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        PRIOR PRINTER'S NO. 1905                      PRINTER'S NO. 1972



No. 1552 Session of 2007

           YUDICHAK AND WANSACZ, JUNE 13, 2007


                                     AN ACT

     1  Establishing the Pennsylvania Infection Control Advisory
     2     Committee; providing for duties of the committee, the
     3     Department of Health, the Pennsylvania Health Care Cost
     4     Containment Council and the Patient Safety Authority;
     5     requiring health care facilities to develop and implement
     6     infection control plans; and imposing penalties.

     7                         TABLE OF CONTENTS
     8  Section 1.  Short title.
     9  Section 2.  Definitions.
    10  Section 3.  Committee.
    11  Section 4.  Duties of department.
    12  Section 5.  Collaboratives.
    13  Section 6.  Health care facilities.
    14  Section 7.  Authority.
    15  Section 8.  Nursing homes.
    16  Section 9.  Electronic surveillance.
    17  Section 10.  Violations and penalties.

     1  Section 11.  Effective date.
     2     The General Assembly of the Commonwealth of Pennsylvania
     3  hereby enacts as follows:
     4  Section 1.  Short title.
     5     This act shall be known and may be cited as the Health Care-
     6  associated Infection Prevention and Control Act.
     7  Section 2.  Definitions.
     8     The following words and phrases when used in this act shall
     9  have the meanings given to them in this section unless the
    10  context clearly indicates otherwise:
    11     "Antimicrobial agent."  A general term for drugs, chemicals
    12  or other substances that kill or slow the growth of microbes,
    13  including, but not limited to, antibacterial drugs, antiviral
    14  agents, antifungal agents and antiparasitic drugs.
    15     "Authority."  The Patient Safety Authority established by the
    16  act of March 20, 2002 (P.L.154, No.13), known as the Medical
    17  Care Availability and Reduction of Error (Mcare) Act.
    18     "Collaborative."  An organized collaborative designated by
    19  the Department of Health in each region of this Commonwealth. An
    20  organized collaborative shall include at least one hospital and
    21  one nursing facility and may include Federal, State and local
    22  entities, other health care facilities, physician practices,
    23  academic institutions or any other organization that may assist
    24  in efforts to reduce or eliminate health care-associated
    25  infections.
    26     "Collaborative partner."  A health care facility that
    27  partners with a collaborative and uses and accesses the
    28  resources that the collaborative offers in accordance with this
    29  act.
    30     "Colonization."  The first stage of microbial infection or
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     1  the presence of nonreplicating microorganisms usually present in
     2  the host tissues that are in contact with the external
     3  environment.
     4     "Committee."  The Pennsylvania Infection Control Advisory
     5  Committee established under section 3.
     6     "Consumer Price Index."  The Consumer Price Index for All
     7  Urban Consumers (CPI-U) for the Pennsylvania, New Jersey,
     8  Delaware and Maryland area for the most recent 12-month period
     9  for which figures have been officially reported by the United
    10  States Department of Labor, Bureau of Labor Statistics,
    11  immediately prior to the subject date.
    12     "Council."  The Pennsylvania Health Care Cost Containment
    13  Council.
    14     "Department."  The Department of Health of the Commonwealth.
    15     "Fund."  The Patient Safety Trust Fund.
    16     "Health care-associated infection."  A localized or systemic
    17  condition that results from an adverse reaction to the presence
    18  of an infectious agent or its toxins that:
    19         (1)  occurs in a patient in a health care setting within
    20     48 hours after admission;
    21         (2)  was not present or incubating at the time of
    22     admission, unless the infection was related to a previous
    23     admission to the same setting; and
    24         (3)  if occurring in a hospital setting, meets the
    25     criteria for a specific infection site as defined by the
    26     Centers for Disease Control and Prevention and its National
    27     Healthcare Safety Network.
    28     "Health care facility." Any health care facility providing
    29  clinically related health services including, but not limited
    30  to, a general or special hospital, including psychiatric
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     1  hospitals, rehabilitation hospitals, ambulatory surgical
     2  facilities, long-term care nursing facilities, abortion
     3  facilities, cancer treatment centers using radiation therapy on
     4  an ambulatory basis and inpatient drug and alcohol treatment
     5  facilities, both profit and nonprofit and including those
     6  operated by an agency or State or local government. The term
     7  shall also include hospice. The term shall not include an office
     8  used primarily for the private or group practice by health care
     9  practitioners where no reviewable clinically related health
    10  service is offered, a facility providing treatment solely on the
    11  basis of prayer or spiritual means in accordance with the tenets
    12  of any church or religious denomination or a facility conducted
    13  by a religious organization for the purpose of providing health
    14  care services exclusively to clergy or other persons in a
    15  religious profession who are members of the religious
    16  denominations conducting the facility.
    17     "Mcare Act."  The act of March 20, 2002 (P.L.154, No.13),
    18  known as the Medical Care Availability and Reduction of Error
    19  (Mcare) Act.
    20     "MRSA."  Methicillin-resistant staphylococcus aureus, a more
    21  serious form of bacterial health care-associated infection that
