HEALTH AND SENIOR SERVICES SENIOR SERVICES AND HEALTH SYSTEMS BRANCH DIVISION OF HEALTH FACILITIES EVALUATION AND LICENSING Adopted Amendments: N.J.A.C. 8:36-5.10; 8:39-9.4; 8:42-3.8; 8:42C-3.8; 8:43-4.9, 8:43A-3.8; 8:43D-4.7; 8:43E-3.4; and 8:43G-6.10 Adopted New Rules: N.J.A.C. 8:43E-10 Adopted Repeals: N.J.A.C. 8:43G-5.6 and 8:43H-3.8 Licensure Standards for Assisted Living Residences, Comprehensive Personal Care Homes, Assisted Living Programs, Long-Term Care Facilities, Home Health Agencies, Hospices, Residential Health Care Facilities, Ambulatory Care Facilities, Pediatric Community Transitional Homes, Hospitals, and Rehabilitation Hospitals General Licensure Procedures and Standards Applicable to All Licensed Facilities Patient or Resident Safety Requirements and Other Reportable Events Enforcement Remedies: Civil Monetary Penalties Proposed: Adopted: February 5, 2007 at 39 N.J.R. 314(a). January 24, 2008 by Heather Howard, Commissioner, Department of Health and Senior Services (with the approval of the Health Care Administration Board).
Filed: February 5, 2008 as R.2008 d.52, with substantive and technical changes not requiring additional public notice and comment (see N.J.A.C. 1:30-6.3). Authority: N.J.S.A. 26:2H-1 et seq., specifically 2H-5, 2H-8, 2H-79 through 81, and 2H-12, particularly 12.23 through 12.25. Effective Date: March 3, 2008.
Expiration Dates: February 5, 2012, N.J.A.C. 8:36; February 15, 2012, N.J.A.C. 8:39; July 1, 2008, N.J.A.C. 8:42; November 22, 2009, N.J.A.C. 8:42C; February 22, 2010, N.J.A.C. 8:43;
December 21, 2012, N.J.A.C. 8:43A; December 1, 2008, N.J.A.C. 8:43D; August 18, 2011, N.J.A.C. 8:43E; July 22, 2010, N.J.A.C. 8:43G; and April 22, 2010, N.J.A.C. 8:43H. Summary of Public Comments and Agency Responses: The public comment period ended on April 6, 2007. Following is a summary of the comments received and the responses of the Department of Health and Senior Services (Department). The commenter is identified at the end of each comment by a number, which corresponds to the following list: 1. Karen S. Ali, Acting General Counsel, Aline M. Holmes, Senior Vice President, Clinical Affairs, and Theresa L. Edelstein, Vice President, Continuing Care Services, New Jersey Hospital Association, Princeton, NJ; 2. Maureen P. Barnes, Vice President, Risk Management and Insurance, Cooper University Hospital, Camden, NJ; 3. Andrew E. Blustein, Esq., Garfunkel, Wild and Travis, P.C., Hackensack, NJ, on behalf of the Saint Barnabas Health Care System, West Orange, NJ; 4. Francis J. Byrne, Vice President - Public Policy, New Jersey Association of Non-Profit Homes for the Aging, Princeton, NJ; 5. John D. Fanburg, Esq., WolfBlock Brach Eichler, Roseland, NJ, on behalf of the New Jersey Association of Ambulatory Surgery Centers; 6. Bob Franks, President, HealthCare Institute of New Jersey, Bridgewater, NJ 7. Bernie Gerard, Jr., Vice President, Health Professionals and Allied Employees, AFT AFL-CIO, Emerson, NJ; 8. David Greenspan, MD, Medical Director, Carrier Clinic, Belle Mead, NJ; 9. John W. Indyk, Director of Governmental Affairs, Health Care Association of New Jersey, Hamilton, NJ; and 10. Carolyn Torre, RN, MA, APN, C., Director of Practice, New Jersey State Nurses Association, Trenton, NJ; and
11. Daniel J. Vukelich, Executive Director, Association of Medical Device Reprocessors, Washington, DC. General Comments 1. COMMENT: A commenter states, "there are 'community unusual incidents' [that] behavioral health facilities [must report] to the . . . Division of Mental Health Services [of the New Jersey Department of Human Services (DHS)] using . . . forms . . . required [pursuant to N.J.A.C.] 10:376.108 [and 9.9(b)3]." The commenter provides text that appears to be from the cited provisions identifying the types of events that behavioral health facilities must report to the Division of Mental Health Services. The commenter states, "The requirements for reporting of incidents identical to that in The NJ Patient Safety Act do not necessarily require the same detail nor the same reporting time frames in either of these currently mandated reporting regulations. Though we understand that different branches of the [State] government may have need for being informed, it is unnecessarily burdensome not to bring all of the reporting requirements and methods into a single procedure so that all agencies can be informed at once by a single document." The commenter recommends "That the need for reporting to all agencies may remain, but that the timeliness of reporting and its content be identical among all branches of the State government. Though some content may be unnecessary for certain agency's purposes, it should be the [State agencies] that sort through and retain the content that they need, rather than burden the reporting facility to create unique reporting documents, content and time frames, when multiple agencies oversee their performance." (8) RESPONSE: The Department acknowledges that the information facilities under the jurisdiction of DHS must report to that agency for purposes of its oversight of mental health services may be partially duplicative of or overlap with information facilities must report to comply with the Patient Safety Act and the proposed new rules at N.J.A.C. 8:43E-10. As discussed more fully in response to a comment that appears elsewhere in this notice, the Patient Safety Act accords special protections or "privileges" to information gleaned or developed by operation of the Act and the proposed new rules at N.J.A.C. 8:43E-10. As the commenter acknowledges, in some cases the Department requires more or different information to implement the Patient Safety Act that DHS does to implement its statutory mandates. To establish concurrent reporting processes and forms for purposes and uses that are disparate and specific to the mandates of each agency, subject to later winnowing by the respective Departments, would be impracticable. In addition, it would risk disclosures of information that are improper under the Patient Safety Act (which could in turn jeopardize the availability of the "privilege") and under other laws applicable to protect the privacy of health information, such as the Federal Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. §§1301 et seq. (HIPAA), and myriad agency- and program-specific laws applicable to the respective Department Commissioners that requires them to maintain the confidentiality of information with which they are entrusted by virtue of their offices. For the foregoing reasons, the Department will make no change on adoption in response to the comment. 2. COMMENT: The commenter states, "It does not appear that the [State] has taken much time to explore the cost burden of these regulations on licensed facilities with particular attention to behavioral health residential programs[, which] deal with seriously and persistently mentally ill children, youth and adults. Though improving safety in these facilities is paramount, the cost of the
patient safety program, especially [root cause analyses] for all 'suicide attempts,' can be very high especially in light of the ambiguity in the 'definition' of suicide attempt. For instance, if all cases of self injury in an adolescent who is chronically suicidal or who may report to be suicidal for the purpose of manipulating or burdening the staff must be addressed with [a root causes analysis] and mandatory reporting, the number of [root cause analyses] may be very high indeed. Given the expense of [a root causes analysis] (often no less than an hour of time among a number of line and administrative staff) not to mention the time it takes to brainstorm a mitigation effort and then implement such an effort, follow-up on that effort's success and report all of this to the [State] will be significant. It is not clear than any or all such effort will lead to productive change in a facility, but will surely lead to continuous meetings, document preparation, and reporting. Surely, post operative infection is often a preventable complication of surgery that may lead to a serious preventable adverse reaction. [Not] all surgical programs are required to conduct [a root cause analysis] on all such events. Falls, medication errors, and bed sores are concerns for which we agree that serious adverse event should be prevented. Yet, these all require the event outcome to be 'serious' before the analysis and reporting trigger is pulled, and rightly so. To conduct [a root causes analysis] and report on all such events would be catastrophic for a facility and may not be all that productive. Programs should be in place to monitor aggregate data and address these concerns. So, too, for facilities that deal with the mentally ill, incident reporting can be done routinely if it benefits the [State's] end, but [root causes analysis] and it reporting should be limited to suicide attempts whose outcome meets the serious adverse event criteria . . . in order to focus the program to mitigate the risk of such events and to analyze those events that actually lead to a real system failure. Otherwise, the State should take the opportunity to meet with the leadership of such license programs and evaluate the true cost to these behavioral health facilities with a plan to mitigate this cost burden." (8) RESPONSE: The Department disagrees with the commenter's assertion that the Department failed to consider the cost of the proposed amendments, repeals, and