New York State Department of Health — Hazardous Materials Safety Interpretation

Page 1= • of Transportation U.S. Department 400 Seventh St., S.W. Research and Washington, D.C. 20590 Administration Special Programs AUG 30 2004 Ellis Jacobs, Ph.D., DABCC Director, Clinical Laboratory Reference No. 03-0113 Evaluation Program Wadsworth Center New York State Department of Health P.O. Box 509 Albany, NY 12201-0509 Dear Dr. Jacobs: This is in response to your letter asking if whole blood samples offered for transportation by your program to administer various proficiency tests for the purpose of licensing laboratories in the State of New York are subject to the Hazardous Materials Regulations (HMR; 49 CFR Parts 171- 180). From telephone conversations with Ms. Kathi Wagner of your staff, we understand the whole blood has been tested and determined to not meet the definition of a hazardous material, but before being offered for commercial transportation to the laboratories for analysis, various chemicals, parasites, or microbiological agents may be added. We apologize for the delay in responding and any inconvenience this may have caused. You are correct that blood collected for transfusion and biological products subject to approval by the Food and Drug Administration or the U.S. Department of Agriculture are not subject to the HMR (see § 173.134(b)). However, the samples you use for your various test programs may be subject to the HMR if you add chemicals or other materials to the samples. Blood and other biological samples that do not meet the definition of a Division 6.2 (infectious) material in § 173.134(a) or the definition of another class of hazardous material in Part 173 are not subject to the HMR. Thus, the blood samples you transport for your engraftment monitoring, immunohematology proficiency test, and parentage/identity testing programs are not regulated under the HMR. Similarly, if the serum samples you transport for your clinical chemistry, cytokines, diagnostic immunology, endocrinology, hematology, oncology, parasitology, therapeutic substance monitoring, and clinical and toxicology proficiency test programs are not infectious and do not meet the definition of another hazard class, they are not subject to the HMR. Sincerely, Haltez mithel Hattie L. Mitchell, Chief Regulatory Review and Reinvention Office of Hazardous Materials Standards#

Page 2OH STATE OF NEW YORK DEPARTMENT OF HEALTH Wadsworth Center The Governor Nelson A. Rockefeller Empire State Plaza P.O. Box 509 Albany, New York 12201-0509 Antonia C. Novello, M.D., M.P.H., Dr.P.H. 5/8/03 Commissioner Dennis P. Whalen Executive Deputy Commissioner Edmonson §113,134 (4) April 3, 2003 Diagnostic Specimen Ryan Posten 03 - 8113 US Department of Transportation 400 7* Street SW Research and Special Programs Administration/DHM31 ..: Washington, DC 20590 Dear Mr. Posten: The Clinical Laboratory Evaluation Program (CLEP) of the Wadsworth Center, New York State Department of Health licenses laboratories conducting testing on any specimens originating in New York State. As part of the licensure program, CLEP administers proficiency testing to the approximately 950 clinical laboratories participating in the program. Proficiency tests for each category required by state and federal regulations are submitted to participating laboratories 'three times per year, except for testing in Urinalysis, Mycobacteriology, and Parentage/Identity Testing, which occur twice per year. We would like to confirm our understanding of the new shipping regulations as they relate to our proficiency testing program. According to Section 173.134(b)(4) blood collected for the purpose of blood transfusion are not subject to the requirements of this subchapter as Division 6.2 materials. The Engraftment Monitoring, Immunohematology and Parentage/Identity Testing proficiency testing programs prepare their proficiency testing samples from whole blood collected by a licensed blood center. requirements for diagnostic specimens. Therefore, we would like to confirm that these four programs are exempt from the packing Engraftment Monitoring This program purchases whole blood from the Red Cross. The blood is tested and blood into plastic cryotubes. Approximately 10 laboratories participate in the bone marrow engraftment monitoring proficiency testing. program that is administered twice a year.#

