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Information to be submitted with the application may include: Individuals who attended foreign schools must have an evaluation of their credentials determining equivalency of their education to education obtained in the United States. I have been saying this our experienced MT are being over looked by are supervisor. As director, you may assume the responsibilities for any position named in the CLIA requirements, such as clinical consultant, technical consultant (moderate complexity testing) or technical supervisor and general supervisor (high complexity testing), as long as you meet the In cases where a premarket submission is not needed but CLIA categorization is still appropriate (e.g., devices exempt from premarket notification), manufacturers may submit a request for CLIA categorization, which includes the package insert test instructions, to CDRH. WebCLIA 88 regulations for minimal educational requirements to perform high complexity testing to be inadequate and outdated (42 CFR493.1489 and 1491). (b) Meet one of the following requirements: (1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or -, (ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes -, (A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either -, (1) 24 semester hours of medical laboratory technology courses; or, (2) 24 semester hours of science courses that include -, (iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and. 5{ "5a:jHDTUYGtdV(gpf`[g. Communicable Disease Control: http://www.in.gov/legislative/iac/iac_title?iact=410. Score 1. After full payment of the certificate fee is received, your next two year certificate cycle is considered renewed. Score 3. by test system name, analyst name, complexity, specialty, and date of categorization, refer to the Public Databases webpage. Facilities performing moderate or high complexity testing must be enrolled in an approved Proficiency Testing program for each regulated analyte. WebCLIA Regulation 42 CFR Part 493.1489 would apply for high complexity testing personnel qualifications. Since November 13, 2003, the Food and Drug Administration (FDA) has had the authority to implement the Clinical Laboratory Improvement Amendments (CLIA) test complexity categorization provisions, which includes, but is not limited to the following: The FDA CLIA database contains the commercially-marketed in vitro test systems categorized by FDA since January 31, 2000, as well as tests categorized by Centers for Disease Control and Prevention prior to that date. Accessibility
WebThe requirements are based on the complexity of the test and not the type of laboratory where the testing is performed. WebCLIA defines six elements of competency assessment for anyone who actually performs testing, and all six must be documented for each person, each year. Specific licensed entities may have additional requirements under their specific license. WebCLIA regulations apply to laboratory testing in all settings including commercial, hospital, and physician office laboratories. However, Medicare and Medicaid will not pay for any laboratory testing not ordered by an authorized person. Submit requests to: E-mail: lswitzer@isdh.in.gov orklara@isdh.in.gov, Certificate of Waiver: $180for 2 year certificate, Certificate of Provider Performed Microscopy Procedures: $240for 2 year certificate. Other state agencies such Indiana Department of Environmental Management (IDEM) Board of Animal Health may have state statutes and regulations that apply to your laboratory. The high complexity testing environments that include blood banking, microbiology identification procedures, microscopy, etc. You will be subject to the destination website's privacy policy when you follow the link. The laboratory must have a director who meets the qualification requirements of 493.1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. Indiana does not currently have any statutes that define an "authorized person". 644 0 obj
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A general supervisor must be licensed to perform high complexity tests or must be a California-licensed physician and surgeon, and must have two years of experience in high-complexity testing in the specialty or specialties he or she is supervising. WebCenters for Medicare and Medicaid Services , the Food and Drug Administration , and the Centers for Disease Control and Prevention all play a role in ensuring quality lab testing in the United States. 1/1.1 -Caroline Satyadi, MT(ASCP), SM, DLM, SLS, MBA, MS, CQA (ASQ) has been a laboratory management professional for over 25 years. (ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or, (iii) Have earned an associate degree related to pulmonary function from an accredited institution; or. All forms (CMS 116 CLIA Application, Enclosure A Disclosure of Ownership and Enclosure I Methodology Test list) must be completed and signed and appropriate documentation attached for initial certificates and most changes of certificate type. You can learn more about the process Proficiency testing is not required for this level of testing. Subpart M contains the personnel sections of the CLIA regulations [Sections 493.1351 through 493.1495], https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/App-C_Survey-Procedures-IGs-for-Labs-Labs-Svcs-Final.pdf. The final rule has been issued for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing (PT) regulations related to analytes