new rules in developing the notice of proposal. The proposal Economic Impact describes the Department's efforts to secure stakeholder input and to build flexibility into the rules to minimize cost burdens. The commenter's concerns appear to stem from its interpretation of the proposed new rules at N.J.A.C. 8:43E-10 as requiring a root cause analysis for every "suicide attempt." As the Department addresses more fully in response to another comment of this commenter that appears elsewhere in this notice, proposed new N.J.A.C. 8:43E-10.6 would require the conduct of a "root cause analysis" for a suicide attempt only if it is a serious preventable adverse event. The commenter's concerns with respect to the cost burdens of compliance also generally appear to stem from the mandate of the Patient Safety Act itself, that facilities address near misses and serious preventable adverse events, and not from any particular provision of the amendments, repeals, and new rules the Department proposes to implement the Act. The Department is without authority to diminish by rule the applicability of this mandate to licensed health care facilities. See N.J.S.A. 26:2H-12.25a (definition of "health care facility" to which the Patient Safety Act applies). Finally, the commenter's concern seems to stem from the fact that the Patient Safety Act and the proposed implementing rules would require mental health facilities to respond to suicide attempts that result in serious preventable adverse events for a population in which suicide attempts may be chronic or endemic. This concern is no more compelling with respect to the cost of compliance than would be the concern of, for example, a long-term care facility administrator who has to respond to chronic problems common among the frail elderly that can result in serious preventable
adverse events, such as bruises, falls, pressure ulcers, elopements, and infection. Problems that are typical and endemic to the particular population treated at a particular facility type are likely to take up most of a facility's initial efforts of compliance with the Patient Safety Act and the proposed implementing amendments, repeals, and new rules. However, the goal of the Patient Safety Act is to assist facilities in avoiding serious preventable adverse events by reviewing past system or process failures, with a view toward reducing the number of future such events through the development of best practices. The Department's data collection activities from facility reports would assist the Department in determining the costeffectiveness of the Patient Safety Act and the proposed implementing amendments, repeals, and new rules. This, in turn, would inform the Department's policymaking and assist in its development of recommendations for amendments to the Patient Safety Act and/or, as appropriate, in promulgating rulemaking to amend the implementing rules. Based on the foregoing, the Department will make no change on adoption in response to the comment. Civil Monetary Penalties 3. COMMENT: With respect to the proposed amendment at N.J.A.C. 8:43E-3.4(a)14, which would establish civil monetary penalties for facilities' failure to report serious preventable adverse events to the Department, a commenter states, "to encourage reporting in accordance with the intent of the Patient Safety Act, the Department needs to temper the punitive nature of the penalty provision associated with failure to submit reports of serious preventable adverse events in a timely manner. A $ 1,000 per day fine for hospitals or $ 250.00 per day for other providers is out of line with the rest of the penalties listed in N.J.A.C. 8:43E where the greatest fine for violation relating to patient care is $ 2,500 per violation, not per day. It has been well documented in the research literature that harsh penalties have a chilling effect on reporting of serious preventable adverse events." The commenter recommends "the Department revise proposed N.J.A.C. 8:43E-3.4(a)14 to reduce the penalties [to] $ 100 per day for general hospitals, with the maximum penalty per event not to exceed $ 2,500; and . . . $ 50 per day for all other facilities, with the maximum penalty per event not to exceed $ 1,250." With respect to the proposed amendment at N.J.A.C. 8:43E-3.4(a)15, which would establish civil monetary penalties for facilities' failure to disclose serious preventable adverse events to patients, the commenter further states, "for the reasons noted [with respect to the proposed amendment at N.J.A.C. 8:43E-3.4(a)14] . . . these penalties should also be significantly reduced. A $ 5,000 fine for failure to disclose an event to patient that was actually reported in a timely manner to the Department seems overly punitive and excessive. It is also punitive to add an additional penalty of $ 1,000 to the per day fine imposed for failure to report the information to the Department in a timely manner." The commenter recommends "the Department . . . delete [proposed] N.J.A.C. 8:43E3.4(a)15 and its penalties [entirely] or revise proposed N.J.A.C. 8:43E-3.4(a)15 to significantly reduce them [to] $ 100 for failure to disclose an event that the health care facility also failed to report, in a timely manner to the Department; and . . . $ 250 for failure to disclose an event that the health care facility reported, in a timely manner, to the Department." (1) Another commenter states, with respect to the proposed amendment at N.J.A.C. 8:43E3.4(a)14 and 15, "These penalties seem excessive, inconsistent with other monetary violations, and out of the spirit of the non-punitive nature of the [patient safety initiative] to encourage reporting in order to improve healthcare in the [State]. (2)
Another commenter states, with respect to the proposed amendment at N.J.A.C. 8:43E3.4(a)14 and 15, "we are greatly concerned that the fines proposed for non compliance with [proposed N.J.A.C. 8:43E-10] are extreme and completely incongruous with the fines already contained in other chapters [addressing licensed health care facilities]. For example, the maximum fine for 'intentionally submitting a false sworn statement' contained in N.J.A.C. 8:43I-7.1 [sic; should be N.J.A.C. 8:43I-4.8] (Criminal Background Checks) is up to $ 1,000, whereas the fine [at proposed N.J.A.C. 8:43E-3.4(a)14] for the 'failure to submit an adverse event report in a timely manner' is up to $ 100,000 per day for a hospital and $ 25,000 per day for all other licensed facilities. [These] fines . . . need to be carefully re-evaluated and adjusted to reflect the more realistic and appropriate levels contained in comparable regulations." (4) RESPONSE: The Department disagrees with the commenters' assertion that the civil monetary penalties in the proposed amendments at N.J.A.C. 8:43E-3.4(a)14 and 15 would be excessive. P.L. 2003, c. 117, §18, approved July 1, 2003, amended N.J.S.A. 26:2H-14 to authorize the Department to assess penalties of up to $ 5,000 per day for violation of rules pertaining to patient care and physical plant standards. The proposed amendment at N.J.A.C. 8:43E-3.4(a)14 would establish a civil monetary penalty of $ 1,000 per day for general hospitals and $ 250.00 per day for all other facilities. The proposed penalty is significantly less than the maximum allowable penalty N.J.S.A. 26:2H authorizes the Department to assess and is comparable to other existing penalties N.J.A.C. 8:43E-3.4(a) establishes relating to patient care, it fairly addresses the impact of noncompliance. Likewise, the penalty the proposed amendment at N.J.A.C. 8:43E-3.4(a)15 would establish is comparable to the other penalties set forth at N.J.A.C. 8:43E-3.4(a) and is within the Department's statutory authority at N.J.S.A. 26:2H-14. N.J.A.C. 8:43I-4.8, which establishes civil monetary penalties relating to false statements a person seeking employment as a nurse aide, personal care assistant, or certified assisted living administrator makes in connection with a criminal background check, is not an appropriate reference for comparison purposes, as it applies to individuals, not institutions, such as licensed health care facilities. For civil monetary penalties to have meaningful deterrent and retributive effect, the penalty must be sufficient to have a noticeable impact on the financial resources of the potential violator. It is appropriate to make the penalty levels necessary to deter untimely reporting and disclosures by licensed health care facilities greater than the penalty levels necessary to deter false statements by individuals, given the relative financial resources of licensed health care facilities as compared to the financial resources of individuals who are essentially job applicants. This is particularly so in view of the low salaries typically associated with the positions of nurse aide, personal care assistant, and certified assisted living administrator, and the typically limited financial resources of persons who hold these kinds of positions. The Department is in the process of developing rulemaking to increase other fines at N.J.A.C. 8:43E-3.4 to reflect the 2003 amendment to N.J.S.A. 26:2H-14. For the foregoing reasons, the Department will make no change on adoption in response to the comments. N.J.A.C. 8:43E-10.2 Scope 4. COMMENT: A commenter expresses appreciation to the Department for the opportunity to participate in stakeholders meetings the Department convened in response to the enactment of the Patient Safety Act. With respect to proposed new N.J.A.C. 8:43E-10.2(a)3i, the commenter thanks
