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The nationwide Blood Lead Proficiency Testing Program (PbPTP) is a cooperative program designed to improve the accuracy and precision of blood lead measurements, primarily in laboratories that test pediatric populations. This program is administered by the Wisconsin State Laboratory of Hygiene (WSLH). Funding is provided by the U.S. Public Health Services Maternal and Child Health Bureau. The PbPTP is an approved PT Program under the Center for Medicare/Medicaid Services/CLIA 88 requirements.
The program provides three blood lead specimens bimonthly to over 700 participating laboratories. Participants receiving regulatory evaluation receive two extra specimens in the January, May, and September testing events, meeting the required regulatory testing configuration. Program data are accepted for certification purposes by CMS (CLIA), OSHA, CAP, JCAHO, COLA, CLF, state-level, and several other regulatory agencies.
Specimens used in the program are whole blood obtained from lead-dosed cows, and provide challenges across the clinical range. The specimens are anticoagulated with EDTA, and aliquots contain approximately 1.0 mL of blood in cryovials, which are frozen prior to shipment. Specimen suitability and homogeneity are checked by the analysis of regularly spaced aliquots from each pool.
Target values for hand-held analyzers are determined by the mean of participant results. Target values for all other analytical methods are determined by averaging the results of fourteen reference laboratories using a variety of methodologies. Participant results are considered acceptable if they fall within 10% of the target value for specimens exceeding 40 mg/dL, or 4 mg/dL for specimens whose target values are less than 40 mg/dL.
Participants receive an individual evaluation of performance for each event, along with a statistical summary that includes pertinent statistical tables and graphic displays of overall event characteristics. Labs receiving regulatory evaluation also receive an individual report configured using the CLIA specified criteria.
Services of the PbPTP, including the regulatory testing service, are provided at no cost to participants enrolled in the monthly program. Laboratories can also enroll only in the regulatory testing program for an annual cost of $375 plus an enrollment fee of $50.
New participants can enroll by phone, fax, or e-mail. To enroll, or for additional information, contact Program staff at 608-224-6252. The fax number is 608-224-6259, and the program e-mail address is toxpt@mail.slh.wisc.edu.
Because the LeadCare II instrument is waived under the CLIA laboratory regulations, PT participation is not required at the federal level, but is considered desirable to assure reliable system performance. A growing number of states require PT participation, and the specific requirements of your state should be investigated. Where testing is required to meet regulatory standards, participants receive two extra specimens in the January, May, and September testing events to meet the required regulatory testing configuration. These results are then automatically reported to the appropriate regulatory agency.
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