NYPORTS - The New York Patient Occurrence and Tracking System - Annual Report 1999

George Pataki
Governor
New York State

Antonia C. Novello, M.D., M.P.H., Dr. P.H.
Commissioner
New York State Health Department
February 2001

Table of Contents

Executive Summary

Governor George E. Pataki and Antonia C. Novello, M.D., M.P.H., Dr. P.H., Commissioner of Health, have affirmed that the most important responsibility of the Department and healthcare community is to assure the highest quality of care to patients. "Achieving this goal takes a dedication to quality assurance and a commitment to realizing that when mistakes happen, they should be identified, reported, analyzed and corrected so that they never happen again."

The New York Patient Occurrence Reporting and Tracking System (NYPORTS) is an adverse event reporting system implemented pursuant to New York State Public Health Law Section 2805-l, Incident Reporting. For the purpose of NYPORTS reporting, an occurrence is an unintended adverse and undesirable development in an individual patient's condition occurring in a hospital. Most occurrences reported are meant to be tracked and trended as groups and are reported on a short form. More serious occurrences defined as patient 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 are investigated individually and require the hospital to conduct a root cause analysis. All adverse events are not medical errors and should not be considered as such. NYPORTS does collect reports on medical errors, but the volume of medical errors in the system is a very small percentage compared to the overall volume of reporting. It should be noted that New York State Public Health Law Section 2805-m Confidentiality prevents disclosure of incident reports under the Freedom of Information Law.

New York State has had a long history of requiring hospitals to report and initiate actions based on adverse events occurring in their facilities. Since October 1, 1985, a mandatory incident reporting system has been in place in New York State. The incident reporting system was initially a paper reporting system; later, an email-based system was developed. Neither of these systems allowed feedback to the hospitals which limited the use of the data for quality improvement. At the direction of Governor Pataki, through a regulatory reform effort, NYPORTS was created to simplify reporting, streamline the coding, coordinate with other reporting systems to reduce duplication, and most importantly, allow hospitals to obtain feedback on their own reporting patterns and compare them with other facilities in the region and the State. Despite these significant improvements, not all hospitals are complying with statutory reporting requirements.

The development of the electronic internet-based system began in 1995, utilizing a statewide workgroup of industry experts and a consumer representative. It was extensively field tested and refined and was implemented on a statewide basis in April 1998. The new system made it easier for hospitals to report adverse incidents, as required by law, and to obtain comparative data. The under-reporting noted in this report appears to represent deliberate failure to report adverse incidents by certain facilities.

With the issuance of the Institute of Medicine's (IOM) Report, To Err is Human, in late 1999 national attention has been focused on the NYPORTS system. As an adverse event reporting system, NYPORTS collects data regarding a wide range of occurrences. Medical errors, which are the focus of the IOM report, represent a relatively small proportion of events reported into NYPORTS. Significantly though, NYPORTS therefore provides hospitals with a tool to reduce medical errors. Thus, through proper usage of the NYPORTS system and process hospitals are aided in improving the safety of patients.

This report is the first public report to be issued from the NYPORTS system. It gives an overview of the background for the system and includes some initial data analyses. It is imperative for all hospitals to report completely into NYPORTS. If data are not reported completely and accurately, it is difficult, if not impossible, to estimate the occurrence frequency or the occurrence rate (number of occurrences/ number of admissions or number of occurrences/number of procedures of a given type) for various kinds of patients. This impedes the determination of which occurrence codes should have the highest priority for quality improvement efforts and exacerbates efforts to measure improvement that has occurred as a result of information derived from NYPORTS. Unfortunately, an analysis of 1999 data includes significant underreporting, particularly by hospitals in the New York City Metropolitan area. There are large regional variations in reporting – three times greater in some parts of the State than others – that can only be explained by hospital underreporting. A comparative test conducted by the Department on one type of occurrence (deaths occurring within 48 hours of surgery) showed a statewide reporting compliance rate of only 16 percent. This is unacceptable and the Department is committed to taking action to improve hospital reporting.

Commissioner Novello notified hospitals in February 2000 that, while the Department is ready to assist hospitals in meeting statutory reporting requirements, it also "stands ready to enforce requirements, and will publicly sanction those facilities that fail to promptly and accurately report incidents."

Hospitals with reporting rates significantly below what is anticipated, despite the Department's efforts to obtain compliance are listed in this report. In the future, the Department plans to undertake further analysis of the NYPORTS database and to provide the results of those analyses to the public.

Introduction and Background

The New York Patient Occurrence Reporting and Tracking System (NYPORTS) is an adverse event reporting system implemented pursuant to New York State Public Health Law Section 2805-l, Incident Reporting. For the purpose of NYPORTS reporting, an occurrence is an unintended adverse and undesirable development in an individual patient's condition occurring in a hospital. Most occurrences reported are meant to be tracked and trended as groups and are reported on a short form. More serious occurrences defined as patient 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 are investigated individually and require the hospital to conduct a Root Cause Analysis. All adverse events are not medical errors and should not be considered as such. NYPORTS does collect reports on medical errors, but the volume of medical errors in the system is a very small percentage compared to the overall volume of reporting. It should be noted that New York State Public Health Law Section 2805-m Confidentiality prevents disclosure of incident reports under the Freedom of Information Law.