    22  is resistant to commonly used antibiotics.
    23     "Multidrug resistant organisms" or "MDROO."  Microorganisms,
    24  predominantly bacteria, that are resistant to one or more
    25  classes of antimicrobial agents.
    26     "Safe practices."  The set of standards endorsed by the
    27  National Quality Forum that should be used by health care
    28  providers to reduce the risk of harm to patients.
    29  Section 3.  Committee.
    30     (a)  Establishment.--The Pennsylvania Infection Control
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     1  Advisory Committee is hereby established.
     2     (b)  Membership.--The advisory committee shall consist of the
     3  following members who shall serve until the expiration of their
     4  terms, membership or employment or until their successors are
     5  appointed:
     6         (1)  The Secretary of Health.
     7         (2)  The executive director of the authority or a
     8     designee.
     9         (3)  The executive director of the council or a designee.
    10         (4)  The director of the Office of Health Care Reform or
    11     a designee.
    12         (5)  The following members chosen by the Governor:
    13             (i)  A representative of each collaborative from a
    14         list submitted by the respective collaborative.
    15             (ii)  Two individuals representing hospitals who are
    16         members of the Hospital and Healthsystem Association of
    17         Pennsylvania.
    18             (iii)  One individual representing a nonprofit
    19         nursing home.
    20             (iv)  One individual representing a for-profit
    21         nursing home.
    22             (v)  Two individuals with a background in infection
    23         control who are members of either the Association of
    24         Professionals in Infection Control (APIC) or the Society
    25         of Healthcare Epidemiology of America (SHEA).
    26             (vi)  One individual who is a patient advocate.
    27             (vii)  Two individuals with a background in
    28         epidemiology.
    29             (viii)  Two individuals representing other licensed
    30         health care facilities.
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     1     (c)  Chairperson.--The Secretary of Health shall be the
     2  chairperson of the committee.
     3     (d)  Meetings.--The committee shall meet quarterly and at
     4  other times at the call of the chairperson.
     5     (e)  Organization.--The committee shall be organized within
     6  the department for organizational, budgetary and administrative
     7  purposes.
     8     (f)  General powers and duties.--The committee shall do the
     9  following:
    10         (1)  Encourage cooperation among Federal, State and local
    11     government agencies, academic institutions and the private
    12     sector to assist in improving best practices and promoting
    13     those practices and programs that reduce or eliminate health
    14     care-associated infections.
    15         (2)  Serve as a forum for presenting information and
    16     studying programs being used within this Commonwealth.
    17         (3)  Develop recommendations regarding best practices to
    18     effectuate screenings of high-risk patients consistent with
    19     the provisions of this act and other means of reduction and
    20     elimination of health care-associated infections and how
    21     these practices may apply to health care facilities.
    22         (4)  Identify financial and technological needs of health
    23     care facilities regarding infection control and prevention.
    24         (5)  Develop recommendations on how best to implement an
    25     outreach process that includes notifying a receiving health
    26     care facility of any patient known to be colonized prior to
    27     transfer to another facility.
    28         (6)  Develop recommendations regarding evidence-based
    29     screening protocols of patients and residents for MDROO upon
    30     admission and randomized screening of inpatients and
    20070H1552B1972                  - 6 -     

     1     residents for MDROO after admission.
     2         (7)  Recommend process for establishing benchmarks based
     3     upon a uniform database that identifies and quantifies health
     4     care-associated infections and will be based on actual
     5     observed experiences of health care facilities in managing
     6     infections to evaluate health care-associated infections for
     7     the department's use during licensure or inspection of a
     8     health care facility. The uniform database shall be
     9     established using payment claims data that is currently
    10     submitted to the Commonwealth and shall be an extension of
    11     the base categorical DRG structure and be based on standard
    12     administrative data. No additional data elements or changes
    13     to the current claim form shall be required. Benchmarks will
    14     be reviewed and updated annually.
    15         (8)  Provide recommendations to the department on the
    16     distribution of any available funds to collaboratives.
    17         (9)  Issue reports on health care facility infection
    18     control and prevention in this Commonwealth.
    19         (10)  Develop annual infection control and prevention
    20     priorities.
    21  Section 4.  Duties of department.
    22     The department shall do the following:
    23         (1)  Designate six infection prevention and control
    24     regions within this Commonwealth.
    25         (2)  Issue grants to collaboratives.
    26         (3)  Designate at least one collaborative in each region.
    27         (4)  When reviewing applications for designating a
    28     collaborative, the department shall give preference to groups
    29     that are currently meeting the requirements of this act and
    30     are implementing best practices to reduce health care-
    20070H1552B1972                  - 7 -     

