{"operation":"document","citation":"03-0113","title":"New York State Department of Health — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2004-08-30","effective_on":null,"summary":"03-0113 response to New York State Department of Health concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-03-0113.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-03-0113.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-03-0113","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2003/030113.pdf","body":"<<<PAGE 1>>>\n\n=\n•\nof Transportation\nU.S. Department\n400 Seventh St., S.W.\nResearch and\nWashington, D.C. 20590\nAdministration\nSpecial Programs\nAUG 30 2004\nEllis Jacobs, Ph.D., DABCC\nDirector, Clinical Laboratory\nReference No. 03-0113\nEvaluation Program\nWadsworth Center\nNew York State Department of Health\nP.O. Box 509\nAlbany, NY 12201-0509\nDear Dr. Jacobs:\nThis is in response to your letter asking if whole blood samples offered for transportation by your\nprogram to administer various proficiency tests for the purpose of licensing laboratories in the\nState of New York are subject to the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-\n180). From telephone conversations with Ms. Kathi Wagner of your staff, we understand the\nwhole blood has been tested and determined to not meet the definition of a hazardous material,\nbut before being offered for commercial transportation to the laboratories for analysis, various\nchemicals, parasites, or microbiological agents may be added. We apologize for the delay in\nresponding and any inconvenience this may have caused.\nYou are correct that blood collected for transfusion and biological products subject to approval\nby the Food and Drug Administration or the U.S. Department of Agriculture are not subject to\nthe HMR (see § 173.134(b)). However, the samples you use for your various test programs may\nbe subject to the HMR if you add chemicals or other materials to the samples.\nBlood and other biological samples that do not meet the definition of a Division 6.2 (infectious)\nmaterial in § 173.134(a) or the definition of another class of hazardous material in Part 173 are\nnot subject to the HMR. Thus, the blood samples you transport for your engraftment monitoring,\nimmunohematology proficiency test, and parentage/identity testing programs are not regulated\nunder the HMR. Similarly, if the serum samples you transport for your clinical chemistry,\ncytokines, diagnostic immunology, endocrinology, hematology, oncology, parasitology,\ntherapeutic substance monitoring, and clinical and toxicology proficiency test programs are not\ninfectious and do not meet the definition of another hazard class, they are not subject to the\nHMR.\nSincerely,\nHaltez mithel\nHattie L. Mitchell, Chief\nRegulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n\n<<<PAGE 2>>>\n\nOH\nSTATE OF NEW YORK\nDEPARTMENT OF HEALTH\nWadsworth Center\nThe Governor Nelson A. Rockefeller Empire State Plaza P.O. Box 509\nAlbany, New York 12201-0509\nAntonia C. Novello, M.D., M.P.H., Dr.P.H.\n5/8/03\nCommissioner\nDennis P. Whalen\nExecutive Deputy Commissioner\nEdmonson\n§113,134 (4)\nApril 3, 2003\nDiagnostic Specimen\nRyan Posten\n03 - 8113\nUS Department of Transportation\n400 7* Street SW\nResearch and Special Programs Administration/DHM31\n..:\nWashington, DC 20590\nDear Mr. Posten:\nThe Clinical Laboratory Evaluation Program (CLEP) of the Wadsworth Center, New York State\nDepartment of Health licenses laboratories conducting testing on any specimens originating in\nNew York State. As part of the licensure program, CLEP administers proficiency testing to the\napproximately 950 clinical laboratories participating in the program. Proficiency tests for each\ncategory required by state and federal regulations are submitted to participating laboratories\n'three times per year, except for testing in Urinalysis, Mycobacteriology, and Parentage/Identity\nTesting, which occur twice per year.\nWe would like to confirm our understanding of the new shipping regulations as they relate to our\nproficiency testing program.\nAccording to Section 173.134(b)(4) blood collected for the purpose of blood transfusion are not\nsubject to the requirements of this subchapter as Division 6.2 materials. The Engraftment\nMonitoring, Immunohematology and Parentage/Identity Testing proficiency testing programs\nprepare their proficiency testing samples from whole blood collected by a licensed blood center.