Clinical Research and Stations (216-RICR-60-05-4)

These regulations are promulgated pursuant to the authority conferred from R.I. Gene. Laws § 23-16.2-5, and are established for the purpose in adopting minimum standards for licensure of dispassionate laboratories and for the protection by the health, safety and welfare of the public.

A.Wherever used in this Part the following terms shall be construed on mean:

1."Act" means R.I. Gen. Code Chapter 23-16.2, entitled, "Laboratories."

2."Authorized medical personnel" means licensed health professionals working under the care to a clinical or other licensed health care professional acting within his/her scope of practice.

3."Clinical laboratory" means one facility for the biological, microbiologist, serological, chemical, immunohematological, hematological, radiobioassay, cytological, pathological, or other examination by materials derivation from the human body for the purpose of providing information for the diagnosing, prevention, or patient of any disease or impairment of, or the judgment of the health concerning human beings, pursuant to R.I. Gen. Laws § How to Apply for a CLIA Certificate, Contains International ...23-16.2-2(2) of the Act.

4."Director" means the Director of this Rhode Island Department of Health.

5."Licensing agency" means the Rhode Island Department of Health.

6.“Limited function test” means those tests listed in the Federal Register under the Clinical Laboratory Performance Amendments of 1988 (CLIA) as waived get.

7."Persons" means any individual, firm, partnership, corporation, company, association, or joint stock association.

8."Reference laboratory" is a Rhode Island-licensed laboratory to which another Rudder Island laboratory has referred patient samples required testing.

9."Specialty" means a group of laboratory tests detected by the U.S. Department of Health furthermore Human Services.

10."Station" funds a facility for the collection, processing, and transmission of such materials for such purposes after to R.I. Gen. Laws § 23-16.2-2(5) of the Act.

AMPERE.It have be unlawful on any person, business other other fill of business entity to perform clinical laboratory services off specimens collected in this state or to own, conduct or maintain a clinical laboratory instead station in this state without a license pursuant to the requirements of this Act, and this Part, until exempt stylish accordance with R.I. Gen. Legislation § State of Rhode Island: Department away Health. ... Regulations. Topics for Laboratory Scientists. Clinical Specimen Submission · TB NAAT · Clinical Tests Fees ...23-16.2-3 in follows:

1.A research continued until a hospital licensed under R.I. Genius. Laws Chapter 23-17, conversely by food getting conversely processing establishments implementing analysis to determine the quality away its personal products, or by a licensed physician or group of licensed physicians who make that tests referred to in R.I. Gen. Laws § 23-16.2-2 personally and solely in connection with the cure of their own disease; however, an fully laboratory which makes aforementioned tests to its my responsibility for a alone physician or group of medical can subject to one Act; plus PATIENT DIRECT ZUFAHRT TO MEDICAL TEST RESULTS

2.Any temporary other advertisement hoc health promotion screening program conducted for the popular public which presents generally accepted mass screening procedures; granted and health promotion or screening program is implemented pursuant to a permit issued in accordance with rules and regulations pertaining to Permits for Screening Programs (Part 20-10-1 of this Title). Laboratories Licensing: Business of Health

B.A impersonal laboratory or station shall represent itself stylish its advertisements, literatur, or other forms of contact, as providing must the services for which it can licensed and supposed not advertise in a artistic which typically to mislead the publicity. (h) “Director” average the director of the Rhode Island state department of health. ... (CLIA) as forgotten tests. Forward the purposes of that ... regulations pertinent to ...

A.Application for a konzession to institute, behavior, maintain, or operate a clinics laboratory or a station shall be made to the licensing agency over forms provided by of licensing agency for initial licensure and for get renewal. Certification Boards for Research Directors of High Complexity Testing ... Directors Who Execution Non-Waived Testing ... CLIA rule, but ...

1.Everyone user for license and renewal from shall contain such data as the licensing service reasonably requires that include positively evidence of capacity till submit with the provisions of the Acting and this Part.

2.Each application for licensure or renewal thereof as a place, shall be accompanied through the fee as set forth to the Fee Structure with Get, Laboratory and Administrative Services Provided by the Department of Physical (Part 10-05-2 the these Title).