the Department for "recognizing the inherent conflicts" arising from "existing [State] and [Federal] reporting requirements by the Centers for Medicare and Medicaid Services [CMS] . . . and the Ombudsman for the Institutionalized Elderly. Exempting [long-term care facilities] from [N.J.A.C.] 8:43E-10.6 is extremely prudent and will serve to enhance continuity between [the proposed amendments, repeals and new rules] and the licensing regulations already in place." (4) A commenter "[acknowledges] the breadth and complexity of issues covered by this proposal [and] applauds the Department for its efforts to develop well thought out, comprehensive regulatory changes. [The commenter is] especially grateful for the Department's willingness to meet with interested parties as it contemplated the rules necessary to implement the Patient Safety Act[. The commenter appreciates] the Department taking into account the CMS reporting requirements with which Medicare and/or Medicaid[-]certified nursing homes must comply and the exemption [at proposed new N.J.A.C. 8:43E-10.2(a)3i] of these compliant facilities from the reporting requirements in proposed new . . . N.J.A.C. 8:43E-10.6." (9) RESPONSE: The Department acknowledges the importance of the stakeholders meetings in the development of the proposal and thanks the commenter for its support of the proposed amendments, repeals, and new rules. The proposal Summary at 39 N.J.R. 314(a), 316, articulates the Department's rationale for establishing the exemption the commenter mentions. 5. COMMENT: With respect to proposed N.J.A.C. 8:43E-10.2(a)7, a commenter states, "the time applicable to [ambulatory care facilities] should be extended from 180 days to 12 months after the effective date [of the proposed amendments, repeals, and new rules, which is the effective date applicable to certain] other facilities[, specifically, assisted living residences and comprehensive personal care homes, assisted living programs, long-term care facilities, residential health care facilities, and adult and pediatric day health services facilities]." The commenter notes that ambulatory care facilities "range in size from entities that are solely owned and operated by one practitioner to larger facilities with multiple owners. However, even the large [ambulatory care facilities] do not approach in size, and in the number of employees, other licensed facilities that are also covered under the Act, such as hospitals and long term care facilities." (5) With respect to proposed new N.J.A.C. 8:43E-10.2(a)4 and 5, a commenter "requests that the compliance timeframe for home health care agencies and hospices be extended from the proposed 180 days to 12 months. [Home] health care agencies and hospices need the additional time to create an appropriate infrastructure, develop policies and procedures and provide appropriate training to their employees regarding the requirements of the Patient Safety Act. This would also be consistent with the compliance glide path given to other facilities . . . such as assisted living and long term care facilities." (1) RESPONSE: The proposed staggered operative dates applicable to particular types of licensed health care facilities at proposed N.J.A.C. 8:43E-10.2 reflect the input and consensus of stakeholders with whom the Department consulted during the rules development process, among whom were representatives of the ambulatory care, home health care and hospice industries. Contrary to the commenter's suggestions, facility size alone was not the exclusive determinant of the operative dates the Department proposes with respect to particular types of facilities. Other factors include particular facility types' access to resources to implement the Act, risk factors of the respective populations served, and input from stakeholders.
Approximately one year has passed since the February 5, 2007 publication of the notice of proposal that is the subject of this notice of adoption. The Department assumes that facilities have used this time, which has been in addition to the staggered operative dates proposed N.J.A.C. 8:43E-10.2 would establish, to conduct preparatory efforts in anticipation of the adoption. The Patient Safety Act, P.L. 2004, c. 9, codified at N.J.S.A. 26:2H-12.23 et seq., was approved April 27, 2004, and the Department has maintained ongoing communication with stakeholders (and the facilities they represent) and an informational website on the patient safety initiative since 2004, providing facilities with additional notice of their obligations and the need to prepare for implementation. For the foregoing reasons, the Department will make no change on adoption in response to the comments. N.J.A.C. 8:43E-10.3 Definitions 6. COMMENT: With respect to the definitions of the terms "pressure ulcer," "stage II pressure ulcer," "stage III pressure ulcer," and "stage IV pressure ulcer" at proposed N.J.A.C. 8:43E10.3, a commenter "believes that all the definitions relation to the term "pressure ulcer" including the various stages should fall under a single definition of pressure ulcer" and "that all of the . . . proposed definitions [associated with pressure ulcers] should be revised to be consistent with the definitions adopted by the National Pressure Ulcer Advisory Panel (NPUAP) [at its] February 2007 national conference [during which] NPUAP released revised definitions of pressure ulcers and [their] stages [that reflect] the culmination of over [five] years of work beginning with the identification of deep tissue injury in 2001." The commenter provides the text of the NPUAP definitions of definitions of pressure ulcers and their stages. (1) RESPONSE: The Department is unable to combine the definitions of "pressure ulcer," "stage II pressure ulcer," "stage III pressure ulcer," and "stage IV pressure ulcer" at proposed N.J.A.C. 8:43E-10.3 into one term in a manner that maintains consistency with Administrative Code style conventions. Each of the stages from I through IV modify the base term "pressure ulcer," and the two terms must be read together, just as the terms "adverse event" and "preventable event" are defined terms that are part of, and must be read together with, the proposed definition of "serious preventable adverse event." Based upon the commenter's representations, the NPUAP released its revised definitions of pressure ulcers and their stages subsequent to the Department's filing of the notice of proposal with the Office of Administrative Law, and almost simultaneously with the February 5, 2007, publication of the proposal in the New Jersey Register. The Department concurs with the commenter's implicit suggestion that use of terms consistent with recommendations of nationally recognized organizations specializing in the particular field or topic is generally a good practice. Based on the Department's preliminary review of the NPUAP definition, it appears the NPUAP has revised the definition to include the original four stages of pressure ulcers and added two stages of deep tissue injury and unstageable pressure ulcers. It further appears that the NPUAP definition provides explanatory and descriptive information that does not appear at proposed new N.J.A.C. 8:43E-10.3 in the definition of "pressure ulcer" and the associated stages. In addition, the NPUAP definition does not conform to New Jersey Administrative Code style conventions and would need to be revised in this respect. The Department is unable to make a change on adoption to incorporate the NPUAP definitions on adoption as this would be a substantive change requiring additional public notice and op-
portunity for comment. The Department will consult with members of the regulated community and experts in the subject matter to evaluate the NPUAP definition and will determine whether it would be appropriate to develop future rulemaking to amend the definitions of "pressure ulcer" and the associated stages thereof for consistency with the NPUAP definition. Based on the foregoing, the Department will make no change on adoption in response to the comment. N.J.A.C. 8:43E-10.4 Patient or Resident Safety Committee 7. COMMENT: The commenter inquires whether "an FMEA (Failure Mode Effects Analysis) project [can] substitute for a 'near miss [root cause analysis]'" and states, "For those licensed facilities that are . . . accredited [by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)], the Joint Commission requires a prospective look at high risk concerns for mitigation. Because this serves the same purpose of a 'near miss' [root cause analysis], it would seem redundant to perform both if the FMEA chosen is in an area related to patient safety as identified in the [proposed amendments, repeals and new rules]." The commenter recommends that "Alternative 'prospective approaches' to safety mitigation . . . be implemented rather than a near miss [root cause analysis]." (8) RESPONSE: Proposed new N.J.A.C. 8:43E-10.4(b)3 would require patient or resident safety committees to conduct analyses of near-misses that occur within facilities. There is a pertinent distinction between a root cause analysis conducted pursuant to the proposed new rules at N.J.A.C. 8:43E-10 and an FMEA conducted in accordance with JCAHO standards. A root cause analysis examines the underlying factors contributing to a specific preventable adverse event or near-miss, whereas