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– PENNSYLVANIA –
Public and Private Policy
Medical Errors and Patient Safety

Overview

Pennsylvania has one of the more robust and more costly adverse event reporting programs in the country. Emerging as a product of complex malpractice legislation, Pennsylvania's program monitors both adverse events and near-miss events.

  • •  Event Reporting Evolves from Medical Liability

    Both the Pennsylvania Department of Health and the General Assembly have addressed mandatory reporting of adverse events in the Commonwealth of Pennsylvania. Administrative rules for Health and Safety first addressed medical error reporting in June 1998, requiring Pennsylvania health-care facilities to report any situation or event that could compromise seriously the health and safety of a patient, and to describe corrective steps [28 PA Code §51.3].

    However, shortly after these rules were established, passage of the Medical Care Availability and Reduction of Error (Mcare) Act, aka Act 13 of 2002, by the General Assembly redefined the reporting program. The Mcare Act is a complex act addressing medical malpractice and tort reform, and less than one-fourth of its text addresses Patient Safety.

  • •  MCARE – Act 13 of 2002
    • ◊  Patient Safety Features

      The laws behind these measures appear in pages 4 through 14 of the 42 page MCARE Act document [PDF]. From the organizational perspective of Patient Safety, Act 13 of 2002 did 4 major things:

      • √  Established the Patient Safety Authority,
      • √  Established the Patient Safety Trust Fund and an assessment authority for facilities to pay for it,
      • √  Redefined an existing mandate for reporting by defining serious events and incidents, and
      • √  Required hospitals to implement and follow internal patient safety plans that includes the requirement for a newly established patient safety committee and a patient safety officer.
    • ◊  Medical Liability Features

      Perhaps at least as significant and impactful as the patient safety issues were the Medical Liability and Malpractice Tort Reform Changes associated with increasing physician reporting and accountabililty, including:

      • √  Physician Licensing-Board Reporting changes,
      • √  Elimination of the state-run Medical Liability Catastrophic Loss Fund (CAT Fund)
      • √  Mandate that the Insurance Department contract out for medical-malpractice claims administration for a newly created Medical Care Availability and Reduction of Error Fund (MCARE Fund),
      • √  MCARE Fund supplements liability insurance for providers by requiring reimbursement of “ . . the fund for the payment of reported claims which became final during the preceding claims period” [40 PA CS §1303.712(2)], and the assessment to meet this deficit is applied upon insured practitioners. 1

      Pennsylvania in 2002 had a very serious Medical Malpractice crisis, and Patient Safety legislative changes should be viewed in context of medical malpractice tort reform and insurance reform. 2


      This payment is calculated as a percentage of the practitioner's malpractice premiums, which were calculated by the Department of Insurance as 43% in 2002 and 46% for 2003; in order to satisfy the $2B in unfunded liability which exists in the fund for 2003, Pennsylvania physicians were charged an additional 46% over and above their malpractice premiums.

      An excellent summary of the Pennsylvania Medical Malpractice Law, plus an array of perspectives on the Medical Practice crisis (e.g., Hospital and Healthsystem of Pennsylvania(HAP), Pennsylvania Medical Society, and Pennsylvania Trial Lawyers Association) provides perspective.

  • •  Notable Features of Reporting Program
    • ◊  Required Facility Participation

      A "Medical facility," defined as "an ambulatory surgical facility, birth center or hospital" is required to participate in reporting to the Patient Safety Authority and the Pennsylvania Department of Health [40 PA CS §1303.302]. In 2005, the PSA has the participation of 241 hospitals, 194 Ambulatory Surgical Facilities (ASFs), and 5 birthing centers.

    • ◊  Establishment of Patient Safety Trust Fund

      The entire first 3-years of expenses ($10M) of the Pennsylvania program were assessed upon healthcare facilities.

      The Patient Safety Trust Fund was created to support the ambitious reporting program conceived by the General Assembly. Facility assessments, which are the only source of funds for the reporting program, have been $2.5M annually, following an initial 2003 assessment of $5M.

      In view of the fact that reporting did not begin until June 2004, it is apparent that the initial 2002-2003 $5M assessment on the hospitals was used entirely for startup costs for this ambitious program. Assessments were $105 per unit according to Robert Muscalus, Pennsylvania Physician General and board member of PSA [PPT presentation]; a unit is defined as a licensed bed for hospitals, as a licensed operating room for Ambulatory Surgical Facilities (ASFs), and as a birthing room for Birthing Centers.

      While the average contribution was $14,000+ for 356 participating facilities in 2002-03 and ~$7,000 for 377 participating facilities in 2003-04, it is apparent that averages are misleading, given that the bulk of Pennsylvania's 38,193 licensed hospital beds [PDF] are concentrated in a small number of larger facilities that have shouldered the bulk of the financial burden.

      The legal basis for the fund is provided in 40 PA CS §1303.305, and further detail regarding project funding is available.

    • ◊  Patient Safety Authority Created

      The Patient Safety Authority (PSA), often referred to as ‘the Authority’, was established in 2003 as a quasi-independent agency with minimal regulatory authority.1

      All of the data collection, analysis, and reporting features of the PSA were out-sourced to Pennsylvania-based sub-contractors, i.e., ECRI and the Institute of Safe Medication Practices (ISMP).

      ECRI created the statewide Pennsylvania Patient Safety Reporting System (PA-PSRS – pronounced “PAY-sirs”), which went into effect on June 28, 2004 for submission of ‘serious events’ and ‘incidents’.


      Whereas the PSA Board of Directors are appointees of the Governor (7) or the General Assembly (4); whereas the PSA must submit annual reports reports to the Governor, the General Assembly, and the DOH; and whereas the PSA must obtain approval from the DOH for release of recommendations and other reporting activities, it is evident that the PSA is not truly an independent state agency. ‘Quasi-independent’ agency is used in this analysis.

    • ◊  PA-PSRS Feedback to Facilties

      PS-PSRS publishes quarterly Patient Safety Advisories and annual Annual reports.

    • ◊  Reporting of ‘Serious Events,’ ‘Incidents,’ and “Infrastructure Failure Events”

      The program defines and requires reporting of both "serious events" and "incidents," the latter being a ’near-miss‘ event associated with no patient injury. Pennsylvania is the only state with a sizeable collection of ‘near-miss’ data. [40 PA CS §1303.313]

      "Incidents" must be reported to the PSA, whereas "serious events" must be reported to both the PSA and the Department of Health. [40 PA CS §1303.306(a)(2)] “Infrastructure failure” events are reported only to the Department of Health.

      Reporting must be performed within 24 hours of knowledge of the event. [40 PA CS §1303.308(a)]

    • ◊  Facilities Must Establish Patient Safety Plans

      Patient Safety Plans must include creation of Patient Safety Committees, a designated Patient Safety Officer, and a reporting system that is accessible 24 hours a day, seven days a week. [40 PA CS §1303.307(b)(2)]

    • ◊  Whistleblower Protections [40 PA CS §1303.307(b)(4)]

      Pennsylvania has a generic Whistleblower protections law dating to 1986. [act of December 12, 1986 (P.L.1559, No.169)]. The MCARE law specifically addressed these protections for reportees of healthcare serious events and incidents. [40 PA CS §1303.307(b)(4)]

    • ◊  Requirement to Notify Patient of Serious event

      Patients and/or surrogates must be notified of "serious events." [40 PA CS §1303.308(b)] Written notification of patients is also required. [40 PA CS §1303.307(b)(5)]

      Pennsylvania followed Tennessee by one-day as the first of 10 states through 2005 to pass legislation mandatating notification of patients.

    • ◊  Confidentiality of all Information via PSA

      All information submitted through PA-PSRS is confidential, and no information about individual facilities or providers will be made public. [40 PA CS §1303.304(c)]

    • ◊  Event Reporting Linked to Reporting Providers to Licensing Boards

      Medical facilities are required to notify a licensee's licensing board of the failure to report a serious event "if [it] discovers that a licensee providing health care services in the medical facility during a serious event failed to report the event in accordance with section 308(a) . . " [40 PA CS §1303.313(e)]

      While all information submitted through PA-PSRS reporting system is confidential, facilities are also required to report all "serious events" to the Department of Health. [40 PA CS §1303.313(a)]

      The DOH has access to all information that is reported and "... may use such information for the sole purpose of any licensure or corrective action against a medical facility." [40 PA CS §1303.311(f)]

      Furthermore, all data collected by the DOH is transparent to the Department of State, which has licensure authority over all health professional licenses. [28 PA Code §51.3(g)and 40 PA CS §1303.311(f)(2)] Hence, Pennsylvania's reporting program incorporates reporting of provider-identified patient safety events into licensure of all providers.

  • •  Reported Pennsylvania Experience

    The Pennsylvania Safety Authority released the first 7-month experience of its reporting program on April 29, 2005 [PDF]. The second annual PSA report of 2005 events was released on April 28, 2006 [PDF]. Annual reports are due by May 1.

    Nearly 240,000 events were reported to PSA through 2005, 95.6% of which were ‘incidents’ and 98.7% of which were reported by hospitals. An overview of the 2004-2005 reports is discussed in Performance Experience.

    An excellent article addressing a broad perspective of responses from Pennsylvania stakeholders is provided by Christopher Guadagnino, Ph.D. in the June 2005 Physician's News Digest. This article expresses cautious optimism but provides little evidence of overwhelming endorsement of the program from the broad spectrum of stakeholders. Program insiders express sentiments that the goals remain unfulfilled and that the program remains understaffed, despite exorbitant funding (relative to other States's programs). Key stakeholders express skepticism and withhold endorsement for the PSA program.

    Guadagnino also points out that the DOH through April 2005 had "20,601 serious event reports, which prompted the DOH to initiate 457 telephone follow-ups with institutions and 383 on-site visits . . " [These numbers correspond to 2.2% telephone follow-up and 1.9% on-site visits]. Furthermore the PSA, despite the abundant resources thrown at it, lacks man-power as evidenced by the fact that ". . . its investigators have spot checked only 60 out of the 207 reported deaths." It is unclear if any of the 453 reported deaths or 7,504 ‘serious events’ reported in 2005 were investigated by either the PSA or the DOH.

