MEDICAL CARE AVAILABILITY AND REDUCTION OF ERROR (MCCARE) ACT - REDUCTION
  AND PREVENTION OF HEALTH CARE-ASSOCIATED INFECTION AND LONG-TERM CARE
                            NURSING FACILITIES
                  Act of Jul. 20, 2007, P.L. 331, No. 52              Cl. 40
                             Session of 2007
                               No. 2007-52

     SB 968

                                  AN ACT

     Amending the act of March 20, 2002 (P.L.154, No.13), entitled
        "An act reforming the law on medical professional liability;
        providing for patient safety and reporting; establishing the
        Patient Safety Authority and the Patient Safety Trust Fund;
        abrogating regulations; providing for medical professional
        liability informed consent, damages, expert qualifications,
        limitations of actions and medical records; establishing the
        Interbranch Commission on Venue; providing for medical
        professional liability insurance; establishing the Medical
        Care Availability and Reduction of Error Fund; providing for
        medical professional liability claims; establishing the Joint
        Underwriting Association; regulating medical professional
        liability insurance; providing for medical licensure
        regulation; providing for administration; imposing penalties;
        and making repeals," providing for reduction and prevention
        of health care-associated infection and for long-term care
        nursing facilities.

        The General Assembly of the Commonwealth of Pennsylvania
     hereby enacts as follows:

        Section 1.  The act of March 20, 2002 (P.L.154, No.13), known
     as the Medical Care Availability and Reduction of Error (Mcare)
     Act, is amended by adding a chapter to read:
                                CHAPTER 4
                    HEALTH CARE-ASSOCIATED INFECTIONS
      Section 401.  Scope of chapter.
        This chapter relates to the reduction and prevention of
     health care-associated infections.
      Section 402.  Definitions.
        The following words and phrases when used in this chapter
     shall have the meanings given to them in this section unless the
     context clearly indicates otherwise:
        "Ambulatory surgical facility."  An entity defined as an
     ambulatory surgical facility under the act of July 19, 1979
     (P.L.130, No.48), known as the Health Care Facilities Act.
        "Antimicrobial agent."  A general term for drugs, chemicals
     or other substances that kill or slow the growth of microbes,
     including, but not limited to, antibacterial drugs, antiviral
     agents, antifungal agents and antiparasitic drugs.
        "Authority."  The Patient Safety Authority established under
     this act.
        "Centers for Disease Control and Prevention" or "CDC."  The
     United States Department of Health and Human Services Centers
     for Disease Control and Prevention.
        "Colonization."  The first stage of microbial infection or
     the presence of nonreplicating microorganisms usually present in
     host tissues that are in contact with the external environment.
        "Council."  The Pennsylvania Health Care Cost Containment
     Council established under the act of July 8, 1986 (P.L.408,
     No.89), known as the Health Care Cost Containment Act.
        "Department."  The Department of Health of the Commonwealth.
        "Fund."  The Patient Safety Trust Fund as defined in section
     305.
        "Health care-associated infection."  A localized or systemic
     condition that results from an adverse reaction to the presence
     of an infectious agent or its toxins that:
            (1)  occurs in a patient in a health care setting;
            (2)  was not present or incubating at the time of
        admission, unless the infection was related to a previous
        admission to the same setting; and
            (3)  if occurring in a hospital setting, meets the
        criteria for a specific infection site as defined by the
        Centers for Disease Control and Prevention and its National
        Healthcare Safety Network.
        "Health Care Facilities Act."  The act of July 19, 1979
     (P.L.130, No.48), known as the Health Care Facilities Act.
        "Health care facility."  A hospital or nursing home licensed
     or otherwise regulated to provide health care services under the
     laws of this Commonwealth.
        "Health payor."  An individual or entity providing a group
     health, sickness or accident policy, subscriber contract or
     program issued or provided by an entity, including any one of
     the following:
            (1)  The act of June 2, 1915 (P.L.736, No.338), known as
        the Workers' Compensation Act.
