Welcome! The material presented by our attorneys at this program have been gathered by Fox Rothschild for general informational purposes only.

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1 Welcome! The material presented by our attorneys at this program have been gathered by Fox Rothschild for general informational purposes only. No information presented at this program constitutes legal advice nor is it intended to be fact-specific. As there may be occasions where Fox Rothschild represents clients who may be adverse to your interests, discussion at this program cannot touch upon any factspecific matters. Attendees should consult with knowledgeable legal counsel to determine how applicable laws pertain to specific facts and situations. These materials are based on the most current information available. Since it is possible laws or other circumstances may have changed since this presentation, please consult with legal counsel to discuss any action you may be considering as a result of attending this program or reading these materials. Attendance at this program and/or receipt of these materials is not intended to create nor does it establish an attorney-client relationship.

2 Patient Safety Evaluation System: Improving Quality While Reducing Legal Risk John D. Shire Fox Rothschild LLP Partner th Street, NW Suite 380 East Washington, DC (202) direct (202) fax Peggy Binzer Alliance for Quality Improvement and Patient Safety AQUIPS Executive Director 5114 Cherokee Avenue Alexandria, VA direct Fox Rothschild

3 Agenda I. Introductory Remarks II. III. What is required under the ACA Tort Reform under the Patient Safety and Quality Improvement Act IV. Patient Safety Evaluation Systems (PSES): 101 Defining and Defending Your PSES What s Happening in the PSES V. The PSO National Landscape Litigation Update CMS Surveyors VI. Q&A VII. Concluding Remarks 3

4 AQIPS National Professional Association of Patient Safety Organizations (PSOs) and their provider members, whose mission is to fosters the ability of PSOs and providers to implement a safety culture to produce highly reliable, quality care for the benefit of patients through the use of the Patient Safety Act s privilege and confidentiality protections. 4

5 Only Program that Allows Providers to Evaluate How They are Doing PSOs are the only program that permit health care providers to investigate how they are providing patient care and how they can do a better job without fear of litigation or harm to professional reputation. Many QI and safety programs look only at the what, whereas a PSO can help health care professionals figure out the how, in a safety culture that reinforces professionalism and learning, to the benefit of patients. Angie Skretta, NorMet PSI 5

6 ACA PSO Mandates CMS Proposed Rule on PSES All hospitals over 50 beds must have a PSES by 2017 to participate in exchanges Final Rule expected early in March Implementation January 1,

7 Under the State Peer Review System Analysis would include: Collecting an event report Conducting peer review Determining corrective actions Instituting corrective actions..all of this stays within the four walls of the health system to avoid lawsuits or professional reputational harm. 7

8 Purpose of the Patient Safety and Quality Improvement Act of 2005 As many as 98,000 patients die each year as a result of medical errors. To Err is Human, Institute of Medicine, The purpose of the PSQIA is to create a culture of safety by providing legal protection for quality information while permitting the sharing of best practices and other information to continuously improve the quality of patient care. Many states peer review protections have been eroded, the protections do not cross state lines, and are generally inadequate for the purpose of sharing information to promote patient safety. Learning System: Congress intended that interventions, protocols, information about best practices, and systems improvements that are developed through the analysis of patient safety work product be shared by providers and PSOs to enable patient safety improvements to occur throughout the health care delivery system. 8

9 Patient Safety and Quality Improvement Act of 2005 Patient Safety Act encourages providers to confidentially share quality information to improve the quality and safety of health care delivery in a culture of safety without fear of litigation or harm to professional reputations. 9

10 The Act Creates Unique Quality Protections With Three Core Elements Patient Safety Organizations (PSO) Selfcertifying experts listed by the Secretary of Health and Human Services as qualified organizations whose mission and primary purpose are to conduct activities aimed at improving patient safety and the quality of health care delivery. 10

11 Patient Safety Evaluation System (PSES) The collection, management, or analysis of confidential information for reporting to or by a PSO. Clinical Prospective: Where providers can evaluate how they improve upon the high quality job they are doing. Legal Prospective: Identifies protected information and protected space. 11