    The Pennsylvania PA-PSRs program is clearly one of the more robust and successful event reporting programs. However, questions regarding the effectiveness of this program in addressing patient safety remain. Evidence of significant variability in event reporting across Pennsylvania's 6 regions and reporting variability across all individual facilities has been documented in both PSA annual reports but not addressed by the DOH.

    Whether facilities' patient safety decisions are made on a day-to-day basis by appropriate providers is not clear since facilities have no statutory requirements to perform root cause analyis, provide an analytical report, or institute an action plan after reporting a ‘serious event’ to both the Authority and the DOH. It appears that the medical facility, after the approval of its patient safety plan in 2002 by the DOH, depends on its safety plan template and the patient safety officer and patient safety committee for most of the insight and analysis of events that occur within the facility, aided by quarterly PSA Advisory analyses of anecdotes of reported facility information.

    It is unclear how the DOH obtains information, other than the initial report from the medical facility, and it is unclear how the DOH interacts with the Authority in matters of licensure sanction. While Pennsylvanians are certainly proud of their PSA program, it is unclear that vital stakeholders and providers agree with state officials that the value justifies the expenses of the program or whether the program seriously addresses patient safety issues.


Rationale

  • •  Rationale for 1998 Department of Health Rule

    A 2001 NASHP report provides insight into the rationale for creation of Pennsylvania's serious event reporting program.

    Pennsylvania used its authority under the state's Certificate of Need (CON) law to leverage quality assurance activities from hospitals until 1996, when the law was allowed to sunset and regulators lost the ability to influence hospital behavior through the CON process. Subsequently, the state began to explore other options to expand its ability to oversee the quality of care provided by licensed facilities. In early 1998, the Department of Health issued a draft regulation that, among other things, required all licensed health facilities to immediately notify the department of occurrences that compromised quality assurance or patient safety.

    The Hospital and Healthsystem Association of Pennsylvania (HAP) initially opposed the draft regulation, because it did not have any confidentiality protections for reported incidents. HAP feared that the department's inability to protect the confidentiality of reported information could lead to increased litigation and potentially damage hospitals' reputations. As a compromise, the department agreed to include a confidentiality provision, and the regulation became final in June 1998 with HAP's support. [28 PA Code §51.3]


    Rosenthal J, Booth M, Flowers L, Riley T, (National Academy for State Health Policy Report GNL-35), "Current State Programs Addressing Medical Errors: An Analysis of Mandatory Reporting and Other Initiatives", January 2001, page 25.
    Abstract Available at: NASHP website.

    Examples of how the CON law was used to require quality-related activities included, but were not limited to, standards for cardiac catheterization (including volume-related stqandards), standards for type of equipment, and standards for staff composition. 35 PS, §448-904(a).

  • •  Rationale for MCARE Reporting Program Mandates

    As provided in the MCARE Act, 40 PA CS §1303.102(5), the rationale for the legislation included efforts to address issues surrounding medical malpractice tort liability issues, medical liability insurance issues, and efforts “to reduce and to eliminate medical errors by identifying problems and implementing solutions that promote patient safety.


Statutes and Administrative Rules

  • •  General Information
    • ◊  Pennsylvania Administrative Code (Pa Code)

      Administrative regulations/rules for the Commonwealth of Pennsylvania are provided in PA Code (Pa Code), which includes 55 titles, numbered 1 through 365, providing regulations for state agencies, commissions, state-supported institutions, and other entities. Each title may contain several ‘Parts’ +/- ‘Subparts,’ and each of these contains chapters, which contain sections of administrative law.

      The Pennsylvania Code addressing patient safety and error reporting facets of healthcare are found in Title 28 (Health and Safety), Title 31 (insurance), and Title 55 (Public Welfare).

      Proper citation of Pennsylvania Code is simply a concatenation of [Title# + Pa Code + [chapter#].[section]. For example, the Pa Code governing ‘Notification’ by hospitals is found in section 3 of chapter 51 (General Information) within subpart A (General Provisions) of Part IV (Health Facilities) of Title 28 (Health and Safety). It is expressed as: 28 Pa Code §51.3. Pennsylvania Code on the General Assembly website is available in HTML format, and chapters are also avialble in .PDF format.

    • ◊  Pennsylvania Laws and Statutes

      The citation of Pennsylvania laws is complex and confusing. Pennsylvania provides access to laws dating from the 1600s to present time, and it has only codifed about half of its statutes, despite almost thirty years of efforts. Consequently contemporary Pennsylvania laws are available as pamphlet laws (P.L.), Pennsylvania Consolidated Statutes (Pa.C.S.) and Unconsolidated Pennsylvania statutes, (which are referenced in complex ways that designate the year and the page location in that year's Pamphlet Laws (P.L.) or that designates a Pennsylvania Statute (P.S.). Westlaw's annotated collection (P.S.A.) reflects "Purdon's Pennsylvania Statutes Annotated." A partial understanding of some of the complexity of Pennsylvania laws is provided at an Unofficial Pennsylvania Statute website that was last updated in 2003.

      Pennsylvania statutes are arranged in 71 titles of consolidated and unconsolidated law. A section of law may be cited by either or both methods. An understanding of the citation of laws is helpful for finding Pennsylvania laws of interest, but searching of Pennsylvania laws remains quite problematic. Citations of Pennsylvania law include:

      • ◊  Pamphlet Laws

        The chronological published Laws of Pennsylvania have historically been referred to as the "Pamphlet Laws" [cited P.L. [page#], which are numbered in their order of passage, and are sometimes referred to as the "Session Laws." While each individual law in a given session is referred to as a ‘slip law,’ the aggregate collection for each annual session's laws that are enacted by the Legislature is published as the ‘Laws of Pennsylvania,’ and all are Pamphlet Laws. On ongoing project ultimately will aggregate all the ‘Pamphlet Laws’ since 1829.

      • ◊  Consolidated Statutes

        Consolidated Pennsylvania statutes (which may or may not be codified) are cited as a concatenation of [title] + Pa. C.S. + [section#], e.g., 1 Pa.C.S. §102.

      • ◊  Unconsolidated Statutes

        Unconsolidated Pennsylvania statutes are cited by reference to the date of enactment of the original Act of the General Assembly and optional [No.#], followed by a concatenation of [page reference in that year's publication of the Pamphlet Laws] + [section# of the act], e.g., Act [No. 10] of March 10, 1949, P.L. 30, §101.

        In addition, there is common alternative usage of citation using a concatenation of [title] + P.S. + [section#] citation for those statutes not yet officially consolidated by the legislature.

      • ◊  Pennsylvania Statutes Annotated (P.S.A.)

        Annotated statutes are provided by Westlaw. The citation for these annotated laws are different. i.e., Pa. S. A. + [title], + [section#]. For example PSA 40, §1303.301

  • •  Laws and Regulations Governing Pennsylvania Programs

    The provisions for medical errors reporting in the Commonwealth of Pennsylvania were begun in June 1998 with the adoption of Chapter 51 into Title 28 (Health and Safety) of the Pennsylvania Code 28 PA Code, §51.3. These regulations required health-care facilities to report a number of events that could seriously compromise the health and safety of a patient and to describe corrective steps.

    Additional provisions for medical errors reporting in the Commonwealth of Pennsylvania were provided by the Medical Care Availability and Reduction of Error (MCARE) Act, otherwise known as Act 13 of 2002. The legislative action was codified under Title 40 – INSURANCE, §§ 1303.101 through 1303.910. The MCARE Act is a complex act that address patient safety issues, medical malpractice tort reform, medical malpractice liabillity insurance reform, mandatory reporting of physician profiles to physician boards, and other changes to be addressed in text that follows.


Definitions

The Commonwealth of Pennsylvania has mandated reporting of three types of events, as defined in 40 PA CS §1303.302.

  • Serious event” – An event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. The term does not include an incident.
  • Incident” – An event, occurrence or situation involving the clinical care of a patient in a medical facility which could have injured the patient but did not either cause an unanticipated injury or require the delivery of additional health care services to the patient. The term does not include a serious event.
  • Infrastructure Failure” – An undesirable or unintended event, occurrence or situation involving the infrastructure of a medical facility or the discontinuation or significant disruption of a service which could seriously compromise patient safety.

Pennsylvania's “Incident” is synonymous with a ‘near-miss’. The Patient Safety Authority is instructed to “Collect, analyze and evaluate data regarding reports of serious events and incidents, including the identification of PERFORMANCE INDICATORS AND PATTERNS in frequency or severity at certain medical facilities or in certain regions of this Commonwealth.” [40 PA CS §1303.304(a)(5)]. This mandate for ‘near-miss’ events is distinctly different from other states that usually mandate reporting of only serious events.

Infrastructure Failure” events are reported only to the Department of Health.


Editorial Note: Maryland began voluntary reporting of near-miss events to the Maryland Patient Safety Center (MPSC) in late 2005, and Washington begins mandatory reporting of near-misses in 2007, once the Internet reporting system is functional.

Pennsylvania Health and Safety regulations provide instructions for interpretation of that statute. [28 PA Code §51.3(g)]. The code states that facilities must report "events which seriously compromise quality assurance or patient safety include, but are not limited to, the following:"

(1)Deaths due to injuries, suicide or unusual circumstances.
(2)Deaths due to malnutrition, dehydration or sepsis.
(3)Deaths or serious injuries due to a medication error.
(4)Elopements.
(5)Transfers to a hospital as a result of injuries or accidents.
(6)Complaints of patient abuse, whether or not confirmed by the facility.
(7)Rape.
(8)Surgery performed on the wrong patient or on the wrong body part.
(9)Hemolytic transfusion reaction.
(10)Infant abduction or infant discharged to the wrong family.
(11)Significant disruption of services due to disaster such as fire, storm, flood or other occurrence.
(12)Notification of termination of any services vital to the continued safe operation of the facility or the health and safety of its patients and personnel, including, but not limited to, the anticipated or actual termination of electric, gas, steam heat, water, sewer and local exchange telephone service.
(13)Unlicensed practice of a regulated profession.
(14)Receipt of a strike notice.

(15)* Transfers to hospitals as a result of injuries or accidents.
(16)* Admissions to hospitals as a result of injuries or accidents.
 

* "In addition to the notification requirements in § 51.3, long-term care nursing facilities shall report these two requirements in writing to the appropriate division of nursing care facilities field office . ." [28 PA Code §201.14(d)]

Editorial Note: It will be noted that that the 16 listed criteria above translate to 21 discrete adverse events. These events incompletely map to 7 of the 27 'Never-events' defined by the [NQF]. There is also incomplete mapping of Pennsylvania criteria to JCAHO definitions of seven (7) 'Reviewable sentinel events.'

