– NEW YORK –
Public and Private Policy
Medical Errors and Patient Safety
New York State has had a long history of requiring hospitals to report and initiate actions based on adverse events occurring in their facilities. These initiatives date to 1985. An emphasis on patient safety became apparent after publication of the IOM report, To Err is Human. Since 2001, New York State has dedicated more than $8 million to support health care providers statewide in developing and implementing patient safety initiatives; this funding is above and beyond substantial federal funding grants from AHRQ to the New York DOH and New York healthcare facilities for patient safety.
- • Early Regulatory Efforts
Regulations in New York State requiring adverse event reporting became effective on October 1, 1985, apparently in response to a series of preventable hospital deaths. The reporting program was subsequently incorporated into legislation designed to address a medical malpractice availability crisis.
In 1993, the mandatory incident reporting system was redesigned and renamed the Patient Event Tracking System (PETS). PETS was an e-mail system based on a decision algorithm of patient harm and therapeutic treatment. It involved subjective judgment regarding incidents through a peer review process, which led to inconsistent data. In 1995, the state convened a task force to examine ways to improve the Patient Event Tracking System (PETS).
- • Cardiac Surgery Reporting System (CSRS)
Following recommendations from the New York State Cardiac Advisory Committee in 1989, The State of New York was the first of only four states (CA, NJ, NY, PA) to implement mandatory Report Cards of physician-identified and facility-identified cardiac outcomes for cardiac surgery and/or percutaneous coronary angioplasty (PCI).1 Coincident with the New York initiative, the risk-adjusted mortality rates for Coronary Artery Bypass surgery decreased significantly and to mortality levels that were less than or equal to the highest performing heart centers in the country. The Department of Health and health policy advocates attributed this phenomenon to the successful implementation of outcomes reporting programs.2, 3, 4
- • New York Patient Occurrence Reporting and Tracking System (NYPORTS)
In 1998, the state passed legislation [NY PBH §2805-L(1)] and began implementing the New York Patient Occurrence Reporting and Tracking System (NYPORTS). Under PETS, hospitals used subjective decisions before reporting an adverse event to the state, but the ‘incident reporting’ initiative of 1998 provided specific examples of adverse events that must be reported to the state. NYPORTS also simplified reporting, streamlined the coding, which was based upon UB-92 Hospital administrative databases, and coordinated it with other reporting systems to reduce duplication. Perhaps most importantly, NYPORTS allowed hospitals to obtain feedback on their own reporting patterns and compare them with other facilities in the region and the State.
Through mid-2006, two extensive and detailed annual reports (1999 and 2000/2001) have been published along with several ‘News and Alert’ Bulletins that historically have been published 2-4 times per year. NYPORTS is also actively involved in the Root Cause Analysis and risk managment reviews at hospitals.
An audit of NYPORTS by Comptroller Alan G. Hevesi was published on September 28, 2004 [PDF], indicating that the information in NYPORTS is not complete and is not reported in a timely manner. Wide variability in reporting by hospitals suggested that persistent under-reporting was a significant issue, as evidenced by the observation that 61 (23 percent) of the 243 reporting hospitals had "occurrence reporting rates that were more than 50 percent lower than the statewide average" in both 2001 and 2002. Furthermore, the audit determined that,in many instances, the occurrences reported by the 1,350 clinics with reporting requirements . . . "were not recorded on NYPORTS, and in some instances, information about facility investigations into most-serious incidents either was not recorded, or was not fully recorded, on NYPORTS." Hospital reports constitute 99.4% of all reports in NYPORTS, according to the audit.
Subsequent heated responses from special interest groups have used this audit as ammunition to indict the DOH for its "Empty Promises" for failing to address patient safety in a meaningful way and for failing to adequately regulate hospitals and physicians accross the state [PDF]. The DOH response to the audit is included as an attachment in the audit, voicing strong disagreement with the conclusions reached in the report.
NYPORTS in 2006 receives significantly more reports of adverse events from hospitals than any other state, no doubt due to its aggressiveness in mandating reporting; however NYPORTS has not published annual reports since 2001, and feedback to the consumer public has been limited.
