La. Admin. Code tit. 48 § V-15109

Current through Register Vol. 50, No. 11, November 20, 2024

Section V-15109 - Use of Hospital Discharge Records in Research

A. Any person may apply to the office to conduct research for health surveillance, public education, administrative, or health industry purposes using patient level data. Non-aggregate data (patient level data) shall be disclosed only when the Hospital Discharge Data Research Panel has deemed that it would be impractical to perform the research with aggregate data. Only the fields and records necessary for the proposed study will be released.

1. Panel. Pursuant to R.S. 40:1300.112.B(1) and D., the Hospital Discharge Data Research Panel is established. It shall operate in accordance with the following guidelines.

a. Membership. The panel shall be composed of at least 15 members with varying background and expertise, to promote complete and adequate review of research activities commonly conducted using hospital discharge data.

i. The panel membership shall reflect sufficient experience and expertise with hospital data and/or data analysis, sensitivity to cultural diversity and privacy issues, and the professional competence necessary to review research proposals in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.

ii. The panel shall include the following representatives of the Office of Public Health:

(a). the state health officer or programmatic designee;

(b). the director of the Division of Health Information; and

(c). the State Registrar of Vital Records. The state health officer or his designee shall chair the panel.

iii. The state health officer shall appoint 12 additional panel members representing groups and organizations that have knowledge and expertise in fields related to research using health care data. Accordingly, the appointees will include a representative of health care consumers, a representative of payors, private hospital representation, and members of the following organizations:

(a). Louisiana Health Care Review Inc.;

(b). Louisiana Health Information Management Association;

(c). Louisiana Hospital Association;

(d). Louisiana State Medical Society;

(e). Louisiana State University;

(f). Metropolitan Hospital Council of New Orleans;

(g). Rural Hospital Coalition;

(h). Tulane University; and

(i). VHA Gulf States.

b. Panel Meetings. The state health officer or designee shall convene panel meetings. The panel will review research requests on a quarterly basis or as needed. Regular meeting dates shall be communicated to panel members in writing at least 21 calendar days prior to the meeting. If any emergency or ad-hoc meetings are required, meeting dates for these additional meetings shall be communicated to panel members, in writing, at least seven calendar days prior to the meeting.

c. Panel Quorum. A quorum shall require the presence of eight members. A majority of the members present must concur via a roll call vote for the panel to take action on the approval or disapproval of any research application.

d. Panel Records. Adequate documentation of the panel activities shall be maintained including the following:

i. copies of all research and special report proposals reviewed, including attachments;

ii. minutes of all panel meetings shall be in sufficient detail to show attendance at meetings, actions taken by the panel, the vote on the actions including the number of members voting for, against or abstaining, the basis for requiring changes in or disapproving research, and a written summary of controversial issues and their resolution;

iii. copies of all correspondence;

iv. the records required by these rules shall be retained for at least three years after completion of the research. These records shall be exempt from the Public Records Law.

2. Research Using Patient Level Records

a. Application. A request for use of hospital discharge information, excluding secure information, in research shall be in writing and shall be addressed to the state health officer. The data request must include:

i. a complete experimental protocol, including health objectives, rationale for the study, design detail and scientific basis for selection of subjects;

ii. a summary of the protocol, including a definition of, and justification for, the particular fields and records necessary for the research;

iii. copy of the informed consent form and an outline of the consent process, if required by the panel (for proposed follow-back research or contact with employers, payors, facilities, physicians or other healthcare providers);

iv. provisions to fully protect the confidentiality of the data and the privacy of patients and insured persons related to the patient;

v. affirmation that data files provided by OPH to the applicant will not be re-released to other researchers or anyone else not connected to the specific study for which the data is released;

vi. resumes of all investigators identifying their specific qualifications to do the research proposed, listing educational degrees and societies, certifying boards and academic institutions which have recognized their competence by granting membership, diploma, or title, previous work in the subject area and employment;

vii. approval from an institutional review board for this study or approval from an educational department chairman where the applicant is employed by or associated with an institution which requires such approval;

viii. affirmation that a report of the findings resulting from the use of the records shall be provided to the state health officer;

ix. a signed agreement to indemnify and hold the office, its employees, panel members, and the original providers of the patient level data harmless from any liability arising out of the authorized or unauthorized use of the data.

b. Use of employer, facility, payor, physician or other healthcare provider identifiers. Researchers requesting any of these identifiers must additionally affirm that none of these identifiers or combinations of elements that identify or tend to identify any of these parties will be published or otherwise disclosed without the specific approval of the panel. If any physicians or other healthcare providers will be identified in a proposed publication, the panel must receive a copy of the study or report prior to submission for publication. Following receipt of this copy, the panel will require a two-week waiting period prior to final approval for publication.

c. Confidentiality of Data Used for Research. The researcher shall establish reasonable administrative, technical and physical safeguards to prevent unauthorized use or disclosure of the records. At the end of the project all confidential information will be destroyed.

d. Criteria for Approval of Research. The criteria for the approval of research shall include, but are not limited to:

i. the study objective and design reflect that the proposal is in the best interest of the public health;

ii. the selection of subjects is made on a scientific basis;

iii. the investigators/researchers are deemed qualified based on their past research, employment and education or other appropriate credentials;

iv. where appropriate, approval of an institutional review board has been obtained;

v. provisions to protect the confidentiality of the data and subjects comply with §15109. B.2 of this rule;

vi. the informed consent process and forms follow the guidelines required in these rules and will be appropriately documented as required.

e. Panel Review and Notification. The panel will review research requests on at least a quarterly basis. Following review, the panel shall notify requesters, in writing, of the decision to approve or disapprove the proposed study or modifications required to secure approval of the research activity. If the panel disapproves a request, it shall include in its written notification a statement of the reasons for its decision and give the investigator/researcher an opportunity to request reconsideration, in writing.

f. Requests for Reconsideration. Requests for reconsideration must be filed within 30 days of the date appearing on the notification. The panel shall schedule a hearing of the appeal to be held within 90 days of the date of receipt of the appeal. The principal investigator/ researcher has the right to appear to defend the proposal at a reconsideration hearing. If on reconsideration the research proposal is denied, the requester shall have a right to appeal the panel's decision in accordance with the procedure outlined below.

g. Appeal of Data Use Denial. Any person who submits a research, educational or administrative use proposal to the panel that is denied shall have a right to petition for judicial review of the panel's final action in accordance with the Administrative Procedure Act (R.S. 49:950 et seq.). This remedy shall be the exclusive means of appealing the action of the panel.

La. Admin. Code tit. 48, § V-15109

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 24:1936 (October 1998).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1300.112(D).