\nrequirements for diagnostic specimens.\nTherefore, we would like to confirm that these four programs are exempt from the packing\nEngraftment Monitoring\nThis program purchases whole blood from the Red Cross. The blood is tested and\nblood into plastic cryotubes.\nApproximately 10 laboratories participate in the bone marrow engraftment monitoring\nproficiency testing. program that is administered twice a year.\n\n<<<PAGE 3>>>\n\n. -\nImmunohematology Proficiency Test\n• The proficiency test consists of five whole blood samples and five lyophilized serum\nsamples.\nwhole blood is dispensed into sterile serum vials, capped with a rubber stopper and\nmetal seal.\nThe serum samples are purchased from reagent manufacturers and have been tested\ntor anti-Hiv-1, anti-HlV-2, HIV-1 p24 antigen, anti-HCV, HBsAg and syphilis. Wadsworth\nCenter staff dilutes the serum in varying concentrations. Three mLs of the diluted serum\nis dispensed into sterile serum vials, lyophilized, and capped with a rubber stopper and\nmetal seal.\nprogram that is administered three times per year.\nApproximately 350 laboratories participate in the Immunohematology proficiency testing\nParentage/Identity Testing\nThis program purchases whole blood from the Red Cross. The blood is tested and\nALT, syphilis and NAT for HIV and HCV. Wadsworth Center staff dispenses the whole\nfound negative for HBsAg, anti-HBo, anti-HIV-1, anti-HIV-2, anti-HCV and anti-HTLV-I,\nblood into plastic cryotubes.\nprogram that is administered twice a year.\nApproximately 25 laboratories participate in the paternity/identity proficiency testing\nAccording to Section 173.134(b)(3), biological products are not subject to the requirements of\nthis subchapter as Division 6.2 materials. The following proficiency testing programs prepare\ntheir proticiency testing samples from materials purchased from a licensed manufacturer.\nrequirements for diagnostic specimens.\nTherefore, we would like to confirm that these programs are exempt from the packing\nClinical Chemistry Proficiency Test\nThe proficiency samples are prepared from bulk serum that is purchased from a licensed\nmanufacturer. The bulk serum has been tested and found negative for HBsAg, anti-HIV-\nthe manufacturer.\n1, anti-HIv-2, HIV-1 antigen and anti-HCV and the results of this testing are provided by\nalkaline phosphatase, amylase, aspartate aminotransferase, total bilirubin, total calcium,\nThe Wadsworth Center staff adds the analytes (alanine aminotransferase, albumin,\nchloride, total cholesterol, HDL Cholesterol, LDL Cholesterol, creatine kinase, creatine\nkinase-MB, creatinine, gamma glutamyltransferase, glucose, homocysteine, iron, lactate\ndehydrogenase, lactate dehydrogenase isoenzyme 1, magnesium, phosphorus,\npotassium, sodium, total protein, Triglycerides, urea nitrogen and uric acid) to the bulk\nserum in varying concentrations.\n2\n\n<<<PAGE 4>>>\n\n=\nThe serum is then sterile filtered and dispensed in six mL aliquots into individual glass\nfrozen.\nserum vials. The vials are capped with a rubber stopper and metal seal and stored\nApproximately 470 laboratories participate in the clinical chemistry proficiency testing\nprogram that is administered three times per year. Five serum vials are sent to each\nlaboratory enrolled in the NYS proficiency testing program for evaluation.\nCytokines Proficiency Test\nmanufacturer. The bulk serum has been tested and found negative for HBsAg, anti-HIV-\nThe proficiency samples are prepared from bulk serum that is purchased from a licensed\nthe manufacturer.\n1, anti-HIV-2, HIV-1 antigen and anti-HCV and the results of this testing are provided by\nthe bulk serum in varying concentrations.\nThe Wadsworth Center staff adds the analytes (INF-gamma, IL-2, IL-6, TNF-alpha) to\nThe serum is dispensed in three mL aliquots into individual 12X75 plastic tubes with a\nsnap cap. The vials are also covered with parafilm and stored frozen.\nApproximately 10 laboratories participate in the proficiency testing program for cytokines\nthat is administered three times per year. Three serum vials are sent to each laboratory\nenrolled in the NYS program for evaluation.