- • New York Patient Safety Center
In 2000, New York State passed legislation that created a web-based statewide health information system that included a Patient Safety Center within the Department of Health. As part of this initiative, publication of several consumer-related health issues were brought together at a single Department of Health website, beginning in 2001. Among these issues were newly-mandated detailed individual physician profiles, physician and hospital Cardiac surgery performance data, hospital surveys, managed care performance, NYPORTS analyses of reported ‘incidents,’ and others.
The information center has benefitted from a three-year (2001-2004) federal AHRQ grant totaling $5.4 million for the New York State Safety Improvement Demonstration Project, whose project goals included identification of the causes of preventable errors and patient injury in health care through the root cause analysis process and the development, demonstration, and evaluation of strategies for reducing errors and improving patient safety through hospital interventions.
- • Niagara Coalition Implementation of IQIs
Another component of the NY Patient Safety system resulted from a regional implementation of AHRQ's Inpatient Quality Indicators (IQIs) to provide patients/consumers with access to credible, uniform information that reflects quality. The New York State DOH has funded regional pilot projects to publish hospital quality indicators, and perhaps the most successful of these funded initiatives was developed in the western part of the state by the Niagara Health Quality Coalition (NHQC). The Niagara Coalition was established in 1996 and has strong representation of business, labor, health plans, hospitals, and physician providers. Building upon a pre-existing patient survey project (the NHQC Patient Survey Project©) and a hospital report-card profiling project started in 1998 with Automakers' and Autoworkers' participation, the NHQC collaborated with its partners and others (including the NY State Department of Health) to form the Alliance for Quality Health Care (AQHC), which annually published state-wide hospital quality report cards using the AHRQ IQIs. Niagara currently publishes these report cards with grant funding.
The reports for 25 of the 34 IQI measures are available at myhealthfinder.com website, which provides bar-graphs with confidence intervals for each of the 25 IQIs. In addition, for those users less inclined to interpret statistics, a ‘3-star’ methodologic representation of quality indicators is provided. (It awards hospitals that perform above or below 95% confidence intervals with 1 and 3 stars respectively, while all other hospitals are given 2 stars.) No opportunity for trending data yet exists. The website also provides Patient Satisfaction survey information, HMO evaluations, and links to other initiatives addressing quality performance measurement in New York. The Niagara Coalition production of state-wide data has not been incorporated or linked to the New York State Patient Safety Center, but it reflects another effort within the State of New York to quantify quality and report patient safety to the public.
1 Web publication of cardiac procedures identifying facilities only has been implemented in Massachusetts, Ohio, Rhode Island, and Virginia.
2 Chassin MR, Hannan EL, DeBuono BA. Benefits and hazards of reporting medical outcomes publicly. N Engl J Med 1996;334:394-8. – [PDF]
3 Contrary to public health experts, a majority of surveyed cardiac surgeons in New York (62%) admitted to refusing to operate on at least one high-risk CAB patient in the prior year, primarily because of potential adverse public reporting, while simultaneously greater proportions of high-risk CABG surgical candidates were denied operative intervention. [Burack JH, Impellizzeri P,Homel P, Cunningham JN, "Public reporting of surgical mortality: a survey of New York State cardiothoracic surgeons," Ann Thor Surg, 1999(Oct); 68(4):1195-200; discussion 1201-2. – PDF] These data are similar to findings in Pennsylvania where 63% of surgeons reported being "much less willing," or "less willing," to operate on severely ill patients. [Schneider EC, Epstein AM. Influence of cardiac surgery performance reports on referral practices and access to care: a survey of cardiovascular specialists. N Engl J Med 1996;335:251-6. – PDF]
4 In addition, reports documented travel of high-risk surgical patients to out-of-state facilities lacking provider report cards for surgery [Omoigui NA, Miller DP, Brown KJ, et al. "Outmigration for coronary bypass surgery in an era of public dissemination of clinical outcomes." Circulation 1996;93:27-33. – [PDF]. This observation was not validated in a subsequent independent analysis. [Peterson ED, DeLong ER, Jollis JG, Muhlbaier LH, Mark DB. "The effects of New York's bypass surgery provider profiling on access to care and patient outcomes in the elderly." J Am Coll Cardiol 1998;32:993-9. – PDF]
At the time of the passage of the Patient Health Information and Quality Improvement Act in 2000 that created the Patient Safety Center, medical error reporting had existed in New York State for over 15 years. The currently implemented programs best represent the rationale for New York's Patient Safety and Medical Error Reporting efforts, and these goals, as stated in the New York statute that created the Patient Safety Center [NY PBH §2998-2], include:
- ◊ maximize patient safety
- ◊ reduce medical errors
- ◊ improve the quality of health care by improving systems of data reporting, collection, analysis and dissemination
- ◊ improve public access to health care information
Statutes and Administrative Rules
- • General Information
- ◊ New York Rules and Regulations (NY CRR)
New York State Code of Rules and Regulations (NY CRR) exist for each New York department, agency, entity, etc., but New York administrative rules and regulations are inconsistently available by department / agency / entity on the Internet. New York regulations are referenced by Title, NY CRR, and the section of rules, e.g., "10 NY CRR §405.8(a)." The relevant New York rules and regulations addressing Public Health are found in the Department of Health. Title 10 consists of 7 volumes (A, A-1, A-1a, A-2, B, C, and D), whereas Title 18 has 3 volumes (A, B, C).
