By Mr. Moore, a petition (accompanied by bill, Senate,
No. 1277) of Richard T. Moore and Denise Provost for
legislation to promote healthcare transparency and
consumer-provider partnerships. Public Health.
Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows:
SECTION 1. Chapter 111 of the General Laws is hereby amended by inserting after Section 53D the following two sections:-
Section 53E.† (a) All hospitals shall establish and convene patient and family advisory councils, referred to in this section as the councils.
(b) The councils shall be composed of current and former patients and members of their immediate families. The minimum size of a council shall be 7 members.† The rules and regulations for the councils shall be established by council members.
(c) Each hospital shall appoint an employee to serve as a resource to the councils and to coordinate their activities.
(d) Each hospital shall develop a committee to establish and maintain a council and to empower the council to provide meaningful input into hospital policy and management. The councils shall meet at least 4 times annually. The hospital shall provide a meeting place for the council.
Section 53F.† (a) All hospitals shall establish rapid response teams.† Each team shall consist of at least one physician, at least one registered nurse, at least one respiratory therapist, and other specialists as determined necessary by the hospital.
(b) Rapid response teams shall be specially trained to assess a patient's condition, stabilize a patient's condition, assist with communication among the attending medical staff and the patient and family, educate and support medical staff and assist with transfers.
(c) All Hospitals shall allow any patient, practitioner, family member, or other person present during the care to activate the rapid response team whenever they detect deterioration in the patient's condition.† Such deterioration shall include but not be limited to changes in heart rate, blood pressure, respiratory status, oxygen saturation, arterial blood gases, and mental functioning.
SECTION 2.† Section 70E of Chapter 111 of the General Laws is hereby amended by inserting after the first paragraph the following paragraphs:-
As used in this section, "adverse event" shall mean injury to a patient resulting from a medical intervention and not from the underlying condition of the patient.
As used in this section, "health care provider" shall mean a person licensed or otherwise authorized under state law to provide health care services, including: a doctor, nurse, physician assistant, nurse practitioner, clinical nurse specialist, certified nurse anesthetist, certified nurse midwife, respiratory therapist, psychologist, certified social worker, registered dietitian or nutrition professional, physical or occupational therapist, pharmacist, or other individual health care practitioner; and any other health care professional specified in regulations promulgated by the secretary of the executive office of health and human services.
SECTION 3. Said section 70E of said chapter 111 is hereby further amended by inserting after the ninth paragraph the following paragraphs:-
††††††††††† A health care provider who reasonably believes that an adverse event has occurred shall report the adverse event to the management of the facility where the event occurred unless the health care provider knows that a report has already been made.† The report shall be made immediately or as soon as practicable, but in no event later than 24 hours after the provider's† discovery of the adverse event.
††††††††††† Facilities, through a health care provider responsible for the patient's care or through an appropriately trained designee, shall provide notification in person and in writing to a patient affected by an adverse event or their health care proxy within 7 days. If no such proxy exists, notice shall be provided to an available family member.† For patients who are under 18 years of age, the parent or guardian shall be notified, except in cases where medical treatment was given with only the consent of the minor patient, in which case only the minor patient shall receive notification unless the minor patient is unresponsive.† If the patient or designee can not be notified in person, written notification shall suffice.
††††††††††† This notification shall include a description of the adverse event, the causes or potential causes of the adverse event as understood at that point in time, the consequences or potential consequences of the adverse event, the courses of action to be taken to alleviate the impact or potential impact on the patient's health, and any other information deemed by the facility or health care provider to be pertinent to the patient's health and understanding.†
SECTION 4. Chapter 111 of the General Laws is hereby amended by inserting after Section 70G the following two sections:-
Section 70H.† (a) As used in this section, the following words, unless the context clearly requires otherwise, shall have the following meanings:-
"Department", the department of public health.
"Hospital", any institution, however named, whether conducted for charity or for profit, which is advertised, announced, established, or maintained for the purpose of caring for persons admitted thereto for diagnosis, medical, surgical or restorative treatment which is rendered within said institution.
"Hospital-acquired infection", a localized or systemic condition (1) that results from adverse reaction to the presence of an infectious agent(s) or its toxin(s) and (2) that was not present or incubating at the time of admission to the hospital.
"Secretary", the secretary of the executive office of health and human services
(b) Individual hospitals shall collect data on hospital-acquired infection rates for the specific clinical procedures determined by the department by regulation, including, but not limited to the following categories: -
(1) Surgical site infections;
(2) Ventilator-associated pneumonia;
(3) Central line-related bloodstream infections;
(4) Urinary tract infections; and
(5) Other categories as provided under subsection (e) of this section.
(c)(1) Hospitals shall submit quarterly reports on their hospital-acquired infection rates to the department. Quarterly reports shall be submitted according to a schedule set forth in regulations adopted by the department. Data in quarterly reports must cover a period ending not earlier than 1 month prior to submission of the report. Quarterly reports shall be made available to the public at each hospital and through the department on its website in a style and format that can be easily understood by the public.
(2) If the hospital is a division or subsidiary of another entity that owns or operates other hospitals or related organizations, the quarterly report shall be for the specific division or subsidiary and not for the other entity.
