The Clinical Laboratory Improvement Act of 1977. Statement submitted to Subcommittee on the Public Health and Environment, Committee on Interstate and Foreign Commerce, US House of Representatives.

Hanscom, Donald, MD, FACP (presented testimony).

Laboratories

Thu, 08/17/2000 - 5:58 PM EDT

Thu, 08/17/2000 - 6:01 PM EDT

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asim_testimony_on_clinical_lab_improvement_act_1977.pdf

{"Author":"Hanscom, Donald, MD, FACP (presented testimony).","Producer":"Acrobat 4.0 Scan Plug-in for Windows\u0000","Creator":"Acrobat 4.0 Capture Plug-in for Windows\u0000","Keywords":"Laboratories","ModDate":"2000-08-17T15:01:24-07:00","Abstract":"In response to the Clinical Laboratory Act of 1977: ASIM has made a continuing appeal that qualifications of a laboratory director and other supervisory and technical personnel be based on demonstrated proficiency of performance rather than solely on designated educational or training criteria. ASIM is pleased to see that the bill prescribes qualifications which may include licensure, training and experience requirements or any combination of such requirements for supervisory and technical personnel. ASIM supports sections which will allow training and experience to be substituted for formal education. ASIM supports the section that allows for standards to vary on the basis of the type of test or other procedures or services performed or the purposes for which such tests, procedures or services are performed. ASIM believes that the requirement for blind proficiency testing if required under the national standards would be prohibitively expensive in both money and manpower. To advocate general use of blind proficiency testing from its limited experience in drug level testing seems premature. ASIM would like to see further demonstration of the usefulness of blind proficiency testing for assessing laboratory performance. ASIM also believes it necessary to correlate blind proficiency testing with effective continuing education programs for improvement in areas of recognized deficiency. ASIM therefore recommends the deletion of the requirement for blind proficiency testing. Sub-paragraph's (D) (i) (I) and (II) of Section 353 (c) (2) state that the national standards shall not apply to the office laboratory operated by a physician or group of physicians in which the only tests performed are performed by such practitioner in connection with the treatment of his patients. ASIM does not believe this provision will aid in upgrading the quality of laboratory performance. ASIM believes all laboratories will benefit from participation in an external proficiency testing program including those where the tests are performed by a physician for his own patient. Sub-section (n) establishes an Advisory Council. ASIM is pleased to see it shall include representation from a variety of groups. ASIM is pleased to see that Sub-section (0) would establish the office of clinical laboratories expressly under the direct supervision of the Assistant Secretary of Health. Since clinical laboratory testing is an integral part of the delivery of medical care, regulations concerning clinical laboratories need to be considered along with other elements of the medical care delivery system and Subject to the same review efforts. ASIM believes the appropriate manner for coordination of activity and regulation relating to clinical laboratories should involve local professional standards review organizations. Section 1902 (a) (23) as it now stands, allows an individual to choose the physician or facility he wishes to provide him with services. We believe this option should be retained and Section (4) (b) (1) deleted.","Title":"The Clinical Laboratory Improvement Act of 1977. Statement submitted to Subcommittee on the Public Health and Environment, Committee on Interstate and Foreign Commerce, US House of Representatives.","DocType":"Formal Statement","CreationDate":"2000-08-17T14:58:29-07:00","DateApproved":"1977-06-14","Pages":6}

1977