Agency Information Collection Activities: Proposed Collection; Comment Request

SUPPLEMENTARY INFORMATION:

Proposed Project

Title: Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.

OMB No.: 0935-0143.

OMB Expiration Date: September 30th, 2024.

Type of Request: Reinstatement, with change, of previously approved collection for which approval has expired.

The Patient Safety and Quality Improvement Act of 2005 (the Patient Safety Act), signed into law on July 29, 2005, was enacted in response to growing concern about patient safety in the United States and the Institute of Medicine's 1999 report, “To Err is Human: Building a Safer Health System”. The Patient Safety Act signifies the Federal Government's commitment to fostering a culture of patient safety among health care providers; it offers a mechanism for creating an environment in which the causes of risks and hazards to patient safety can be thoroughly and honestly examined and discussed without fear of penalties and liabilities. It provides for the voluntary formation of Patient Safety Organizations (PSOs) that can collect, aggregate, and analyze confidential information reported voluntarily by health care providers. By analyzing substantial amounts of patient safety event information across multiple institutions, PSOs are able to identify patterns of failures and propose measures to eliminate or reduce risks and hazards.

In order to implement the Patient Safety Act, the Department of Health and Human Services (HHS) issued the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule, 42 CFR part 3), which became effective on January 19, 2009. The Patient Safety Rule outlines the requirements that entities must meet to become and remain listed as PSOs, the process by which the Secretary of HHS (Secretary) will accept certifications and list PSOs, and provisions pertaining to the confidentiality and privilege protections for patient safety work product (PSWP).

When specific statutory requirements are met, the information collected and the analyses and deliberations regarding the information receive confidentiality and privilege protections under this legislation. The Secretary delegated authority to the Director of the Office for Civil Rights (OCR) to interpret and enforce the confidentiality protections of the Patient Safety Act ( Federal Register , 71 FR 28701-2, May 17, 2006). Civil money penalties may be imposed for knowing or reckless impermissible disclosures of identifiable PSWP. AHRQ implements and administers the rest of the statute's provisions.

Pursuant to the Patient Safety Rule (42 CFR 3.102), an entity that seeks to be listed as a PSO by the Secretary must certify that it meets certain requirements and, upon listing, would meet other criteria. To remain listed for renewable three-year periods, a PSO must re-certify that it meets these obligations and would continue to meet them while listed. The Patient Safety Act and Patient Safety Rule also impose other obligations discussed below that a PSO must meet to remain listed. In accordance with the requirements of the Patient Safety Rule (see, e.g., 42 CFR 3.102(a)(1), 3.102(b)(2)(i)(E), 3.102(d)(1), and 3.112), the entities seeking to be listed and to remain listed must complete the proposed forms, in order to attest to compliance with statutory criteria and the corresponding regulatory requirements.

Proposed Revisions

The following forms have revisions for clarification which are described below:

1. PSO Certification for Initial Listing—This form has been revised to include clarification on the role of the primary point of contact.

2. PSO Certification for Continued Listing—This form has been revised to include clarifications on the role of the primary point of contact, more precise language about whether there are any changes to the parent organization or any additional parent organizations and an additional note to clarify how users should determine the response to the standardized way they collect patient safety work product (PSWP).

3. PSO Profile form—The form has been revised to add a new clinical discipline, “Clinical Dialysis Services”.

4. PSO Change of Listing Form—This form has been revised to note clarifications for the parent and the point of contact sections.

5. PSO Voluntary Relinquishment Form—This form has been revised to include a change from street to mailing address for future contacts with delisted PSOs.

6. Patient Safety Confidentiality Complaint Form—The form has two parts, the complaint form and the consent form. The complaint form was updated (1) to conform the notice to individuals about confidentiality of identifying information submitted on the complaint form with the existing approved OCR HIPAA Rules complaint form and (2) to update OCR contact information. The consent form was updated (1) to conform notice to individuals about confidentiality of identifying information submitted on the consent form with the existing approved OCR HIPAA Rules consent form, (2) to more fully describe OCR authorities allowing collection of information in Privacy Act of 1974 notices, and (3) to update OCR contact information.