Furthermore, nursing homes are NOT mandatory reporting participants facilities in the PSA program in 2006, so that these latter two reporting requirements are not included in the annual PSA reports.


Facility Participation

  • •  Incident Reporting System

    Participation is mandatory for every “medical facility”, which is defined by 40 PSA §1303.302 to include "an ambulatory surgical facility, birth center or hospital".

    35 PSA §448.802a of the Health Care Facilities Act further defines "hospital" as:

    "An institution having an organized medical staff established for the purpose of providing to inpatients, by or under the supervision of physicians, diagnostic and therapeutic services for the care of persons who are injured, disabled, pregnant, diseased, sick or mentally ill, or rehabilitation services for the rehabilitation of persons who are injured, disabled, pregnant, diseased, sick or mentally ill. The term includes facilities for the diagnosis and treatment of disorders within the scope of specific medical specialties, but not facilities caring exclusively for the mentally ill."

    Therefore, Pennsylvania requires reporting by birthing centers, ambulatory surgical facilities (ASFs), hospitals, rehabilitation hospitals, and specialty hospitals with the exception of psychiatric hospitals.

    According to the PSA 2005 Annual Report [PDF], the PSA has the participation of 440 health facilities including 241 hospitals, 194 Ambulatory Surgical Facilities (ASFs), and 5 birthing centers.

  • •  Health Facility-identified Outcomes Reporting

    Pennsylvania uses administrative data to publish outcomes data on hospitals, ambulatory surgical facilities, and HMOs.

    The Pennsylvania Health Care Cost Containment Council (PHC4), aka "the Council," is a independent state agencies that was established by statute with three responsibilities including: 1) to collect, analyze and make available to the public data about the cost and quality of health care; 2) to study access to care for uninsured; 3) to review and make recommendations about proposed or existing mandated health insurance benefits upon request of lawmakers.

    In order to achieve its mandate for transparency, PHC4 collates UB-92 administrative discharge records for all inpatient and ambulatory/outpatient procedure records from hospitals and freestanding ambulatory surgery centers in Pennsylvania. Using these discharge data and voluntarily-submitted HEDIS data from managed care plans (HMOs), the Council has provided outcomes reports for several facets of Pennsylvania health care.

    Among facility-identified and HMO-identified outcomes that have been reported are utilization and charge data, outcomes on multiple DRG-code related diagnostic groups, selective DRG-based procedure-related outcomes, and specific analyses of complications, such as Hospital Acquired Infections (HAI).

  • •  Physician-identified Outcomes Reporting from Hospital Data

    Pennsylvania also uses facility outcomes data to publicly identify cardiac surgeons and orthopedic surgeons associated with outcomes of CABG surgery and Total hip and total knee joint replacement surgeries.

    Pennsylvania has published annual facility-identified and physician-identified risk-adjusted mortality outcomes for coronary artery bypass surgery procedures since 1994.

    Beginning in 2005, Pennsylvania began reporting physician-identified volumes, infections, leg clots, and device problems for total hip and/or knee arthroplasty procedures. Pennsylvania becomes the first state to report physician-identified non-cardiac procedure outcomes.


Physician Participation

Physician participation in the patient safety programs is mandatory, but physicians are participants with little control and are subject to significant punitive licensure actions for failure of compliance.

  • •  Physician-identified Outcomes Reporting

    As noted in the Facility Participation, Pennsylvania facilities provide UB-92 hospital outcomes data to publicly identify cardiac surgeons performing coronary artery bypass graft (CABG) surgeries and orthopedic surgeons performing total hip or total knee arthroplasty procedures.

  • •  Physician Role in Incident Reporting System

    With respect to the Mcare Act, there are several changes that impact physicians that address non-Patient Safety issues such as Medical liability tort reforms, physician reporting to licensing boards, and medical liability insurance changes including financial obligations for newly created MCARE fund. A requirement for physician input to the formation of the patient safety plan at the medical facility is mandated via participation in the Patient Safety Committee, where participation must include ‘members of the medical staff’ that are presumably appointed, (since the process is not controlled by the Medical Staff). The PSC is headed by the facility's Patient Safety Officer. Participation of non-appointed members of the medical staff in the PSC processes and decisions is not address and is presumably minimal. Some of the relevant issues affecting physicians include the following:

    • ◊  Consultants in Development of Patient Safety Plan

      Medical facilities are required to develop a plan, but the “plan shall be developed in consultation with the licensees providing health care services in the medical facility.” [40 PA CS §1303.307(a)]

    • ◊  Patient Safety Committee

      While the composition is required to include a Patient Safety Officer and hospital staff, there is a requirement that “The committee shall include members of the medical facility's medical and nursing staff.” [40 PA CS §1303.310(a)]

    • ◊  Licensees must report ‘serious event’

      Mandatory reporting of a ‘serious event’ by a ‘health care worker’, (which includes all licensees), is mandatated in 40 PA CS §1303.308(a)]

    • ◊  Licensees Can Be Reported to licensing Board for failure to report a ‘serious event’

      Mandatory reporting of a ‘serious event’ by a licensee is directly addressed by 40 PA CS §1303.308(a) within the 24-hour reporting timeline. 40 PA CS §1303.313(e) states that a medical facility shall notify the licensee's licensing board

      " . . . if a medical facility discovers that a licensee providing health care services in the medical facility during a serious event failed to report the event. . . " subject to " . . . an administrative penalty of $1,000 per day imposed by the department . . .” [40 PA CS §1303.313(f)]

      The statute does not discriminate or address responsible vs. non-responsible licensees for any ‘serious event.’ While presumably these details might be addressed within local medical facility policies, any and all licensees involved in the care of a patient sustaining a ‘serious event’ are subject to reporting to a licensing authority.

    • ◊  Failure of a licensee to report a ‘serious event’ constitutes Unprofessional Conduct

      Per 40 PA CS §1303.308(d), a medical facility [may] “take corrective action against a licensee for unprofessional conduct, including making false reports or failure to report serious events under this chapter.

    • ◊  Reporting of Physician Profile Requirements to Medical Board

      Per 40 PA CS §1303.903, practitioners are mandated to report to their licensing Board within 60 days all medical malpractice complaints, prior disciplinary actions by a licensing authority of another state, sentencing of the physician, and information regarding an arrest of the physician for one of 4 felony charges (criminal homicide, aggravated assault, sexual offenses, violation of The Controlled Substance Act). Each physician is required to report this information by March 1 of each year, is it is combined with 5-years of license sanction information for each physicians. This information is posted on the web site for public consumption by each licensure board per 40 PA CS §1303.909(b).

    • ◊  Continuing Medical Education Requirement

      40 PA CS §1303.910(b) – Continuing Medical Education - Required Completion stipulates that every practitioner must report CME, including 3 credits of CME addressing patient safety and risk management with every licensure renewal, as stated in a Secretary of State memo. [PDF]

    • ◊  Requirement to Notify Patients of ‘Serious Event’

      The requirement to notify the Patient or family within 7 days of the occurrence was placed upon the “ medical facility through an appropriate designee . .” [40 PA CS §1303.308(b)], and it appears as part of the duty of the Patient Safety Plan to “provide for written notification to patients in accordance with section 308(b).

      As provided in Transparency & Provider-identified Information, the Pennsylvania Medical Society recommends that responsible physician take charge of these notifications.


State Agency Roles

  • •  Patient Safety Authority (PSA)

    The Patient Safety Authority (PSA) is a non-regulatory, quasi-independent agency that serves the needs of three bosses – the Department of Health, the General Assembly (who appoints 4 of the 11 members of the Board of Directors), and the Governor (who appoints 7 of the 11 members of the Board of Directors). Its function is chiefly organizational, providing the reporting, analysis, and evaluation of the reported “serious event” and “incidents” data. Its function is also education in view of the fact that it provides feedback to medical facilities. It has limited punitive authority (see 40 PA CS §1303.304(b). Among its duties are included:

    • ◊  Authority – Assume major responsibility for Patient Safety Reporting under direction of 11-member Board, adoption of bylaws, employment of staff, and authority to make contracts for this entity.
    • ◊  Management of Patient Safety Fund Trust – The funding for the PSA comes from contributions of participating organizations, and the PSA is responsible for managing it.
    • ◊  Manage Sub-contracting for companies or entities – PSA is instructed to subcontract with entities, other than a health care provider, for collection, analysis, and evaluation of data regarding reports of serious events and incidents. PSA contracts permitted the development of the Pennsylvania Patient Safety Reporting System (PA-PSRS – pronounced “PAY-sirs”) , a secure, web-based system that permits healthcare facilities to submit reports. PA-PSRS was developed under contract with ECRI, a Pennsylvania-based independent, non-profit health services research agency, in partnership with EDS, a leading international, information technology firm, and the Institute for Safe Medication Practices (ISMP), also a Pennsylvania-based, non-profit health research organization. These organizations have the responsibility to provide recommendations to the Authority, provide advise / recommendations to reporting facilities if their analysis suggests it, and conduct reviews.
    • ◊  All PSA contracts are based upon evaluation and agreement of DOH
    • ◊  Issue Recommendations to Medical facilitiesAfter consultation and approval by the DOH recommendations are provided to medical facilities on a facility-specific or on a Statewide basis. In addition, statewide recommendations are to be issued to medical facilities on a continuing basis and shall be published and posted on the department's and the Authority's publicly accessible World Wide Web site.
    • ◊  Anonymous reports to the Authority – Health care workers can file anonymous reports. In these situations, the Authority provides notice to the affected medical facility that a report has been filed and conducts its own review of the report once it is completed. The Authority has the power to refer a medical facility and any involved licensee to the department for failure to report or because of the return of an analysis that is insufficient.
    • ◊  Annual report to General Assembly, DOH, and public is required annually no later than May 1 with distribution to the Secretary of Health, the chair and minority chair of the Public Health and Welfare Committee of the Senate, and the chair and minority chair of the Health and Human Services Committee of the House of Representatives and to the public via PSA's World Wide Web site.