an FMEA evaluates a process prior to its implementation, with the purpose of identifying in the abstract, that is, on a deductive basis without reference to particular facts or experience, the ways in which a process may potentially fail to eliminate or reduce the likelihood and/or severity of such events. This distinction explains why it would be inappropriate for the Department to authorize the use of FMEA interchangeably with a root cause analysis. In the aftermath of a near-miss or a serious preventable adverse event, the prospectively applied FMEA approach has already failed to identify the system or process flaw or weakness. In contrast, the root cause analysis process enables the facility to conduct a retrospective review based on fact-based actual experience, rather than hypotheses, to assist the facility in identifying and correcting the system or process flaw or weakness. JCAHO requires licensed facilities that it accredits to conduct root cause analyses only in response to "sentinel events" and to conduct at least one FMEA annually. JCAHO's definition of a "sentinel event" is comparable but not identical to the Patient Safety Act's definitions of a "near-miss" and a "serious preventable adverse event" at N.J.S.A. 26:2H-12.25, Thus, the events and timing that trigger each review process are not identical and preclude the Department from making use of the two processes interchangeable within the context of rules implementing the Patient Safety Act. Based upon the distinctions between the existing JCAHO FMEA process and the proposed root cause analysis to implement the Patient Safety Act, the Department declines to make a change on adoption in response to the comment. 8. COMMENT: A commenter states, "Many . . . licensed facilities have limited administrative staff in efforts to keep costs down and ensure that the majority of their staffing expenses are on
direct patient care. Though the idea of a committee dedicated to patient safety is one that elevates the importance of patient safety, as it should, it is also awkward and inconvenient if patient safety issues come up intermittently during the course of the year and are likely to be addressed by the same staff that questions the need for a committee dedicated solely to patient safety as patient[]related quality concerns that may not be within 'patient safety,' such as infection control, grievances and complaints, and patient/client satisfaction for example. A 'dedicated committee' meeting and minutes would disrupt the work of such teams, may postpone efforts to address patient safety (other than [root cause analysis] reporting that is time based, and create other inefficiencies without improving benefits of prompt attention and reporting directly to the leadership." The commenter recommends that "Patient Safety can be a unique committee with its own minutes and reporting or it may be embedded in a committee that deals with other patient[-]related quality concerns so long as the Patient Safety elements meet the other requirements [of the proposed new rules applicable to patient safety committees]." (8) RESPONSE: Proposed new N.J.A.C. 8:43E-10.4(c)4 would require the patient safety committee to function as a unique committee rather than as a subcommittee of an existing committee. This provision would implement the requirement at N.J.S.A. 26:2H-12.25b that every health care facility develop and implement patient safety plan that includes, at a minimum, a patient safety committee. The Patient Safety Act at N.J.S.A. 26:2H-12.25g confers confidentiality and nondiscoverability protections or "privileges" only upon documents, information and materials a facility develops pursuant to N.J.S.A. 26:2H-12.25b. Intermingling the work of the patient safety committee with the work of a larger committee with a broader focus than that reflected at N.J.S.A. 26:2H12.25b risks improper disclosure of those documents, information and materials, and could jeopardize the availability of the "privilege," thereby undermining public confidence in the patient safety initiative and impairing the free flow of information that encourages facilities to engage in selfcritical evaluation that enables them to develop strategies to reduce serious preventable adverse events and near misses. For foregoing reasons, the Department declines to make a change on adoption in response to the comment. 9. COMMENT: A commenter states, "the term 'When the nature of the facility and staffing permits' as used [at proposed new N.J.A.C. 8:43E-10.4(c)2] is vague and would lead to confusion as to when a facility's safety committee should contain the ad hoc members." The commenter recommends that the Department exempt "small facilities, such as most [ambulatory care facilities] from this requirement." (5) RESPONSE: The Department disagrees with the commenter's assertion that the phrase is vague and confusing. As the Department addresses more fully in response to a previous comment, proposed N.J.A.C. 8:43E-10.4(c)2 responds to concerns for flexibility that stakeholders raised during the rulemaking development process with respect to the composition of patient or resident safety committee. The paragraph would require facilities to appoint additional members to the safety committee whose knowledge and experience are relevant to a particular event under review, subject only to staffing constraints the nature of the facility may impose. The Department perceives no basis to exempt outright small facilities from this requirement; moreover, the regulation does not prohibit facilities from accepting the services of persons who are not facility staff from participating in the safety committee.
For the foregoing reasons, the Department will make no change on adoption in response to the comment. 10. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.4(c)3, which provides that "a facility that is part of a health care system that owns or operates multiple New Jersey facilities, the patient or resident safety committee may be operated at the system level," and proposed new N.J.A.C. 8:43E-10.4(c)4, which prohibits safety committees from constituting subcommittees of other committees of a facility or system, a commenter states that these provisions "could be construed to prohibit the development of both Facility Committees and System Committees," and recommends that the Department make changes to specifically authorize safety committees to operate at both the facility and system levels. The commenter recommends that the Department change proposed new N.J.A.C. 8:43E-10.4(c)4 to specify (1) that facility-level safety committees can be either subcommittees of the system level committee or can be independent committees, and (2) that the protections N.J.S.A. 26:2H-12.25f through h and proposed new N.J.A.C. 8:43E-10.9 provides to safety committee documents, information, and materials continue to apply when these documents, information and materials are shared among and between facility-level safety committees with other facility-level safety committees of the same system, and/or with system-level safety committees. The commenter asserts, "If this ambiguity is not corrected in the regulation, health care systems will be forced to make the unnecessary choice of either protecting the interests of each facility or protecting the interest of the health care system[, which would] negate the very purpose of an integrated health care system - which is to allow facilities within a system to share resources and information to provide the best treatment possible to the community." (3) RESPONSE: The Department disagrees with the commenter's assertion that proposed new N.J.A.C. 8:43E-10.4(c)3 and 4 are ambiguous, particularly in view of the Department's use of the permissive word "may" at proposed new N.J.A.C. 8:43E-10.4(c)3. These provisions would not preclude the establishment of safety committees at both the facility and system levels. The Department declines to change proposed N.J.A.C. 8:43E-10.4(c)4 to specify that facility-level safety committees can be "subcommittees" of a system-level committee. Use of the term "subcommittee" could imply that a facility-level safety committee is subservient to a system-level committee, and that its exercise of judgment in developing frank recommendations and implementing corrective measures for a particular facility is contingent upon the system-level committee's approval. The Department declines to establish rulemaking that could be construed to impede the independent decision-making processes of safety committees. The Department believes N.J.A.C. 8:43E-10.4(c) as proposed provides confidentiality protections between each facility and its system partners consistent with the statutory language and intent. The Department does not agree with the requestor regarding the ambiguity of the language set forth in N.J.A.C. 8:43E-10.9. N.J.A.C. 8:43E-10.9(b) provides confidentiality protections to documents, materials and information developed by a health care facility exclusively during the process of self-critical examination. The protections extend to information developed by the patient or resident safety committee, regardless of whether the health system operates patient safety committees at the system level or the facility level or both. The Department will not amend N.J.A.C. 8:43E10.4(c)4 upon adoption. Based on the foregoing, the Department will make no change on adoption in response to the comment.