            (2)  The act of May 17, 1921 (P.L.682, No.284), known as
        The Insurance Company Law of 1921.
            (3)  The act of December 29, 1972 (P.L.1701, No.364),
        known as the Health Maintenance Organization Act.
            (4)  The act of May 18, 1976 (P.L.123, No.54), known as
        the Individual Accident and Sickness Insurance Minimum
        Standards Act.
            (5)  40 Pa.C.S. Ch. 61 (relating to hospital plan
        corporations).
            (6)  40 Pa.C.S. Ch. 63 (relating to professional health
        services plan corporations).
        "Medical assistance."  The Commonwealth's medical assistance
     program established under the act of June 13, 1967 (P.L.31,
     No.21), known as the Public Welfare Code.
        "Methicillin-resistant Staphylococcus aureus" or "MRSA."  A
     strain of bacteria that is resistant to certain antibiotics and
     is difficult to treat medically.
        "Multidrug-resistant organism" or "MDRO."  Microorganisms,
     predominantly bacteria, that are resistant to more than one
     class of antimicrobial agents.
        "National Healthcare Safety Network" or "NHSN."  A secure
     Internet-based data collection system managed by the Division of
     Healthcare Quality Promotion at the Centers for Disease Control
     and Prevention.
        "Nationally recognized standards."  Standards developed by
     the Department of Health and Human Services Centers for Disease
     Control and Prevention (CDC) and its National Healthcare Safety
     Network.
        "Nursing home."  An entity licensed as a long-term care
     nursing facility under the act of July 19, 1979 (P.L.130,
     No.48), known as the Health Care Facilities Act.
        "Surveillance system."  An ongoing and comprehensive method
     of measuring health status, outcomes and related processes of
     care, analyzing data and providing information from data sources
     within a health care facility to assist in reducing health care-
     associated infections.
      Section 403.  Infection control plan.
        (a)  Development and compliance.--Within 120 days of the
     effective date of this section, a health care facility and an
     ambulatory surgical facility shall develop and implement an
     internal infection control plan that shall be established for
     the purpose of improving the health and safety of patients and
     health care workers and shall include:
            (1)  A multidisciplinary committee including
        representatives from each of the following if applicable to
        that specific health care facility:
                (i)  Medical staff that could include the chief
            medical officer or the nursing home medical director.
                (ii)  Administration representatives that could
            include the chief executive officer, the chief financial
            officer or the nursing home administrator.
                (iii)  Laboratory personnel.
                (iv)  Nursing staff that could include a director of
            nursing or a nursing supervisor.
                (v)  Pharmacy staff that could include the chief of
            pharmacy.
                (vi)  Physical plant personnel.
                (vii)  A patient safety officer.
                (viii)  Members from the infection control team,
            which could include an epidemiologist.
                (ix)  The community, except that these
            representatives may not be an agent, employee or
            contractor of the health care facility or ambulatory
            surgical facility.
            (2)  Effective measures for the detection, control and
        prevention of health care-associated infections.
            (3)  Culture surveillance processes and policies.
            (4)  A system to identify and designate patients known to
        be colonized or infected with MRSA or other MDRO that
        includes:
                (i)  The procedures necessary for requiring cultures
            and screenings for nursing home residents admitted to a
            hospital.
                (ii)  The procedures for identifying other high-risk
            patients admitted to the hospital who necessitate routine
            cultures and screening.
            (5)  The procedures and protocols for staff who may have
        had potential exposure to a patient or resident known to be
        colonized or infected with MRSA or MDRO, including cultures
        and screenings, prophylaxis and follow-up care.
            (6)  An outreach process for notifying a receiving health
        care facility or an ambulatory surgical facility of any
        patient known to be colonized prior to transfer within or
        between facilities.
            (7)  A required infection-control intervention protocol
        which includes:
                (i)  Infection control precautions, based on
            nationally recognized standards, for general surveillance
            of infected or colonized patients.