     1     associated infections.
     2         (5)  In cooperation with the authority, develop a public
     3     outreach program on health care-associated infections. The
     4     program shall:
     5             (i)  Provide information to the public on causes and
     6         symptoms of health care-associated infections, prevention
     7         methods and the proper use of antibiotics.
     8             (ii)  Encourage that individuals receiving treatment
     9         or admitted to a health care facility ask health care
    10         professionals about efforts to control and eliminate
    11         health care-associated infections within the health care
    12         facility.
    13             (iii)  Determine the process to be used by health
    14         care facilities for notifying a health care facility of
    15         any patient known to be colonized prior to transfer
    16         within or between health care facilities.
    17         (6)  Develop programs that inform facilities of the
    18     purpose and function of collaboratives and encourage the use
    19     of collaboratives for assistance.
    20         (7)  Publish in the Pennsylvania Bulletin, within 45 days  <--
    21     after receipt of the committee's recommendation on
    22     benchmarks, THE SPECIFIC BENCHMARKS the department shall use   <--
    23     to measure the progress of health care facilities in reducing
    24     health care-associated infections.
    25         (8)  Require best practices to effectuate screenings of
    26     staff and patients based on suspicion of transmission of an
    27     infection.
    28         (9)  In cooperation with the authority, act as a
    29     repository for information on current health care-associated
    30     infections and for newly identified infections and treatment
    20070H1552B1972                  - 8 -     

     1     protocols.
     2  Section 5.  Collaboratives.
     3     To receive grant funding, a collaborative shall do the
     4  following:
     5         (1)  Establish an advisory body that includes, but is not
     6     limited to, the following:
     7             (i)  An epidemiologist with a background in health
     8         care-associated infections.
     9             (ii)  An infection control professional.
    10             (iii)  A professional from a laboratory that tests
    11         samples for testing of microbial infection or the
    12         presence of nonreplicating microorganisms.
    13         (2)  Establish an educational structure that can work
    14     with the authority and other organizations to offer various
    15     options for training in best practices.
    16         (3)  Identify effective measures for the detection,
    17     control and prevention of health care-associated infections
    18     that include, but are not limited to, the following:
    19             (i)  An active culture surveillance process and
    20         policies.
    21             (ii)  A system to identify and designate patients
    22         known to be colonized or infected with MRSA or other
    23         MDROO in accordance with the requirements of this act.
    24             (iii)  An infection control intervention protocol
    25         which, at a minimum, addresses:
    26                 (A)  Infection control precautions based on best
    27             practices for general surveillance of infected or
    28             colonized patients.
    29                 (B)  Treatment protocols based on evidence-based
    30             standards.
    20070H1552B1972                  - 9 -     

     1                 (C)  Isolation procedures.
     2                 (D)  Physical plant operations related to
     3             infection control.
     4                 (E)  Educational programs for personnel.
     5                 (F)  Fiscal and human resource requirements
     6             related to infection control and prevention.
     7         (4)  Use grant money to provide financial assistance to
     8     health care facilities to invest in technologies and
     9     infrastructure designed to reduce health care-associated
    10     infections.
    11  Section 6.  Health care facilities.
    12     (a)  Development and compliance.--Within 120 days after
    13  enactment, a health care facility shall develop and implement an
    14  internal infection control plan that shall include, but is not
    15  limited to, the following:
    16         (1)  A multidisciplinary committee including
    17     representatives from each of the following:
    18             (i)  Medical staff, including the chief medical
    19         officer.
    20             (ii)  Administration, including the chief executive
    21         officer and the chief financial officer. For a nursing
    22         home the committee shall include the director.
    23             (iii)  Laboratory personnel.
    24             (iv)  Nursing, including the director of nursing.
    25             (v)  Pharmacy, including the chief of pharmacy.
    26             (vi)  The physical plant manager.
    27             (vii)  A patient safety officer.
    28             (viii)  Members from the infection control team.
    29         (2)  In addition to standards adopted by the department:
    30             (i)  Effective measures for the detection, control
    20070H1552B1972                 - 10 -     