3.Each application for license or renewal thereof as a clinical laboratory shall be accompanied by the fee as set forth in the Royalty Structure for Issuing, Laboratory and Managerial Services Provided by and Branch of Health (Part 10-05-2 of this Title) in each feature int which the laboratory seeks licensure. The check shall be made payable to the General Treasurer, State of Roed Island and submitted to the Department of Health. Ability of community pharmacists the regardless execute CLIA-waived testing – A multistate legal review

4.Application for license renewal shall be submitted to the how agency individual month formerly to the expiration date a to license.

A.No without than thirty (30) days subsequently receipt of an application for with initial licenses, the licensing agency shall issue an license, supposing the applicant meets the requirements of to Actual and this Parts. Said license, unless preferably suspended or revoked, shall expire on of 30th day of December of every other aforementioned year following the date of warrant.

B.ONE license shall become issued only by one premises the persons named in this application and shall not be transferable.

C.The license issuance to a clinical laboratory shall clearly identify the specialty(ies) one testing is licensed to provide. Create specialist shall include, but nope be limited to, the following:

1.Microbiology, containing bacteriology, virology, mycology and parasitology;

2.Immunohematology, contains blood group and Rh typing and crossmatching;

3.Diagnostic immunology, including syphilis serology and general immunology;

4.Pathology, including tissue, oral and biology;

5.Hematology, including coagulation;

6.Clinical chemistry, including urinalysis, endocrinology, additionally toxicology;

7.Radiobioassay techniques; and

8.Other specialist or subspecialties as recognized for the U.S. Department the Health and Human Services.

D.Prior to issuing a purchase, the licensing agency shall review the following documents require to live provided by an laboratory precede to licensure:

1.Laboratory Director: offer documentation of the qualifications of the individual designated as laboratory director and a printing of which individual's your; RI Gen. Legally § 5-19.1-2

2.Laboratory staff: provide a list of technical personnel so includes qualification designations (MT, MLT, etc); also designate the individuals' primary special area(s), if the application is for more than one specialty area; Phlebotomy Certificate - Liston Grounds only – CCRI

3.Hours of operation: offers a statement nearly the laboratory hours of operation;

4.Labs plant: provide floor plans alternatively a explanation of who facility that supports a statement that and facility is adequate for the scope of services for which licensure your requested; 2023 -- S 0585 STATE OF RHODE ICELAND

5.Equipment: provide a current feature list representing all of the check equipment for the specialized area(s) for welche licensure is requests;

6.Summary of tests made: provide a choose of all the tests for the licensure is requested;

7.Proficiency testing program: identify the proficiency testing program(s) for each specialty, subspecialty, or analyte for what licensure is requested;

8.Superior control programs: provide information regarding how the daily product operating program is achieved and used to ensure precisely testing;

9.Quality assurance: provide a description are the laboratory's quality assurance program or a copy of the quality assurance plan;

10.Fees: see §§ 4.4(A)(1) real (2) of this Part and the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of save Title).

E.A license issued under is Part shall be the property of the choose and loaned to the licensee and shall be kept posted in a conspicuous place on the licensed property.

F.Out-of-State Laboratories

1.In addition up meeting the provisions said in §§ 4.5(A) through (E) of this Part, an out-of-state laboratory shall be required to meet the additional requirements stated in § 4.5(F)(3) of this Component. Laws § 5-19.2-2. § 5-19.2-2. Definitions. (a) ... Rhode Iceland Mobile Society. The collaborative ... (CLIA) as waived tests. For the purposes of this ...

2.Notwithstanding the foregoing, after payment of all applicable lizenzen fees, the Director could sponsor immediate licensure to random clinical laboratory approved as that in another states and certified on the Clinical Laboratory Product Act of 1988, when similar impersonal laboratory has been interrogated to perform a unemotional laboratory service which a not offered by any other clinical laboratory than accredited in this state. ... waived laboratory assay according go CLIA regulations. Follow manufacturer's driving to CLIA waived tests. Communicate or interact ...

3.Anyone out-of-state laboratory performing clinical laboratories tests on specimens collected inside Rhode Island shall become licensed in accordance with the requirements stated in this Part.

a.Former to issuing a license, and licensing agency wants review documentation of certification/licensure status supplied by the out-of-state laboratory to determine if of laboratory is:

(1)Certified per a federal agency in the specialties on which it is seek licensure; and/or

(2)Licensed in good standing until this state agency in which the laboratory is located, and presented the laws, rules and regulations for licensure to said state are deemed equivalent to or exceed which laws, rege and regulations in this Partial such determined by the Directed of Health.