\nDiagnostic Immunology Proficiency Test\nThe proficiency samples are prepared from bulk serum purchased from a licensed\nmanufacturer. The certificate of analysis provided by the manufacturers indicates the\nvarious concentration of the analytes (IgA, IgG, IgM, IgE, C3, C4, heterophile, rubella\nantibody, alpha-1 antitrypsin, antinuclear antibody, antistreptolysin O, anti-CMV,\nrheumatoid factor, syphilis reagin, syphilis treponemal antibody and lyme disease\nantibody) and that the bulk serum tested negative for HBsAg, anti-HIV-1 and anti-HTLV-\nlabeled plastic vials, capped and shipped liquid with identification as to contents. Up to\nI/II. Bulk serum is dispensed under sterile conditions in 0.3 mL to 3.0 mL aliquots into\nsixteen sets containing five serum vials each are sent to laboratories enrolled in the NYS\nimmunology proficiency testing program that is administered three times per year.\nprogram for evaluation. Approximately 450 laboratories participate in the diagnostic\nEndocrinology Proficiency Test\nThe proficiency samples are prepared from bulk serum that is purchased from a licensed\n1, anti-HIV-2, HIV-1 antigen and anti-HCV and the results of the testing are provided by\nmanures been tested and found negative for HBsAg, anti-HIV-\nthe manufacturer.\nThe Wadsworth Center staff adds different hormones (e.g. cortisol, estradiol, folic acid,\nestriol, follicle stimulating hormone, human chorionic gonadotropin, insulin, luteinizing\nhormone, testosterone, triiodothyronine (T3), Thyroxin (T4), Thyroid Stimulating\nHormone, Vitamin B-12, prolactin, and progesterone) to the bulk serum in varying\nconcentrations.\nThe serum is sterile filtered and dispensed in six mL aliquots into individual glass serum\nvials. The vials are then capped with a rubber stopper and metal seal and stored frozen.\n3\n\n<<<PAGE 5>>>\n\nApproximately 430 laboratories participate in the endocrinology proficiency testing\nprogram that is administered three times per year. Five serum vials are sent to each\nlaboratory enrolled in the NYS program for evaluation.\nHematology Proficiency Testing\nThe proficiency test package consists of five stabilized whole blood products, five\nfibrinogen testing, and photographic transparencies for cell identification.\nlyophilized plasma samples for coagulation studies, five lyophilized plasma samples for\nThe stabilized whole blood products (HP-5 materials) are purchased from a licensed\nmL samples are shipped by the manufacturer in 5 mL vacutainers.\nmanufacturer and are tested and found nonreactive for HBsAg and anti-HIV. The 1.5\nThe lyophilized plasma samples for coagulation studies and fibrinogen are purchased\nfrom a licensed manufacturer and are tested and found nonreactive for HBsAg, anti-HIV\nWheaton vials with a flanged rubber stopper and plastic screw-top caps.\nand anti-HCV. The one mL samples are packaged by the manufacturer in 5 mL\nApproximately 500 laboratories participate in the Hematology proficiency testing\nprogram that is administered three times per year.\nOncology Proficiency Test\nbovine serum albumin that is purchased from a licensed manufacturer.\nThe proficiency samples are prepared in a non-human, protein-based matrix of 6%\nThe Wadsworth Center staff adds the analytes alpha-fetoprotein (AFP), CA125, CA15-3,\nCA19-9, CA27.29, Carcinoembryonic antigen (CEA) and prostate specific antigen (PSA)\nto the matrix in varying, very small concentrations (ug/L). All analytes are either from\ncell culture or human sources and have been screened by the manufacturer for HIV and\nhepatitis virus.\nThe samples are sterile filtered and aseptically dispensed in five mL aliquots into\nindividual glass serum vials using a GMP process. The vials are then capped leakproof\nwith a rubber stopper and metal seal and stored refrigerated.\nApproximately 320 laboratories participate in the Oncology proficiency testing program\nthat is administered three times per year. Five serum vials are sent to each laboratory\nenrolled in the NYS program for evaluation.\nParasitology Proficiency Test\nThe proficiency samples are purchased from a licensed manufacturer. The test kit\nmethanol fixed blood smear for malaria and one unstained PVA fixed fecal smear.