Form #2 Form #2 Recertification Form

Form Approved


OMB No. 0935-XXXX


Exp. Date XX/XX/20XX

PATIENT SAFETY ORGANIZATION

CERTIFICATION FOR CONTINUED LISTING

Before completing this form, review the requirements of the Patient Safety and Quality Improvement regulation, 42 CFR Part 3 (available at www.pso.ahrq.gov). In particular, see sections 3.102, 3.20(5), and 3.108, which are excerpted in a separate file on the website. To review the confidentiality requirements see Subpart C of the regulation.

A Patient Safety Organization (PSO) seeking continued listing must complete the attestations on this form, which restate the 15 statutory requirements that all PSOs must meet and the three additional criteria that Component PSOs must meet.

The Secretary will continue to list a PSO based on its responses to this attestation form and, if applicable, the history of any prior actions related to the PSO (see 42 CFR §3.104(a)(2)). If the Secretary is required to take into account the PSO’s history, the Secretary may request additional information or assurances from the PSO. The Secretary will notify the PSO in writing of his acceptance or non-acceptance of this certification. If this certification is accepted, the Secretary will list the PSO for an additional three years. If possible, a period of continued listing will begin on the same month and day on which the PSO was initially listed to maintain continuity and minimize confusion.

PART I: ORGANIZATION CONTACT INFORMATION

NAME AND ADDRESS – PATIENT SAFETY ORGANIZATION

Street Address City State Zip Code

Mailing Address (if different) City State Zip Code

Telephone Number Website Address Fax Number

PART II: CERTIFICATION FOR CONTINUED LISTING The Patient Safety and Quality Improvement regulation at 42 CFR §3.102(b) requires a PSO seeking continued listing to certify that (a) it is currently performing each of the patient safety activities described in the Patient Safety Act at 42 USC 299b-21(5) and complying with the statutory criteria listed in 42 U.S.C. 299b-24(b) and to certify that (b) the PSO will continue to perform each patient safety activity and meet each statutory criterion throughout the period of continued listing. The person completing the form must be able to affirm both parts of an item to check “yes”. If a PSO is either not in current compliance or cannot certify that it will continue to comply while listed, the “no” box must be checked. If any box is checked “no,” additional clarification may be provided and may also be sought before the Secretary makes a determination regarding relisting.
Attestations Regarding Patient Safety Activities As specifically certified below, the PSO listed in Part I attests that it is currently performing, and will continue to perform, each of the statutorily-required patient safety activities (items 1-7) throughout the period of continued listing.
1.	Undertaking actions to improve patient safety and the quality of health care dlivery?	 YES  NO
2.	Collecting and analyzing patient safety work product?	 YES  NO
3.	Developing and disseminating information to improve patient safety?	 YES  NO
4.	Utilizing patient safety work product to encourage a culture of safety, and to provide feedback and assistance to effectively minimize patient risk?	 YES  NO
5.	Implementing and maintaining procedures to preserve confidentiality of patient safety work product in conformity with the regulation and authorizing legislation?	 YES  NO
6.	Implementing and maintaining security measures to protect patient safety work product in conformity with the regulation and the authorizing legislation?	 YES  NO
7.	Using appropriately qualified staff to improve patient safety and quality of health care delivery?	 YES  NO
Attestations Regarding Patient Safety Organization Criteria As specifically certified below, the PSO listed in Part I attests that it is currently complying with, and will continue to comply with, each of the statutorily-required criteria for PSOs (items 8-15) throughout the period of continued listing.
8.	Performing the collection, management, or analytic activities related to the operation of a patient safety evaluation system (PSES), including providing feedback to participants in a PSES?	 YES  NO
9.	Making the improvement of patient safety and the quality of health care delivery the PSO’s mission and primary activity?	 YES  NO
10.	Employing licensed or certified medical professionals as employees or contractors?	 YES  NO
11.	Meeting the requirement to enter into at least two bona fide contracts as defined by the regulation in section 3.20 within each of the required sequential 24-month periods following initial listing?	 YES  NO
12.	Not being a health insurance issuer nor a component of a health insurance issuer?	 YES  NO
13.	Fully disclosing to the Secretary relationships with contracting providers as required by section 3.102(d)(2) of the regulation?	 YES  NO
14.	Collecting patient safety work product in a standardized manner, to the extent practical and appropriate, informed by ongoing guidance provided by the Secretary on common and consistent definitions that permit valid comparisons of similar cases?	 YES  NO
15.	Using patient safety work product to provide feedback and help to providers in order to minimize patient risk?	 YES  NO
Attestations Required Of Component Patient Safety Organizations (NOTE: Only answer questions 16-18 if your entity is a component PSO. There is no need to attach contact information for the component PSO’s parent organization(s) unless there has been a change since the information was last submitted. If there has been a change, please attach new contact information.) As specifically certified below, the PSO listed in Part I attests that it is currently complying with, and will continue to comply with, each of the additional statutorily-requirements for component PSOs (items 16-18) throughout the period of continued listing.
16.	Maintaining patient safety work product separately from the PSO’s parent organization(s), in accordance with section 3.102(c)(1) of the regulation on shared data systems and parent organization subcontracts?	 YES  NO
17.	Preventing unauthorized disclosure of patient safety work product to persons in the PSO’s parent organization(s) and complying with limitations in section 3.102(c)(2) of the regulation on use of shared personnel?	 YES  NO
18.	Assuring that there is no conflict of interest between the mission of the component PSO and the rest of the parent organization(s)?	 YES  NO

PART III: CERTIFICATION OF ATTESTATIONS

I am authorized to complete this form on behalf of the entity seeking continued listing as a PSO. The statements on this form, and any submitted attachments or supplements to it, are true, complete, and correct to the best of my knowledge and belief and are made in good faith. I understand that a knowing and willful false statement on this form, including any attachments, can be punished by fine or imprisonment or both (United States Code, Title 18, Section 1001). I also understand that the regulation requires that if any change takes place that would render any attestation inaccurate or incomplete, or if there is a change in the PSO contact information, the entity seeking listing must notify the Secretary within 45 days of any such change.

Authorized Official Signature: ______________________________________________________________________

Date: ___________________________________________________________________________________________

Authorized Official Printed Name: ___________________________________________________________________

Authorized Official Title: ___________________________________________________________________________

Telephone:________________________________________________________________________________________

Fax: ____________________________________________________________________________________________

E-mail: __________________________________________________________________________________________

Burden Statement

Public reporting burden for the collection of information on this complaint form is estimated to average 30 minutes per response, including the time for reviewing instructions, gathering the data needed and entering and reviewing the information on the completed complaint form. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: HHS/OS Reports Clearance Officer, Office of Information Resources Management, 200 Independence Ave. S.W., Room 531H, Washington, D.C. 20201