1403 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

    [44 Pa.B. 4255]
    [Saturday, July 5, 2014]

     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 reportable. Approved laboratories that 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 proto- porphyrin 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, as well as the personnel and testing procedures, can change. 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, 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. James R. Lute, Assistant Bureau Director, 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. James R. Lute 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).

    31609
    ACCU REFERENCE MEDICAL LABATORY—L
    1901 EAST LINDEN AVENUE
    SUITE 4
    LINDEN, NJ 07036
    (908) 474-1004

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

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

    21613
    ARUP LABORATORIES INC—L
    500 CHIPETA WAY
    SALT LAKE CITY, UT 84108
    (800) 242-2787

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

    22757
    BIOREFERENCE LABORATORIES INC—L
    481B EDWARD H ROSS DRIVE
    ELMWOOD PARK, NJ 07407
    (201) 791-3600

    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
    3401 CIVIC CENTER BLVD.
    MAIN BLDG.—5TH FLOOR—ROOM 5135
    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 CENTER—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

    32839
    GENOVA DIAGNOSTICS—L
    3425 CORPORATE WAY
    DULUTH, GA 30096
    (678) 638-2918

    00654
    GUTHRIE MEDICAL GROUP LABORATORIES—L
    ONE GUTHRIE SQUARE
    SAYRE, PA 18840
    (570) 887-5797

    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 HOSPITALS LAB-LANKENAU—L
    100 EAST LANCASTER AVENUE
    WYNNEWOOD, PA 19096
    (610) 645-2615

    29685
    MAYO CLINIC LABS-ROCH SUPERIOR DR—L
    3050 SUPERIOR DRIVE NW
    ROCHESTER, MN 55901
    (507) 538-6449

    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

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

    00504
    NATIONAL MED SVCS INC/DBA NMS LABS—LP
    3701 WELSH ROAD
    WILLOW GROVE, PA 19090
    (215) 366-1222

    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

    31516
    PAML LLC—L
    110 W. CLIFF AVENUE
    SPOKANE, WA 99204
    (509) 755-8645

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

    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 HEALTH CARE SERVICES INC—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) 685-6501

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

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

    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 LABORATORY—L
    6TH AND SPRUCE STREETS
    WEST READING, PA 19611
    (484) 628-8615

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

    27649
    SMA MEDICAL LABORATORIES—L
    940 PENNSYLVANIA BOULEVARD UNIT E
    FEASTERVILLE, PA 19053
    (215) 322-6590

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

    32074
    UNITED MEDICAL LABORATORY INC.—L
    495 N 13TH STREET
    NEWARK, NJ 07107

    00083
    UPMC PRESBYTERIAN SHADYSIDE CP PUH—L
    UPMC CLINICAL LABORATORY BUILDING
    3477 EULER WAY
    PITTSBURGH, PA 15213
    (412) 647-5855

    00018
    WBGH COMMONWEALTH HEALTH LAB SVS—L
    575 NORTH RIVER STREET
    WILKES-BARRE, PA 18764
    (570) 829-8111

    26198
    WRIGHT CENTER MEDICAL GROUP, PC—L
    5 SOUTH WASHINGTON AVENUE
    JERMYN, PA 18433
    (570) 383-9934

    MICHAEL WOLF, 
    Secretary

    [Pa.B. Doc. No. 14-1403. Filed for public inspection July 3, 2014, 9:00 a.m.]

Document Information