and acceptable performance. Each CLIA certificate represents a laboratory, and each laboratory is responsible for complying with the applicable CLIA requirements. It is true they dont have as extensive a general studies education as the MT/CLS, but they do have 2 years of education concentrated in laboratory technology. By requiring personnel licensure, the state government has taken additional measures to protect harm to the public in the state. ( a) Possess a current license issued by the State in which the laboratory is located, if such licensing is required; The in-page Table of Contents is available only when multiple sections are being viewed. means youve safely connected to the .gov website. This subpart addresses qualifications information or personal data. Would you tell me the difference? Official websites use .govA 2013-2022, Lablogatory, All Rights Reserved. He recently just made a MLT with less then 3 years experience the micro supervisor! WebAll LDTs are classified as high complexity tests, the most stringent category of testing under CLIA. Can I have more than 1 CLIA number at the same location? The final rule has been issued for Clinical Laboratory The PPM subcategory includes a limited set of microscopic evaluations listed in the CLIA regulations that are performed on samples such as urine, skin scrapings and excretions. I am no longer performing laboratory testing in my office. Ms Satyadi may be referring to California law in my research on this, California is the only state Ive found (as of the date of this posting) that has restrictions close to what she has mentioned here. Lab personnel includes those employees (such as data entry) that do not test specimens; testing personnel are employees that perform the actual testing. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. I am a MLT/HTL ASCP certified with ten years of experience in general lab and five years in histopathology/cytology. The Office of the Federal Register publishes documents on behalf of Federal agencies but does not have any authority over their programs. The role and requirements are below. As a retired MLT, I have always resented the assumption that MLTs dont know what they are doing. The role and requirements are below. Information on policies or practices are solely from my personal experience ONLY and have NO relation to my affiliation with any regulatory or government agency. result, it may not include the most recent changes applied to the CFR. However, according to CLIA regulations, MLTs should only work in moderate complexity testing areas that require limited independent judgments. Matthew, I agree with you. Regulations and Statutes Enforced by LFS Regulations and statutes that pertain to LFS regulatory responsibility. Once ISDH performs the survey and determines that your laboratory is compliant with applicable CLIA regulations, a certificate fee coupon will be mailed to you. Background and more details are available in the Occasionally, a validation inspection is conducted to evaluate the accrediting agency inspection process. Navigate by entering citations or phrases (A) Minimal interpretation and judgment are required to perform preanalytic, analytic and postanalytic processes; and (B) Resolution of problems requires limited independent interpretation and judgment. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Hospital satellites or auxiliary laboratories located outside a hospital must each make a separate application. What are the requirements for testing personnel? All information these cookies collect is aggregated and therefore anonymous. What does this mean? For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology (dentists), 42 U.S.C. For commercially available FDA-cleared or approved tests, FDA scores the tests using these criteria during the pre-market approval process. complicated laboratory tests requiring the most rigid testing requirements outlined in the CLIA regulations. Changes in ownership, location, and type of testing performed must be reported to the following agency within 30 days of the change. All facilities performing laboratory testing are subject to inspection by CMS. These facilities are inspected every two years to ensure compliance with federal regulations. user convenience only and is not intended to alter agency intent It would not be in compliance with the regulations when the clinical laboratory general supervisors are chosen from MLTs or related field, such as cytology or histology or radiology. 5 - Calibration, quality control, and proficiency testing materials, 6 - Test system troubleshooting and equipment maintenance. (ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (A) Have earned a high school diploma or equivalent; and, (B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. A new CMS 116 CLIA Application may be completed for any changes. Check it out in the link you provided. Unfortunately, Caroline Satyadi, Federal Regulation 493.1489 says that associate degree (MLT) can perform high complexity testing. Proof of these requirements for the laboratory director must be provided and submitted with the application. 