Page 3. - Immunohematology Proficiency Test • The proficiency test consists of five whole blood samples and five lyophilized serum samples. whole blood is dispensed into sterile serum vials, capped with a rubber stopper and metal seal. The serum samples are purchased from reagent manufacturers and have been tested tor anti-Hiv-1, anti-HlV-2, HIV-1 p24 antigen, anti-HCV, HBsAg and syphilis. Wadsworth Center staff dilutes the serum in varying concentrations. Three mLs of the diluted serum is dispensed into sterile serum vials, lyophilized, and capped with a rubber stopper and metal seal. program that is administered three times per year. Approximately 350 laboratories participate in the Immunohematology proficiency testing Parentage/Identity Testing This program purchases whole blood from the Red Cross. The blood is tested and ALT, syphilis and NAT for HIV and HCV. Wadsworth Center staff dispenses the whole found negative for HBsAg, anti-HBo, anti-HIV-1, anti-HIV-2, anti-HCV and anti-HTLV-I, blood into plastic cryotubes. program that is administered twice a year. Approximately 25 laboratories participate in the paternity/identity proficiency testing According to Section 173.134(b)(3), biological products are not subject to the requirements of this subchapter as Division 6.2 materials. The following proficiency testing programs prepare their proticiency testing samples from materials purchased from a licensed manufacturer. requirements for diagnostic specimens. Therefore, we would like to confirm that these programs are exempt from the packing Clinical Chemistry Proficiency Test The proficiency samples are prepared from bulk serum that is purchased from a licensed manufacturer. The bulk serum has been tested and found negative for HBsAg, anti-HIV- the manufacturer. 1, anti-HIv-2, HIV-1 antigen and anti-HCV and the results of this testing are provided by alkaline phosphatase, amylase, aspartate aminotransferase, total bilirubin, total calcium, The Wadsworth Center staff adds the analytes (alanine aminotransferase, albumin, chloride, total cholesterol, HDL Cholesterol, LDL Cholesterol, creatine kinase, creatine kinase-MB, creatinine, gamma glutamyltransferase, glucose, homocysteine, iron, lactate dehydrogenase, lactate dehydrogenase isoenzyme 1, magnesium, phosphorus, potassium, sodium, total protein, Triglycerides, urea nitrogen and uric acid) to the bulk serum in varying concentrations. 2#

Page 4= The serum is then sterile filtered and dispensed in six mL aliquots into individual glass frozen. serum vials. The vials are capped with a rubber stopper and metal seal and stored Approximately 470 laboratories participate in the clinical chemistry proficiency testing program that is administered three times per year. Five serum vials are sent to each laboratory enrolled in the NYS proficiency testing program for evaluation. Cytokines Proficiency Test manufacturer. The bulk serum has been tested and found negative for HBsAg, anti-HIV- The proficiency samples are prepared from bulk serum that is purchased from a licensed the manufacturer. 1, anti-HIV-2, HIV-1 antigen and anti-HCV and the results of this testing are provided by the bulk serum in varying concentrations. The Wadsworth Center staff adds the analytes (INF-gamma, IL-2, IL-6, TNF-alpha) to The serum is dispensed in three mL aliquots into individual 12X75 plastic tubes with a snap cap. The vials are also covered with parafilm and stored frozen. Approximately 10 laboratories participate in the proficiency testing program for cytokines that is administered three times per year. Three serum vials are sent to each laboratory enrolled in the NYS program for evaluation. Diagnostic Immunology Proficiency Test The proficiency samples are prepared from bulk serum purchased from a licensed manufacturer. The certificate of analysis provided by the manufacturers indicates the various concentration of the analytes (IgA, IgG, IgM, IgE, C3, C4, heterophile, rubella antibody, alpha-1 antitrypsin, antinuclear antibody, antistreptolysin O, anti-CMV, rheumatoid factor, syphilis reagin, syphilis treponemal antibody and lyme disease antibody) and that the bulk serum tested negative for HBsAg, anti-HIV-1 and anti-HTLV- labeled plastic vials, capped and shipped liquid with identification as to contents. Up to I/II. Bulk serum is dispensed under sterile conditions in 0.3 mL to 3.0 mL aliquots into sixteen sets containing five serum vials each are sent to laboratories enrolled in the NYS immunology proficiency testing program that is administered three times per year. program for evaluation. Approximately 450 laboratories participate in the diagnostic Endocrinology Proficiency Test The proficiency samples are prepared from bulk serum that is purchased from a licensed 1, anti-HIV-2, HIV-1 antigen and anti-HCV and the results of the testing are provided by manures been tested and found negative for HBsAg, anti-HIV- the manufacturer. The Wadsworth Center staff adds different hormones (e.g. cortisol, estradiol, folic acid, estriol, follicle stimulating hormone, human chorionic gonadotropin, insulin, luteinizing hormone, testosterone, triiodothyronine (T3), Thyroxin (T4), Thyroid Stimulating Hormone, Vitamin B-12, prolactin, and progesterone) to the bulk serum in varying concentrations. The serum is sterile filtered and dispensed in six mL aliquots into individual glass serum vials. The vials are then capped with a rubber stopper and metal seal and stored frozen. 3#