(d) (1) The statewide infection prevention and control program established in item 4570-1502 of section 2A of chapter 58 of the acts of 2006, and the Betsy Lehman Center for Patient Safety and Medical Error Reduction Expert Panel on Healthcare Associated Infection, referred to in this section as the Expert Panel, shall assist the department in the development of all aspects of the department's methodology for collecting, analyzing, and disclosing the information collected under this section, including collection methods, formatting, and methods and means for release and dissemination.
(2) The department shall disclose the data collection and analysis methodology as well as any public disclosure of hospital-acquired infection rates to the public through its website.
(3) The department and the Expert Panel shall evaluate at least annually the quality and accuracy of hospital information reported under this section and the data collection, analysis, and dissemination methodologies.
(e) The department may, after consultation with the Expert Panel, require hospitals to collect data on hospital-acquired infection rates in categories additional to those set forth in subsection (b).
(f) (1) The department shall annually submit to the joint committees on public health and health care finance and the clerks of the house and senate a report summarizing the hospital quarterly reports and shall publish the annual report on its website. The department may issue quarterly informational bulletins at its discretion, summarizing all or part of the information submitted in the hospital quarterly reports.
(2) All reports issued by the department pursuant to this section shall be risk adjusted, consistent with the recommendations of the Expert Panel.
(3) The annual report shall annually compare the risk-adjusted hospital-acquired infection rates, collected under subsection (c) of this section, for each individual hospital in the state. The department, in consultation with the Expert Panel, shall make this comparison as easy to comprehend as possible for the benefit of health care consumers. The report shall also include an executive summary, written in plain language, that shall include, but not be limited to, a discussion of findings, conclusions, and trends concerning the overall state of hospital-acquired infections in the state, including a comparison to prior years. The report may include policy recommendations.
(4) The department shall publicize the report and its availability as widely as practical to interested parties, including, but not limited to, hospitals, providers, media organizations, health insurers, health maintenance organizations, purchasers of health insurance, organized labor, consumer or patient advocacy groups, and individual consumers. The annual report shall be made available through the departmentís web site and also to any person upon request.
(5) No hospital report or department disclosure may contain information identifying a patient, hospital employee, or licensed health care professional in connection with a specific infection incident.
(g) A patient's right of confidentiality shall not be violated in any manner. Notwithstanding any general or special law to the contrary, patient social security numbers and any other information that could be used to identify an individual patient shall not be released.
(h) Hospitals shall reduce the rates of hospital-acquired infections reportable under this section to zero or as close to zero as feasible, in accordance with the recommendation of the statewide infection prevention and control program established in item 4570-1502 of section 2A of chapter 58 of the acts of 2006, and the Betsy Lehman Center for Patient Safety and Medical Error Reduction Expert Panel on Healthcare Associated Infection.
(i) A determination by the department that a hospital has violated the provisions of subsections (a) to (g) inclusive of this section may result in any or all of the following:
(1)† Termination of licensure or other sanctions, as imposed by the department, relating to licensure under this chapter.
(2)† A civil penalty of up to $1,000 per day per violation for each day the hospital††††††††† is in violation of the act.
(j) The department shall promulgate regulations consistent with this section.
Section 70I.† (a) As used in this section, the following words, unless the context clearly requires otherwise, shall have the following meanings:-
"Health care facility" shall have the same meaning as found in section 70E.
"Health care professional", a person licensed or otherwise authorized under Massachusetts law to provide health care services, including:-
(1) a doctor, nurse, physician assistant, nurse practitioner, clinical nurse specialist, certified nurse anesthetist, certified nurse midwife, respiratory therapist, psychologist, certified social worker, registered dietitian or nutrition professional, physical or occupational therapist, pharmacist, or other individual health care practitioner; and
(2) any other health care professional specified in regulations promulgated by the secretary of the executive office of health and human services.
(b)† Each health care facility shall report to the department† the occurrence of any of the adverse medical events, known as "never events", described in items (1) to (6) of this subsection as soon as is reasonably and practically possible, but no later than 15 working days after discovery of the event. The report shall be filed in a format specified by the department and shall identify the facility, but shall not include any information identifying any of the health care professionals, facility employees, or patients involved. The department may consult with experts and organizations familiar with patient safety when developing the format for reporting and in further defining events in order to be consistent with industry standards.† These reports shall be available to the public through the department's website.
(1) Surgical events reportable under this subsection shall include:-
(i) surgery performed on a wrong body part that is not consistent with the documented informed consent for that patient. Reportable events under this clause do not include situations requiring prompt action that occur in the course of surgery or situations whose urgency precludes obtaining informed consent;
(ii) surgery performed on the wrong patient;
(iii) the wrong surgical procedure performed on a patient that is not consistent with the documented informed consent for that patient. Reportable events under this clause do not include situations requiring prompt action that occur in the course of surgery or situations whose urgency precludes obtaining informed consent;
(iv) retention of a foreign object in a patient after surgery or other procedure, excluding objects intentionally implanted as part of a planned intervention and objects present prior to surgery that are intentionally retained; and
(v) death during or immediately after surgery of a normal, healthy patient who has no organic, physiologic, biochemical, or psychiatric disturbance and for whom the pathologic processes for which the operation is to be performed are localized and do not entail a systemic disturbance.
