Patient Safety Organization: Certification For Continued Listing

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Form Approved
OMB No. 0935-0143
Exp. Date 8/31/2011

PATIENT SAFETY ORGANIZATION:

CERTIFICATION FOR CONTINUED LISTING

Before completing this form, please review the requirements of the rule specified in 42 CFR Part 3, especially sections 3.102 and 3.106. The rule implements the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), which authorizes the creation of Patient Safety Organizations (PSOs). The Agency for Healthcare Research and Quality (AHRQ) of the Department of Health and Human Services (HHS) administers the provisions of the Patient Safety Act dealing with PSO operations. The rule and other PSO-related information are available on AHRQ's PSO Web site at www.pso.ahrq.gov.

An entity seeking continued listing by the HHS Secretary as a PSO must complete this form, which restates the 15 statutory requirements that all PSOs must certify they meet, the three additional statutory criteria that component PSOs must meet, and other listing requirements specified in this rule.

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 section 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 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.

Please submit this form to AHRQ's PSO Office via email, if possible, at PSO@ahrq.hhs.gov. To submit a hard copy, please send to: PSO Office, AHRQ, 540 Gaither Road, Rockville, MD 20850.

PART I: PSO CONTACT INFORMATION

Please complete the following information about your PSO, which will be used for the "Listed PSOs" section (http://www.pso.ahrq.gov/listing/psolist.htm) of the AHRQ PSO Web site.

PSO Name	AHRQ PSO Assigned Number

PSO Web site

Street Address	City	State	Zip Code

Mailing Address (if different than street address)	City	State	Zip Code

PSO Certification for Continued Listing Page 1 of 4

PART II: ATTESTATION REGARDING REGULATORY REQUIREMENTS

A. Are all of the attestations and the information you submitted, in support of your current certification for listing, still accurate with respect to the PSO?

If the answer is “yes”, this means that you also attest that there have been no changes in the activities of the PSO that would make it ineligible for continued listing. Consult section 3.102(a)(2) of the rule for activities that make an entity ineligible for listing.

If the answer is “no”, please explain your changes here. If necessary, attach an additional sheet to this certification form with the PSO name prominently noted at the top.

___ Yes

___ No

B1. Is the PSO a component of another organization?

If the answer is “no”, please proceed to Part III.

___ Yes

___ No

B2. Regarding your parent organization(s), is the information submitted in support of your current certification for listing still accurate and complete?

A “yes” answer means that there has been no change in the contact information for the parent organization(s) or the number of parent organizations. If there has been no change in either the contact information or the number of parent organizations, there is no need to resubmit contact information below; this attestation will meet the requirement in section 3.102(c)(1)(i) of the rule that the PSO provide contact information for its parent organization(s) when seeking continued listing.

If the answer is “no”, please provide the correct information here. If necessary, attach an additional sheet to this certification form with the PSO name prominently noted at the top.

___ Yes

___ No

B3. Is the component PSO subject to the requirements of section 3.102(c)(1)(ii) of the rule (i.e. the parent organization is an excluded entity)?

If the answer is “no”, proceed to Part III.

___ Yes

___ No

B4. Has the component PSO complied with the requirements of section 3.102(c)(4) of the rule during its current period of listing?

If the answer is “no”, provide details here.

___ Yes

___ No

B5. If the Secretary approves the request for continued listing, will the component PSO comply with the requirements of section 3.104(c)(4) during its period of continued listing?

___ Yes

___ No

PSO Certification for Continued Listing Page 2 of 4

PART III: CERTIFICATION FOR CONTINUED LISTING

Attestations Regarding Patient Safety Activities

As specifically certified below, the PSO listed in Part I attests that it is (a) currently performing, and (b) will continue to perform, each of the statutorily-required patient safety activities (items 1-8) throughout the period of continued listing. A “yes” answer means that you are attesting to both (a) and (b).

Undertaking actions to improve patient safety and the quality of health care delivery?

___ Yes

___ No

Collecting and analyzing patient safety work product (PSWP)?

___ Yes

___ No

Developing and disseminating information to improve patient safety?

___ Yes

___ No

Utilizing PSWP to encourage a culture of safety, and to provide feedback and assistance to effectively minimize patient risk?

