[31 Pa.B. 2271]
[Continued from previous Web Page] Initial specimen--The first sample of blood collected [for testing purposes] from the newborn [on a special filter paper collecting device] child and submitted for testing purposes on a specimen collection form.
[Initial test--The first analysis performed on an initial specimen.]
* * * * * Newborn screening program--The association of the Department, the testing laboratory and the health care provider to ensure that every newborn child born in this Commonwealth has a blood specimen collected and screened for the newborn diseases listed in § 28.2 (relating to newborn diseases listed).
[Phenylketonuria Program Clinic--A clinic sponsored and supported by the Department to provide expert consultation, diagnosis and treatment for children with phenylketonuria.]
Presumptive abnormal test result--An abnormal screening test result which is sufficiently abnormal to indicate the probable presence of a newborn disease listed in § 28.2.
[Recall] Repeat specimen--A specimen collected from [the] a newborn child on a specimen collection form after the initial specimen [; the specimens are collected for one of the following reasons:
(i) Early discharge of newborn child from hospital.
(ii) Unacceptable specimen.
(iii) Inconclusive test result].
[Recall] Repeat test--The [test] laboratory testing performed on a [recall] repeat specimen.
Specimen collection form--The official newborn screening program specimen form that includes both a multipart section for providing required information about the newborn child and a filter paper tab for application of blood.
Testing laboratory--[Licensed] The licensed clinical laboratory under contract with the Department to perform [screening tests] testing for the [metabolic] newborn diseases listed in § 28.2.
Transfer--The release of the newborn child from care and custody within and by [the health care facility for] a birth center or hospital and subsequent admission to [care and custody of] another [health care facility or to a similar health care facility in another state] hospital.
Treatment center--A center under contract with the Department to provide expert consultation, diagnosis and treatment for children with a presumptive abnormal test result.
Unacceptable specimen--[Blood] A blood specimen collected from a newborn child on a [special filter paper collecting device] specimen collection form which is found to be [unacceptable] unsuitable for testing in accordance with [standards established or approved] accepted laboratory testing standards as determined by the [Bureau] Department.
§ 28.2. [Metabolic] Newborn diseases listed.
[The] A newborn child born in this Commonwealth shall be screened for the following [metabolic] diseases [of the newborn child are believed to] which may cause mental retardation [or], physical defects, or death [in the newborn child] if not detected and treated soon after birth:
(1) Congenital adrenal hyperplasia (CAH).
(2) Galactosemia.
(3) Hemoglobin diseases.
(4) Maple syrup urine disease (MSUD).
[(1)] (5) Phenylketonuria (PKU).
[(2)] (6) [Hypothyroidism] Primary congenital hypothyroidism.
§ 28.3. [Tests to be performed] (Reserved).
[(a) The following tests have been approved for the screening and detection of the these respective diseases:
(1) Phenylketonuria. The following tests are approved for the detection of phenylketonuria:
(i) The Guthrie Bacterial Inhibition Assay (GBIA).
(ii) The McCaman and Robins Fluorometric method.
(iii) Other tests approved by the Bureau.
(2) Hypothyroidism. The following tests are approved for detection of hypothyroidism:
(i) Radioimmunoassay techniques for Thyroxine (T4) and Thyroid Stimulating Hormone (TSH) according to standards established or approved by the Bureau.
(ii) Other tests approved by the Bureau.
(b) Tests may not be administered if the parent or guardian of the newborn child objects on the grounds that the tests conflict with parent's or guardian's religious beliefs or practices.]
§ 28.4. [Standards for collecting and testing specimens] (Reserved).
[A health care facility or practitioner required by law or regulation to administer or cause to be administered tests for the detection of metabolic diseases in the newborn child, as specified in § 28.2 (relating to metabolic diseases listed), shall collect specimens necessary to conduct the tests in accordance with standards established by the Bureau. Specimens collected shall be sent by first class mail or by other means acceptable to the Department to laboratory specified by the Department within 48 hours of collection. The Bureau will ensure the commencement of testing procedures by the testing laboratory within 48 hours of receipt of the specimen. Chapter 5 (relating to clinical laboratories), applies to the laboratories performing the tests specified in § 28.3 (relating to tests to be performed).]