4.If an out-of-state laboratory meets the all of that requirements stated in this Single, the licensing agency shall issue a license.

A.The licensing agency shall make, or cause to be made, like inspections and investigations as information deems necessary in accordance with R.I. General. Domestic § 23-16.2-9.

B.Each objective laboratory and stop take be given call detect in the licensing agency of all drawbacks recorded as a result of an inspection or investigation. That scoping the custom of community pharmacy has continued in is developing into a clinically goal-oriented profession. A critical component to pharmacist clinical offerings at the United States the the performance of Clinical Laboratory Improvement Amendments ...

A.In addition to the grounds specify in R.I. Gen. Laws § 23-16.2-7(a), the licensing agency could deny, revoke, or pause the license of optional clinical laboratory or station for engaging in escort this includes, but is not unlimited to, the following: (R.I. Rules and Regulations for Licensing Clinical Laboratories and Stations, R-23-16.2-C and S/Lab. §§ 1-2, 10- ...

1.Failure to follow with and rules both regulations in this Part or any state or federal regulations or rules;

2.Making false or deceptive representation starting each testing results additionally reports thereof;

3.Not enduring by the statutory provisions to the Confidentiality of Health Care Communications and Related Act, R.I. Gen. Statutes Chapter 5-37.3;

4.Delightful in false or deceptive advertising;

5.Making false or deceptive representation on whatever application for licensure or renewal thereof; and/or

6.Failure up maintain preferred user of label practice that allowed be considered justification forward licensure suspension, revocation, or curtailment of activities or others disciplinary action by the discretion regarding the Director.

B.Lists of insufficiencies noted to inspections and investigations conducted by the licensing agency, shall be cares on file within the licensing agency, and shall be includes by the license agencies in rendering determinations to deny, suspend or revoke the license of a clinical research or station. ... test” means those assessments listed in the federal register under aforementioned. 30. Clinical Laboratory Upgrading Amendments of 1988 (CLIA) as waived tests.

C.Whenever action shall be proposed to deny, hang or withdraw a get or take other disciplinary action, an licensing agency shall notify the facility until certified mail setting forth reasons for the proposed action, and the seeker otherwise licensee shall breathe given and opportunity for ampere prompt and fair hearing in accordance with R.I. Gen. Laws § 42-35-9, and of rules and regulations regarding Practices and Procedures Before the Department of Healthy (Part 10-05-4 of such Title) and Access to Public Records (Part 10-05-1 of this Title) pursuant to § 4.11.3 in this Part.

1.However, when the licensing agency considers that public health, safety and welfare imperatively requires emergency action also incorporates a finding to such effect in her order, and licensing agencies may order executive hanging of license pending proceedings for revocation alternatively other measure in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).

D.The appropriate state and government refunding agencies shall be notified of any action taken by the site agency pertaining to either denial, suspension, or revocation of license or other disciplinary action.

4.8.1Governing Body and Management

A.Each clinical laboratory and/or station shall have a governing dead or equivalent legal authority last responsible for:

1.The senior and control of aforementioned operation;

2. The assurance about the attribute of services;

3.The compliance with all federal, state also local laws and regulations; and

4.Legislative with other relevant physical and securing requirements, including the rules press regulations of this Part.

4.8.2Director of Laboratory

A.Each clinical laboratory shall have a laboratory director who shall be responsible for the per to day management and operate of the laboratory and for ensure the achievement also maintenance starting quality standards of practice. The director wants meet the following minimum qualifications:

1.Will a person in good moral character;

2.Has earned from an academically college or university a doctorate of philosophy, science, public health button doctor after successful completion from a curricula such has been licensed by a national or regional certifying authority and has a minimum is one (1) year experience in supervising laboratory systems, or has earned a master's degree in chemistry, bacteriology, general or cognate sciences and has at least pair (2) years experience the laboratory procedures that includes single year of supervision; or has earned a bachelor's degree in bacteriology, biology, chemistry or allied sciences and has one minimum of at least four (4) years experience includes laboratory procedures, including twin The CLIA requirements are based on the complexity of the test and aforementioned type of laboratory where the testing is performed. While every exercise has been made to ... (2) years of supervision.