      According to 40 PA CS §1303.304(c.1), the Patient Safety Authority's annual report will contain the following information

      • 1.  A schedule of the preceding year's meetings.
      • 2.  A list of contracts entered into pursuant to this section, including the amounts awarded to each contractor.
      • 3.  A summary of the fund receipts and expenditures, including a financial statement and balance sheet.
      • 4.  The number of serious events and incidents reported by medical facilities on a geographical basis (i.e., facilities are not individually identified).
      • 5.  The information derived from the data collected including any recognized trends concerning patient safety.
      • 6.  The number of anonymous reports filed and reviews conducted by the Authority.
      • 7.  The number of referrals to licensure boards for failure to report under this chapter.
      • 8.  Recommendations for statutory or regulatory changes which may help improve patient safety in the Commonwealth.
  • •  Licensing Agency investigations – Department of Health

    The Department of Health (DOH) is the regulatory agency with licensure and regulatory control over medical facilities, and it plays a significant complementary role to the PSA in the Patient Safety reporting program with the power to trump PSA contracts and recommendations. Amongst its duties are included:

    • ◊  Approve / Disapprove PSA's Recommendations from Sub-contractors – Per 40 PA CS §1303.304(a.6), the Department must provide approval / disapproval within 30-days for recommendations from entities with which PSA subcontracts.
    • ◊  Approve / Disapprove PSA's issue Recommendations for medical facilities – [40 PA CS §1303.304(a.7)] DOH-Approved State-wide recommendations are published on the websites for both the PSA and the DOH.
    • ◊  Act upon Failure to Report Events provided from PSA – [40 PA CS §1303.304(b)]
    • ◊  Receive Annual Report from PSA – (before May 1) [40 PA CS §1303.304(c)]
    • ◊  Act as Intermediary for Collection of Payments to Patient Safety Trust Fund – This function includes the assessment, collection, transfer of funds to the Trust fund, and enforcement of sanctions against the medical facilities who might not comply. [40 PA CS §1303.305]
    • ◊   Review and approve patient safety plans – within 60-days of submission [40 PA CS §1303.307(c)]
    • ◊  Receive reports of serious events and infrastructure failures – [40 PA CS §1303.313(a) and 40 PA CS §1303.313(c)]
    • ◊  Investigate serious events and infrastructure failures
    • ◊   Work together with PSA – analyze and evaluate existing health care procedures and approve recommendations issued by the PSA
    • ◊  Meet with PSA to implement Patient Safety Plan
    • ◊  Consider Licensure Sanctions based on Recommendations – [40 PA CS §1303.306(b)]
    • ◊  Maintain strict confidentiality of all program documents, meetings, communications – [40 PA CS §1303.311]
    • ◊  May use information for licensing sanctions – [40 PA CS §1303.311(f)] The disciplinary action and licensing sanctions may be taken against a medical facility or a healthcare worker.
    • ◊  Determination of ‘Patient Safety Discount’ – As determined by 40 PA CS §1303.312, the Department of Health will work with the Department of Insurance to develop criteria for certification, although the Department of Insurance will determine the actual discount for which qualifying medical facilities are eligible.
    • ◊  Enforce Penalties against Medical Facilities – As determined by 40 PA CS §1303.313(f), the Department of Health can enforce penalties for a medical facility's failure to report or notify the Department of Health of a ‘serious event’ or an infrastructure failure.
  • •  Other Agencies – Department of State

    According to 40 PA CS §1303.302 – licensee, the Department of State has licensing authority over professional licensees. Per 40 PA CS §1303.313(f), the Secretary of State

    " . . . shall have access to the information under section 313(a) and may use such information for the sole purpose of any licensure or disciplinary action against a health care worker. This exemption to use the information received pursuant to section 313(a) shall only apply to licensure or disciplinary actions and shall not be utilized to permit the disclosure of any information obtained under section 313(a) for any other purpose."

    Therefore, Patient Safety Information is transparent for the licensure sanctions of health professionals.


Operational Features of Programs

  • •  Scope of Mandatory Medical Facility Duties/Reports
    • ◊  Adopt Patient Safety Plan

      Unlike the methodology that is used in JCAHO and some state reporting programs (e.g., use of root cause analysis and Action Plans), the Pennsylvania methodology requires that the methodology be uniquely defined by each medical facility in its Patient Safety Plan. This plan must insure around-the-clock reporting capabilities and prohibit retaliatory action against any reporting employee, and it must be submitted to the Department of Health for approval within 60 days of the effective date of the legislation.. For existing health facilities, this deadline was July 18, 2002.

    • ◊  Appoint a patient safety committee
    • As part of the patient safety plan, a patient safety committee, which is composed of at least 3 health care workers and two residents of the community, is appointed to act upon recommendations from the patient safety officer and review and evaluate patient safety initiatives and quarterly reports to the health facility governing body.

    • ◊  Empower Patient Safety Officer

      For each individual serious event or incident that is investigated at a facility, the Patient Safety Officer is then empowered to

      • √  ensure the investigation of all reports of serious events and incidents,
      • √  take such action as is immediately necessary to ensure patient safety as a result of any investigation, [and]
      • √  report to the patient safety committee regarding any action taken . . as a result of investigations” . .
      • √  Quarterly Notification of Governing Board of facility of by Patient Safety Committee activity [40 PA CS §1303.s310(b.5)]
    • ◊  Notify Department and PSA of Reportable Events

      "A health care worker . . . shall report the serious event or incident according to the patient safety plan of the medical facility . . . The report shall be made immediately or as soon thereafter as reasonably practicable, but in no event later than 24 hours after the occurrence or discovery of a serious event or incident.

      Per 40 PA CS §1303.313, both the PSA and the DOH must be notified for serious events, but only the PSA must be notified for ‘incidents,’ with exclusion of patient identifiers. In addition, the DOH must be notified for all Infrastructure Failure Reports.

    • ◊  Notification of Patient In writing within 7 days by the medical facility is mandatory. No such notification by health professionals is mandated. However, the Pennsylvania Medical Society encourages physician leadership and responsibility and provides a protocol for advising patients in the Patient Safety Section of its website, including a link to a sample Disclosure and Written Notification Policy [PDF].
    • ◊  Extend Whistleblower Protections to health care worker for reporting a serious event or incident
    • ◊  Provide Authority for Sanctions and Fines to medical facilities and the Department of Health with several punitive options to assure compliance with the incident reporting system, including disciplinary action against medical worker employees, contractors, or licensed professions. In addition licensed professionals may be reported to licensing boards for unprofessional conduct if they fail to report events or for other sanctions if their actions constitute unsatisfactory health care.
  • •  Transparency of all Information to regulatory authorities

    Reported information regarding reportable events is available to the Department of Health for licensing sanctions against all licensed healthcare facilities and to the Department of State for licensing sanctions against all licensed healthcare professionals.

  • •  Confidentiality of Information

    Except for access of all information to the Secretary of State (noted above), the Mcare Act, §1303.311 provides protections for all documents and meetings associated with a facility's patient safety reporting activities, including the Patient Safety Committees and governing boards of medical facilities, etc.

    • ◊  Anonymity for Facilities in Public Report

      According to 40 PA CS §1303.304(c.1), the Patient Safety Authority's annual report will contain

      The number of serious events and incidents reported by medical facilities on a geographical basis. Facilities are grouped by geographic region and are not individually identified in reports.

  • •  Education

    Education mandates are provided in the legislation. Under 40 PA CS §1303.910(b) – Continuing Medical Education - Required Completion,

    "Beginning with the licensure period commencing January 1, 2003, and following written notice to licensees by the licensure board, individuals licensed to practice medicine and surgery without restriction shall be required to enroll and complete 100 hours of mandatory continuing education during each two-year licensure period. As part of the 100-hour requirement, the licensure board shall establish a minimum number of hours that must be completed in improving patient safety and risk management subject areas."

    There has been a delay in full implementation of the CME requirement until 2007, according to a Department of State memo [PDF] that states that 3 hours of CME per licensure period dedicated to patient safety and risk management will be required beginning with 2005 license renewals.

  • •  No Feedback Report from Facility to PSA or DOH

    This feature of the plan is distinctly unusual, and it is unique to Pennsylvania. JCAHO and most states require the performance of an analysis of the serious event and a recommendation for an action plan that is implemented with/without regulatory authority, and this written record is sent to the regulatory authorities. However, no such feedback and no such trail of action is required in Pennsylvania.

  • •  Limited Feedback from PSA or DOH to Individual Facility

    Individual feedback to facilities within the Pennsylvania reporting program is distinctly unusual. The Patient Safety Authority extended subcontracts to trusted 3rd parties for the collection, analysis, and documents to be developed from the reported ‘serious events’ and ‘incidents’. This mechanism was supported by the Hospital and Healthservices Association of Pennsylvania (HAP), who further stated that “these two distinct and important roles – that of regulator and safety improvement resource – must be kept separate.

    In many States with reporting programs, written analysis and an action plan for each serious event is shared with a regulatory authority. This requirement does not exists in Pennsylvania, thereby limiting this avenue for interaction between state authority and facilities.

    The defined duties of PSA or its subcontractors include: “directly advise reporting medical facilities of immediate changes that can be instituted to reduce serious events and incidents.” This goal is addressed almost entirely via quarterly Patient Safety Advisories that are distributed to participating facilities and published on the PSA website. Individual responses to nearly 230,000 incidents and 11,000+ serious events that were reported in the first 18 months of PSA is impossible.

    Clifford Reiders, Esq. (former president of the Pennsylvania Trial Lawyers Association, PSA board member with active participation in all its subcommittees) even commented that

    "A more serious deficiency in the system is that the PSA does not have the staff to investigate every death, and its investigators have spot checked only 60 out of the 207 reported deaths." [Guadagnino, C, "Patient Safety Authority data emerges," Physician's News Digest, June 2005]

    Only in situations of an anonymous report that was not previously reported by the facility does the PSA analytic group get involved to conduct reviews or create official reports with interchanges and/or responses. However, a PSA board member confirmed that only one validated anonymous report was received in the first 6 months of the program operation. Therefore, very little one-on-one in-depth interchange of information for ‘serious events’ occurs between PSA and hospitals.

    Information exchange between the DOH and facilities is also relatively sparse. The June 2005 Physician's News Digest article observed that the DOH through April 2005 had received

    "20,601 serious event reports, which prompted the DOH to initiate 457 telephone follow-ups with institutions and 383 on-site visits . . "

    Assuming these numbers are correct, they correspond to 2.2% telephone follow-up and 1.9% on-site visits.

