.511

is to specify and provide for the limited disclosure of those quality

assurance documents which are confidential under the provisions of 38

U.S.C. 5705.

(c) For purposes of the regulations in Secs. 17.500 through 17.511,

the VA's medical quality assurance program consists of systematic

healthcare reviews carried out by or for VA for the purpose of

improving the quality of medical care or improving the utilization of

healthcare resources in VA medical facilities. These review activities

may involve continuous or periodic data collection and may relate to

either the structure, process, or outcome of health care provided in

the VA.

(d) Nothing in the regulations in Secs. 17.500 through 17.511 shall

be construed as authority to withhold any record or document from a

committee or subcommittee of either House of Congress or any joint

committee or subcommittee of Congress, if such record or document

pertains to any matter within the jurisdiction of such committee or

joint committee.

(e) The regulations in Secs. 17.500 through 17.511 do not waive the

sovereign immunity of the United States, and do not waive the

confidentiality provisions and disclosure restrictions of 38 U.S.C.

5705.

(Authority: 38 U.S.C. 5705)

Sec. 17.501 Confidential and privileged documents.

(a) Documents and parts of documents are considered confidential

and privileged if they were produced by or for the VA in the process of

conducting systematic healthcare reviews for the purpose of improving

the quality of health care or improving the utilization of healthcare

resources in VA healthcare facilities and meet the criteria in

paragraphs (b) and (c) of this section. The four classes of healthcare

quality assurance reviews with examples are:

(1) Monitoring and evaluation reviews conducted by a facility:

(i) Medical records reviews,

(ii) Drug usage evaluations,

(iii) Blood usage reviews,

(iv) Surgical case/invasive procedure reviews,

(v) Service and program monitoring including monitoring performed

by individual services or programs, several services or programs

working together, or individuals from several services or programs

working together as a team,

(vi) Mortality and morbidity reviews,

(vii) Infection control review and surveillance,

(viii) Occurrence screening,

(ix) Tort claims peer reviews (except reviews performed to satisfy

the requirements of a governmental body or a professional health care

organization which is licensing practitioners or monitoring their

professional performance),

(x) Admission and continued stay reviews,

(xi) Diagnostic studies utilization reviews,

(xii) Reports of special incidents (VA Form 10-2633 or similar

forms) and follow-up documents unless developed during or as a result

of a Board of Investigation;

(2) Focused reviews which address specific issues or incidents and

which are designated by the reviewing office at the outset of the

review as protected by 38 U.S.C. 5705 and the regulations in

Secs. 17.500 through 17.511; focused reviews may be either:

(i) Facility focused reviews;

(ii) VA Central Office or Regional focused reviews;

(3) VA Central Office or Regional general oversight reviews to

assess facility compliance with VA program requirements if the reviews

are designated by the reviewing office at the outset of the review as

protected by 38 U.S.C. 5705 and the regulations in Secs. 17.500 through

17.511; and

(4) Contracted external reviews of care, specifically designated in

the contract or agreement as reviews protected by 38 U.S.C. 5705 and

the regulations in Secs. 17.500 through 17.511.

(b) The Under Secretary for Health, Regional Director or facility

Director will describe in advance in writing those quality assurance

activities included under the classes of healthcare quality assurance

reviews listed in paragraph (a) of this section. Only documents and

parts of documents resulting from those activities which have been so

described are protected by 38 U.S.C. 5705 and the regulations in

Secs. 17.500 through 17.511. If an activity is not described in a VA

Central Office or Regional policy document, this requirement may be

satisfied at the facility level by description in advance of the

activity and its designation as protected in the facility quality

assurance plan or other policy document.

