PRINTER'S NO. 1905
No. 1552 Session of 2007
INTRODUCED BY DeLUCA, MICOZZIE, SHIMKUS, THOMAS, DeWEESE,
EACHUS, KENNEY, BELFANTI, BIANCUCCI, BLACKWELL, CALTAGIRONE,
CREIGHTON, FABRIZIO, FRANKEL, FREEMAN, GIBBONS, GRUCELA,
GOODMAN, HALUSKA, JOSEPHS, KORTZ, KOTIK, KULA, LENTZ,
MAHONEY, MANDERINO, MARKOSEK, McILVAINE SMITH, MUNDY, MYERS,
SAYLOR, SOLOBAY, TANGRETTI, J. TAYLOR, R. TAYLOR, WALKO AND
YUDICHAK, JUNE 13, 2007
REFERRED TO COMMITTEE ON INSURANCE, 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
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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-
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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 benchmarks
22 the department shall use to measure the progress of health
23 care facilities in reducing health care-associated
24 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
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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.
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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
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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.
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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
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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
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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. Qualified systems shall include the following minimum
27 elements:
28 (1) Extraction of existing electronic clinical data from
29 hospital systems on an ongoing basis.
30 (2) Translation of nonstandardized laboratory, pharmacy
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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
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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.
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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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