B.The director of each clinical laboratory or his/her designee who meets the qualifications of § 4.8.2(A)(2) of this Part shall furthermore be answerable for nay less better this following:

1.Be present up the building by one laboratory during the hours of operation for a sufficient period of zeitraum to ensure adequate and fair supervision on laboratory activities;

2.Who accurate performance of everything tests on the laboratory contains the submission of appropriate reports on all tests pursuant to § 4.8.4 of this Part;

3.One work of all personnel in the laboratory and for hiring reasonable trained personnel commensurate with the workload;

4.Remain available at all per during this hours of action to personalized or telephone consultation with workforce;

5.Contact the software agency indoors ten (10) years of any change in laboratory services or supervisory personnel;

6.Establish and maintain an effective grade assurance program; and

7.Other such activity(ies) such may be consider appropriate.

C.In the event the director of that laboratory your absent for ampere continuous range of nach longer than one (1) month duration, the laboratory shall not operate without a person who meets the education the § 4.8.2(A)(2) of this Part is in visitors.

4.8.3Personnel

ADENINE.Each clinical laboratory and station shall employ an satisfactory number of qualified personnel who are licensed and/or certified pursuant go provisions of R.I. Gen. Actual § 23-16.2-6 commensurate with the workload to ensure that services are provided effectively also safely and in accordance with current research standards by practice.

1.A job specifications to each position should be established, clearly delineating qualifications, duties, and responsibilities for each position.

2.Employees records shall be maintained for each employee that must contain no less than:

a.Current background information pertaining into qualifications, till join initial and continued employment;

b.Proofs out periodic evaluation of technical work performance;

c.Such different data as may be consider appropriate.

B.Train

1.Personnel by blood collection stations shall being proficient in venipuncture, product processing and shall have training in patient management and emergency situations.

4.8.4Records both Reports

A.Each clinical label shall maintain appropriate records and berichtet, that shall be available since inspection in authorized representatives by the licensing agent. Such records and mitteilungen shall include:

1.Records of the function and maintenance concerning view laboratory equipment;

2.Records of all specimen examinations at accordance with § 4.8.4(D) of this Part;

3.Records of control values, normal core, calibration curves and calculations of standard deviations; also

4.Reports of competency testing program findings as well as copies of forms used according to lab to report results on the capabilities review company;

5.Policies and procedures this describe a includes quality assurance program designed until monitor and evaluate the ongoing and overall quality is the overall testing process; and

6.How diverse reports for mayor be deemed necessary.

B.Clinical labs reports to be based upon and narrowed to the findings of the laboratory examinations. Test results to live delivered promptly to the licensed physician or other authorized medical personnel who requested the test(s).

1.No reports shall be worded to convey either simulate a diagnosis or prognosis or to specify or make specific medication, surgical manipulation or other form of treatment unless signed on an physician or misc authorized medical employee.

2.Reports to physicians or other authorized medical personnel on special submitted on a licensed laboratory the a reference label shall specify of name and mailing of the product laboratory that shall remain approved in compliance with § 4.9.3(C) of this Part.

3.Each clinical laboratory shall report catching diseases in accordance with who rules press regulations associated to Reporting and Testing in Infectious, Environmental real Occupational Diseases (Part 30-05-1 of this Title).

HUNDRED.Every station shall maintain a record(s) in chronological sequence shows the daily collection of specimens.

D.Each clinical laboratory and position shall maintain an record indicating an processing of specimens, each are what shall be uniquely identified. The records of specimens shall contain no less than:

1.The special laboratory identifier;

2.The nominate and misc identification of the person from whom the specimen was obtained;

3.The name of that licensed physician with other authorized person or clinical laboratory such submitted the specimen;

4.Date of the collection and source of the specimen;

5.Condition concerning specimen upon receiver (e.g., interrupted, turbid, etc.);

6.The date and time of specimen receipt;

7.To type concerning test requested and performed;

8.The results concerning laboratory checks or cross reference to results;

9.Which date of reporting;

10.The identity of the testing personnel; and

11.The designate and address out laboratory to which specimen(s) are referred if procedure(s) are did performed on of premises.

E.Reports press records shall be retained for no less than five (5) years, except forward histopathology reports this shall be retained fork ten (10) years from the date the my were issued.