                (ii)  Intervention protocols based on evidence-based
            standards.
                (iii)  Isolation procedures.
                (iv)  Physical plant operations related to infection
            control.
                (v)  Appropriate use of antimicrobial agents.
                (vi)  Mandatory educational programs for personnel.
                (vii)  Fiscal and human resource requirements.
            (8)  The procedure for distribution of advisories issued
        under section 405(b)(4) so as to ensure easy access in each
        health care facility for all administrative staff, medical
        personnel and health care workers.
        (b)  Department review.--No later than 14 days after
     implementation of its infection control plan, a health care
     facility and an ambulatory surgical facility shall submit the
     plan to the department. The department shall review each health
     care facility's and ambulatory surgical facility's infection
     control plan to ensure compliance under the Health Care
     Facilities Act and section 408(3). If, at any time, the
     department finds that an infection control plan does not meet
     the requirements of this chapter or any applicable laws, the
     health care facility or ambulatory surgical facility shall
     modify its plan to come into compliance.
        (c)  Notification.--Upon submission to the department of its
     infection control plan, a health care facility and an ambulatory
     surgical facility shall notify all health care workers, physical
     plant personnel and medical staff of the facility of the
     infection control plan. Compliance with the infection control
     plan shall be enforced by the facility.
      Section 404.  Health care facility reporting.
        (a)  Nursing home reporting.--In addition to reporting
     pursuant to the Health Care Facilities Act, a nursing home shall
     also electronically report health care-associated infection data
     to the department and the authority using nationally recognized
     standards based on CDC definitions, provided that the data is
     reported on a patient-specific basis in the form, with the time
     for reporting and format as determined by the department and the
     authority.
        (b)  Hospital reporting.--A hospital shall report health
     care-associated infection data to the CDC and its National
     Healthcare Safety Network no later than 180 days following the
     effective date of this section. A hospital shall:
            (1)  Report all components as defined in the NHSN Manual,
        Patient Safety Component Protocol and any successor edition,
        for all patients throughout the facility on a continuous
        basis.
            (2)  Report patient-specific data to include, at a
        minimum, patient identification number, gender and date of
        birth. The patient identification number must be compatible
        with the patient identifier on the uniform billing forms
        submitted to the council.
            (3)  Report data on a monthly basis in accordance with
        protocols defined in the NHSN Manual as updated by the CDC.
            (4)  Authorize the department, the authority and the
        council to have access to the NHSN for facility-specific
        reports of health care-associated infection data contained in
        the NHSN database for purposes of viewing and analyzing that
        data.
        (c)  Strategic assessments.--Each hospital, other than those
     currently using a qualified electronic surveillance system,
     shall by December 31, 2007, conduct a strategic assessment of
     the utility and efficacy of implementing a qualified electronic
     surveillance system pursuant to subsections (d) and (e) for the
     purpose of improving infection control and prevention. The
     assessment shall also include an examination of financial and
     technological barriers to implementation of a qualified
     electronic surveillance system pursuant to subsections (d) and
     (e). The assessment shall be submitted to the department within
     14 days of completion.
        (d)  Qualified electronic surveillance system.--A qualified
     electronic surveillance system shall include the following
     minimum elements:
            (1)  Extractions of existing electronic clinical data
        from health care facility systems on an ongoing, constant and
        consistent basis.
            (2)  Translation of nonstandardized laboratory, pharmacy
        and/or radiology data into uniform information that can be
        analyzed on a population-wide basis.
            (3)  Clinical support, educational tools and training to
        ensure that information provided under this subsection will
        assist the hospital in reducing the incidence of health care-
        associated infections in a manner that meets or exceeds
        benchmarks.
            (4)  Clinical improvement measurements designed to
        provide positive and negative feedback to health care
        facility infection control staff.
            (5)  Collection of data that is patient-specific for the
        entire facility.
