P2 Policies and Procedures for Institutions Working with PSOs

Transcription

1 Working With Patient Safety Organizations (PSOs) Ronni P. Solomon ECRI Institute P2 Policies and Procedures for Institutions Working with PSOs Ronni P. Solomon, Executive Vice President and General Counsel, ECRI Institute Agenda Background of Patient Safety Act Key concepts Reporting to a PSO Setting up your PSES Questions & Discussion

2 About ECRI Institute Independent, not-for-profit applied research institute, 40-year history Helping the healthcare community to determine the best ways of delivering care Patient Safety, Quality and Risk Management Technology Assessment, Effectiveness Medical Product Evaluation, Planning, Procurement Strict conflict of interest rules Qualified PSO staff; 300 person interdisciplinary staff Clinical, safety, risk management, healthcare quality, engineering, life sciences, information technology, statisticians, data analysts Federally-certified PSO Why ECRI Institute is a PSO

3 Annual Accidental Deaths (from Lucian Leape) What Should We Do? Implement known best practices Redesign faulty systems Change the culture - from a culture of blame to a culture of safety Congress should pass legislation to protect the development and analysis of information related to improving safety and quality.

4 Why Federal Protection is Needed Providers fear that patient safety reports could be used against them State protections vary may offer no or inadequate protections (e.g., no protection if data is shared outside the hospital) For improvement, we need robust reporting and aggregation of data; by analyzing more events, patterns of failures could be more rapidly identified Near-miss data for the health care domain should be analyzed more extensively than is currently the case. The data provide two types of information relevant to patient safety on weaknesses in the health care system and, equally important, on recovery processes.

5 Stories from Pennsylvania Near Miss Color Coded Wristbands Near failure to rescue patient who arrested

6 Look-Alike Packaging Confusingly similar packaging for insulin and tuberculin syringes Potential tenfold overdose of insulin Discovering the Unexpected Medication errors involving incorrect patient weights 40% from the ED. Many don t have scales capable of weighing immobilized or unconscious patients without removing them from a gurney or stretcher. The not-so unusual Patients scheduled for gall bladder removal only to find that the gall bladder was already removed. Failure to obtain a proper history (patients had dementia), and all the patients were diagnosed with ultrasound (a non-specific test) with no further confirmation. 200 reports of staff who misunderstood the distinctions between living wills and DNR orders. Many cases involved inappropriate withholding of treatment, failure to rescue.

7 Frequency, Severity Medication Errors 22% of overall 4% of events involving harm and 1% of events contributing to or resulting in death. Complications related to Procedures/Treatments/Tests 13% of overall 43% of events involving harm and 59% of events resulting in or contributing to the patient s death. Share, Learn, Change 218 Patient Safety Officers reported 607 changes in 2008 Hand hygiene practices Wrong site surgery prevention Anticoagulation management Medication assessment and fall risk Many more

8 Collaboratives, Analysis, Tools The Patient Safety Act Many Benefits; Know the Details

9 Federal Patient Safety Act PSOs and providers are mutually responsible Federal Patient Safety Act To improve healthcare quality and patient safety To share data within a protected legal environment To identify and reduce the potential risks associated with patient care The Act is voluntary and does not provide federal funding of PSOs

10 Legal Protections Not subject to subpoena in civil, criminal, administrative proceedings Not subject to discovery Not admissible into evidence Not subject to FOIA Goes beyond state law for some Participation with a PSO is voluntary legal protections only kick-in if provider participates What Does It Mean? Patient Safety Organizations (PSOs) Entities that meet the requirements of the Patient Safety Act and Rule Patient Safety Work Product (PSWP) Information that is privileged and confidential Patient Safety Evaluation System (PSES) The protected space in which PSWP is assembled or developed for reporting to or from a PSO A provider s deliberations and analyses within a PSES are confidential and privileged

11 Collaborative Model Patient Safety Organizations (PSO) Federally designated by AHRQ PSO must comply with a host of requirements Information reported to or developed by a PSO for the purpose of conducting patient safety activities is protected

12 Patient Safety Work Product (PSWP) 1. PSWP 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. Which could improve patient safety, health care quality, or health care outcomes; and H O W A. Which are assembled or developed by a provider for reporting to a PSO and are reported to a PSO, which includes information that is documented as within a patient safety evaluation system for reporting to a PSO, and such documentation includes the date the information entered the patient safety evaluation system; or B. Are developed by a PSO for the conduct of patient safety activities; or 2. Which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system. What is not PSWP Patient medical records, billing and discharge information, other original patient or provider information Information that is collected, maintained, or developed separately, or exists separately, from a PSES. Information collected to comply with external obligations: e.g., state reporting requirements; FDA Medwatch; NPDB.

13 When is PSWP protected? Upon collection Provider documents that the information was collected for reporting to a PSO and the date of collection Query: How long is too long before submission to the PSO? Documenting PSWP Label PSWP Helps to prevent inappropriate disclosure. P & Ps CONFIDENTIAL PATIENT SAFETY WORK PRODUCT. Protected under the Patient Safety and Quality Improvement Act. Do not disclose unless authorized by [name of governing document, office, or body].

14 Patient Safety Evaluation System (PSES) Defined as: the collection, management, or analysis of information for reporting to or by a PSO Meant to be flexible and scalable to individual operations Best practice is to document the PSES PSES The regulations say A protected space or system that is separate, distinct, and resides alongside but does not replace other information collection activities mandated by laws, regulations, and accrediting and licensing requirements as well as voluntary reporting activities that occur for the purpose of maintaining accountability in the health care system.

15 Keep in Mind.. PSWP submitted to the PSO is forever privileged and confidential and cannot be disclosed except in limited circumstances called permissible disclosures. You Can Remove PSWP from the PSES Facility may remove PSWP from PSES before submitting; no longer PSWP; a virtual copy can be sent to the PSO; PSO still treats it as confidential.

16 Internal Use of PSWP Is NOT regulated Affiliated providers may share identifiable PSWP May share with practitioners having privileges May share de-identified data with non-affiliated providers Establishing the PSES Take inventory Committees, Departments Set goals Develop recommendation, Obtain agreement Document the PSES Implement Monitor

17 Questions to Consider Where to start what types of data? How to use existing structures, processes? Centralize the PSES? Multi-hospital systems? Access to PSES data? How long data can stay in the PSES before reporting to a PSO? Patient Safety Officer PSO Prioritizing Reportable Data Prioritize based on criteria: Promotes a culture of safety/improves care Impressions/subjective data that is not available in the medical record Not required to be reported elsewhere (although there are permissible disclosures) Data will not be used to make adverse employment decisions

18 Documenting the PSES Some ideas. Processes, activities, the physical space, computer systems, and equipment that compose the PSES Procedures for entering data and information into the PSES Personnel who have access to the PSES and how they carry out their duties and the system's operations Conditions for accessing PSWP that is part of the PSES Procedures for reporting information to the PSO and receiving feedback form the PSO Procedures for disseminating information outside the PSES P&Ps Purposes and Scope Definitions Describe your PSES Reporting to PSO Confidentiality, Security Permissible Disclosures

19 Resources Advisories, audioconferences Best Practices Structures P&Ps Documenting the PSES Questions & Discussion