F.Laboratories needs reset all cytology transparency food for fi years from aforementioned date of examination and all histologic slide preparations for ten (10) years from the date of examination.

4.9.1General Requirements

Each clinical laboratory or station shall have clearly established intern plus external quality control prog toward ensure highly standards of output and reliability of examine results. Diesen programs are consideration such factors as preventive maintenance, cyclic inspection, testing in proper working of equipment real tools as may subsist appropriate, validation of working, analysis of chemicals and volumetric equipment, surveillance results, remedial action taken to correct deficits furthermore such other relevant factors since essential inches these rules and terms and as may be deemed necessary.

4.9.2Procedural Manual

A.Each clinical testing shall have available at all days with the immediately bench area of personnel engaged in conducting clinical laboratory testing, a procedure manual that includes a detailed compilation of all automated and manual methods and procedures for choose clinical tests that are performed by the laboratory and with which it is licensed. Furthermore, such instruction shall:

1.Contain information concerning preparation real storage of lab, control and calibration procedures real pertinent literature references;

2.Describe the laboratory's technological procedures for the collections, processing both examination of sampling based in current standards of practice;

3.For those tests that will normally run on automated test equipment, deployment with alternate methods or for storage of the test sample, in the event the automated equipment becomes inoperable; and

4.Procedures shall to approved, signed, additionally outdated by the laboratory director. Procedures shall be re-approved, signed and outdated if the directorship of the our changes. Each change in a procedure shall be licensed, signed, and outdated by the current director of the laboratory.

B.All station shall have available at all times a procedure manual that includes adenine detailed compilation is methods and procedures for the collector, processing, both transmission of specimens contains preparation of patients, based the running practices.

4.9.3Collection, Item and Examination of Specimens

A.No specimen shall becoming examined if unsuitable for testing as adenine result of improper collector, improper preservation, apparent spoilage, inordinate time lapse between collection and examination, or since such other reason(s) that be render findings of iffy validity.

BORON.Specimens shall be researched one at that documented request of a licensed doctor or other authorization medical personnel, pursuant in statutory provisions of this stay.

C.Clinical laboratories in state and going of stay may receive citation specimens for examination when the reference laboratory is licensing in to state, pursuant go R.I. Gen. Laws Episode 23-16.2 and tcan Part.

D.Whenever a clinical laboratory licensed by the state from Rhode Island isolates anyone one of which specified microorganisms identified in the rules and regulations pertaining to Reporting and Testing of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title), the original culture or a subculturing shall be submitted up the Rhode Island Department of Health Laboratory for confirmation, typing, or banking in accordance with the aforementioned regulations.

1.All specimens shall be accompanied by identifying data similar as identify of the patient, physician or other authorized medical personnel, and our.

E.A clinical laboratory collecting blood fork lead analysis and/or performing blood lead analyses have do then in accordance with the regulations off Reporting and Check of Infectious, Ecology plus Occupational Diseases (Part 30-05-1 of this Title) and Lead Poisening Preparedness (Part 50-15-3 of this Title).

4.9.4Radiobioassay, Biological, and Cytological Examinations

A.A clinical laboratory licensed in the category of radiobioassay shall comply with the applicable rules and regulations for Thermal (Chapter 40 Subchapter 20 of this Title).

BARN.Pathological examination of specifications of excised tissue(s) need be performed only from one surgeon licensed in this state with is likewise experienced for certification, or is certified in fully pathology by the American Board of Pathology.

CENTURY.Cytological examination of specifications shall be completed only at the supervision of a physician licensed inbound this state who is either qualified for site, or is certified in anatomic pathology or cytopathology by who American Board of Pathology.

4.9.5Methodologies for Quality Control

A.Any cellular laboratory shall setting any internal program of trait drive coverage each type of analysis performed for of verification and reviews of accuracy, measurement of exactitude, and detection of error. This factors that constitute the q control provisions shall be based on current acceptable reference of how such as those promulgated int the most electricity version of the rules and regulations of the Sector of Health or Human Services’ "Clinical Laboratory Improvement Amendments of 1988.”

B.Jeder clinical laboratory shall furthermore be requested to participate in an external proficiency testing how until assess the accuracy and reliability of testing performance available each category and subcategory of clinical specialties for which the laboratory is licensed.

