NOTICES
Laboratories Approved to Perform Blood Lead and/or Erythrocyte Protoporphyrin Determinations under the Clinical Laboratory Act
[40 Pa.B. 3741]
[Saturday, July 3, 2010]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 hardcopy 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 protopor- phyrin 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 (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 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 AVENUE
WEST ALLIS, WI 53227
(414) 328-794529169
ADVANCED TOXICOLOGY NETWORK—LP
3560 AIR CENTER COVE
SUITE 101
MEMPHIS, TN 38118
(901) 794-577000016
ANGELINE KIRBY MEM HEALTH CENTER—L
71 NORTH FRANKLIN STREET
WILKES-BARRE, PA 18701
(570) 822-427824997
ATLANTIC DIAGNOSTIC LABORATORIES LLC—LP
3520 PROGRESS DRIVE
UNIT C
BENSALEM, PA 19020
(267) 525-247020506
CENTRAL PA ALLIANCE LABORATORY—L
1803 MT ROSE AVENUE
SUITE C3-C4
YORK, PA 17403
(717) 851-142600228
CHILDRENS HOSPITAL OF PHILADELPHIA—L
ONE CHILDRENS CENTER
34TH & CIVIC
PHILADELPHIA, PA 19104
(215) 590-444627845
CLINICAL REFERENCE LABORATORY—LP
8433 QUIVIRA ROAD
LENEXA, KS 66215
(913) 492-365200561
EAST PENN MFG. CO., INC.—LP
DEKA RD
KELLER TECH CENTER
P. O. BOX 147
LYONS STATION, PA 19536
(610) 682-636100332
ELLWOOD CITY HOSPITAL—LP
724 PERSHING STREET
ELLWOOD CITY, PA 16117
(724) 752-008131378
ENZO CLINICAL LABS—L
60 EXECUTIVE BOULEVARD
FARMINGDALE, NY 11735
(631) 755-550000173
GEISINGER MEDICAL LABORATORIES—L
100 N ACADEMY AVENUE
DANVILLE, PA 17822-0131
(570) 271-633825914
GENOVA DIAGNOSTICS—L
63 ZILLICOA STREET
ASHEVILLE, NC 28801
(828) 253-062120802
HAGERSTOWN MEDICAL LABORATORY—L
11110 MEDICAL CAMPUS ROAD
SUITE 230
HAGERSTOWN, MD 21742
(301) 790-867024655
HEALTH NETWORK LABORATORIES—LP
2024 LEHIGH STREET
ALLENTOWN, PA 18103-4798
(610) 402-815029723
IMPACT HEALTH BIOMETRIC TESTING, INC.—L
1040 FIRST AVENUE
SUITE 100
KING OF PRUSSIA, PA 19406
(610) 962-933305618
LAB CORP. OF AMERICA HOLDINGS—LP
6370 WILCOX ROAD
DUBLIN, OH 43016-1296
(800) 282-730021885
LAB CORP. OF AMERICA HOLDINGS—LP
1447 YORK COURT
BURLINGTON, NC 27215
(800) 334-516101088
LAB CORP. OF AMERICA HOLDINGS—LP
69 FIRST AVENUE
P. O. BOX 500
RARITAN, NJ 08869
(908) 526-240000242
MAIN LINE HEALTH LABORATORIES—L
100 EAST LANCASTER AVENUE
WYNNEWOOD, PA 19096
(610) 645-261529685
MAYO CLINIC DEPARTMENT OF LAB MEDICINE & PATHOLOGY—L
3050 SUPERIOR DRIVE NW
ROCHESTER, MN 55901
(507) 538-345809003
MAYO CLINIC DEPT LAB MED & PATH—P
200 FIRST STREET
SW HILTON 530
ROCHESTER, MN 55905
(507) 284-301829251
MAYO MEDICAL LABORATORIES NEW ENGLAND—
LP
160 DASCOMB ROAD