- ◊ New York Statutes / Laws
Citation of New York law is convoluted, if not complicated, and Internet-accessibility to New York's laws is similarly not user-friendly in 2005.
The session laws of New York are entitled McKinney's Session Laws of New York. This set is a chronological compilation of New York laws, published in order of passage for a given session of the legislature. For example, the Patient Health Information and Quality Improvement Act of 2000 was introduced as SB 8127 and passed as L. 2000, c. 542, i.e., chapter 542 of the laws of 2000, the 542nd law passed by the 223rd New York Legislature in 2000. Searches by year of session laws are possible on the NY legislature website, although in early 2006, only 2005 laws were available.
The codified laws of New York are available as 90 separate groupings of Consolidated Laws and 32 groupings of Unconsolidated Laws. The New York Code is entitled McKinney's Consolidated Laws of New York Annotated.
New York statutes are cited: NY + [Code Abbreviation] + [Section]]. For example, NY PBH §2998 represents the section of ‘The Patient Health Information and Quality Improvement Act of 2000’ that was codified into section 2998 of the Public Health Code Article 29-D in Titles 2, authorizing creation of the Patient Safety Center. "PBH" is the abbreviation for the "Public Health" Code, which contains 50 Articles, each containing 2 to 11 distinct Titles, arranged from sections 1 through 5003. A list of all the title abbreviations can be found on the web at the Table of Contents of the New York legislature database.
- • Laws and Regulations Governing New York's Programs
In 1998, New York passed legislation [NY PBH §2805-L] that implemented the New York Patient Occurrence Reporting and Tracking System (NYPORTS) for the reporting of ‘incidents’. DOH regulations were promulgated for NYPORTS [10 NYCRR § 405.8(a)], and the reported ‘incidents’ were defined in 10 NYCRR § 405.8(b). The NYPORTS database began to collect ‘incidents’ / ‘patient occurrences’ [used interchangeably] in 1999.
In October 2000, Governor Pataki signed into law the Patient Health Information and Quality Improvement Act [NY PBH §§2995-2999(a)]. It called for the creation of a statewide health information system designed to collect a wide range of data on heath care providers and practitioners with the intent to make provider-specific profiles and other information available to the public on an ongoing basis. It also established a Patient Safety Center within the New York State Department of Health.
All of New York's activity on Patient Safety and Medical Errors has been available to the public at the Center for Consumer Health Care Information since 2001.
The State of New York mandates reporting of “incidents” that are defined by law [NY PBH §2805-L] with identical language in the New York Code of Rules and Regulation [CRR] for Health [10 NYCCR §405.8. Reportable incidents are defined as:
- b. The following incidents shall be reported to the department:
- (1) patients' deaths or 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;
- (2) fires in the hospital which disrupt the provision of patient care services or cause harm to patients or staff;
- (3) equipment malfunction during treatment or diagnosis of a patient which did or could have adversely affected a patient or hospital personnel;
- (4) poisoning occurring within the hospital;
- (5) strikes by hospital staff;
- (6) disasters or other emergency situations external to the hospital environment which affect hospital operations; and
- (7) termination of any services vital to the continued safe operation of the hospital or to the health and safety of its patients and personnel, including but not limited to the anticipated or actual termination of telephone, electric, gas, fuel, water, heat, air conditioning, rodent or pest control, laundry services, food or contract services.