12 Patient Safety Work Product Any data, reports, records, memoranda, analysis (such as root cause analysis), or written or oral statements which are: assembled or developed by a provider for reporting to a patient safety organization and are reported to a patient safety organization or developed by a PSO and which could result in improved patient safety, health care quality, or health care outcomes or which identify or constitute the deliberations or analysis of a patient safety evaluation system. 12

13 Patient Safety Work Product Patient Safety Work Product is NOT Original records medical records, billing records Event reports required to be reported to the state Separate records or information collected, maintained or developed separately, or which exists separately, from a PSES. 13

14 Protections for Data and Health Care Privilege: Providers Information is not subject to subpoena, discovery, or admission into evidence Federal privilege preempts state tort laws but not reporting laws Federal privilege does not preempt state laws that provide stronger peer review protections Provides federal liability protections to providers: Federal privilege and confidentiality protections cross state lines Federal privilege preempts state tort laws but not state reporting laws Establishes a federal peer review privilege for all licensed providers (e.g., pharmacists) Preempts use of protected information in federal cases (e.g., racial discrimination) Confidentiality: The Act places a statutory requirement on providers not to disclose Patient Safety Work Product, except under certain circumstances and imposes penalties of up to $11,000 per violation against any person or principal who knowingly or recklessly violates the confidentiality provisions 14

15 Privilege As Provided For By The Act Patient Safety Work Product is privileged pursuant to 42 U.S.C. 299b-22(a), and therefore, it is not: Subject to a federal, state or local civil, criminal or administrative subpoena or order; Subject to discovery in connection with a federal, state or local civil, criminal or administrative proceeding; Subject to disclosure under federal or state Freedom of Information Act requests; Admissible in evidence in any federal, state or local governmental civil, criminal or administrative proceeding; or Admissible in any state professional disciplinary proceeding. The privilege does not preclude voluntary disclosure of nonidentifiable patient safety work product. 42 U.S.C. 299b- 22(c)(3). 15

16 Privilege Comparison Elements Waiver Scope of Protection Attorney Client Privilege Communication by or to a client To an attorney with no third parties present Communication is for the purpose of securing legal advice Claimed or waived by client only Subject matter when disclosure occurs in litigation context Actual outside litigation context Excluded from discovery or compelled disclosure so long as confidence has been maintained with narrow exceptions (crime, fraud) PSQIA Privilege Information assembled or developed by a provider for reporting to a PSO; reported to a PSO; or developed by a PSO, which could result in improved patient safety or health care quality or which identify the fact of reporting or constitute the deliberations or analysis of a PSES. Held by the data claimed by provider or PSO Waived if all providers agree to disclose but then privilege reattaches after the disclosure Nonidentifiable data can be voluntarily disclosed Limited to PSWP actually disclosed Excluded from compelled disclosure by third parties including litigants, government and disciplinary bodies with narrow exception (crime) 16

17 Protections for the PSO A PSO Cannot be Compelled: A patient safety organization cannot be compelled to disclose information collected or developed whether or not such information is patient safety work product unless the court or government can: Identify the specific information, Prove the information is not patient safety work product, and Show they cannot reasonably be available from another source. The exception is for a criminal action 17

18 Preemption The Federal PSQIA provides that nothing in the privilege or confidentiality provisions shall be construed to limit the application of other federal, state or local laws that provide greater privilege or confidentiality protections than the privilege and confidentiality protections provided for in the Federal PSQIA. 18

19 PSES Protections Go Where State Peer Statutes Do Not Innovative health care delivery systems integrated models (ACO), physician alignment (CIN) New performance assessments outcomes, quality measures, modified peer review in ambulatory care Performance assessment tools (physician score cards, dashboards) Systemizing care for high reliability (surveillance peer systems, checklists and clinical guidelines) Need for transparency among affiliated and unaffiliated health care providers (Learning system across hospitals/ambulatory care, including across state lines) Assess gaps in coordination of chronic care 19