In this first report on the NYPORTS system, the Department will provide some background information regarding the development and implementation of NYPORTS as well as initial analysis of data collected during 1999, the first full year of data in the system. We will also provide some background information regarding activities undertaken to assure complete reporting by hospitals into this mandatory system and present a description of future plans. Future plans include further improvement of the system, additional training and support, further more in-depth analyses and a range of activities designed to improve the quality of care and safety of patients in hospitals in New York State. Sanctions will be imposed on those hospitals that continue to fail to report as required.

New York State has had a long history of requiring hospitals to report and initiate actions based on adverse events occurring in their facilities. Since October 1, 1985, a mandatory incident reporting system has been in place in New York State. The incident reporting system was initially a paper reporting system; later, an email-based system was developed. Neither of these systems allowed feedback to the hospitals which limited the use of the data for quality improvement. At the direction of Governor Pataki, through a regulatory reform effort, NYPORTS was created to simplify reporting, streamline the coding, coordinate with other reporting systems to reduce duplication, and most importantly, allow hospitals to obtain feedback on their own reporting patterns and compare them with other facilities in the region and the State. Despite these significant improvements, not all hospitals are complying with statutory reporting requirements.

The development of the electronic internet-based system began in 1995, utilizing a statewide workgroup of industry experts and a consumer representative. The workgroup included a practicing surgeon, a practicing anesthesiologist, facility medical directors, internal medicine practitioners, nursing, quality assurance, and risk management professionals. The chair is the chief quality officer at an academic medical center. 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. The resulting system is based on objective criteria and information and provides hospitals with clear definitions of what must be reported. It was extensively field tested and refined and was implemented on a statewide basis in April 1998. The new system made it easier for hospitals to report adverse incidents, as required by law, and to obtain comparative data. The underreporting noted in this report appears to represent deliberate failure to report adverse incidents by certain facilities.

During the development of the system, there were three in-depth field tests. For each phase of testing, feedback and input from facilities involved was incorporated, further improving the system. After extensive field testing and system refinement, the NYPORTS reporting system was implemented on a statewide basis on April 1, 1998. Refinements and improvements in the system are an on-going activity and will continue.

To facilitate reporting by hospitals, a computer based electronic reporting system was created. The system is an Internet based system with all the required security measures included in its construct. Hospitals that report NYPORTS occurrences can query the database to compare their experience with reported events to the statewide, regional or peer group experience. While the identity of individual hospitals in the comparative groups is not disclosed, the comparative database is a useful tool in support of hospital quality improvement activities. Additionally, hospitals can use the system to create comparative reports in a variety of graphic formats.

The Department believes that before improvements can be made, there must be an awareness and recognition of events by facilities (i.e., before one can fix a problem, it must be identified.) For events with significant negative or lasting impact on patients, facilities must conduct internal investigations into the system of care. These investigations, known as root cause analyses, must identify root causes for such events, enact systems improvements and build in back-up, "fail-safe" procedures to prevent reoccurrence. Hospitals are then required to monitor the implementation and effectiveness of these system improvements through quality assurance activities to assure that they function as intended. For events of lesser patient consequence, hospitals are expected to collect and aggregate data regarding these occurrences to identify system weaknesses before more consequential events occur. Through access to a comparative database, a hospital can identify through its own reporting circumstances where the hospital stands by comparison. This helps to identify the system of care upon which the hospital should focus its attention and efforts and to monitor the effectiveness of improvement efforts. By completing this process, the number of adverse events will be reduced and the quality of care and the level of safety for hospital patients will improve. The Department oversees hospital compliance with NYPORTS responsibilities to ensure the process is fulfilled. The Department also directly investigates a portion of the most significant occurrences. Further, through overall NYPORTS system management and analysis, the Department identifies areas of significant concern noted by individual hospitals and provides alerts to all hospitals in the State. It is expected that hospitals will institute measures, known as "best practices," to prevent or reduce these occurrences in their own facilities. By sharing such information with all hospitals in the State, the Department is trying to bring about industry-wide improvement.

Completeness of Reporting in NYPORTS

One of the concerns about the full usefulness of NYPORTS as a tool to improve the quality of care in the State is the completeness of reporting. If data are not reported completely and accurately, it is difficult, if not impossible, to estimate the statewide occurrence frequency or the occurrence rate (number of occurrences/ number of discharges or number of occurrences/number of procedures of a given type) for various kinds of patients. This impedes the determination of which occurrence codes should have the highest priority for quality improvement efforts and exacerbates efforts to measure improvement that has occurred as a result of information derived from NYPORTS.

Despite efforts to improve the completeness of reporting in NYPORTS, an analysis of 1999 data continues to show significant underreporting of reportable occurrences. This assessment is based upon 1) wide regional variations; 2) a check on reporting accuracy comparing NYPORTS data with discharge data; and 3) low individual hospital reporting rates that can only be explained by consistent underreporting.

1) Examination of Regional Variation in Reporting NYPORTS Data

In order to equitably assess reporting frequency by region, the number of cases reported needs to be scaled by the "at risk" population of patients in the region. Some possibilities for denominators to use are the number of acute care patients (discharges), the number of patient days, and the population of the region. The first of these, number of discharges, has been used as a scaling factor in the table below, which presents the number of acute care discharges, number of NYPORTS cases submitted, and number of NYPORTS cases submitted per 100,000 discharges by region of the state in 1999. Note that the table reflects cases that were entered into the NYPORTS system as of September 15, 2000. The regions are defined as Western New York, Finger Lakes, Central New York, Northeastern New York, Hudson Valley, Long Island, and New York City. The counties comprising these regions are listed in Appendix 5.