        (e)  Electronic surveillance system implementation.--Except
     as otherwise provided in this subsection, a hospital shall have
     a qualified electronic surveillance system in place by December
     31, 2008. The following apply:
            (1)  If a determination has been made under subsection
        (c) that a qualified electronic surveillance system can be
        implemented, the hospital shall comply with subsection (f)
        until implementation.
            (2)  If a determination has been made under subsection
        (c) that a qualified electronic surveillance system cannot be
        implemented, by December 31, 2008, the hospital shall comply
        with subsection (f) until such time as a qualified electronic
        surveillance system is implemented.
        (f)  Surveillance system.--Until a hospital implements a
     qualified electronic surveillance system, the facility shall use
     a surveillance system that includes:
            (1)  A written plan of the elements of the surveillance
        process to include, but not be limited to, definitions,
        collection of surveillance data and reporting of information.
            (2)  Identification of personnel resources that will be
        used in the surveillance process.
            (3)  Identification of information or technological
        support needed to implement the surveillance system.
            (4)  A process for periodic evaluation and validation to
        ensure accuracy of surveillance.
        (g)  Continued reporting.--Until hospitals begin reporting to
     NHSN and have authorized access to the department, the authority
     and the council, hospitals shall continue to meet reporting
     requirements pursuant to Chapter 3 of this act and section 6 of
     the act of July 8, 1986 (P.L.408, No.89), known as the Health
     Care Cost Containment Act.
      Section 405.  Patient Safety Authority jurisdiction.
        (a)  Health care facility reports to authority.--The
     occurrence of a health care-associated infection in a health
     care facility shall be deemed a serious event as defined in
     section 302. The report to the authority shall also be subject
     to all of the confidentiality protections set forth in section
     311. The occurrence of a health care-associated infection shall
     only constitute a serious event for hospitals if it meets the
     criteria for reporting as defined by the current CDC and NHSN
     Manual, Patient Safety Component Protocol and any successor
     edition.
        (b)  Duties.--In addition to its existing responsibilities,
     the authority is responsible for all of the following:
            (1)  Establishing, based on CDC definitions, uniform
        definitions using nationally recognized standards for the
        identification and reporting of health care-associated
        infections by nursing homes.
            (2)  Publishing a notice in the Pennsylvania Bulletin
        stating the uniform reporting requirements established
        pursuant to this subsection and the effective date for the
        commencement of required reporting by hospitals consistent
        with this chapter, which, at a minimum, shall begin 120 days
        after publication of the notice.
            (3)  Publishing a notice in the Pennsylvania Bulletin
        stating the uniform reporting requirements established
        pursuant to this subsection and section 404(a) and the
        effective date for the commencement of required reporting by
        nursing homes consistent with this chapter, which, at a
        minimum, shall begin 120 days after publication of the
        notice.
            (4)  Issuing advisories to health care facilities in a
        manner similar to section 304(a)(7).
            (5)  Including a separate category for providing
        information about health care-associated infections in the
        annual report under section 304(c).
            (6)  Creating and conducting training programs for
        infection control teams, health care workers and physical
        plant personnel about the prevention and control of health
        care-associated infections. Nothing in this act shall
        preclude the authority from working with the department or
        any organization in conducting these programs.
            (7)  Appointing an advisory panel of health care-
        associated infection control experts, including at least one
        representative of a not-for-profit nursing home, at least one
        representative of a for-profit nursing home, at least one
        representative of a county nursing home and at least two
        representatives of a hospital, one of which must be from a
        rural hospital, to assist in carrying out the requirements of
        this chapter.
        (c)  Public comment.--Prior to publishing a notice under
     subsection (b)(2) and (3), the authority shall solicit public
     comments for at least 30 days. The authority shall respond to
     the comments it receives during the 30-day public comment
     period.
      Section 406.  Payment for performing routine cultures and
                    screenings.