ANDOVER, MA 01810
(978) 658-360026302
MEDICAL ASSOCIATES BDHG—P
935 HIGHLAND BOULEVARD
SUITE 2200
BOZEMAN, MT 59715
(406) 587-512305574
MEDTOX LABORATORIES INC—LP
402 WEST COUNTY ROAD D
ST. PAUL, MN 55112
(651) 286-621700504
NATIONAL MED SVCS INC/DBA NMS LABS—LP
3701 WELSH ROAD
WILLOW GROVE, PA 19090
(215) 657-490030553
NATIONWIDE CHILDRENS HOSPITAL—LP
CORE LAB AND LAB INFORMATION SYSTEMS
700 CHILDRENS DRIVE
COLUMBUS, OH 43205
(614) 722-537623801
PACIFIC TOXICOLOGY LABORATORIES—LP
9348 DE SOTO AVENUE
CHATSWORTH, CA 91311
(818) 598-311002125
PED ALLIANCE ST. CLAIR PED. DIV.—L
1580 MCLAUGHLIN RUN ROAD
PINERIDGE COMMONS
SUITE 208
UPPER ST CLAIR, PA 15241
(412) 221-212122533
PENNSYLVANIA DEPT. OF HEALTH—LP
110 PICKERING WAY
EXTON, PA 19341
(610) 280-346400022
POCONO MEDICAL CENTER LAB—L
206 EAST BROWN STREET
EAST STROUDSBURG, PA 18301
(570) 476-354400324
PRIMARY CARE HEALTH SERV. INC. LAB—L
7227 HAMILTON AVENUE
PITTSBURGH, PA 15208
(412) 244-472800255
PUBLIC HEALTH LAB CITY OF PHILA.—L
500 SOUTH BROAD STREET
ROOM 359
PHILADELPHIA, PA 19146
(215) 685-681222715
QUEST DIAGNOSTICS—LP
10101 RENNER BOULEVARD
LENEXA, KS 66219-9752
(913) 888-177000315
QUEST DIAGNOSTICS CLINICAL LABS, INC.—LP
900 BUSINESS CENTER DRIVE
HORSHAM, PA 19044
(215) 957-930000669
QUEST DIAGNOSTICS INCORPORATED—L
ONE MALCOLM AVENUE
TETERBORO, NJ 07608
(201) 393-589501136
QUEST DIAGNOSTICS NICHOLS INSTITUTE—LP
14225 NEWBROOK DRIVE
P. O. BOX 10841
CHANTILLY, VA 20153-0841
(703) 802-690000482
QUEST DIAGNOSTICS OF PA, INC.—LP
875 GREENTREE ROAD
4 PARKWAY CENTER
PITTSBURGH, PA 15220-3610
(412) 920-760025461
QUEST DIAGNOSTICS VENTURE, LLC—LP
875 GREENTREE ROAD
4 PARKWAY CENTER
PITTSBURGH, PA 15220-3610
(412) 920-763100150
READING HOSPITAL & MED. CTR.—L
6TH AND SPRUCE STREETS
WEST READING, PA 19611
(610) 988-808022376
SPECIALTY LABORATORIES, INC.—L
27027 TOURNEY ROAD
VALENCIA, CA 91355
(661) 799-654300151
ST. JOSEPH QUALITY MEDICAL LAB—L
2500 BERNVILLE ROAD
READING, PA 19605-9453
(610) 378-220000104
THE UNIONTOWN HOSPITAL LABORATORY—L
500 WEST BERKELEY STREET
UNIONTOWN, PA 15401
(724) 430-514300083
UPMC PRESBYTERIAN SHADYSIDE CP PUH—L
ROOM 5929
MAIN TOWER CHP
200 LOTHROP STREET
PITTSBURGH, PA 15213-2582
(412) 648-600031400
WARDE MEDICAL LABORATORY—L
300 WEST TEXTILE ROAD
ANN ARBOR, MI 48108
(734) 214-030000018
WVHCS HOSP DBA PENNANT LABORATORY—L
575 NORTH RIVER STREET
WILKES-BARRE, PA 18764
(570) 829-8111EVERETTE JAMES,
Secretary
[Pa.B. Doc. No. 10-1216. Filed for public inspection July 2, 2010, 9:00 a.m.]
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