the patient safety and quality improvement act does not allow providers to report

as there is no statutory authority to allow PSOs to report patient safety work product to the FDA or to an entity required to report to the FDA. However, the statute does permit providers to report patient safety work product to the FDA or to an entity required to report to the FDA.” (emphasis added)

Full Answer

What is the patient safety and Quality Improvement Act?

The Patient Safety and Quality Improvement Act (Patient Safety Act) amended Title IX of the Public Health Service Act. The statute provides for the improvement of patient safety and the reduction of the incidence of events that adversely affect patient safety. See GPO.gov for online reference to the Patient Safety Act.

Does the Patient Safety Act shield providers from reporting information?

28. See 73 FR 70742, Nov. 21, 2008 (“Even when laws or regulations require the reporting of information regarding the type of events also reported to PSOs, the Patient Safety Act does not shield providers from their obligation to comply with such requirements.”).

Can a provider place information into its patient safety evaluation system?

12. Id. (“We note, however, that a provider should not place information into its patient safety evaluation system unless it intends for that information to be reported to the PSO.”).

How does the Patient Safety Act Protect Patient Safety Information?

The Patient Safety Act and Rule provide privilege and confidentiality protections to specific types of information developed when a provider works with a PSO, such as the data collected and reported to PSOs by providers and the communications and feedback a provider receives from the PSO.

What is the purpose of the Patient Safety and Quality Improvement Act?

The Patient Safety and Quality Improvement Act of 2005 (PSQIA) establishes a voluntary reporting system designed to enhance the data available to assess and resolve patient safety and health care quality issues.

Which entity is mandated to provide a report on the status of patient safety to Congress each year?

Congress vested the authority for implementing the Patient Safety Act with AHRQ by incorporating its provisions into AHRQ's authorizing statute. As the lead Federal agency for patient safety research, AHRQ is an appropriate partner for PSOs and healthcare providers.

WHO reports patient safety to Congress?

Final Report to Congress To Improve Patient Safety Outlines Strategies To Speed Progress. A final report (PDF, 1.16 MB) on strategies to improve patient safety and reduce medical errors has been delivered to Congress by the U.S. Department of Health and Human Services in consultation with AHRQ.

Why was the Patient Safety and Quality Improvement Act of 2005 enacted?

The Patient Safety and Quality Improvement Act of 2005 (the “Act”) was enacted in response to reports that preventable medical errors result in billions of dollars in increased health care costs, disability and death.

What reports are encouraged as a result of the Patient Safety and Quality Improvement Act?

What reports are encourage as a result of the patient safety and quality improvement act? near misses, unsafe conditions, adverse events, events the threaten patient safety.

Which created patient safety organizations PSOs to collect aggregate and analyze confidential information reported by health care providers?

The Patient Safety and Quality Improvement Act signifies the Federal Government's commitment to fostering a culture of patient safety. It creates Patient Safety Organizations (PSOs) to collect, aggregate, and analyze confidential information reported by health care providers.

What is the patient safety Rule?

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) establishes a framework by which hospitals, doctors, and other healthcare providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for the aggregation and analysis of patient ...

Is patient safety a right or privilege?

Medical Malpractice and Professional Liability Defense To further this goal, Congress passed the Patient Safety and Quality Improvement Act of 2005 (“PSA”), which provides the protection of privilege to documents created as part of patient safety efforts in patient safety organizations.

What is the privacy rule in healthcare?

The Privacy Rule protects all "individually identifiable health information" held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral. The Privacy Rule calls this information "protected health information (PHI)."

What is patient safety and quality?

Quality has been defined by the federal Agency for Healthcare Research and Quality (AHRQ) as “doing the right thing at the right time for the right person and having the best possible result.” Patient safety is simply defined by the World Health Organization as “the prevention of errors and adverse effects to patients ...

Who is responsible for patient safety quizlet?

The nurse has the professional responsibility to be engaged in the activities that support a patient-centered safety culture.

