HLT-09-12-00001-RP Adverse Event Reporting Via NYPORTS System

3/20/13 N.Y. St. Reg. HLT-09-12-00001-RP

NEW YORK STATE REGISTER

VOLUME XXXV, ISSUE 12

March 20, 2013

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

REVISED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. HLT-09-12-00001-RP

Adverse Event Reporting Via NYPORTS System

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following revised rule:

Proposed Action:

Amendment of sections 405.8 and 751.10 of Title 10 NYCRR.

Statutory authority:

Public Health Law, section 2805-1

Subject:

Adverse Event Reporting Via NYPORTS System.

Purpose:

To update current provisions to conform with current practice.

Text of revised rule:

Section 405.8 is repealed.

A new section 405.8 is added to read as follows:

405.8 Adverse Event Reporting

(a) Any adverse event required to be reported pursuant to subdivision (b) of this section shall be reported to the department. Hospitals shall report such adverse events, as defined in subdivision (b) of this section, within 24 hours or one business day of when the adverse event occurred or when the hospital has reasonable cause to believe that such an adverse event has occurred. This report to the department shall be submitted in a format specified by the department and shall at a minimum include: the date, the nature, classification and location of the adverse event; and medical record numbers of all patients directly affected by the adverse event.

(b) Adverse events to be reported are:

(1) patients' deaths in circumstances other than those related to the natural course of illness, disease or proper treatment in accordance with generally accepted medical standards;

(2) injuries and impairments of bodily functions, in circumstances other than those related to the natural course of illness, disease or proper treatment in accordance with generally accepted medical standards that necessitate additional or more complicated treatment regimens or that result in a significant change in patient status;

(3) equipment malfunction or equipment user error during treatment or diagnosis of a patient which results in death or serious injury of a patient;

(4) patient elopements resulting in death or serious injury;

(5) abduction of a patient of any age;

(6) sexual abuse/sexual assault on a patient or staff member within or on the grounds of a general hospital;

(7) physical assault of a patient or staff member within or on the grounds of a general hospital;

(8) discharge or release of a patient of any age, who is unable to make decisions, to other than an authorized person;

(9) patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process;

(10) patient suicide, attempted suicide or self harm resulting in serious injury;

(11) poisoning occurring within the hospital;

(12) fires or other internal disasters in the hospital which disrupt the provision of patient care services or cause harm to patients or staff members;

(13) disasters or other emergency situations external to the hospital environment which affect hospital operations;

(14) termination of any services vital to the continued safe operation of the hospital or to the health and safety of its patients and staff members, including but not limited to the termination of telephone, electric, gas, fuel, water, heat, air conditioning, rodent or pest control, laundry services, food, or contract services; and

(15) strikes by staff members.

(c) The hospital shall conduct an investigation of adverse events described in paragraphs (1-10) of subdivision (b) of this section. Such investigations shall be thorough and credible and occur within thirty days of when the adverse event occurred or when the hospital has reasonable cause to believe that such an adverse event occurred or upon determination by the department that an investigation is warranted in order to protect patient health and safety. If the hospital reasonably expects such investigation to extend beyond the thirty day period, the hospital shall notify the department electronically of such expectation and the reason(s) and shall inform the department of the expected date of completion, not to exceed sixty days. For adverse events described in paragraphs (1-10) of subdivision (b) of this section, the hospital shall submit its investigative report electronically, in a format prescribed by the department. The investigative report shall document all hospital efforts to identify and analyze the circumstances surrounding the adverse event and to develop and implement appropriate measures to prevent recurrence and improve the overall quality of patient care. This report shall be credible and thorough and contain all information in a format specified by the department.

(d) The requirements of this section shall be in addition to and shall not replace other reporting required by this Part.

(e) Nothing in this section shall prohibit the department from investigating any adverse event occurring in general hospitals.

Section 751.10 is repealed.

A new section 751.10 is added to read as follows:

751.10 Adverse Event Reporting

(a) Any adverse event required to be reported pursuant to subdivision (b) of this section shall be reported to the department within 24 hours or one business day of when the adverse event occurred or when the center has reasonable cause to believe that such an adverse event has occurred. This notification shall be submitted in a format specified by the department and shall at least include: the date, the nature, classification, and location of the adverse event and medical record numbers of all patients directly affected by the adverse event.