20 Trends in Health Care Delivery Patient centered Coordinated care/physician alignment (ACO, CIN, CCO) Focus on disease management, population health and prevention Greater sharing of information, data mining and predictive analytics Transparency of information (payment, some quality) focus Patient Outcomes 20

21 Innovative Models of Care PSQIA is flexible to accelerate the development of new, voluntary provider-driven opportunities for improvement and to set the stage for breakthroughs in our understanding of how best to improve patient safety. Patient Safety and Quality Improvement, Proposed Rule, 73 Fed. Reg. 8112, 8113 (February 12, 2008). 21

22 Few Limits for the PSO Protections Thinking Inside the Box Administrative practices, e.g., billing, Mandatory Report to State Facts in the medical record or from interviews Communications with other institutions; Peer Review; Coordinating care; missed or delayed diagnosis; Gap or Systems Analysis; laboratory testing review; convenings; surveys; real time monitoring by the PSO; scorecards; clinical protocol development; FMEA; peer meetings; case studies; core measures; bench marking; safety culture surveys; dashboards; statistical analysis; analysis of factors that affect quality; root cause analysis; peer conversations; quality meetings; real time analysis of errors; near misses; interviews; reports; incident reports; PSO takes the signals and investigates/evaluates; trigger tool; event registries; employee or visitor injury related to patient safety; utilization; drug compliance; transfer gaps; medical necessity; second victim Criminal Activity HIPAA: Written information relied upon for treatment decisions 22

23 Integrate PSES allow the confidential sharing of case studies, events and solutions throughout the facilities. Provider External PSO PSO = Integrated Dashboard EMS Long-term care Home Care Health System Ambulatory Care 23

24 Sharing PSWP: Affiliated Providers Definition of affiliated provider identifies to whom identifiable patient safety work product may be disclosed to under the disclosure provision (42 CFR 3.06(b)(4)(iii). Affiliated Provider Legally separate provider that is the parent organization of the provider, is under common ownership, management, or control with the provider, or is owned, managed or controlled by the provider. (42 CFR 3.20) Affiliated providers include: doctors with hospital privileges, (Coordinated care?). More analysis must be performed in the PSO than the provider PSES 24

25 Sharing PSWP: Affiliated Providers Analysis (outcomes, peer review, scorecards/dashboards, performance data, convening) must be sent through the PSO Want PSO protections PSO can share PSWP about providers who are employed or have privileges in their hospitals 25

26 Sharing PSWP: Unaffiliated Providers, Clinical Contracts, and Health Care Suppliers PSOs can share deidentified PSWP among unaffiliated providers. If all providers agree the PSWP can be identifiable (can be a condition of employment in certain circumstances). (42 CFR 3.206(b)(4)). PSOs can bring unaffiliated providers together to discuss how to improve care or find gaps (convenings). OCR has stated that providers can share identifiable PSWP with EHR vendors/medical device manufacturers provided that all providers agree to the disclosure and the vendor has a PSES. PSOs can bring vendors in the culture of safety to analyze functionality/workflow issues. 26

27 Elements of Documentation How information enters the Patient Safety Evaluation System. What processes, activities, physical space(s) and equipment comprise the PSES. Identification of personnel who, or categories of personnel which, need access to patient safety work product to carry out their duties as they relate to the PSES. Identification of the category of Patient Safety Work Product to which access is needed and any conditions appropriate to access. Procedures the Patient Safety Evaluation System uses to report information to a PSO or disseminate information outside of PSES. Fed. Reg. Vol. 73, No. 226, p (November 21, 2008). Courts ultimately will determine whether a document or communication constitutes PSWP and is privileged and confidential; therefore, the PSES documentation should be sufficient to execute the appropriate affidavit. 27

28 Use of PSO for Peer Review Providers: Hospitals; CAHs; Health Systems Nursing facility, comprehensive outpatient rehabilitation facility, home health agency, hospice, renal dialysis facility, ambulatory surgery center, pharmacy, long-term care facility, behavioral health residential treatment facility, clinical laboratory Physician or health care practitioner s office including a group practice Management Company Purposes Adverse Events, RCAs Medical Necessity Non-biased OPPE 28

