NOTICES
Laboratories Approved to Perform Blood Lead and/or Erythrocyte Protoporphyrin Determinations under The Clinical Laboratory Act
[47 Pa.B. 5892]
[Saturday, September 16, 2017]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 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 proto-porphyrin analyses should determine that the laboratory employs techniques and procedures acceptable for the purpose for which the analyses are sought.
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 before 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 & Medicaid Services. Successful participation in the Department's proficiency testing program will satisfy the compliance requirements for both the Department and Centers for Medicare & Medicaid Services.
The symbols L and P indicate the following:
L = approved for blood lead analyses
P = approved for erythrocyte protoporphyrin analyses
LP = approved for blood lead and erythrocyte proto- porphyrin analyses31609
ACCU REFERENCE MEDICAL LABATORY—L
1901 EAST LINDEN AVENUE
SUITE 4
LINDEN, NJ 07036
(908) 474-100422912
ACL LABORATORIES—LP
8901 WEST LINCOLN AVE
WEST ALLIS, WI 53227
(414) 328-794503224
ADVOCARE CHILDRENS MEDICAL ASSOCIATES—L
1510 CHESTER PIKE, SUITE 105
EDDYSTONE, PA 19022
(610) 521-129700016
ANGELINE KIRBY MEM HEALTH CENTER—L
71 NORTH FRANKLIN STREET
WILKES-BARRE, PA 18701
(570) 822-427821613
ARUP LABORATORIES INC—LP
500 CHIPETA WAY
SALT LAKE CITY, UT 84108
(800) 242-278724997
ATLANTIC DIAGNOSTIC LABORATORIES LLC—LP
3520 PROGRESS DRIVE UNIT C
BENSALEM, PA 19020
(267) 525-247033959
BEST CARE LABORATORY LLC—L
14 APPLEGATE DRIVE, SUITE B
ROBBINSVILLE, NJ 08691
(973) 949-396322757
BIOREFERENCE LABORATORIES INC—L
481 EDWARD H ROSS DRIVE
ELMWOOD PARK, NJ 07407
(201) 791-360030248
CARING HANDS PEDIATRICS—L
300 CEDAR RIDGE DRIVE SUITE 309
PITTSBURGH, PA 15205
(412) 921-234530249
CARING HANDS PEDIATRICS—L
105 BRAUNLICH DRIVE, SUITE 102
PITTSBURGH, PA 15237
(412) 369-772020506
CENTRAL PA ALLIANCE LABORATORY—L
1803 MT ROSE AVENUE SUITE C3-C4
YORK, PA 17403
(717) 851-142600228
CHILDRENS HOSP OF PHILADELPHIA—L
3401 CIVIC CENTER BLVD
MAIN BLDG—5TH FLOOR—ROOM 5135
PHILADELPHIA, PA 19104
(215) 590-444631847
DOCTOR'S DATA, INC—L
3755 ILLINOIS AVENUE
ST CHARLES, IL 60174-2420
(630) 377-813900561
EAST PENN MFG CO INC—LP
DEKA RD KELLER TECH CENTER
PO BOX 147
LYONS STATION, PA 19536
(610) 682-636110266
EDEN PARK PEDIATRIC ASSOCIATES—L
1725 OREGON PIKE
LANCASTER, PA 17601
(717) 569-851829462
EDEN PARK PEDIATRIC ASSOCIATES—L
4221 OREGON PIKE
EPHRATA, PA 17522
(717) 859-143432339
EDEN PARK PEDIATRIC ASSOCIATES—L
779 E MAIN STREET
MOUNT JOY, PA 17552
(717) 569-851831378
ENZO CLINICAL LABS—L
60 EXECUTIVE BLVD
FARMINGDALE, NY 11735
(631) 755-550031400
FRANCES WARDE MEDICAL LABORATORY—LP
300 WEST TEXTILE ROAD
ANN ARBOR, MI 48108
(734) 214-030000173
GEISINGER MEDICAL CENTER—L
100 N ACADEMY AVENUE
DANVILLE, PA 17822-0131
(570) 271-744325914