14, 1990, unless otherwise noted. A separate drafting site Multiple laboratories may operate at the same physical location (e.g., same building or suite, as applicable) with separate CLIA numbers as long as each laboratory can demonstrate that it is operating as a separate and distinct entity. under CLIA that meet requirements to perform high-complexity tests. Saving Lives, Protecting People, Clinical Laboratory Improvement Amendments (CLIA), list of PPMP tests (including CPT/HCPCS codes), FDAs Tests Waived by FDA 2000 to Present, CMS List of Tests Granted Waived Status Under CLIA, U.S. Department of Health & Human Services, Certain tests listed in the CLIA regulations, Tests that the manufacturer applies to the FDA for waived status by providing scientific data that verifies that the CLIA waiver criteria have been met. Laboratories that perform Nanobiosym is looking for a General Supervisor for its High-Complexity Testing CLIA LAB. Requests to terminate your CLIA certificate must be submitted in writing to ISDH. WebCenters for Medicare and Medicaid Services , the Food and Drug Administration , and the Centers for Disease Control and Prevention all play a role in ensuring quality lab testing in the United States. Score 3. For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology (dentists), Reimbursements by Medicare may be denied if the test submitted does not match the certificate. WebNanobiosym is hiring for a Testing Personnel ASCP, for its High-Complexity Testing CLIA LAB. It is up to STATE regulations or even facility preference to hold higher qualification standards. The categories of tests a laboratory offers is also a factor in determining the appropriate CLIA certificate for the laboratory. High-complexity tests should be performed in a CLIA accredited WebQualifications specified in the CLIA regulations to direct a clinical laboratory offering high complexity genetic molecular biology tests Experience as a lab director with advanced genomics technologies, performing high-complexity molecular and genetic testing [57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5236, Jan. 19, 1993; 58 FR 39155, July 22, 1993; 60 FR 20050, Apr. Please click on the link below and follow the instructions: Documentation Required for Change for Indiana CLIA Information for Laboratories. under Tools to verify laboratory information. Contact CMS directly at CMS Lab Excellence for questions about a CLIA certificate. SEARCH ON EXEMPT LABORATORIES ONLY. Select a column header to sort the results. Select Export to get an MS Excel spreadsheet of your search results with a more comprehensive categorization of data. https:// Complaints and revisit surveys are always unannounced. These terms do not relate directly to the test complexity categories, and it cannot be assumed that a test system is waived simply because it is performed at the point of care. I have a question regarding MLTs working in Micro, if anyone will be able to answer. I am the key operator of the Vitek and the BacTalert. Currently, there are 12 states with laboratory personnel licensure requirements (California, Florida, New York, North Dakota, Rhodes Island, Tennessee, Louisiana, Nevada, West Virginia, Montana and Georgia). FAR). Score 3. While some point-of-care tests are approved for a CLIA waiver, advances in technology that enhance the rapidity of testing enable more complex, nonwaived testing to be performed at or near the site of patient care. For commercially available FDA-cleared or approved tests, FDA scores the tests using these criteria during the pre-market Point-of-care testing is a phrase used to describe the location where testing is performed, such as at the bedside or near the site of patient care. and documentation of training before performing tests. Full payment must be received before a compliance survey will be scheduled by ISDH. Currently, the Indiana State Department of Health (ISDH) does not license laboratories or laboratory personnel. CLIA covers around 320,000 laboratory entities. The surveyor will schedule routine surveys within six months of the certificate expiration date. However, the Medicare regulation specifies that the "authorized person" must be a doctor with a current state medical license. 5 and 1/2 years after being published and several commenters pointing out the major error contained in it, this article remains uncorrected. CLIA 88 regulations for minimum personnel requirements do not reflect the associated liability and potential effect on patient safety related to examining tissue specimens. Some of these tests are even available over the counter. They are excellent laboratorians whom I would trust with my life. or Share sensitive information only on official, secure websites. Certificate of Accreditation Facilities with this type of certificate have opted to have a CMS approved accrediting agency perform the biannual inspections instead of CMS for an additional fee. WebClinical laboratory test systems are assigned a moderate or high complexity category on the basis of seven criteria given in the CLIA regulations. Patients may also be considered individuals responsible for using test results if state law does not expressly prohibit release of test results directly to patients. 2)The hours of operation must be specified for each laboratory. Please follow the instructions below. IVD Regulatory Assistance, Recalls, Market Withdrawals and Safety Alerts, Clinical Laboratory Improvement Amendments (CLIA), Device Advice: Comprehensive Regulatory Assistance, Administrative Procedures for CLIA Categorization. 