Page 5Approximately 430 laboratories participate in the endocrinology proficiency testing program that is administered three times per year. Five serum vials are sent to each laboratory enrolled in the NYS program for evaluation. Hematology Proficiency Testing The proficiency test package consists of five stabilized whole blood products, five fibrinogen testing, and photographic transparencies for cell identification. lyophilized plasma samples for coagulation studies, five lyophilized plasma samples for The stabilized whole blood products (HP-5 materials) are purchased from a licensed mL samples are shipped by the manufacturer in 5 mL vacutainers. manufacturer and are tested and found nonreactive for HBsAg and anti-HIV. The 1.5 The lyophilized plasma samples for coagulation studies and fibrinogen are purchased from a licensed manufacturer and are tested and found nonreactive for HBsAg, anti-HIV Wheaton vials with a flanged rubber stopper and plastic screw-top caps. and anti-HCV. The one mL samples are packaged by the manufacturer in 5 mL Approximately 500 laboratories participate in the Hematology proficiency testing program that is administered three times per year. Oncology Proficiency Test bovine serum albumin that is purchased from a licensed manufacturer. The proficiency samples are prepared in a non-human, protein-based matrix of 6% The Wadsworth Center staff adds the analytes alpha-fetoprotein (AFP), CA125, CA15-3, CA19-9, CA27.29, Carcinoembryonic antigen (CEA) and prostate specific antigen (PSA) to the matrix in varying, very small concentrations (ug/L). All analytes are either from cell culture or human sources and have been screened by the manufacturer for HIV and hepatitis virus. The samples are sterile filtered and aseptically dispensed in five mL aliquots into individual glass serum vials using a GMP process. The vials are then capped leakproof with a rubber stopper and metal seal and stored refrigerated. Approximately 320 laboratories participate in the Oncology proficiency testing program that is administered three times per year. Five serum vials are sent to each laboratory enrolled in the NYS program for evaluation. Parasitology Proficiency Test The proficiency samples are purchased from a licensed manufacturer. The test kit methanol fixed blood smear for malaria and one unstained PVA fixed fecal smear. consists of three fecal specimens suspended in 1.5 mL of 10% formalin, one unstained Approximately 180 laboratories participate in the parasitology proficiency testing sent to each laboratory enrolled in the NYS program for evaluation program that is administered three times per year. Five samples as defined above are Therapeutic Substance Monitoring (TSM) Proficiency Test The proficiency samples are prepared from bulk serum that is purchased from a licensed 1, anti-HIV-2, HIV-1 antigen and anti-HCV and the results of the testing are provided by manuracturer. The bulk serum has been tested and found negative for HBsAg, anti-HIV- the manufacturer. 4#

Page 6The Wadsworth Center staff adds the drugs (ethanol, acetaminophen, carbamazepine, digoxin, ethosuximide, gentamicin, lithium, N-acetyl procainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid, vancomycin) to the bulk serum in varying concentrations. The serum is sterile filtered and dispensed in five mL aliquots into individual glass serum frozen. vials. The vials are then capped with a gray butyl stopper and metal seal and stored Approximately 350 laboratories participate in the TSM proficiency testing program that is in the NYS program for evaluation. administered three times per year. Five serum vials are sent to each laboratory enrolled Clinical and Forensic Toxicology Proficiency Test The proficiency samples are prepared from urine that is collected from healthy volunteer benzodiazepines, benzoylecgonine, ethanol, fentanyl, methadone, opiates, donors. The Wadsworth Center staff adds the drugs (Amphetamines, barbiturates, in varying concentrations. phencyclidine, propoxyphene, THC-cannabinoids, tricyclic antidepressants) to the urine The urine is filtered and dispensed in 50 mL aliquots into plastic containers and/or into 10 mL aliquots in Wheaton glass serum bottles, gray butyl stopper, aluminum seal, crimped and frozen. Approximately 250 laboratories participate in the Clinical and Forensic Toxicology are sent to each laboratory enrolled in the NYS program for evaluation. proficiency testing program that is administered three times per year. Four to eight vials We look forward to hearing from you soon regarding our interpretation of the new shipping regulations. If you have any questions or need further information, you may contact Kathi Wagner at (518) 485-5399. Sincerely, Allis four Ellis Jacobs, Ph.D., DABCC Director, Clinical Laboratory Evaluation Program 5#

