PRIOR PRINTER'S NO. 1160 PRINTER'S NO. 1169
No. 968 Session of 2007
INTRODUCED BY ERICKSON, PILEGGI, SCARNATI, WONDERLING, MADIGAN, McILHINNEY, MELLOW, TARTAGLIONE, WASHINGTON, ORIE, M. WHITE, MUSTO, KITCHEN, GORDNER, FOLMER, O'PAKE, PIPPY, TOMLINSON, RAFFERTY, VANCE, BAKER, C. WILLIAMS, D. WHITE, FERLO AND FONTANA, JUNE 11, 2007
SENATOR ERICKSON, PUBLIC HEALTH AND WELFARE, AS AMENDED, JUNE 13, 2007
AN ACT 1 Amending the act of March 20, 2002 (P.L.154, No.13), entitled 2 "An act reforming the law on medical professional liability; 3 providing for patient safety and reporting; establishing the 4 Patient Safety Authority and the Patient Safety Trust Fund; 5 abrogating regulations; providing for medical professional 6 liability informed consent, damages, expert qualifications, 7 limitations of actions and medical records; establishing the 8 Interbranch Commission on Venue; providing for medical 9 professional liability insurance; establishing the Medical 10 Care Availability and Reduction of Error Fund; providing for 11 medical professional liability claims; establishing the Joint 12 Underwriting Association; regulating medical professional 13 liability insurance; providing for medical licensure 14 regulation; providing for administration; imposing penalties; 15 and making repeals," providing for reduction and prevention 16 of health care-associated infection. 17 The General Assembly of the Commonwealth of Pennsylvania 18 hereby enacts as follows: 19 Section 1. The act of March 20, 2002 (P.L.154, No.13), known 20 as the Medical Care Availability and Reduction of Error (Mcare) 21 Act, is amended by adding a chapter to read: 22 CHAPTER 4 23 HEALTH CARE-ASSOCIATED INFECTIONS
1 Section 401. Scope. 2 This chapter relates to the reduction and prevention of 3 health care-associated infections. 4 Section 402. Definitions. 5 The following words and phrases when used in this chapter 6 shall have the meanings given to them in this section unless the 7 context clearly indicates otherwise: 8 "Antimicrobial agent." A general term for drugs, chemicals 9 or other substances that kill or slow the growth of microbes, 10 including, but not limited to, antibacterial drugs, antiviral 11 agents, antifungal agents and antiparasitic drugs. 12 "Authority." The Patient Safety Authority. 13 "Colonization." The first stage of microbial infection or 14 the presence of nonreplicating microorganisms usually present in 15 host tissues that are in contact with the external environment. 16 "Department." The Department of Health of the Commonwealth. 17 "Fund." The Patient Safety Trust Fund as defined in section 18 305. 19 "Health care-associated infection." A localized or systemic 20 condition that results from an adverse reaction to the presence 21 of an infectious agent or its toxins that: 22 (1) occurs in a patient in a health care setting; 23 (2) was not present or incubating at the time of 24 admission, unless the infection was related to a previous 25 admission to the same setting; and 26 (3) if occurring in a hospital setting, meets the 27 criteria for a specific infection site as defined by the 28 Centers for Disease Control and Prevention and its National 29 Health Care Safety Network. 30 "Health care facility." A hospital or nursing home licensed 20070S0968B1169 - 2 -
1 or otherwise regulated to provide health care services under the 2 laws of this Commonwealth. 3 "Health payor." An individual or entity providing a group 4 health, sickness or accident policy, subscriber contract or 5 program issued or provided by an entity subject to any one of 6 the following: 7 (1) The act of June 2, 1915 (P.L.736, No.338), known as 8 the Workers' Compensation Act. 9 (2) The act of May 17, 1921 (P.L.682, No.284), known as 10 The Insurance Company Law of 1921. 11 (3) The act of December 29, 1972 (P.L.1701, No.364), 12 known as the Health Maintenance Organization Act. 13 (4) The act of May 18, 1976 (P.L.123, No.54), known as 14 the Individual Accident and Sickness Insurance Minimum 15 Standards Act. 16 (5) 40 Pa.C.S. Ch. 61 (relating to hospital plan 17 corporations). 18 "Medicaid." The program established under Title XIX of the 19 Social Security Act (49 Stat. 620, 42 U.S.C. § 1396 et seq.). 20 "Medicare." The program established under section 1886 of 21 the Social Security Act (49 Stat. 620, 42 U.S.C. § 1395ww). 22 "Methicillin Resistant Staphylococcus Aureus" or "MRSA." A 23 strain of bacteria that is resistant to certain antibiotics and 24 is difficult to treat medically. 25 "Multidrug resistant organism" or "MDRO." Microorganisms, 26 predominantly bacteria, that are resistant to one or more 27 classes of antimicrobial agents. 28 "Nationally recognized standards." Standards developed by 29 organizations specializing in the control of infectious diseases 30 such as the Society for the Healthcare Epidemiology of America 20070S0968B1169 - 3 -