11. COMMENT: A commenter states, proposed N.J.A.C. 8:43E-10.4(c)3 would allow "providers who own and operate multiple licensed facility systems . . . to maintain the Patient and Resident Safety Committee at the system level" and "will greatly reduce duplication and prevent providers from wasting critical financial and human resources." (4) RESPONSE: The Department thanks the commenter for its support of the proposed amendments, repeals, and new rules. 12. COMMENT: A commenter "commend[s] the Department on initiating the Patient or Resident Safety Requirements. Health care consumers will be better served if adverse or near miss events can be reported, reviewed, and studied using Root Cause Analysis. Sharing this information will only help to make health care delivery systems in this [State] stronger and error free." The commenter "propos[es] that staff Registered Nurses [RN] be included as . . . members [of the patient or Resident Safety Committee. Proposed new N.J.A.C. 8:43E-10.4(c)1 does] not include the requirement that the makeup of the Committee include staff or 'front line' Registered Nurses. Yet, it is critical that staff RNs serve as members of the Committee. . . [The] Committee's goals are to develop a safety plan for the facility; conduct on-going analysis of evidence-based safety practices; and analyze near misses and adverse events. Who better to bring to the attention of the committee members than the front line care givers who are witness to mishaps and preventable adverse events? Staff nurses are eyewitnesses to these events and the inclusion of staff RNs will better serve the Committee's purpose by identifying issues of implementation, and evaluation of proposed safety plans. As such, RNs will be an invaluable asset to the success of the program. As the proposal is written, it appears the expectation of the Department was that RNs would be included in the formation and process of the Safety Committee. This is only implied. However, it is important to specify that RNs, the front line caregivers, be identified as part of the Committee make up, thus, leaving nothing to assumption. In addition, the proposal does not specify that RNs would be expected to participate on the . . . Committee. Rather they are ad hoc members as noted at [proposed new N.J.A.C.] 8:43E-10.4(c)2 . . . As the proposal is written, this assumed conclusion is to bring RNs in to help conduct a Root Cause Analysis of a specific adverse event or near miss under investigation. As to facilities that do not employ RNs but are regulated by the Department and, therefore, required to abide by [the proposed amendments, repeals, and new rules, the commenter] propose[s] the following language: 'Where applicable, staff RNs, involved in direct patient care shall be members of the Patient or Resident Safety Committee. A facility, to the best of its ability, shall have one direct care RN from each of its divisions: Medical, Family, and Surgical.' [Including] staff RNs as regular Committee Members [would use] their knowledge and expertise in helping develop safe patient or resident environments rather than assessing situations after they have become adverse events." (7) Similarly, a commenter inquires whether it is "correct in making the assumption that if the 'specific adverse event or near-miss under investigation' involves staff nurses, that [proposed new N.J.A.C. 8:43E-10.4(c)2 directs] the chairperson of the patient or resident safety committee . . . to select ad hoc members who are staff nurses to address these particular issues and to conduct a root cause analysis." The commenter "contends that when nurses are an elemental part of the problem, nurses must be an integral part of the solution." (10)
RESPONSE: The Department thanks the commenter for its support of the proposed amendments, repeals, and new rules and agrees with the commenter's assertion that participation of staff registered nurses as members of patient or resident safety committees would add value to the work of these committees. Proposed N.J.A.C. 8:43E-10.4(c)1iii would require a facility's chief nursing executive, vicepresident for nursing, or director of nursing, who must also be a nurse, to be a member of the committee, provided the applicable facility licensure standards require the facility to have such an executive on staff. Proposed N.J.A.C. 8:43E-10.4(c)2 would require committee chairs to appoint ad hoc members whose job responsibilities and professional experience are relevant to the work of the committee, subject only to limitations imposed by the nature of the facility and its staffing. Proposed N.J.A.C. 8:43E-10.4(c)2 does not require these ad hoc members to be staff nurses, but it is likely that staff nurses would be called on to fill these positions because, as the commenter notes, they are "on the front lines" of patient care and are able to provide practical insight into assessing the causes of reportable events and developing and implementing solutions. The Department developed this provision in response to stakeholders' concerns that the proposed amendments, repeals, and new rules should provide facilities with flexibility in constituting their committees to include the staff a facility deems most appropriate to serve, in view of its particular workforce. The Department declines to make a change on adoption to require committee chairs to appoint staff nurses to the committee as this would undermine the Department's attempt to provide flexibility as to this issue. The rule as proposed would maintain this flexibility while providing a mechanism for inclusion of staff nurses and others with relevant experience as committee members. A limited number of facilities subject to the proposed amendments, repeals, and new rules may have a waiver not to have a registered nurse on staff . Proposed N.J.A.C. 8:43E-10.4(c)2 would authorize but not require the safety committee chairperson to appoint persons who are not otherwise part of a facility's existing staff, including registered nurses, as ad hoc committee members. To preserve the intended flexibility of the proposed new rule, discussed above, the Department declines to mandate by rule whom the chairperson must appoint. 13. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.4(c)6, a commenter states, "the requirement that the patient safety committees for [ambulatory care facilities] meet at leasts quarterly will be overly burdensome and unnecessary because the number of incidents at these facilities will, in all likelihood, be at low levels when compared to hospital or long-term [care] facility settings." The commenter suggests that ambulatory care facilities "be required to meet on an annual basis." (5) RESPONSE: The Department disagrees with the assertion that quarterly meetings would create an undue burden for any facility. Quarterly meetings would allow committee members to discuss issues while individuals' and institutional memories remain fresh and before staff turnover can occur, and would provide an opportunity to consider and respond to problems as, or soon after, they arise. The Department does not believe the commenter accurately speaks for the ambulatory care facility industry in suggesting that facilities committed to patient safety would be unwilling to meet on at least a quarterly basis. Proposed new N.J.A.C. 8:43E-10.4(c)6 represents the consensus of stakeholders who participated in the Department's process to develop rulemaking to implement the Patient Safety Act, among whom were representatives of the ambulatory care facility industry. Therefore, the Department will make no change on adoption in response to the comment.
14. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.4(d)1, which would require safety committees to develop written safety plan for the facility within 180 days after the effective date of N.J.A.C. 8:43E-10 applicable to the particular facility type specified at proposed N.J.A.C. 8:43E-10.2(a), a commenter recommends the Department extend from 180 days to one year, "to provide an adequate amount of time." (5) RESPONSE: 180 days is, on its face, an "adequate," reasonable, and appropriate period in which to develop a safety plan, given public concern with the issue of patient safety, as reflected in the Patient Safety Act. The commenter provides no basis for its assertion that the period is inadequate. Proposed new N.J.A.C. 8:43E-10.4(d)2 would authorize the safety committee to revise the plan as needed if it were to find the initial plan inadequately responsive to the safety needs of the facility and its patients or residents. Proposed new N.J.A.C. 8:43E-10.4(d)1 represents the consensus of stakeholders who participated in the Department's process to develop rulemaking to implement the Patient Safety Act, among whom were representatives of the ambulatory care facility industry. For the foregoing reasons, and for the reasons the Department provides above in response to previous comments requesting an extension of the facility-specific operative dates, the Department declines make a change on adoption in response to the comment. 15. COMMENT: With respect to proposed N.J.A.C. 8:43E-10.4(d)1i, which requires a facility-specific plan for facilities that are part of a health care system that employs a system-level safety committee, a commenter states, "the need for an individual, facility[-]specific plan should be [dependent] upon the type of care, services and staff at each facility within a health system. Rather than require a plan for each licensed facility, health systems should have the option to provide either individual facility plans or a master plan [that] identifies the individual facilities and delineates within the plan the special needs of individual facilities. As the [proposed new rules would permit] a system[-]wide . . . Safety Committee for a Health System, it would be logical to permit a system-wide plan [that] takes into account the facilities [that] are part of the system, rather than require a separate facility[-]specific plan for each facility. (2) RESPONSE: Different types of licensed health care facilities, such as nursing homes and ambulatory care centers, can be part of a health care system. Even systems comprised of more than one of the same facility type can have different safety needs. Proposed N.J.A.C. 8:43E-10.4(d)1i would ensure that safety committees establish safety plans that are customized and specific to each facility. A master plan, even one that contains customized sections applicable to particular system facilities and/or facility types, will necessarily contain sections that are inapplicable to every facility in the system. This would increase the likelihood of it being an unwieldy, oversized document that collects dust on a shelf, and decrease the likelihood of it being a user-friendly, localized, responsive, living document that serves as a convenient source of frequent reference by staff and administration. The latter is more in keeping with the Department's intention with respect to the safety plan, as reflected in proposed N.J.A.C. 8:43E-10.4(d)1i. A system-level safety committee can repeat plan provisions in each facility-specific plans when those provisions are appropriate for repetition, but the requirement that system-level safety committees establish facility-specific plans will ensure that the committee customizes each facility's plan to address the facility's particular needs and is written a manner that effectively communicates and emphasizes the importance of event reporting in a manner that is accessible to the facility's particular staff population.