(c) Documents and parts of documents generated by activities which

meet the criteria in paragraphs (a) and (b) of this section shall be

confidential and privileged only if they:

(1) Identify, either implicitly or explicitly, individual

practitioners, patients, or reviewers except as provided in paragraph

(g)(6) of this section; or

(2) Contain discussions relating to the quality of VA medical care

or utilization of VA medical resources by healthcare evaluators during

the course of a review of quality assurance information or data, even

if they do not identify practitioners, patients, or reviewers; or

(3) Are individual committee, service, or study team minutes,

notes, reports, memoranda, or other documents either produced by

healthcare evaluators in deliberating on the findings of healthcare

reviews, or prepared for purposes of discussion or consideration by

healthcare evaluators during a quality assurance review; or

(4) Are memoranda, letters, or other documents from the medical

facility to the Regional Director or VA Central Office which contain

information generated by a quality assurance activity meeting the

criteria in Sec. 17.501 (a) and (b); or

(5) Are memoranda, letters, or other documents produced by the

Regional Director or VA Central Office which either respond to or

contain information generated by a quality assurance activity meeting

the criteria in Sec. 17.501 (a) and (b).

(d) Documents which meet the criteria in this section are

confidential and privileged whether they are produced at the medical

facility, Regional or VA Central Office levels, or by external

contractors performing healthcare quality assurance reviews.

(e) Documents which are confidential and privileged may be in

written, computer, electronic, photographic or any other form.

(f) Documents which contain confidential and privileged material in

one part, but not in others, such as Clinical Executive Board minutes,

should be filed and maintained as if the entire document was protected

by 38 U.S.C. 5705. This is not required if the confidential and

privileged material is deleted.

(g) The following records and documents and parts of records and

documents are not confidential even if they meet the criteria in

paragraphs (a) through (c) of this section:

(1) Statistical information regarding VA healthcare programs or

activities that does not implicitly or explicitly identify individual

VA patients or VA employees or individuals involved in the quality

assurance process;

(2) Summary documents or records which only identify study topics,

the period of time covered by the study, criteria, norms, and/or major

overall findings, but which do not identify individual healthcare

practitioners, even by implication;

(3) The contents of Credentialing and Privileging folders as

described in VACO policy documents (38 U.S.C. 5705-protected records

shall not be filed in Credentialing and Privileging folders);

(4) Records and documents developed during or as a result of Boards

of Investigations;

(5) Completed patient satisfaction survey questionnaires and

findings from patient satisfaction surveys;

(6) Records and documents which only indicate the number of

patients treated by a practitioner, either by diagnosis or in

aggregate, or number of procedures performed by a practitioner, either

by procedure or in aggregate;

(7) Records and documents developed during or as a result of

reviews performed to satisfy the requirements of a governmental body or

a professional healthcare organization which is licensing practitioners

or monitoring their professional performance, e.g., National

Practitioner Data Bank, Federation of State Medical Boards, and

National Council of State Boards of Nursing;

(8) Documents and reports developed during or as a result of site

visits by the Office of the Medical Inspector except to the extent that

the documents and reports contain information that meets the criteria

described in this section and are produced by or for VA by other than

the Office of Medical Inspector;

(9) External reviews conducted by VA Central Office or a Region

other than those designated by the reviewing office under paragraph

(a)(2) or (a)(3) of this section as protected by 38 U.S.C. 5705 and the

regulations in Secs. 17.500 through 17.511;

(10) Documents and reports of Professional Standards Boards,

Credentialing Committees, Executive Committees of Medical Staff, and

similar bodies, insofar as the documents relate to the credentialing

and privileging of practitioners;

(11) Documents and reports developed during or as a result of data

validation activities;

(12) Documents and reports developed during or as a result of

occupational health monitoring;

(13) Documents and reports developed during or as a result of

safety monitoring not directly related to the care of specified

individual patients;

(14) Documents and reports developed during or as a result of

resource management activities not directly related to the care of

specified individual patients; and

(15) Information and records derived from patient medical records

or facility administrative records, which are not protected by 38

U.S.C. 5705 and the regulations in Secs. 17.500 through 17.511, may be

sent or communicated to a third party payor who has asked for this

information in response to a VA request for reimbursement based on

Public Law 99-272 and Public Law 101-508. Reviews conducted at the

request of the third party payor do not generate records protected by

38 U.S.C. 5705 and the regulations in Secs. 17.500 through 17.511 since

the reviews are not undertaken as part of the VA's quality assurance

program.

(Authority: 38 U.S.C. 5705)

Sec. 17.502 Applicability of other statutes.

(a) Disclosure of quality assurance records and documents which are

not confidential and privileged under 38 U.S.C. 5705 and the

confidentiality regulations in Secs. 17.500 through 17.511 will be

governed by the provisions of the Freedom of Information Act, and, if

applicable, the Privacy Act and any other VA or federal confidentiality

statutes.