NYPORTS Cases Submitted/100,000 Discharges by Region: 1999
Region 1999 Acute Care Discharges All 1999
NYPORTS Cases
NYPORTS
Cases/100,000 Discharges
       
Western New York 190,671 1,390 729
Finger Lakes 139,455 1,536 1,101
Central New York 201,851 2,153 1,067
Northeastern New York 163,877 1,616 986
Hudson Valley 254,657 1,744 685
Long Island 339,916 2,417 711
New York City 1,131,582 4,271 377
       
TOTAL 2,422,009 15,127 625

As indicated in Table 1, a total of 15,127 NYPORTS cases were submitted electronically in 1999 for all of the various occurrence codes in NYPORTS, and a total of 2,422,009 patients were discharged from New York State acute care hospitals in 1999. The number of NYPORTS cases submitted per 100,000 discharges in the State was 625.

The number of NYPORTS cases submitted per 100,000 discharges varied by a factor of almost 3 (2.92) from 1,101 in Finger Lakes to 377 in New York City. Three regions (Finger Lakes, Central New York, and Northeastern New York) had similar reporting rates (ranging from 986 reported occurrences per 100,000 discharges in Northeastern New York to 1,101 reported occurrences per 100,000 discharges in Finger Lakes). Three other regions (Western New York, Long Island, and Hudson Valley) had similar reporting rates, ranging from 685 occurrences per 100,00 discharges in Hudson Valley to 729 occurrences per 100,000 discharges in Western New York. New York City reported far fewer occurrences per 100,000 discharges (377), with only as many per 100,000 discharges as the next lowest reporter (Hudson Valley).

These variations in reporting frequencies could be a result of variety of factors, including quality of care, types of hospital admissions and procedures performed, and accuracy and completeness of reporting. It is the Department's view that differences in types of patients and in treatments performed should have a minor impact on the variations because the sizes of the regions used to calculate the rates were large enough to level major differences in types of patients and treatments. Furthermore, it seems unlikely that

there would be large differences among regions in the overall quality of care provided. This leaves reporting accuracy/completeness as the most likely candidate for the bulk of the differences in Table 1. Also, since it is doubtful that there is widespread reporting of occurrences that did not take place, the variation is most likely caused by underreporting (or at least more underreporting) in the regions with the lowest reporting rates.

2) Matching NYPORTS 605 Occurrences with SPARCS Data

Whenever possible, it is preferable to check on reporting accuracy by comparing NYPORTS data with data from another database that reports the same type of information. This is especially desirable in view of the large regional differences in NYPORTS cases reported per 100,000 discharges, as noted above.

Although there is no such database for most types of NYPORTS occurrence codes, the New York State Department of Health does have an acute care discharge database, the Statewide Planning and Research Cooperative System (SPARCS), that can be used for some comparisons. SPARCS contains all acute care discharges and contains up to 15 diagnoses and 15 procedures performed, as well as the date of the procedures, the discharge disposition, and the date of discharge.

There is one NYPORTS occurrence code that can be matched reasonably well with SPARCS data: occurrence code 605, which specifies that a NYPORTS record be submitted for each patient dying within 48 hours of an "operating room procedure", regardless of whether the death was expected. There are two reasons why SPARCS and NYPORTS will not yield exactly the same set of patients when an attempt is made to identify all patients discharged in a given time period. First, SPARCS identifies times in days, but not in hours. For example, SPARCS can be used to identify patients who died the same day, one day, or two days after a procedure was performed, but not 48 hours after a procedure was performed.

Another reason why SPARCS cannot precisely identify which patients should be reported in NYPORTS under code 605 is that the current NYPORTS definition of an operating room procedure is hospital-specific, and many procedures are performed in an operating room in some hospitals and are not performed in an operating room in other hospitals. Thus, the best that could be done in SPARCS (which does not contain hospital-specific information regarding the site in which various procedures are performed) to simulate the NYPORTS definition is to identify a common set of procedures that are customarily performed in an operating room. This can be done by choosing those procedures that are labeled as "valid operating room procedures" by the standard ICD-9-CM coding book that is used to classify procedures in SPARCS.

Process for Measuring Underreporting of 605 Occurrences

In light of the differences between NYPORTS and SPARCS mentioned above, the following process was used to target a set of discharges reported in SPARCS that should have been reported in NYPORTS:

  1. For 1999, all SPARCS cases in which the patient died within one day (the same day or the day after) of what is designated as a "valid operating room procedure" in the 1999 ICD-9-CM manual (4th edition) were identified.
  2. The subset of cases in (1) that were not entered into NYPORTS by September 15, 2000, were identified. Hospitals were requested to explain why the case did not qualify for NYPORTS. Reasons for exclusion were reviewed by the Department and exclusions were allowed for reasons that had merit. The most common reason for which an exclusion was allowed was that the procedure was not an operating room procedure in that hospital (i.e., it was performed in a location other than the operating room).
  3. The total number of deaths identified in SPARCS as deaths on the same day or the day after an operating room procedure was decreased by the number of upheld requests for exclusions. The remaining cases were regarded as cases that should have been entered in NYPORTS as 605 occurrence codes (deaths within 48 hours of an operating room procedure).

