1405 Equipment and procedures for chemical testing of blood and urine

Equipment and Procedures for Chemical Testing of Blood and Urine

[34 Pa.B. 4079]

   Under 75 Pa.C.S. § 1547(c)(2)(ii) (relating to chemical testing to determine amount of alcohol or controlled substance), the Department of Health (Department) reviews procedures and equipment used by laboratories for testing to determine the alcohol and controlled substance content of blood and urine. As amended September 30, 2003, 75 Pa.C.S. § 1547(c)(2)(ii) requires the Department to review the procedures and equipment by May 31, 2004, giving consideration to scientific and technological advances to ensure that the testing is done in a manner that ensures that the test results are as accurate and reliable as science and technology permit. The Department completed its review within the prescribed time and concluded that no change in science and technology required the Department to prescribe new procedures or equipment to ensure that test results are accurate and reliable.

   Equipment and procedures utilized by laboratories for this purpose are reviewed three times annually to confirm that they are scientifically acceptable and capable of producing reliable results. When new technology becomes available, laboratories planning to utilize this technology must submit documentation describing in detail the procedures and equipment to be employed along with quality assurance data attesting to the reliability of the testing results. Verification of the efficacy of new technology as well as the continuing acceptability of existing methodologies is obtained through proficiency testing which is conducted three times annually in conjunction with the triannual equipment and procedure reviews.

   The Department approves laboratories to perform chemical testing of blood and urine, rather than equipment and procedures alone, since approving laboratories provides assurance that not only are acceptable equipment and procedures being employed, but also they are being utilized properly and reliable results are being obtained. This is a more comprehensive process, which provides assurance that all aspects of a laboratory's operation are functioning properly.

   Questions regarding this notice should be directed to M. Jeffery Shoemaker, Ph.D., Director, Division of Chemistry and Toxicology, Department of Health, Bureau of Laboratories, P. O. Box 500, Exton, PA 19341, [phone], Ext. 3229. Persons with a disability who require an alternative format of this notice (for example, large print, audiotape or Braille) should contact Dr. Shoemaker at V/TT [phone] or through the Pennsylvania AT&T Relay Service at [phone] (TT).

CALVIN B. JOHNSON, M.D., M.P.H.,   
Secretary

[Pa.B. Doc. No. 04-1405. Filed for public inspection July 30, 2004, 9:00 a.m.]