29 Advantages of Using a PSO PSQIA is the only means to protect the review across separate institutions Ability to proactively identify issues and improve care of individual practitioners or entire departments Patient Safety Act ensures confidentiality of review beyond that afforded by state peer protections Create a learning system to prevent recurrence of mistakes Less expensive than external third party review Raise level of care and make patient care more reliable 29

30 Target of Reviews Review of quality of care/outcomes to standardize care Coop Peer review where the hospital or medical group may have difficulty adequately reviewing performance (in primary care) Monitor use of checklists Review appropriateness and necessity of high risk and invasive procedure Review compliance with the current guidelines for certain procedures 30

31 Medical Necessity Review Pattern of Medicare claims for medically unnecessary procedures is a significant compliance risk False Claims Act: Treble damages, additional per claim monetary penalties and administrative sanctions, including exclusion from federal health care programs Private Payers: Demand reimbursement for claims paid Malpractice claims/class action lawsuits to compensate patients for injuries related to unnecessary care PSQIA Protects the surveillance review and permits the learnings to be shared across health systems to prevent the quality errors and make health care more reliable. 31

32 High Reliability of Care System-Wide Learning Best Practices Shared Standards Raised Standardize Process PSO Convening of Advisors: Set standards of review/credential Reviewers/Review and Improve Clinical Guidelines Facilities collect records-blinds by physician/facility Hospital Assessment Provide feedback to physician/facility with training recommendations Medical Officer validates findings and best practices/ PSO creates Physician Scorecard/ Facility Dashboard/ Best Practices Tracking and Trending Physician Reviewers (Certified Reviewers) review for quality/technical excellence and error 32

33 PSQIA Does Not Hide Bad Performance Can disclose PSWP to legal if there is a reasonable belief a crime was committed. Can send a message to raise a duty for the medical staff to investigate care Financial information is not PSWP can identify overpayments to compliance 33

34 Transfer of Patient Safety Work Product In order to obtain the privilege and confidentiality protections, patient safety work product usually must be transferred to the PSO. ( When in doubt, transfer. ) Compare, 42 U.S.C. 299b-21(7)(A)(i) (materials that must be transferred) with 42 U.S.C. 299b- 21(7)(A)(ii) (no transfer requirement). Under the regulations, transfers can occur in one of three ways: physical transfer, electronic transfer, or functional transfer. See, 42 C.F.R Definition of Disclosure ; 42 C.F.R (a) requiring security measures wherever PSO has access to PSWP. Functional Transfer means providing access to patient safety work product to PSO equal to that obtained by physical transfer. 34

35 PSES Flow Diagram Pharmacy Provider PSES EMS Hospitals Clinics LTC Patent Safety Work Product Incident reports RCA/Peer Review FMEA Investigation Analysis- Patterns and Trends Best Practices Case Studies Recommendations Quality Committee Discussion Privileged and Confidential Culture of Safety PSO Dashboard Best practices Drop out Not PSWP 35

36 Using PWSP for Purposes Other than Reporting to a PSO Information collected or developed must be for the Purpose of Reporting to a PSO to improve quality of patient care. The information can be used for other purposes. Records used to fulfill state reporting obligations cannot be PSWP, but a copy can be reported to the PSO and protected as PSWP. Use of PSWP means the sharing of PSWP for any purpose within a legal entity (hospital or health system). A hospital may use PSWP for any purpose within the hospital with two caveats, confidential information should be treated as being confidential and PSWP cannot be used in personnel actions. Disclosure is the release of information outside of the hospital for which a specific disclosure permission must be applicable. 36

37 Disclosure of Patient Safety Work Product The disclosure of Patient Safety Work Product is prohibited unless the transfer or release falls within one of the statutory exceptions identified in 42 C.F.R (b): Disclosure authorized in writing by all identified providers; To carry out Patient Safety Activities; between a Provider, its contractor and a PSO; among affiliated providers; to another PSO or provider in a redacted form; Disclosure for non-identifiable work product; To grantees carrying out research authorized by the Secretary; To the Food and Drug Administration with respect to a regulated product or activity; Voluntary disclosure by the Provider to an accrediting body; 37