    It is unknown how many of the 453 reported deaths or 7,504 ‘serious events’ reported in 2005 were investigated by either the PSA or the DOH. However, the breadth of this task is overwhelming, and meaningful interchange between the DOH and facilities regarding reported serious events is limited.


Transparency And Provider-Identified Information

  • •  Provider-identified Information Available to Public

    The PSA program provides that no provider-identified information is available to the public.

    PSA reports group all medical facilities into one of Pennsylvania's 6 public health regions, and only statewide and/or regional analyses are provided. Therefore, Pennsylvania effectively offers only aggregate data, and NO meaningful information is available for individual indentified healthcare facilities.

  • •  Transparency of patient safety information to Licensure Authorities
    • ◊  Patient safety reports and information are available to the Department of Health for licensing sanctions against all licensed healthcare facilities [40 PA CS §1303.311(f)(1)].
    • ◊  Patient safety reports and information are available to the Department of State for licensing sanctions against all licensed healthcare professionals [40 PA CS §1303.311(f)(2)]
  • •  Confidentiality of Information – Except for access of all information to the Department of Health and Secretary of State (noted above), the Mcare Act, §1303.311 provides protections for all documents and meetings associated with a facility's patient safety reporting activities, including the Patient Safety Committees and governing boards of medical facilities, etc.

Disclosure

  • •  Disclosure to Patient

    The Commonwealth of Pennsylvania mandates written notification of patients who are involved in serious events. In particular, 40 PA CS §1303.308(b) – Duty to notify patient states:

    "A medical facility through an appropriate designee shall provide written notification to a patient affected by a serious event or, with the consent of the patient, to an available family member or designee, within seven days of the occurrence or discovery of a serious event. If the patient is unable to give consent, the notification shall be given to an adult member of the immediate family. If an adult member of the immediate family cannot be identified or located, notification shall be given to the closest adult family member. For unemancipated patients who are under 18 years of age, the parent or guardian shall be notified in accordance with this subsection. The notification requirements of this subsection shall not be subject to the provisions of section 311(a). Notification under this subsection shall not constitute an acknowledgment or admission of liability.”

    While the statute provides that the medical facility has responsibility for notifying the patient of ‘serious events’, The Pennsylvania Medical Society web site, in its Patient Safety Section provides a protocol for advising patients. In addition to providing a URL link to a sample Disclosure and Written Notification Policy [PDF], the statements for physicians from the Pennsylvania Medical Society include:

    • 1. “the best person for informing the patient is the attending physician or the physician with overall responsibility for managing the patient's care, and
    • 2. using another individual (non-physician) may send the wrong signal to the patient.”

    Perusal of the sample protocol [PDF] for disclosure and written notification is instructive.

    By the Governor's signature to the MCARE Act on March 20, 2002 [just one day after the “Health Data Reporting Act of 2002” was signed by Tennessee's Governor], the Commonwealth of Pennsylvania became the second of ten states through 2005 to monitor or require facilities or physicians to notify patients or family of a reported event.

    Broad disclosure of an “incident” or “event” to the patient or patient's family is also specifically addressed by statutes in Florida [both Florida hospitals and Florida physicians], Nevada, New Jersey, Oregon, and Washington.

    Three States mandate notification of patients via agency rules. The State of South Carolina regulations SC Code Regs. 61-91-601(A) mandate reporting in the Ambulatory Surgery Center setting only, while regulations in Maryland and Connecticut were promulgated only for hospitals, the latter included only as a reporting requirement in the Adverse Event Reporting Form [PDF file].

  • •  Public Disclosure

    Information related to ‘serious event’ and ‘incident’ reporting is available in the annual reports from the Patient Safety Authority as mandated by 40 PA CS §1303.304(c) in which “serious events and incidents .. [are] .. reported by medical facilities on a geographical basis.” The information is released to the public by both the Patient Safety Authority and the Department of Health. Information related to individual reports or to individually identified facilities is NOT available to the public.

  • •  Provider Identification
    • ◊  ID of Medical Facility

      The identification of facilities are included in the individual reports to the PSA and the DOH. However, regulations provide that ‘serious events’ and ‘incidents’ are “ reported by medical facilities on a geographical basis in the annual report submitted by the Patient Safety Authority.

    • ◊  ID of Physician – NOT INCLUDED IN REPORTS
  • •  Content of Report

    The statutory requirements for content of the report prepared by the Patient Safety Authority is defined in 40 PA CS §1303.304(c).

  • •  Other disclosable Information – NONE

Data Protections

40 PA CS §1303.311, the Patient Safety Reporting Program provides protections to data and to participants. The protections to the data include:

  • •  Non-DisclosureNOT MENTIONED
  • •  Confidentiality
    • ◊  40 PA CS §1303.311 – [Documents, materials or information of patient safety committee and governing board of facility]
  • •  Non-discoverability
    • ◊  40 PA CS §1303.311 – [Documents, materials or information of patient safety committee and governing board of facility]
  • •  Not-subject to SubpoenaNOT MENTIONED
  • •  Not Admissible as Evidence
    • ◊  40 PA CS §1303.311 – [Documents, materials or information of patient safety committee and governing board of facility]
  • •  Right-To-Know Requests Denied
    • ◊  40 PA CS §1303.311 – [Documents, materials or information of patient safety committee and governing board of facility]

Protections for Participants

  • •  General Protections

    The Commonwealth of Pennsylvania provides Immunity from criminal and civil liability. Per 40 PA CS §1303.311(i)

    "no person providing information or services to the patient safety committee, governing board of a medical facility, authority or department shall be held by reason of having provided such information or services to have violated any criminal law, or to be civilly liable under any law, unless such information is false and the person providing such information knew, or had reason to believe, that such information was false and was motivated by malice toward any person directly affected by such action."

    Furthermore, per 40 PA CS §1303.311(b),

    "No person who performs responsibilities for or participates in meetings of the patient safety committee or governing board of a medical facility pursuant to section 310(b) shall be allowed to testify as to any matters within the knowledge gained by the person's responsibilities or participation on the patient safety committee or governing board of a medical facility provided, however, the person shall be allowed to testify as to any matters within the person's knowledge which was gained outside of the persons's responsibilities or participation on the patient safety committee or governing board of a medical facility pursuant to section 310(b)."

  • •  Patient Safety Officer40 PA CS §1303.311(i) and 40 PA CS §1303.311(b)
  • •  Informant40 PA CS §1303.311(i) and 40 PA CS §1303.311(b)
  • •  Whistleblower Protection

    40 PA CS §1303.308(c) – Liability states that

    "A health care worker who reports the occurrence of a serious event or incident in accordance with subsection (a) or (b) shall not be subject to any retaliatory action for reporting the serious event or incident, and shall have the protections and remedies set forth in the act of December 12, 1986 (P.L.1559, No.169), known as the Whistleblower Law."


Punitive Measures and Sanctions

  • •  Authority for Punitive Measures against Health Care Workers

    Facilties are granted the power to bring sanctions upon all health care workers, whether they include employees, independent contractors, or licensed nurses, pharmacists, or physicians. According to Section 308(d),

    "Limitation. – Nothing in this section shall limit a medical facility's ability to take appropriate disciplinary action against a health care worker for failure to meet defined performance expectations or to take corrective action against a licensee for unprofessional conduct, including making false reports or failure to report serious events under this chapter."

  • •  Authority for Punitive Measures against Health Professionals

    The Department of State has regulatory authority over professional licences held by all health care workers, including physicians, nurses, pharmacists, etc. According to 40 PA CS §1303.311(f.2),

    "The Department of State shall have access to the information under section 313(a) and may use such information for the sole purpose of any licensure or disciplinary action against a health care worker. This exemption to use the information received pursuant to section 313(a) shall only apply to licensure or disciplinary actions and shall not be utilized to permit the disclosure of any information obtained under section 313(a) for any other purpose."

    Therefore, it would appear that information held by the Department of Health regarding ‘serious events’ is transparent to the licensure boards for all professionals.

  • •  Authority for Punitive Measures against Facilities

    The Department of Health has authority over licences held by all medical facilities, including hospitals, ambulatory surgical facilities, birthing centers, etc. According to 40 PA CS §1303.311(f.1),

    "The department shall have access to the information under section 313(a) or (c) and may use such information for the sole purpose of any licensure or corrective action against a medical facility. This exemption to use the information received pursuant to section 313(a) or (c) shall only apply to licensure or corrective actions and shall not be utilized to permit the disclosure of any information obtained under section 313(a) or (c) for any other purpose."

  • •  Penalty for Late Notification

    Medical facilities are liable for fines of $1,000 per day for ‘failure to report or notify’ the DOH, the licensure board, or an injured patient regarding an acknowledged serious event [40 PA CS §1303.313(f)]:

    "Failure to report a serious event or an infrastructure failure as required by this section or to develop and comply with the patient safety plan in accordance with section 307 or to notify the patient in accordance with section 308(b) shall be a violation of the Health Care Facilities Act. In addition to any penalty which may be imposed under the Health Care Facilities Act, a medical facility which fails to report a serious event or an infrastructure failure or to notify a licensure board in accordance with this chapter may be subject to an administrative penalty of $1,000 per day imposed by the department."

  • •  Penalty for Late Payment of Assessment Surcharge

    Medical facilities are liable for fines of $1,000 per day for failing to pay the special assessment fee or ‘surcharge’ to the DOH in support of the PSA program [40 PA CS §1303.305(g)]:

    " If after 30 days' notice a medical facility fails to pay a surcharge levied by the department under this chapter, the department may assess an administrative penalty of $1,000 per day until the surcharge is paid."


Patient Safety Coalitions

Pennsylvania has two entities that function as Patient Safety Coalitions.

  • •  Pennsylvania Patient Safety Collaborative

    The collaborative is a network of 27 organizations representing health care providers, insurers, organized labor, private industry, and consumers whose goal is to address the systematic issues that lead to medical errors and to work to reduce patient injury from errors through identification and correction of the causes of medical errors. The stated MISSION is:

    To foster the sharing of knowledge and information about optimal patient safety practices and models; to identify causes and influence change in systems to prevent these; and to convene stakeholders for ongoing dialogue in support of patient safety improvements.