GENOVA DIAGNOSTICS—L
63 ZILLICOA STREET
ASHEVILLE, NC 28801
(828) 253-062132839
GENOVA DIAGNOSTICS—L
3425 CORPORATE WAY
DULUTH, GA 30096
(678) 638-291831348
GREENVILLE COMMUNITY HEALTH CENTER—L
348 MAIN STREET
GREENVILLE, PA 16125
(724) 588-525001711
HANOVER PEDIATRICS—L
217 BROADWAY
HANOVER, PA 17331
(717) 632-391124655
HEALTH NETWORK LABORATORIES—L
794 ROBLE ROAD
ALLENTOWN, PA 18109-9110
(610) 402-815035025
HEALTH NETWORK LABORATORIES—L
5 SOUTH WASHINGTON AVENUE
JERMYN, PA 18433
(610) 402-814026490
HOPE PEDIATRICS—L
3512 STATE ROUTE 257 SUITE 106
SENECA, PA 16346
(814) 677-371733708
INFINITY DIAGNOSTIC LABORATORIES—L
370 NORTH STREET
TETERBORO, NJ 07608
(201) 843-775029564
JAMESTOWN COMMUNITY HEALTH—L
865 E JAMESTOWN ROAD
JAMESTOWN, PA 16134
(724) 932-229929136
KIDS PLUS PEDIATRICS—L
108 HORNER LANE
LATROBE, PA 15650
(724) 537-213134794
KIDS CARE PEDIATRICS INC—L
8279 STATE RT 22 SUITE 2
NEW ALEXANDRIA, PA 15670
(724) 668-502305618
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
LABCORP OF AMERICA HOLDINGS—LP
69 FIRST AVENUE PO BOX 500
RARITAN, NJ 08869
(908) 526-240022715
LABONE LLC DBA QUEST DIAGNOSTICS—LP
10101 RENNER BOULEVARD
LENEXA, KS 66219-9752
(913) 577-170310270
LANCASTER PEDIATRIC ASSOCIATES—L
2106 HARRISBURG PIKE
SUITE 1 MED OFFICE PO BOX 3200
LANCASTER, PA 17601
(717) 291-593134187
LENCO DIAGNOSTIC LABORATORIES INC—L
1857 86TH STREET
BROOKLYN, NY 11214
(718) 232-151500242
MAIN LINE HOSPITALS LAB-LANKENAU—L
100 EAST LANCASTER AVENUE
3RD FLOOR
WYNNEWOOD, PA 19096
(484) 476-352129685
MAYO CLINIC LABS-ROCH SUPERIOR DR—LP
3050 SUPERIOR DRIVE NW
ROCHESTER, MN 55901
(507) 538-345824668
MCMURRAY PEDIATRIC & ADOLESCENT MEDI-
CINE—L
6000 WATERDAM PLAZA DRIVE # 280
MCMURRAY, PA 15317
(724) 941-819928806
MEDIA PEDIATRICS—L
401 MOORE ROAD
WALLINGFORD, PA 19086
(610) 565-333605574
MEDTOX LABORATORIES INC—LP
402 COUNTY ROAD D WEST
ST PAUL, MN 55112
(651) 636-746620802
MERITUS MEDICAL LABORATORY, LLC—L
11110 MEDICAL CAMPUS RD STE 230
HAGERSTOWN, MD 21742
(301) 665-490000504
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) 722-533528787
NEXT GENERATION PEDIATRICS—L
100 TECHNOLOGY DRIVE
SUITE 2
BUTLER, PA 16001
(724) 482-222023801
PACIFIC TOXICOLOGY LABORATORIES—LP
9348 DE SOTO AVENUE
CHATSWORTH, CA 91311
(818) 598-311031516
PAML LLC—L
110 W CLIFF AVENUE
SPOKANE, WA 99204
(509) 755-867022712
PEDIATRIC ALLIANCE GREENTREE DIVISION—L
969 GREENTREE ROAD
PRIMARY CARE CENTER OF GREENTREE
PITTSBURGH, PA 15220
(412) 922-525028416
PEDIATRIC ALLIANCE PC, ARCADIA DIVISION—L
9795 PERRY HIGHWAY, SUITE 100
WEXFORD, PA 15090
(412) 358-954802125
PEDIATRIC ALLIANCE ST CLAIR PED DIV—L
1580 MCLAUGHLIN RUN ROAD
PINERIDGE COMMONS SUITE 208
UPPER ST CLAIR, PA 15241
(412) 221-212125436
PEDIATRIC SPECIALISTS OF FRANKLIN COUNTY—L
27 VISTA DRIVE
UNIT 3
WAYNESBORO, PA 17268
(717) 765-662133953
PEDIATRIC URGENT CARE OF FRANKLIN
COUNTY—L
5 ROADSIDE AVE
WAYNESBORO, PA 17268
(717) 765-662122533