§ 28.5. Confidentiality.
(a) No health care provider, testing laboratory, the Department, or any other entity involved in the newborn screening program may release any identifying information relating to a newborn child screened in the newborn screening program to anyone other than a parent or guardian of the newborn child or the health care provider for the newborn child designated by a parent or the guardian except as follows:
(1) As may be necessary to provide services to the newborn child.
(2) With the consent of the newborn child's parent or guardian.
(3) With the child's consent when the child is 18 years of age or older, has graduated from high school, has married or has been pregnant.
(b) Only the Department will have the authority to release or authorize the release of nonidentifying information concerning the newborn screening program.
[ADVICE TO PARENTS EXPLAINING] PURPOSE AND ADMINISTRATION OF TESTS § 28.11. Informing the parent or guardian.
[The] Prior to specimen collection, the health care [facility or practitioner responsible for care of the pregnant woman or mother] provider shall provide [her] the pregnant woman, prior to the infant's birth, or the mother or guardian, after the infant's birth, with a pamphlet supplied by the Department to explain the nature of the newborn screening [neonatal] blood tests for the [metabolic] diseases listed in § 28.2 (relating to [metabolic] newborn diseases listed).
§ 28.12. Religious objections.
(a) No health care provider may collect or cause to be collected, a specimen from a newborn child if the parent or guardian of the newborn child objects on the ground that the specimen collection conflicts with religious beliefs or practices held by the parent or guardian.
(b) If the parent or guardian of the newborn child objects to [a test] the collection of the specimen for screening on the ground that the [test] specimen collection conflicts with [his] religious beliefs or practices held by the parent or guardian, the health care [facility or practitioner responsible for the care of the newborn child shall be responsible to see] provider shall ensure that the recorded objection of the parent or guardian is entered into the medical record of the newborn child. The entry shall include a written statement of the objection signed by the parent or guardian.
[TIMING OF COLLECTION, HANDLING OF SPECIMENS, AND REPORTS] SPECIMEN COLLECTION AND FOLLOWUP § 28.21. Responsibility for collecting and testing initial and repeat specimens.
[The health care facility or practitioner to whom care of the newborn has been entrusted or who assisted the mother at delivery shall direct blood specimens to be collected and sent for testing in accordance with §§ 28.4, 28.11 and 28.12 (relating to standards for collecting and testing specimens; informing the parent or guardian; and religious objections)] (a) A birth center or hospital shall collect or cause to be collected from each newborn child delivered in that birth center or hospital, in accordance with instructions for newborn screening specimen collection in subsection (d), the initial and repeat specimens necessary to conduct the tests necessary for the detection of the newborn diseases specified in § 28.2 (relating to newborn diseases listed).
(b) When a newborn child is delivered other than in a birth center or hospital, the health care practitioner who delivered the newborn child shall collect or cause to be collected from the newborn child, in accordance with instructions for newborn screening specimen collection in subsection (d), the initial and repeat specimens necessary to conduct the tests necessary for the detection of the newborn diseases specified in § 28.2.
(c) The health care provider shall designate a newborn screening coordinator to do the following:
(1) Ensure that a specimen collection form contains correct and complete information.
(2) Ensure that the individual who collected the specimen records that act in the newborn child's medical record.
(3) Send all specimens collected by first class mail to the testing laboratory within 24 hours of collection.
(4) Record the laboratory screening results in the newborn child's medical records.
(5) Check each newborn child's record prior to discharge or release to ensure that a specimen has been collected.
(6) Ensure, in the event of transfer of the newborn child prior to 48 hours of age, that the receiving health care provider has been notified that it has the responsibility to collect the initial specimen.
(7) Assist the Department in followup of an abnormal or presumptive abnormal test result.
(8) Followup inconclusive test results.
(9) Receive notification from the testing laboratory or from the Department of the need for a repeat specimen.