(2) Product or device events reportable under this subsection shall include:-
(i) patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the facility when the contamination is the result of generally detectable contaminants in drugs, devices, or biologics regardless of the source of the contamination or the product;
(ii) patient death or serious disability associated with the use or function of a device in patient care in which the device is used or functions other than as intended. Device includes, but is not limited to, catheters, drains, and other specialized tubes, infusion pumps, and ventilators; and
(iii) patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a facility, excluding deaths associated with neurosurgical procedures known to present a high risk of intravascular air embolism.
(3) Patient protection events reportable under this subsection include:-
(i) an infant discharged to the wrong person;
(ii) patient death or serious disability associated with patient disappearance for more than 4 hours, excluding events involving adults who have decision-making capacity; and
(iii) patient suicide or attempted suicide resulting in serious disability while being cared for in a facility due to patient actions after admission to the facility, excluding deaths resulting from self-inflicted injuries that were the reason for admission to the facility.
(4) Care management events reportable under this subsection include:-
(i) patient death or serious disability associated with a medication error, including, but not limited to, errors involving the wrong drug, the wrong dose, the wrong patient, the wrong time, the wrong rate, the wrong preparation, or the wrong route of administration, excluding reasonable differences in clinical judgment on drug selection and dose;
(ii) patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products;
(iii) maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a facility, including events that occur within 42 days postdelivery and excluding deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy, or cardiomyopathy;
(iv) patient death or serious disability directly related to hypoglycemia, the onset of which occurs while the patient is being cared for in a facility;
(v) death or serious disability, including kernicterus, associated with failure to identify and treat hyperbilirubinemia in neonates during the first 28 days of life. "Hyperbilirubinemia" means bilirubin levels greater than 30 milligrams per deciliter;
(vi) stage 3 or 4 ulcers acquired after admission to a facility, excluding progression from stage 2 to stage 3 if stage 2 was recognized upon admission; and
(vii) patient death or serious disability due to spinal manipulative therapy.
(5) Environmental events reportable under this subsection include:-
(i) patient death or serious disability associated with an electric shock while being cared for in a facility, excluding events involving planned treatments such as electric countershock;
(ii) any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances;
(iii) patient death or serious disability associated with a burn incurred from any source while being cared for in a facility;
(iv) patient death associated with a fall while being cared for in a facility; and
(v) patient death or serious disability associated with the use of restraints or bedrails while being cared for in a facility.
(6) Criminal events reportable under this subsection include:-
(i) an instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider;
(ii) abduction of a patient of any age;
(iii) sexual assault on a patient within or on the grounds of a facility; and
(iv) death or significant injury of a patient or staff member resulting from a physical assault that occurs within or on the grounds of a facility.
(c) The department shall annually submit to the joint committees on health care finance and public health and the clerks of the house and senate a report summarizing the hospital quarterly reports and shall publish the annual report on the internet. The department may issue quarterly informational bulletins at its discretion, summarizing all or part of the information submitted in the hospital quarterly reports.
(d) Notwithstanding any general or special law to the contrary, no third party payer, including the commonwealth, an insurer licensed or otherwise authorized to transact accident or health insurance organized under chapter 175, a nonprofit hospital service corporation organized under chapter 176A, a nonprofit medical service corporation organized under chapter 176B, a health maintenance organization organized under chapter 176G and an organization entering into a preferred provider arrangement under chapter 176I, may knowingly reimburse a health care professional or a health care facility for services that resulted in any of the adverse health care events listed above, and no health care professional or health care facility may bill the patient for such services.
(e) A determination by the department that a hospital has violated the provisions of this section may result in any of the following:
(1)† Termination of licensure or other sanctions relating to licensure under this chapter, as determined by the department.
(2)† A civil penalty of up to $1,000 per day per violation for each day the hospital is in violation of the act.
SECTION 5. Section 23D of chapter 233 of the General Laws is hereby amended by inserting after the definition of "Family", the following definition:-
"Provider of health care", shall have the same meaning as found in section 60B of chapter 231.
SECTION 6. Section 23D of said chapter 233 is hereby further amended by inserting at the end thereof the following paragraph:-
††††††††††† In an action for malpractice, negligence, error, omission, mistake, or the unauthorized rendering of professional services against a provider of health care, statements or writings by such provider of health care expressing apology or sympathy relating to the pain, suffering or death of a person which is not the result of intentional misconduct by such provider of health care and made to such person or to the family of such person shall be inadmissible as evidence of an admission of liability.
SECTION 7. Section 1 shall take effect on January 1, 2010.
SECTION 8.† The reports required by subsections (c) and (f) of section 70H of Chapter 111 of the General Laws, created by section 4 of this act, shall be submitted on January 1, 2009.
SECTION 9. Subsection (h) of section 70H of chapter 111 of the General Laws, as created by section 4 of this act, shall take effect on January 1, 2010.