However, it is abundantly clear in §405.8(b)(1) above that there exists alot of room for judgment as to what ‘deaths’ and what ‘impairments of bodily functions’ are not related to the natural course of illness, disease, or proper treatment. In order to deal with the ambiguity of subjective judgment, NYPORTS provides ‘interpretive guidelines’ provided in forms with predefined lists of reportable events.
A sampling of NYPORTS ‘incident’ forms are available on the S U N Y Upstate Medical University (aka University Hospital) Risk Management Functions website or from NYPORTS, as noted:
- ◊ ‘NYPORTS Includes/Excludes List’• (A list of occurrences that constitute the reportable events),
- ◊ Health Department Occurrence Tracking Form [PDF],
- ◊ Medication Occurrence Reporting Form [PDF], and
- ◊ Occurence Reporting Form [PDF]
The NYPORTS Includes/Excludes List provides the interpretation of the ‘incidents’ listed in NY PBH §2805-L that translate to “quasi”-ICD-9-CM-based NYPORTS codes for reporting to NYPORTS. [“quasi” denotes that some codes are hospital-specific and not uniformly defined across all NY hospitals.] These codes are cross-checked against the New York Statewide Planning and Research Cooperative System (SPARCS), which is the database containing information on all inpatient stays in New York State acute care hospitals. The NYPORTS codes and the SPARCS ICD-9-CM codes are compared to evaluate performance of the incident reporting. The two database systems do not always agree, and NYPORTS provides information on Selected Codes that are useful in the proper identification of ‘incidents.’
The New York Department of Health has expressed a strong sentiment of extensive under-reporting of ‘incidents’ to the NYPORTS. The efforts to standardize reporting reinforce NY Health Department attempts to minimize ambiguity in event definitions so as to fascilitate identification of patients with reportable events. What also is implicit in the NY system is that the identification of patients with reportable events is in the hands of medical coders and not in the hands of physicians or other health providers.
- • Participation in NYPORTS Adverse Event Reporting
Participation is mandatory for “hospitals.” As defined in NY PBH § 2801.1,
"Hospital means a facility or institution engaged principally in providing services by or under the supervision of a physician or, in the case of a dental clinic or dental dispensary, of a dentist, for the prevention, diagnosis or treatment of human disease, pain, injury, deformity or physical condition, including, but not limited to, a general hospital, public health center, diagnostic center, treatment center, dental clinic, dental dispensary, rehabilitation center other than a facility used solely for vocational rehabilitation, nursing home, tuberculosis hospital, chronic disease hospital, maternity hospital, lying-in-asylum, out-patient department, out-patient lodge, dispensary and a laboratory or central service facility serving one or more such institutions, but the term hospital shall not include an institution, sanitarium or other facility engaged principally in providing services for the prevention, diagnosis or treatment of mental disability and which is subject to the powers of visitation, examination, inspection and investigation of the department of mental hygiene except for those distinct parts of such a facility which provide hospital service. The provisions of this article shall not apply to a facility or institution engaged principally in providing services by or under the supervision of the bona fide members and adherents of a recognized religious organization whose teachings include reliance on spiritual means through prayer alone for healing in the practice of the religion of such organization and where services are provided in accordance with those teachings. "
"General hospital" means a hospital engaged in providing medical or medical and surgical services primarily to in-patients by or under the supervision of a physician on a twenty-four hour basis with provisions for admission or treatment of persons in need of emergency care and with an organized medical staff and nursing service, including facilities providing services relating to particular diseases, injuries, conditions or deformities. The term general hospital shall not include a residential health care facility, public health center, diagnostic center, treatment center, out-patient lodge, dispensary and laboratory or central service facility serving more than one institution."