2. require a high level of independent judgment and should only be performed by MTs. A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services. In some instances the terms can be interchangeable: all testing personnel are lab personnel but not all lab personnel are testing personnel. Those regulations required, among other things, for laboratories conducting moderate or high-complexity testing to enroll in an approved proficiency testing (PT) program for each specialty, subspecialty, and analyte or test for which the laboratory is certified under CLIA. Local state regulations must also be considered when using lab tests on the CLIA-waived list. Renewed CLIA certificates will be mailed approximately two weeks prior to your current expiration date if full payment of CLIA fees is received. CMS 116 CLIA Application: http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads//cms116.pdf, Enclosure A Disclosure of Ownership (Also, include documents requested on page 1: IRS letter of Tax ID and Secretary of State Certification), Proficiency Testing: 2011 CLIA Approved Proficiency Testing Providers: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//ptlist.pdf, Additional Information on Proficiency Testing:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//CLIAbrochure8.pdf, CLIA Brochure:http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads//CLIABrochure.pdf, Calibration and Calibration Verification Procedures:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//6065bk.pdf, Good Laboratory Practices for Waived Laboratories:https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//wgoodlab.pdf, How to obtain a CLIA certificate:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//HowObtainCLIACertificate.pdf, Laboratory Complaints:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//CLIAbrochure9.pdf, Laboratory Director Responsibilities:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//brochure7.pdf, Certification Boards for High Complexity Laboratory Directors:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Certification_Boards_Laboratory_Directors.html, CME Credits for Moderately Complex Laboratory Directors:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CME_Courses_for_Laboratory_Directors_of_Moderate_Complexity_Laboratories.html, Verification of Performance Specifications:http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//6064bk.pdf, OSHA Blood Borne Pathogens standards:http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051, Individualized Quality Control Plan (IQCP):https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html, Individualized Quality Control Plan (IQCP) Developing an IQCP:https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/IQCP-Workbook.pdf, Ready Set Test:http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/ReadySetTestBooklet.pdf, To Test or Not to Test:http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/WavedTestingBookletWeb.pdf, What Do I Need to Do to Assess Personnel Competency?:https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf. contains the commercially-marketed in vitro test systems categorized by FDA since January 31, 2000, as well as tests categorized by Centers for Disease Control and Prevention prior to that date. Local state regulations must also be considered when using lab tests on the CLIA-waived list. lock CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Coupons for CLIA Certificate of Wavier, Certificate of Microscopy and Certificate of Accreditation renewals will be mailed out six months prior to your current certificate expiration date. They were not even offered either position! Who knows? Reviews and reports lab results. Otherwise, the FDA determines the tests complexity by reviewing the package insert test instructions, and using a criteria scorecard to categorize a test as moderate or high complexity (42 CFR 493.17). For further information, please see http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//CLIA_certificate_fee_schedule.pdf. The final score determines whether the test system is categorized as moderate or high complexity. Since CLIA has regulated this as high complexity testing, are MLTs not allowed to perform any aspects of susceptibility testing, particularly setting up the testing such as picking isolated pure colonies and preparing a 0.5 McFarland, and loading onto an instrument such as Vitek 2 or inoculating a lawn onto a Mueller Hinton plate? 0
I am a MLT and I have been working in Microbiology performing ALL aspects of testing. Certificate of Compliance or Certificate of Accreditation: Fees depend on the annual test volume and number of laboratory specialties/subspecialties. Complaint investigations are performed as needed. WebUnder CLIA, a laboratory is defined as a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of health of, human beings. site when drafting amendatory language for Federal regulations: My understanding is, for example an HTL qualifies as testing personnel but a histology trainee would then qualify to be lab personnel? The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for In addition, not just anyone can perform the assessments. WebNanobiosym is hiring for a Testing Personnel ASCP, for its High-Complexity Testing CLIA LAB. For a general overview of CLIA certificate types, see CMS Clinical Laboratory Improvement Amendments (CLIA) Brochure. Score 1. I feel that the testing personnel should be at least overseen by MTs for the purpose of maintaining a quality standard (ie; MT supervisors). Failure to submit this information will delay the processing of your application. WebNanobiosym is hiring for a Testing Personnel ASCP, for its High-Complexity Testing CLIA LAB. WebThe type