    Other than an differently-named persistant website, the collaborative in 2006 appears to be non-existent or dormant. No new reports have been filed since 2001, and all references to activity in 2000 or earlier no longer appear on the website.

  • •  Delaware Valley Healthcare Council (DVHC)

    The Regional Medication Safety Program for Hospitals is a collaborative patient safety effort among 65 local hospitals in Bucks, Chester, Delaware, Montgomery, and Philadelphia counties to uniformly focus on 16 proven action goals to reduce medication errors. The program, introduced to the region in June 2001, is the result of a unique partnership between the Delaware Valley Healthcare Council (DVHC) and its affiliate, the Health Care Improvement Foundation (HCIF), the Institute for Safe Medication Practices (ISMP), and ECRI.

    The mission of the Delaware Valley Healthcare Council is to assist member organizations to improve the health status of their communities and to exercise leadership in addressing the appropriate restructuring of the regional health care system through advocacy, information and education in the public interest.

    The Primary Patient Safety Initiative is the Regional Medication Safety Program [final report]. This program includes 16 medication action goals addressing multiple aspects of institutional culture, infrastructure, clinical practice, and technology.

    The 2006 activity of the collaborative includes four initiatives: cultural competence, disaster preparedness, stroke, and patient safety.

  • •  Pittsburgh Regional Healthcare Initiative (PRHI)

    PRHI is a consortium of the institutions and people who provide, purchase, insure and support healthcare services in the region, dating to 1997. Its partners include hundreds of clinicians, 42 hospitals, four major insurers, dozens of major and small-business healthcare purchasers, corporate and civic leaders, and elected officials. According to the website, PRHI is working to achieve perfect patient care in more than a dozen counties in the Pittsburgh area using the following, patient-centered goals:

    • ◊  Zero medication errors.
    • ◊  Zero healthcare-acquired (nosocomial) infections (HAI).
    • ◊  Perfect clinical outcomes, as measured by complications, readmissions and other patient outcomes, in:
      • √  Coronary artery bypass graft surgery.
      • √  Chronic conditions: depression and diabetes.
      • √  Obstetrics: maternal and child outcome.
      • √  Orthopedics: hip and knee replacement surgery.

    The consortium appears to rely on educational outreach, concentrating mostly on process-oriented interventions. It has an active clinical base and lots of current activity.


Finance / Funding Issues

The Patient Safety Authority that was created by the Mcare Act, is paid entirely by the participating hospitals. Pennsylvania code addressing the Patient Safety Trust Fund stipulates that

“each medical facility shall pay the department a surcharge on its licensing fee as necessary to provide sufficient revenues to operate the authority. The total assessment for all medical facilities shall not exceed $5,000,000.”

The Authority administers the Patient Safety Trust Fund, which is independent of the General Fund, and all assessments are paid to the Department of Health [40 PA CS §1303.305 ]. Adjustments for inflations, via the Consumer Price Index for subsequent years after the first year are also stipulated. The Hospital and Healthsystem Association of Pennsylvania (HAP) notes a total of 262 hospitals in Pennsylvania, whereas the PSA 2005 report indicates 241 reporting hospitals, 5 reporting birthing centers, and 194 reporting ambulatory surgical centers, i.e., 440 reporting facilities at the end of 2005.

According to a PA-PSRS September 10, 2004 presentation to the National Governors Association (NGA) Center for Best Practices, an assessment of $105 per unit was levied on each participating facility. A ‘unit’ is defined as a licensed bed for hospitals, a licensed operating room for ambulatory surgical facilities, and a licensed birthing room for birthing centers.

Given that the DOH reports 38,193 licensed hospital beds in the Commonwealth of Pennsylvania [PDF] and 448 operating rooms for 165 ASFs in 2003 [PDF], it is not clear how this information meshes with the financial information provided by PSA that appears in the tables below. Under the assumption that nearly all moneys were assessed uniformly against only these participating institutions, the average assessment for 356 facilities for 2002-03 is $14,045, and the average assessment for 377 facilities for 2003-04 is $6,800. It is apparent that averages are misleading, given that the bulk of Pennsylvania's 38,193 licensed hospital beds are concentrated in a small number of larger facilities that have shouldered the bulk of the financial burden. It is unlikely that the assessments on fewer than 500 ‘units’ from all ambulatory surgical facilities and birthing centers would modify the financial burden on larger hospitals significantly.

According to the PSA's Annual Reports for 2004 [PDF] and 2005 [PDF], at the Authority's recommendation, the Department of Health issued a facility assessment for a partial assessment of $2.5 million for 2004-2005 and 2005-2006.

Budget information for PSA has been published for May 1, 2003 [PDF], April 30, 2004 [PDF], April 29, 2005 [PDF], and April 28, 2006 [PDF].

Pennsylvania Facililty Assessments for Patient Safety Authority
Fiscal
Year
Number of
Facilities
Total
Assessments
1 DOH Collected
Assessments
  2002 - 03 356 $ 4,999,922 0 $ 4,663,000
  2003 - 04 377 $ 2,562,938 0 $ 2,542,316
  2004 - 05 414 $ 2,500,159 2 $ 2,508,787
  2005 - 06 3 450   $ 2,499,906 4 $ 0,000,000
  TOTALS - - - - - - 0 $ 9,714,103
1
Amounts assessed and amounts received will differ because a few facilities may have closed in the interim or are in bankruptcy. In a few cases, the Department of Health is pursuing action to enforce facility compliance with Act 13's assessment requirement.
 
2
Total assessments received are greater than assessments made because some funds received were late payments for the previous year's assessment.
 
3
The number of facilities assessed by the Department of Health differs from the number of Act 13 facilities cited elsewhere in this report due to differences in the dates chosen to calculate the number of facilities for these two different purposes. At the end of 2005, there were 440 active facilities, including 241 hospitals, 194 Ambulatory surgical centers, and 5 birthing centers. [PDF, p26]
 
4
At the start of the 2005-06 fiscal year, the Authority conveyed its recommendation to the Department of Health that the Department assess facilities at a partial (i.e., 50%) rate. The Department issued assessment letters to facilities in the second half of the fiscal year. At the time of preparing the 2006 Annual Report, no funds for FY2005-06 had been received or transferred to the Patient Safety Trust Fund.
 
Pennsylvania Patient Safety Authority Expenditures
Expenditure
Year
  2002 2003 2004 2005
Personnel $ 162,855 $ 208,794 $ 247,538 $ 235,198
Operating Expenses $ 117,872 $ 1,098,364 $ 2,567,383 $ 2,480,829
Fixed Costs $ 0 $ 0 $ 27,390 $ 0
Sub-Total $ 280,727 $ 1,307,158 $ 2,842,311 $ 2,716,027
Contract Expenses
(While contract amounts are given for the fiscal year, actual amounts expended
are given for the calendar year)
1 Computer Aid, Inc. $ 68,380 $ 68,380 - - - $ 21,094
2 McKissock and Hoffman, PC $ 10,000 $ 70,000 $ 57,570 $ 82,091
3 Memorandum Of Understanding – Department of State $ - - - $ 10,000 $ 10,000 $ 10,000
4 Information Services Group, Inc. (ISG) $ - - - $ 209,324 $ 194,017 $ 165,244
5 ECRI $ - - - $  2,872,980 $ 2,154,096 $ 2,067,632
6 ASAP Software $ - - - $ 66,688 $ 907 $ 2,031
7 Veritas $ - - - $ 6,837 $ 6,837 $ - - -
8 Dell Computer $ - - - $ 40,319 $ 40,318 $ - - -
9 EIKI International, Inc $ - - - $ - - - $ 2,293
10 York Stenographic Services, Inc. $ - - - $ 2,262 $ 396 $ 7,336
11 Websurveyor $ - - - $ - - - $ - - - $ 2,500
12 Organizational Effectiveness Services, Inc (OES) $ - - - $ - - - $ - - - $ 2,145
 
1 Expenses for assistance in preparing Request for Proposal
2 Legal Counsel
3 For ongoing support services in the areas of financial management, human resources and procurement/contracting
4 For services related to project management
5 For technical and clinical assistance in developing and implementing a statewide reporting system as required under Act 13. This amount is for anticipated first-year charges against a $9.1 million five year contract.
6 For software
7 For software
8 For hardware application at the Commonwealth Technology Center
9 For Audio-visual Equipment
10 For Stenographic Services
11 For Survey and communications distribution software
12 For IT Staff Augmentation: Consulting Service
 
Adapted from the May 1, 2003 [PDF], April 30, 2004 [PDF], April 29, 2005 [PDF], and April 28, 2006 [PDF] Annual Reports for the PSA.

Other Factors And Organizations

  • •  COMMUNITY PARTICIPATION

    The Patient Safety Committee - Composition for each medical facility is required to included “two residents of the community served by the medical facility who are not agents, employees or contractors of the medical facility, . [and] . . [n]o more than one member of the patient safety committee shall be a member of the medical facility's board of trustees.” [40 PA CS §1303.310(a.1)] While the language does not specifically incorporate residents with interests and aptitudes outside of the ‘medicine’, the intent of the Commonwealth of Pennsylvania is to include a community resident who is not directly affiliated with the medical facility.

  • •  STAKEHOLDER PERCEPTIONS OF PSA REPORTING PROGRAM

    Adapted from the June 2005 Physician's News Digest publication of a report by Christopher Guadagnino, Ph.D. that commented upon the PSA 2004 Annual Report [PDF].

    • ◊  Misclassification Problems with ‘Serious Events’

      Some interesting and potentially important details are presented in the PSA's 2004 Annual Report, which also becomes the baseline with which future reports will be compared. Interpretation of the data, however, is not straightforward and may lead casual audiences to draw erroneous conclusions. A reported incident, for example, could be negatively interpreted as a medical error that almost happened, or positively interpreted as effective prevention. A serious event may involve a medical error, or may reflect an unanticipated adverse outcome not clearly attributable to error.

    • ◊  DOH – Investigation of ‘Serious Events’

      ". . . As of early May, the PSA has received about 130,000 incident and serious event reports, according to Rabinowitz [PSA Administrator Alan B.K. Rabinowitz]. Between July 1, 2004 and April 30, 2005, PA-PSRS had collected 20,601 serious event reports, which prompted the DOH to initiate 457 telephone follow-ups with institutions and 383 on-site visits, according to Richard Lee, DOH's deputy secretary of quality assurance. Citing data from a different time frame – between July 1, 2004 and Feb. 28, 2005 – Lee notes that site visits prompted by PA-PSRS reports resulted in the DOH identifying 12 deficiencies, each requiring facilities to submit a plan of correction to the department."

