April 14, 2008
Center for Quality Improvement and Patient Safety
Attention: Patient Safety Act NPRM Comments
540 Gaither Road
Rockville, MD 20850
RE Docket RIN 0919-AA01 January 2008, Federal Register, pages 8111–8183, 2/12/08), Agency for Healthcare Research and Quality, Office of Civil Rights, Department of Health and Human Services proposed regulations to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act).
Dear HHS Dockets Manager:
AABB is an international association dedicated to advancing transfusion and cellular therapies worldwide. Our members include more than 1,800 hospital and community blood centers and transfusion and transplantation services as well as approximately 8,000 individuals involved in activities related to transfusion, cellular therapies and transplantation medicine. For over 50 years, AABB has established voluntary standards for, and accredited institutions involved in, these activities. AABB is focused on improving health through the advancement of science and the practice of transfusion medicine and related biological therapies, developing and delivering programs and services to optimize patient and donor care and safety.
AABB appreciates this opportunity to comment on the regulations implementing the Patient Safety and Quality Improvement Act of 2005 (“Patient Safety Act”) recently proposed by the U.S. Department of Health and Human Services (“DHHS”) through its Agency for Health Research and Quality (“AHRQ”).
AABB currently is partnering with the Department of Health and Human Services, including the Centers for Disease Control and Prevention, to establish a nationwide Biovigilance program over the next several years that will improve patient safety and care in the transfusion and transplantation areas. The Biovigilance program will be based on an internet-accessible reporting system that will allow various health care institutions to submit adverse event data, including adverse reactions and near miss events, for analysis by AABB. The system is being designed to collect data that can be used to provide an analysis of participating health care institutions’ performance and recommend improvements as part of AABB’s quality-based efforts to advance the practice and standards of transfusion and transplantation medicine. In addition, it is anticipated that these quality improvements will result in lower health care costs on both a micro- and macro-level.
To encourage participation, the Biovigilance program must protect the confidentiality of a participating health care institution’s adverse reaction and incident reporting, and must provide participating institutions with meaningful, confidential feedback and assistance with preventing adverse events. AABB believes that the proposed regulations provide an invaluable assurance of confidentiality that will be critical to the success of patient safety initiatives such as AABB’s Biovigilance program. Once listed as a component PSO, AABB’s Patient Safety group should be able to receive and analyze patient safety information and provide its analyses, in the form of patient safety work product, confidentially to health care providers and policymakers.
The proposed regulations provide specific requirements that entities must meet to become PSOs, as well as the processes for the Secretary of DHHS to review and accept certifications and to list PSOs. AABB’s comments will focus on these requirements and processes.
As stated more fully below, because DHHS has created a restriction not contained in the PSA on accreditation bodies being listed as PSOs, AABB believes that the component PSO exception to the restriction on such entities applying for PSO status is a key provision that represents an appropriate balance of competing interests. In addition, there are a few areas in the proposed regulations, also enumerated below, that would benefit from clarification and/or modification.
Each specific item addressed in this correspondence is formatted as follows:
Section – language from draft guidance reprinted along with page number and other identifying information.
Recommendation – comment and/or recommended modifications with supporting rationale.
Section 3-102(a)(2) Eligibility (FR 8172)
Restrictions on certain entities. Entities that may not seek listing as a PSO include: health insurance issuers or components of health insurance issuers. Any other entity, public or private, that conducts regulatory oversight of health care providers, such as accreditation or licensure, may not seek listing, except that a component of such an entity may seek listing as a component PSO. An applicant completing the required certification forms described in paragraph (a)(1) of this section will be required to attest that the entity is not subject to the restrictions of this paragraph. (Italics added)
Recommendation – It is important to note at the outset that DHHS has created this restriction on accreditation bodies being listed as PSOs; no such restriction exits in the Patient Safety Act itself. DHHS acknowledges in its comments: “We propose this restriction for consistency with the statute, which seeks to foster a ‘culture of safety’ in which health care providers are confident that the patient safety events that they report will be used for learning and improvement, not oversight, penalties, or punishment. Listing organizations with regulatory authority as PSOs would be likely to undermine provider confidence that adequate separation of PSO and regulatory activities would be maintained.” (FR 8127)
AABB does not agree that this restriction is consistent with the statute or that it is necessary to create the ‘culture of safety’ envisioned by the Act. Nevertheless, AABB does not object to this restriction so long as the component entity exception is maintained and not interpreted so strictly as to be effectively unavailable. In this regard, DHHS comments: “As drafted, this proposed regulation permits a component organization of an entity with any degree of regulatory authority to seek listing as a component PSO. We have not proposed any restrictions on such component organizations for several reasons. First, we expect that the statutory requirement for a strong firewall between a component PSO and its parent organization(s) with respect to its activities as a PSO and the protected information it holds will provide adequate safeguards. Second, providers will have access to the names of parent organizations of component PSOs. …. Finally, we believe that allowing the marketplace to determine whether a component PSO has acceptable or unacceptable ties to an entity with regulatory authority is consistent with our overall approach to regulation of PSOs.” (FR 8127) AABB agrees with this approach, so long as it is reasonably applied.
