switch to drafting.ecfr.gov. information or personal data. (1) Meet one of the following requirements: (i) (A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and. We look forward to reviewing your resume. Learn more about the eCFR, its status, and the editorial process. The qualifications required for the role of general supervisor can be found at CLIA regulation 42 CFR 493.1461. (2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology. 0000003012 00000 n 3. (ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. will bring you to those results. In high complexity testing environments (all blood bank is high complexity) to be a general supervisor you only need an associates degree and two years experience of high complexity testing. A Technical Supervisor is responsible for the technical and scientific oversight of a laboratory performing high complexity testing. 4. The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical supervision for each of the specialties and subspecialties of service in which the laboratory performs high complexity tests or procedures. (2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. endstream endobj 293 0 obj<>/OCGs[295 0 R]>>/PieceInfo<>>>/LastModified(D:20071227092830)/MarkInfo<>>> endobj 295 0 obj<>/PageElement<>>>>> endobj 296 0 obj<>/Font<>/ProcSet[/PDF/Text]/ExtGState<>/Properties<>>>/StructParents 0>> endobj 297 0 obj<> endobj 298 0 obj<> endobj 299 0 obj<> endobj 300 0 obj[/ICCBased 306 0 R] endobj 301 0 obj<> endobj 302 0 obj<> endobj 303 0 obj<>stream (a) The technical consultant must possess a current license issued by the State in which the laboratory is located, if such licensing is required. Navigate by entering citations or phrases You are using an unsupported browser. (ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Please review the list of responsibilities and qualifications. y'(C-:) &B(v+ >PH2Mpeb6'0 List any licenses or certifications required by the position: (1) Meet one of the following requirements: (A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and. Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in at least one (1) state in the U.S. and have successfully completed 32 semester hours (minimum) in chemistry or the biological sciences acceptable to the board and have at least one (1) year of clinical laboratory training or experience within the ten (10) years immediately prior to the application date on human specimens, or a combination of both, in high complexity testing within the specialty; Hold an earned masters degree from an accredited institution (see rule 11 under General Regulations) in a chemical, physical, biological or clinical laboratory science or medical technology and have successfully completed 32 semester hours (minimum) in chemistry or the biological sciences acceptable to the board and have at least two (2) years of clinical laboratory training or experience within the ten (10) years immediately prior to the application date on human specimens, or a combination of both, in high complexity testing within the specialty; Hold an earned bachelors degree from an accredited institution (see rule 11 under General Regulations) in a chemical, physical or biological science or medical technology and have successfully completed 32 semester hours (minimum) in chemistry or the biological sciences acceptable to the board and have at least four (4) years of clinical laboratory training or experience within the ten (10) years immediately prior to the application date on human specimens, or a combination of both, in high complexity testing within the specialty. 0000093711 00000 n This is not a requirement for ELD certification. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must -, (i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent. Ten (10) competencies listed in this document reflect those considered as most important for successful performance of . (3) An individual qualified under 493.1449(b) or paragraph (m) (1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m) (1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. Information on study materials and strategies to successfully challenge the ABB exams. (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must -. (ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. Technical, Engineering, Education, Science, Medical Technology, Management, Performance, Medical Science, Computer Science, Graduate. - Instantly download in PDF format or share a custom link. The director of a laboratory performing high complexity testing may function as the technical supervisor provided he or she meets the qualifications specified in this section. Find details on ABB's CLIA-approved supervisor and director certifications and the application process. Uses technical skills to influence strategic direction. (3) For tests in ophthalmic pathology, meet one of the following requirements: (B) Must meet one of the following requirements: (2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certitication and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or, (ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must -, (ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or, (ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or, (ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or. Enforces safety policies and recommends changes . Search | Help | Sitemap | Contact ABB | Return and Cancellation Policy | Privacy Policy, The American Board of Bioanalysis (2) For tests in dermatopathology, meet one of the following requirements: (i) (A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and -. (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and -, (ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or, (2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or. 0000006411 00000 n The laboratory must have a technical consultant qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties tested. 55 FR 9576, Mar. CLIA Section Role Complexity . All rights reserved. degree, or the equivalent, must also be licensed to practice medicine in at least one (1) state in the U.S. This is an automated process for Technical supervisors usually study business, electrical engineering or computer science. HTP=o0+\~H0DpU{tFKqq+kNX.g=+2m 8w4:h! 493.1449 Standard; Technical supervisor qualifications. Effective January 1, 2021, Molecular Diagnostics is defined as "testing that involves the manipulation and examination of nucleic acid in a high complexity testing environment." For Immunology, Chemistry, Hematology, or Radiobioassay: Licensed MD/DO.DPM or Ph.D. AND certified in clinical pathology OR 1 year lab training or experience in the high complexity testing specialties performed Supervisor Hiring guide Consider modifying CLIA requirements for technical consultants at 493.1411 (b)(4)(i-ii) to add the option that individuals with an associate degree in chemical, biologic, or medical (ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. The technical supervisor requirements for laboratory training or experience, or both in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. 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 personnel qualification requirements of education, experience, and training for the position in order to fulfill the responsibilities. xbbg`b``3 H` b (ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. 292 22 (1) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must -, (ii) Meet one of the following requirements -, (A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or. Our growing company is searching for experienced candidates for the position of technical supervisor.