Based on these "hospital" definitions, it is clear that there is sufficient lattitude so as to include most facilities with physician-directed or dentist-directed healthcare in the reporting requirements. These clinics might include all physicians offices and/or larger group practices. However, according a 2003 audit of NYPORTS performed by the State Comptroller, "Maintaining Information on Adverse Patient Incidents at Hospitals and Clinics, 2003-S-27" [PDF]
"An occurrence is defined as an unintended adverse and undesirable development in an individual patient's condition, such as death or impairment of bodily functions in circumstances other than those related to the natural course of illness, disease or proper treatment. Occurrences, which must be reported by a total of 263 hospitals and approximately 1,350 clinics, are classified by the Department as most serious or less serious. All occurrences classified as most serious must be investigated by the medical facility, and an investigation report identifying the cause of the occurrence must be submitted by the facility and entered onto the NYPORTS database."
There are obviously far more than 1,350 provider offices throughout New York, so it is clear that the NYSDOH does not pursue reporting from all physician-directed healthcare facilities. Although the NYSDOH expects reporting from diagnostic and treatment center clinics, It is not clear why some physician clinics qualify for reporting and why some do not.
This issue has very little relevance based on experience, since the 2003 NYPORTS audit indicated that less than 1% of all events were contributed by clinics, and there was evidence that some of the clinic data was never entered, even when it was provided to the NYSDOH offices. Noteworthy is that general hospitals enter information directly into the NYPORTS system through a statewide computer network: health clinics do not have access to this network, so they report information to DOH field offices where it is then entered into NYPORTS.
Based on the definition of "hospital", psychiatric hospitals are excluded from incidence reporting requirements.
Ambulatory surgery centers and other centers providing short-term or out-patient care are not included in the NYPORTS reporting requirement. The freestanding diagnostic and treatment centers, including ambulatory surgery centers, report a limited list of incidents to the New York State Department of Health (NYSDOH) by regulation, (e.g., patient deaths or transfers to hospitals). NYPORTS adverse event reporting does not cover long-term care (e.g., nursing homes, hospices), private medical practices, retail pharmacies, and home care.
- • Participation in Statewide Planning and Research Cooperative System (SPARCS)
All hospitals and ambulatory surgery centers are required since 1979 to provide administrative data to the SPARCS program, as authorized by Department of Health Regulations [10 NY CCR, §400.18] The Department of Health has provided a Universal Data Set specification which includes reporting codes for use with the UB-92 billing forms. These reported data are currently used by the Niagara Health Quality Coalition that has begun to provide report cards of all New York Hospitals according to AHRQ's Inpatient Quality Indicators.
- • Participation in Mandatory Cardiac Outcome Reporting
Cardiac procedure reporting is required by 45 of New York's 273 hospitals that perform either Percutaneous Coronary Interventions (PCIIs), aka angioplasties or PTCAs, or cardiac surgical procedures, including valve surgeries and coronary artery bypass procedures.
In 1974, the NYS Cardiac Advisory Committee (CAC) was formally instituted by the Commisisoner of DPH. In an effort to improve upon existing aggregate data and as a sytem for Quality Improvment, in the early 1990s this group authorized the development of the Cardiac Surgery reporting System (CSRS). The data is reported in a database format to the DOH, which checks for authenticity against SPARCS administrative data. Risk-adjustment models of mortality have been developed under the direction of the Cardiac Advisory Committee. Public reporting of 1992-1994 New York CABG surgery data began in 1996, but cardiac data back to 1989 has been evaluated by the mortality risk-adjustment model. All 37 cardiac hospitals in New York performing CABG and/or valve surgery and the 45 hospitals performing Percutaneous Coronary Angioplasties are required to report under authority of 10 NYCRR Section 405.22 (Critical care and special care services). These regulations stipulate that the CAC,
“. . . at the request of the commissioner, shall consider any matter relating to cardiac diagnostic centers [and cardiac surgical centers] and shall advise the commissioner thereon.”
These same regulations provide control of organ transplantation and burn units/centers.
Neither Voluntary or Mandatory participation of physicians in NYPORTS is mentioned in New York Statutes nor Regulations. However, it is clear the physicians are included in all NYPORTS reports. Although physicians are not included in the language of the statute [Article 28 §2805-L], the regulations of the NY DOH [Title 10, § 405.8] state that:
". . . The hospital shall give written notification within seven calendar days of the initial notification. This notification shall be submitted in a format specified by the department and shall record the nature, classification and location of the incident; medical record numbers of all patients directly affected by the incident; the full name and title of physicians and hospital staff involved in the incident as well as their license, permit, certification or registration numbers; the effect of the incident on the patient; follow-up treatments and evaluations planned; the expected completion date for the hospital's investigation and identification information required by the department."