\nconsists of three fecal specimens suspended in 1.5 mL of 10% formalin, one unstained\nApproximately 180 laboratories participate in the parasitology proficiency testing\nsent to each laboratory enrolled in the NYS program for evaluation\nprogram that is administered three times per year. Five samples as defined above are\nTherapeutic Substance Monitoring (TSM) Proficiency Test\nThe proficiency samples are prepared from bulk serum that is purchased from a licensed\n1, anti-HIV-2, HIV-1 antigen and anti-HCV and the results of the testing are provided by\nmanuracturer. The bulk serum has been tested and found negative for HBsAg, anti-HIV-\nthe manufacturer.\n4\n\n<<<PAGE 6>>>\n\nThe Wadsworth Center staff adds the drugs (ethanol, acetaminophen, carbamazepine,\ndigoxin, ethosuximide, gentamicin, lithium, N-acetyl procainamide, phenobarbital,\nphenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin,\nvalproic acid, vancomycin) to the bulk serum in varying concentrations.\nThe serum is sterile filtered and dispensed in five mL aliquots into individual glass serum\nfrozen.\nvials. The vials are then capped with a gray butyl stopper and metal seal and stored\nApproximately 350 laboratories participate in the TSM proficiency testing program that is\nin the NYS program for evaluation.\nadministered three times per year. Five serum vials are sent to each laboratory enrolled\nClinical and Forensic Toxicology Proficiency Test\nThe proficiency samples are prepared from urine that is collected from healthy volunteer\nbenzodiazepines, benzoylecgonine, ethanol, fentanyl, methadone, opiates,\ndonors. The Wadsworth Center staff adds the drugs (Amphetamines, barbiturates,\nin varying concentrations.\nphencyclidine, propoxyphene, THC-cannabinoids, tricyclic antidepressants) to the urine\nThe urine is filtered and dispensed in 50 mL aliquots into plastic containers and/or into\n10 mL aliquots in Wheaton glass serum bottles, gray butyl stopper, aluminum seal,\ncrimped and frozen.\nApproximately 250 laboratories participate in the Clinical and Forensic Toxicology\nare sent to each laboratory enrolled in the NYS program for evaluation.\nproficiency testing program that is administered three times per year. Four to eight vials\nWe look forward to hearing from you soon regarding our interpretation of the new shipping\nregulations. If you have any questions or need further information, you may contact Kathi\nWagner at (518) 485-5399.\nSincerely,\nAllis four\nEllis Jacobs, Ph.D., DABCC\nDirector, Clinical Laboratory Evaluation Program\n5\n\n<<<PAGE 7>>>\n\nContainthe Clinical Laboratory Evaluation Program\nPage 1 of 1\nContact CLEP\nDirector:\nEllis Jacobs, Ph.D., DABCC\nGeneral Information:\n(518) 485-5378\n830-4445 go\nCertification Unit:\n(518) 402-4019\nLimited Testing Sites:\n(518) 402-4253\nSurvey and Compliance:\n(518) 402-4018\nFees, Gross Annual Receipts:\n(518) 402-2972\nFAX:\n(518) 485-5414\nEmail:\nCLEP@health.state.ny.us\nClinical Laboratory Evaluation Program\nWadsworth Center\nMailing address:\nNew York State Department of Health\nPO Box 509\nAlbany, NY 12201-0509\nValid XHTML 1.0!\n4121 Katitt no longer maste.\n1l79 LaTe a Cous on wet for\nhttp://www.wadsworth.org/labcert/clep/contactus.htm\n4/29/2004\n\n<<<PAGE 8>>>\n\nPhone Numbers and Mailing Addresses at Wadsworth Center\nPage 1 of 1\nPhone Numbers and Mailing Addresses\nBiggs Laboratory -- (518) 474-2160\nPost Office Address:\nShip To Address:\nBiggs Laboratory\nWadsworth Center\nNadsworth Center\nBiggs Laboratory\nNYS Department of Health\nEmpire State Plaza\n1 South Dock 1\nYS Department of Healt\nP.O. Box 509\nEmpire State Plaza\nAlbany, New York 12201-0509\nAlbany, New York 12237\nDavid Axelrod Institute -- (518) 473-3837\nPost Office Address:\nShip To Address:\nDavid Axelrod Institute\nDavid Axelrod Institute\nWadsworth Center\nWadsworth Center\nNYS Department of Health\nNYS Department of Health\nP.O. Box 22002\n120 New Scotland Avenue\nAlbany, New York 12201-2002\nAlbany, New York 12208\nGenomics Institute -- (518) 880-1300\nPost Office Address:\nShip To Address:\nThe Genomics Institute\nThe Genomics Institute\nWadsworth Center\nWadsworth Center\nNYS Department of Health\nNYS Department of Health\n465 Jordan Road\n465 Jordan Road\nTroy, New York 12180\nTroy, New York 12180\nGriffin Laboratory -- (518) 869-4500\nPost Office Address:\nShip