104 Mass. Reg. 27.16

Current through Register 1524, June 21, 2024

Section 27.16 - Records and Records Privacy

(1) Each facility shall maintain a patient record containing all significant clinical information for each patient admitted to the facility. "Patient record" shall refer to the medical and psychiatric record of a patient admitted to a facility providing care and treatment, and shall not include any financial, statistical or bookkeeping records of the facility.

(2)Contents of Patient Record. A patient record shall include:

(a) identification data, including patient's admission status;

(b) admission information, including admission diagnosis;

(c) health care proxies and advance directives;

(d) history and results of physical examination and psychiatric examination or mental status;

(e) consent forms;

(f) social service and nurses' notes, and psychological reports;

(g) reports of clinical laboratory examinations and X-rays, if any;

(h) reports of diagnostic and therapeutic procedures;

(i) diagnoses recorded in accordance with the Diagnostic and Statistical Manual of Mental

Disorders (DSM-5), 5^th edition published by the American Psychiatric Association;

(j) progress notes;

(k) reports of periodic reviews;

(l) conclusions, including primary and secondary final diagnoses and clinical resume;

(m) all restraint and seclusion orders, including comment forms;

(n) legal documents, including commitment orders and records of transfer, including notices of transfer, advanced directives, guardianship;

(o) records of all placements;

(p) reports of treatment for accidents, injuries or severe illnesses while the patient is in the care of the facility;

(q) any required risk identifications and assessments;

(r) requests for and authorizations to disclose information from such individual patient record;

(s) discharge information; and

(t) any other information deemed necessary and significant to the care and treatment of the patient.

The patient record shall not include evaluations of competence to stand trial or criminal responsibility conducted pursuant to M.G.L. c. 123, §§ 15 or 16, unless such evaluations have been released to the record by the court that ordered such evaluation.

(3)Maintenance of Records for 20 Years. Each facility shall maintain each patient record for at least 20 years after closing of the record due to discharge or death or the last date of service. Prior to destruction of a record, the facility must notify the Department of Public Health in accordance with the process specified in 105 CMR 130.370: Retention of Records. Each facility shall develop and comply with written procedures concerning maintenance and destruction of records.

(4)Format and Storage of Records. Patient records may be handwritten, printed, typed or in electronic digital format, or any combination thereof, or converted to electronic digital format or an alternative archival method. Handwritten, printed or typed medical records that have been converted to electronic digital format or an alternative archival format may be destroyed before the expiration of the 20-year retention period. The manner of destruction must ensure the confidentiality of patient information. Medical records in electronic digital format shall have the same force and effect as the original records from which they were made. Any form of electronic storage system shall have adequate backup and security provisions to safeguard against data loss, as well as against unauthorized access.

(5)Notice of Privacy Practices. Each facility shall provide each patient with a notice of privacy practices which meets the requirements set forth in 45 CFR 164.520. Additionally, such notice shall describe the facility procedures regarding retention of records.

(6)Reporting Patient Data to the Department. Each facility shall maintain and make available to the Department such statistical and diagnostic data as may be required by the Department.

(7)Confidentiality of Records. Each facility shall employ reasonable physical, technical and administrative safeguards to ensure the confidentiality, integrity and availability of patient records, and shall comply with all applicable federal and state laws and regulations. Except as provided in 104 CMR 27.16, all records relating to any patients admitted to or treated by a facility shall be private and not open to public inspection.

(8)Inspection by Patient, Legally Authorized Representative or Patient's Attorney.

(a) A patient and the patient's legally authorized representative shall be permitted to inspect the patient's records, unless a licensed health care professional of the facility determines that:

1. inspection by the patient is reasonably likely to endanger the life or physical safety of the patient or another person;

2. the record makes reference to another person (other than a health care provider) and inspection is reasonably likely to cause substantial harm to such other person; or

3. inspection by the legally authorized representative is reasonably likely to cause substantial harm to the patient or another person.

(b) If access to a record is denied based on the criteria in 104 CMR 27.16(8)(a), the patient or legally authorized representative shall be informed of, and have, the right to appeal. The determination on appeal must be made by a licensed healthcare professional, other than the person who made the initial decision to deny access, and such determination shall be final.

(c) The patient's attorney shall be permitted to inspect the record upon request. The Commissioner or designee may require that the request be in writing and may further require appropriate verification of the attorney client relationship.

(d) Clinical staff may offer to read or interpret the record, when necessary, for the understanding of the patient or his or her legally authorized representative. However, in no circumstance may a patient be denied access to a record solely because he or she declines the offer of clinical staff to read or interpret the record.

