NOTICES

DEPARTMENT OF HEALTH

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

[32 Pa.B. 5133]

   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 (Department).

   Lead poisoning is a reportable noncommunicable disease. Approved laboratories which offer blood lead testing services are required to inform the Department of actual or possible incidents of this condition in accordance with 28 Pa. Code § 27.34 (relating to reporting cases of lead poisoning). These regulations specify the following requirements for reporting by clinical laboratories.

   (1)  A clinical laboratory shall report all blood lead test results on both venous and capillary specimens for persons under 16 years of age to the Department's Childhood Lead Poisoning Prevention Program, Division of Maternal and Child Health, Bureau of Family Health.

   (2)  A clinical laboratory shall report an elevated blood lead level in a person 16 years of age or older to the Department's Division of Environmental Health Epidemiology, Bureau of Epidemiology or to other locations as designated by the Department. An elevated blood lead level is defined by the National Institute for Occupational Safety and Health (NIOSH). As of January 26, 2002, NIOSH defines an elevated blood lead level as a venous blood lead level of 25 micrograms per deciliter (µg/dL) or higher. The Department will publish in the Pennsylvania Bulletin any NIOSH updates of the definition within 30 days of NIOSH's notification to the Department.

   (3)  A clinical laboratory which conducts blood lead tests on 100 or more specimens per month shall submit results electronically in a format specified by the Department.

   (4)  A clinical laboratory which conducts blood lead tests on less than 100 blood lead specimens per month shall submit results either electronically or by hard copy in the format specified by the Department.

   (5)  A laboratory which performs blood lead tests on blood specimens collected in this Commonwealth shall be licensed as a clinical laboratory and shall be specifically approved by the Department to conduct those tests.

   (6)  Blood lead analyses requested for occupational health purposes on blood specimens collected in this Commonwealth shall be performed only by laboratories which are licensed and approved as specified in paragraph (5) and which are also approved by the Occupational Safety and Health Administration of the United States Department of Labor under 29 CFR 1910.1025(j)(2)(iii) (relating to lead).

   (7)  A clinical laboratory shall complete a blood lead test within 5 work days of the receipt of the blood specimen and shall submit the case report to the Department by the close of business of the next work day after the day on which the test was performed. The clinical laboratory shall submit a report of lead poisoning using either the hard-copy form or electronic transmission format specified by the Department.

   (8)  When a clinical laboratory receives a blood specimen without all of the information required for reporting purposes, the clinical laboratory shall test the specimen and shall submit the incomplete report to the Department.

   Erythrocyte protoporphyrin determinations may be performed as an adjunct determination to substantiate blood lead levels of 25 µg/dL 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 µg/dL.

   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.''

   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 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 Centers for Medicare and Medicaid Services. 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) 280-3464, ext. 3273. Persons with a disability who require an alternative format of this notice (for example, large print, audiotape, Braille) should contact Dr. Shoemaker at V/TT: (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT).