        The cost of routine cultures and screenings performed on
     patients in compliance with a health care facility's and
     ambulatory surgical facility's infection control plan shall be
     considered a reimbursable cost to be paid by health payors and
     medical assistance upon Federal approval. These costs shall be
     subject to any copayment, coinsurance or deductible in amounts
     imposed in any applicable policy issued by a health payor and to
     any agreements between a health care facility, ambulatory
     surgical facility and payor.
      Section 407.  Quality improvement payment.
        (a)  General rule.--Commencing on January 1, 2009, the
     Department of Public Welfare in consultation with the department
     shall make a quality improvement payment to a health care
     facility that achieves at least a 10% reduction for that
     facility in the total number of reported health care-associated
     infections over the preceding year pursuant to section
     408(7)(i). For calendar year 2010 and thereafter, the Department
     of Public Welfare shall consult with the department to establish
     appropriate percentage benchmarks for the reduction of health
     care-associated infections in each health care facility in order
     to be eligible for a payment pursuant to this section.
        (b)  Additional quality improvement payments.--Nothing in
     this section shall prevent the Department of Public Welfare in
     consultation with the department from providing additional
     quality improvement payments to a health care facility that has
     implemented a qualified electronic surveillance system and has
     achieved or exceeded reductions in the total number of reported
     health care-associated infections for that facility over the
     preceding year as provided in subsection (a).
        (c)  Eligibility.--In addition to meeting the requirements
     contained in this section, to be eligible for a quality
     improvement payment, a health care facility must be in
     compliance with health care-associated reporting requirements
     contained in this act and the Health Care Facilities Act.
        (d)  Distribution of funds.--Funds for the purpose of
     implementing this section shall be appropriated to the
     Department of Public Welfare and distributed to eligible health
     care facilities as set forth in this section. Quality
     improvement payments to health care facilities shall be limited
     to funds available for this purpose.
      Section 408.  Duties of Department of Health.
        The department is responsible for the following:
            (1)  The development of a public health awareness
        campaign on health care-associated infections to be known as
        the Community Awareness Program. The program shall provide
        information to the public on causes and symptoms of health
        care-associated infections, diagnosis and treatment
        prevention methods and the proper use of antimicrobial
        agents.
            (2)  The consideration and determination of the
        feasibility of establishing an active surveillance program
        involving other entities, such as athletic teams or
        correctional facilities for the purpose of identifying those
        persons in the community that are colonized and at risk of
        susceptibility to and transmission of MRSA bacteria.
            (3)  The review of each health care facility's and
        ambulatory surgical facility's infection control plan. This
        review shall be performed pursuant to the department's
        authority under the Health Care Facilities Act and the
        regulations promulgated thereunder.
            (4)  The development of recommendations and best
        practices that implement and effectuate improved screenings
        and cultures and other means for the reduction and
        elimination of health care-associated infections.
            (5)  The development of recommendations regarding
        evidence-based screening protocols for an individual with
        MRSA and MDRO prior to admission to a hospital.
            (6)  The review of strategic assessments under section
        404(c) and the provision of assistance to hospitals in
        implementing a qualified electronic surveillance system
        pursuant to the requirements of section 404(d) and (e).
            (7)  The development of a methodology, in consultation
        with the authority and the council, for determining and
        assessing the rate of health care-associated infections that
        occur in health care facilities in this Commonwealth. This
        methodology shall be used:
                (i)  to determine the rate of reduction in health
            care-associated infection rates within a health care
            facility during a reporting period;
                (ii)  to compare health care-associated infection
            rates among similar health care facilities within this
            Commonwealth; and
                (iii)  to compare health care-associated infection
            rates among similar health care facilities nationwide.