38 Disclosure Of Patient Safety Work Product, (continued) Disclosures to attorneys, accountants or other professionals for business operations or disclosures which the Secretary may determine are necessary for business operations; To law enforcement agencies relating to the commission of a crime; Disclosure in criminal proceedings (after in camera review to determine whether the PSWP contains material evidence of a crime unavailable from another source); Disclosure to permit equitable relief for reporters. Patient Safety Work Product remains privileged and confidential in the hands of the transferee, with the exception of non-identifiable patient safety work product. 42 U.S.C b(d)(2)(B). 38

39 Recommendations Whistleblower protections equitable relief for providers Keep the Quality/Patient Safety Review/Risk Investigation separate from any employment, disciplinary or liability claim/litigation investigation. To the extent possible, segregate those employees performing Quality/Patient Safety Review from those performing the employment or liability claim/litigation related investigation. Separate files maintained in separate places for the two investigations. Avoid storing any file relating to the employment investigation within the PSES. If a supervisor is both a participant in the PSES and the employment decision, he or she should maintain separate files. 39

40 Steps to Implementation Separate entity component PSO under apparent entity Select program to be listed (add others later) Staff may be shared with the Parent Organization IT systems may be shared with Parent Select the backroom PSO to collect events, RCA s other quality information, provide analysis, expertise and feedback AHRQ Listing Roll-out to providers training and PSES implementation assistance Sharing, learning, teaching 40

41 Case Law Efforts to obtain Patient Safety Work Product are most likely to occur in state court actions involving medical malpractice claims. As with all privileges, the defendant bears the burden of establishing the Patient Safety Work Product privilege. To protect and establish the privilege, the defendant must: Raise the appropriate objection; Identify the documents alleged to be Patient Safety Work Product in a discovery response and/or privilege log; and Provide key facts regarding the document (i.e. date the document was created, the time of submission to a Patient Safety Organization, etc.) in an affidavit when necessary. Generally if the PSES is documented properly the privilege is upheld (Illinois Department of Financial and Professional Regulation v. Walgreens) Federal Courts have upheld the privilege particularly in Employment Actions (Tinal v. Norton Healthcare Inc.) 41

42 PSQIA Clarification, 42 U.S.C. 299b- 21(7)(B) Information described in subparagraph (A) does not include a patient s medical record, billing and discharge information, or any other original patient or provider record. Information described in subparagraph (A) does not 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 patient safety organization shall not by reason of its reporting be considered patient safety work product. ''(iii) Nothing in this part shall be construed to limit: I. the discovery of or admissibility of information described in this subparagraph in a criminal, civil, or administrative proceeding; II. the reporting of information described in this subparagraph to a Federal, State, or local governmental agency for public health surveillance, investigation, or other public health purposes or health oversight purposes; or III. a provider's recordkeeping obligation with respect to information described in this subparagraph under Federal, State, or local law. 42

43 Tibbs v. Bunnell, 448 S.W. 3d 796 (Ky. 2014) Appellant physicians argued that certain incident or event reports were privileged patient safety work product. Court of Appeals held that the PSQIA privilege extended only to documents containing a self-examining analysis and remanded the matter to the trial court to conduct an in camera review to determine whether any contained self-examining analysis. The Kentucky Supreme Court reversed the Court of Appeals decision that in order to be protected patient safety work product the document must contain self-examining analysis. 43

44 Tibbs v. Bunnell, 448 S.W. 3d 796 (Ky. 2014) The Kentucky Supreme Court held In fact, as the statutory language indicates, the privilege also extends to certain types of information and data underlying, supporting, or triggering such an analysis. 42 U.S.C.A. 299b-21 (7). The Kentucky Supreme Court held that the incident reports at issue were not privileged patient safety work product. Kentucky state regulations governing hospitals require that administrative reports shall be established, maintained and utilized as necessary to guide the operation, measure the productivity and restart the programs of the facility. 902 KAR 20:016 3(3)(2) (includes incident investigation reports) Under Kentucky law, these types of reports are required in the regular course of business, are hospital records, and, are generally discoverable. 44