Who created the Patient Safety and Quality Improvement Act?

Sen. Jim JeffordsThe PSQIA was introduced by Sen. Jim Jeffords [I-VT]. It passed in the Senate July 21, 2005 by unanimous consent, and passed the House of Representatives on July 27, 2005, with 428 Ayes, 3 Nays, and 2 Present/Not Voting.

What is the purpose of PSQIA?

To encourage the reporting and analysis of medical errors, PSQIA provides Federal privilege and confidentiality protections for patient safety information, called patient safety work product.

What is the purpose of the Patient Safety and Quality Improvement Act of 2005?

The Patient Safety and Quality Improvement Act of 2005 (PSQIA) establishes a voluntary reporting system designed to enhance the data available to assess and resolve patient safety and health care quality issues. To encourage the reporting and analysis of medical errors, PSQIA provides Federal privilege and confidentiality protections ...

What is the subpart C of the Patient Safety Rule?

Subpart C of the Patient Safety Rule establish es the confidentiality provisions and disclosure permissions for patient safety work product and the enforcement procedures for violations of confidentiality pursuant to section 922 of the statute. OCR enforces these confidentiality protections.

What is the purpose of the NPSD?

It will be used to analyze national and regional statistics, including trends and patterns of patient safety events. The NPSD will employ common formats (definitions, data elements, and so on) and will promote interoperability among reporting systems. The Department of Health and Human Services will provide technical assistance to PSOs.

What is the Patient Safety and Quality Improvement Act?

The Patient Safety and Quality Improvement Act signifies the Federal Government's commitment to fostering a culture of patient safety. It creates Patient Safety Organizations (PSOs) to collect, aggregate, and analyze confidential information reported by health care providers. Currently, patient safety improvement efforts are hampered by the fear ...

How to contact PSO office?

To contact PSO Office staff, go to the PSO site at http://www.pso.ahrq.gov/contact/contact.htm.

What are ineligible organizations?

Ineligible organizations include insurance companies or their affiliates.

Do PSOs have to work with more than one provider?

PSOs are required to work with more than one provider.

What is the agency for healthcare research and quality?

In response, PSQIA created a framework for establishing patient safety organizations (PSOs) that could collect and analyze confidential patient information from healthcare providers. The Agency for Healthcare Research and Quality (AHRQ), a part of the U.S. Department of Health and Human Services ...

When did the PSQIA start?

Implementation of PSQIA began in January 2009 under the Patient Safety Rule. Information collected under the auspices of PSQIA has confidentiality protections as well as federal privilege. PSOs are considered HIPAA business associates according to the HIPAA Privacy Rule if they collect and analyze information on behalf of HIPAA-covered entities.

What is the purpose of the Patient Safety and Quality Improvement Act?

As a healthcare leader, another key law to understand is the Patient Safety and Quality Improvement Act (PSQIA), which is designed to facilitate the confidential gathering of information about patient safety events.

When was PSQIA signed into law?

When it was signed into law in 2005, PSQIA served as a relatively quick response to a landmark 1999 report from the Institute of Medicine (IOM; now the Health and Medicine Division of the National Academies) entitled “To Err is Human: Building a Safer Health System.” That report had identified the considerable costs ― mostly important in terms of lives lost but also in the form of higher healthcare expenses ― of the many types of medical error.

What is HCMBA online?

Its 100 percent online format provides a convenient and self-directed track toward a recognized professional degree from an accredited institution, free from the time-consuming constraints of traditional in-class education. Graduates are prepared to navigate a complex healthcare system in which PSQIA, HIPAA, PPACA, and other regulations are central to the work of multiple professionals.

What is a HCMBA?

Earning a healthcare-focused Master of Business Administration (HCMBA) can be a gateway to new professional opportunities in healthcare leadership. The George Washington University (GW) offers a fully online HCMBA program that combines a comprehensive core in the economic, financial and administrative dimensions of healthcare with extensive options for customizing the curriculum.

Does HIPAA apply to PSOs?