The identification of physicians is verified in all of the NYPORTS report forms [PDF], clearly demonstrating the the NYDOH targets physicians over other licensed professionals who are not included in these report forms. Therefore, whether willing or not, physician participation is manifest in NYPORTS as a focus of every report and investigation.
The Patient Health Information and Quality Improvement Act Article 29-D, Title 1 §2995(a) called for the creation of Physician Profiles. Physicians were mandated to provide reports and provide extensive and complete professional data designed for web reporting. The extensive list of mandated information is provided in the statute.
Also note that New York is one of the leaders in the country in disciplining of physicians.
The States with the 5 largest increases in physician disciplinary actions are:
Source: Federation of State Medical Boards. State medical board reforms partially account for the increases in Texas and Florida; Florida's numbers reflect MDs only. Percentages are rounded.
Roles of State Agencies
The New York Department of Health manages several initiatives under the aegis of the Center for Consumer Health Care Information, which went live in August 2001. In December 2001, the NY State Health Department was awarded a four-year federal grant from AHRQ totaling $5.4 million to support its ongoing hospital patient safety improvement efforts, known as the New York State Safety Improvement Demonstration Project (Grant Number: U18 HS11880). Support extended from September 30, 2001 through August 31, 2005.
- • New York Patient Occurence And Tracking System (NYPORTS)
NYPORTS is an adverse event reporting system implemented pursuant to New York State Public Health Law (Article 28) Section 2805-l, Incident Reporting. As detailed in the Annual Report 1999, the NYPORTS system was developed by a statewide workgroup of industry experts and multiple actively-practicing health care professionals and quality assurance and risk management professionals. The Department participated on the group and provided the necessary support to carry out development and implementation activities. The statewide hospital association and its regional affiliates also participated in development and implementation in support of the group's activities. A statewide roll-out of the system occurred in April 1998.
- • Licensing Agency investigations – Department of Health
The New York State Department of Health (DOH) is the regulatory agency with licensure and regulatory control over medical facilities, and it plays a significant supportive role in support of the NYPORTS and Cardiac Surgery Reporting System (CSRS) programs, which publish annual risk-adjusted outcomes for cardiac surgery and percutaneous coronary interventions (PCIs).
The regulatory tenor of the New York program is established by DOH Commissioner Antonia C. Novello, who on occasion has issued threats of severe sanctions to healthcare facilities for failure to report to NYPORTS. Examples include a February 13, 2001 directive to Hospital administrators and an excerpt appearing in peer review [Health Affairs, p. 287, May/June 2001] in which she indicated that
"For those hospitals that have ignored these critical reporting requirements, we will identify you, single you out and sanction you in a public forum."
The DOH has a history of active intervention in response to reports of perceived poor performance in healthcare. [Chassin MR, "Achieving And Sustaining Improved Quality: Lessons From New York State And Cardiac Surgery," (July/August 2002) 21 (2): 40-51. [PDF]
- • Statewide Planning and Research Cooperative System (SPARCS)
SPARCS is a comprehensive patient data system established in 1979 as a result of cooperation between the health care industry and government. In April 1983 and June 1985, the State Hospital Review and Planning Council adopted additional regulations regarding the reporting of ambulatory surgery data to the New York State Department of Health. The authority for SPARCS is provided in Section 400.18 of Title 10 (Health) of the Official Compilation of Codes, Rules, and Regulations of the State of New York (NYCRR), with additional specifications for Outpatient Ambulatory Surgery in Section 755.10 and Ambulatory Surgery Definition in Section 755.1. The regulations require that inpatient data be submitted by all Article 28 facilities certified for inpatient and that outpatient data be submitted by all hospital-based ambulatory surgery services and all other facilities providing ambulatory surgery services. All data has to be submitted according to a designated format and schedule. In April 1993, a Universal Data Set task force released a new UDS specification which included reporting codes for use with the UB-92 paper form and a new electronic format. The resulting system streamlined multiple data submission formats into a single format, removing redundant reporting requirements for hospitals and other health care facilities
The SPARCS data is currently used by the Niagara Health Quality Coalition (NHQC) for the outcomes of the AHRQ Inpatient Quality Indicators that provides hospital comparisons in a report-card format for 25 of the 34 identified Inpatient Quality Indicators. These IQIs are published on the website for the Alliance for Quality Health Care (AQHC).