For the foregoing reasons, the Department will make no change on adoption in response to the comment. 16. COMMENT: With respect to proposed N.J.A.C. 8:43E-10.4(d)3, a commenter asserts that the phrase, "Foster attitudes, beliefs, and behaviors supporting open communication within the facility about adverse events and near-misses," is "vague and expands upon the directives of the statute." The commenter recommends the Department replace this phrase with "inform employees of their responsibilities and options regarding the reporting of adverse events and near-misses." (5) RESPONSE: The phrase, "Foster attitudes, beliefs, and behaviors supporting open communication within the facility about adverse events and near-misses," accurately reflects the Department's intent that safety committees encourage the development of an institutional culture that supports reporting to improve safety, and discourages fear of retribution, as reflected in responses to comments submitted by representatives of the unionized employees of health care facilities that appear elsewhere in this notice of adoption. The Department disagrees with the commenter's assertion that the phrase is vague; safety committees would have an objective minimum standard by which to achieve this responsibility by performing the activities listed at proposed N.J.A.C. 8:43E-10.4(d)3i through iii. The terminology the commenter suggests to replace the phrase as proposed would not adequately convey the Department's intention that safety committees, in all their activities, foster and encourage culture change; it simply reiterates the tasks or activities that proposed N.J.A.C. 8:43E10.4(d)3i and ii would require safety committees to perform. For the foregoing reasons, the Department will make no change on adoption in response to the comment. 17. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.4(d)8, a commenter states, "the requirement that the aggregated data in the internal facility tracking system be analyzed on a quarterly basis would be overly burdensome for an [ambulatory care facility]" and recommends that that analysis be done on an annual basis if events have occurred during the preceding time period." (5) RESPONSE: The goals of the Patient Safety Act are to enhance patient safety and to permit facilities to analyze, learn from, and thereby decrease, adverse events in a non-punitive environment. To accomplish these goals, facilities must analyze available data expeditiously. Quarterly analysis of the aggregated data promotes prompt response to data trends that suggest patterns in facility operations contributing to adverse events, "which may not otherwise be detected by the . . . safety committee." Waiting for a year to pass before tracking system data is analyzed risks loss of institutional and staff memories of specific incidents in time to study them, and could render the tracking system pointless. The Department disagrees with the commenter's suggestion that quarterly analysis will be too burdensome for ambulatory care facilities. If there have been few or no recordable events, then the review will take little or no time, and if there have been events in a significant quantity or that are few in number but of significant import with respect to patient safety, then the facility's timely review thereof to facilitate change is worth the burden. For the foregoing reasons, the Department will make no change on adoption in response to the comment.
N.J.A.C. 8:43E-10.5 Patient or Resident Safety Plan 18. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.5(a)3, a commenter states, "the requirement that the facility annually perform root cause analysis for at least one preventable adverse event not subject to mandatory reporting or a near miss reported to the Committee may not be possible in a small [ambulatory care facility]." The commenter suggests "adding 'if such an event has been reported to the Committee in the preceding year' at the end of the last sentence" of this provision. (5) RESPONSE: In the unlikely event that a facility has experienced no events during the previous year with respect to which a facility could conduct the root cause analysis N.J.A.C. 8:43E10.5(a)3 would require, the safety committee can document this in its records. The Department assumes facilities will be able to comply with the requirement at N.J.A.C. 8:43E-10.5(a)3. Therefore, the Department will not revise the proposed rule to include the language suggested by the commenter. 19. COMMENT: A commenter recommends adding the phrase "Effective one year following the operative date of this subchapter applicable to the particular type of facility" at proposed new N.J.A.C. 8:43E-10.5(a)5ii, "to make clear that . . . facilities are not required to train new employees before the time that they are required to train current employees." (5) RESPONSE: The Department disagrees with the commenter. To decrease or eliminate any disruption of facility operations during the year, proposed new N.J.A.C. 8:43E-10.5(a)5 allows facilities up to one year following the effective date of the subchapter, as determined by the type of facility, to provide training to existing employees. The Department recognizes that a facility will schedule periodic employee orientation for new employees during the year. Since the orientation of new employees would occur anyway, the Department believes a facility would include patient safety and reportable events as part of the orientation session. Depending on when the new employee orientation is held, it is possible, as the commenter states, that new employees could obtain training before current employees. The Department does not agree, however, that the rules imply that facilities must train new employees before it trains current employees. Therefore, the Department will make no change on adoption in response to the comment. 20. COMMENT: A commenter asserts that the phrase "on-going training" at proposed new N.J.A.C. 8:43E-10.5(a)5 "is not well defined. The frequency of the training should either be stated with a timeframe or specifically noted as defined by the facility/health system." (2) RESPONSE: Proposed new N.J.A.C. 8:43E-10.5(a)5 does not specify the frequency in which on-going training should occur because the Department anticipates that after the initial training proposed new N.J.A.C. 8:43E-10.5(a)5ii would require each facility to conduct, that facilities will conduct additional training as appropriate to promptly implement best practices and policy changes the safety committee develops. While, as the commenter suggests, proposed new N.J.A.C. 8:43E-10.5(a)5 reflects the Department's intention that that facilities will conduct ongoing training in accordance with their particular resources and other facility-specific circumstances, the Department also anticipates that facilities will not delay training on an important new safety policy or safety plan amendment in order to adhere to a rigid preset training schedule. The existence and ur-
gency of safety concerns that may otherwise proceed unabated if left uncorrected will inform facilities as to the frequency with which they need to conduct training. For the foregoing reasons, the Department will make no change on adoption in response to the comment. N.J.A.C. 8:43E-10.6 Reporting of Serious Preventable Adverse Events 21. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.6(a)2, requiring facilities to report serious preventable adverse events that are within the control of the facility or directly caused by, or related to, services of the facility, a commenter recommends that the Department delete the phase "or related to" because "this phrase is very broad and vague." The commenter further recommends addition of the phrase "or program" at the end of N.J.A.C. 8:43E-10.6(a)2, but provides no rationale for the suggested addition. (1) RESPONSE: The Department agrees that, viewed broadly, the phrase "or related to" at proposed new N.J.A.C. 8:43E-10.6(a)2 could be construed to require the reporting of events that that are not attributable to a facility's remediable action or inaction and that the Patient Safety Act and the proposed new rules at N.J.A.C. 8:43E-10 cannot fix through the application of facility selfevaluation processes. This would negate the exception the Department intends proposed new N.J.A.C. 8:43E-10.6(a)2 to establish. For the foregoing reasons, the Department will develop rulemaking to appear in a future issue of the New Jersey Register to articulate with greater specificity the nature of the events the facilities listed in proposed new N.J.A.C. 8:43E-10.6(a)2 would be required to report. The Department assumes that the commenter intends the suggested addition of the phrase "or program" to capture the earlier phrase "assisted living program." However, use of "facility" adequately captures all the services and programs in the list, due to the use earlier in the paragraph of the phrase introducing the list, "facilities that provide home-based services." Therefore, the Department will not make this latter suggested change on adoption in response to the comment, but will replace the semicolons used throughout this paragraph with commas, to ensure the understanding that each of the facilities listed after home health care facilities are part of the list of "facilities that provide home-based services. 22. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.6(b), a commenter states, "the phrase 'or should have discovered' should be deleted" because it "is extremely subjective and open to interpretation. Since providers cannot always determine cause and effect, they will not always be able to determine whether an event is a serious preventable adverse event until the completion of an investigation or perhaps even after the [root cause analysis] is completed." The commenter provides a hypothetical example of a situation in which a patient on anticoagulants takes aspirin given to the patient by a family member, unbeknownst to the facility. A day later, the patient has become ill and facility staff test the patient's blood in response to the illness. Thereafter, when the tests reveal a problem with the patient's coagulation level, the patient's physician learns (presumably from the patient and/or the patient's family member) that the patient has been self-medicating. The commenter inquires whether the facility could be held responsible under the "should have discovered" standard in these circumstances. (1)
