CLEAN VERSION (09-26-2024)
Form
Approved
OMB No. 0935-0143
Exp. Date ?????????
PATIENT SAFETY ORGANIZATION:REQUEST FOR VOLUNTARY RELINQUISHMENT |
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The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) 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 and Patient Safety Rule dealing with PSO operations. Information related to PSOs is available on AHRQ's PSO website at www.pso.ahrq.gov. All references to Secretary within this form refer to the Secretary of HHS.
An entity is listed as a PSO when the Secretary accepts the entity’s certification submission and determines that it meets the applicable statutory and regulatory requirements. A PSO can be "delisted" by the Secretary if: (a) the PSO no longer meets the requirements of the Patient Safety Act and/or Patient Safety Rule; (b) the PSO’s three-year listing period expires; or (c) the PSO chooses to voluntarily relinquish its status as a PSO for any reason. Section 3.108(d) of the Patient Safety Rule states that when a PSO is delisted, the Secretary will promptly publish in the Federal Register and on the AHRQ PSO website, or in a comparable future form of public notice, a notice of the actions taken and the effective dates.
A PSO can notify AHRQ of its intention to voluntarily relinquish its status as a PSO at any time. The requirements for seeking voluntary relinquishment can be found at section 3.108(c) of the Patient Safety Rule. In particular, please review sections 3.108(c)(2)(i) and (c)(2)(ii) of the Patient Safety Rule concerning the requirements for the disposition of patient safety work product (PSWP) at delisting.
In order to request voluntary relinquishment, please submit this form to AHRQ's PSO Office via email, at pso@ahrq.hhs.gov. To submit a hard copy, please send to: PSO Office, AHRQ, 5600 Fishers Lane, MS 06N100B, Rockville, MD 20857. This form must be signed by the Authorized Official. |
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PART I: PSO INFORMATION |
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PART II: REQUEST FOR VOLUNTARY RELINQUISHMENT |
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PART III: ATTESTATIONS REGARDING DISPOSITION REQUIREMENTS |
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1. |
Does the PSO have PSWP?
If answer is “Yes,” proceed to questions 2 and 3, and then sign form.
If answer is “No”, skip questions 2 and 3, and then sign form. |
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2. |
Do you attest that all reasonable efforts have been made, or will have been made by the PSO within 15 calendar days of this statement, to notify the sources (including other PSOs) from which the PSO received PSWP of the PSO’s intention to: 1) cease PSO operations and activities; 2) relinquish voluntarily its status as a PSO; 3) request that these other entities cease reporting or submitting any further information to the PSO as soon as possible; and 4) inform the sources that any information reported after the effective date and time of delisting that the Secretary sets will not be protected as PSWP under the Patient Safety Act? |
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3. |
Do you attest that the entity has established a plan, or within 15 calendar days of this statement, will have made all reasonable efforts to establish a plan, in consultation with the sources from which it received PSWP, that provides for the disposition of the PSWP held by the PSO that is consistent with, to the extent practicable, the statutory options for disposition of PSWP as set out in section 3.108 (b)(3) of the Patient Safety Rule? The options are: (i) Transfer such PSWP or data, with the approval of the source from which it was received, to a PSO that has agreed to receive such patient safety work product or data; (ii) Return such work product or data to the source from which it was submitted; or (iii) If returning such PSWP or data to its source is not practicable, destroy such PSWP or data.
NOTE: If the PSWP or data contains protected health information, the PSO must ensure that it meets the Patient Safety Rule disposition requirements as well as the terms of its business associate agreements and all applicable HIPAA requirements.
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PART IV: CERTIFICATION OF ATTESTATIONS |
I am legally authorized to complete this form on behalf of the entity seeking voluntary relinquishment as a PSO. The statements on this form 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 can be punished by fine or imprisonment or both (United States Code, Title 18, Section 1001). Authorized Official Information Name Title Organization (if different from PSO) Phone Extension (if applicable) ***This form must be signed and dated by the authorized official on record with AHRQ.*** Signature Date This completed form is considered public information. |
Burden Statement |
This survey is authorized under 42 U.S.C. 299a. This information collection is voluntary and the confidentiality of your responses to this survey is protected by Sections 944(c) and 308(d) of the Public Health Service Act [42 U.S.C. 299c-3(c) and 42 U.S.C. 242m(d)]. Information that could identify you will not be disclosed unless you have consented to that disclosure. Public reporting burden for this collection of information is estimated to average 30 minutes per response, the estimated time required to complete the survey. 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. The data provided will help AHRQ’s mission to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable. 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 (OMB control number 0935-0143) AHRQ, 5600 Fishers Lane, Room #07W42, Rockville, MD 20857, or by email to REPORTSCLEARANCEOFFICER@ahrq.hhs.gov. |
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
File Title | Patient Safety Organization: Certification For Continued Listing |
Author | Department of Health and Human Services |
File Modified | 0000-00-00 |
File Created | 2024-10-28 |