As has been noted, the total number of SPARCS-identified NYPORTS is a subset of all 605 occurrences that should be reported in NYPORTS. This is because some deaths within 48 hours of an operating room procedure occurred two calendar days after the procedure was performed. However, choosing deaths that occurred the same day or the day after an operating room procedure in SPARCS (which resulted in an undercount of reportable NYPORTS 605 occurrences) was regarded as preferable to choosing deaths that occurred either the same day or within two days of an operating procedure in SPARCS, which would have resulted in an overstatement of reportable NYPORTS cases).

Results of Process

Using the methods described above, a total of 1,420 SPARCS cases were identified among 1999 discharges as being potentially reportable under NYPORTS occurrence code 605. After excluding cases based on upheld challenges by hospitals, the total number of reportable 605 occurrences that were identified in SPARCS was reduced to 1,030 cases. Of these patients, a total of 167 (16.2%) were reported by hospitals to NYPORTS as of September 15, 2000.

One explanation for this low reporting rate is that there were misunderstandings regarding the definition of a 605 code. The most common reasons for not reporting cases were that the death was expected or that the case was reported under another code. These are not valid reasons because deaths are supposed to be reported under 605 regardless of whether they are expected, and cases that qualify for another occurrence code are also supposed to be reported as 605 occurrences. The definition (any death within 48 hours of an operating room procedure) seems to be quite unambiguous, especially if each hospital's definition of an operating room procedure is honored. Another more likely explanation is that many hospitals may have not instituted an effective process for identification and reporting occurrences. Although this problem may be limited to occurrence code 605, this seems unlikely because 605 is more objective than most other occurrence codes.

3) Hospitals with the Lowest NYPORTS Reporting Rates

The following 25 hospitals had the lowest NYPORTS occurrence reporting rates in 1999 (defined as number of occurrences reported in NYPORTS in 1999 divided by the total number of (SPARCS) discharges in 1999. Note again that there were 15,127 NYPORTS cases reported and 2,422,009 acute care discharges in 1999, yielding an average of 62.5 NYPORTS cases per 10,000 acute care discharges on average per hospital.

Information By Hospital (Discharges >1,000),

Sorted by Number of Unduplicated NYPORTS Occurrences/10,000 SPARCS Discharges

Name of Hospital NYPORTS Occurrences/
10,000 Discharges
Kingsbrook Jewish Medical Center 0.00
St. Clare's Hospital and Health Center 0.00
Mount Vernon Hospital 0.00
Island Medical Center 0.00
Ellenville Community Hospital 0.00
Staten Island University Hospital-North and South 1.80
Hospital for Joint Diseases at Orthopaedic Institute, Inc. 4.07
Wyckoff Heights Medical Center 4.21
Bertrand Chaffee Hospital 5.13
Woodhull Medical & Mental Health Center 8.91
University Hospital of Brooklyn 9.32
Queens Hospital Center 9.91
Brunswick Hospital Center, Inc. 10.29
Montefiore Medical Center at Moses and Weiler Divisions 10.64
North General Hospital 10.64
Doctors Hospital of Staten Island, Inc. 11.41
Kings County Hospital Center 12.27
Jacobi Medical Center 12.57
Sisters of Charity Medical Center at Bayley Seton and St. Vincent's 12.94
Interfaith Medical Center, Jewish and St. John's Divisions 13.50
St. Barnabas Hospital 13.55
Bellevue Hospital Center 13.84
Jamaica Hospital Medical Center 14.35
Metropolitan Hospital Center 14.69
Mary McClellan Hospital 14.72

Benefits of the NYPORTS System

Although NYPORTS has only been in existence a short time and while there are concerns with reporting consistency, there have been many instances where the data system has been responsible for a quality of care improvement in a participating hospital. The following scenarios illustrate just a few of these initiatives.

  • One hospital used NYPORTS to produce a listing of the most common occurrence codes which its hospital reported and a similar report for all of the hospitals in its region. These data were reviewed by a medical director in a hospital who noticed that his hospital had a higher incidence of new Deep Vein Thromboses (DVTs) than was usual in the region. He thought this peculiar since he had participated in the development of a DVT protocol that was to have reduced the problem in his hospital. Upon further investigation, he discovered that the protocol, although developed, had never been implemented hospital-wide. He revived the initiative and made sure that it became the official policy in the hospital. He will be repeating his examination of the data in the future with the hope that he will see a decrease of new DVTs in his hospital.
  • At a recent regional meeting, local NYPORTS data were reviewed and compared to statewide data. Complications arising from tonsillectomy/adenoidectomy surgery were reviewed due to a higher than statewide occurrence rate in their region. It was noted that post-operative bleeding was identified as the most frequent complication. A review of individual cases revealed that post-surgical diet was a critical factor in reducing the risk of post-op bleeds. This led to re-enforcing to local hospitals the message that the importance of dietary restrictions should be re-emphasized.
  • One region recently collected information from NYPORTS on retained foreign bodies. A review of the statewide experience was conducted and published in the NYPORTS newsletter. The items typically left behind (sponges, needles) were listed and some of the risk reduction strategies shared. Hospitals' strategies stressed the need for x-rays when an incorrect count is discovered but also identified other factors that contribute such as staff changes, distractions such as cell phones, and lack of standardized trays.
  • At a recent workshop for pharmacists, an actual NYPORTS case was reviewed. It involved a patient who received ten times the dosage of a chemotherapeutic agent. The math involved with determining the dose was checked and rechecked but the actual error, the original dosage prescribed, was not uncovered. Recommendations for system improvements included dosage protocols to be available for doctor/nurse/pharmacists to check before administration and the importance of counter signatures.
  • Although instances of wrong-sided surgeries have received much appropriate media attention, it was revealed from a review of incorrect procedures or treatments in NYPORTS that the problem extends beyond surgery to minimally invasive procedures and treatments. Insertion of chest tubes on the wrong side was identified in several cases. It was noted that these errors resulted from a failure to compare x-rays with previous studies or re-examine the patient at bedside before placement. This led Commissioner Novello to establish a panel of experts to make recommendations on pre-operative procedures to prevent recurrence. The report on Pre-Operative Protocols was released in January 2001.
  • A hospital in reviewing its own experience over time identified an increase in a specific reporting category. As a result, it conducted a detailed root cause analysis and implemented system changes intended to prevent recurrence. It is presently reviewing the effectiveness of those system improvements.