7. Common Formats—Since the last approval, AHRQ has released Common Formats Event Reporting for Diagnostic Safety, Version 1.0 (CFER-DS V1.0) and the Common Formats for Surveillance- Hospital V1.0 (CFS-H V1.0), which is a revision/update from the last version (CFS- H V0.3 Beta).

OMB previously approved the Common Formats and forms described above in 2008, 2011, 2014, 2018, and 2021. AHRQ will use these forms, other than the Patient Safety Confidentiality Complaint Form, to obtain information necessary to carry out its authority to implement the Patient Safety Act and Patient Safety Rule. This includes obtaining initial and subsequent certifications from entities seeking to be or remain listed as PSOs and for making the statutorily required determinations prior to and during an entity's period of listing as a PSO. The PSO Division, housed in AHRQ's Center for Quality Improvement and Patient Safety, uses this information. OCR will use the Patient Safety Confidentiality Complaint Form to collect information for the initial assessment of an incoming complaint. The form is modeled on OCR's form for complaints alleging violations of the privacy of protected health information.

Method of Collection

The PSO forms are available in a format that allows completion and submission of the information online. AHRQ has updated the electronic submission of all forms, except the Patient Safety Confidentiality Compliant For which is administered by OCR, including the capability of the system to auto populate certain fields based on prior submissions by the PSOs. In addition, paper forms can be downloaded, completed and submitted through electronic mail, to pso@ahrq.hhs.gov, or via postal mail. The Common Formats, accompanying user guide, and technical specifications are available as printable electronic files on the PSOPPC website at www.PSOPPC.org.

In addition to paper submission of complaints, OCR facilitates electronic submission of complaints. First, the Patient Safety Confidentiality Complaint Form is available on the OCR website at https://www.hhs.gov/hipaa/filing-a-complaint/patient-safety-confidentiality/index.html. The form is available to be downloaded electronically to a user's own computer in a form that allows a complainant to fill out the form electronically if they so choose. The Patient Safety Confidentiality Complaint Form can then be printed and submitted, or submitted electronically via electronic mail. Second, the form is available in a format that allows completion and submission of the information online.

Estimated Annual Respondent Burden

Exhibit 1 shows the estimated annualized burden hours for the respondent to provide the requested information and Exhibit 2 shows the estimated annualized cost burden associated with the respondents' time to provide the requested information. The total burden hours are estimated to be 100,811.58 hours annually and the total cost burden is estimated to be $4,946,824.23 annually.

1. PSO Certification for Initial Listing Form: The average annual burden for the collection of information requested by the certification forms for initial listing is based upon a total average estimate of 11 respondents per year and an estimated time of 18 hours per response. The estimated response number includes submissions by not only entities listed as PSOs, but also entities that submit initial listing forms that do not become PSOs.

2. PSO Certification for Continued Listing Form: The average annual burden for the collection of information requested by the certification form for continued listing has an estimated time of eight hours per response and 40 responses annually.

3. PSO Two Bona Fide Contracts Requirement Certification Form: The average annual burden for the collection of information requested by the PSO Two Bona Fide Contract Certification Form is based upon an estimate of 56 respondents per year and an estimated one hour per response.

4. PSO Disclosure Statement Form: The overall annual burden for the collection of information requested by the PSO Disclosure Statement Form is based upon an estimate of 3 respondents per year and estimated 3 hours per response.

5. PSO Profile Form: The overall annual burden for the collection of information requested by the PSO Profile Form is based upon an estimate of 74 respondents per year and an estimated three hours per response.

6. PSO Change of Listing Information Form: The average annual burden for the collection of information requested by the PSO Change of Listing Information Form is based upon an estimate of 51 respondents per year and an estimated time of five minutes per response.

7. PSO Voluntary Relinquishment Form: The average annual burden for the collection of information requested by the PSO Voluntary Relinquishment Form is based upon a total average estimate of four respondents per year and an estimated time of thirty minutes per response.

8. OCR Patient Safety Confidentiality Complaint Form: The overall annual burden estimate of one hour for the collection of information requested by the form is based on an estimate of one respondent per year and an estimated twenty minutes per response.

9. Common Formats: AHRQ estimates that 5% FTE of a patient safety manager at a facility will be spent to administer the Common Formats, which is approximately 100 hours a year.