1. For the purpose of this section unless the context otherwise requires:
a. "Clinical laboratory" means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or assessment of a medical condition.
b. "Blood bank" means a facility for the collection, processing, or storage of human blood or blood derivatives, or from which or by means of which human blood or blood derivatives are distributed or otherwise made available.
c. "Laboratory" includes a clinical laboratory and a blood bank.
2. Beginning July 1, 1988, human immunodeficiency virus screening and confirmatory testing shall be performed only by laboratories certified on an annual basis pursuant to this section.
3. The director of public health shall adopt rules establishing standards for the accreditation of laboratories to perform human immunodeficiency virus screening and confirmatory testing. The rules shall include but are not limited to standards relating to proficiency testing, record maintenance, adequate staffing, and confirmatory testing. The rules shall provide for acceptance of accreditation programs which are in conformance with the standards established by the rules.
4. The Iowa department of public health shall provide application forms for certification of a laboratory. The director shall prescribe by rule the information to be included on the application form.
5. A laboratory shall not be certified unless the laboratory meets all standards established by the Iowa department of public health.
6. The Iowa department of public health may conduct periodic inspections of laboratory facilities, methods, procedures, materials, staff, and equipment for compliance with the standards established pursuant to this section. The department may delegate this authority to the state hygienic laboratory.
7. A laboratory's certification may be revoked, suspended, or limited, if at any time the laboratory is found to be in violation of any of the standards adopted by the department pursuant to this section.
88 Acts, ch 1224, §8
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