From our initial review of data, we have identified some "best practices" and have shared them statewide (as we have done throughout the history of incident reporting). In that context, we issue a quarterly news letter to facilities, the NYPORTS News and Alert, which provides systems updates and best practices information. Each of these efforts is undertaken in support of improving quality.

Future NYPORTS Initiatives

As stated earlier, the primary goal of NYPORTS is to improve the overall quality of hospital care in the State by identifying types of occurrences and by developing methods for reducing those occurrences. In the interest of achieving this over-arching goal, the following initiatives will be undertaken next:

  • The preceding narrative indicates that there is an underreporting problem for 605 occurrences, and suggests that there is probably an underreporting problem for other occurrence codes as well. Existing databases will be used to assess completeness of reporting for occurrence codes other than 605. We expect that the 605 study described above will result in substantially improved processes among hospitals for identifying other occurrence codes, and that in the future the degree of underreporting for 605 and for other codes will not be as extreme as that reported for the 605 code in 1999. However, completeness of reporting is important for all occurrence codes, and concerted efforts will be made to test reporting completeness for other codes.
  • In addition to improving reporting completeness, it is also essential that hospitals collaboratively engage in efforts to reduce the rates for all types of occurrences. The Department of Health will encourage groups of hospitals and regions of the State to collaborate in attempts to address specific types of occurrences. These efforts will involve: 1) the identification of occurrence codes that are of high priority based on the frequency with which they occur and the relative severity of the outcomes associated with them; 2) the exploration of strategies to ensure complete reporting of the chosen occurrence codes; 3) the establishment of new processes of care to reduce the frequency of the occurrences and to minimize the severity of the outcome associated with the occurrences; and 4) proposals for documenting and quantifying the outcome improvements resulting from the processes of care that were implemented.
  • The Department will continue to monitor reporting compliance through overall hospital surveillance activities and appropriate enforcement actions and sanctions will be taken for continued failure to report as required. These hospitals will continue to be publicly identified.
  • The Department will continue to improve the NYPORTS system through further refinement of definitions and improvement in reporting processes.
  • The Department will provide additional ongoing training to hospitals regarding proper implementation of the NYPORTS system including how to conduct a proper thorough and credible root cause analysis in their internal investigation.
  • The Department will continue to identify "best practices" and provide them to all hospitals and will continue to issue alerts.
  • Analysis of data by the State University of New York School of Public Health will continue and broaden in depth and scope.

Appendix 1

Public Health Law
Article 28 HOSPITALS
S 2805-l.

S2805-l. Incident reporting
  1. All hospitals, as defined in subdivision ten of section twenty-eight hundred one of this article, shall be required to report incidents described by subdivision two of this section to the department in a manner and within time periods as may be specified by regulation of the department.
  2. 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.
  3. The hospital shall conduct an investigation of incidents described in paragraphs (a) through (d) of subdivision two of this section and shall inform the department of the expected completion date of the investigation. The hospital shall provide to the department a copy of the investigation report within twenty-four hours of completion. Nothing herein shall limit the authority of the department to conduct an investigation of incidents occurring in general hospitals.
  4. The Commissioner shall make, adopt, promulgate and enforce such rules and regulations, as he may deem appropriate to effectuate the purposes of this section.

S 2805-m. Confidentiality.

  1. The information required to be collected and maintained pursuant to sections twenty-eight hundred five-j and twenty-eight hundred five-k of this article, reports required to be submitted pursuant to section twenty-eight hundred five-l of this article and any incident reporting requirements imposed upon diagnostic and treatment centers pursuant to the provisions of this chapter shall be kept confidential and shall not be released except to the department or pursuant to subdivision four of section twenty-eight hundred five-k of this article.
  2. Notwithstanding any other provisions of law, none of the records, documentation or committee actions or records required pursuant to sections twenty-eight hundred five-j and twenty-eight hundred five-k of this article, the reports required pursuant to section twenty-eight hundred five-l of this article nor any incident reporting requirements imposed upon diagnostic and treatment centers pursuant to the provisions of this chapter shall be subject to disclosure under article six of the public officers law or article thirty-one of the civil practice law and rules, except as hereinafter provided or as provided by any other provision of law. No person in attendance at a meeting of any such committee shall be required to testify as to what transpired thereat. The prohibition relating to discovery of testimony shall not apply to the statements made by any person in attendance at such a meeting who is a party to an action or proceeding the subject matter of which was reviewed at such meeting.
  3. There shall be no monetary liability on the part of, and no cause of action for damages shall arise against, any person, partnership, corporation, firm, society, or other entity on account of the communication of information in the possession of such person or entity, or on account of any recommendation or evaluation, regarding the qualifications, fitness, or professional conduct or practices of a physician, to any governmental agency, medical or specialists society, or hospital as required by sections twenty-eight hundred five-j, twenty-eight hundred five-k and twenty-eight hundred five-l of this article or any incident reporting requirements imposed upon diagnostic and treatment centers pursuant to the provisions of this chapter. The foregoing shall not apply to information which is untrue and communicated with malicious intent.