Accordingly, all of the requirements of the HIPAA Privacy Rule apply to PSOs and providers participating in the voluntary reporting frameworks of PSQIA. The noncompliance penalties associated with the HIPAA Privacy Rule follow a tiered system. As such, they vary widely depending on the circumstances of the incident in question, including whether it was a product of willful neglect and if there was a reasonable expectation that the involved entities could have known about and avoided the violation. Monetary penalties may apply.

What is not a PSWP?

Specifically excluded from the definition of PSWP is, “a patient's medical record, billing and discharge information, or any other original patient or provider information.” [ 13] The Patient Safety Act and Rule also exclude from the PSWP definition “information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system.” [ 14] Put another way, information prepared for purposes other than reporting to a PSO is not PSWP under the reporting pathway. [ 15]

What is a PSWP copy?

Consistent with the Patient Safety Rule's definition of PSWP, copies of information initially prepared as PSWP within the PSES are PSWP. [ 36] For example, if a provider originally develops information to improve patient safety in its PSES solely for reporting to the PSO, that information is PSWP. If the provider then makes a copy of this information for the PSO and retains another copy of it in its PSES, both the copy of the information disclosed to the PSO and the copy maintained in the provider's PSES are PSWP, and thus privileged and confidential under the Patient Safety Rule.

What is the purpose of a PSO?

HHS believes that most providers that engage with a PSO are doing so to further learning about patient safety and health care quality, consistent with the intent of the Patient Safety Act. Nevertheless, we are concerned about two ways that some providers may be attempting to misuse the Patient Safety Act protections to avoid their external obligations—in particular, to circumvent Federal or state regulatory obligations. First, some providers with recordkeeping or record maintenance requirements appear to be maintaining the required records only in their PSES and then refusing to disclose the records, asserting that the records in their PSES fulfill the applicable regulatory requirements while at the same time maintaining that the records are privileged and confidential PSWP. Second, some providers appear to develop records to meet external obligations outside of the PSES, place a duplicate copy of the required record into the PSES, then destroy the original Start Printed Page 32658 outside of the PSES and refuse to disclose the remaining copy of the information, asserting that the copy is confidential and privileged PSWP. The Patient Safety Act was not intended to give providers such methods to evade their regulatory obligations. Here, we clarify HHS' interpretation of how the Patient Safety Act prohibits providers from using the PSES to protect from disclosure records subject to such external obligations.

Why is it important to know if information is prepared for reporting to a PSO?

As such, uncovering the purpose for which information is prepared can be a critical factor in determining whether the information is PSWP. Since some types of information can be PSWP or not depending upon why the information was assembled or developed, it is important for providers to be aware of whether information is prepared for reporting to a PSO. The chart below includes some examples.

How does the Patient Safety Act help improve patient safety?

The Patient Safety Act promotes the goal of improving patient safety and reducing medical errors by establishing a system in which health care providers can voluntarily collect and report information related to patient safety, health care quality, and health care outcomes to PSOs. The PSOs aggregate and analyze this information and give feedback to the providers to encourage learning and prevent future errors. The providers are motivated to report such information to PSOs because the Patient Safety Act provides broad privilege and confidentiality protections for information meeting the definition of PSWP, which alleviates concerns about such information being used against a provider, such as in litigation.

What is table of contents?

This table of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no substantive legal effect.

Why are markup elements important?

These markup elements allow the user to see how the document follows the Document Drafting Handbook that agencies use to create their documents. These can be useful for better understanding how a document is structured but are not part of the published document itself.

What is AHRQ common format?

AHRQ has also developed Common Formats —standardized definitions and reporting formats for patient safety events— in order to facilitate aggregation of patient safety information. Since their initial release in 2009, the Common Formats have been updated and expanded to cover a broad range of safety events.

What is the Patient Safety and Quality Improvement Act?