      [Comment: The DOH follow-up calculates to 2.2% telephone follow-up and 1.9% on-site visits.]

    • ◊  Clifford Reiders, Esq. (former president of the Pennsylvania Trial Lawyers Association, PSA board member with active participation in all its subcommittees) – [comments on 1) inadequacy of staffing to meet goals of PSA, 2) need for greater accountability, and 3) non-use of anonymous reporting, despite Whistle-blower protection features of MCARE Act.]

      "A more serious deficiency in the system is that the PSA does not have the staff to investigate every death, and its investigators have spot checked only 60 out of the 207 reported deaths, says Rieders."

      Rieders further believes that the public has a right to know details about reports from specific hospitals, which he says would further spur self-improvement through accountability and competition, and outweighs the risk of squelching hospitals' reporting.

      Rieders finds it odd that, despite the reliance on whistleblower protections for persons who anonymously inform the PSA of a facility's failure to comply with mandatory reporting requirements, only one valid anonymous report of noncompliance was received during the six-month interval of the PSA's report. That institution was subsequently allowed to supply the information without sanction.

    • ◊  Cliff Shannon, president of SMC Business Councils – [comments on value of PSA to Consumers]

      From a purchaser perspective, the PSA's ability to share root-cause information with hospitals is an important part of the process of patient safety but, "as a stand-alone agency, this safe place to share information also becomes a safe place to do nothing," says Cliff Shannon, president of SMC Business Councils, which represents 4,000 employers, primarily in southwestern Pa. "I am indicting the idea that the PSA is going to catalyze and facilitate significant improvement in patient safety," he says, adding: "My skepticism is that the creation of the PSA was politically calculated to let off steam from the medical malpractice debate."

      Shannon says the PSA lacks any mechanism that purchasers can rely on to ensure that hospitals will use data to improve patient safety in any measurable way. "When health care premiums are approaching $2,000 a month and families are still imperiled, ‘Take our word for it’ is not enough. I do not trust the ‘power’ of retrospective reporting of numbers of events, especially when they are not validated, as proof of improvement."

      Shannon is further skeptical that mandatory reporting systems provide sufficient compliance incentive, and he points to a recent law that requires reporting of hospital-acquired infections to the PHC4, and which has produced 12,000 such reports for all of 2004 – a figure he says is at least ten times lower than billing records and national literature say it should be. "The PSA needs to be appreciated against the backdrop of failure to report by most hospitals in the state, despite a legal requirement that they report accurately," says Shannon. "The PSA has no such teeth. What am I, as a purchaser, to assume about methodical, effective improvement by the PSA?" he asks.

    • ◊  Barry Boughton (Public Citizen's Congress Watch Division) – [comments on value of PSA to Consumers]

      Boughton is critical of the PSA's "overblown concern" with confidentiality, especially for serious events, which he believes merit disclosing the names of institutions and doctors to allow public comparison across institutions, and to spur greater accountability and deter errors within institutions. He is skeptical that confidentiality is necessary to create a "culture of learning," and he points to literature that disclosure and apologies to patients for mistakes do not increase the risk or cost of litigation to an institution.

    • ◊  Alan B.K. Rabinowit (PSA Administrator) – [comments on future plans for PSA and the extreme value of ‘near-miss’ analyses]

      Still, the PSA's board is examining its goals and activities for the next few years, including ways to encourage full and open disclosure by facilities, to promote research, and to collaborate with other organizations around the state. The board is looking at ways to expand its research and scholarship, including the possibility of a peer-review mechanism for its advisories, making its data available to researchers, and running educational outreach symposia and CME sessions sponsored by the PMS and by individual hospitals, says Rabinowitz.

      PSA analysts tap several sources to generate solutions to problems, Rabinowitz notes, including reports from facilities themselves indicating what they did to avert patient harm, libraries and databases garnered by ECRI and ISMP during their national patient safety operations, and literature reviews which appear as footnotes in the advisories. Rabinowitz notes that PSA solutions are mostly gleaned from the "near-miss" incident reports which, as "serious events waiting to happen," are regarded by patient safety literature to be the key source of opportunity to learn how events are averted. A fair amount of solutions the PSA has offered so far are essentially reminders of safe practices that are widely-know but not followed, such as measures to avoid patient misidentification, he adds.

    • ◊  Dr. John Clarke (PA-PSRS Clinical Director at ECRI) – [comments on PSA analytic methodology and comparison of Pennsylvania data to national data]

      The methods used by PSA's team of full-time analytical staff to triage data for follow-up are working well, says PA-PSRS Clinical Director Clarke. The team uses a cost-benefit analysis to determine which data are important to investigate further and what subjects merit inclusion in advisories. Analysis criteria include frequency and severity of an event, how representative the event is of a broader issue, how likely the team can develop a solution for it, how feasible it would be for institutions to implement the solution, and what kind of improvement can be anticipated if the solution were implemented, according to Clarke. The team meets weekly to identify "high-impact areas that would make a difference," and a diversity of content is selected for publication in the advisories to be useful to a diverse audience of facilities, he adds.

      The taxonomy chosen by the PSA is proving useful and, to the extent that value can be added by mapping to NQF's categories, the PSA will do so, adds Clarke. He candidly says, however, that making national benchmark comparisons is not only of secondary importance to PSA's goal of spurring patient safety improvement among Pa.'s health care institutions, but may also be misleading and inappropriate. Real improvement, he argues, does not come from comparing performance to averages – national or otherwise – but comes instead by adopting the process-based paradigm of pursuing optimality, for example, eliminating all wrong-site surgeries or all nosocomial infections. "The best performance one can expect under optimal circumstances: that's the benchmark," he says.

    • ◊  Value of PSA in Interviews/Survey of Hospitals – [comments on impact of PSA upon hospitals]

      The ultimate measure of the PSA's success will be the degree to which health care facilities actually use its data to improve patient safety. That appears to be happening, at least to some extent, among Pa.'s hospitals. More than 30 percent of all hospitals responding to a PSA survey (with a 62 percent response rate) indicated that they have implemented patient safety protocols as a result of specific articles in the advisories. The PSA's 2004 Annual Report also offers anecdotes of specific changes hospitals have made as a result of information they used from the advisories, such as: training to avoid fires attributed to oxygen pooling in the operating room, improving MRI screening to include implantable devices, converting to latex-free products when such a choice is available, and tracking transdermal patches to prevent overdosing.

      The Hospital & Healthsystem Association of Pennsylvania (HAP) says it is very pleased with how the PSA is functioning and says it receives positive feedback about the advisories from hospital patient safety officers, according to Paula Bussard, vice president of policy and regulatory services.

      Lebanon's Good Samaritan Hospital was among 10 hospitals in Pa., and 135 hospitals nationwide, that recently received a Distinguished Hospital Award for Patient Safety from HealthGrades, and attributed its performance to increased awareness of patient safety issues, for which it explicitly credited the PSA, according to the Harrisburg Patriot-News.

      Jersey Shore Hospital in Lycoming Co. uses PA-PSRS data at its monthly patient safety meetings, reviewing every event and conducting root cause analyses if it sees something that poses risk to patients, according to the hospital's patient safety officer, Betsy Crossley. Based on one such review, the critical access hospital streamlined its patient transfer process. [She also notes[ . . . that PSA's reporting requirement has motivated the hospital to give its staff better guidelines on how to report events, to whom, and to stress the process of timely review.

      Somerset Hospital says that the web-based PA-PSRS trending tool offers useful ways to track incidents and events, such as by unit or time period, and gives the hospital a mechanism of comparing its performance against its peers – which helps affirm the hospital's ongoing root cause activities, says Craig Saylor, assistant vice president of quality and patient safety officer. The PA-PSRS trending tool is much more convenient than the paper-based reporting system the hospital previously used, he notes. Staff awareness of PSA advisories also gives tremendous clout, he adds . . .

      Based on communications with colleagues elsewhere, Saylor believes that hospitals may be over-reporting incidents and events through PA-PSRS, for fear of being audited and sanctioned, while a "blame-free" culture change may also be encouraging staff members to discover and report more than they have in the past. Somerset's volume of events reported has increased because of education since the system's implementation – averaging 14 incidents and events per month in FY05, compared to nine per month in FY04, says Saylor.

      Diane Christie, patient safety officer at Riddle Memorial Hospital in Delaware Co., says she copies articles from PSA advisories and distributes them to different department directors, or in some cases, chiefs of surgery . . . to help hospital staff become more aware of their procedures and tweak them if necessary.

      Riddle is also using the PA-PSRS trending tool to study its medication administration process on a monthly basis and has noticed that its medication errors are decreasing.

      Mount Nitanny is a member of CHART, a 33- hospital risk retention group malpractice insurance provider in central Pa., and is using CHART's software instead of the PA-PSRS trending tool to conduct risk management benchmarking, says Herb Wilson, the hospital's risk manager and patient safety officer. Wilson says he is more comfortable using CHART's tool, which also allows benchmarking against a group of similar hospitals using CHART's database. Mount Nitanny is double-reporting patient safety events, and Wilson says he will be glad when PA-PSRS is able to interface with CHART's system to eliminate the reporting duplication burden.

      University of Pittsburgh Medical Center circulates PSA advisories among patient safety officers at various institutions throughout the UPMC Health System and, although they have had minimal impact thus far, they can help a hospital make changes to avert possible problems, says Richard Kidwell, J.D., UPMC's director of risk management. At least one or two UPMC hospitals made changes as a result of an item in the March 2005 Advisory about dangers associated with unlabeled basins, bowls and cups on the surgical field, he notes.

      While UPMC hospitals collect and trend patient safety data using their own internal system, Kidwell says it is useful to get information from a wider spectrum of institutions, and he notes that some UPMC hospitals are using PA-PSRS data for such comparisons. The PSA's 2004 Annual Report is very helpful, as institutions generally don't share medical error data across health systems, and the report reveals regional trends across the state, says Daniel Feinberg, M.D., patient safety officer and director of informatics at Pennsylvania Hospital.

      [Comment: Example in which hospitals would prefer non-confidential dissemination of hospital-identified event information for all hospitals.]

