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PA Bulletin, Doc. No. 98-1069


Laboratories Approved to Perform Blood Lead and/or Erythrocyte Protoporphyrin Determinations under the Clinical Laboratory Act

[28 Pa.B. 3116]

   The following laboratories are licensed in accordance with the Clinical Laboratory Act (35 P. S. §§ 2151--2165) and/or the Federal Clinical Laboratory Improvement Act of 1967 (42 U.S.C.A. § 263a), and are currently approved under 28 Pa. Code § 5.50 (relating to approval to provide special analytical services) to perform analyses of blood for lead or erythrocyte protoporphyrin content. This approval is based on demonstrated proficiency in periodic evaluations conducted by the Bureau of Laboratories of the Department of Health.

   Lead poisoning is a reportable noncommunicable disease. Approved laboratories which offer blood lead or erythrocyte protoporphyrin testing services are required to inform the Department of actual or possible incidents of this condition in accordance with 28 Pa. Code § 27.4 (relating to reportable noncommunicable diseases and conditions). In addition, the Department requests laboratories to submit reports on children under 6 years of age and pregnant women, on whom laboratory tests confirm venous blood lead concentrations of 15 micrograms per deciliter or higher. The Department's collection and review of these latter reports would be consistent with the most recent revision of the guideline titled, Preventing Lead Poisoning in Young Children, which was published in 1991 by the United States Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, and is available from them.

   All reports must be sent to the Department of Health, Division of Environmental Health, P. O. Box 90, Harrisburg, PA 17108. Report forms are available on request from the Division of Environmental Health.

   Erythrocyte protoporphyrin determinations may be performed as an adjunct determination to substantiate blood lead levels of 25 micrograms per deciliter or higher. Since erythrocyte protoporphyrin concentrations may not increase as a result of low level exposures to lead, direct blood lead analysis is the only reliable method for identifying individuals with blood lead concentrations below 25 micrograms per deciliter.

   Persons seeking blood lead or erythrocyte protoporphyrin analyses should determine that the laboratory employs techniques and procedures acceptable for the purpose for which the analyses are sought. Laboratories offering blood lead analysis only are designated with the letter ''L'' following the name of the laboratory. Those offering erythrocyte protoporphyrin analysis only are designated with the letter ''P.'' Laboratories offering both services are designated with the letters ''LP.''

   Blood lead analyses performed for occupational safety and health purposes must be conducted by a laboratory which also meets the requirements of the Occupational Safety and Health Administration of the United States Department of Labor as specified in 29 CFR 1910.1025(j)(2)(iii).

   The list of approved laboratories will be reviewed semiannually and if there are any changes to the list, a notice to that effect will be published in the Pennsylvania Bulletin at that time.

   The Department's blood lead proficiency testing program is approved by the United States Department of Health and Human Services (HHS) in accordance with the requirements contained in the Clinical Laboratory Improvement Amendments of 1988 (42 CFR 493.901 and 493.937) which are administered by the Health Care Financing Administration (HCFA). Participation in these programs may therefore be used to demonstrate acceptable performance for approval purposes under both Federal and Commonwealth statutes.

   Questions regarding this list should be directed to Dr. M. Jeffery Shoemaker, Director, Division of Chemistry and Toxicology, Department of Health, Bureau of Laboratories, P. O. Box 500, Exton, PA 19341-0500, (610) 363-8500. Persons with a disability, may also submit questions to Dr. Shoemaker in alternative formats, such as by audio tape, braille or using TDD: (717) 783-6514. Persons with a disability who require an alternative format of this document (for example, large print, audio tape, braille), should contact Dr. Shoemaker so that he may make the necessary arrangements.