The legislation provides confidentiality and privilege protections for patient safety information when health care providers work with new expert entities known as Patient Safety Organizations (PSOs). Health care providers may choose to work with a PSO and specify the scope and volume of patient safety information to share with a PSO. Because health care providers can set limits on the ability of PSOs to use and share their information, this system does not follow the pattern of traditional voluntary reporting systems. However, health care providers and PSOs may aggregate patient safety event information on a voluntary basis, and AHRQ will establish a network of patient safety databases that can receive and aggregate nonidentifiable data that are submitted voluntarily. AHRQ has also developed Common Formats —standardized definitions and reporting formats for patient safety events—in order to facilitate aggregation of patient safety information. Since their initial release in 2009, the Common Formats have been updated and expanded to cover a broad range of safety events.

How is event reporting used in health care?

A 2016 article contrasted event reporting in health care with event reporting in other high-risk industries (such as aviation), pointing out that event reporting systems in health care have placed too much emphasis on collecting reports instead of learning from the events that have been reported. Event reporting systems are best used as a way of identifying issues that require further, more detailed investigation. While event reporting utilization can be a marker of a positive safety culture within an organization, organizations should resist the temptation to encourage event reporting without a concrete plan for following up on reported events. A PSNet perspective described a framework for incorporating voluntary event reports into a cohesive plan for improving safety. The framework emphasizes analysis of the events and documenting process improvements arising from event analysis, rather than encouraging event reporting for its own sake.

What is patient safety event reporting?

Patient safety event reporting systems are ubiquito us in hospitals and are a mainstay of efforts to detect patient safety events and quality problems. Incident reporting is frequently used as a general term for all voluntary patient safety event reporting systems, which rely on those involved in events to provide detailed information. Initial reports often come from the frontline personnel directly involved in an event or the actions leading up to it (e.g., the nurse, pharmacist, or physician caring for a patient when a medication error occurred), rather than management or patient safety professionals. Voluntary event reporting is therefore a passive form of surveillance for near misses or unsafe conditions, in contrast to more active methods of surveillance such as direct observation of providers or chart review using trigger tools. The Patient Safety Primer Detection of Safety Hazards provides a detailed discussion of other methods of identifying errors and latent safety problems.

Why are voluntary events important?

The advantages of voluntary event reporting systems include their relative acceptability and the involvement of frontline personnel in identifying safety hazards for the organization. Because event reports usually are submitted by personnel involved in the events themselves , these caregivers may have legitimate concerns about the effects reporting will have on their performance records. Voluntary event reporting systems are generally confidential, in that the identity of the reporter is known, but legal protection is provided unless professional misconduct or criminal acts took place. Some systems, such as the ICU Safety Reporting System, are entirely anonymous–neither the patient nor the reporter can be identified.

What is PSNet perspective?

A PSNet perspective described a framework for incorporating voluntary event reports into a cohesive plan for improving safety. The framework emphasizes analysis of the events and documenting process improvements arising from event analysis, rather than encouraging event reporting for its own sake.

Why are event reports limited?

The spectrum of reported events is limited, in part due to the fact that physicians generally do not utilize voluntary event reporting systems.

What is a PSO?

PSOs, and entities that seek to be PSOs, are reminded that an enti ty that is a unit or division of a legal entity, or that is owned, managed or controlled by one or more legally separate parent organizations, and that seeks to be a PSO, must apply as a component PSO. Thus, an entity that would be operating as a PSO and that is part of a larger organization that engages in FDA-regulated reporting activities, or that has a parent organization that engages in FDA-regulated reporting activities must seek listing as a component PSO. In addition, under 42 U.S.C. 299b-24(b)(1)(A), a PSO’s mission and primary activity must be to conduct activities to improve patient safety and the quality of health care delivery. Seeking listing as a component PSO helps to ensure that entities with multiple missions and activities (such as FDA-regulated reporting activities) are in compliance with this statutory requirement. Given the issues identified in this Guidance, AHRQ will also be engaging in additional inquiry of applicants and PSOs to determine whether the entity is organizationally related to an FDA-regulated reporting entity such that it should be listed as a component PSO (i.e., it is a unit or division of a legal entity, or is owned, managed or controlled by one or more legally separate parent organizations). If the entity should be listed as a component PSO, AHRQ will work with the entity to pursue such appropriate listing.