AABB believes that this exception to the restriction on accrediting organizations’ eligibility for PSO status is crucial to the health care community in general and to the success of the PSO program in particular. By permitting accrediting bodies and professional societies to participate in patient safety activities and affording them the protections available to PSOs, these organizations can capitalize on their distinctive strengths and make important contributions to patient safety through the collection and analysis of data relating to adverse events.
AABB, for example, is well-established in the transfusion medicine and related biological therapy community and, as such, is uniquely positioned to partner with CDC to collect and analyze data relating to adverse reactions and incidents, including near-miss events, that occur in these particular medical environments. Without the allowance of component PSOs, the nationwide Biovigilance program will be stymied and AABB’s Patient Safety group will not be able to receive and analyze patient safety information and provide analyses in the form of patient safety work product confidentially to health care providers.
Moreover, AABB, as other accrediting bodies undoubtedly do, already has in place a robust firewall policy to ensure the independence of its accrediting activities from its consulting and other operational activities. This structure was created precisely to avoid even the appearance of impropriety. AABB is confident that it can structure a Patient Safety component entity that would qualify as a PSO consistent with the proposed certifications.
Section 3-102(c)(ii)(B)(2) (FR 8174)
Nondisclosure of patient safety work product. A component PSO must require that members of its workforce and any other contractor staff, or individuals in, or units of, its parent organization(s) that receive access in accordance with paragraph (c)(1)(ii) of this section to its identifiable patient safety work product, not be engaged in work for the parent organization(s) of which it is a part, if the work could be informed or influenced by such individuals' knowledge of identifiable patient safety work product, except for individuals whose other work for the rest of the parent organization(s) is solely the provision of clinical care. (Italics added)
Recommendation – DHHS’s comments include a requirement for a component entity to have “separate staff”: “It is fitting, in our view, that a component entity certify, as we propose in Sec. 3.102(c), that there is “no conflict” between its mission as a PSO and all of the rest of the parent or affiliated organizations that undertake a jointly sponsored PSO enterprise. Similarly, it is also appropriate that the additional certifications required of component entities in proposed Sec. 3.102(c) regarding separation of patient safety work product and the use of separate staff be required of an entity that has several co-founder parent organizations that exercise ownership, management or control, (i.e. to assure that the intended “firewalls” exist between the component entity and the rest of any affiliated organization that might exercise ownership, management or control over a PSO). (FR 8127) (Italics added).
It is unclear whether the proposed regulation, as written, is intended to prohibit members of the component PSO’s workforce from participating in any activities of the parent organization, regardless of whether such activities are related to the parent’s accreditation program. Such a result is unnecessarily restrictive. For example, staff of the component PSO may occasionally provide expertise to the parent organization on technical issues that are completely unrelated to the parent’s accreditation program. Firewall policies are necessary to prevent component PSO staff from using patient-protected information in a way that would actually or apparently compromise the integrity of the parent’s accreditation activities, but they need not restrict component PSO staff from contributing to the parent organization on issues that do not relate to accreditation (e.g., educational programs, communications, marketing). Clarification of the italicized phrase is needed in order to allow staff of the component PSO to engage in non-accreditation-related work for the parent organization.
