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State laws and regulations that affect your medical practice

1. What is the definition of a medical test unit?

"Medical test unit" means any facility or other area used for any physical, physiological or laboratory examination of persons to detect abnormalities of blood, urine, bodily organs or functions, or of any parts or the whole of the human body, for the purpose of providing information for the diagnosis, prevention or treatment of any human disease or impairment or for the assessment of human health.

C.G.S.A. § 19a-115

(a) The owner shall apply to the Department of Health for registration or renewal biennially on forms provided by the department. No health testing or examinations shall be performed until the registrant has received a registration certificate from the department. No health testing or examinations shall be performed after a registration is expired, suspended or revoked.

(b) The registration certificate or a readable copy of it shall be posted at a location readily visible to those using the medical test unit. In those instances where the medical test unit operates in more than one location, a copy of the registration certificate shall be posted in each location.

( c ) Applications for renewal of registration shall be signed by the owner designating a registrant who shall not be a corporation, a permanent home office address to which the certificate is to be issued, and all permanent satellite facilities. Application shall be made biennially within thirty (30) calendar days prior to expiration of the registration, accompanied by a fee of $200.00.

(d) The owner shall update the registration by notifying the department in writing at least fourteen (14) days before:

(1) a change in ownership;

(2) a change in registrant;

(3) a change in director; or

(4) expansion or alteration in the part of the building housing the medical test unit.

CT ADC § 19a-115-2

3. What are the conditions of operation of medical test units?

(a) Responsibilities of registrant are as follows:

(1) designate a director to be in control of the medical test unit;

(2) employ a physician licensed in this or any other state to: supervise the development of medical policy, periodically review health testing, provide medical interpretations and decisions to staff, explain medical interpretations and decisions to subjects and physicians of reference;

(3) ensure the proper performance of all tests and examinations; and

(4) designate an alternate who shall assume the director's responsibilities in the absence of the director.

(b) Responsibilities of the director are as follows:

(1) ensure the continuous application of quality control procedures in accordance with recommendations and directions from the department;

(2) maintain standardization and calibration of instruments;

(3) supervise services;

(4) supervise the performance of the staff and be readily available for in-person or telephone consultation;

(5) arrange counseling for subjects, both before and after the examination; and

(6) ensure that the medical test complies with all applicable state and federal statutes and regulations.

( c ) Facility and equipment:

(1) The space in which examinations are conducted or specimens collected shall be kept free from filth, excessive dirt, litter, or other unsanitary conditions. The area shall be adequately lighted and ventilated. They shall be adequately equipped for the work, of adequate size, and arranged for the proper conduct of the work. The area shall be free from safety hazards. Smoking and the consumption of food or beverages shall be prohibited in those areas where the examination or collection of specimens is performed. There shall be refrigeration available where specimens are stored. No food or beverage shall be stored in a refrigerator or freezer used for storing specimens or potentially infectious materials.

(2) Equipment shall be in good working order and appropriate to the work for which the registration certificate is held.

(3) There shall be an area for testing, with privacy and conditions that are conducive to accurate testing.

(4) Facilities shall be available for hand washing for staff after each subject, and for cleansing of equipment.

(5) A source of clean drinking water and a toilet shall be readily available on the premises for use by subjects as well as staff.

(d) Testing standards:

(1) Appropriateness of test or examination. Tests selected shall be based upon specifications of the physician of reference, or if they were not requested by a physician, upon the recommendations of the medical test unit's supervising physician or a municipal or district director of health.

(2) Utilization of current methodology and technology. All examinations and tests performed shall be within accepted standards for medical and laboratory practice.

(3) Follow up. When a test produces abnormal values, the supervising physician, director, or designated alternate shall expeditiously inform the physician of reference.

(e) Records and Reports:

(1) A dated record of the examination and testing, findings obtained, and disposition shall be made and kept on file for a minimum of two (2) years. Such record shall be kept confidential and available only to the subject, physician of reference, and other persons authorized by law.

(2) The registrant shall file with the department a list of out-of-state medical test units, laboratories, or testing sites to which specimens are referred, stating the types of tests or examinations, interpretations, or analyses for which such specimens are submitted.

(3) A report of findings shall be provided to the physician of reference or other persons authorized by law.

(4) Any laboratory finding that is reportable under Connecticut regulations shall be reported as required under those regulations.

CT ADC § 19a-115-3

3. What are the qualifications required of personnel at medical test units?

(a) Director: The director of a medical test unit shall be deemed qualified when the registrant documents to the satisfaction of the commissioner that the director possesses the training and experience necessary to fulfill the responsibilities for the type of health testing and laboratory examinations performed in that particular medical test unit. A certificate of qualification shall be issued by the Department of Health to a person qualifying as a director.

(b) Each person engaged in the performance of tests and examinations in the medical test unit shall be at least a high school graduate, and shall possess documentation of having demonstrated to the director of that medical test unit proficiency in the skills required for that particular job.

( c ) Physicians and nurses providing services to subjects shall be in compliance with the appropriate licensing or certification required by the State of Connecticut for that profession.

CT ADC § 19a-115-4

4. How long must records be kept at medical test units?

All records, memos and reports, medical or others such as personnel and payroll reports shall be maintained on the premises of the facility for a minimum of two years.

CT ADC § 19a-115-5

5. What are the grounds for suspension or revocation of registration?

Registration may be suspended or revoked whenever, in the judgment of the commissioner, any one of the following conditions exists:

(a) the medical test unit has operated in violation of any applicable statute or regulation, or the terms of its registration;

(b) the findings of the medical test unit are found after investigation to be inaccurate or unreliable beyond the limits of error inherent in the particular testing method used;

( c ) findings have been reported on health testing that was either not conducted, or not subjected to the examination implicit in such findings;

(d) the owner or registrant has failed to comply with instructions from the commissioner for the correction of conditions adversely affecting the quality of work; or

(e) any condition of the medical test unit is deemed harmful to the public health.

CT ADC § 19a-115-6

Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.

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