Appendix 2

Effective Date: 10/14/98
Title: Section 405.8 - Incident reporting

405.8 Incident reporting.
  1. Any incident required to be reported pursuant to subdivision (b) of this section shall be reported to the departments investigation and identification information required by the department.
  2. Incidents 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. 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 and that necessitate additional or more complicated treatment regimens or that result in a significant change in patient status, shall also be considered reportable under this subdivision;
    2. Fires or internal disasters in the facility which disrupt the provision of patient care services or cause harm to patients or personnel;
    3. Equipment malfunction or equipment user error during treatment or diagnosis of a patient which did or could have adversely affected a patient or personnel;
    4. Poisoning occurring within the facility;
    5. Patient elopements and kidnappings;
    6. Strikes by personnel;
    7. Disasters or other emergency situations external to the hospital environment which affect facility operations; and
    8. Unscheduled termination of any services vital to the continued safe operation of the facility or to the health and safety of its patients and personnel, 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.
  3. The hospital shall conduct an investigation of incidents described in paragraphs (b)(1)-(6) of this section and those incidents in paragraphs (7)-(9) deemed appropriate by the department.
  4. The hospital shall provide a copy of its investigative report to the area administrator within 24 hours of its completion. This report shall document all hospital efforts to identify and analyze the circumstances surrounding the incident and to develop and implement appropriate measures to improve the overall quality of patient care. This report shall contain all information required by the department including:
    1. An explanation of the circumstances surrounding the incident;
    2. An updated assessment of the effect of the incident on the patient(s);
    3. A summary of current patient status including follow-up care provided and post-incident diagnosis;
    4. A chronology of steps taken to investigate the incident that identifies the date(s) and person(s) or committee(s) involved in each review activity;
    5. The identification of all findings and conclusions associated with the review of the incident;
    6. Summaries of any committee findings and recommendations associated with the review of the incident; and
    7. A summary of all actions taken to correct identified problems, to prevent recurrence of the incident and/or to improve overall patient care and to comply with other requirements of this Part.
  5. e) This section does not replace other reporting required by this Part.
  6. f) Nothing in this section shall prohibit the department from investigating any incident included in subdivision (b) of this section.

Volume:C

Appendix 3

(Commissioner's 2/23/00 Dear Administrator Letter)

State of New York
Department of Heath
Corning Tower, Empire State Plaza
Albany, New York 12237

ANTONIA C. NOVELLO, M.D., M.P.H.
Commissioner
February 23, 2000
Phone: (518) 474-2011
Fax: (518) 474-5450

Dear Administrator:

Providing the highest quality of care to patients is our most important responsibility. Achieving this goal takes a dedication to quality assurance and a commitment to realizing that when mistakes happen, they should be identified, reported, analyzed and corrected so that they never happen again.

The New York Patient Occurrence Reporting and Tracking System (NYPORTS) is a national model for medical error reporting. Its development was due to the collaboration and hard work of hospitals, consumers and the State Health Department, and to our collective commitment to protecting patients at all costs.

Today we have a reporting system that is based upon objective criteria and information and has clear definitions of what needs to be reported. As a result, reporting is more consistent statewide. And, hospitals know what is expected of them should an incident occur. Most importantly, we have a system that will help improve the quality of care and reduce medical errors in New York State.

A key ingredient of NYPORTS, as a reporting and quality improvement mechanism for reducing medical errors, is hospitals reporting. Recent disturbing events at three hospitals in New York City lead us to reemphasize the importance of prompt reporting, and to stress that failure to report comes with consequences and cannot be tolerated.

The creation of a national reporting system and new agencies to oversee medical quality is being discussed in Washington. We have an important opportunity in New York State to reduce medical errors and improve the quality of care provided to our citizens, since we in New York have a model that is already developed and working. I will not see that opportunity lost.

The Department stands ready to enforce reporting requirements, and will publicly sanction those facilities that fail to promptly and accurately report incidents that result in patient death, injury or potential injury. The Department also stands ready to assist your facility in meeting the statutory requirements of NYPORTS.