      [Feinberg added that] . . . Information in the PSA advisories is inherently practical because it is derived from actual Pa. events, whereas some academic articles about patient safety may have scientific relevance without immediate clinical relevance. The advisories are also growing more useful over time, he adds, offering a greater variety of information as the PSA accumulates more data.


Performance and Experience of Program

  • •  Reported Events for 2004 - 2005

    The PSA program implementation began in June 2004. The "PSA 2004 Annual Report" [PDF] was released on April 29, 2005, and the "PSA 2005 Annual Report" [PDF] was released on April 28, 2006. Over the first 18+ months of reporting, facilities have reported ‘serious events’ at a rate of 625/month, while ‘incidents’ (representing near-miss events) appear to be approaching an average of 14,000/month. Therefore, 95.6% of all reported events have been incidents that did not result in patient harm. The remaining 4.4% were Serious Events, in which the patient received some level of harm, ranging from minor, temporary harm to death.

Summary of Reports Submitted to PA-PSRS
Compiled from PSA Annual Reports for 2004 [PDF] and 2005 [PDF]
Month
Event Type
 
Incidents[1]
 
All Events
 
2004
2005
 
2004
2005
 
2004
2005
January - - - 603 - - - 13,135 - - - 13,738
February - - - 622 - - - 12,876 - - - 13,498
March - - - 687 - - - 14,518 - - - 15,205
April - - - 559 - - - 12,254 - - - 12,813
May - - - 606 - - - 12,892 - - - 13,498
June [2] 266 661 3,050 13,316 3,316 13,977
July 623 607 9,370 11,965 9,993 12,572
August 626 697 10,405 15,717 11,031 16,414
September 553 649 10,299 12,940 10,852 13,589
October 567 661 11,126 13,614 11,693 14,275
November 578 578 11,538 14,051 12,116 14,629
December 534 574 11,316 14,290 11,850 14,864
Totals 3,747 7,504   67,104 161,568   70,851 169,072
 

[1]  "Incidents" are ‘near-miss’ events that cause no harm. "Serious Events" are events that result in death or that compromise patient safety and result in an unanticipated injury requiring the delivery of additional health care services to the patient.

[2]  Event reporting began June 7, 2004; numbers reflect only a portion of state reporting facilities
  • •  Reported Events by Facility Type
Reports to PA-PSRS by Facility Type
Compiled from PSA Annual Reports for 2004 [PDF] and 2005 [PDF]
Facility Type
REPORTED EVENT TYPE[1], [2]
 
Incidents
 
All Events
 
2004
2005
 
2004
2005
 
2004
2005
Hospitals - - - 6,939 - - - 160,059 69,926 166,998
Amb. Surg. Facilities
& Birthing Centers
- - - 565 - - - 1,509 925 2,074
Totals 3,747 7,504 67,104 161,568 70,851 169,072
 

[1]  Event reporting began June 7, 2004; numbers reflect only a portion of state reporting facilities since not all facilities were required to report until late June 2004.

[2]   Neither the PSA 2004 or 2005 report provides precise data for ‘serious events’ for ASFs and Birth Centers. The PSA 2004 report acknowledges 173 ASFs and 5 BCs reporting 925 events in 2004, while the PSA 2005 report acknowledges 194 ASFs and 5 BCs reporting a combined total of 2,074 events (of the total 169,072 reported events) for 2005.

However, the PSA provides a table in the report [PDF, p62] that indicates that over a 14-month period, 154 ASFs and Birth centers with an average of 3.06 beds (total of ~471 beds), reported an average of 0.10 'serious events' per bed per month, or 1.20 'serious events' per bed-year. These numbers calculate to 471 * 1.20 = 565 'serious events' per year reported by ASF and Birthing Centers of the 2005 total 7,504 reported 'serious events' for Pennsylvania. Hence the number of ‘serious events’ reported for hospitals for 2005 is calculated as 7,504 - 565 = 6,939. This number is utilized for population-indexed hospital incidence calculations.

  • •  Calculations of Hospital Incidence of Serious Events

    Utilizing the following facts and assumptions:

    • ◊  6,939 Serious Events were measured for hospitals in 2005
    • ◊  1,702,971 admissions and 8,597,945 patient-days per year for the Commonwealth of Pennsylvania, based upon DOH 2003-2004 Inpatient Data – [PDF],
    • ◊  Similar distribution of admissions/hospitalizations for 2003-04 hospitalization utilization as the 2005 period of serious event reporting

    Pennsylvania serious event reporting calculates to:

    81 serious events per 100,000 patient-days, or

    408 serious events per 100,000 admissions.

    Comparative hospital reportable event performance data for 11 states that publish aggregate state data in 2000 through 2005 on reportable events are available.

    Among these 11 states, two states (Connecticut, Minnesota) report NQF-events. New York and Tennessee utilize Occurrence Codes based on International Classification of Diseases, 9th Edition, Clinical Modification (ICD-9-CM) taxonomy of administrative data, whereas Florida, Massachusetts. and Colorado utilize unique state reportable event definitions. Pennsylvania and three other states (Maine, Utah, Washington) utilize varying numbers and versions of JCAHO's ‘voluntary reportable sentinel events’.

    Except for Pennsylvania's serious events that approach 40% of population-adjusted serious events reported by New York, the occurrence rates for states reporting NQF events and JCAHO events are much lower than the ‘adverse events’ published by New York. While under-reporting obviously occurs in several states, the major significant message to be garnered from these comparative data is that there is lack of standardization of reported events and their definitions across States.

  • •  Highlights of Pennsylvania Event Reporting

    Highlights of data submitted through PA-PSRS through the 2005 calendar year are:

    • ◊  241 hospitals, 194 Ambulatory Surgical Facilities (ASFs), and 5 birthing centers compose the group of facilities in 2005 that are reporting as required by Act 13,
    • ◊  95.3% of all 2004-05 reports were Incidents [near-miss], in which the patient was not harmed; 4.7% of all reports were Serious Events, which indicates that the patient received some level of harm, ranging from minor, temporary harm to death.
    • ◊  Hospitals accounted for 98.7% of all reports submitted.
    • ◊  DEATHS

      In 2004, 207 Serious Events reported a patient death, representing 0.3% of all reports and 5.5% of all Serious Events.

      In 2005, 453 Serious Events reported a patient death, representing 0.3% of all reports and 6.0% of all Serious Events.

      In some cases, the death was the result of the patient's underlying clinical condition. In other cases, the death was a result of a "systems" issue, a series of events involving multiple, complex processes. In 61% of cases, deaths were associated with complications, but these complications did not necessarily reflect errors and not all were preventable. Reports also indicate that the facility penalized or sanctioned a provider – for example, by revoking medical privileges at the facility [PDF, p2 & p33].

      Editorial:  Independent of the appropriateness of these facilities' decisions, the reporting of these anecdotal observations confirms that the Pennsylvania patient safety effort does not entirely promote a ‘blameless’ culture nor does it segregate patient safety efforts from punitive measures or sanctions upon providers for medical errors. Pennsylvania statute independently endorses transparency of patient safety information to regulatory authorities for facilities [40 PA CS §1303.311(f)(1)] and individual healthcare providers [40 PA CS §1303.313(f)(2)].

    • ◊  MEDICATION ERRORS (most commonly reported event)
      • √  medication-related errors accounted for 25% of all reports and 4.0% of all serious errors,
      • √  0.7% of medication-related errors caused Serious Events
      • √  Although most medication errors involve adults, medication errors involving children or adolescents are more likely to result in patient harm.
    • ◊  ERRORS RELATED TO PROCEDURES | TREATMENTS | TESTS (2nd most commonly reported event)
      • √  these errors accounted for 21% of all reports and 8.7% of all serious errors,
      • √  1.9% of errors related to procedures, treatments, or tests caused serious events
      • √  20% of all events reported in ASFs were errors related to procedures, treatments, or tests caused serious events
    • ◊  COMPLICATIONS RELATED TO PROCEDURES | TREATMENTS | TESTS (4th most commonly reported event)
      • √  these complications accounted for 13% of all reports and 37.6% of all serious errors,
      • √  12.7% of all complications related to procedures, treatments, or tests caused serious events
      • √  37% of all events reported in ASFs were complications related to procedures, treatments, or tests caused serious events
      • √  61.1% of all reported deaths are associated with complications related to procedures, treatments, or tests caused serious events
    • ◊  FALLS (3rd most commonly reported event)
      • √  errors accounted for 20% of all reports and 17.2% of all serious errors,
      • √  0.9% of Falls caused serious events
      • √  Patients over age 65 represent 64% of all patient falls.
    • ◊  ELDERLY
      • √  Patients over age 65 represent 53% of all reports submitted to PA-PSRS from hospitals,
      • √  Patients over age 65 represent 59% of all Serious Events,
      • √  Patients over age 65 represent 73% of all pressure sores, bruises and other skin-related conditions.
      • √  Patients over age 65 represent 64% of all patient falls.
    • ◊  UNDER-REPORTING vs. REGIONAL REPORTING VARIABILITY (addressed mostly in 2005 report)
      • √  Pennsylvania does not report by facility; Pennsylvania reports by 6 geographical regions that reflect the 6 Public Health Districts within the Commonwealth
      • √  The number of reports per patient day in the Northcentral region was considerably higher than in other regions
      • √  The number of reports per patient day in the Southeast region was considerably lower than in other regions, and 1/3rd of that of the Northcentral region,
      • √  The Northcentral region reported a significantly greater proportion of Incidents (97.8% of their reports) than the statewide average (95.6%)
      • √  For Healthcare Associated Infections (HAIs), there is a 20-fold variation in reporting incidence with apparent under-reporting in the Southeast region,
      • √  This geographical pattern persists from 2004 to 2005
      • √  Whereas numbers are not provided in the PSA 2004 Annual Report [PDF, p21], Figure 4 suggests that there is greater than three-fold differences in reporting of serious events and incidence across the 6 regional public Health districts in Pennsylvania (see below)
      • √  Visual evidence of differential reporting of serious events across geographic regions was not addressed,
  • PA 2004 reporting by Region

    Figure 4. Reports from Hospitals per 1,000 patient-days by Region
    (July through December, 2004)

    The complete Annual Report, as well as more information about the Authority and access to Patient Safety Advisories, is available on the Authority's website, www.psa.state.pa.us.


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