PENNSYLVANIA DEPT OF HEALTH—L
110 PICKERING WAY
EXTON, PA 19341
(610) 280-346400022
POCONO MEDICAL CENTER LAB—L
206 EAST BROWN STREET
EAST STROUDSBURG, PA 18301
(570) 476-337000255
PUBLIC HEALTH LAB CITY OF PHILA—L
500 SOUTH BROAD STREET, RM 359
PHILADELPHIA, PA 19146
(215) 685-650100669
QUEST DIAGNOSTICS INCORPORATED—LP
ONE MALCOLM AVENUE
TETERBORO, NJ 07608
(201) 393-589521422
QUEST DIAGNOSTICS INCORPORATED—LP
1901 SULPHUR SPRING ROAD
BALTIMORE, MD 21227
(410) 247-910001136
QUEST DIAGNOSTICS NICHOLS INSTITUTE—LP
14225 NEWBROOK DRIVE
CHANTILLY, VA 20151
(703) 802-690022376
QUEST DIAGNOSTICS NICHOLS INSTITUTE OF
VALENCIA—LP
27027 TOURNEY ROAD
VALENCIA, CA 91355
(661) 799-654300482
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) 920-767522899
RED ROSE PEDIATRIC ASSOCIATES—L
233 COLLEGE AVENUE
SUITE 200
LANCASTER, PA 17603
(717) 291-722124657
SANDY LAKE COMMUNITY HEALTH CENTER—L
3205 SOUTH MAIN STREET
SANDY LAKE, PA 16145
(724) 342-300222196
SHARON MEDICAL GROUP—L
63 PITT STREET
SHARON, PA 16146
(724) 342-660427649
SMA MEDICAL LABORATORIES—L
940 PENNSYLVANIA BOULEVARD UNIT E
FEASTERVILLE, PA 19053
(215) 322-659034171
SONIC REFERENCE LABORATORY, INC—L
9200 WALL STREET, SUITE 200
AUSTIN, TX 78754
(512) 531-210024582
SOUTH PHILA PEDIATRICS—L
1400 S 5TH STREET
PHILADELPHIA, PA 19147
(215) 467-351500151
ST JOSEPH QUALITY MEDICAL LAB—L
2500 BERNVILLE ROAD
READING, PA 19605-9453
(610) 378-220022718
SUNRISE MEDICAL LABORATORIES INC—L
250 MILLER PLACE
HICKSVILLE, NY 11801
(631) 435-151523999
SUSQUEHANNA COMMUNITY HEALTH AND DENTAL CENTER—L
471 HEPBURN STREET
WILLIAMSPORT, PA 17701
(570) 567-540021547
THE CLINIC FOR SPECIAL CHILDREN INC—L
535 BUNKER HILL RD PO BOX 128
STRASBURG, PA 17579
(717) 687-940730336
TRI COUNTY PEDIATRICS—L
821 HUNTINGDON PIKE, SUITE 207
HUNTINGDON VALLEY, PA 19006
(215) 379-302204159
TRI COUNTY PEDIATRICS INC—L
205 NEWTOWN ROAD SUITE 210
WARMINSTER, PA 18974
(215) 884-571504575
TRI COUNTY PEDIATRICS INC—L
1939 CHELTENHAM AVENUE
ELKINS PARK, PA 19027
(215) 884-571527432
TRI COUNTY PEDIATRICS INC—L
140 EAST BUTLER AVENUE
CHALFONT, PA 18914
(215) 822-177030337
TRI COUNTY PEDIATRICS, INC—L
729 GROVE AVENUE
SUITE 1
SOUTHAMPTON, PA 18966
(215) 322-080029164
TRI COUNTY PEDIATRICS INC—L
9121 E ROOSEVELT BLVD
PHILADELPHIA, PA 19114
(215) 884-571500083
UPMC PRESBYTERIAN SHADYSIDE CP PUH—L
UPMC CLINICAL LABORATORY BUILDING
3477 EULER WAY
PITTSBURGH, PA 15213
(412) 647-5855Questions regarding this list should be directed to Jennifer Okraska, 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 Jennifer Okraska at the previously referenced address or phone number. Persons who are speech or hearing impaired may call the Pennsylvania AT&T Relay Service at (800) 654-5984 (TDD users) or (800) 654-5988 (voice users).
RACHEL L. LEVINE, MD,
Acting Secretary
[Pa.B. Doc. No. 17-1531. Filed for public inspection September 15, 2017, 9:00 a.m.]
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