ALLEG CNTY CORONERS DIV OF LABS-L
542 FORBES AVENUE
ROOM 10 COUNTY OFFICE BUILDING
PITTSBURGH, PA 15219
(412) 350-6873

AMERICAN MEDICAL LABORATORIES INC-LP
14225 NEWBROOK DRIVE
PO BOX 10841
CHANTILLY, VA 20153-0841
(703) 802-6900

ANGELINE KIRBY MEM HEALTH CENTER-L
71 NORTH FRANKLIN STREET
WILKES-BARRE, PA 18701
(570) 823-5450

ASSOCIATED REGIONAL & UNIV PATH-LP
500 CHIPETA WAY
SALT LAKE CITY, UT 84108
(800) 242-2787

AURORA CONSOLIDATED LABORATORIES-LP
8901 WEST LINCOLN AVE
WEST ALLIS, WI 53227
(414) 328-7945

CLINICAL LABORATORIES INC-LP
901 KEYSTONE INDUSTRIAL PARK
THROOP, PA 18512-1534
(570) 346-1759

CLINICAL REFERENCE LABORATORY-LP
8433 QUIVIRA ROAD
LENEXA, KS 66215
(913) 492-3652

EAST PENN MFG CO INC-LP
DEKA RD KELLER TECH CENTER
LYONS STATION, PA 19536
(610) 682-6361

ELLWOOD CITY GENERAL HOSPITAL-LP
724 PERSHING ST
ELLWOOD CITY, PA 16117
(724) 752-0081

EVANGELICAL MEDICAL SERVICES BUILDING-L
905 US 522
SELINSGROVE, PA 17870
(570) 372-6119

GEISINGER MEDICAL CENTER-L
N ACADEMY RD
DANVILLE, PA 17822
(570) 271-6338

GEORGE TOLSTOI LAB--UNIONTOWN HSP-L
500 WEST BERKELEY STREET
UNIONTOWN, PA 15401
(724) 430-5143

GREAT SMOKIES DIAGNOSTIC LAB-L
63 ZILLICOA STREET
ASHEVILLE, NC 28801
(828) 253-0621

HAGERSTOWN MEDICAL LABORATORY-L
11110 MEDICAL CAMPUS RD STE 230
HAGERSTOWN, MD 21742
(301) 790-8670

HEALTH NETWORK LABORATORIES-LP
2024 LEHIGH STREET
ALLENTOWN, PA 18103-4798
(610) 402-8150

LAB CORP OF AMERICA HOLDINGS-LP
6370 WILCOX ROAD
DUBLIN, OH 43016-1296
(800) 282-7300

LAB CORP OF AMERICA HOLDINGS-LP
1447 YORK COURT
BURLINGTON, NC 27215
(800) 334-5161

LABCORP OF AMERICA HOLDINGS-LP
69 FIRST AVE PO BOX 500
RARITAN, NJ 08869
(201) 526-2400

LABONE INC-LP
10101 RENNER BOULEVARD
LENEXA, KS 66219-9752
(913) 888-1770

LABORATORY CORP OF AMERICA-L
13900 PARK CENTER ROAD
HERNDON, VA 20171
(703) 742-3100

LEAD LAB AT LASALLE UNIVERSITY-L
500 ADAMS AVENUE
PHILADELPHIA, PA 19120
(215) 728-6404

MAIN LINE CLIN LABS LANKENAU CP-L
100 EAST LANCASTER AVENUE
WYNNEWOOD, PA 19096
(610) 645-2615

MAYO CLINIC-LP
200 FIRST ST SW HILTON 530
ROCHESTER, MN 55905
(507) 284-3018

MEDICAL ASSOCIATES PC-P
935 HIGHLAND BLVD SUITE 4400
BOZEMAN, MT 59715
(406) 587-5123

MEDTOX LABORATORIES INC-LP
402 WEST COUNTY ROAD D
ST PAUL, MN 55112
(612) 636-7466

MERCY HEALTH LAB/MFH-L
1500 LANSDOWNE AVENUE
DARBY, PA 19023
(610) 237-4262

MERCY HOSPITAL LABORATORY-L
PRIDE & LOCUST STREETS
PITTSBURGH, PA 15219
(412) 232-7831

NATIONAL MED SERVICES INC LAB-LP
3701 WELSH ROAD
WILLOW GROVE, PA 19090
(215) 657-4900

OMEGA MEDICAL LABORATORIES INC-L
2001 STATE HILL ROAD SUITE 100
WYOMISSING, PA 19610-1699
(610) 378-1900

PACIFIC TOXICOLOGY LABORATORIES-LP
6160 VARIEL AVENUE
WOODLAND HILLS, CA 91367
(818) 598-3110

PENNSYLVANIA DEPT OF HEALTH-LP
110 PICKERING WAY
LIONVILLE, PA 19353
(610) 280-3464

POCONO MEDICAL CENTER LAB-L
206 EAST BROWN STREET
EAST STROUDSBURG, PA 18301
(570) 476-3544

PRIMARY CARE HLTH SERV INC LAB-L
7227 HAMILTON AVE
PITTSBURGH, PA 15208
(412) 244-4728

PUBLIC HEALTH LAB CITY OF PHILA-L
500 SOUTH BROAD STREET
PHILADELPHIA, PA 19146
(215) 685-6811

QUEST DIAGNOSTICS CLIN LABS INC-L
7600 TYRONE AVENUE
VAN NUYS, CA 91405
(818) 376-6195

QUEST DIAGNOSTICS CLINICAL LABS INC-LP
900 BUSINESS CENTER DRIVE
HORSHAM, PA 19044
(215) 957-9300

QUEST DIAGNOSTICS INCORPORATED-LP
33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO, CA 92690-6130
(949) 728-4000

QUEST DIAGNOSTICS OF PA INC-LP
875 GREENTREE RD 4 PARKWAY CENTER
PITTSBURGH, PA 15220-3610
(412) 920-7600

QUEST DIAGNOSTICS VENTURE LLC-L
875 GREENTREE ROAD
4 PARKWAY CENTER
PITTSBURGH, PA 15220-3610
(412) 920-7631

READING HOSPITAL & MED CTR-L
6TH AND SPRUCE STREETS
WEST READING, PA 19611
(610) 988-8080

SPECIALTY LABORATORIES-L
2211 MICHIGAN AVENUE
SANTA MONICA, CA 90404
(310) 828-6543

ST JOSEPH QUALITY MEDICAL LAB-L
215 NORTH 12TH STREET BOX 316
READING, PA 19603
(610) 378-2200

TAMARAC MEDICAL-LP
7000 SOUTH BROADWAY SUITE 2C
LITTLETON, CO 80122
(303) 794-1083

TOXI-CON LABORATORY-LP
201 SMALLACOMBE DRIVE
SCRANTON, PA 18508
(570) 963-0722

UPMC PRESBYTERIAN SHADYSIDE CP PUH-L
ROOM 5929 MAIN TOWER CHP
200 LOTHROP STREET
PITTSBURGH, PA 15213-2582
(412) 648-6000

ROBERT S. ZIMMERMAN, Jr.,   
Secretary

[Pa.B. Doc. No. 02-1786. Filed for public inspection October 11, 2002, 9:00 a.m.]

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