La. Admin. Code tit. 48 § I-4569

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

Section I-4569 - Medical Records

A. Each ASC shall make provisions for securing medical records of all media types, whether stored electronically or in paper form. The identified area or equipment shall be secured to maintain confidentiality of records and shall be restricted to staff movement and remote from treatment and public areas.

B. All records shall be protected from loss or damage.

C. The ASC shall have a designated area located within the ASC which shall provide for the proper storage, protection and security for all medical records and documents.

D. The ASC shall develop a unique medical record for each patient. Records may exist in hard copy, electronic format or a combination thereof.

E. ASCs that enter into a use agreement shall integrate the medical records of patients into the medical records of the ASC and shall comply with all requirements of this Section.

F. The ASC shall ensure the confidentiality of patient records, including information in a computerized medical record system, in accordance with the Health Insurance Portability and Accountability Act (HIPAA) regulations and any state laws, rules and regulations.

1. If computerized records are used, the ASC shall develop:

a. a back-up system for retrieval of critical medical records;

b. safeguards/firewalls to prevent unauthorized use and access to information; and

c. safeguards/firewalls to prevent alterations of electronic records.

G. A unique medical record shall be maintained for every patient admitted and/or treated.

H. The medical record cannot become part of any other medical record associated with another entity.

I. The following data shall be documented and included as part of each patients basic medical record:

1. unique patient identification;

2. admission and discharge date(s) and times;

3. medical and social history;

4. physical examination notes in accordance with medical staff bylaws, policies and procedures;

5. chief complaint or diagnosis;

6. physicians orders;

7. clinical laboratory report(s);

8. pathology report(s), when appropriate;

9. radiological report(s), when appropriate;

10. consultation report(s), when appropriate;

11. medical and surgical treatment regimen;

12. physician progress notes;

13. nurses records of care provided and medications administered;

14. authorizations, consents or releases;

15. operative report;

16. anesthesia record to include, but not limited to:

a. type of anesthesia used;

b. medication administered;

c. person administering the anesthesia; and

d. post-anesthesia report;

17. name of the treating physician(s), names of surgical assistants, and nursing personnel (scrub and circulator(s));

18. start and end time of the surgery/procedure;

19. a current informed consent for surgery/procedure and anesthesia that includes the following:

a. name of the patient;

b. patient identification number;

c. name of the procedure or operation being performed;

d. reasonable and foreseeable risks and benefits;

e. name of the licensed medical practitioner(s) who will perform the procedure or operation;

f. signature of patient or legal guardian or individual designated as having power of attorney for medical decisions on behalf of the patient;

g. date and time the consent was obtained; and

h. signature and professional discipline of the person witnessing the consent;

20. special procedures report(s);

21. patient education and discharge instructions;

22. a discharge summary, including:

a. physician progress notes and discharge notes; and

23. a copy of the death certificate and autopsy findings, when appropriate.

J. The medical records shall be under the custody of the ASC and maintained in its original, electronic, microfilmed or similarly reproduced form for a minimum period of 10 years from the date a patient is discharged, pursuant to R.S. 40:2144(F)(1). The ASC shall provide a means to view or reproduce the record in whatever format it is stored.

K. Medical records may be removed from the premises for computerized scanning for the purpose of storage. Contracts entered into, for the specific purpose of scanning at a location other than the ASC, shall include provisions addressing how:

1. the medical record shall be secured from loss or theft or destruction by water, fire, etc.; and

2. confidentiality shall be maintained.

L. Medical records may be stored off-site provided:

1. the confidentiality and security of the medical records are maintained; and

2. a 12-month period has lapsed since the patient was last treated in the ASC.

M. Each clinical entry and all orders shall be signed by the physician, and shall include the date and time. Clinical entries and any observations made by nursing personnel shall be signed by the licensed nurse and shall include the date and time.

1. If electronic signatures are used, the ASC shall develop a procedure to assure the confidentiality of each electronic signature, and shall prohibit the improper or unauthorized use of any computer-generated signature.

2. Signature stamps shall not be used.

N. All pertinent observations, treatments and medications given to a patient shall be entered in the nurses notes as part of the medical record. All other notes relative to specific instructions from the physician shall be recorded.

O. Completion of the medical record shall be the responsibility of the admitting physician within 30 days of patient discharge.

P. All hardcopy entries into the medical record shall be legible and accurately written in ink. The recording person shall sign the entry to the record and include the date and time of entry. If a computerized medical records system is used, all entries shall be authenticated, dated and timed, complete, properly filed and retained, accessible and reproducible.

Q. Written orders signed by a member of the medical staff shall be required for all medications and treatments administered to patients, and shall include the date and time ordered. Verbal orders shall include read-back verification. All verbal orders shall be authenticated by the ordering physician within 48 hours to include the signature of the ordering physician, date and time.

R. The use of standing orders shall be approved by the medical staff, and the standing orders shall be individualized for each patient. Standing orders shall be approved for use by the medical staff on a yearly basis. If standing orders are utilized, the standing orders shall become part of the medical record and include the patients name, date of surgery and shall be authenticated by the ordering physicians signature, date and time. Any changes to the pre-printed orders shall be initialed by the physician making the entry or change to the pre-printed form. The changes shall be legible, noted in ink (if hard copy), and shall include the date and time.

1. Range orders are prohibited.

La. Admin. Code tit. 48, § I-4569

Promulgated by the Department of Health, Bureau of Health Services Financing, LR 431750 (9/1/2017).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:2131-2141.