RESPONSE: Use of the phrase "should have discovered" would shorten the period in which a report is due if a facility belatedly becomes aware of a reportable event because of an act or omission of the facility. An example would include a situation in which facility personnel fail to perform scheduled routine patient checks that if timely performed would have caused the facility to observe a reportable event sooner. In the example the commenter posits, the facility "discovers" the event (and the clock starts on the facility's time to report the event) when the patient admits the selfmedication to the physician. This would be true unless facility staff should have but failed to perform more frequent blood screening as part of a regular routine that would have revealed the coagulation problem sooner, and led to the physician's questioning of the patient sooner. Likewise, the facility's reporting time would be shortened if the facility were aware that the patient had a history of self-medication during family visits and the facility failed to either supervise visits or exclude non-compliant visitors. The facility "should have discovered" the event during or immediately after the visit because the facility was aware of the patient's past actions. The Department will make a change on adoption to delete the phrase "or should have discovered" at proposed N.J.A.C. 8:43E-10.6(b). This will remove a potential deterrent to reporting of belatedly discovered events, while ensuring that patient safety is addressed through the application of the root cause analysis process to the underlying event. However, facilities that discover events after they "should have discovered" them should address, as part of their root cause analysis of the underlying event, the cause of the delay in discovering the event, to ascertain whether delays of similar nature to discover error are preventable through corrective action. 23. COMMENT: A commenter recommends that the Department revise proposed new N.J.A.C. 8:43E-10.6(g)4 to require "the reporting of . . . only those falls [that] result in patient or resident death. This recommendation is consistent with the criteria developed by the [National Quality Forum (NQF). The] Department has recognized the standards of the NQF as 'comprehensive, nationally recognized criteria' and used these standards in developing the framework for New Jersey's mandatory reporting of serious preventable adverse events. With respect to falls, the NQF only requires the reporting of patient deaths related to falls within a facility and does not list any of the other items noted in proposed N.J.A.C. 8:43E-10.6(g)4. [The commenter] suggests that proposed N.J.A.C. 8:43E-10.6(g)4 be revised to be consistent with the NQF standards. (1) RESPONSE: The National Quality Forum revised its reportable event categories to include falls with serious injury in its publication "Serious Reportable Events in Healthcare: 2006 Update" (National Quality Forum, Washington, DC 2006). A preventable fall that does not result in death but that has a serious result can impair quality of life. Therefore, requiring facilities to report and to conduct root cause analysis of falls that meet the criteria at proposed new N.J.A.C. 8:43E-10.6(g)4 is consistent with the intent of the Patient Safety Act and with the NQF recommendation. Based on the foregoing, the Department will make no change on adoption in response to the comment. 24. COMMENT: A commenter inquires whether root cause analysis reporting is required "if the program has an active falls reduction and review program" and states that in "many licensed facilities, falls and fall risk have been a concern. Many have an active falls reduction program that address[es] falls risk on a continuous basis and evaluates this risk and the literature for further fall reduction strategies. Though [the commenter has] no objection to the reporting of falls for tracking and improvement purposes, the . . . reporting standards [limit] the nature of the reporting to [root
cause analyses] as designated by the [Department. This] reporting standard is too rigid and places a needless burden on facilities that can document their falls reduction program." The commenter recommends the Department establish "the option for a facility that has an active fall reduction program to report the configuration and deliberation of their fall program effort as an alternative to the [root cause analysis]." (8) RESPONSE: A falls reduction program identifies individuals at risk for a fall event upon consideration of patients' physical abilities and medical conditions in the context of facilities' operational and environmental risk factors, and develops strategies to reduce falls risk. The Department acknowledges the value of a falls reduction and review program and encourages facilities to use such a program in providing an action plan on how to deal with falls. However, the occurrence of a fall that is a serious preventable adverse event, despite the existence of a falls reduction and review program, may signify a breakdown within the program that should have, but failed, to prevent the event. Such an occurrence requires the level of scrutiny that a root cause analysis provides, conducted in accordance with the procedures at proposed new N.J.A.C. 8:43E-10.6(k). The conduct of a root cause analysis of the occurrence is necessary to ensure the facility responds to the particular event and addresses the factors leading to the individual's fall in accordance with uniform minimum standards. The Department disagrees with the commenter's suggestion that the conduct and reporting of a root cause analysis pursuant to proposed new N.J.A.C. 8:43E-10.6(k) would "limit the nature of the reporting," and "is too rigid." Proposed new N.J.A.C. 8:43E-10.6(k) would not limit facilities to the conduct and reporting of root cause analyses as an exclusive measure to address falls; facilities would remain free to establish and operate other proactive efforts to reduce falls, such as by the establishment of falls reduction programs. However, such programs will vary in their constitution, operation, and effectiveness from facility to facility. Proposed new N.J.A.C. 8:43E-10.6(k) would establish a uniform minimum standard to ensure the occurrence of the analysis and development of avoidance measures that the Patient Safety Act requires. Moreover, proposed new N.J.A.C. 8:43E10.6(k) would establish uniform minimum data reporting standards that facilitate the Department's collection and analysis of industry-wide data that may be instrumental in its development of best practice recommendations and standards. 25. COMMENT: A commenter "strongly supports the [Department's] efforts to track problems and document issues associated with all single[-]use medical devices as part of an overall campaign to increase patient safety. Like the existing [Federal] system of reporting of medical device failures and malfunction, we are confident that the New Jersey data collection efforts will provide further confirmation that . . . [medical devices labeled for single use] reprocessed in accordance with [Federal] law are safe[; that there] is no increased rate of failure or patient injury with reprocessed devices versus original equipment[; and that] reprocessed devices may fail or malfunction less often than original equipment. The reprocessing of [medical devices labeled for single use] is stringently regulated by [the US Food and Drug Administration (FDA)] and is widely practiced in New Jersey and nationwide, as a means for controlling rising healthcare costs and reducing regulated medical waste. [The commenter] commends the Department for the proposed [rule's] treatment of reprocessed devices in the same manner as new devices, requiring adverse event reporting in either case where a serious patient injury has been caused by the use or function of a device other than as intended. This require-
ment should help fulfill an important public health objective--developing accurate and reliable information about failure rates for new and reprocessed devices. Third-party reprocessing has a long and positive clinical history in the United States." The commenter attaches "some background information on the industry and the practice." (11) RESPONSE: The Department thanks the commenter for its support of the proposed amendments, repeals, and new rules. 26. COMMENT: A commenter thanks the "Department for recognizing the appropriateness in collecting data concerning the use of reprocessed single use devices . . . in New Jersey health care facilities. While this is a positive step forward, . . . the proposed regulations can be improved so that the data the Department seeks to collect is credible and accurately reflects the usage of reprocessed [single-use medical devices] and any associated product failures. [The regulations] should contain a provision requiring health care facilities to notify their medical staffs as to their policy on reusing [single-use medical devices] and what specific [singleuse medical devices] the facility is reprocessing for additional use." The commenter states that its comments "pertain to invasive [single-use medical devices] devices intended to penetrate normally sterile tissue or body spaces or contact intact mucous membranes during use." The commenter states, with respect to the patient and resident safety committees proposed new N.J.A.C. 8:43E-10 would require, that "the proposed rules make no reference to the use or tracking of reprocessed [single-use medical devices]. Patient and resident safety committees should be directed to review the use of reprocessed [single-use medical devices] within their facility to ensure the appropriate use of these devices and proper record keeping [and] to notify their medical staffs that reprocessed single-use devices are utilized in their facilities. Physicians are on the frontlines of patient care and must be adequately informed about the devices they are being provided. Through a peer-reviewed process, physicians can determine the efficacy of reprocessed [single-use medical devices]. The adverse event reporting system implemented under the Patient Safety Act is an instrumental tool of the patient and resident safety committee. If health care providers are not made aware that their facility uses reprocessed [single-use medical devices], the reporting will be faulty. The ability of the safety committees to adequately perform their function is [dependent] upon transparency in order to collect credible data. The Report of Serious Preventable Adverse Event in New Jersey Health Care Facility is a critical data collection tool [that] will ensure proper analysis of adverse events and serious patient injury and death. The reporting form will allow the [Department] to collect and analyze relevant data in order to develop new policies and protocols to prevent further adverse events. The inclusion of the 'Product or Device Events' section, which asks if the device in question is a new device or a reprocessed [single-use medical device] is critically important and [the commenter] commends the Department on taking this step. In order to fully evaluate the efficacy of reprocessed [single-use medical devices], it is important to distinguish reprocessed [single-use medical devices] from new devices when examining why a device failed. However, an adverse event report is filed only when a patient is harmed. If a device fails but the patient is not harmed, an adverse event report is not required. [The commenter] urges the Department to require adverse event reports to be filed on all failed devices, whether or not the patient is harmed. Collecting this data will provide the Department with a more substantive and credible view of the integrity of reprocessed [single-use medical devices].
