216-40-10 R.I. Code R. § 6.8

Current through June 12, 2024

Section 216-RICR-40-10-6.8 - Application For Certification

6.8.1General Requirements

A. Certification Required. A patient safety organization (PSO) shall be certified by the Director pursuant to this Part before entering into a contract with a reporting entity.

B. Submission of Application. Any entity, except as specified in § 6.4(A) of this Part may request an initial or renewal certification as a PSO by submitting a completed application form to the Director on forms provided by the Department. An individual with authority to make commitments on behalf of the entity seeking certification will be required to acknowledge each of the certification requirements, attest that the entity meets each requirement, provide contact information for the entity, and certify that the PSO will promptly notify the Department during its period of certification if it can no longer comply with any of the criteria in this Part.

C. Notification of Changes. Any PSO certified pursuant to this section shall notify the Department in writing before making any change which would render the information contained in their application for certification no longer accurate.

D. Federal Certification Required. Any entity requesting certification as a PSO pursuant to this Part shall also obtain and maintain certification/listing as a PSO pursuant to the Patient Safety and Quality Improvement Act, 42 U.S.C. §§ 299b-21 through 299b-26, and any implementing regulations promulgated by the U.S. Agency for Healthcare Quality and Research.

1. Any PSO certified pursuant to this Part prior to the establishment of a federal PSO certification/listing program shall be required to obtain such certification when it becomes available. The PSO shall provide copies of all federal PSO certification/listing documents to the Director pursuant to §6.8.1(C) of this Part.

2. Any entity requesting certification as a PSO pursuant to this Part after the establishment of a federal PSO certification/listing program shall be required to provide copies of all federal PSO certification/listing documents with their application.

3. Renewal. A PSO seeking renewal of certification after the establishment of a federal PSO certification/listing program shall include documentation that the PSO maintains current certification/listing pursuant to that federal PSO program.

6.8.2Certification Application

A. An application for certification as a PSO shall include, as a minimum, the following information for review by the Department:

1. Certification Regarding Patient Safety Activities. An entity seeking initial certification as a PSO shall attest that it has written policies and procedures in place to perform each of the following eight (8) patient safety activities:

a. Efforts to improve patient safety and the quality of health care delivery;

b. Collection and analysis of patient safety work product;

c. Development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices;

d. Utilization of patient safety work product for the purposes of encouraging a culture of safety and of providing feedback and assistance to effectively minimize patient risk;

e. Maintenance of procedures to preserve confidentiality with respect to patient safety work product;

f. Provision of appropriate security measures with respect to patient safety work product;

g. Utilization of qualified staff; and

h. Activities related to the operation of a patient safety evaluation system and to the provision of feedback to participants in a patient safety evaluation system.

2. The policies and procedures referenced in §6.8.2(A)(1) of this Part shall provide for compliance with the privilege and confidentiality provisions of § 6.5 of this Part and the appropriate safeguards and security measures required by §6.7.3 of this Part.

3. Renewal. A PSO seeking renewal of certification shall attest that it is performing, and will continue to perform, each of the eight (8) patient safety activities referenced in §6.8.2(A)(1) of this Part, and is and will continue to comply with the privilege and confidentiality provisions of § 6.5 of this Part and the appropriate safeguards and security measures required by §6.7.3 of this Part.

4. Certification Regarding PSO Criteria. An entity seeking initial certification as a PSO shall attest that it will comply with each of the following seven (7) criteria:

a. The mission and primary activity of a PSO shall be to conduct activities that are to improve patient safety and the quality of health care delivery.

b. The PSO shall have appropriately qualified workforce members, including licensed or certified medical professionals.

c. The PSO, within the initial two (2) year certification period, and within each sequential two (2) year certification renewal period, shall have entered into at least two (2) bona fide contracts, each of a reasonable period of time, each with a different reporting entity for the purpose of receiving and reviewing patient safety work product.

d. The PSO is not a health insurance issuer, and is not a component of a health insurance issuer.

e. The PSO shall make disclosures to the Director as required under §6.7.4 of this Part.

f. To the extent practical and appropriate, the PSO shall collect patient safety work product from reporting entities in a standardized manner that permits valid comparisons of similar cases among similar reporting entities.

g. The PSO shall utilize patient safety work product for the purpose of providing direct feedback and assistance to reporting entities to effectively minimize patient risk.

h. Renewal. A PSO seeking renewal of certification shall also attest that it is complying with, and will continue to comply with, each of the seven (7) PSO criteria referenced in §6.8.2(A)(4) of this Part.

5. Additional Certifications Required of Component Organizations. An entity seeking initial certification as a PSO, that is a component of another organization or enterprise, shall also attest that it will comply with the following requirements:

a. Separation of Patient Safety Work Product. A component PSO shall:

(1) Maintain patient safety work product separately from the rest of the parent organization(s) of which it is a part; and

(2) Not have a shared information system that could permit access to its patient safety work product to an individual(s) in, or unit(s) of, the rest of the parent organization(s) of which it is a part.

b. Notwithstanding the requirements of paragraph §6.8.2(A)(5)(a) of this Part, a component PSO may provide access to identifiable patient safety work product to an individual(s) in, or a unit(s) of, the rest of the parent organization(s) of which it is a part if the component PSO enters into a written agreement with such individuals or units that requires that:

(1) The component PSO will only provide access to identifiable patient safety work product to enable such individuals or units to assist the component PSO in its conduct of patient safety activities, and

(2) Such individuals or units that receive access to identifiable patient safety work product pursuant to such written agreement will only use or disclose such information as specified by the component PSO to assist the component PSO in its conduct of patient safety activities, will take appropriate security measures to prevent unauthorized disclosures and will comply with the other certifications the component has made pursuant to §§6.8.2(A)(5)(c) through (d) of this Part regarding unauthorized disclosures and conflicts with the mission of the component PSO.

c. Nondisclosure of Patient Safety Work Product. A component PSO shall require that members of its workforce and any other contractor staff, or individuals in, or units of, its parent organization(s) that receive access in accordance with §6.8.2(A)(5)(b) of this Part to its identifiable patient safety work product, not be engaged in work for the parent organization(s) of which it is a part, if the work could be informed or influenced by such individuals' knowledge of identifiable patient safety work product, except for individuals whose other work for the rest of the parent organization(s) is solely the provision of clinical care.

d. Conflict of Interest. The pursuit of the mission of a component PSO shall not create a conflict of interest with the rest of the parent organization(s) of which it is a part.

e. Renewal. A component PSO seeking renewal of certification shall also certify that it is complying with, and will continue to comply with, each of the additional requirements referenced in §§6.8.2(A)(5)(a) through (d) of this Part.

6.8.3Issuance and Renewal of Certification.

A. Issuance of Certification. Pursuant to the provisions of R.I. Gen. Laws § 23-17.21-5(a), the Director shall grant certification to a PSO which meets the certification requirements set forth in this Part. The certification shall expire on the last day of the month two (2) years from the date of issue, unless sooner suspended or revoked.

B. Renewal of Certification. A PSO may renew a certification every two (2) years upon submission of an application in accordance with the provisions of §§6.8.2(A)(3), 6.8.2(A)(4)(h), and 6.8.2(A)(5)(e) (if applicable) of this Part. In any case in which the responsible individual of a PSO has filed a renewal application in proper form, including compliance with the notification requirements of §6.7.4(A)(1) of this Part, not less than forty-five (45) calendar days prior to expiration of its existing certification, the existing certification shall not expire until final action on the renewal application has been taken by the Department.

216 R.I. Code R. § 216-RICR-40-10-6.8