1105 Laboratories approved to perform blood lead and/or erythrocyte protoporphyrin determinations under the Clinical Laboratory Act?  

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

    [41 Pa.B. 3609]
    [Saturday, July 2, 2011]

     The following laboratories are licensed in accordance with The Clinical Laboratory Act (35 P. S. §§ 2151—2165), 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 update of the definition within 30 days of NIOSH's notification to the Department.

     (3) A clinical laboratory which conducts blood lead tests of 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 of 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 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 protoporphy- rin 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 revised approximately semiannually and published in the Pennsylvania Bulletin.

     The name or location of a laboratory is sometimes changed but the personnel and testing procedures of the facility remain unchanged. When changes of this type occur, the Clinical Laboratory Permit number does not change. If questions arise about the identity of a laboratory due to a name or location change, the Clinical Laboratory Permit number should be used as the primary identifier. To assist in identifying a laboratory that performed a test if the name or location of the facility changed, the Clinical Laboratory Permit number of the facility at the time the list was prepared is included in the list of approved laboratories above the name of the laboratory.

     The Department's blood lead proficiency testing program is approved by the United States Department of Health and Human Services in accordance with 42 CFR 493.901 and 493.937 (relating to approval of proficiency testing programs; and toxicology), 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, Ph.D., Director, Division of Chemistry and Toxicology, Department of Health, Bureau of Laboratories, P. O. Box 500, Exton, PA 19341-0500, (610) 280-3464.

     Persons with a disability who require an alternative format of this notice (for example large print, audiotape, Braille) should contact Dr. Shoemaker at the previously referenced address or phone number. Persons who are speech or hearing impaired may use V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT).

    22912
    ACL LABORATORIES—LP
    8901 WEST LINCOLN AVE
    WEST ALLIS, WI 53227
    (414) 328-7945

    29169
    ADVANCED TOXICOLOGY NETWORK—LP
    3560 AIR CENTER COVE
    SUITE 101
    MEMPHIS, TN 38118
    (901) 794-5770

    00016
    ANGELINE KIRBY MEM HEALTH CENTER—L
    71 NORTH FRANKLIN STREET
    WILKES BARRE, PA 18701
    (570) 822-4278

    24997
    ATLANTIC DIAGNOSTIC LABORATORIES LLC—LP
    3520 PROGRESS DRIVE UNIT C
    BENSALEM, PA 19020
    (267) 525-2470

    26302
    BDHG FAMILY MEDICINE AND PEDIATRICS—P
    935 HIGHLAND BLVD
    SUITE 2200
    BOZEMAN, MT 59715
    (406) 587-5123

    20506
    CENTRAL PA ALLIANCE LABORATORY—L
    1803 MT ROSE AVENUE
    SUITE C3-C4
    YORK, PA 17403
    (717) 851-1426

    00228
    CHILDRENS HOSP OF PHILADELPHIA—L
    ONE CHILDRENS CENTER 34TH & CIVIC
    PHILADELPHIA, PA 19104
    (215) 590-4446

    31847
    DOCTOR'S DATA, INC.—L
    3755 ILLINOIS AVENUE
    ST. CHARLES, IL 60174-2420
    (630) 377-8139

    00561
    EAST PENN MFG CO INC—LP
    DEKA RD KELLER TECH CENTER
    PO BOX 147
    LYONS STATION, PA 19536
    (610) 682-6361

    00332
    ELLWOOD CITY HOSPITAL—LP
    724 PERSHING ST
    ELLWOOD CITY, PA 16117
    (724) 752-0081

    31378
    ENZO CLINICAL LABS—L
    60 EXECUTIVE BLVD
    FARMINGDALE, NY 11735
    (631) 755-5500

    00173
    GEISINGER MEDICAL LABORATORIES—L
    100 N ACADEMY AVENUE
    DANVILLE, PA 17822—0131
    (570) 271-6338

    25914
    GENOVA DIAGNOSTICS—L
    63 ZILLICOA STREET
    ASHEVILLE, NC 28801
    (828) 253-0621

    20802
    HAGERSTOWN MEDICAL LABORATORY—L
    11110 MEDICAL CAMPUS RD
    STE 230
    HAGERSTOWN, MD 21742
    (301) 790-8670

    24655
    HEALTH NETWORK LABORATORIES—L
    2024 LEHIGH STREET
    ALLENTOWN, PA 18103-4798
    (610) 402-8150

    05618
    LAB CORP OF AMERICA HOLDINGS—LP
    6370 WILCOX ROAD
    DUBLIN, OH 43016-1296
    (800) 282-7300

    21885
    LAB CORP OF AMERICA HOLDINGS—LP
    1447 YORK COURT
    BURLINGTON, NC 27215
    (800) 334-5161

    01088
    LABCORP OF AMERICA HOLDINGS—LP
    69 FIRST AVENUE
    PO BOX 500
    RARITAN, NJ 08869
    (908) 526-2400

    00242
    MAIN LINE HEALTH LABORATORIES—L
    100 EAST LANCASTER AVENUE
    WYNNEWOOD, PA 19096
    (610) 645-2615

    29685
    MAYO CLINIC DEPARTMENT OF LAB MEDICINE &  PATHOLOGY—L
    3050 SUPERIOR DRIVE NW
    ROCHESTER, MN 55901
    (507) 538-3458

