Section R9-4-503. Review of Records; Information Collected

A.      Upon notice from the Department of at least five business days, the following persons or facilities shall allow the Depart- ment access to the facility and the electronic or written records specified in subsection (B)(1) to collect the information speci- fied in subsection (B)(2):

1.        A hospital,

2.        A clinic,

3.        A physician,

4.        A midwife,

5.        A registered nurse practitioner,

6.        A genetic testing facility,

7.        A prenatal diagnostic facility,

8.        A physician assistant,

9.        A clinical laboratory, or

10.     A medical examiner.

B.       The Department may:

1.        Review any of the following records in electronic or writ- ten format, as are applicable to the person or facility spec- ified in subsection (A):

a.         Patient medical records;

b.        Medical records for the mother of a patient;

c.         Reports from:

i.         Physicians or other individuals who clinically evaluated, diagnosed, or treated a patient or the patient’s mother,

ii.       High-risk perinatal practices,

iii.      Prenatal diagnostic facilities,

iv.      Genetic testing facilities,

v.        Pathology laboratories, or

vi.       Other facilities or clinical laboratories that per- formed a test for a patient or the patient’s mother;

d.        Logs and registers containing information about sur- gical procedures, as specified in A.A.C. R9-10- 214(A)(6) or A.A.C. R9-10-1709(A);

e.         Other logs that may contain information about a patient or the mother of a patient with a birth defect, such as:

i.         Labor and delivery unit logs,

ii.       Nursery unit logs,

iii.      Pediatric unit logs,

iv.       Intensive care unit logs,

v.        Autopsy logs, and

vi.       Ultrasound logs;

f.         Autopsy reports; and

g.        Records other than those specified in subsections (B)(1)(a) through (f) that contain information about or may lead to information about:

i.         A patient,

ii.        The patient’s mother, or

iii.      The patient’s biological sibling; and

2.        Collect the following information from a person or facil- ity specified in subsection (A), as applicable to a patient or the mother of a patient:

a.         The name, address, and telephone number of the person or facility, or the identification number assigned by the Department to the person or facility;

b.        The date of first contact and the date of last contact;

c.         The date the patient was admitted to a hospital;

d.        The date the patient was discharged from a hospital;

e.         The dates the mother of the patient was admitted to and discharged from a hospital for:

i.         The birth of the patient, or

ii.        Treatment related to a possible birth defect in the patient;

f.         The name and address of the hospital or other loca- tion in which the patient was born;

g.        The name and address of a hospital in which the patient or the mother of the patient was admitted for treatment related to a possible birth defect in the patient;

h.        The specific unit of a hospital that provided medical services to the patient or the patient’s mother;

i.         The medical record number of the patient or the patient’s mother;

j.         The patient’s name and any other name by which the patient is known;

k.        The names, addresses, and dates of birth of the patient’s parents;

l.         The name, address and telephone  number  of the patient’s guardian, if a parent of the patient does not have physical custody of the patient;

m.       The patient’s date of birth and hour of birth;

n.        The estimated date of confinement for the pregnancy resulting in the patient’s birth;

o.        The estimated gestational age, length, weight, and head circumference of the patient at birth;

p.        The patient’s gender, race, and ethnicity;

q.        The race and ethnicity of the patient’s biological mother and father;

r.         The address of the patient’s mother at the time of the patient’s birth;

s.         The address and telephone number of the patient at the date of last contact;

t.         The county in which the patient was born;

u.        The name of each physician, registered nurse practi- tioner, physician assistant, or other person that clini- cally evaluated, diagnosed, ordered a test for, or treated the patient or the patient’s mother;

v.        The names of any facility from which or to which the patient or the patient’s mother was transferred or referred;

w.       Whether the patient was referred to or is enrolled in CRS and, if so, the date of referral or enrollment;

x.        Whether the patient is receiving any other follow-up services, medical services, nursing services, or health-related services related to a birth defect, and, if so, the name of the person providing the services and the date the provision of the services began;