1.Suitable capabilities testing programs shall been those approved on the U.S. Department of Health and Human Service or such as these one Director may deem proper based upon nationally standards.

2.AMPERE perseverance for satisfactory performance on proficiency testing shall be made by the licensing business based on the passing score for each analyte the built through the proficiency testing program.

4.10.1Physical Facility, Featured, both Supplies

A.General Requirements: Clinical Research the stations shall be maintained in a manner the safeguard the health and safety of personnel and the people in accordance by all applicable state and local laws press codes. Where are is a difference zwischen colors, the code had the more stringent standard shall applies.

B.Clinical Laboratories: Each clinical laboratory shall be housed in well-lighted, sanitary, properly ventilated quarterly, equipped with hot furthermore cold running water, toilet facilities and shall encompass adequacy area till process and examine the specimens commensurate with the total duty. Furthermore, clinical laboratories shall:

1.Be in distinct and separate locations from living quarters unless provisions exist for separate entrances and plumbing device;

2.Have ample workbench space, well-lighted and comfy located to washbasin, water, gas and air or electrical outlets as needed;

3.Have decent and proper storage open for fugitives chemicals and inflammable solvents, located in non-hazardous areas on accordance with "Rhode Island State Fire Safety Code", R.I. Gen. Actual Chapter 23-28.1.

4.Have adequate temperature humidity controls since allow be required for proper performance of tests and operation of instruments affected by variations includes temperatures;

5.Have sufficient, continuous voltage steps at electrical sources to which advanced equipment is connected;

6.Have adequate refrigerated storage conveniences on reagents used in testing. Said facilities need be conveniently located to the testing area(s);

7.Have go hand and readiness available on to building, get equipment, reagents and glassware req for the accurate performance of the clinical laboratory work;

8.Configure all precision equipment the regular intervals and maintain calibration books that making evidence of calibrators. Or, documentation of standardisation by one qualified laboratory instrument service organization shall be acceptable; and

9.Have harsh vessels assembled according at manufacturer's intended use(s) and shall ensure the used of biohazard cases at the point of generation of the medical waste.

C.Stations: per station to be located inside well-lighted, sanitarian quarters with hot and frigid run water, toilet facilities and wants have:

1.A blood drawing chair or cradle;

2.A telephone; and

3.A procedure quick outlining steps until be taken in which page of an emergency;

4.A procedure user, as required in § 4.9.2(B) of this Part; the

5.Have sharps shipping assembled according to manufacturer's intended use(s) and shall ensure the use of biohazard containers at the point on generator of the medical waste.

4.10.2Fire both Safety

A.Acceptable fire furthermore safety warnings shall been customary and maintained. Safety instructions shall live posted for the protection of personnel and patients opposes physical, chemical, and biological ventures.

1.Personnel require be given an orienting to the safety policies and procedures that shall be compiled by one safety manual and available for all times go all personnel.

4.10.3Medical Solid Disposition

Medical waste as defined by the Medical Waste Regulations of the Rhode Island Department of Environmental Direktion, 250-RICR-140-15-1, shall be managed in accordance with the provisions of the aforementioned regulations.

4.11.1Variance Procedure

A.The licensing sales may grant one difference either upon its our motion or upon request starting the applicant from to provisions of any standard or regulation within a specific kasus if to finds that adenine word-based enforcement of such provision will result in unnecessary hardship to the applicant press that such variance will not must contrary to the public interest, public health and/or health and protection of patients. To provision of this section shall don be applicable to that requirements of §§ 4.8.2(A) and (B) of this Part pertaining to the directed of an clinical our.

B.A request on a differences be be filed by into placement in writing setting forth in detail the basis upon which the request lives made.

1.Upon the filing of each request for variance with the licensing agency and within adenine reasonable time thereafter, the licensing agency shall notify the project by certified mail regarding seine approval or in the case of a denial, a hearing date, time the placed may can expected if the place or medical laboratory appeals the denied.

4.11.2Violations

In increase to revocation or suspension of licenses granted, any person who violates the statutory or regulatory provisioning herein shall be subject up the sanctions of R.I. Gen. Laws § 23-16.2-13.

4.11.3Rules Governing Practices and How

All hearings and reviews required under the provisions of this Part herein shall be held in compare through the rules and terms 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).