of CLIA certificate a laboratory obtains depends upon the complexity of the tests it performs. So now there is only 2 MLTs in micro! WebQualifications specified in the CLIA regulations to direct a clinical laboratory offering high complexity genetic molecular biology tests Experience as a lab director with advanced genomics technologies, performing high-complexity molecular and genetic testing If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Regulation Y The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. Sign up to get the latest information about your choice of CMS topics. Content disclaimer: posts written by our bloggers may contain content that is not the opinion, stance, or policy of the ASCP. WebCLIA Regulation 42 CFR Part 493.1489 would apply for high complexity testing personnel qualifications. Include laboratory name, CLIA number, name of the laboratory director and/or owner, the reason your certificate should be terminated, the effective date of termination, your laboratory contact information and the signature of the laboratory director or his/her designee. These tests include: microscopic sediment analysis, wet preps, KOH preps, and other microscope based procedures. For tests classified as moderately complex, testing personnel must have at least a high school diploma or G.E.D. Tracy, (3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (4) On or before April 24, 1995 be a high school graduate or equivalent and have either -, (i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Certificates must be renewed every two years for as long as testing is being performed. Under the nonwaived category are moderate- and high-complexity testing. The only requirements for this type of testing are that the manufacturer's instructions are followed exactly and perform only waived tests. Clinical laboratories or other testing sites need to know whether a test system is waived, moderate, or high complexity for each test on their menu because this determines the applicable CLIA requirements. Provider Performed Microscopy (PPM) These are tests performed by a health care provider such as a doctor, physician's assistant, or nurse practitioner. Accept and Processes and tests all types of laboratory specimens; reviews and reports lab results. The Technical Supervisor for high complexity testing (42 CFR 493.1451(b)(8)) is responsible for performing and documenting competency assessments. This responsibility can be delegated, in writing, to a General Supervisor as long as the GS meets the regulatory qualifications as a GS for high complexity testing. It is recommended that each laboratory follow Good Laboratory Practice including documenting training performed for each person performing tests. WebMedicare/CLIA independent lab personnel requirements Testing Personnel (include total # of personnel performing testing in front of appropriate categories) as high complexity testing director before 2/24/03 ___5. For example, some laboratories allow medical lab technicians (MLTs) to perform high-complexity testing due to the medical lab technologists (MTs) shortages across the country. An official website of the United States government (A) Minimal training is required for preanalytic, analytic and postanalytic phases of the testing process; and (B) Limited experience is required to perform the test. Thank you for taking the time to confirm your preferences. Following categorization, a manufacturer of a test categorized as moderate complexity may request categorization of the test as waived through a CLIA Waiver by Application (CW) submission to the FDA. This content is from the eCFR and may include recent changes applied to the CFR. CMS maintains a complete list of PPM tests. CLIA Proficiency Testing Final Rule The Proficiency Testing Final Rule was published on July 11, 2022. A test is designated moderate or high complexity after being evaluated on seven criteria: Knowledge; Training and experience; Reagents and materials preparation If youd like more information about these regulations, please read the Code of Federal Regulations part 493. The role and requirements are below. Thank you for posting this, it was very informative. The lab director is responsible for assessing employee competency. will bring you directly to the content. Copyright 2023 State of Indiana - All rights reserved. A state licensed physician who is board certified or board eligible in anatomic or clinical pathology meets the requirements to direct a laboratory of any complexity. The FDA will notify the sponsor of their CLIA categorization usually within two weeks of the marketing clearance or approval. WebApplication Information and Resources: CLIA The Certificate of Compliance and Certificate of Accreditation authorizes a high complexity laboratory to perform all levels of testing. A non Other sources of information are the Indiana Professional Licensing Agency (IPLA), Indiana Board of Pharmacy, and the Indiana Board of Nursing. All other individuals who wish to direct a laboratory holding a Certificate of Compliance or a Certificate of Accreditation should call 317-233-7502 for further information. Acceptable documentation includes a copy of a letter from the laboratory to the accrediting program requesting laboratory accreditation, a copy of the laboratory accreditation application submitted to the accrediting program, or a welcome letter from the accrediting program to the laboratory.
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