(b) Adverse events to be reported are:

(1) patients' deaths in circumstances other than those related to the natural course of illness, disease or proper treatment in accordance with generally accepted medical standards;

(2) injuries and impairments of bodily functions, in circumstances other than those related to the natural course of illness, disease or proper treatment in accordance with generally accepted medical standards that necessitate additional or more complicated treatment regimens or that result in a significant change in patient status;

(3) equipment malfunction or equipment user error during treatment or diagnosis of a patient which results in death or serious injury of a patient;

(4) patient elopements resulting in death or serious injury;

(5) abduction of a patient of any age;

(6) sexual abuse/sexual assault on a patient or staff member within or on the grounds of a center;

(7) physical assault of a patient or staff member within or on the grounds of a center;

(8) discharge or release of a patient of any age, who is unable to make decisions, to other than an authorized person;

(9) patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process;

(10) patient suicide, attempted suicide or self harm resulting in serious injury;

(11) poisoning occurring within the center;

(12) fires or other internal disasters in the center which disrupt the provision of patient care services or cause harm to patients or staff members;

(13) disasters or other emergency situations external to the center environment which affect center operations;

(14) termination of any services vital to the continued safe operation of the center or to the health and safety of its patients and staff members, including but not limited to the termination of telephone, electric, gas, fuel, water, heat, air conditioning, rodent or pest control, laundry services, food, or contract services; and

(15) strikes by staff members.

(c) The center shall conduct an investigation of any adverse events described in paragraphs (1-10) of subdivision (b) of this section. Such investigation shall be thorough and credible and occur within thirty days of when the adverse event occurred or when the center has reasonable cause to believe that such an adverse event occurred or upon determination by the department that an investigation is warranted in order to protect patient health and safety. If the center reasonably expects such investigation to extend beyond the thirty day period, the center shall notify the department electronically of such expectation and the reason(s) and shall inform the department of the expected date of completion, not to exceed sixty days. This investigative report shall be thorough and credible and the center shall submit its report electronically, in a format prescribed by the department.

(d) Nothing in this section shall prohibit the department from investigating any adverse event included in subdivision (b) of this section occurring in such centers.

(e) The requirements of this section shall be in addition to and shall not replace other reporting required by this Chapter.

Revised rule compared with proposed rule:

Substantive revisions were made in sections 405.8(b)(3) and 751.10(b)(3).

Text of revised proposed rule and any required statements and analyses may be obtained from

Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Same as above.

Public comment will be received until:

30 days after publication of this notice.

Revised Regulatory Impact Statement

Statutory Authority:

The authority for the promulgation of this regulation is contained in Section 2805-l of the Public Health Law (PHL). PHL Section 2805-l outlines the adverse event reporting requirements for hospitals and diagnostic and treatment centers and directs the Commissioner to make, adopt, promulgate and enforce such rules and regulations as he deems appropriate to effectuate the purposes of PHL Section 2805-l. PHL Section 2805-l also authorizes the Commissioner, after consultation with experts, to add, modify or eliminate by regulation one or more of the adverse events at PHL Section 2805-l consistent with the standards of a consensus based entity selected by the U.S. Department of Health and Human Services pursuant to the Medicare Improvement for Patients and Providers Act. That entity is currently the National Quality Forum (NQF).

Legislative Objectives:

The legislative intent of PHL Article 28 is to provide for the protection and promotion of the health of the inhabitants of the State of New York by delivering high quality hospital and related services in a safe and efficient manner at a reasonable cost. PHL Section 2805-l is intended to strengthen New York State’s hospital and diagnostic and treatment center system by enhancing safeguards and protocols to ensure patient safety with its adverse event reporting requirements. Its aim is to ensure that facility staff become promptly aware of problems, take necessary corrective action and minimize the potential for recurrence. The Department has over time developed and implemented a state of the art and nationally recognized adverse event reporting system, the New York Patient Reporting System (NYPORTS), with a strong reliance on each facility’s statutory reporting obligation.