To Address:\nGriffin Laboratory\nWadsworth Center\nGriffin Laboratory\nWadsworth Center\nNYS Department of Health\nNYS Department of Health\nEmpire State Plaza\n5668 State Farm Road\nP.O. Box 509\nSlingerlands, New York 12159\nAlbany, New York 12201-0509\nCenter for Medical Science\nPost Office Address:\nShip To Address:\nCenter for Medical Science\nCenter for Medical Science\nWadsworth Center\nWadsworth Center\nNYS Department of Health\nNYS Department of Health\nEmpire State Plaza\nP1 South Dock J3\nP.O. Box 509\nEmpire State Plaza\nAlbany, New York 12201-0509\nAlbany, New York 12237\nMost Wadsworth Center personnel are reachable by e-mail using this addressing scheme:\nfirstname.lastname@wadsworth.org\nhttp://www.wadsworth.org/wcinfo.htm\n4/29/2004\n\n<<<PAGE 9>>>\n\nEabormory Services - Laboratory Quality Certification at Wadsworth Center\nPage 1 of 1\nLaboratory Quality Certification\nClinical Laboratory Evaluation Program\nOn July 1, 1965, New York became the first state in the nation to initiate a\ncertification and licensing program for a limited number of clinical\nlaboratories operating within the state in selected areas of patient testing.\nSince then the program has expanded and now monitors, through the\nIn The\nClinical Laboratory Evaluation Program (CLEP) of the Wadsworth Center, the\nNews\noverall quality of testing conducted by all clinical laboratories and blood\nbanks throughout the state, as well as out-of-state facilities and international\nProgram\nlaboratories that accept clinical specimens obtained in New York State. CLEP\nGuide\ndraws on the expertise of the Wadsworth Center's scientific staff to help\nmeet three objectives:\nPermit\nApplication\n1. to monitor, improve, and broaden the clinical capabilities of participating laboratories\nMaterials\nand blood banks;\n2. to provide guidelines, quality control standards and procedures to be used by permit-\nholding clinical facilities; and,\nApproved\n3. to expand the clinical and educational background of medical technologists,\nLabs\nlaboratorians, and other personnel involved in the operation of clinical laboratories\nthrough training and remediation programs.\nProficiency\nTesting\nIn meeting these objectives, CLEP seeks to ensure the accuracy and\nreliability of results of laboratory tests on specimens obtained within the\nLaboratory\nstate through on-site inspections, proficiency testing and evaluation of the\nStandards\nqualifications of personnel of state permit-holding clinical laboratories and\nblood banks. The proper performance of diagnostic laboratory tests is a\nTest\nmatter of vital concern, affecting the public health, safety and welfare of all\nApproval\nNYS residents. Clinical laboratories and blood banks provide essential public\nhealth services in aiding the medical practitioner by furnishing information\nFrequently\ninvaluable in the diagnosis and treatment of disease. Substandard\nAsked\nperformance of such tests may and has contributed to erroneous diagnoses\nQuestions\nand/or the selection of inappropriate treatment protocols.\nContact\nCLEP currently issues on an annual basis permits to over 1,000 laboratories,\nCLEP\nand 600 patient service centers in NYS. In addition, CLEP certifies, on a\nbiennial basis, approximately 2,300 certificates of qualification to individuals\nto serve as directors/assistant directors of these clinical laboratories and\nblood banks. The excellence of the center's Clinical Laboratory Evaluation\nProgram has been acknowledged by the federal Centers for Medicare and\nMedicaid Services through their granting of exempt status from the federal\nClinical Laboratory Improvement Amendments of 1988 for laboratories\nlocated in and holding NYS clinical laboratory permits.\nValid XHTML 1.0!\nhttp://www.wadsworth.org/labcert/clep/clep.html\n4/29/2004\n\n<<<PAGE 10>>>\n\nJOH\nSTATE OF NEW YORK Call\nDEPARTMENT OF HEALTH\nWadsworth Center\nThe Governor Nelson A. Rockefeller Empire State Plaza\nP.O. Box 509\nAlbany, New York 12201-0509\nAntonia C. Novello, M.D., M.P.H., Dr.P.H.