            (8)  The development, in consultation with the authority
        and the council, of reasonable benchmarks to measure the
        progress health care facilities make toward reducing health
        care-associated infections. Beginning in 2010, all health
        care facilities shall be measured against these benchmarks. A
        health care facility with a rate of health care-associated
        infections that does not meet the benchmark appropriate to
        that type of facility shall be required to submit a plan of
        correction to the department within 60 days of receiving
        notification that the rate does not meet the benchmark. After
        180 days, a facility that has not shown progress in reducing
        its rate of infection shall consult with and obtain
        department approval for a new plan of correction that
        includes resources available to assist the health care
        facility. After an additional 180 days, a facility that fails
        to show progress in reducing its rate of infection may be
        subject to action under the Health Care Facilities Act.
            (9)  Publishing a notice in the Pennsylvania Bulletin of
        the specific benchmarks the department shall use to measure
        the progress of health care facilities in reducing health
        care-associated infections. Prior to publishing the notice,
        the department shall seek public comments for at least 30
        days. The department shall respond to the comments it
        receives during the 30-day public comment period.
      Section 409.  Nursing home assessment to Patient Safety
                    Authority.
        (a)  Assessment.--Commencing July 1, 2008, each nursing home
     shall pay the department a surcharge on its licensing fee as
     necessary to provide sufficient revenues for the authority to
     perform its responsibilities under this chapter. The total
     annual assessment for all nursing homes shall not be more than
     an aggregate amount of $1,000,000. The department shall transfer
     the total assessment amount to the fund within 30 days of
     receipt.
        (b)  Base amount.--For each succeeding calendar year, the
     authority shall determine the appropriate assessment amount and
     the department shall assess each nursing home its proportionate
     share of the authority's budget for its responsibilities under
     this chapter. The total assessment amount shall not be more than
     $1,000,000 in fiscal year 2008-2009 and shall be increased
     according to the Consumer Price Index in each succeeding fiscal
     year.
        (c)  Expenditures.--Money appropriated to the fund under this
     chapter shall be expended by the authority to implement this
     chapter.
        (d)  Dissolution.--In the event that the fund is discontinued
     or the authority is dissolved by operation of law, any balance
     paid by nursing homes remaining in the fund, after deducting
     administrative costs of liquidation, shall be returned to the
     nursing homes in proportion to their financial contributions to
     the fund in the preceding licensing period.
        (e)  Failure to pay surcharge.--If, after 30 days' notice, a
     nursing home 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.
        (f)  Reimbursable cost.--Subject to Federal approval, the
     annual assessment amount paid by a nursing home shall be a
     reimbursable cost under the medical assistance program. The
     Department of Public Welfare shall pay each nursing home, as a
     separate, pass-through payment, an amount equal to the
     assessment paid by a nursing home multiplied by the facility's
     medical assistance occupancy rate as reported in its annual cost
     report.
      Section 410.  Scope of reporting.
        For purposes of reporting health care-associated infections
     to the Commonwealth, its agencies and independent agencies, this
     chapter sets forth the applicable criteria to be utilized by
     health care facilities in making such reports. Nothing in this
     act shall supersede the requirements set forth in the act of
     April 23, 1956 (1955 P.L.1510, No.500), known as the Disease
     Prevention and Control Law of 1955, and the regulations
     promulgated thereunder.
      Section 411.  Penalties.
        (a)  Violation of Health Care Facilities Act.--The failure of
     a health care facility to report health care-associated
     infections as required by sections 404 and 405 or the failure of
     a health care facility or ambulatory surgical facility to
     develop, implement and comply with its infection control plan in
     accordance with the requirements of section 403 shall be a
     violation of the Health Care Facilities Act.
        (b)  Administrative penalty.--In addition to any penalty that
     may be imposed under the Health Care Facilities Act, a health
     care facility which negligently fails to report a health care-
     associated infection as required under this chapter may be
     subject to an administrative penalty of $1,000 per day imposed
     by the department.
        Section 2.  The act is amended by adding a chapter to read:
                                CHAPTER 6
                    LONG-TERM CARE NURSING FACILITIES
                                (Reserved)
        Section 3.  This act shall take effect in 30 days.

     APPROVED--The 20th day of July, A. D. 2007.

     EDWARD G. RENDELL