Page 7Containthe Clinical Laboratory Evaluation Program Page 1 of 1 Contact CLEP Director: Ellis Jacobs, Ph.D., DABCC General Information: (518) 485-5378 830-4445 go Certification Unit: (518) 402-4019 Limited Testing Sites: (518) 402-4253 Survey and Compliance: (518) 402-4018 Fees, Gross Annual Receipts: (518) 402-2972 FAX: (518) 485-5414 Email: CLEP@health.state.ny.us Clinical Laboratory Evaluation Program Wadsworth Center Mailing address: New York State Department of Health PO Box 509 Albany, NY 12201-0509 Valid XHTML 1.0! 4121 Katitt no longer maste. 1l79 LaTe a Cous on wet for http://www.wadsworth.org/labcert/clep/contactus.htm 4/29/2004#

Page 8Phone Numbers and Mailing Addresses at Wadsworth Center Page 1 of 1 Phone Numbers and Mailing Addresses Biggs Laboratory -- (518) 474-2160 Post Office Address: Ship To Address: Biggs Laboratory Wadsworth Center Nadsworth Center Biggs Laboratory NYS Department of Health Empire State Plaza 1 South Dock 1 YS Department of Healt P.O. Box 509 Empire State Plaza Albany, New York 12201-0509 Albany, New York 12237 David Axelrod Institute -- (518) 473-3837 Post Office Address: Ship To Address: David Axelrod Institute David Axelrod Institute Wadsworth Center Wadsworth Center NYS Department of Health NYS Department of Health P.O. Box 22002 120 New Scotland Avenue Albany, New York 12201-2002 Albany, New York 12208 Genomics Institute -- (518) 880-1300 Post Office Address: Ship To Address: The Genomics Institute The Genomics Institute Wadsworth Center Wadsworth Center NYS Department of Health NYS Department of Health 465 Jordan Road 465 Jordan Road Troy, New York 12180 Troy, New York 12180 Griffin Laboratory -- (518) 869-4500 Post Office Address: Ship To Address: Griffin Laboratory Wadsworth Center Griffin Laboratory Wadsworth Center NYS Department of Health NYS Department of Health Empire State Plaza 5668 State Farm Road P.O. Box 509 Slingerlands, New York 12159 Albany, New York 12201-0509 Center for Medical Science Post Office Address: Ship To Address: Center for Medical Science Center for Medical Science Wadsworth Center Wadsworth Center NYS Department of Health NYS Department of Health Empire State Plaza P1 South Dock J3 P.O. Box 509 Empire State Plaza Albany, New York 12201-0509 Albany, New York 12237 Most Wadsworth Center personnel are reachable by e-mail using this addressing scheme: firstname.lastname@wadsworth.org http://www.wadsworth.org/wcinfo.htm 4/29/2004#

Page 9Eabormory Services - Laboratory Quality Certification at Wadsworth Center Page 1 of 1 Laboratory Quality Certification Clinical Laboratory Evaluation Program On July 1, 1965, New York became the first state in the nation to initiate a certification and licensing program for a limited number of clinical laboratories operating within the state in selected areas of patient testing. Since then the program has expanded and now monitors, through the In The Clinical Laboratory Evaluation Program (CLEP) of the Wadsworth Center, the News overall quality of testing conducted by all clinical laboratories and blood banks throughout the state, as well as out-of-state facilities and international Program laboratories that accept clinical specimens obtained in New York State. CLEP Guide draws on the expertise of the Wadsworth Center's scientific staff to help meet three objectives: Permit Application 1. to monitor, improve, and broaden the clinical capabilities of participating laboratories Materials and blood banks; 2. to provide guidelines, quality control standards and procedures to be used by permit- holding clinical facilities; and, Approved 3. to expand the clinical and educational background of medical technologists, Labs laboratorians, and other personnel involved in the operation of clinical laboratories through training and remediation programs. Proficiency Testing In meeting these objectives, CLEP seeks to ensure the accuracy and reliability of results of laboratory tests on specimens obtained within the Laboratory state through on-site inspections, proficiency testing and evaluation of the Standards qualifications of personnel of state permit-holding clinical laboratories and blood banks. The proper performance of diagnostic laboratory tests is a Test matter of vital concern, affecting the public health, safety and welfare of all Approval NYS residents. Clinical laboratories and blood banks provide essential public health services in aiding the medical practitioner by furnishing information Frequently invaluable in the diagnosis and treatment of disease. Substandard Asked performance of such tests may and has contributed to erroneous diagnoses Questions and/or the selection of inappropriate treatment protocols. Contact CLEP currently issues on an annual basis permits to over 1,000 laboratories, CLEP and 600 patient service centers in NYS. In addition, CLEP certifies, on a biennial basis, approximately 2,300 certificates of qualification to individuals to serve as directors/assistant directors of these clinical laboratories and blood banks. The excellence of the center's Clinical Laboratory Evaluation Program has been acknowledged by the federal Centers for Medicare and Medicaid Services through their granting of exempt status from the federal Clinical Laboratory Improvement Amendments of 1988 for laboratories located in and holding NYS clinical laboratory permits. Valid XHTML 1.0! http://www.wadsworth.org/labcert/clep/clep.html 4/29/2004#