1 (SHEA), the Association for Professionals in Infection Control 2 and Epidemiology (APIC) and the Infectious Disease Society of 3 America (IDSA) and such methods, recommendations and guidelines 4 developed by the Centers for Disease Control and Prevention 5 (CDC) and its National Healthcare Safety Network. 6 Section 403. Infection control plan. 7 (a) Development and compliance.--Within 120 days of the 8 effective date of this section, a health care facility shall 9 develop and implement an internal infection control plan that 10 shall be established for the purpose of improving the health and 11 safety of patients and health care workers and shall include: 12 (1) A multidisciplinary committee including 13 representatives from each of the following if applicable to 14 that specific health care facility: 15 (i) Medical staff. 16 (ii) Administration. 17 (iii) Laboratory. 18 (iv) Nursing. 19 (v) Pharmacy. 20 (vi) The community. 21 (2) Effective measures for the detection, control and 22 prevention of health care-associated infections. 23 (3) An active culture surveillance process and policies. 24 (4) A system to identify and designate patients known to 25 be colonized or infected with MRSA or other MDRO. 26 (5) The procedure for identifying other high-risk 27 patients admitted to the facility who shall receive routine 28 cultures and screenings. 29 (6) An outreach process for notifying a receiving health 30 care facility of any patient known to be colonized prior to 20070S0968B1169 - 4 -
1 transfer within or between facilities. 2 (7) A required infection-control intervention protocol 3 which includes: 4 (i) Infection control precautions, based on 5 nationally recognized standards, for general surveillance 6 of infected or colonized patients. 7 (ii) Treatment protocols based on evidence-based 8 standards. 9 (iii) Isolation procedures. 10 (iv) Physical plant operations related to infection 11 control. 12 (v) Appropriate use of antimicrobial agents and 13 antibiotics. 14 (vi) Mandatory educational programs for personnel. 15 (vii) Fiscal and human resource requirements. 16 (b) Department review.--The department shall review each 17 health care facility's infection control plan to ensure 18 compliance with this section in accordance with the department's 19 authority under 28 Pa. Code § 146 (relating to infection 20 control) during its regular licensure inspection process. 21 (c) Notification.--Upon review of its infection control 22 plan, a health care facility shall notify all health care 23 workers and medical staff of the health care facility of the 24 infection control plan. Compliance with the infection control 25 plan shall be required as a condition of employment or 26 credentialing at the health care facility. 27 Section 404. Patient Safety Authority jurisdiction. 28 (a) Health care facility reports to authority.--The 29 occurrence of a health care-associated infection in a health 30 care facility shall be deemed a serious event or incident as 20070S0968B1169 - 5 -
1 applicable as defined in section 302 and shall be reported to 2 the authority within 24 hours of the health care facility's 3 confirmation of its occurrence. The report to the authority 4 shall be in form and manner prescribed by the authority and 5 shall not include the name of any patient or any other 6 identifiable individual information. The occurrence of a health 7 care-associated infection shall otherwise be subject to other 8 requirements of Chapter 3. 9 (b) Report submission.--Within 60 days of the effective date 10 of this section, a health care facility shall begin reporting 11 health care-associated infections in its facility as serious 12 events or incidents, consistent with the requirements of this 13 section. 14 (c) Duties.--In addition to its existing responsibilities, 15 the authority is responsible for all of the following: 16 (1) Establishing uniform definitions based on nationally 17 recognized standards for the identification and reporting of 18 health care-associated infections. 19 (2) Developing and implementing uniform reporting 20 requirements utilizing the uniform definitions established 21 under paragraph (1), which a health care facility shall 22 follow for purposes of reporting health care-associated 23 infections: 24 (i) to the authority pursuant to subsection (b); 25 (ii) to the Health Care Cost Containment Council 26 pursuant to section 6(c)(7) of the act of July 8, 1986 27 (P.L.408, No.89), known as the Health Care Cost 28 Containment Act; and 29 (iii) to any other State agency, including 30 independent State agencies. 20070S0968B1169 - 6 -
1 (3) Developing a methodology using nationally recognized 2 standards for determining and assessing the rate of health 3 care-associated infections that occur in health care 4 facilities in this Commonwealth as compared with the rate of 5 health care-assessed CARE-ASSOCIATED infections occurring in <-- 6 health care facilities on a nationwide basis. 7 (4) Publishing a notice in the Pennsylvania Bulletin 8 stating the uniform reporting requirements established 9 pursuant to this subsection and the effective date for the 10 commencement of required reporting by health care facilities 11 consistent with this chapter, which, at a minimum, shall 12 begin 120 days after publication of the notice. 13 (5) Issuing advisories under section 304(a)(7). 14 (6) Including a separate category for providing 15 information about health care-associated infections in the 16 annual report under section 304(c). 