     1         and prevention of health care-associated infections.
     2             (ii)  An active culture surveillance process and
     3         policies.
     4             (iii)  A system to identify and designate patients
     5         known to be colonized or infected with MRSA or other
     6         MDROO.
     7             (iv)  Procedures for identifying other high-risk
     8         patients admitted to the health care facility who shall
     9         receive routine cultures and screenings.
    10             (v)  An outreach process for notifying a receiving
    11         health care facility of any patient known to be colonized
    12         prior to transfer within or between facilities.
    13             (vi)  A required facility-specific infection control
    14         intervention protocol which, at a minimum, addresses:
    15                 (A)  Infection control precautions based on
    16             nationally recognized standards for general
    17             surveillance of infected or colonized patients.
    18                 (B)  Treatment protocols based on evidence-based
    19             standards.
    20                 (C)  Isolation procedures.
    21                 (D)  Physical plant operations related to
    22             infection control.
    23                 (E)  Appropriate use of antimicrobial agents and
    24             antibiotics.
    25                 (F)  Mandatory educational programs for
    26             personnel.
    27                 (G)  Fiscal and human resource requirements
    28             related to infection control and prevention.
    29         (3)  Any other requirements that the department shall
    30     require through rules and regulations.
    20070H1552B1972                 - 11 -     

     1     (b)  Department review.--The department shall review each
     2  health care facility's infection control plan to ensure
     3  compliance with this act in accordance with the department's
     4  authority under 28 Pa. Code Ch. 146 (relating to infection
     5  control) during its regular licensure inspection process.
     6     (c)  Notification.--Upon approval of its infection control
     7  plan, a health care facility shall notify all health care
     8  workers and medical staff of the health care facility of the
     9  infection control plan. Compliance with the infection control
    10  plan shall be required as a condition of licensure, employment
    11  or credentialing at the health care facility.
    12  Section 7.  Authority.
    13     (a)  Duties.--In addition to its existing responsibilities,
    14  the authority is responsible for all of the following:
    15         (1)  Providing nursing homes with patient safety
    16     advisories issued by the authority pursuant to section
    17     304(a)(7) of the Mcare Act.
    18         (2)  Issuing alerts and reports to health care facilities
    19     as required by the board.
    20         (3)  Including a separate category for providing
    21     information about health care-associated infections in the
    22     annual report under section 304(c) of the Mcare Act.
    23     (b)  Training.--The authority shall as recommended by the
    24  board create and conduct training programs for infection control
    25  teams, health care workers and consumers about the prevention
    26  and control of health care-associated infections. Nothing in
    27  this act precludes the authority from collaborating with the
    28  department, collaboratives or other organizations in conducting
    29  these programs.
    30     (c)  Monitoring.--Health care facility patient safety plans
    20070H1552B1972                 - 12 -     

     1  will identify how the facility will distribute patient safety
     2  advisories, alerts and reports required under this act so that
     3  they are easily accessible and widely distributed in each health
     4  care facility to administrative staff, medical personnel and
     5  health care workers.
     6  Section 8.  Nursing homes.
     7     (a)  Reporting.--Nursing homes shall report to the council
     8  the same infections and in the same manner that hospitals are
     9  required to report to the council under the act of July 8, 1986
    10  (P.L.408, No.89), known as the Health Care Cost Containment Act.
    11  Reporting shall begin within 30 days following the effective
    12  date of this section. For purposes of this section, nursing
    13  homes shall be additional data sources as defined in the Health
    14  Care Cost Containment Act, and covered services as defined in
    15  that act shall include those services provided by nursing homes.
    16     (b)  Analysis of nursing home data by authority.--
    17         (1)  At the request of the department or the board, but
    18     no less frequently than once per year, the authority shall
    19     analyze data without patient identifying information reported
    20     to the department by nursing homes with respect to events
    21     compromising patient safety as required by 28 Pa. Code § 51.3
    22     (relating to notification).
    23         (2)  A nursing home may request the authority to conduct
    24     an analysis of the data collected under paragraph (1) in
    25     order to provide information to nursing homes which can be
    26     used to improve patient safety and quality of care.
    27     (c)  Surcharge.--Commencing January 1, 2008, each nursing
    28  home shall pay the department a surcharge on its licensing fee
    29  as necessary to provide sufficient revenues to operate the
    30  authority for its responsibilities under this act. The following
    20070H1552B1972                 - 13 -     