Allegheny County Coroners Office-L
3441 Forbes Avenue Oakland
Pittsburgh, PA 15213

Allegheny General Hospital-L
320 East North Avenue
Pittsburgh, PA 15212

American Medical Laboratories, Inc.-LP
14225 Newbrook Drive
Chantilly, VA 20153

Angeline Kirby Memorial Health Center-L
71 North Franklin Street
Wilkes-Barre, PA 18701

Associated Regional & University Pathologists-LP
500 Chipeta Way
Salt Lake City, UT 84108

Aurora Consolidated Labs-LP
8901 West Lincoln Avenue
West Allis, WI 53227

Children's Hospital of Philadelphia-P
One Children's Center, 34th and Civic
Philadelphia, PA 19104

Clarendon Laboratory-L
1125 Flatbush Avenue
Brooklyn, NY 11226

East Penn Manufacturing Company, Inc.-LP
Deka Road
Lyons Station, PA 19536

Edison Medical Laboratories, Inc.-LP
1692 Oak Tree Road, Suite 12
Edison, NJ 08820

Ellwood City General Hospital-LP
724 Pershing Street
Ellwood City, PA 16117

Exide Corp. Indus. Hygiene Lab.-L
6313 Rising Sun Avenue
Philadelphia, PA 19111

Geisinger Medical Center-L
North Academy Road
Danville, PA 17822

Health Network Laboratories-LP
2024 Lehigh Street
Allentown, PA 18103

Helena Laboratories-P
P. O. Box 752
Beaumont, TX 77704

LabCorp of America Holdings-LP
6370 Wilcox Road
Dublin, OH 43016

LabCorp of America Holdings-LP
1447 York Court
Burlington, NC 27215

LabCorp of America Holdings-LP
69 First Avenue, P. O. Box 500
Raritan, NJ 08869

Laboratory Corp of America-LP
13900 Park Center Road
Herndon, VA 22071

LabOne, Inc.-LP
8915 Lenexa Drive
Overland Park, KS 66214

Lancaster General Hospital-L
555 North Duke Street, P. O. Box 3555
Lancaster, PA 17603

LeadTech Corporation-L
1 Marine Plaza
N. Bergen, NJ 07047

Liberty Testing Lab-L
25 Chapel Street
Brooklyn, NY 11201
(718) 647-7080

Main Line Clinical Laboratory-L
Lankenau Hospital
100 East Lancaster Avenue
Wynnewood, PA 19096

Mayo Clinic-LP
200 First Street, S.W., Hilton 530
Rochester, MN 55905

Medlab Clinical Testing, Inc.-L
212 Cherry Lane
New Castle, DE 19720

Mercy Health Lab-Mercy Fitzgerald Hospital-L
Lansdowne Avenue and Bailey Road
Darby, PA 19023

Mercy Hosptial Lab-L
Pride and Locust Streets
Pittsburgh, PA 15219

National Medical Services-LP
3701 Welsh Road
Willow Grove, PA 19090

Omega Medical Laboratories, Inc.-L
2001 State Hill Road, Suite 100
Wyomissing, PA 19610

Pacific Toxicology Laboratories-LP
1545 Pontius Avenue
Los Angeles, CA 90025

Pennsylvania Department of Health-LP
Bureau of Laboratories
P. O. Box 500
Exton, PA 19341-0500

Public Health Laboratory City of Philadelphia-L
500 South Broad Street
Philadelphia, PA 19146

Quest Diagnostics Incorporated-LP
One Malcolm Avenue
Teterboro, NJ 07608

Quest Diagnostics of PA, Inc.-LP
875 Greentree Road
Four Parkway Center
Pittsburgh, PA 15220-3610

Quest Diagnostics of Pa., Inc.-LP
900 Business Center Drive
Horsham, PA 19044

Quest Diagnostics, Inc.-LP
33608 Ortega Highway
San Juan Capistrano, CA 92690

Reading Hospital and Medical Center-L
6th and Spruce Streets
Reading, PA 19603

SmithKline Beecham Clinical Laboratories-LP
400 Egypt Road
Norristown, PA 19403

SmithKline Bioscience Laboratories-LP
7600 Tyrone Avenue
Van Nuys, CA 91405

Specialty Laboratories-L
2211 Michigan Avenue
Santa Monica, CA 90404

St. Joseph Quality Medical Laboratory-L
215 North 12th Street, Box 316
Reading, PA 19603

7000 South Broadway, Suite 2C
Littleton, CO 80122

Toxi-Con Laboratories-LP
120 Monahan Avenue, Suite 101
Dunmore, PA 18512

University of Pittsburgh Medical Center-LP
Room 5929 CLSI MT
200 Lothrop Street
Pittsburgh, PA 15213-2582


[Pa.B. Doc. No. 98-1069. Filed for public inspection July 2, 1998, 9:00 a.m.]

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