Ariz. Admin. Code § R9-10-1512 - Medical Records

A. A licensee shall ensure that

1. a medical record is established and maintained for a patient that contains:

a. 1. Patient identification including:

i. a. The patient's name, address, and date of birth;

ii b. The designated patient's representative, if applicable; and

iii. c. The name and telephone number of an individual to contact in an emergency;

b. 2. The patient's medical history required in R9-10-1509(A)(1) ;

c. 3. The patient's physical examination required in R9-10-1509(A)(2) ;

d. 4. The laboratory test results required in R9-10-1509(A)(3) ;

5. The ultrasound results, including the original print, required in R9-10-1509(A)(4) ;

e. 6. The physician's estimated gestational age of the fetus required in R9-10-1509(C) ;

f. The ultrasound results, including the original print, required in R9-10-1508(D) ; g.

g. 7. Each consent form signed by the patient or the patient's representative;

h. 8. Orders issued by a physician, physician assistant, or registered nurse practitioner;

i. 9. A record of medical services, nursing services, and health-related services provided to the patient;

j. 10. The patient's medication information;

11. Documentation related to follow-up care specified in R9-10-1509(I) ; and

12. If the abortion procedure was performed at or after 20 weeks gestational age and the fetus was not delivered alive, documentation from the physician and other patient care staff member present certifying that the fetus was not delivered alive.

B. A licensee shall ensure that a medical record is established and maintained for a fetus delivered alive that contains:

1. An identification of the fetus, including:

a. The name of the patient from whom the fetus was delivered alive, and

b. The date the fetus was delivered alive;

2. Orders issued by a physician, physician assistant, or registered nurse practitioner;

3. A record of medical services, nursing services, and health-related services provided to the fetus delivered alive;

4. If applicable, information about medication administered to the fetus delivered alive; and

5. If the abortion procedure was performed at or after 20 weeks gestational age:

a. Documentation of the requirements in R9-10-1509(G)(4) ; and

b. If the fetus had a lethal fetal condition, the results of the confirmation of the lethal fetal condition.

C. A licensee shall ensure that:

2. 1. A medical record is accessible only to the Department or personnel authorized by policies and procedures;

3. 2. Medical record information is confidential and released only with the written informed consent of a patient or the patient's representative or as otherwise permitted by law;

4. 3. A medical record is protected from loss, damage, or unauthorized use and is maintained and accessible for at least seven years after the date of an adult patient's discharge or if the patient is a child, either for at least three years after the child's 18th birthday or for at least seven years after the patient's discharge, whichever date occurs last;

5. 4. A medical record is maintained at the abortion clinic for at least six months after the date of the patient's discharge; and

6. 5. Vital records and vital statistics are retained according to A.R.S. § 36-343.

B. A licensee shall comply with Department requests for access to or copies of patient medical records as follows:

1. Subject to the redaction permitted in subsection (B)(5), for patient medical records requested for review in connection with a compliance inspection, the licensee shall provide the Department with the following patient medical records related to medical services associated with an abortion, including any follow-up visits to the abortion clinic in connection with the abortion:

a. Patient identification including:

i. The patient's name, address, and date of birth;

ii. The designated patient's representative, if applicable; and

iii. The name and telephone number of an individual to contact in an emergency;

b. The patient's medical history required in R9-10-1508(A)(1) ;

c. The patient's physical examination required in R9-10-1508(A)(2) ;

d. The laboratory test results required in R9-10-1508(A)(3) ;

e. The physician's estimated gestational age of the fetus required in R9-10-1508(C) ;

f. The ultrasound results required in R9-10-1508(D) ;

g. Each consent form signed by the patient or the patient's representative;

h. Orders issued by a physician, physician assistant, or registered nurse practitioner;

i. A record of medical services, nursing services, and health-related services provided to the patient; and

j. The patient's medication information.

2. For patient medical records requested for review in connection with an initial licensing or compliance inspection, the licensee is not required to produce for review by the Department any patient medical records created or prepared by a referring physician or any of that referring physician's medical staff.; and

3. The licensee is not required to provide patient medical records regarding medical services associated with an abortion that occurred before:

a. The effective date of these rules, or

b. A previous licensing or compliance inspection of the abortion clinic.

4. The patient medical records may be provided to the Department in either paper or in an electronic format that is acceptable to the Department.

5. When access to or copies of patient medical records are requested from a licensee by the Department, the licensee shall redact only personally identifiable patient information from the patient medical records before the disclosure of the patient medical records to the Department, except as provided in subsection (B)(8).

6. For patient medical records requested for review in connection with an initial licensing or compliance inspection, the licensee shall provide the redacted copies of the patient medical records to the Department within two business days of the Department's request for the redacted medical records if the total number of patients for whom patient medical records are requested by the Department is from one to ten patients, unless otherwise agreed to by the Department and the licensee. The time within which the licensee shall produce redacted records to the Department shall be increased by two business days for each additional five patients for whom patient medical records are requested by the Department, unless otherwise agreed to by the Department and the licensee.