Needs and Benefits:

Current adverse event reporting practice includes the reporting of defined occurrences, adverse events and unexpected deaths to the Department’s Office of Health Systems Management’s New York Patient Reporting System (NYPORTS). NYPORTS has been in place since 1998 and serves as a nationally recognized adverse event reporting system. NYPORTS is an internet-based system with all required security measures in place. Facilities can query the database to compare their experience with reported events statewide, regionally or within their peer group. While the identity of individual facilities in the comparative groups is not disclosed, the comparative database is a useful tool in support of facility quality improvement activities.

Chapter 542 of the Laws of 2000 created Article 29-D of the Public Health Law, known as the Patient Health Information and Quality Improvement Act of 2000. This law included provisions that established a patient safety center to maximize patient safety, reduce medical errors, and improve the quality of health care. This was to be accomplished by improving systems of data reporting, collection, analysis and dissemination, and to improve public access to health care information not otherwise restricted. The Department’s NYPORTS activities support the mission of the patient safety center through its efforts to collect adverse event report data, analyses of the data and dissemination of such analyses to the hospital community.

A collaborative effort between the Department and stakeholders to align the NYPORTS system with national reporting trends resulted in statutory changes made by the Legislature in 2011. PHL Section 2805-l was revised to allow the Department to modify the reporting requirements so they align with the standards of a consensus based entity selected by the U.S. Department of Health and Human Services pursuant to the Medicare Improvement for Patients and Providers Act. That entity is currently the National Quality Forum (NQF). The amendments to PHL 2805-l also allow the Department to release, in a format that does not identify patients, analyses and findings derived from adverse event data to hospitals or the public and adverse event data to researchers for patient safety research projects approved by the Commissioner. These regulatory amendments: update the adverse reporting requirements to more closely align with NQF standards; update the process for reporting; and change the term “incident reporting” to conform with the terminology now used in PHL 2805-l which is ”adverse event reporting”.

Costs:

This proposal will not increase costs to the Department or to the facilities required to report adverse events to the Department via the NYPORTS system. These amendments update the regulations to: more closely align with NQF standards for reporting; update the process for reporting to reflect current practice; and conform terminology to statutory changes.

Local Government Mandates:

This regulation does not impose any new programs, services, duties, or responsibilities upon any county, city, town, village, school district, fire district or other special district including local government run general hospitals and diagnostic and treatment centers.

Paperwork:

There will be no additional paperwork as these amendments merely update the regulation to more closely align with NQF standards for reporting; update the process for reporting to reflect current practice; and conform terminology to statutory changes.

Duplication:

This regulation does not duplicate any other state or federal law or regulation.

Alternatives:

There are no other alternatives. The current regulation is out of date. This proposal updates the regulation to reflect current practice and to implement and conform with statutory changes.

Federal Standards:

This regulatory amendment does not exceed any minimum standards of the federal government.

Compliance Schedule:

The proposed rule will become effective upon publication of a Notice of Adoption in the State Register for Section 405.8 and 150 days after publication of a Notice of Adoption in the State Register for section 751.10.

Revised Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement

Changes made to the last published rule do not necessitate revision to the previously published Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement.

Assessment of Public Comment

The Department received comments from 4 associations during the public comment period. They came from the following: Institute for Policy Integrity (Policy Integrity), New York State Trial Lawyers Association (NYSTLA), New York Public Interest Research Group (NYPIRG), and Healthcare Association of New York State (HANYS).

