7 PROPOSED ADMINISTRATIVE RULES

 

 

ORR # 2002-043 DEPARTMENT OF COMMUNITY HEALTH

PHENYLKETONURIA TEST ON NEWBORN INFANTS

 

Filed with the Secretary of State on

These rules take effect 7 days after filing with the Secretary of State.

 

(By authority conferred on the department of community health by section 710g of 1949 PA 300, MCL 257.710g and Executive Reorganization Order No. 1996-1, MCL 330.3101)

 

R 325.1471, R 325.1472, R 325.1473, R 325.1474, and R 325.1475 of the Michigan Administrative Code are rescinded as follows:

 

R 325.1471 Phenylketonuria tests; approval. RESCINDED.

Rule 1. The test for phenylketonuria screening approved by the state health director is the Guthrie test, which shall be provided without charge by the department of public health to all Michigan physicians and hospitals. The use of other tests under controlled research conditions may be permitted when prior written application has been made and written approval given by the state health director.

 

R 325.1472 Blood specimens; when obtained. RESCINDED.

Rule 2. The blood specimen for testing shall be obtained at least 24 hours after the first protein feeding and within the first 3 days of life except:

(a) An infant receiving only breast milk shall have the specimen taken during the fourth to the tenth day  of life.

(b) An infant of less than 4 1/2 pounds birth weight shall have the specimen taken during the seventh to fourteenth day of life.

(c) An infant from whom a specimen cannot be obtained in the hospital within these criteria (for  example, discharge from hospital too soon, born outside hospital) shall have the specimen taken within the first 2 weeks of life.

 

R 325.1473 Laboratories; quality control. RESCINDED.

Rule 3. A private or hospital laboratory performing the Guthrie test is subject to quality control by the department of public health. A laboratory shall:

(a) Apply to the state health director for approval.

(b) Use the standard Guthrie test for the screening test, except under controlled research conditions as  provided in R 325.1471.

(c) Perform tests on unknown control specimens sent to them by the bureau of laboratories of the department of public health.

(d)Perform tests as soon as possible after receipt of the specimens and not later than 3 days after such  receipt.

(e) Include a control series of filter paper discs with known concentrations of phenylalanine (2, 4, 6, 8, 12, and 20 mg. %) with each test plate.

 

 

(f)Report immediately presumptive positive tests by telephone to the responsible physician and by  telephone or telegraph to the offices of the state health director.

(g) Provide written reports of tests or unsatisfactory specimens to the responsible physician.

 

R 325.1474 Inadequate specimens.  RESCINDED.

Rule 4. Upon notification that a specimen is inadequate or unsatisfactory for testing, a repeat specimen shall be submitted within 72 hours.

 

R 325.1475 Reporting of test results.  RESCINDED.

Rule 5. (1) A presumptive positive test result shall be immediately reported to the physician by  telephone or telegraph and a second specimen shall be requested to be submitted within 72 hours. No  therapy should be instituted until confirmatory diagnostic testing beyond the Guthrie

screening is reported positive.

(2) Written reports of tests shall be made to the responsible physician through the agency submitting the specimen.