45 Tibbs v. Bunnell, 448 S.W. 3d 796 (Ky. 2014) Kentucky regulations give the hospital regulatory agency the right to enter upon the premises for the purpose of inspection. The incident report in question could not be PSWP because its collection, creation, maintenance and utilization is mandated by the Commonwealth of Kentucky as part of its regulatory oversight of its health care facilities. Congress never intended the Act to deprive the states of state-mandated information relevant to their regulatory duties. 42 U.S.C.A. 299b-29(7)(B); H.R. Rep , 14. Remanded with an order to conduct an in camera review for a determination of privilege issues. 45

46 Tibbs v. Bunnell, 448 S.W. 3d 796 (Ky. 2014) Dissent The Act envisions a national medical error reporting system apart from and insulated from the fault-based tort (professional liability) and peer review (professional discipline) systems, a system that will enhance patient care by identifying systemic failures in health care delivery through the vast collection and analysis of pertinent data. Participation in a PSES does not excuse compliance with those state record-keeping requirements [P]atients continue to have access to [state-mandated reports] but the source must be the hospital s state mandated internal record system and not the PSES. 46

47 Tibbs v. Bunnell, 448 S.W. 3d 796 (Ky. 2014) Dissent What happens when a provider fails to generate a state mandated report? The remedy is not to permit a trial court to rummage through to provider s PSES as to do so would completely undermine Congress s assurances to providers that they may participate in this patient safety system without fear of liability or harm to reputation. [T]he hospital could be compelled to prepare the incident report required by state law and such a report would be discoverable 47

48 Southern Baptist Hospital of Florida v. Charles (C.A. No ) (Fla. Ct. App., 1st Dist. 2015) Medical malpractice plaintiffs filed three discovery requests seeking documents related to (1) adverse medical incidents, and (2) related to any physician who worked for the hospital or related to treatment rendered by the Hospital for three years preceding the incident resulting in adverse incident reports. Hospital produced numerous documents, including statemandated Code 15 reports, annual reports and two occurrence reports relating to the patient which were removed from the PSES before being reported to the PSO. The Hospital refused to release other occurrence reports because they constituted PSWP. 48

49 Southern Baptist Hospital of Florida v. Charles (C.A. No ) (Fla. Ct. App., 1st Dist. 2015) Plaintiffs moved to compel production of the occurrence reports arguing that the Patient Safety Act protects only those documents which are created solely to transfer to a PSO (dual purpose argument). The court ordered the documents produced, holding that the documents were created, in part, to satisfy state regulatory requirements and, therefore, were not protected. The hospital appealed. 49

50 Southern Baptist Hospital of Florida v. Charles (C.A. No ) (Fla. Ct. App., 1st Dist. 2015) The Court of Appeals reversed holding that the occurrence reports were Patient Safety Work Product because they were placed into [the Hospital s] PSE system where they remained pending submission to a PSO. Further, the occurrence reports were not original patient records nor were they collected, maintained, or developed separately from the PSES. Plaintiff s contention that the occurrence reports were required to be maintained under state law, and, therefore, serve a dual purpose and are not protected, fails because, even if true, federal protection under the Act and state compliance [are not] mutually exclusive. 50

51 Southern Baptist Hospital of Florida v. Charles (C.A. No ) (Fla. Ct. App., 1 st Dist. 2015) The Act is clear that it is the provider who determines how information is stored and reported and the provider must face any consequences of noncompliance with state or federal reporting requirements. Even if the provider were to place state-mandated reports in its PSES and, fail to report them, the appropriate sanction is to be imposed by state regulators, not the courts. 51

52 Analysis The question with which the courts in Tibbs and Charles are grappling is the meaning of the PSQIAs CLARIFICATION. Does the PSQIA leave the determination as to what is placed in the PSES solely in the hands of the provider or does the CLARIFICATION restrict what is first eligible to be PSWP? What remedy against non-compliant providers? 52

53 Questions? 53