1) COMMENT: The Regulatory Impact Statement (RIS) failed to weigh the costs and benefits of this proposal and examine alternative approaches by conducting to the best of its ability, an empirically grounded analysis of the economic impacts of its proposed rule, and compare those impacts across all reasonable regulatory alternatives. The Department’s explanation of the economic costs of its proposed rulemaking is insufficient for similar reasons. (Policy Integrity) The Regulatory Impact Statement should explain the reasoning and likely impact of the changes that would eliminate existing duties or otherwise make the rule-making less strict. (NYPIRG)

1) RESPONSE: This proposal updates the regulation to reflect current practice and to implement and conform to the 2011 changes in Public Health Law (PHL) Section 2805-l. It will not increase costs to the Department or the affected parties. It does not impose any new programs, services, duties or responsibilities upon any county, city, town, village school district, fire district or other special district including local government run general hospitals and diagnostic and treatment centers. There will be no additional paperwork as these amendments merely update the regulation to more closely align with National Quality Forum (NQF) standards for reporting, update the process for reporting to reflect current practice; and conform terminology to statutory changes. In conformance with the changes in PHL Section 2805-l the regulation allows the Department to release, in a format that does not identify patients, analyses and findings derived from adverse event data to hospitals or the public and adverse event data to researchers for patient safety research projects approved by the Commissioner.

2) COMMENT: The absence of original text in the Notice of Proposed Rulemaking makes it difficult for readers to identify all of the proposed regulatory changes and to assess their substantive impacts, if any. A mark-up or redline version would demonstrate more clearly how the existing language compares with that being prepared. This would improve transparency and enable stakeholders to provide better feedback through the notice and comment process. (Policy Integrity) (NYPIRG)

2) RESPONSE: Please see attached Appendix A which sets forth two tables summarizing existing and proposed language as well as Department rationale.

3) COMMENT: The proposed amendment deletes the seven day deadline for notifying the Department of many adverse events. (NYSTLA) A major loophole is created for timeliness of filing of preliminary notice of adverse event occurrence. The proposed amendment eliminates the preliminary written notification of adverse event and essential information. We are mystified over how the purported alignment of New York with recent changes to the NQF updated serious reportable events listing necessitates proposed changes with respect to the timeliness, reporting detail, and investigation methodology. (NYPIRG) Some of the revisions to the proposal would alter the timelines by which hospitals must report the occurrence of a “possibly adverse event”; others would modify the methodology hospitals must use when conducting investigations of adverse events. (Policy Integrity)

3) RESPONSE: The seven day deadline for notifying the Department of many adverse events is a remnant of the paper process and pre-dates the electronic process currently in place. Hospitals and diagnostic and treatment centers must report adverse events within 24 hours or one business day of when the adverse event occurred or when the hospital has reasonable cause to believe that such an adverse event occurred. This report must be submitted in a format specified by the Department and must at a minimum include: the date, the nature, classification and location of the adverse event; and medical record numbers of all patients directly affected by the adverse event. Justification must be included in the description of the event for delays between the date of occurrence and the date of awareness.

4) COMMENT: While the Department claims that this proposal will more closely align with standards promulgated by the NQF, it does not clarify which of its proposed changes will do so. The Department also does not explain why such alignment is necessary or beneficial to public health. (Policy Integrity)

4) RESPONSE: Please see attached Appendix A which sets forth two tables summarizing existing and proposed language as well as Department rationale. The statutory authority for this proposal is Public Health Law (PHL) Section 2805-l. It was revised in 2011 to allow the Department to be consistent with other states and provide uniformity with the standards of a consensus based entity selected by the U.S. Department of Health and Human Services pursuant to the Medicare Improvement for Patients and Providers Act. That entity is currently the NQF. It benefits the pubic by clarifying the definitions of reportable events, permitting comparisons of the rates of reporting of adverse events among hospitals and diagnostic and treatment centers and among states. In conformance with the changes in PHL Section 2805-l the regulation allows the Department to release, in a format that does not identify patients, analyses and findings derived from adverse event data to hospitals and diagnostic and treatment centers or the public and adverse event data to researchers for patient safety research projects approved by the Commissioner.

5) COMMENT: The proposed amendment deletes the current requirement for an adverse event report to contain the “full name and title of physicians and hospital staff involved in the incident as well as their license, permit, certification or registration numbers.” (NYSTLA)

5) RESPONSE: The need to include information identifying professionals is believed to deter facility staff from filing adverse event reports. The Department does not need such information in order to analyze adverse events. If there is reason to believe, based on an adverse event report, that a professional or other licensed staff engaged in misconduct, the Department may report the event to the applicable professional conduct or licensing entity. In addition it is the responsibility of the facility to maintain compliance with the reporting requirements as set forth in Section 405.3 (Administration), Subdivision (e) (Other Reporting Requirements), Paragraphs (1) (OPMC) and (2) (SED) of Title 10 of the Official Compilation of Codes, Rules and Regulations of the State of New York (10 NYCRR). The professional conduct or licensing entities can obtain the identities of the professionals and staff from the facilities.

