Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 667 - Hospital Standards › Subchapter 19 - Medical Records Department › Section 310:667-19-2 - Reports and records

Current through Vol. 41, No. 20, July 1, 2024
(a) Reports
				shall be made by each hospital to the appropriate agency, including but not
				limited to the following:
(1) Communicable
				disease.
(2) Births and
				deaths.
(3) Periodic reports to the
				Department on forms supplied for this purpose.
(4) Newborn hearing screening report.
(A) All hospital nurseries shall complete a
				newborn hearing screening report form on all live newborns discharged from
				their facility. For facilities with a two-year average annual birth census of
				fifteen (15) or greater, physiologic hearing screening results as well as "at
				risk" indicators must be recorded on the report form; for facilities with a
				two-year average annual birth census of fewer than fifteen (15), "at risk"
				indicators must be recorded and if physiologic hearing screening is conducted,
				those results also must be recorded on the report form. It shall be the
				responsibility of the hospital administrator to assure that the Newborn Hearing
				Screening Report Form is correctly completed and subsequently submitted to the
				Department. The hospital administrator may designate one individual, who shall
				then be responsible for review of all newborn discharge summaries to insure
				that a report form has been completed for each infant and that the report form
				is a permanent part of that infant's record. A copy of the hearing screening
				report form must be given to the infant's caregiver at discharge.
(B) If an infant is transferred from one
				hospital to another, the second hospital shall be responsible for providing
				physiologic hearing screening, "risk indicator" screening, and for completion
				of the report form.
(C) It shall be
				the responsibility of the hospital administrator to insure that all completed
				report forms are mailed to the Department within seven (7) days of an infant's
				birth.
(D) It shall be the
				responsibility of the attending physician or licensed independent practitioner
				to inform parents if their infant passed or was referred on the physiologic
				hearing screening and/or if the infant is to be considered "at risk" for
				hearing impairment. Prior to discharge, the attending physician or licensed
				independent practitioner shall review the completed report form and shall
				inform the parents of their infant's status. Infants who do not pass the
				physiologic screening shall be referred for a diagnostic audiological
				evaluation as soon as possible.
(E)
				It shall be the responsibility of the coordinator of the Newborn Hearing
				Screening Program at the Department to arrange for hospital in-service training
				for all hospital personnel involved in the process of completion of report
				forms. A manual of procedures shall be available in regard to processing of
				screening forms. The literature for distribution to parents shall be available
				from the Department.
(5)
				Newborn metabolic disorder screening.
(A)
Testing of newborns.
All newborns in Oklahoma shall be tested for
				phenylketonuria, hypothyroidism, galactosemia and sickle cell diseases, cystic
				fibrosis, congenital adrenal hyperplasia, medium-chain acyl coenzyme A
				dehydrogenase deficiency (MCAD), biotinidase deficiency, amino acid disorders,
				fatty acid oxidation disorders, organic acid disorders, severe combined
				immunodeficiency (SCID), spinal muscular atrophy (SMA), x-linked
				adrenoleukodystrophy (X-ALD), mucopolysaccharidoisis type I (MPS I) and Pompe
				disease upon completion of laboratory validation studies, establishment of
				short-term follow-up services, and approval by the Commissioner of Health as
				defined in Chapter 550 of this Title. All infants born at a birthing facility
				in Oklahoma shall be screened for Critical Congenital Heart Disease (CCHD)
				utilizing pulse oximetry. A parent or guardian may refuse newborn screening
				and/or pulse oximetry screening of their newborn on the grounds that such
				examination conflicts with their religious tenets and/or practices. A parent or
				guardian who refuses newborn screening or pulse oximetry screening of their
				newborn on the grounds that such examination conflicts with their religious
				tenets and/or practices shall also indicate in writing this refusal in the
				newborn's medical record with a copy sent to the Newborn Screening Program,
				Oklahoma State Department of Health, 1000 NE Tenth Street, Oklahoma City,
				Oklahoma 73117-1299.
