Current through Register 1531, September 27, 2024
(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),
5th 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
(d) if the records are created
in anticipation of litigation.
