216 R.I. Code R. 216-RICR-60-05-5.4

Current through December 26, 2024

Section 216-RICR-60-05-5.4 - Certification

5.4.1General Requirements

A. It shall be unlawful for any analytical laboratory to perform testing or analyses of samples originating in this state, for which the Department requires certification, without obtaining certification pursuant to the Act and this Part.

B. Certification for specific analytes and methods shall be required for laboratory testing of potable water, non-potable water, and environmental samples for lead content. Certification for potable water is required whenever a laboratory performs analytical tests on drinking water supply samples. Certification for non-potable water is required whenever a laboratory performs analytical tests on water other than drinking water.

C. Certification is required for laboratories performing environmental lead analysis in accordance with the rules and regulations for Lead Poisoning Prevention (Part 50-15-3 of this Title). A certificate for environmental lead analysis shall be issued only to laboratories providing documentation of accreditation through a program recognized by the EPA's National Environmental Lead Laboratory Accreditation Program (e.g., A2LA or AIHA).

D. An analytical laboratory shall represent itself in its advertisements, publications, or other forms of communication, as providing only those services for which it is certified and shall not advertise in a manner that tends to mislead the public.

5.4.2Application for Certification

A. Application for certification to conduct laboratory testing of potable water, non-potable water, and environmental lead shall be made to the Department on forms provided for initial certification and for certification renewal.

B. Applications for certification renewal shall be submitted to the Department on or before the date specified by the Department.

C. Each application for certification and renewal thereof shall contain such information as the Department reasonably requires which may include affirmative evidence of ability to comply with the provisions of the Act and the rules and regulations herein.

D. Each application for certification or renewal thereof must be accompanied by the non-refundable fee as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) for each category for which the laboratory is requesting certification, and made payable to the General Treasurer of the State of Rhode Island and submitted to the Department of Health.

E. The annual fee schedule per category for both in-state and out-of-state laboratory certification is as set forth in in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title).

5.4.3Issuance of a Certificate && Renewal of Certification

A. No less than thirty (30) days after receipt of a satisfactorily completed application for initial certification, the Department shall issue a certificate if the applicant meets the requirements of the Act and this Part for certification. Said certification, unless sooner suspended or revoked, shall expire by limitation on the thirtieth (30th) day of December, of every year following the date of certification and shall be renewed annually.

B. Certificates shall not be issued to an analytical laboratory located in Rhode Island prior to an inspection and correction of any deficiencies in a manner acceptable to the Department as specified in § 5.4.4 of this Part. Further, said laboratory must comply with the proficiency testing requirements for initial certification as described in § 5.7.5 of this Part.

C. The Department may issue a certificate to an out-of-state laboratory provided the laboratory is:

1. Certified by the EPA in the analytes and methods it is to perform; or

2. Licensed, certified, or accredited by the state agency in the state where the laboratory is located, and provided the laws, rules and regulations for licensure, certification or accreditation of said state agency are deemed equivalent to or exceed the Act and this Part, as determined by the Director; or

3. Accredited by NELAP for analytes and methods not offered by the state where the laboratory is located, but allowable by these rules.

D. Analytical laboratories in this state and out-of-state may receive samples from another laboratory for examination provided the laboratory is certified in this state pursuant to the Act and this Part.

E. A certificate shall be issued only for the premises and persons named in the application and shall not be transferable or assignable.

F. The certificate issued to an analytical laboratory shall clearly identify the laboratory and those analytes and methods under each category for which the laboratory is certified. Such categories include:

1. Potable Water pertaining to the following subcategories:

a. microbiology,

b. organic chemistry, and

c. inorganic chemistry.

2. Non-Potable Water pertaining to the following subcategories:

a. microbiology,

b. organic chemistry, and

c. inorganic chemistry.

3. Radiochemistry

4. Environmental Lead

G. A certificate issued hereunder shall be the property of the state and loaned to the laboratory and shall be kept posted in a conspicuous place on the premises.

5.4.4Inspections

A. The Director or authorized agent(s) or employees shall at all reasonable times have authority to enter upon all parts of the premises on which any analytical laboratory is located and of the premises appurtenant thereto, to make any examination or investigation whatsoever for determining compliance with the provisions of the Act and this Part.

B. Each analytical laboratory shall be provided a written report by the Department of all deficiencies recorded as a result of an inspection or investigation within sixty (60) days of such inspection or investigation.

C. The analytical laboratory shall provide a plan of corrective action, including expected completion dates for all deficiencies listed on such report within thirty (30) days of receipt.

D. At the discretion of the Director, a follow-up inspection may be conducted to assure that all deficiencies have been corrected.

5.4.5Denial, Suspension, or Revocation of Certificate

A. In addition to the grounds for revocation and suspension stated in R.I. Gen. Laws § 23-16.2-7, the Department may deny, revoke, or suspend the certificate of any analytical laboratory for engaging in conduct that includes but is not limited to:

1. making false or deceptive representation on any application for certification or renewal thereof;

2. failure to maintain professional and competent standards of practice;

3. making false or deceptive representation of any testing results and reports thereof;

4. engaging in false or deceptive advertising;

5. failure to maintain a quality assurance system and follow a quality assurance plan;

6. failure to perform proper managerial review and approval prior to issuance of reports of any testing results; and

7. for certified out-of-state laboratories, failure to comply with § 5.4.5(D) of this Part.

B. Lists of deficiencies noted in inspections and investigations conducted by the Department shall be maintained on file in the Department and shall be considered by the Department in rendering determinations to deny, suspend, or revoke the certificate of an analytical laboratory.

C. Whenever action shall be proposed to deny, suspend, or revoke the certificate or take another disciplinary action, the Department shall notify the facility by certified mail setting forth reasons for the proposed action, and the applicant or certified laboratory shall be given an opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws § 42-35-9, Practices and Procedures Before the Rhode Island Department of Health (Part 10-05-4 of this Title), and § 5.13 of this Part.

1. However, if the Department finds that public health, safety, and welfare imperatively requires emergency action and incorporates a finding to that effect in its order, the Department may order summary suspension of certification pending proceedings for revocation or other action in accordance with R.I. Gen. Laws §§ 23-1-21 and 42-35-14(c).

D. Certified laboratories not located in Rhode Island shall notify the Department of changes in its accreditation, certification, or licensure status within fourteen (14) days of receiving a notification of such changes.

216 R.I. Code R. 216-RICR-60-05-5.4

Amended effective 4/30/2019