6) COMMENT: The proposed amendment deletes the entire list of specific requirements for the information hospitals must include in their adverse event investigations as currently enumerated in Section 405.8(d)(1) to (7). (NYSTLA) The proposal would weaken investigation methodology. The proposed regulatory changes would eliminate the entire list of specific requirements that hospitals must include in their adverse event investigations. (NYPIRG)

6) RESPONSE: These elements are still captured in an electronic format as prescribed by the Department. Facilities are directed in 405.8(c) and 751.10(c) to conduct an investigation that shall be thorough and credible and contain all information in a format specified by the Department.

7) COMMENT: The current regulation requires submission of a report and investigation when there is “equipment malfunction or equipment user error during treatment or diagnosis of a patient which did or could have adversely affected a patient or personnel.” The proposed amendment requires a report/investigation only for “equipment malfunction during treatment or diagnosis of a patient which results in death or serious injury.” The proposed amendment omits the words “could have” and “user error”. It is important for the Department to be told about all near misses and instances of patient harm in order to prevent more serious incidents. (NYSTLA) The proposed regulation requires a report/investigation only for “equipment malfunction during treatment or diagnosis of a patient which results in death or serious injury.” Deleting reporting in cases that “could have resulted in death or serious injury or that were the result of “user error” undermines the potential to identify potentially deadly circumstances before serious harm results. It is important to know about all of the near misses and about user error which could indicate lack of supervision or training. The proposal would also weaken the scope of reportable “elopements” – circumstances when patients leave a hospital or facility without discharge or other appropriate reason – to those incidents that result in death or serious injury (NYPIRG)

7) RESPONSE: The Department clarified that the proposed regulation, consistent with NQF standards, is intended to include equipment user error by now stating that language in both Sections 405.8(b)(3) and 751.10(b)(3). The Department cannot possibly track all “near misses,” nor can it track and enforce compliance with reporting “near misses.” Attempting to do so would divert Department resources from focusing on the events that actually cause harm. The NQF has appropriately concluded that tracking and analyzing events that cause serious harm provides the most effective means of identifying the causes of adverse incidents and disseminating information to prevent them in the future.

8) COMMENT: There is a gap in information on who will investigate adverse events. The proposal eliminates poisoning from the list of adverse events that the hospital must investigate, and also deletes the provision authorizing the Department to determine in some instances that the hospital should investigate incidents related to disasters, emergency situations or termination of vital services. (NYPIRG)

8) RESPONSE: Both the hospitals and the centers must investigate certain adverse events. Poisonings must be reported to the Department by general hospitals and treatment and diagnostic centers. Upon review of the facility’s report by the Department, it will be determined if the poisoning jeopardized patient safety, and/or actually caused harm to patients or staff. If the poisoning jeopardized patient safety by actually causing harm to patients or staff, the Department will direct the facility to conduct an investigation of the event. Nothing in this regulation will prohibit the Department from investigating any adverse event in these provisions.

9) COMMENT: HANYS is supportive of the changes to the New York Patient Occurrence Reporting and Tracking System (NYPORTS) program and regulatory efforts to align the measure with the NQF’s serious reportable events. Standardizing the definitions and reporting methodologies of the NYPORTS measures with NQF provisions will reduce duplicative misaligned reporting obligations. HANYS also recommends that the Department continue to work with the NYPORTS Council to develop further specificity in the definitions and guidelines for these events. It encourages the Department to provide additional resources to the NYPORTS program to enable it to make the necessary changes to conduct comprehensive analyses of the data and share lessons learned with the hospital community. (HANYS)

9) RESPONSE: The Department agrees that is should continue to work with the NYPORTS Council to further develop specificity of the definitions and guidelines for these events.