(d) The health care provider shall ensure that the individual responsible for specimen collection shall collect the specimen necessary to conduct tests in accordance with consensus standards developed by the National Committee for Clinical Laboratory Standards (NCCLS) and accepted by the Department. The Department will publish these standards, and any revisions thereto, in a notice in the Pennsylvania Bulletin.
§ 28.22. Timing of initial specimen collection [and handling in health care facilities] by birth centers or hospitals.
(a) [An] A birth center or hospital shall collect the initial specimen [shall be collected in health care facilities] from each newborn [infants, irrespective] child regardless of [age or] feeding history[, discharged on or before the fifth day of age, as close to the time of discharge from the health care facility as is practicable] or medical condition, as close to 48 hours of age as possible but not later than 72 hours of age unless the newborn child falls into one of the following categories:
(1) Transfer. If the newborn child is transferred to another [health care facility] hospital for continuing care [on or before the fifth day of age, the initial] prior to 48 hours of age, the hospital to which the newborn child has been transferred shall collect a specimen [shall be collected between the fifth and sixth day of age] from the newborn child, [irrespective] regardless of feeding history [, by the health care facility to which the newborn child has been transferred] or medical condition, as close to 48 hours of age as possible but not later than 72 hours of age.
[(2) Late discharge. If the newborn child is discharged from the health care facility beyond the fifth day of age, the initial blood specimen shall be collected from the newborn child between the fifth and sixth day of age, irrespective of feeding history.
(3) Instability. If the newborn child is transferred or detained and the child's medical condition is unstable and renders the collection of the specimen undesirable at the designated time as stated in paragraph (1) or (2), whenever practicable, the initial specimen shall be collected as soon as it is deemed appropriate, but within the first 6 to 9 days of age.]
[(4)] (2) Exchange transfusion. [Where] If the newborn child is to undergo an exchange transfusion, the birth center or hospital shall collect the initial specimen [shall be collected] for testing immediately prior to the exchange transfusion.
[(5)] (3) Early discharge. [Where] If the newborn child is discharged from the [health care facility] birth center or hospital before 24 hours of age, the birth center or hospital shall collect the initial [blood] specimen [shall be collected] from the newborn child as close to the time of discharge as is practicable, [irrespective] regardless of feeding history or medical condition. [Arrangements with the parent or guardian shall be made by the health care facility or the practitioner] The birth center or hospital shall give the parent or guardian in whose care and custody the newborn child is discharged written notification of the need for a repeat specimen and shall also provide instructions to the parent or guardian for obtaining a [recall blood] repeat specimen from the newborn child as described in § 28.26 (relating to timing of [recall] repeat specimen collection [, handling and reporting]).
(b) When a newborn child, who was delivered other than in a birth center or hospital, is admitted to a hospital within the first 27 days of age and the hospital has received no record of results of an approved screening test for the newborn diseases listed in § 28.2 (relating to newborn diseases listed), the hospital to which the newborn child is admitted shall collect the initial specimen within 48 hours of admission to the hospital and shall send the specimen to the testing laboratory specified by the Department within 24 hours of collection.
§ 28.23. Timing of initial specimen collection [and handling for home births] by health care practitioners.
[(a) When a newborn child is born at home and is not admitted to a health care facility by the fifth day of age,] A health care practitioner who delivers a newborn child other than in a birth center or hospital shall collect or cause to be collected the initial specimen [shall be obtained] from the newborn child [and sent for testing between the second and sixth day of age by the practitioner to whom care of the newborn child has been entrusted or who assisted the mother at time of delivery or by the person who signed the newborn child's birth certificate], regardless of feeding history or medical condition, as close to 48 hours as possible but not later than 72 hours of age.
[(b) When a newborn child is admitted to a health care facility within the first 27 days of age who has not been born in nor admitted to a health care facility within the first 5 days of age and who has no record of results of an approved screening test for the metabolic diseases listed in § 28.2 (relating to metabolic diseases listed), the initial specimen shall be collected within 48 hours of admission to a health care facility and sent for testing.]
§ 28.24. [Negative] Normal test results.
(a) No later than 7-calendar days following the day when the testing laboratory obtains the [negative] normal test results, the testing laboratory shall send those results to the health care [facility or practitioner under whose care the specimen was collected] provider that collected the specimen from the newborn child.