Operational Features of NYPORTS Program
New York provides timelines by which reporting shall be done. These include:
- • Serious occurrences: 24 hours/one business day: (includes codes 108–110, 911–913, 915–923, 938, 961–963).
- • Other occurrences: 24 hours/one business day: (codes 901, 902, 914, 931–935, and 939), fires or external disasters, strikes, and unscheduled termination of services vital to the continued safe operation of the facility or safety of its patients and personnel).
- • Less serious occurrences: Within 30 days (codes 201–854): adverse events with less serious patient outcomes, such as complications of surgery, burns, and falls.
NYPORTS requires that a Root Cause Analysis (RCA), as outlined in Medical Facilities Participation be performed. The action plans are a required component of all serious occurrences reports and/or may be requested by the DOH. The RCA must be completed within 30 days and reported electronically to NYPORTS .
Transparency – Provider-identified Information
The State of New York Department of Health does not provide any facility-identified information as part of the NYPORTS adverse event reporting program, although the 1999 NYPORTS report did identify the facilities with the lowest quartile of completeness of NYPORTS reported data. The names and licenses of all physicians associated with adverse envents are tracked as part of the NYPORTS program, although these physicians are not publicly identified.
New York publishes two sources for provider-identified information. The Cardiac Surgery Reporting System (CSRS) has provided report cards on the Internet for heart surgeries dating to 1992 and for percutaneous coronary interventions (PCIs) since 1995. Risk-adjusted provider-identified cardiac outcomes performance data are provided for all cardiac physicians and heart centers performing cardiac surgery and/or PCIs.
The second source of facility-identified information is provided in the published Inpatient Quality Indicators that are collected and published on the Internet by Niagara Health Quality Coalition (NHQC). The Niagara Coalition was established in 1996 and has strong representation of business, labor, health plans, hospitals, and physician providers, and it has collaborated with the NY State Department of Health to publish annual state-wide hospital quality AHRQ IQIs report cards. Niagara currently publishes these report cards with grant funding. Reports for 25 of the 34 IQI measures are available at the myhealthfinder.com website.
Punitive Measures And Sanctions
- • Authority for Punitive Measures against Health Professionals
- • Authority for Punitive Measures against Facilities
Antonia C. Novello, M.D., M.P.H., Dr.P.H., the Commissioner of the New York State Health Department, identified the under-reporting as a significant problem in a February 13, 2001 directive to Hospital administrators, stating:
“The Department does want to work cooperatively with hospitals. However, we cannot tolerate continued under-reporting. The Department will impose sanctions and fines against any hospital that is not complying with the NYPORTS reporting requirements. In addition, as we view the identification of adverse events as a key component of a hospital's quality improvement process, as well as the overall operation of the hospital, NYPORTS' compliance will be considered in relation to other hospital matters that come before the Department.”
The Commissioner, in a separate press release following the release of the Annual Report 1999 in 2001, used even stronger warnings, stating:
“For those hospitals that have ignored these critical reporting requirements, we will identify you, single you out and sanction you in a public forum.” [Health Affairs, p. 287, May/June 2001]
This rhetoric emphasizes, especially relative to other states, that New York is a state that is dedicated to addressing the problem of medical errors/adverse events with the full might of regulation and the threat of licensure sanctions that a regulatory authority provides.
- • Penalty for Late Filing of Report
In a September 28, 2004 press release acknowledging an audit of NYPORTS by Comptroller Alan G. Helvesi [PDF], the DOH indicated that
"A hospital or clinic that fails to comply with reporting requirements can be fined as much as $2,000 per violation. DOH also issues citations for noncompliance, which do not carry a fine but require facilities to submit a written corrective action plan. However, auditors determined that DOH did not have formal criteria to determine when hospitals and clinics should be fined or cited for failure to report incidents, and that different DOH field offices around the State responded differently to reporting violations. Auditors found that, during the 29-month period covered in the audit, only two facilities were fined and only 20 citations were issued."