(B)
Specimen collection for hospital births.
For all live hospital
				births, the physician or licensed independent practitioner shall order the
				collection of a newborn screening specimen prior to transfusion, as early as
				possible after twenty-four (24) hours of age or immediately prior to discharge,
				whichever comes first. Specimens shall be collected on the Newborn Screening
				Form Kit using capillary or venous blood. Cord blood is unacceptable. The
				hospital is responsible for collecting specimens on all infants.
(i) If the initial specimen for any infant is
				collected at or prior to twenty-four (24) hours of age, the hospital and the
				physician or licensed independent practitioner are responsible for notifying
				the infant's parents that a repeat specimen is necessary at three to five days
				of age. The infant's physician or licensed independent practitioner is
				responsible for ensuring that the repeat specimen is collected.
(ii) The hospital is responsible for
				submitting a satisfactory specimen and for documenting all requested
				information on the form kit including the parent/guardian's name, address,
				phone or contact phone number and the planned health care provider who will be
				providing well care for the infant after discharge. Or if the infant is to be
				hospitalized for an extended period of time, the name of the infant's physician
				or licensed independent practitioner.
(iii) The hospital is responsible for
				documenting specimen collection and results in the infant's hospital
				record.
(iv) Infants transferred
				from one hospital to another during the newborn period shall have specimen
				collection documented in the infant's hospital record. It is the responsibility
				of the physician or licensed independent practitioner and the receiving
				hospital to insure a specimen is collected.
(v) It is the responsibility of the hospital
				and physician or licensed independent practitioner to ensure that all infants
				are screened prior to discharge. If an infant is discharged prior to specimen
				collection, the Newborn Screening Program Coordinator shall be notified by
				contacting Newborn Screening Program,, Oklahoma State Department of Health,
				1000 NE Tenth Street, Oklahoma City, Oklahoma 73117-1299, (405) 271-6617, FAX
				(405) 271-4892, 1-800-766-2223, ext. 6617. The physician or licensed
				independent practitioner is responsible for ensuring the specimen is collected
				as early as possible after twenty-four (24) hours of age.
(C)
Pulse oximetry screening for
				birthing hospitals.
For all live hospital births, the physician or
				licensed independent practitioner shall order the pulse oximetry screening for
				newborns to be performed after twenty-four (24) hours of age or prior to
				discharge from a facility.
(i) If unable to
				perform the screening after twenty-four (24) hours of age or prior to
				discharge, schedule the infant to be screened at the hospital between
				twenty-four (24) hours and forty-eight (48) hours of life; or notify the
				infant's physician if screening was not performed.
(ii) If the newborn infant is discharged from
				a facility after twelve (12) hours of life but before twenty-four (24) hours of
				life, the birthing facility shall perform screening as late as is practical
				before the newborn infant is discharged from the birthing facility.
(iii) If the infant is discharged before
				twelve (12) hours of life, the birthing facility shall perform the screening
				between twenty-four (24) hours and forty-eight (48) hours of life.
(iv) For newborn infants in special care or
				intensive care, birthing facilities shall perform pulse oximetry screen on
				infants prior to discharge utilizing recommended protocol, unless the infant
				has an identified congenital heart defect or has an echocardiogram performed.
				Continuous pulse oximetry monitoring may not be substituted for CCHD
				screening.
(v) There may be
				instances where screening for CCHD is not indicated, including but not limited
				to instances where:
(I) The newborn infant's
				clinical evaluation to date has included an echocardiogram which ruled out
				CCHD; or
(II) The newborn infant
				has confirmed CCHD based on prenatal or postnatal testing.
(III) Indicate on NBS filter paper that
				screening was not performed.
(D)
Screening for premature/sick
				infants.