What is the Patient Safety Act?

. . to limit, alter, or affect any requirement for reporting to the Food and Drug Administration information regarding the safety of a product or activity regulated by the Food and Drug Administration.” (emphasis added) The Patient Safety Act added sections 921 to 926 to the Public Health Service Act. The “section” that is referenced in the FDA Rule of Construction is section 922 of the Public Health Service Act, 42 U.S.C. § 299b-22, which includes all of the Patient Safety Act’s privilege and confidentiality protections and exceptions. Thus, the privilege and confidentiality protections in the Patient Safety Act cannot be construed to limit, alter, or affect any requirement for reporting information to the FDA regarding the safety of an FDA-regulated product or activity.

What is the confidentiality requirement for the Patient Safety Act?

The confidentiality requirements of the Patient Safety Act do not apply to or prohibit a “[d]isclosure by a provider to the Food and Drug Administration with respect to a product or activity regulated by the Food and Drug Administration .” 42 U.S.C. § 299b-22(c)(2)(D). The final rule implementing the Patient Safety Act regulation at 42 CFR 3.206(b)(7)(i) provides that the confidentiality provisions shall not apply to or prohibit: "Disclosure by a provider of patient safety work product concerning an FDA-regulated product or activity to the FDA, an entity required to report to the FDA concerning the quality, safety, or effectiveness of an FDA-regulated product or activity, or a contractor acting on behalf of FDA or such entity for these purposes.” Subsection (b)(7)(ii) provides that: “Any person permitted to receive patient safety work product pursuant to paragraph (b)(7)(i) of this section may only further disclose such patient safety work product for the purpose of evaluating the quality, safety, or effectiveness of that product or activity to another such person or the disclosing provider.”1

What is the Patient Safety and Quality Improvement Act?

The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorized the creation of PSOs to improve quality and safety by reducing the incidence of events that adversely affect patients. To implement the Patient Safety Act, the Department of Health and Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ) ...

Who enforces the Patient Safety Act?

Often referred to as the Patient Safety Act, the provisions of this law dealing with PSOs are administered by the Agency for Healthcare Research and Quality (AHRQ) and the provisions dealing with its confidentiality protections are interpreted and enforced by the Office for Civil Rights (OCR).

What is PSWP in healthcare?

Any information that is eligible to become PSWP reported to a PSO by a healthcare provider is protected. The definition of PSWP ( Patient Safety Rule Section 3.20) provides important detail on what information is eligible for protection and when those protections apply.

What is a PSO readmission?

The PSO readmissions Web page contains helpful information and tools that can be used by such hospitals, and PSOs that work with those hospitals, to address the causes of unnecessary readmissions. In fact, any hospital can work with a PSO on any patient safety issue of the hospital's choice.

What are uniform federal protections?

The uniform Federal protections that apply to a provider's relationship with a PSO are expected to remove significant barriers that can deter the participation of healthcare providers in patient safety and quality improvement initiatives , such as fear of legal liability or professional sanctions.

What is the Patient Safety Act?

The Patient Safety Act and Rule provide protections that are designed to allay fears of providers of increased risk of liability if they voluntarily participate in the collection and analysis of patient safety events.

What is the role of OCR?

OCR is responsible for the investigation and enforcement of the confidentiality provisions of the Patient Safety Rule. OCR will investigate allegations of violations of confidentiality through a complaint-driven system.

What is the purpose of PDSA?

