Current through Register Vol. 30, No. 38, September 20, 2024
A. A licensee
shall ensure that
a medical record is
established and maintained for a patient that contains:
1. Patient
identification including:
a. The patient's name, address, and date of
birth;
b. The designated patient's representative, if
applicable; and
c. The name and telephone number of an individual to
contact in an emergency;
2. The patient's
medical history required in
R9-10-1509(A)(1);
3. The
patient's physical examination required in
R9-10-1509(A)(2);
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);
6. The
physician's estimated gestational age of the fetus required in
R9-10-1509(C);
7. Each consent form signed by the patient or the
patient's representative;
8. Orders issued by a
physician, physician assistant, or registered nurse practitioner;
9. A
record of medical services, nursing services, and health-related services
provided to the patient;
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:
1. A
medical record is accessible only to the Department or personnel authorized by
policies and procedures;
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;
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;
4. A medical record is maintained at the abortion
clinic for at least six months after the date of the patient's discharge;
and
5. Vital records and vital statistics are retained
according to A.R.S. §
36-343.
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.
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;
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.
F. As
required by A.R.S. §
36-449.03(J),
the Department shall not release any personally identifiable patient or
physician information.