\nCommissioner\nDennis P. Whalen\nExecutive Deputy Commissioner\nwww.wadsworth.org\nEdmonson\n518-4027266\n§113,134 (4)\nKathy\nApril 3, 2003\nwagner\nDiagnostic Specimen\nRyan Posten\n03-8113\nUS Department of Transportation\n400 7' Street SW\nResearch and Special Programs Administration/DHM31\nWashington, DC 20590\nDear Mr. Posten:\nThe Clinical Laboratory Evaluation Program (CLEP) of the Wadsworth Center, New York State\nDepartment of Health licenses laboratories conducting testing on any specimens originating in\nNew York State. As part of the licensure program, CLEP administers proficiency testing to the\napproximately 950 clinical laboratories participating in the program. Proficiency tests for each\ncategory required by state and federal regulations are submitted to participating laboratories\nTesting, which occur twice per year.\nthree times per year, except for testing in Urinalysis, Mycobacteriology, and Parentage/identity\nWe would like to confirm our understanding of the new shipping regulations as they relate to our\nproficiency testing program.\nAccording to Section 173.134(b)(4) blood collected for the purpose of blood transfusion are not\nsubject to the requirements of this subchapter as Division 6.2 materials. The Engraftment\nMonitoring, Immunohematology and Parentage/Identity Testing proficiency testing programs\nprepare their proficiency testing samples from whole blood collected by a licensed blood center.\nrequirements for diagnostic specimens.\nTherefore, we would like to confirm that these four programs are exempt from the packing\nEngraftment Monitoring\nThis program purchases whole blood from the Red Cross. The blood is tested and\nfound negative for HBsAg, anti-HBc, anti-HIV-1, anti-HIV-2, anti-HCV and anti-HTLV-I,\nALT, syphilis and NAT for HIV and HCV. Wadsworth Center staff dispenses the whole\nblood into plastic cryotubes.\n1\nApproximately 10 laboratories participate in the bone marrow engraftment monitoring\nproficiency testing program that is administered twice a year.\nRid X blood w hitting ashed\nit path added its b. 2\ni rigad techanges\nspecmesto\nclass 3 Grikey 419104\n\n<<<PAGE 11>>>\n\nImmunohematology Proficiency Test\n.The proficiency test consists of five whole blood samples and five lyophilized serum\nsamples.\nThe Immunohematology program purchases whole blood from the Red Cross from their\ninventory of blood collected for transfusion. The blood is tested and found negative for\nHBsAg, anti-HBc, anti-HIV-1, anti-HIV-2, anti-HCV and anti-HTLV-I, ALT, syphilis and\nNAT for HIV and HCV and meets all requirements for transfusable blood. Two mL of\nwhole blood is dispensed into sterile serum vials, capped with a rubber stopper and\nmetal seal.\nThe serum samples are purchased from reagent manufacturers and have been tested\nfor anti-HIV-1, anti-HIV-2, HIV-1 p24 antigen, anti-HCV, HBsAg and syphilis. Wadsworth\nCenter staff dilutes the serum in varying concentrations. Three mLs of the diluted serum, the\nWhat?\nis dispensed into sterile serum vials, lyophilized, and capped with a rubber stopper anc\nmetal seal.\nSaline boise albumen added\nApproximately 350 laboratories participate in the Immunohematology proficiency testing\nprogram that is administered three times per year.\nParentage/Identity Testing\nThis program purchases whole blood from the Red Cross. The blood is tested and\n. found negative for HBsAg, anti-HBc, anti-HIV-1, anti-HIV-2, anti-HCV and anti-HTLV-I,\nALT, syphilis and NAT for HIV and HCV. Wadsworth Center staff dispenses the whole\nblood into plastic cryotubes.\nApproximately 25 laboratories participate in the paternity/identity proficiency testing\nprogram that is administered twice a year.\nAccording to Section 173.134(b)(3), biological products are not subject to the requirements of\nthis subchapter as Division 6.2 materials. The following proficiency testing programs prepare\ntheir proficiency testing samples from materials purchased from a licensed manufacturer. mud,\nTherefore, we would like to confirm that these programs are exempt from the packing\nrequirements for diagnostic specimens.\nClinical Chemistry Proficiency Test\nThe proficiency samples are prepared from bulk serum that is purchased from a licensed\nmanufacturer. The bulk serum has been tested and found negative for HBsAg, anti-HIV-\n1, anti-HIV-2, HIV-1 antigen and anti-HCV and the results of this testing are provided by\nthe manufacturer.