    09003
    MAYO CLINIC DEPT LAB MED & PATH—P
    200 FIRST STREET SW HILTON 530
    ROCHESTER, MN 55905
    (507) 284-3018

    29251
    MAYO MEDICAL LABORATORIES NEW
     ENGLAND—LP
    160 DASCOMB ROAD
    ANDOVER, MA 01810
    (978) 658-3600

    24668
    MCMURRAY PEDIATRIC & ADOLESCENT
     MEDICINE—L
    6000 WATERDAM PLAZA DRIVE #280
    MCMURRAY, PA 15317
    (724) 941-8199

    05574
    MEDTOX LABORATORIES INC—LP
    402 WEST COUNTY ROAD D
    ST PAUL, MN 55112
    (651) 286-6217

    00504
    NATIONAL MED SVCS INC/DBA NMS LABS—LP
    3701 WELSH ROAD
    WILLOW GROVE, PA 19090
    (215) 657-4900

    30553
    NATIONWIDE CHILDRENS HOSPITAL—LP
    CORE LAB AND LAB INFORMATION SYSTEMS
    700 CHILDRENS DRIVE
    COLUMBUS, OH 43205
    (614) 722-5376

    23801
    PACIFIC TOXICOLOGY LABORATORIES—LP
    9348 DE SOTO AVENUE
    CHATSWORTH, CA 91311
    (818) 598-3110

    02125
    PED ALLIANCE ST CLAIR PED DIV—L
    1580 MCLAUGHLIN RUN ROAD
    PINERIDGE COMMONS
    SUITE 208
    UPPER ST CLAIR, PA 15241
    (412) 221-2121

    25170
    PEDIATRIC CARE SPECIALISTS—L
    1322 EISENHOWER BOULEVARD
    JOHNSTOWN, PA 15904
    (814) 266-8840

    22533
    PENNSYLVANIA DEPT OF HEALTH—LP
    110 PICKERING WAY
    EXTON, PA 19341
    (610) 280-3464

    00022
    POCONO MEDICAL CENTER LAB—L
    206 EAST BROWN STREET
    EAST STROUDSBURG, PA 18301
    (570) 476-3544

    00324
    PRIMARY CARE HLTH SERV INC LAB—L
    7227 HAMILTON AVE
    PITTSBURGH, PA 15208
    (412) 244-4728

    00255
    PUBLIC HEALTH LAB CITY OF PHILA—L
    500 SOUTH BROAD STREET
    ROOM 359
    PHILADELPHIA, PA 19146
    (215) 685-6812

    22715
    QUEST DIAGNOSTICS—LP
    10101 RENNER BOULEVARD
    LENEXA, KS 66219-9752
    (913) 888-1770

    00669
    QUEST DIAGNOSTICS INCORPORATED—L
    ONE MALCOLM AVENUE
    TETERBORO, NJ 07608
    (201) 393-5895

    21422
    QUEST DIAGNOSTICS INCORPORATED—LP
    1901 SULPHUR SPRING ROAD
    BALTIMORE, MD 21227
    (301) 247-9100

    01136
    QUEST DIAGNOSTICS NICHOLS INSTITUTE—LP
    14225 NEWBROOK DRIVE
    PO BOX 10841
    CHANTILLY, VA 20153-0841
    (703) 802-6900

    22376
    QUEST DIAGNOSTICS NICHOLS INSTITUTE OF
     VALENCIA—L
    27027 TOURNEY ROAD
    VALENCIA, CA 91355
    (661) 799-6543

    00482
    QUEST DIAGNOSTICS OF PA INC—LP
    875 GREENTREE ROAD
    4 PARKWAY CENTER
    PITTSBURGH, PA 15220-3610
    (412) 920-7600

    25461
    QUEST DIAGNOSTICS VENTURE LLC—LP
    875 GREENTREE ROAD
    4 PARKWAY CENTER
    PITTSBURGH, PA 15220-3610
    (412) 920-7631

    00150
    READING HOSPITAL & MED CTR—L
    6TH AND SPRUCE STREETS
    WEST READING, PA 19611
    (610) 988-8080

    31527
    SHIEL MEDICAL LABORATORY—L
    63 FLUSHING AVENUE
    BROOKLYN NAVY YARD UNIT 336
    BROOKLYN, NY 11205
    (718) 552-1000

    00151
    ST JOSEPH QUALITY MEDICAL LAB—L
    2500 BERNVILLE ROAD
    READING, PA 19605-9453
    (610) 378-2200

    00104
    THE UNIONTOWN HOSPITAL LABORATORY—L
    500 WEST BERKELEY STREET
    UNIONTOWN, PA 15401
    (724) 430-5143

    00083
    UPMC PRESBYTERIAN SHADYSIDE CP PUH—L
    ROOM 5929 MAIN TOWER CHP
    200 LOTHROP STREET
    PITTSBURGH, PA 15213-2582
    (412) 648-6000

    00018
    WVHCS HOSP DBA PENNANT LABORATORY—L
    575 NORTH RIVER STREET
    WILKES BARRE, PA 18764
    (570) 829-8111

    ELI N. AVILA, MD, JD, MPH, FCLM, 
    Secretary

    [Pa.B. Doc. No. 11-1105. Filed for public inspection July 1, 2011, 9:00 a.m.]

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