(b) When included in a quality assurance review, confidential

records protected by other confidentiality statutes such as 5 U.S.C.

552a (the Privacy Act), 38 U.S.C. 7332 (drug and alcohol abuse, sickle

cell anemia, HIV infection), and 38 U.S.C. 5701 (veterans' names and

addresses) retain whatever confidentiality protection they have under

these laws and applicable regulations and will be handled accordingly.

To the extent that information protected by 38 U.S.C. 5701 or 7332 or

the Privacy Act is incorporated into quality assurance records, the

information in the quality assurance records is still protected by

these statutes.

(Authority: 38 U.S.C. 5705)

Sec. 17.503 Improper disclosure.

(a) Improper disclosure is the disclosure of confidential and

privileged healthcare quality assurance review records or documents (or

information contained therein), as defined in Sec. 17.501, to any

person who is not authorized access to the records or documents under

the statute and the regulations in Secs. 17.500 through 17.511.

(b) ``Disclosure'' means the communication, transmission, or

conveyance in any way of any confidential and privileged quality

assurance records or documents or information contained in them to any

individual or organization in any form by any means.

(Authority: 38 U.S.C. 5705)

Sec. 17.504 Disclosure methods.

(a) Disclosure of confidential and privileged quality assurance

records and documents or the information contained therein outside VA,

where permitted by the statute and the regulations in Secs. 17.500

through 17.511, will always be by copies, abstracts, summaries, or

similar records or documents prepared by the Department of Veterans

Affairs and released to the requestor. The original confidential and

privileged quality assurance records and documents will not be removed

from the VA facility by any person, VA employee or otherwise, except in

accordance with Sec. 17.508(c) or where otherwise legally required.

(b) Disclosure of confidential and privileged quality assurance

records and documents to authorized individuals under either

Sec. 17.508 or Sec. 17.509 shall bear the following statement: ``These

documents or records (or information contained herein) are confidential

and privileged under the provisions of 38 U.S.C. 5705, which provide

for fines up to $20,000 for unauthorized disclosures thereof, and the

implementing regulations. This material shall not be disclosed to

anyone without authorization as provided for by that law or the

regulations in Secs. 17.500 through 17.511.''

(Authority: 38 U.S.C. 5705)

Sec. 17.505 Disclosure authorities.

The VA medical facility Director, Regional Director, Under

Secretary for Health, or their designees are authorized to disclose any

confidential and privileged quality assurance records or documents

under their control to other agencies, organizations, or individuals

where 38 U.S.C. 5705 or the regulations in Secs. 17.500 through 17.511

expressly provide for disclosure.

(Authority: 38 U.S.C. 5705)

Sec. 17.506 Appeal of decision by Veterans Health Administration to

deny disclosure.

When a request for records or documents subject to the regulations

in Secs. 17.500 through 17.511 is denied in whole or in part by the VA

medical facility Director, Regional Director or Under Secretary for

Health, the VA official denying the request in whole or in part will

notify the requestor in writing of the right to appeal this decision to

the General Counsel of the Department of Veterans Affairs within 60

days of the date of the denial letter. The final Department decision

will be made by the General Counsel or the Deputy General Counsel.

(Authority: 38 U.S.C. 5705)

Sec. 17.507 Employee responsibilities.

(a) All VA employees and other individuals who have access to

records designated as confidential and privileged under 38 U.S.C. 5705

and the regulations in Secs. 17.500 through 17.511 will treat the

findings, views, and actions relating to quality assurance in a

confidential manner.

(b) All individuals who have had access to records designated as

confidential and privileged under 38 U.S.C. 5705 and the regulations in

Secs. 17.500 through 17.511 will not disclose such records or

information therein to any person or organization after voluntary or

involuntary termination of their relationship to the VA.

(Authority: 38 U.S.C. 5705)

Sec. 17.508 Access to quality assurance records and documents within

the agency.