Page 10JOH STATE OF NEW YORK Call DEPARTMENT OF HEALTH Wadsworth Center The Governor Nelson A. Rockefeller Empire State Plaza P.O. Box 509 Albany, New York 12201-0509 Antonia C. Novello, M.D., M.P.H., Dr.P.H. Commissioner Dennis P. Whalen Executive Deputy Commissioner www.wadsworth.org Edmonson 518-4027266 §113,134 (4) Kathy April 3, 2003 wagner Diagnostic Specimen Ryan Posten 03-8113 US Department of Transportation 400 7' Street SW Research and Special Programs Administration/DHM31 Washington, DC 20590 Dear Mr. Posten: The Clinical Laboratory Evaluation Program (CLEP) of the Wadsworth Center, New York State Department of Health licenses laboratories conducting testing on any specimens originating in New York State. As part of the licensure program, CLEP administers proficiency testing to the approximately 950 clinical laboratories participating in the program. Proficiency tests for each category required by state and federal regulations are submitted to participating laboratories Testing, which occur twice per year. three times per year, except for testing in Urinalysis, Mycobacteriology, and Parentage/identity We would like to confirm our understanding of the new shipping regulations as they relate to our proficiency testing program. According to Section 173.134(b)(4) blood collected for the purpose of blood transfusion are not subject to the requirements of this subchapter as Division 6.2 materials. The Engraftment Monitoring, Immunohematology and Parentage/Identity Testing proficiency testing programs prepare their proficiency testing samples from whole blood collected by a licensed blood center. requirements for diagnostic specimens. Therefore, we would like to confirm that these four programs are exempt from the packing Engraftment Monitoring This program purchases whole blood from the Red Cross. The blood is tested and found negative for HBsAg, anti-HBc, anti-HIV-1, anti-HIV-2, anti-HCV and anti-HTLV-I, ALT, syphilis and NAT for HIV and HCV. Wadsworth Center staff dispenses the whole blood into plastic cryotubes. 1 Approximately 10 laboratories participate in the bone marrow engraftment monitoring proficiency testing program that is administered twice a year. Rid X blood w hitting ashed it path added its b. 2 i rigad techanges specmesto class 3 Grikey 419104#