Sincerely,

Antonia C. Novello, M.D., M..P.H.
Commissioner of Health

Appendix 4

OCCURRENCE INCLUDES EXCLUDES
Medication Errors:
Topical, Injectables, IV, PO
Treatment Medications, Contrasts, Chemotherapy
108. A medication error occurred that resulted in permanent patient harm. 108-110. Any adverse drug reaction that was not the result of a medication error.
109. A medication error occurred that resulted in a near-death event (e.g., anaphylaxis, cardiac arrest).
110. A medication error occurred that resulted in a patient death.
Aspiration 201. Aspiration pneumonitis/pneumonia in a non-intubated patient related to conscious sedation. 201. Patients intubated on ventilation, or with known history of chronic aspiration.
Intravascular Catheter Related 301. Necrosis or infection requiring repair (incision and drainage (I&D), debridement, or other surgical intervention), regardless of the location for the repair (e.g., at the bedside, in a treatment room, in the OR). 301. Any infiltration or infection treated exclusively with cold or warm packs, wound irrigation, IV change, and/or medication use (e.g., IV, PO, topical).
302. Volume overload leading to pulmonary edema. 302. Pulmonary edema clearly secondary to acute myocardial infarction. Pulmonary edema occurring in patients with previously known, predisposing conditions such as CHF, cardiac disease, renal failure, renal insufficiency or hemodynamic instability in critically ill patients.
303. Pneumothorax, regardless of size or treatment (including pneumothoraces resulting from a procedure performed through an intravascular catheter, e.g., temporary pacemaker insertion). 303. Non-intravascular catheter related pneumothoraces such as those resulting from lung biopsy, thoracentesis, permanent pacemaker insertion, etc.
Embolic and Related Disorders
  • include readmissions within 30 days
401. New, acute pulmonary embolism, confirmed, or suspected and treated. 401. New, acute pulmonary embolism is suspected cause of sudden death but there is no autopsy to confirm. Acute pulmonary embolism present on admission and not associated with previous hospitalization within the past 30 days.
402. New documented DVT (deep vein thrombosis) 402. Superficial thrombophlebitis.
Laparoscopic 501. All unplanned conversions to an open procedure because of an injury and/or bleeding during the laparoscopic procedure. 501. Diagnostic laparoscopy with a planned conversion or conversion based on a diagnosis made during the laparoscopic procedure. Conversions due to difficulty in identifying anatomy.
Perioperative/
Periprocedural Related
  • within 48 hours
  • regardless of setting of operation or procedure
  • include readmissions.
600's category:

601-605. Cardiac related occurrences reported in the cardiac reporting systems. NOTE: Consider the 911-963 codes when applicable.

ESRD (End Stage Renal Disease) patients post dialysis treatment. (Include only if occurs while patient is in dialysis area.)
601. Any new central neurological deficit (e.g., TIA, stroke, hypoxic/anoxic encephalopathy). 601. Central neurological deficits due to direct procedures on the central nervous system (e.g., tumor dissection or removal). Transient metabolic encephalopathy.
602. Any new peripheral neurological deficit (e.g., palsy, paresis) with motor weakness. 602. Deficits due to operative or other procedure on a specific nerve (e.g., procedures involving neurofibroma, acoustic neuroma). Sensory symptoms or deficits without motor weakness (e.g., numbness or tingling, alone).
NOTE: Deficits due to central neurological insults (such as hemiparesis) are submitted as a 601.
603. Cardiac arrest with successful resuscitation. 603. Intentional arrest during cardiopulmonary procedures. Cardiac arrest with unsuccessful resuscitation (submit as a 605).
604. AMI (Acute Myocardial Infarction) – unrelated to a cardiac procedure. 603-605 Multiple trauma, AAA rupture known at time of surgery.
605. Death (include ASA class if the procedure involves general anesthesia or conscious sedation).
Burns
Falls
701. 2nd and/or 3rd degree burns. 701. 1st degree burns.
751. Falls resulting in x-ray proven fractures, subdural or epidural hematoma, cerebral contusion, traumatic subarachnoid hemorrhage, and/or internal trauma (e.g., hepatic or splenic injury). 702. Falls resulting in soft tissue injuries.
Procedure Related
  • regardless of setting
  • within 30 days of the procedure
  • include readmissions.
800's category 801-819. Cardiac related occurrences reported in the cardiac reporting systems.
801-853. Birth related occurrences reported in the perinatal data system.
NOTE: Consider the 911-963 codes, when applicable.
801. Procedure related injury requiring repair, removal of an organ, or other procedural intervention.
Any procedural injury to liver or spleen, including injury associated with lysis of adhesions or manipulation of the organ.
801. Procedure related injuries which do not penetrate, perforate or enter a lumen, require only a suture(s) to serosal/muscular layers to repair, or which do not require removal of an organ. Procedure related injuries resulting from intended, direct operation on an organ or other anatomical structure based on disease process or lack of an alternative approach available to address the presenting surgical condition.
803. Hemorrhage or hematoma requiring drainage, evacuation or other procedural intervention.  
804. Anastomatic leakage requiring repair.  
805. Wound dehiscence requiring repair.  
806. Displacement, migration or breakage of an implant, device, graft, or drain, whether repaired, intentionally left in place or removed 806. Occurrences reported in 913 (retained foreign body) or occurrences due to equipment malfunction or defective product reported in 937 or 938.
807. Thrombosed distal bypass graft requiring repair. 807. AV grafts and fistulas used for dialysis.
808. Post-op wound infection following clean or clean/contaminated case requiring drainage or hospital admission within 30 days. ASA class is required to be noted. 808. Contaminated or dirty case procedure
819. Any unplanned operation or reoperation (RTOR) related to the primary procedure, regardless of setting of primary procedure. (If occurrence involves 801 or 803-808, enter 801 or 803-808 in the 1st occurrence code field, followed by 819 in the 2nd occurrence code field.) 819. Non-anesthesia procedural interventions (e.g., ERCP) usually performed in special procedure rooms in larger hospitals but which are performed in the OR in a smaller hospital simply due to lack of specialized facilities.
Procedures that are commonly sequential or repeated (skin flaps, colostomy closure, 2nd look trauma, biopsy follow-up, documented planned 2nd look for ischemia after bowel resection or whenever intestinal ischemia is expected. Also lap 2nd look post oncologic procedure when post-op adjuvant therapy was given (ovarian cancer, Hodgkin's and non-Hodgkins lymphoma). Excludes debridement, vascular cases where conservative approach tried first (thrombectomy, fem-pop bypass) but ultimately fails (BKA done as last resort).
851. Hysterectomy in a pregnant woman 801-853. Birth related occurrences reported in the perinatal data system. NOTE: Consider the 911-963 codes, where applicable.
852. Inverted uterus
853. Ruptured uterus
854. Circumcision requiring repair
Root Cause Analysis Required 900's category
Serious events such as unexpected deaths are reportable as 900 codes even if the surgery was a CABG.
915-919. Any unexpected adverse occurrence directly related to the natural course of the patient's illness or underlying condition (e.g., terminal or severe illness present on admission).
Any cases involving malfunction of equipment resulting in death or serious injury should be reported under 938.
911. Wrong Patient, Wrong Site – Surgical Procedure  
912. Incorrect Procedure or Treatment - Invasive  
913. Unintentionally retained foreign body due to inaccurate surgical count or break in procedural technique (sponges, lap pads, instruments, guidewires from central line insertion, cut intravascular cannulas, needles, etc.) 913. Foreign bodies retained due to equipment malfunction or defective product (report under 937 or 938) or those reported under 806.
915-919. Unexpected adverse occurrence not directly related to the natural course of the patient's illness or underlying condition resulting in: 915-919. Any unexpected adverse occurrence directly related to the natural course of the patient's illness or underlying condition (e.g., terminal or severe illness present on admission).
915. Death (e.g., brain death).  
916. Cardiac and/or respiratory arrest requiring BLS/ACLS intervention. 916. Events not requiring BLS/ACLS intervention.
917. Loss of limb or organ.  
918. Impairment of limb (limb unable to function at same level prior to occurrence) and impairment present at discharge or for at least 2 weeks after occurrence if patient is not discharged. 918. Limb functions at the same level as prior to the occurrence, impairment resolves by discharge or within two weeks if not discharged. Excludes positioning parathesias. Excludes newborn related occurrences that are reported in the perinatal data system.
919. Loss or impairment of bodily functions (sensory, motor, communication or physiologic function diminished from level prior to occurrence) and present at discharge or for at least 2 weeks after occurrence if patient is not discharged. 919. Bodily function at the same level as prior to the occurrence, impairment resolves by discharge or within two weeks if not discharged. Excludes positioning parathesias. Excludes newborn related occurrences that are reported in the perinatal data system.
920. Errors of OMISSION resulting in death or serious injury RELATED to the patient's underlying condition.  
921. Crime resulting in death or serious injury, as defined in 915-919.  
922. Suicides and attempted suicides with serious injury as defined in 915-919.  
923. Elopement from the hospital resulting in death or serious injury as defined in 915-919. 923. Cases in which the patient outcome would have been the same whether or not the elopement occurred (cancer death, etc.).
938. Malfunction of equipment during treatment or diagnosis or a defective product which resulted in death or serious injury as described in 915-919.
  • Please include:
    • a. equipment/device name
    • b. manufacturer
    • c. model #
    • d. serial #
 