17 (7) Appointing an advisory panel of health care- 18 associated infection control experts to assist in carrying 19 out the requirements of this chapter. 20 Section 405. Payment for performing routine cultures and 21 screenings. 22 The cost of routine cultures and screenings performed on 23 patients in compliance with a health care facility's infection 24 control plan shall be considered a reimbursable cost to be paid 25 by health payors and Medicaid. 26 Section 406. Incentive payment. 27 (a) General rule.--Commencing on January 1, 2009, a health 28 care facility that achieves at least a 10% reduction for that 29 facility in the total number of reported health care-associated 30 infections over the preceding year shall be eligible to receive 20070S0968B1169 - 7 -
1 an incentive payment. For calendar year 2010 and thereafter, the 2 Department of Public Welfare shall consult with the authority to 3 establish appropriate percentage benchmarks for the reduction of 4 health care-associated infections in health care facilities in 5 order to be eligible for an incentive payment pursuant to this 6 section. 7 (b) Distribution of funds.--Funds for the purpose of 8 implementing this section shall be appropriated to the 9 Department of Public Welfare and distributed to eligible health 10 care facilities as set forth in this section. Incentive payments 11 to health care facilities shall be limited to funds available 12 for this purpose. 13 Section 407. Duties of Department of Health. 14 The department is responsible for the following: 15 (1) The development of a public health awareness 16 campaign on health care-associated infections to be known as 17 the Community Awareness Program. The program shall provide 18 information to the public on causes and symptoms of health 19 care-associated infections, diagnosis and treatment 20 prevention methods and the proper use of antibiotics. 21 (2) The consideration and determination of the 22 feasibility of establishing an active surveillance program 23 involving other entities, such as athletic teams, 24 correctional facilities or other entities to identify those 25 persons in the community that are actively colonized and at 26 risk of susceptibility to and transmission of MRSA bacteria. 27 Section 408. Nursing home assessment to Patient Safety 28 Authority. 29 (a) Assessment.--Commencing January 1, 2008, each nursing 30 home shall pay the department a surcharge on its licensing fee 20070S0968B1169 - 8 -
1 as necessary to provide sufficient revenues to operate the 2 authority for its responsibilities under this chapter. The total 3 assessment for all nursing homes shall not be more than 4 $1,000,000. The department shall transfer the total assessment 5 amount to the fund within 30 days of receipt. 6 (b) Base amount.--For each succeeding calendar year, the 7 authority shall determine the appropriate assessment amount and 8 the department shall assess each nursing home its proportionate 9 share of the authority's budget for its responsibilities under 10 this chapter. The total assessment amount shall not be more than 11 $1,000,000 in fiscal year 2007-2008 and shall be increased 12 according to the Consumer Price Index in each succeeding fiscal 13 year. 14 (c) Expenditures.--Money appropriated to the fund under this 15 chapter shall be expended by the authority to implement this 16 chapter. 17 (d) Dissolution.--In the event that the fund is discontinued 18 or the authority is dissolved by operation of law, any balance 19 paid by nursing homes remaining in the fund, after deducting 20 administrative costs of liquidation, shall be returned to the 21 nursing homes in proportion to their financial contributions to 22 the fund in the preceding licensing period. 23 (e) Failure to pay surcharge.--If after 30 days' notice a 24 nursing home fails to pay a surcharge levied by the department 25 under this chapter, the department may assess an administrative 26 penalty of $1,000 per day until the surcharge is paid. 27 Section 409. Scope of reporting. 28 This chapter shall satisfy the sole and exclusive requirement 29 for health care facilities to report health care-associated 30 infections to the Commonwealth. 20070S0968B1169 - 9 -
1 Section 410. Penalties. 2 (a) Violation of Health Care Facilities Act.--The failure of 3 a health care facility to report a health care-associated 4 infection as a serious event or incident as required by this 5 chapter or the failure of a health care facility to develop, 6 implement and comply with its infection control plan in 7 accordance with the requirements of section 403 shall be a 8 violation of the act of July 19, 1979 (P.L.130, No.48), known as 9 the Health Care Facilities Act. 10 (b) Administrative penalty.--In addition to any penalty that 11 may be imposed under the Health Care Facilities Act or under 18 12 Pa.C.S. Ch. 32 (relating to abortion), a health care facility 13 which fails to report a health care-associated infection as a 14 serious event or incident may be subject to an administrative 15 penalty of $1,000 per day imposed by the department. 16 Section 2. This act shall take effect in 30 days. F8L40BIL/20070S0968B1169 - 10 -