(a) Access to confidential and privileged quality assurance records

and documents within the Department pursuant to this section is

restricted to VA employees (including consultants and contractors of

VA) who have a need for such information to perform their government

duties or contractual responsibilities and who are authorized access by

the VA medical facility Director, Regional Director, the Under

Secretary for Health, or their designees or by the regulations in

Secs. 17.500 through 17.511.

(b) To foster continuous quality improvement, practitioners on VA

rolls, whether paid or not, will have access to confidential and

privileged quality assurance records and documents relating to

evaluation of the care they provided.

(c) Any quality assurance record or document, whether confidential

and privileged or not, may be provided to the General Counsel or any

attorney within the Office of General Counsel, wherever located. These

documents may also be provided to a Department of Justice (DOJ)

attorney who is investigating a claim or potential claim against the VA

or who is preparing for litigation involving the VA. If necessary, such

a record or document may be removed from the VA medical facility to the

site where the General Counsel or any attorney within the Office of

General Counsel or the DOJ attorney is conducting an investigation or

preparing for litigation.

(d) Any quality assurance record or document or the information

contained therein, whether confidential and privileged or not, will be

provided to the Department of Veterans Affairs Office of Inspector

General upon request. A written request is not required.

(e) To the extent practicable, documents accessed under paragraph

(b) of this section will not include the identity of peer reviewers.

Reasonable efforts will be made to edit documents so as to protect the

identities of reviewers, but the inability to completely do so will not

bar access under paragraph (b).

(f) No individual shall be permitted access to confidential and

privileged quality assurance records and documents identified in

Sec. 17.501 unless such individual has been informed of the penalties

for unauthorized disclosure. Any misuse of confidential and privileged

quality assurance records or documents shall be reported to the

appropriate VHA official, e.g., Service Chief, Medical Center Director.

(g) In general, confidential and privileged quality assurance

records and documents will be maintained for a minimum of 3 years and

may be held longer if needed for research studies or quality assurance

or legal purposes.

(Authority: 38 U.S.C. 5705)

Sec. 17.509 Authorized disclosure: Non-Department of Veterans Affairs

requests.

(a) Requests for confidential and privileged quality assurance

records and documents from organizations or individuals outside VA must

be made to the Department and must specify the nature and content of

the information requested, to whom the information should be

transmitted or disclosed, and the purpose listed in paragraphs (b)

through (j) of this section for which the information requested will be

used. In addition, the requestor will specify to the extent possible

the beginning and final dates of the period for which disclosure or

access is requested. The request must be in writing and signed by the

requestor. Except as specified in paragraphs (b) and (c) of this

section, these requests should be forwarded to the Director of the

facility in possession of the records or documents for response. The

procedures outlined in 38 CFR 1.500 through 1.584 will be followed

where applicable.

(b) Disclosure shall be made to Federal agencies upon their written

request to permit VA's participation in healthcare programs including

healthcare delivery, research, planning, and related activities with

the requesting agencies. Any Federal agency may apply to the Under

Secretary for Health for approval. If the VA decides to participate in

the healthcare program with the requestor, the requesting agency will

enter into an agreement with VA to ensure that the agency and its staff

will ensure the confidentiality of any quality assurance records or

documents shared with the agency.

(c) Qualified persons or organizations, including academic

institutions, engaged in healthcare program activities shall, upon

request to and approval by the Under Secretary for Health, Regional

Director, medical facility Director, or their designees, have access to

confidential and privileged medical quality assurance records and

documents to permit VA participation in a healthcare activity with the

requestor, provided that no records or documents are removed from the

VA facility in possession of the records.

(d) When a request under paragraphs (b) or (c) of this section

concerns access for research purposes, the request, together with the

research plan or protocol, shall first be submitted to and approved by

an appropriate VA medical facility Research and Development Committee

and then approved by the Director of the VA medical facility. The VA

medical facility staff together with the qualified person(s) conducting

the research shall be responsible for the preservation of the anonymity

of the patients, clients, and providers and shall not disseminate any

records or documents which identify such individuals directly or

indirectly without the individual's consent. This applies to the

handling of data or information as well as reporting or publication of

findings. These requirements are in addition to other applicable

protections for the research.

(e) Individually identified patient medical record information

which is protected by another statute as provided in Sec. 17.502 may

not be disclosed to a non-VA person or organization, including

disclosures for research purposes under paragraph (d), except as

provided in that statute.

