Form #1 Form #1 Patient Safety Organization Certification Form 10/2/2008

Form Approved


OMB No. 0935-XXXX


Exp. Date XX/XX/20XX

PATIENT SAFETY ORGANIZATION: CERTIFICATION FOR INITIAL LISTING
Before completing this form, please review the Interim Guidance Implementing the Patient Safety and Quality Improvement Act of 2005 (available at www.pso.ahrq.gov). An entity seeking initial listing by the Secretary as a Patient Safety Organization (PSO) must complete this form, which restates the 15 statutory requirements that all PSOs must certify they meet and the 3 additional statutory criteria that Component PSOs must meet. The Secretary will notify the entity in writing of his acceptance or non-acceptance of this certification. If this certification is accepted, the Secretary will list the PSO for three years beginning on a date and time specified in the notice. An entity is encouraged, but not required, to develop and post on a website a supplementary narrative that: 1) addresses how the entity will approach its mission and carry out required patient safety activities, and 2) outlines the expertise of its personnel (both employees and contractors) to carry out its mission.
PART I: ORGANIZATION CONTACT INFORMATION
NAME AND ADDRESS – ENTITY SEEKING LISTING AS A PATIENT SAFETY ORGANIZATION
Street Address City State Zip Code
Mailing Address (if different) City State Zip Code
Telephone Number Email and Website Address Fax Number
PART II: ATTESTATION REGARDING COMPLIANCE WITH REGULATORY REQUIREMENTS
Until the effective date of the final rule implementing the Patient Safety and Quality Improvement Act of 2005, entities will be listed as Patient Safety Organizations (PSOs) based upon the Interim Guidance available at www.pso.ahrq.gov. Following publication of the final rule, this part of the form (Part II) will include additional attestations based upon the requirements of the final rule. At that time, entities listed as PSOs during the interim period will be asked to submit the additional required attestations that will subsequently be included here. Entities that are listed as PSOs during the interim period are reminded that, on the day that the final rule becomes effective, they must be in compliance with all of the requirements of the final rule. If an entity is a component of another organization, please attach the name(s) of the organization(s) of which the entity is a component.
PART III: ATTESTATIONS REGARDING STATUTORY REQUIREMENTS FOR INITIAL CERTIFICATION
1.	Does the entity have policies and procedures to improve patient safety and the quality of health care delivery?	 YES  NO
2.	Does the entity have policies and procedures for the collection and analysis of patient safety work product?	 YES  NO
3.	Does the entity have policies and procedures to develop and disseminate information with respect to improving patient safety, such as recommendations, protocols, and best practices?	 YES  NO
4.	Does the entity have policies and procedures to utilize patient safety work product to encourage a culture of safety, to provide feedback and assistance to effectively minimize patient risk?	 YES  NO
5.	Does the entity have policies and procedures to preserve confidentiality of patient safety work product in conformity with the rule and the authorizing statute?	 YES  NO
6.	Does the entity have policies and procedures to protect patient safety work product in conformity with the rule and the authorizing statute?	 YES  NO
7.	Does the entity have policies and procedures in place to assure the utilization of appropriately qualified staff?	 YES  NO
8.	Does the entity have policies and procedures to perform the collection, management and analytic activities related to the operation of a patient safety evaluation system (PSES) including the provision of feedback to participants in a PSES?	 YES  NO
9.	Upon listing, will improvement of patient safety and the quality of health care delivery be the entity’s mission and primary activity?	 YES  NO
10.	Upon listing, will the entity’s employees or contractors include licensed or certified medical professionals?	 YES  NO
11.	Upon listing, will the entity meet the requirement to enter at least two bona fide contracts within 24 months of its initial listing (and meet that test in every subsequent 24-month period)?	 YES  NO
12.	Does the entity comply with the prohibition that it may not be a health insurer or a health insurer component?	 YES  NO
13.	Upon listing, will the entity meet the requirement to fully disclose to the Secretary relationships with contracting providers?	 YES  NO
14.	Upon listing, will the entity collect patient safety work product in a standardized manner, to the extent practical and appropriate, that permits valid comparisons of similar cases? Note: The Secretary is providing guidance on common formats and definitions, which is available at www.pso.ahrq.gov.	 YES  NO
15.	Upon listing, will the entity utilize patient safety work product for the purpose of providing direct feedback and assistance to providers to effectively minimize patient risk?	 YES  NO
ONLY ANSWER QUESTIONS 16-18 IF YOUR ENTITY IS A COMPONENT ORGANIZATION
16.	Will the component entity maintain patient safety work product separately from the rest of the organization(s) of which it is a part?	 YES  NO
17.	Will the component entity prevent unauthorized disclosure of patient safety work product to any person in the rest of its organization(s) of which it is a part?	 YES  NO
18.	Will the mission of the component entity create a conflict of interest with the rest of its organization(s) of which it is a part?	 YES  NO

PART IV: CERTIFICATION OF ATTESTATIONS

I am authorized to complete this form on behalf of the entity seeking 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, 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 Interim Guidance 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.

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