(e) The facility director may require the legally authorized representative's consent before permitting a patient younger than 18 years old to inspect his or her own records, provided that a patient who is 16 or 17 years of age and admitted himself or herself pursuant to M.G.L. c. 123, §§ 10 and 11, may inspect records of the admittance without such consent. The records of drug or medical or dental treatment of a patient younger than 18 years old who has been determined to be an emancipated or mature minor as provided in 104 CMR 25.03: Emancipated and Mature Minors shall be confidential between the minor and physician or dentist and shall not be released, except in accordance with M.G.L. c. 112, § 12F.

(9)Inspection by or Disclosure to Other Persons.

(a) The records of a patient shall be open to inspection or disclosure upon proper judicial order, whether or not such order is made in connection with pending judicial proceedings.

1. For the purposes of 104 CMR 27.16(9), "proper judicial order" shall mean an order signed by a justice or special justice of a court of competent jurisdiction as defined by the General Laws, or a clerk or assistant clerk of such a court acting upon instruction of such a justice. A subpoena shall not be deemed a "proper judicial order".

2. Whenever practicable, a patient and the patient's legally authorized representative, if any, shall be informed of a court order for the production of the patient's record.

(b) The records of a patient, or parts thereof, shall be open to inspection or disclosure by other third parties, upon receipt of written authorization from the patient or the patient's legally authorized representative, provided that such written authorization shall meet the requirements set forth in 45 CFR 164.508.

(c) The Commissioner or designee may permit inspection or disclosure of the records of a patient where he or she has made a determination that such inspection or disclosure:

1. would be in the best interest of the patient; and

2. is permitted by the privacy regulations promulgated under the Health Insurance Portability and Accountability Act (HIPAA) at 45 CFR Parts 160 and 164.

(d) Without limiting the discretionary authority of the Commissioner or designee to identify other situations where inspection or disclosure is in the patient's best interest, the following inspections or disclosures are deemed to be in the patient's best interest:

1. for purposes of treatment, payment, and health care operations as permitted by the privacy regulations promulgated under HIPAA at 45 CFR Parts 160 and 164;

2. to obtain authority for a legally authorized representative to act on the patient's behalf, or to obtain a judicial determination of substituted judgment, when a clinical determination has been made that the patient lacks capacity to render informed consent to treatment;

3. to persons conducting an investigation involving the patient pursuant to 104 CMR 32.00: Investigation and Reporting Responsibilities;

4. to persons engaged in research if such access is approved by the Department pursuant to 104 CMR 31.00: Human Subject Research Authorization and Monitoring;

5. to make reports of communicable and other infectious disease to the Department of Public Health and/or local board of health consistent with 105 CMR 300.000: Reportable Diseases, Surveillance, and Isolation and Quarantine Requirements; and

6. in the case of death, to coroners, medical examiners or funeral home directors.

(e) Records may be disclosed as required by law. In addition to the laws and regulations of the Department, such laws include, but are not limited to:

1. M.G.L. c. 6, §§ 178C through 178Q (Sex Offender Registry Law);

2. M.G.L. c. 19A, § 15 (Executive Office of Elder Affairs - abuse of elderly persons, 60 years of age or older);

3. M.G.L. c. 19C, § 10 (Disabled Persons Protection Commission - abuse of disabled persons 18 through 59 years of age);

4. M.G.L. c. 119, § 51A and 51B (Department of Children and Families - abuse or neglect of children younger than 18 years old);

5.42 U.S.C. 10806 (Protection and Advocacy for Mentally Ill Individuals); and

6. M.G.L. c. 221, § 34E (Mental Health Legal Advisors Committee).

(f) Pursuant to M.G.L. c. 6A, § 16, the Department must offset the costs of the services which it provides directly or through contract by maximizing all Title XIX and other federal, state and private health insurance reimbursement which might be available for such services. Accordingly, without limiting 104 CMR 27.16(9)(d)1., records may be disclosed by the Department and/or its agents for the purposes of:

1. benefits/insurance coverage/availability inquiries;

2. obtaining third-party reimbursement;

3. appeals of reimbursement denials; and

4. charging fee payers as set forth in 104 CMR 30.04: Charges for Services.

(g) Any inspection or disclosure pursuant to 104 CMR 27.16(9)(c) through (f) shall be limited to the minimum information necessary to achieve the permitted inspection or disclosure.

(10) Notwithstanding the provisions of 104 CMR 27.16(8) and (9), inspection or disclosure of records or information shall not be permitted in the following circumstances:

(a) if the record or information was obtained from someone other than a health care provider under a promise of confidentiality, and the requested disclosure would likely reveal the source;

(b) on a temporary basis only, by or to the patient during the course of research involving treatment, where the patient agreed to such temporary suspension of access when consenting to participation in the research study;

(c) if the subject of the record is in the custody of a correctional institution and the correctional institution has requested that access not be provided for health and safety reasons; or