961. Infant Abduction.  
962. Infant discharged to wrong family.  
963. Rape by another patient or staff.  
Submit Short Form Only
Root Cause Analysis Not Required
901. Serious occurrence warranting DOH notification, not covered by codes 911-963.  
902. Patients transferred to the hospital from a diagnostic and treatment center. 902. Planned hospital admission from a diagnostic and treatment center.
914. Misadministration of radioactive material (as defined by BERP, Section 16.25, 10NYCRR).  
931. Strike by hospital staff.  
932. External disaster outside the control of the hospital which affects facility operations. 932. Situations that are related to termination of service should be reported under 933.
933. 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.  
934. Poisoning occurring within the hospital (water, air, food).  
935. Hospital fire disrupting patient care or causing harm to patients or staff.  
937. Malfunction of equipment during treatment or diagnosis or a defective product which has a potential for adversely affecting patient or hospital personnel or a resulting in a retained foreign body.
  • Please include:
    • a. equipment/device name
    • b. manufacturer
    • c. model #
    • d. serial #
 

Appendix 5

WESTERN NEW YORK
  • Allegany
    Cattaraugus
    Chautauqua
    Erie
    Genesee
    Niagara
    Orleans
    Wyoming
FINGER LAKES
  • Chemung
    Livingston
    Monroe
    Ontario
    Schuyler
    Seneca
    Steuben
    Wayne
    Yates
NORTHEASTERN NEW YORK
  • Albany
    Clinton
    Columbia
    Delaware
    Essex
    Franklin
    Fulton
    Greene
    Hamilton
    Montgomery
    Otsego
    Rensselaer
    Saratoga
    Schenectady
    Schoharie
    Warren
    Washington
CENTRAL NEW YORK
  • Broome
    Cayuga
    Chenango
    Cortland
    Herkimer
    Jefferson
    Lewis
    Madison
    Oneida
    Onondaga
    Oswego
    St. Lawrence
    Tioga
    Tompkins
LONG ISLAND
  • Nassau
    Suffolk
HUDSON VALLEY
  • Dutchess
    Orange
    Putnam
    Rockland
    Sullivan
    Ulster
    Westchester
NEW YORK CITY
  • Bronx
    Kings
    New York
    Queens
    Richmond