(b) The health care [facility or practitioner] provider to whom the [negative] normal test results are reported shall record the test results in the medical record of the [patient] newborn child.
§ 28.25. [Followup recall] Circumstances requiring repeat specimens.
(a) [If] The health care provider responsible for collecting the initial specimen shall collect or cause to be collected and submit for testing a repeat specimen if the initial specimen collected is either of the following:
(1) [unacceptable] Unacceptable for testing [if the results of testing are inconclusive, a recall specimen is required].
(2) Yields an inconclusive screening test result.
(b) If a birth center or hospital collects the initial specimen from a newborn child prior to 24 hours of age because the newborn child is discharged from the birth center or hospital prior to 24 hours of age, the birth center or hospital shall collect or cause to be collected a repeat specimen.
(c) If the initial specimen collected yields an abnormal screening test result, the Department may require the health care provider responsible for collecting the initial specimen to collect a repeat specimen.
§ 28.26. Timing of [recall] repeat specimen collection[, handling, and reporting].
(a) When the newborn child has been discharged from [the health care facility] a birth center or hospital before 24 hours of age, [a recall filter paper specimen shall be collected for testing between the sixth to ninth day whenever practicable by the health care facility or practitioner to whom care of the newborn has been entrusted] the birth center or hospital shall collect or cause to be collected a repeat specimen from the newborn child, regardless of feeding history or medical condition, as close to 48 hours of age as possible but not later than 72 hours of age.
(b) When the initial specimen is unacceptable [for testing] or when [the results of] the initial specimen [are] yields an inconclusive screening test result, [a recall filter paper specimen shall be obtained promptly from the newborn child upon telephone notification by] the Department [to] or testing laboratory will notify the health care [facility or practitioner who is providing ongoing care to the child according to procedures delineated in §§ 28.3(b) and 28.12 (relating to tests to be performed; and religious objections)] provider that collected the initial specimen. Within 72 hours of receipt of notice from the Department or testing laboratory, the health care provider that collected the initial specimen shall collect or cause to be collected from the newborn child a repeat specimen.
[(c) In a case where the parent or guardian has no ongoing health care provider for the newborn child, the Department will assist the parent or guardian in arranging for recall specimen collection.
(d)] (c) If the [appropriate] health care [facility or practitioner] provider cannot locate [the parents] a parent or guardian of the newborn child within 4 days of notification of need for a [filter paper recall] repeat specimen, the health care [facility or practitioner] provider shall [telephone] contact the Department[, which will assist in location of the parents] for consultation regarding additional means for locating a parent or guardian.
§ 28.27. [Followup of presumptive positive] Abnormal screening test results.
(a) [If the results of any filter paper test are presumptive positive, the health care facility or practitioner to whom the results were reported shall promptly notify the parents or guardian and arrange for followup and shall enter the report of the result into the patient's medical record.] When testing of the initial or repeat specimen yields an abnormal screening test result, the Department will notify the health care provider that collected thespecimen. The health care provider shall promptly notify a parent or guardian of the newborn child.
(b) If the health care [facility or practitioner to whom the presumptive positive test report was made] provider cannot locate the newborn child's parent or guardian within 48 hours of receiving [the report] notice from the Department, the health care [facility or practitioner] provider shall [notify] contact the Department [, which will assist in] for consultation regarding additional means for locating [the parents] a parent or guardian.
(c) The Department will assist the health care provider with and make available confirmatory testing.
(d) If the result of the confirmatory test is abnormal, the Department will assist with referral for diagnosis, treatment and other followup services for the newborn child through designated treatment centers or clinical specialists.
§ 28.28. Followup of symptoms consistent with [metabolic] newborn diseases.
When a sick child exhibits [signs] symptoms suggestive of a [metabolic] newborn disease listed in § 28.2 (relating to [metabolic] newborn diseases listed) and has not already been determined to have one of those [metabolic] newborn diseases, [a] the health care [facility or practitioner] provider to whom care of the sick child has been entrusted by the parent or guardian shall collect and submit a blood specimen for [metabolic] newborn disease testing in accordance with standard diagnostic procedures.