\nThe Wadsworth Center staff adds the analytes (alanine aminotransferase, albumin,\nalkaline phosphatase, amylase, aspartate aminotransferase, total bilirubin, total calcium,\nchloride, total cholesterol, HDL Cholesterol, LDL Cholesterol, creatine kinase, creatine\nkinase-MB, creatinine, gamma glutamyltransferase, glucose, homocysteine, iron, lactate\ndehydrogenase, lactate dehydrogenase isoenzyme 1, magnesium, phosphorus,\npotassium, sodium, total protein, Triglycerides, urea nitrogen and uric acid) to the bulk,\nserum in varying concentrations.\n2\n\n<<<PAGE 12>>>\n\nThe serum is then sterile filtered and dispensed in six mL aliquots into individual glass\nfrozen.\nserum vials. The vials are capped with a rubber stopper and metal seal and stored\nApproximately 470 laboratories participate in the clinical chemistry proficiency testing\nprogram that is administered three times per year. Five serum vials are sent to each\nlaboratory enrolled in the NYS proficiency testing program for evaluation.\nCytokines Proficiency Test\nThe proficiency samples are prepared from bulk serum that is purchased from a licensed\nmanufacturer. The bulk serum has been tested and found negative for HBsAg, anti-HIV-\nthe manufacturer.\n1, anti-HIV-2, HIV-1 antigen and anti-HCV and the results of this testing are provided by\nthe bulk serum in varying concentrations.\nThe Wadsworth Center staff adds the analytes (INF-gamma, IL-2, IL-6, TNF-alpha) to\nThe serum is dispensed in three mL aliquots into individual 12X75 plastic tubes with a\nsnap cap. The vials are also covered with parafilm and stored frozen.\nApproximately 10 laboratories participate in the proficiency testing program for cytokines\n• enrolled in the NYS program for evaluation.\nthat is administered three times per year. Three serum vials are sent to each Taboratory\nDiagnostic Immunology Proficiency Test\nThe proficiency samples are prepared from bulk serum purchased from a licensed\nmanutacturer. The certificate of analysis provided by the manufacturers indicates the\nvarious concentration of the analytes (IgA, IgG, IgM, IgE, C3, C4, heterophile, rubella\nantibody, alpha-1 antitrypsin, antinuclear antibody, antistreptolysin O, anti-CMV,\nrheumatoid factor, syphilis reagin, syphilis treponemal antibody and lyme disease\nantibody) and that the bulk serum tested negative for HBsAg, anti-HIV-1 and anti-HTLV-\nVIl. Bulk serum is dispensed under sterile conditions in 0.3 mL to 3.0 mL aliquots into\nlabeled plastic vials, capped and shipped liquid with identification as to contents. Up to\nsixteen sets containing five serum vials each are sent to laboratories enrolled in the NYS\nprogram for evaluation. Approximately 450 laboratories participate in the diagnostic\nimmunology proficiency testing program that is administered three times per year.\nEndocrinology Proficiency Test\nThe proficiency samples are prepared from bulk serum that is purchased from a licensed\n1, anti-HIV-2, HIV-1 antigen and anti-HCV and the results of the testing are provided by\nmanufacturer. The bulk serum has been tested and found negative for HBsAg, anti-HIV-\nthe manufacturer.\nThe Wadsworth Center staff adds different hormones (e.g. cortisol, estradiol, folic acid,\nestriol, follicle stimulating hormone, human chorionic gonadotropin, insulin, luteinizing\nhormone, testosterone, triiodothyronine (T3), Thyroxin (T4), Thyroid Stimulating\nHormone, Vitamin B-12, prolactin, and progesterone) to the bulk serum in varying\nconcentrations.\nThe serum is sterile filtered and dispensed in six mL aliquots into individual glass serum\nvials. The vials are then capped with a rubber stopper and metal seal and stored frozen.\n3\n\n<<<PAGE 13>>>\n\nApproximately 430 laboratories participate in the endocrinology proficiency testing\nlaboratory enrolled in the NYS program for evaluation.\nprogram that is administered three times per year. Five serum vials are sent to each\nHematology Proficiency Testing\nThe proficiency test package consists of five stabilized whole blood products, five\nlyophilized plasma samples for coagulation studies, five lyophilized plasma samples for\nfibrinogen testing, and photographic transparencies for cell identification.\nThe stabilized whole blood products (HP-5 materials) are purchased from a licensed\nmanufacturer and are tested and found nonreactive for HBsAg and anti-HIV. The 1.5\nmL samples are shipped by the manufacturer in 5 mL vacutainers.