New Born Screening Standards.pdf

NEW BORN SCREENING CONTRACT STANDARDS

BACKGROUND AND PURPOSE OF THE CONTRACT

1. Purpose of this contract is to provide what is commonly referred to as new born screening for physical and genetic disorders in new born babies. Most newborn screening tests are mandated by the

State and follow an individual State approved panel of tests. Most newborn screening labs are part of the State Health Department and are not privately owned.

ACCREDITATION STANDARDS

2. The vendor must be approved by the State in which they perform testing or accredited by other accrediting agencies. Other agencies may include all or some of the following, College of American

Pathologists (CAP), The Joint Commission (TJC), or any agency commonly recognized as being able to accredit new born screening labs. As to personnel who perform tests, the vendor must adhere to the provisions of Title 42, United States Code, Section 493. (Clinical Laboratory Improvement Act or CLIA).

The vendor will provide proof of certification as the testing lab is re-certified, and as needed by the government, that the lab is accredited.

TESTS REQUIRED

3. New Born screening is performed as a panel of tests which are mandated by the State in which the lab is located and are considered standard of care within the pediatric specialty of medicine. The list may change slightly over time as the standard of care changes and as new tests or methodologies are developed. For that reason, the following list of tests is a guideline for testing needed by Weed Army

Community Hospital. If one or two tests below are not part of the panel required by the State in which the lab is located, or if there are tests that a vendor may perform that are not on this list, then that is acceptable.

Further, as part of the standard of care, certain tests on the panel may require repeating for various reasons. For that reason, for some infants it may be necessary to perform two or more screenings.

The overriding goal is to meet the standards of care in the medical community and meet the laws of the

State in which the vendor is located. The list below will meet the standards of the medical community and has some room for adjustment if necessary.

The following list is a good guide to use to select the lab that performs the testing:

First Screen (Generally collected 24-48 hours after birth)

Congenital Hypothyroidism (CH)

Congenital Adrenal Hyperplasia (CAH)

Galactosemia, Biotinidase deficiency, A panel of metabolic disorders which include at least a PKU and MCAD test.

Hemoglobinopathies and Thalassemias.

Cystic Fibrosis

Severe Combined Immunodeficiency (SCID)

Lysosomal Storage Disorders

Second Screen or Third Screen (If needed) (approximately 10-14 days after birth) will include all or part of the tests on the first panel.

4. OTHER SUPPLIES:

The vendor should provide the test cards needed to collect the sample. If the price of the test card is not included in the price of the test then the vendor must make clear to the government’s contracting officer who pays for the cards, and how much so that the cards are included in the contract.

5. SHIPPING: The Government will pay the cost to ship specimens to the vendor. Vendor will pay to ship results back to the Government.

5. DURATION/TERMINATION

This contract will consist of the first “base” year with options to renew up to four annual renewable options years.

Termination: Either party may terminate this contract with 90 day notice to the other party, or sooner if mandated by law.

Failure of the vendor to provide proof of accreditation or loss of accreditation is grounds for immediate termination of the contract.

6. NUMBER OF TESTS REQUESTED: This contract is for a dollar amount and not specific quantity due to the unpredictable nature of babies being born. Estimated number of tests will be 25 per month first test and 20 per month second test.

7. TURN AROUND TIME: Turn around time is expected to be seven (7) days from receipt of specimens by the vendor.