(f) Under paragraph (b), the Under Secretary for Health or designee

or under paragraph (c), the Under Secretary for Health, Regional

Director, medical facility Director, or their designees may approve a

written request if it meets the following criteria:

(1) Participation by VA will benefit VA patient care; or

(2) Participation by VA will enhance VA medical research; or

(3) Participation by VA will enhance VA health services research;

or

(4) Participation by VA will enhance VA healthcare planning or

program development activities; or

(5) Participation by VA will enhance related VA healthcare program

activities; and

(6) Access to the record by the requester is required for VA to

participate in a healthcare program with the requester.

(g) Protected quality assurance records or documents, including

records pertaining to a specific individual, will for purposes

authorized under law be disclosed to a civil or criminal law

enforcement governmental agency or instrumentality 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 received from an official of

such an organization. The request must state the purpose authorized by

law for which the records will be used. The Under Secretary for Health,

Regional Director, medical facility Director, or their designees will

determine the extent to which the information is disclosable.

(h) Federal agencies charged with protecting the public health and

welfare, federal and private agencies which engage in various

monitoring and quality control activities, agencies responsible for

licensure of individual health care facilities or programs, and similar

organizations will be provided confidential and privileged quality

assurance records and documents if a written request for such records

or documents is received from an official of such an organization. The

request must state the purpose for which the records will be used. The

Under Secretary for Health, Regional Director, medical facility

Director, or their designees will determine the extent to which the

information is disclosable.

(i) JCAHO (Joint Commission on Accreditation of Healthcare

Organizations) survey teams and similar national accreditation agencies

or boards and other organizations requested by VA to assess the

effectiveness of quality assurance program activities or to consult

regarding these programs are entitled to disclosure of confidential and

privileged quality assurance documents with the following

qualifications:

(1) Accreditation agencies which are charged with assessing all

aspects of medical facility patient care, e.g., JCAHO, may have access

to all confidential and privileged quality assurance records and

documents.

(2) Accreditation agencies charged with more narrowly focused

review (e.g., College of American Pathologists, American Association of

Blood Banks, Nuclear Regulatory Commission, etc.) may have access only

to such confidential and privileged records and documents as are

relevant to their respective focus.

(j) Confidential and privileged quality assurance records and

documents shall be released to the General Accounting Office if such

records or documents pertain to any matter within its jurisdiction.

(k) Confidential and privileged quality assurance records and

documents shall be released to both VA and non-VA healthcare personnel

upon request to the extent necessary to meet a medical emergency

affecting the health or safety of any individual.

(l) For any disclosure made under paragraphs (a) through (i) of

this section, the name of and other identifying information regarding

any individual VA patient, employee, or other individual associated

with VA shall be deleted from any confidential and privileged quality

assurance record or document before any disclosure under these quality

assurance regulations in Secs. 17.500 through 17.511 is made, if

disclosure of such name and identifying information would constitute a

clearly unwarranted invasion of personal privacy.

(m) Disclosure of the confidential and privileged quality assurance

records and documents identified in Sec. 17.501 will not be made to any

individual or agency until that individual or agency has been informed

of the penalties for unauthorized disclosure or redisclosure.

(Authority: 38 U.S.C. 5705)

Sec. 17.510 Redisclosure.

No person or entity to whom a quality assurance record or document

has been disclosed under Sec. 17.508 or Sec. 17.509 shall make further

disclosure of such record or document except as provided for in 38

U.S.C. 5705 and the regulations in Secs. 17.500 through 17.511.

(Authority: 38 U.S.C. 5705)

Sec. 17.511 Penalties for violations.

Any person who knows that a document or record is a confidential

and privileged quality assurance document or record described in

Secs. 17.500 through 17.511 and willfully discloses such confidential

and privileged quality assurance record or document or information

contained therein, except as authorized by 38 U.S.C. 5705 or the

regulations in Secs. 17.500 through 17.511, shall be fined not more

than $5,000 in the case of a first offense and not more than $20,000 in

the case of each subsequent offense.

(Authority: 38 U.S.C. 5705)

[FR Doc. 94-26210 Filed 10-21-94; 8:45 am]

BILLING CODE 8320-01-P