Rhode Island Code of Regulations
Title 216 - Department of health
Chapter 60 - Laboratories and Medical Examiner
Subchapter 05 - State Laboratory
Part 4 - Clinical Laboratories and Stations (216-RICR-60-05-4)
Section 216-RICR-60-05-4.11 - Practices and Procedures, and Violations
Universal Citation: 216 RI Code of Rules 60 05 4.11
Current through September 18, 2024
4.11.1 Variance Procedure
A. The
licensing agency may grant a variance either upon its own motion or upon
request of the applicant from the provisions of any rule or regulation in a
specific case if it finds that a literal enforcement of such provision will
result in unnecessary hardship to the applicant and that such variance will not
be contrary to the public interest, public health and/or health and safety of
patients. The provisions of this section shall not be applicable to the
requirements of §§4.8.2(A) and (B) of this Part pertaining to the
director of the clinical laboratory.
B. A request for a variance shall be filed by
an applicant in writing setting forth in detail the basis upon which the
request is made.
1. Upon the filing of each
request for variance with the licensing agency and within a reasonable time
thereafter, the licensing agency shall notify the applicant by certified mail
of its approval or in the case of a denial, a hearing date, time and place may
be scheduled if the station or clinical laboratory appeals the
denial.
4.11.2 Violations
In addition to revocation or suspension of licenses granted, any person who violates the statutory or regulatory provisions herein shall be subject to the sanctions of R.I. Gen. Laws § 23-16.2-13.
4.11.3 Rules Governing Practices and Procedures
All hearings and reviews required under the provisions of this Part herein shall be held in accordance with the rules and regulations regarding Practices and Procedures Before the Department of Health (Part 10-05-4 of this Title) and Access to Public Records (Part 10-05-1 of this Title).
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