\nThe lyophilized plasma samples for coagulation studies and fibrinogen are purchased\nfrom a licensed manufacturer and are tested and found nonreactive for HBsAg, anti-HIV\nand anti-HCV. The one mL samples are packaged by the manufacturer in 5 mL\nWheaton vials with a flanged rubber stopper and plastic screw-top caps.\nApproximately 500 laboratories participate in the Hematology proficiency testing\nprogram that is administered three times per year.\nOncology Proficiency Test\nThe proficiency samples are prepared in a non-human, protein-based matrix of 6%\nbovine serum albumin that is purchased from a licensed manufacturer.\nThe Wadsworth Center staff adds the analytes alpha-fetoprotein (AFP), CA125, CA15-3,\nCA19-9, CA21.29, Carcinoembryonic antigen (CEA) and prostate specific antigen (PSA)\ncell culture or human sources and have been screened by the manufacturer for HIV and\nto the matrix in varying, very small concentrations (ug/L). All analytes are either from\nhepatitis virus.\nThe samples are sterile filtered and aseptically dispensed in five mL aliquots into\nindividual glass serum vials using a GMP process. The vials are then capped leakproof\nWith a rubber stopper and metal seal and stored refrigerated.\nApproximately 320 laboratories participate in the Oncology proficiency testing program\nenrolled in the NYS program for evaluation.\nthat is administered three times per year. Five serum vials are sent to each laboratory\nParasitology Proficiency Test\nThe proficiency samples are purchased from a licensed manufacturer. The test kit\nconsists of three fecal specimens suspended in 1.5 mL of 10% formalin, one unstained\nmethanol fixed blood smear for malaria and one unstained PVA fixed fecal smear.\nApproximately 180 laboratories participate in the parasitology proficiency testing\nprogram that is administered three times per year. Five samples as defined above are\nsent to each laboratory enrolled in the NYS program for evaluation.\nTherapeutic Substance Monitoring (TSM) Proficiency Test\nThe proticiency samples are prepared trom bulk serum that is purchased from a licensed\nmauracturer buk serum has been tested and found negative for HBsAg, anti-HIV-\nthe manufacturer.\n1, anti-HIV-2, HIV-1 antigen and anti-HCV and the results of the testing are provided by\n4\n\n<<<PAGE 14>>>\n\nThe Wadsworth Center staff adds the drugs (ethanol, acetaminophen, carbamazepine,\ndigoxin, ethosuximide, gentamicin, lithium, N-acetyl procainamide, phenobarbital,\nvalproic acid, vancomycin) to the bulk serum in varying concentrations.\nphenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin,\nThe serum is sterile filtered and dispensed in five mL aliquots into individual glass serum\nvials. The vials are then capped with a gray butyl stopper and metal seal and stored\nfrozen.\nApproximately 350 laboratories participate in the TSM proficiency testing program that is\nin the NYS program for evaluation.\nadministered three times per year. Five serum vials are sent to each laboratory enrolled\nClinical and Forensic Toxicology Proficiency Test\nThe proficiency samples are prepared from urine that is collected from healthy volunteer\ndonors. The Wadsworth Center staff adds the drugs (Amphetamines, barbiturates,\nbenzodlazepines, benzoylecgonine, ethanol, fentanyl, methadone, opiates,\nin varying concentrations.\nphencyclidine, propoxyphene, THC-cannabinoids, tricyclic antidepressants) to the urine\nThe urine is filtered and dispensed in 50 mL aliquots into plastic containers and/or into\n10 mL aliquots in Wheaton glass serum bottles, gray butyl stopper, aluminum seal,\ncrimped and frozen.\nApproximately 250 laboratories participate in the Clinical and Forensic Toxicology\nproficiency testing program that is administered three times per year. Four to eight vials\nare sent to each laboratory enrolled in the NYS program for evaluation.\nWe look forward to hearing from you soon regarding our interpretation of the new shipping\nregulations. If you have any questions or need further information, you may contact Kathi\nWagner at (518) 485-5399.\nSincerely,\n61114742121\n51\nCelia fear 618485-5378\nEllis Jacobs, Ph.D., DABCC\nIATA 650\nDirector, Clinical Laboratory Evaluation Prosper\ndefient themical:\nnote fro\n5","truncated":false,"body_characters":33400}