7. Upon request by the Department, in addition to redacting only personally identifiable patient information, the licensee shall code the requested patient medical records by a means that allows the Department to track all patient medical records related to a specific patient without the personally identifiable patient information.

8. For patient medical records requested for review in connection with a complaint investigation, the Department shall have access to or copies of unredacted patient medical records.

9. If the Department obtains copies of unredacted patient medical records, the Department shall:

a. Allow the examination and use of the unredacted patient medical records only by those Department employees who need access to the patient medical records to fulfill their investigative responsibilities and duties;

b. Maintain all unredacted patient medical records in a locked drawer, cabinet, or file or in a password-protected electronic file with access to the secured drawer, cabinet, or file limited to those individuals who have access to the patient medical records according to subsection (B)(9)(a);

c. Destroy all unredacted patient medical records at the termination of the Department's complaint investigation or at the termination of any administrative or legal action that is taken by the Department as the result of the Department's complaint investigation, whichever is later;

d. If the unredacted patient medical records are filed with a court or other judicial body, including any administrative law judge or panel, file the records only under seal; and

e. Prevent access to the unredacted records by anyone except as provided in subsection (B)(9)(a) or subsection (B)(9)(d).

D. If the Department requests patient medical records for review, the licensee:

1. Is not required to produce any patient medical records created or prepared by a referring physician's office;

2. May provide patient medical records to the Department either in paper or in an electronic format that is acceptable to the Department;

3. Shall provide the Department with the following patient medical records related to medical services associated with an abortion, including any follow-up visits to the abortion clinic in connection with the abortion:

a. The patient's medical history required in R9-10-1509(A)(1) ;

b. The patient's physical examination required in R9-10-1509(A)(2) ;

c. The laboratory test results required in R9-10-1509(A)(3) ;

d. The physician's estimate of gestational age of the fetus required in R9-10-1509(C) ;

e. The ultrasound results required in R9-10-1509(D)(2) ;

f. Each consent form signed by the patient or the patient's representative;

g. Orders issued by a physician, physician assistant, or registered nurse practitioner;

h. A record of medical services, nursing services, and health-related services provided to the patient; and

i. The patient's medication information;

4. If the Department's request is in connection with a licensing or compliance inspection:

a. Is not required to produce any patient medical records associated with an abortion that occurred before the licensing inspection or a previous compliance inspection of the abortion clinic; and

b. Shall:

i. Redact only personally identifiable patient information from the patient medical records before the licensee discloses the patient medical records to the Department;

ii. Upon request by the Department, code the requested patient medical records by a means that allows the Department to track all patient medical records related to a specific patient without the personally identifiable patient information; and

iii. Unless the Department and the licensee agree otherwise, provide redacted copies of patient medical records to the Department:

(1) For one to ten patients, within two working days after the request, and

(2) For every additional five patients, within an additional two working days; and

5. If the Department's request is in connection with a complaint investigation, shall:

a. Not redact patient information from the patient medical records before the licensee discloses the patient medical records to the Department; and

b. Ensure the patient medical records include:

i. The patient's name, address, and date of birth;

ii. The patient's representative, if applicable; and

iii. The name and telephone number of an individual to contact in an emergency.

C. E. A medical director shall ensure that only personnel authorized by policies and procedures, records or signs an entry in a medical record and:

1. An entry in a medical record is dated and legible;

2. An entry is authenticated by:

a. A signature; or

b. An individual's initials if the individual's signature already appears in the medical record;

c. A rubber-stamp signature; or

d. An electronic signature;

3. An entry is not changed after it has been recorded, but additional information related to an entry may be recorded in the medical record;

4. When a verbal or telephone order is entered in the medical record, the entry is authenticated within 21 calendar days by the individual who issued the order;

5. If a rubber-stamp signature or an electronic signature is used:

a. An individual's rubber stamp or electronic signature is not used by another individual;

b. The individual who uses a rubber stamp or electronic signature signs a statement that the individual is responsible for the use of the rubber stamp or the electronic signature; and

c. The signed statement is included in the individual's personnel record; and

6. If an abortion clinic maintains medical records electronically, the medical director shall ensure the date and time of an entry is recorded by the computer's internal clock.

D. F. As required by A.R.S. § 36-449.03(J), the Department shall not release any personally identifiable patient or physician information.

Notes

Ariz. Admin. Code § R9-10-1512

Adopted effective August 6, 1993, under an exemption from the provisions of the Administrative Procedure Act pursuant to Laws 1993, Ch. 163, Section 3(B). Repealed effective November 1, 1998, under an exemption from the provisions of the Administrative Procedure Act pursuant to Laws 1998, Ch. 178, §17; filed with the Office of the Secretary of State October 2, 1998 (Supp. 98-4). New Section adopted effective April 1, 2000, under an exemption from the provisions of the Arizona Administrative Procedure Act pursuant to Laws 1999, Chapter 311; filed with the Office of the Secretary of State December 23, 1999 at 6 A.A.R. 351 (Supp. 99-4). Amended by exempt rulemaking at 20 A.A.R. 448, effective 4/1/2014. Renumbered from R9-10-1511 by final rulemaking at 24 A.A.R. 3020, effective 10/2/2018.