The language in section 3-102(c)(ii)(B)(2) should be revised to read, “Nondisclosure of patient safety work product. A component PSO must require that members of its workforce and any other contractor staff, or individuals in, or units of, its parent organization(s) that receive access in accordance with paragraph (c)(1)(ii) of this section to its identifiable patient safety work product, not be engaged in regulatory oversight of health care providers, such as accreditation or licensure work for the parent organization(s) of which it is a part, if the work could be informed or influenced by such individuals' knowledge of identifiable patient safety work product, except for individuals whose other work for the rest of the parent organization(s) is solely the provision of clinical care.” (Italics indicate language added). Adopting this suggested wording clarifies the extent to which members of the component workforce may participate in non-accreditation-related activities on behalf of the parent organization.
Sec. 3.20 Definitions (FR 8173)
Patient safety work product (PSWP).
(1) Except as provided in paragraph (2) of this definition, patient safety work product means any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements (or copies of any of this material)
(i)(A) Which are assembled or developed by a provider for reporting to a PSO and are reported to a PSO; or
(B) Are developed by a PSO for the conduct of patient safety activities; and which could improve patient safety, health care quality, or health care outcomes; or
(ii) Which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.
(2)(i) Patient safety work product does not include a patient's medical record, billing and discharge information, or any other original patient or provider information; nor does it include
information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system. Such separate information or a copy thereof reported to a PSO shall not by reason of its reporting be considered patient safety work product. (Italics added.)
Recommendation – DHHS comments that:
“Records collected or developed for a purpose other than for reporting to a PSO, such as to support internal risk management activities or to fulfill external reporting obligations, cannot become patient safety work product. However, copies of information collected for another purpose may become patient safety work product if, for example, the copies are made for the purpose of reporting to a PSO.” (FR 81210) (Italics added).
“The Patient Safety Act also states that information that is collected, maintained, or developed separately, or exists separately from a patient safety evaluation system, is not patient safety work product. Therefore, if records are collected, maintained, or developed for a purpose other than for reporting to a PSO, those records cannot be patient safety work product. However, if, for example, a copy of such record is made for reporting to a PSO, the copy and the fact of reporting become patient safety work product. Thus, a provider could collect incident reports
for internal quality assurance purposes, and later, determine that one incident report is relevant to a broader patient safety activity. If the provider then reports a copy of the incident report to a PSO, the copy of the incident report received by the PSO is protected as is the copy of the incident report as reported to the PSO that is maintained by the provider, while the original incident report collected for internal quality assurance purposes is not protected.” (FR 8124)(Italics added).
It does not appear that the rule as proposed would provide the protections intended by the comments. In order for PSOs to be viable, they need to be able to rely on the above-quoted language in the comments to ensure that patient safety work product is protected once it is in the hands of the PSO. To that end, Section 3.20 Patient safety work product (PSWP) (2)(i) should be amended to state: “Patient safety work product does not include a patient's medical record, billing and discharge information, or any other original patient or provider information; nor does it include information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system. Such separate information or a copy thereof reported to a PSO shall not by reason of its reporting be considered patient safety work product. However, if, for example, a copy of such record is made for reporting to a PSO, the copy and the fact of reporting become patient safety work product.” (Italics indicate language added). Without this clarification, PSOs will not be able to provide reporting organizations with the assurance they need that the patient safety work product will be appropriately protected.
Recommendation Relating to Timing – In order to maximize the positive impact of the proposed regulations, AABB urges DHHS to expedite finalizing the rules so that PSOs can become registered and begin doing the critical work anticipated by the Patient Safety Act.
AABB’s interest in becoming a component PSO is illustrative of the urgent need for the protections offered by the regulations to be available as soon as possible. As noted above, AABB and the Centers for Disease Control are developing a national Biovigilance system to measure, analyze, and then reduce adverse reactions and incidents related to blood transfusion and tissue transplantation. Component PSO status is key to AABB’s participation in the ongoing development and implementation of the Biovigilance program. Therefore, any steps that can be taken by DHHS to expedite the rulemaking process will help AABB and other organizations engaged in patient safety efforts move forward with initiatives to improve patient safety and lower health care costs.
AABB strongly supports initiatives that improve the safety of patients and donors and stands ready to interact with HHS as necessary. AABB requests that DHHS carefully consider the foregoing points when evaluating the comments and recommendations relating to the proposed regulations.
Questions concerning these comments may be directed to Barbee Whitaker, PhD, Director, Data and Special Programs, AABB, firstname.lastname@example.org.
Barbee I. Whitaker, PhD
Director, Data and Special Programs