Page 11Immunohematology Proficiency Test .The proficiency test consists of five whole blood samples and five lyophilized serum samples. The Immunohematology program purchases whole blood from the Red Cross from their inventory of blood collected for transfusion. The blood is tested and found negative for HBsAg, anti-HBc, anti-HIV-1, anti-HIV-2, anti-HCV and anti-HTLV-I, ALT, syphilis and NAT for HIV and HCV and meets all requirements for transfusable blood. Two mL of whole blood is dispensed into sterile serum vials, capped with a rubber stopper and metal seal. The serum samples are purchased from reagent manufacturers and have been tested for anti-HIV-1, anti-HIV-2, HIV-1 p24 antigen, anti-HCV, HBsAg and syphilis. Wadsworth Center staff dilutes the serum in varying concentrations. Three mLs of the diluted serum, the What? is dispensed into sterile serum vials, lyophilized, and capped with a rubber stopper anc metal seal. Saline boise albumen added Approximately 350 laboratories participate in the Immunohematology proficiency testing program that is administered three times per year. Parentage/Identity Testing This program purchases whole blood from the Red Cross. The blood is tested and . found negative for HBsAg, anti-HBc, anti-HIV-1, anti-HIV-2, anti-HCV and anti-HTLV-I, ALT, syphilis and NAT for HIV and HCV. Wadsworth Center staff dispenses the whole blood into plastic cryotubes. Approximately 25 laboratories participate in the paternity/identity proficiency testing program that is administered twice a year. According to Section 173.134(b)(3), biological products are not subject to the requirements of this subchapter as Division 6.2 materials. The following proficiency testing programs prepare their proficiency testing samples from materials purchased from a licensed manufacturer. mud, Therefore, we would like to confirm that these programs are exempt from the packing requirements for diagnostic specimens. Clinical Chemistry Proficiency Test The proficiency samples are prepared from bulk serum that is purchased from a licensed manufacturer. The bulk serum has been tested and found negative for HBsAg, anti-HIV- 1, anti-HIV-2, HIV-1 antigen and anti-HCV and the results of this testing are provided by the manufacturer. The Wadsworth Center staff adds the analytes (alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, total bilirubin, total calcium, chloride, total cholesterol, HDL Cholesterol, LDL Cholesterol, creatine kinase, creatine kinase-MB, creatinine, gamma glutamyltransferase, glucose, homocysteine, iron, lactate dehydrogenase, lactate dehydrogenase isoenzyme 1, magnesium, phosphorus, potassium, sodium, total protein, Triglycerides, urea nitrogen and uric acid) to the bulk, serum in varying concentrations. 2#

Page 12The serum is then sterile filtered and dispensed in six mL aliquots into individual glass frozen. serum vials. The vials are capped with a rubber stopper and metal seal and stored Approximately 470 laboratories participate in the clinical chemistry proficiency testing program that is administered three times per year. Five serum vials are sent to each laboratory enrolled in the NYS proficiency testing program for evaluation. Cytokines Proficiency Test The proficiency samples are prepared from bulk serum that is purchased from a licensed manufacturer. The bulk serum has been tested and found negative for HBsAg, anti-HIV- the manufacturer. 1, anti-HIV-2, HIV-1 antigen and anti-HCV and the results of this testing are provided by the bulk serum in varying concentrations. The Wadsworth Center staff adds the analytes (INF-gamma, IL-2, IL-6, TNF-alpha) to The serum is dispensed in three mL aliquots into individual 12X75 plastic tubes with a snap cap. The vials are also covered with parafilm and stored frozen. Approximately 10 laboratories participate in the proficiency testing program for cytokines • enrolled in the NYS program for evaluation. that is administered three times per year. Three serum vials are sent to each Taboratory Diagnostic Immunology Proficiency Test The proficiency samples are prepared from bulk serum purchased from a licensed manutacturer. The certificate of analysis provided by the manufacturers indicates the various concentration of the analytes (IgA, IgG, IgM, IgE, C3, C4, heterophile, rubella antibody, alpha-1 antitrypsin, antinuclear antibody, antistreptolysin O, anti-CMV, rheumatoid factor, syphilis reagin, syphilis treponemal antibody and lyme disease antibody) and that the bulk serum tested negative for HBsAg, anti-HIV-1 and anti-HTLV- VIl. Bulk serum is dispensed under sterile conditions in 0.3 mL to 3.0 mL aliquots into labeled plastic vials, capped and shipped liquid with identification as to contents. Up to sixteen sets containing five serum vials each are sent to laboratories enrolled in the NYS program for evaluation. Approximately 450 laboratories participate in the diagnostic immunology proficiency testing program that is administered three times per year. Endocrinology Proficiency Test The proficiency samples are prepared from bulk serum that is purchased from a licensed 1, anti-HIV-2, HIV-1 antigen and anti-HCV and the results of the testing are provided by manufacturer. The bulk serum has been tested and found negative for HBsAg, anti-HIV- the manufacturer. The Wadsworth Center staff adds different hormones (e.g. cortisol, estradiol, folic acid, estriol, follicle stimulating hormone, human chorionic gonadotropin, insulin, luteinizing hormone, testosterone, triiodothyronine (T3), Thyroxin (T4), Thyroid Stimulating Hormone, Vitamin B-12, prolactin, and progesterone) to the bulk serum in varying concentrations. The serum is sterile filtered and dispensed in six mL aliquots into individual glass serum vials. The vials are then capped with a rubber stopper and metal seal and stored frozen. 3#