§ 28.29. [Confirmatory test specimen required] (Reserved).
[If the results of any test are presumptive positive, collection of a confirmatory test specimen is required. Within 24 hours after the test results have been obtained, the Department will telephone the results to the appropriate health care facility or practitioner and followup with a written report.]
§ 28.30. [Phenylketonuria] (Reserved).
[(a) Presumptive positive tests. For presumptive positive tests the following shall apply:
(1) If the results of any test for phenylketonuria are presumptive positive, the Department will provide prompt confirmatory testing of the newborn child in accordance with standards established by the Bureau.
(2) The confirmatory laboratory testing of the newborn child will be completed within 24 hours of the receipt of the confirmatory test specimen or as soon as thereafter as practicable by the Department and will be reported and followed up under the same procedures set forth for presumptive positive tests in §§ 28.27 and 28.29 (relating to followup of presumptive positive test results; and confirmatory test specimen required).
(3) The Department will telephone confirmatory test results to its designated Phenylketonuria Program Clinics.
(b) Positive confirmatory tests. If the results of the confirmatory tests for phenylketonuria are positive, the Department will arrange for referral, diagnosis, treatment, and habititative and other followup services for the child and family in accordance with standards set or approved by the Department.]
§ 28.31. [Hypothyroidism] (Reserved).
[(a) Presumptive positive tests. If the results of any hypothyroidism tests are presumptive positive, the Department will make available confirmatory laboratory testing in accordance with standards established or approved by its Bureau. Testing will be initiated within 24 hours of receipt of the specimen or as soon thereafter as is practicable by the Department's designated Hypothyroid Referral Clinics/Laboratories and will be reported and followed up under the same procedures set forth for presumptive positive tests in §§ 28.27 and 28.29 (relating to followup of presumptive positive test results; and confirmatory test specimen required).
(b) Positive confirmatory tests. If the results of any tests for neonatal hypothyroidism are positive, the Department will provide telephone or clinic consultative services through its designated Hypothyroid Referral Clinics/Laboratories in accordance with standards set or approved by the Department.]
RECORDS § 28.41. Recordkeeping requirements.
A health care [facility providing] provider offering maternity and newborn services shall [be required by the Department to keep data] collect and forward data semi-annually to the Department on the number of patients for whom specimens for [metabolic] newborn disease testing have been collected and the number of patients for whom the specimens have not been collected, together with the reason in each instance for the failure to collect.
PART IV. HEALTH FACILITIES
Subpart E. Birth Center
CHAPTER 501. BIRTH CENTERS § 501.3. Reports/contact person.
(a) The facility shall report regularly to the Department, on forms issued by the Department, statistical information that the Department may request and shall comply with the requirements for recordkeeping in § 28.41 (relating to recordkeeping requirements).
* * * * * § 501.49. Newborn infant care policies and procedures.
The newborn infant care policies, protocols[,] and procedures shall include, but not be limited to, the following:
* * * * * (4) The birth center shall explain to the mother the purpose and nature of the screening tests for metabolic diseases, required by Chapter 28 (relating to [metabolic] screening and followup for diseases of the newborn), give her an informational pamphlet provided by the Department, inform her of her right to refuse the tests because of religious beliefs or practices, and see that the recorded written objection is entered into the medical record of the newborn child and signed by the parent or guardian, if screening is refused.
(5) The birth center shall [collect an initial filter paper blood specimen, for the detection of metabolic diseases, as close to the time of discharge from the facility as is practicable, irrespective of feeding history, unless the newborn is transferred to another health care facility for continuing care. Arrangements with the parent shall be made by the birth center, for collecting an additional blood filter paper specimen between the 2nd to 9th day of age] comply with the requirements for specimen collection, testing and followup set forth in §§ 28.21--28.28.
* * * * *
[Pa.B. Doc. No. 01-724. Filed for public inspection April 27, 2001, 9:00 a.m.]
No part of the information on this site may be reproduced for profit or sold for profit.This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.