The purpose of PDSA quality improvement efforts is to establish a functional or causal relationship between changes in processes (specifically behaviors and capabilities) and outcomes. Langley and colleagues51proposed three questions before using the PDSA cycles: (1) What is the goal of the project? (2) How will it be known whether the goal was reached? and (3) What will be done to reach the goal? The PDSA cycle starts with determining the nature and scope of the problem, what changes can and should be made, a plan for a specific change, who should be involved, what should be measured to understand the impact of change, and where the strategy will be targeted. Change is then implemented and data and information are collected. Results from the implementation study are assessed and interpreted by reviewing several key measurements that indicate success or failure. Lastly, action is taken on the results by implementing the change or beginning the process again.51

What is the importance of quality improvement?

Quality improvement requires five essential elements for success: fostering and sustaining a culture of change and safety, developing and clarifying an understanding of the problem, involving key stakeholders, testing change strategies, and continuous monitoring of performance and reporting of findings to sustain the change.

What is failure mode and effects analysis?

Failure modes and effects analysis (FMEA) is an evaluation technique used to identify and eliminate known and/or potential failures, problems, and errors from a system, design, process, and/or service before they actually occur .74–76FMEA was developed for use by the U.S. military and has been used by the National Aeronautics and Space Administration (NASA) to predict and evaluate potential failures and unrecognized hazards (e.g., probabilistic occurrences) and to proactively identify steps in a process that could reduce or eliminate future failures.77The goal of FMEA is to prevent errors by attempting to identifying all the ways a process could fail, estimate the probability and consequences of each failure, and then take action to prevent the potential failures from occurring. In health care, FMEA focuses on the system of care and uses a multidisciplinary team to evaluate a process from a quality improvement perspective.

Why are people hesitant to participate in quality improvement efforts?

Even with strong and committed leadership, some people within the organization may be hesitant to participate in quality improvement efforts because previous attempts to create change were hindered by various system factors,93a lack of organization-wide commitment,94poor organizational relationships, and ineffective communication.89However the impact of these barriers were found to be lessened if the organization embraced the need for change,95changed the culture to enable change,90and actively pursued institutionalizing a culture of safety and quality improvement. Yet adopting a nonpunitive culture of change took time,61, 90even to the extent that the legal department in one hospital was engaged in the process to turn the focus to systems, not individual-specific issues.96Also, those staff members involved in the process felt more at ease with improving processes, particularly when cost savings were realized and when no layoff policies were put in place to protect job security even when efficiencies were realized.84

How is quality measured in health care?

More than 40 years ago, Donabedian27proposed measuring the quality of health care by observing its structure, processes, and outcomes. Structure measures assess the accessibility, availability, and quality of resources, such as health insurance, bed capacity of a hospital, and number of nurses with advanced training. Process measures assess the delivery of health care services by clinicians and providers, such as using guidelines for care of diabetic patients. Outcome measures indicate the final result of health care and can be influenced by environmental and behavioral factors. Examples include mortality, patient satisfaction, and improved health status.

Why is it important to adopt process improvement techniques?

Because errors are caused by system or process failures,5 it is important to adopt various process-improvement techniques to identify inefficiencies, ineffective care, and preventable errors to then influence changes associated with systems.

What is RCA technique?

RCA is a technique used to identify trends and assess risk that can be used whenever human error is suspected65with the understanding that system, rather than individual factors, are likely the root cause of most problems.2 , 4A similar procedure is critical incident technique, where after an event occurs, information is collected on the causes and actions that led to the event.63

Background

HHS Approach to Patient Safety Act Interpretation

How Information Becomes PSWP

Information That Is Not PSWP

Purpose For Which The Information Was Assembled Or Developed

Meeting External Obligations

• The Patient Safety Act Does Not Relieve a Provider From Its External Obligations
  As discussed above, the Patient Safety Act does not permit providers to use the privilege and confidentiality protections for PSWP to shield records required by external recordkeeping or reporting requirements. To this end, the Patient Safety Act specifically states that it shall not limi…
• Original Patient and Provider Records
  As stated in the Patient Safety Act and Patient Safety Rule, original patient and provider records, such as a patient's medical record, billing information, and discharge information, are not PSWP.[30] We now provide further clarification regarding what constitutes other types of origina…

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