Section 216-RICR-20-10-1.5 - Delivery of Services1.5.1Medical Direction && ResponsibilityA. Every person conducting or operating a screening program shall enter into a provider arrangement with either a physician or an independent clinical laboratory or a clinical laboratory of a hospital, all of whom must be licensed in Rhode Island, and who will be responsible for the overall medical direction and supervision of the operation of the screening program and services and ensure the delivery of quality services, unless the person conducting or operating the screening program is either a physician, an independent clinical laboratory, or a hospital clinical laboratory licensed in this state. 1. Furthermore the person responsible for the medical direction of the screening program shall: a. Develop and/or approve the professional components of the screening program(s) including policies and procedures governing the technical practices pertaining to no less than the provisions of §1.4.2(A) of this Part; andb. Ensure that the specific screening tests being offered shall be conducted in a manner consistent with the guidelines established by the Rhode Island Department of Health, Division of Facilities Regulation.1.5.2PersonnelA. Staff Personnel 1. On-site Supervisor a. Every screening program shall have a person designated to supervise the program and personnel;b. The supervisor shall be a medical health professional, licensed and/or registered in this state, who must have the appropriate training in the specific instrumentation(s) to be used in conducting the screening program. The training shall consist of no less than one (1) day (i.e., 7 hours) training conducted by an experienced laboratory instructor (at the minimum level of a medical technologist). Said training shall consist of instruction in no less than: (1) Calibration and operation of the specific instrument(s) to be used in the screening program;(2) Detecting problems and performing usual instrument maintenance;(3) Handling emergencies and medical waste;(4) Participant education and referral protocols; and(5) Such other areas as may be deemed relevant.c. Furthermore, the on-site supervisor shall be required to be on the premises at all times during the screening program and shall be responsible to oversee the work performance of the individuals conducting the screening tests in order to ensure the accuracy of the methods and the maintenance of quality controls and the provision of appropriate education and/or referral.2. Screening Personnel a. Individuals performing procedures defined herein as "limited function tests" shall be required to complete a training program that shall consist of no less than a minimum of one (1) day's training (i.e., 7 hours) conducted by experienced laboratory trainer(s) and shall include no less than:(1) Calibration and operation of the specific instrument (s) to be used;(2) Detecting problems and performing usual instrument maintenance;(3) Educational and referral protocols; and(4) Such other areas as may be deemed relevant.b. In addition to this training, a minimum of one (1) week (i.e., 35 hours) supervised field experience in operating the instrument(s) shall be required. Screening personnel shall be subject to ongoing supervision for all aspects of their performance at the screening program.3. First Aid or Cardiopulmonary Resuscitation (CPR)a. At least one (1) staff person shall hold a current certificate in first aid or CPR and must be on the premises and available at all times during the testing.B. Worker Safety 1. In order to protect screening personnel from occupational exposure to blood borne pathogens, procedures for workers' safety should be carried out in accordance with the Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogen Standards, 29 C.F.R. § 1910.1030 (2017). Work practices should be designed to minimize or eliminate exposure to blood and other body fluids.1.5.3Methodologies for Quality ControlA. Each screening program shall establish an acceptable internalprogram of quality control covering each type of screening procedure performed for the verification and assessment of accuracy, measurement of precision, and detection of error. The factors which constitute the quality control provisions shall be based on current acceptable national standards of practice.B. Each screening program shall establish an acceptable external program of quality control covering each type of screening procedure performed for the verification and assessment of accuracy, measurement of precision, and detection of error. The factors which constitute the quality control provisions shall be based on current acceptable national standards of practice.1.5.4Prohibitions Against ReferralNo licensed physician or clinical laboratory shall make any referral which would violate the provisions of R.I. Gen. Laws §§ 23-16.2-5.1 or 5-37-21, or any other relevant provisions of the law.
216 R.I. Code R. 216-RICR-20-10-1.5