Louisiana Administrative Code
Title 48 - PUBLIC HEALTH-GENERAL
Part I - General Administration
Subpart 3 - Licensing and Certification
Chapter 67 - Free-Standing Birth Centers
Subchapter E - Facility Responsibilities
Section I-6773 - Clinical Records

Universal Citation: LA Admin Code I-6773

Current through Register Vol. 50, No. 9, September 20, 2024

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

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

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

D. The FSBC shall develop and maintain a unique clinical record for each client admitted and/or treated. Records may exist in hard copy, electronic format, or a combination thereof.

E. The FSBC shall ensure the confidentiality of client records, including information in a computerized clinical 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 FSBC shall develop:
a. a back-up system for retrieval of critical clinical records;

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

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

F. A unique clinical record shall be maintained for every client admitted and/or treated.

G. The following data shall be documented and included as part of each client's basic clinical record:

1. unique client identification;

2. admission and discharge date(s) and times of mother and infant;

3. clinical and social history;

4. physical examination notes of mother and infant in accordance with clinical staff bylaws, policies, and procedures;

5. diagnosis(es);

6. licensed practitioner's orders;

7. clinical laboratory report(s), if any;

8. pathology report(s), if any;

9. radiological report(s), if any;

10. consultation report(s), when appropriate;

11. delivery and treatment regimen;

12. licensed practitioner's progress notes;

13. nurses' records of care provided, and medications administered, if any;

14. authorizations, consents, or releases;

15. delivery report;

16. medication record to include, but not limited to:
a. type of medication or local anesthetic, if used;

b. route of medication administered, if any;

c. person administering the medication or local anesthetic, if used; and

d. post-medication assessment, when appropriate;

17. name(s) of the treating licensed healthcare practitioner(s);

18. start and end time of the delivery procedure and time of birth of infant;

19. a current informed consent for delivery procedure and local anesthetics that includes the following:
a. name of the client;

b. client individual identification number;

c. name of the procedure being performed;

d. reasonable and foreseeable risks and benefits;

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

f. signature of client or legal guardian or individual designated as having power of attorney for clinical decisions on behalf of the client, if any;

g. date and time the consent was obtained; and

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

20. delivery procedures report(s);

21. client education and discharge instructions; and

22. a discharge summary, including:
a. licensed healthcare practitioner progress notes; and

b. discharge notes.

H. The clinical records shall be under the custody of the FSBC and maintained in its original, electronic, microfilmed, or similarly reproduced form for a minimum period of 10 years from the date a client is discharged. The FSBC shall provide a means to view or reproduce the record in whatever format it is stored.

I. Clinical records may be removed from the premises for computerized scanning for the purpose of storage. Contracts, for the specific purpose of scanning at a location other than the FSBC, shall include provisions addressing how:

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

2. confidentiality shall be maintained.

J. Clinical records may be stored off-site provided that:

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

2. a 12-month period has lapsed since the client was last treated in the FSBC.

K. Each clinical entry and all orders shall be signed by the licensed healthcare practitioner(s) and shall include the date and time. Clinical entries and any observations made by the licensed healthcare practitioner(s) shall be signed by the licensed healthcare practitioner and shall include the date and time.

1. If electronic signatures are used, the FSBC 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.

L. All pertinent observations, treatments, and medications given to a client shall be entered in the staff notes as part of the clinical record. All other notes relative to specific instructions from the licensed healthcare practitioner shall be recorded.

M. Completion of the clinical record shall be the responsibility of the admitting licensed healthcare practitioner within 30 days of client discharge.

N. All hardcopy entries into the clinical 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 clinical records system is used, all entries shall be authenticated, dated and timed, complete, properly filed and retained, accessible and reproducible.

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

P. The use of standing orders is prohibited.

AUTHORITY NOTE: Promulgated in accordance with R.S. 36:254 and R.S. 40:2180.21-2180.28.

Disclaimer: These regulations may not be the most recent version. Louisiana may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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