     1  apply:
     2         (1)  For each calendar year, the department shall
     3     determine and assess each nursing home its proportionate
     4     share of the authority's budget for its responsibilities
     5     under this act. The total assessment amount shall not be more
     6     than $1,000,000 in fiscal year 2007-2008 and shall be
     7     increased according to the Consumer Price Index in each
     8     succeeding fiscal year.
     9         (2)  Money appropriated to the fund under this act shall
    10     be expended by the authority to implement this act.
    11         (3)  In the event that the fund is discontinued or the
    12     authority is dissolved by operation of law, any balance paid
    13     by nursing homes remaining in the fund, after deducting
    14     administrative costs of liquidation, shall be returned to the
    15     nursing homes in proportion to their financial contributions
    16     to the fund in the preceding licensing period.
    17         (4)  If after 30 days' notice a nursing home fails to pay
    18     a surcharge levied by the department under this section, the
    19     department may assess an administrative penalty of $1,000 per
    20     day until the surcharge is paid.
    21  Section 9.  Electronic surveillance.
    22     (a)  Electronic surveillance of health care-associated
    23  infections.--By January 1, 2008, the department shall identify
    24  qualified systems which can be used by health care facilities by
    25  July 1, 2008, to report health care-associated infections to the
    26  committee COUNCIL. Qualified systems shall include the following  <--
    27  minimum elements:
    28         (1)  Extraction of existing electronic clinical data from
    29     hospital systems on an ongoing basis.
    30         (2)  Translation of nonstandardized laboratory, pharmacy
    20070H1552B1972                 - 14 -     

     1     and/or radiology data into uniform information that can be
     2     analyzed on a population-wide basis.
     3         (3)  Clinical support, educational tools and training to
     4     ensure that information provided under this subsection will
     5     lead to change.
     6         (4)  Clinical improvement measurement and the structure
     7     to provide ongoing positive and negative feedback to hospital
     8     staff who implement change.
     9     (b)  Classifications.--Hospitals shall report the following
    10  classifications of infections and, as to each infection acquired
    11  in the facility, whether the infection was caused by a
    12  multidrug-resistant organism:
    13         (1)  Patients with positive MRSA at admission or
    14     preadmission screening.
    15         (2)  Urinary tract infections.
    16         (3)  Surgical site infections.
    17         (4)  Ventilator-associated pneumonia.
    18         (5)  Blood stream infections.
    19         (6)  Bone and joint infections.
    20         (7)  Central nervous system infections.
    21         (8)  Cardiovascular infections.
    22         (9)  Eye, ear, nose and throat infections.
    23         (10)  Gastrointestinal infections.
    24         (11)  Lower respiratory infections.
    25         (12)  Reproductive system infections.
    26         (13)  Systemic infections.
    27         (14)  Multiple infections.
    28     (c)  Benchmarks.--The department shall establish reasonable
    29  benchmarks against which to measure the progress of health care
    30  facilities to reduce health care-associated infections. All
    20070H1552B1972                 - 15 -     

     1  facilities will be measured against the benchmarks. Those
     2  facilities with rates of associated infections that are above
     3  the benchmark will be required to submit a plan of remediation
     4  to the department within 60 days after being notified of missing
     5  the standard. If after 180 days, the facility has shown no
     6  progress in reducing rates of infections, the facility is
     7  required to consult with the regional collaborative to further
     8  develop a plan of remediation. If after an additional 180 days
     9  the facility continues to fail to progress in lowering its rates
    10  of infection, the penalties in section 10 shall apply.
    11     (d)  Other technologies.--Nothing in this section shall
    12  prevent health care facilities from having the flexibility to
    13  use other technologies to manage infections as they see fit.
    14  Section 10.  Violations and penalties.
    15     (a)  General rule.--When appropriate, the department will
    16  work with the health care facility to rectify a violation of
    17  this act.
    18     (b)  Health care facility violations.--A health care facility
    19  that violates this act may be subject to sanctions by the
    20  department, which include:
    21         (1)  Suspension of its license.
    22         (2)  Revocation of its license.
    23         (3)  Refusal to renew its license.
    24         (4)  Limitation of its license as to operation of a
    25     portion of the health care facility or to the services which
    26     may be provided at the health care facility.
    27         (5)  Issuance of a provisional license.
    28         (6)  Submission of a plan of correction.
    29         (7)  Limitation or suspension of admissions to the health
    30     care facility.
    20070H1552B1972                 - 16 -     

     1     (c)  Penalty.--A facility who violates this act may be
     2  subject to a civil penalty not to exceed $500 per day.
     3  Section 11.  Effective date.
     4     This act shall take effect in 90 days.

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