For all premature/sick infants, the physician or licensed
				independent practitioner shall order the collection of a newborn screening
				specimen prior to red blood cell transfusion, as early as possible after 24
				hours of age but no later than three to seven days of age, or immediately prior
				to discharge, whichever comes first. Due to the need to identify infants at
				risk for the disorders quickly, the specimen should be collected as early as
				possible after twenty-four (24) hours of age. It is recommended that a repeat
				newborn screening specimen be collected at fourteen (14) days of age. Specimens
				shall be collected on the Newborn Screening Form Kit using capillary or venous
				blood. The hospital is responsible for collecting specimens on all
				premature/sick infants.
(i) Premature/sick
				infants screened prior to twenty-four (24) hours of age must be re-screened
				between seven to fourteen (7-14) days of age.
(ii) Premature/sick infants who could not be
				screened prior to a red blood cell transfusion should be re-screened by the
				seventh (7 
				th ) day of life and a repeat specimen
				collected when plasma and/or red cells will again reflect the infant's own
				metabolic processes or phenotype. The accepted time period to determine
				hemoglobin type is ninety to one hundred and twenty (90 to 120) days after
				transfusion.
(iii) The recommended
				follow-up study for an abnormal thyroid screen in a premature infant is a serum
				free T4 (measured by direct dialysis or an equivalent method) and TSH at seven
				to fourteen (7-14) days of age.
(E)
Newborn Screening Hospital
				recording.
The hospital shall implement a procedure to assure that a
				newborn screening specimen has been collected on every newborn and mailed to
				the Newborn Screening Laboratory within twenty four to forty-eight (24 - 48)
				hours of collection.
(i) The hospital shall
				immediately notify the infant's physician or licensed independent practitioner,
				and parents or guardians if an infant is discharged without a sample having
				been collected. This notification shall be documented in the infant's hospital
				record.
(ii) If no test results are
				received within fifteen (15) days after the date of collection, the hospital
				shall contact the Newborn Screening Laboratory to verify that a specimen had
				been received. If no specimen has been received, the hospital shall notify the
				physician or licensed independent practitioner.
(iii) Any hospital or any other laboratory
				which collects, handles or forwards newborn screening samples shall keep a log
				containing name and date of birth of the infant, name of the attending
				physician or licensed independent practitioner, name of the health care
				provider who will be providing well care for the infant after discharge,
				medical record number, serial number of the form kit used, date the specimen
				was drawn, date the specimen was forwarded, date the test results were received
				and the test results, and pulse oximetry screening results.
(F)
Pulse oximetry screening
				hospital recording.
The hospital shall implement a procedure to assure
				that pulse oximetry screening has been performed on every newborn prior to
				discharge.
(i) All pulse oximetry screening
				results shall be recorded in the newborn infant's medical record and results
				reported to a parent or guardian prior to discharge from the
				hospital.
(ii) All pulse oximetry
				screening results shall be recorded on the Newborn Screening Form Kit, or faxed
				to the Oklahoma State Department of Health Newborn Screening Program.
(G)
Parent and health care
				provider education.
The hospital will be responsible or designate a
				responsible party to distribute the Newborn Screening Program's written
				educational materials on newborn screening and pulse oximetry screening
				provided by the Department to at least one of each newborn's parent or legal
				guardian.
(H)
Training.
Hospitals shall provide ongoing training programs for
				their employees involved with newborn screening procedures. These training
				programs shall include methods of collecting a satisfactory newborn screening
				specimen and proper pulse oximetry screening methods. The hospital is
				responsible for ensuring that employees who collect, handle or perform newborn
				screening tests; or perform pulse oximetry screening are informed of their
				responsibilities with respect to screening procedures.
(6)
Birth defects.
Each hospital
				shall maintain a list of patients up to six (6) years of age who have been
				diagnosed with birth defects, and all women discharged with a diagnosis of
				stillbirth or miscarriage. On request, each hospital shall make the medical
				records of these individuals available to the State Department of
				Health.
(7)
Abortions.
Attending physicians shall complete and submit to the Department a report form
				for each abortion performed or induced as required by 63 O.S. 1999, Section
				1-738.