y.        The name of the insurance company, if applicable, that:

i.         Paid for the birth of the patient, and

ii.        Is currently covering medical expenses for the patient or the patient’s mother;

z.        Any perinatal risk factors documented in:

i.         The patient’s medical record,

ii.        The patient’s mother’s medical record, or

iii.      The patient’s family medical history;

aa. Whether any tests were performed on the patient or the patient’s mother by a genetic testing facility and, if so:

i.         The types of tests performed,

ii.        The test dates,

iii.      The test results,

iv.       The  age  or estimated  gestational   age  of  the patient at the time of each test,

v.        The  estimated  date  of  confinement   of  the patient’s mother at the time of each test,

vi.       The name of the genetic testing facility that performed each test; and

vii.     The names of the individuals who interpreted the test results;

bb. Whether any tests were performed on the patient or the patient’s mother by a prenatal diagnostic facility and, if so:

i.         The types of tests performed,

ii.        The test dates,

iii.      The test results,

iv.       The estimated gestational age of the patient at the time of each test,

v.        The  estimated  date  of  confinement   of  the patient’s mother at the time of each test,

vi.       The name of the prenatal diagnostic facility that performed each test, and

vii.     The names of the individuals who interpreted the test results;

cc. Whether any other types of tests were performed on the patient or the patient’s mother that may enable the diagnosis of a birth defect and, if so:

i.         The types of tests performed,

ii.        The test dates,

iii.      The test results,

iv.       The  age  or estimated  gestational   age  of  the patient at the time of each test,

v.        The  estimated  date  of  confinement   of  the patient’s mother at the time of each test,

vi.       The names of the facilities that performed the tests, and

vii.     The names of the individuals who interpreted the test results;

dd. Whether any surgical procedures associated with a birth defect were performed on the patient or the patient’s mother and, if so:

i.         The types of surgical procedures performed,

ii.        The dates of the surgical procedures,

iii.      The results of the surgical procedures,

iv.       The ages or estimated gestational ages of the patient at the time of the surgical procedures,

v.        The estimated date of confinement of the patient’s mother at the times of the surgical pro- cedures, and

vi.       The names of the facilities at which the surgical procedures were performed, and

vii.     The names of the individuals who performed the surgical procedures;

ee. For each diagnosis made for the patient or the patient’s mother:

i.         The diagnosis,

ii.        Whether the diagnosis is a principal or second- ary diagnosis,

iii.      The facility at which the diagnosis was made,

iv.       The date on which the diagnosis was made, and

v.        The name of the individual who made the diag- nosis;

ff. The number of times the patient’s mother has been pregnant;

gg. The number of times a pregnancy of the patient’s mother has lasted:

i.         More than 37 weeks,

ii.       Between 20 and 37 weeks, and

iii.      Less than 20 weeks;

hh. The number of children who were born as a result of the patient’s mother’s pregnancies, and whether the children were born alive or dead;

ii.        Whether the patient is from a singleton or multiple gestation, and, if from a multiple gestation, whether a co-twin of the patient:

i.         Is identical or fraternal;

ii.        Is alive, and, if not alive, the co-twin’s date of death; and

iii.      Has:

(1)      The same birth defect as the patient,

(2)      A different birth defect from that of the patient, or

(3)     No birth defect;

jj. If the patient is being adopted or living with a guard- ian rather than a parent;

kk. If the patient is being adopted, the name, address, and telephone number of the individual who will adopt the patient;

ll.     The date of last contact; and mm. If the patient has died:

i.         The patient’s date and county of death,

ii.        The   facility   in   which   the   patient’s    death occurred, and

iii.      Whether  an  autopsy  was  performed   on  the patient.

Historical Note

New Section made by final rulemaking at 13 A.A.R.

1702, effective June 30, 2007 (Supp. 07-2).