___ Yes

___ No

Implementing and maintaining procedures to preserve confidentiality of PSWP in conformity with the rule and authorizing legislation?

___ Yes

___ No

Implementing and maintaining security measures to protect PSWP in conformity with the rule and the authorizing legislation?

___ Yes

___ No

Using appropriately qualified staff to improve patient safety and quality of health care delivery?

___ Yes

___ No

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

Attestations Regarding PSO Criteria

As specifically certified below, the PSO listed in Part I attests that it is (a) currently complying with, and (b) will continue to comply with, each of the statutorily-required criteria for PSOs (items 9-15) throughout the period of continued listing. A “yes” answer means that you are attesting to both (a) and (b).

Making the improvement of patient safety and the quality of health care delivery (a) the PSO's mission and (b) the PSO's primary activity? A “yes” answer attests that both conditions are met.

___ Yes

___ No

10.

Having staff (employees or contractors) who are both (a) appropriately qualified and (b) include licensed or certified medical professionals?

___ Yes

___ No

11.

Meeting the requirement to enter into at least two bona fide contracts 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?

___ Yes

___ No

14.

A. Using the Secretary's published guidance for common definitions and reporting formats (Common Formats) in its collection of PSWP? If the answer is “yes”, proceed to question 15.

B. Using an alternate system of formats and definitions in its collection of PSWP that permits valid comparisons among similar providers? If the answer is “yes”, proceed to question 15.

C. Attest that it is not practical or appropriate to comply with the options described in questions 14A or 14B. If the answer is “yes”, attach a separate sheet with a clear explanation of why it is not practical or appropriate for the PSO to comply with those options.

D. If the answer to 14C is “yes”, is the required explanatory statement attached to this form?

___ Yes

___ No

15.

Using PSWP to provide feedback and help to providers in order to minimize patient risk?

___ Yes

___ No

ONLY ANSWER QUESTIONS 16-18 IF YOUR PSO IS A COMPONENT ORGANIZATION

As specifically certified below, the PSO listed in Part I attests that it is (a) currently complying with, and (b) will continue to comply with, each of the additional statutory requirements for component PSOs (items 16-18) throughout the period of continued listing.

16.

Maintaining PSWP separately from the PSO's parent organization(s) and has established appropriate security measures to maintain the confidentiality of PSWP?

___ Yes

___ No

17.

Requiring that members of its workforce and any other contractor staff not make unauthorized disclosures of PSWP to the rest of the parent organization(s)?

___ Yes

___ No

18.

Ensuring that the pursuit of its mission is not creating a conflict of interest with the rest of its parent organization(s)?

___ Yes

___ No

Please note that if the answer is “no” for any of the questions (1-18), additional clarification may be sought before the Secretary makes a determination regarding continued listing.

PSO Certification for Continued Listing Page 3 of 4

PART IV: 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 made in good faith and are true, complete, and correct to the best of my knowledge and belief. I understand that a knowing and willful false statement on this form, attachments or supplements to it, can be punished by fine or imprisonment or both (United States Code, Title 18, Section 1001). I also understand that the rule requires that if any change takes place that would render any attestation inaccurate or incomplete, or if there is a change in the contact information provided, the entity seeking listing must promptly notify the Secretary of any such change by contacting AHRQ's PSO Office via email at PSO@ahrq.hhs.gov or toll free at (866) 403-3697 or (866) 438-7231 (TTY).

Authorized Official Signature: ____________________________________________________________________

Authorized Official Printed Name: _________________________________________________________________

Authorized Official Title: ________________________________________________________________________

Date: ______________________________________________________________________________________

Telephone: __________________________________________________________________________________

Fax: _______________________________________________________________________________________

E-mail: _____________________________________________________________________________________

If the person completing this form will not be the primary point of contact, please provide the point of contact information below:

Point of Contact: ______________________________________________________________________________

Point of Contact Telephone: ______________________________________________________________________

Point of Contact E-mail: _________________________________________________________________________

This completed form is considered public information

Burden Statement

Public reporting burden for the collection of information is estimated to average 15 minutes per response. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: AHRQ Reports Clearance Officer, Attention: PRA, Paperwork Reduction Project (0935-0143), AHRQ, 540 Gaither Road, Room #5036, Rockville, MD 20850.

PSO Certification for Continued Listing Page 4 of 4

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Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1364