Funding of Event Reporting Program
The state of New York, which established the New York Patient Occurrence Reporting and Tracking System (NYPORTS) reporting system in 1998, reports that their Web-based system is run using existing staff, required an initial investment of $160,000, and needs $20,000 in maintenance per year (per Fred Heigel, AHRQ conference call series on medical error, May 24, 2000). This represents an unusual example of a state able to implement a major initiative in an extremely cost-effective way.
In consideration of much higher costs in other less populace states for the entire patient safety projects (e.g., $2.5M first-year investment and $2.5 Million/year maintenance as in Pennsylvania, 50% of ~$1.5 Million annual budget for Maryland's Patient Safety Center (MPSC), and $500,000/year like Oregon), one must assume that these costs address only software-based issues and do incorporate computer time spent in doing analysis and developing reports.
Other Factors and Organizations
- • Niagara Health Quality Coalition (NHQC)
The NHQC with funding from the New York Department of Health, has developed state-wide hospital report cards for Inpatient Quality Indicators (IQIs) that were released by the AHRQ in 2002. In early 2006, New York joins the Texas Health Care Information Council (THCIC), the public-private Colorado Hospital Quality Initiative, and the Health Web of Maine as the only efforts providing state-level report-card analyses of the IQIs.
The NHQC was established in 1996 following the loss of western New York's state Health Systems Agency funding, and it was builit upon collaboration from hospitals, health plans, consumer groups and others under the leadership of the Buffalo Niagara Partnership that represents over 3,300 businesses and 200,000 employees. Its governing board of directors is comprised mostly of employers, providers, insurers, and some physicians in Western New York.
The NHQC created the Alliance for Quality Health Care in collaboration with the New York State Department of Health and its partners in the Buffalo Niagara Partnership and other hospitals, health plans, and insurors. The Alliance for Quality Health Care (AQHC) has been the support organization from which this information is distributed to the State of New York.
The reports are available at the myhealthfinder.com website.
Reported Performance / Experience
The NYPORTS has published two ‘annual ’ reports, the Annual Report 1999 was released in 2001 and the Annual Report 2000/2001 was released in 2003. Subsequent reports have not been released to the public through mid-2006.
NYPORTS also publishes a quarterly News and Alert bulletin, as shown in the example. The News and Alert Bulletins are not publicly available/distributed on the website, as is done in Pennsylvania.
As demonstrated in the table below, the number of reports submitted to NYPORTS increased from 16,939 cases in 1999 to 28,689 in 2001. Subsequent reports have not been issue by NYPORTS through mid-2006. The New York discharge numbers in SPARCS confirms 1999, 2000, and 2001 hospital utilization information, which is used in the table below to provide calculations of events per 100,000 discharges and events per 100,000 patient-days. It should be noted that definitions for several of the NYPORTS codes changed between 1999 and 2001. Data in the 2001 report demonstrated some regional variations with reporting.
||Events per 100,000 discharges
||Events per 100,000 patient-days
Comparative hospital reportable event performance data for the 11 states that publish any aggregate state data on reportable events are available. New York and Tennessee report ‘adverse events’ using Occurrence Codes based on International Classification of Diseases, 9th Edition, Clinical Modification (ICD-9-CM) taxonomy of administrative data. However, NYPORTS measures 54 specified events compared to Tennessee's 45.
Two states (Connecticut, Minnesota) report NQF-events. Four states (Maine, Pennsylvania, Utah, Washington) utilize varying numbers and versions of JCAHO's ‘voluntary reportable sentinel events’. Florida, Massachusetts, and Colorado utilize unique state reportable event definitions.
New York's population-adjusted occurrence reporting rate is signficantly larger than that of other states. Except for Pennsylvania, whose 2005 reported serious events were 40% of population-adjusted 2001 adverse events reported by New York, the occurrence rates for states reporting NQF events and JCAHO events are much lower than the ‘adverse events’ published by New York.
While under-reporting obviously occurs in several states, the major significant message to be garnered from these comparative data is that there is lack of standardization of reported events and their definitions across States.