Page 13Approximately 430 laboratories participate in the endocrinology proficiency testing laboratory enrolled in the NYS program for evaluation. program that is administered three times per year. Five serum vials are sent to each Hematology Proficiency Testing The proficiency test package consists of five stabilized whole blood products, five lyophilized plasma samples for coagulation studies, five lyophilized plasma samples for fibrinogen testing, and photographic transparencies for cell identification. The stabilized whole blood products (HP-5 materials) are purchased from a licensed manufacturer and are tested and found nonreactive for HBsAg and anti-HIV. The 1.5 mL samples are shipped by the manufacturer in 5 mL vacutainers. The lyophilized plasma samples for coagulation studies and fibrinogen are purchased from a licensed manufacturer and are tested and found nonreactive for HBsAg, anti-HIV and anti-HCV. The one mL samples are packaged by the manufacturer in 5 mL Wheaton vials with a flanged rubber stopper and plastic screw-top caps. Approximately 500 laboratories participate in the Hematology proficiency testing program that is administered three times per year. Oncology Proficiency Test The proficiency samples are prepared in a non-human, protein-based matrix of 6% bovine serum albumin that is purchased from a licensed manufacturer. The Wadsworth Center staff adds the analytes alpha-fetoprotein (AFP), CA125, CA15-3, CA19-9, CA21.29, Carcinoembryonic antigen (CEA) and prostate specific antigen (PSA) cell culture or human sources and have been screened by the manufacturer for HIV and to the matrix in varying, very small concentrations (ug/L). All analytes are either from hepatitis virus. The samples are sterile filtered and aseptically dispensed in five mL aliquots into individual glass serum vials using a GMP process. The vials are then capped leakproof With a rubber stopper and metal seal and stored refrigerated. Approximately 320 laboratories participate in the Oncology proficiency testing program enrolled in the NYS program for evaluation. that is administered three times per year. Five serum vials are sent to each laboratory Parasitology Proficiency Test The proficiency samples are purchased from a licensed manufacturer. The test kit consists of three fecal specimens suspended in 1.5 mL of 10% formalin, one unstained methanol fixed blood smear for malaria and one unstained PVA fixed fecal smear. Approximately 180 laboratories participate in the parasitology proficiency testing program that is administered three times per year. Five samples as defined above are sent to each laboratory enrolled in the NYS program for evaluation. Therapeutic Substance Monitoring (TSM) Proficiency Test The proticiency samples are prepared trom bulk serum that is purchased from a licensed mauracturer buk serum has been tested and found negative for HBsAg, anti-HIV- the manufacturer. 1, anti-HIV-2, HIV-1 antigen and anti-HCV and the results of the testing are provided by 4#

Page 14The Wadsworth Center staff adds the drugs (ethanol, acetaminophen, carbamazepine, digoxin, ethosuximide, gentamicin, lithium, N-acetyl procainamide, phenobarbital, valproic acid, vancomycin) to the bulk serum in varying concentrations. phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, The serum is sterile filtered and dispensed in five mL aliquots into individual glass serum vials. The vials are then capped with a gray butyl stopper and metal seal and stored frozen. Approximately 350 laboratories participate in the TSM proficiency testing program that is in the NYS program for evaluation. administered three times per year. Five serum vials are sent to each laboratory enrolled Clinical and Forensic Toxicology Proficiency Test The proficiency samples are prepared from urine that is collected from healthy volunteer donors. The Wadsworth Center staff adds the drugs (Amphetamines, barbiturates, benzodlazepines, benzoylecgonine, ethanol, fentanyl, methadone, opiates, in varying concentrations. phencyclidine, propoxyphene, THC-cannabinoids, tricyclic antidepressants) to the urine The urine is filtered and dispensed in 50 mL aliquots into plastic containers and/or into 10 mL aliquots in Wheaton glass serum bottles, gray butyl stopper, aluminum seal, crimped and frozen. Approximately 250 laboratories participate in the Clinical and Forensic Toxicology proficiency testing program that is administered three times per year. Four to eight vials are sent to each laboratory enrolled in the NYS program for evaluation. We look forward to hearing from you soon regarding our interpretation of the new shipping regulations. If you have any questions or need further information, you may contact Kathi Wagner at (518) 485-5399. Sincerely, 61114742121 51 Celia fear 618485-5378 Ellis Jacobs, Ph.D., DABCC IATA 650 Director, Clinical Laboratory Evaluation Prosper defient themical: note fro 5#