In order for the [Department] to collect credible data, it is incumbent upon facilities to strictly adhere to the FDA's recently adopted protocol regarding listing the use of reprocessed [single-use medical devices] in a patient's record. In many cases, this will require the doctor, nurse or medical technician to transfer a detachable label from the packaging of the reprocessed [single-use medical device] into the patient file. There is concern that these labels will not be transferred into patient records. Thus, if a reprocessed device fails, the presumption will be that it was a new device rather than a reprocessed one. The commenter urges the Department to develop procedures for tracking the inventories of reprocessed [single-use medical devices] at health care facilities and a process to compare the usage of reprocessed [single-use medical devices] to patient records to determine if proper record keeping is being employed. [The] Department should track every [single-use medical devices] that a New Jersey health care facility reprocesses or purchases. This will help the Department analyze the data it collects to determine how safe it is to reprocess certain [single-use medical devices] and to ensure that [singleuse medical devices] that are being reprocessed are approved for reprocessing by the FDA. [The commenter] urges the Department to require New Jersey health care facilities to disclose if they outsource their reprocessing to third party vendors. This will enable the Department to ensure that such vendors have FDA approval to reprocess [single-use medical devices] and are in compliance with all FDA requirements. [The commenter] encourages the Department to publicly disclose the data it collects and finding pertaining to the usage of reprocessed [single-use medical devices], the rate of failure of reprocessed [single-use medical devices], health care facility compliance with patient record keeping, and third party vendors who are being employed by health care facilities to perform any reprocessing. [The commenter] urges the Department to more closely examine the use of reprocessed single-use devices in ambulatory care settings. There is concern that these facilities may be reprocessing [single-use medical devices] in-house when they are not properly equipped to do so. These providers are not monitored by the FDA and therefore the State has appropriate jurisdiction to regulate the activities within these facilities. [Ambulatory] care facilities should be held to the same standards as other [State]-regulated health care facilities. [The commenter] feels that all New Jersey patients have a right to know which health care facilities are using reprocessed [single-use medical devices]. This disclosure is critical in providing all New Jersey patients with the information necessary in order to make an informed decision about which facility they wish to receive their health care. With this knowledge patients can adequately consult with their health care providers to ensure that they are receiving the best medical advice and care possible. (6) RESPONSE: The Department thanks the commenter for its support of the proposed amendments, repeals and new rules. Proposed new N.J.A.C. 8:43E-10.6(c) requires facilities subject to the chapter to submit the form at proposed N.J.A.C. 8:43E-10 Appendix A, Report of Serious Preventable Adverse Event in a New Jersey Licensed Health Care Facility, in the event of a serious preventable adverse event, and to identify the type of event. If the event is a product or medical device-related event within the meaning of proposed N.J.A.C. 8:43E-10.6(h), then the proposed form at Section B-5-C-4 would require the facility to report whether the patient or resident death or harm is due to the use of a singleuse device in which the device is used and/or functions other than as intended, and whether it is a
new or reprocessed single-use device. Proposed N.J.A.C. 8:43E-1.6(k) would require the facility's patient and resident safety committee to conduct a root-cause analysis. Thus, a facility, and its patient and resident safety committee reviewing a reportable event, and facility staff involved in an event, would necessarily have to know whether a device implicated in harm or a death was new or reprocessed, to enable the facility to file the necessary report, and to enable the committee to conduct the required root-cause analysis. Thus, the commenter is incorrect in asserting that the proposed amendments, repeals, and new rules "make no reference to the use or tracking of reprocessed [single-use medical devices]" and it would be redundant of proposed N.J.A.C. 8:43E-10.6 to establish additional requirements to direct committees "to review the use of reprocessed [single-use medical devices]," and "to notify their medical staffs" that the facility uses such devices, as the commenter suggests. The Department declines to implement the commenter's suggestion that it collect data on failures of new and reprocessed single-use devices absent patient harm. The failure of devices absent patient harm may implicate economic inefficiencies but reporting of these occurrences would be irrelevant to the purposes of the Patient Safety Act and would exceed the Department's rulemaking authority under that Act. To require reporting of such occurrences would burden the regulated community without correspondingly enhancing patient safety. Facilities are free to retain data relating to failures of both new and reprocessed devices that do not result in patient harm, as this may aid them in their future selection of vendors from whom to purchase such devices. The commenter provides no citation to the "FDA's recently adopted protocol" relating to recording devices used in a patient's record. If this is a Federal law, then facilities must to adhere to the recording requirement, and if device labels fail, then facilities would presumably implement other measures to ensure their compliance with the Federal law. The Department is unaware of a system-wide failure of facilities to adhere to applicable patient recordkeeping requirements and addresses such allegations in the context of licensure inspections on a case-by-case basis. To adhere to the reporting and analysis requirements at proposed N.J.A.C. 8:43E-10.6 discussed above, facilities would need to know whether a reportable event implicates either a new or a reprocessed device. Other than as provided in the proposed amendments, repeals, and new rules, the Department declines to mandate the procedure by which facilities will maintain records to ensure their ability to report and analyze reportable events in accordance with proposed N.J.A.C. 8:43E-10.6, and assumes that each facility will develop appropriate policies and procedures to facilitate their compliance with this obligation. The commenter provides no basis to support the suggestion that the Department should track only reprocessed single-use devices. The data the Department would collect from facilities realizing device-related reportable events will inform the Department's future policymaking with respect to whether there are reasons relating to patient safety or health care quality to establish special requirements or rulemaking distinctions for reprocessed as opposed to new single-use medical devices. Likewise, the commenter provides no basis to support the suggestion that the Department require licensed facilities to report the vendors from whom they purchase reprocessed devices. The Department does not oversee licensed facilities' purchasing of any other equipment that may be subject to FDA regulation, and the commenter provides no rationale as to why reprocessed devices are any different from any other medical equipment a licensed facility may purchase. The Department declines to establish a redundant system to replicate the FDA's existing regulatory oversight in such matters and will make no change on adoption in response to the comment.
Disclosure of data the Department collects pursuant to the proposed N.J.A.C. 8:43E-10 is subject to the Patient Safety Act, and the Department will maintain and use the data in accordance with the strictures of that Act. See particularly N.J.S.A. 26:2H-12.25f. To the extent the Act may authorize use of collected data for research purposes and the Department conducts research on that data, depending on the nature of the research the Department conducts and the nature of the request, that research report may be subject to public access and disclosure in accordance with applicable requirements of N.J.S.A. 47:1A-1 et seq., an Act concerning public access to government records, subject to the authorization of the Department's Human Research Ethics Program and, as applicable in accordance with procedures of that Program, the Department's Institutional Review Board. While, as the commenter suggests, ambulatory care facilities may not be subject to FDA oversight, the reprocessing of single-use devices is subject to FDA oversight. Again, the Department declines to implement measures to establish oversight of these devices that is redundant of FDA oversight. To the extent the commenter reports to the Department a specific factual basis or incident underlying its "concern" that a particular ambulatory care facility is violating either Federal law or State licensing standards, the Department would either investigate that allegation within applicable licensure standards, and/or report it to the FDA, as appropriate, to ensure that patient safety and health care quality are not compromised. The Department takes no position on the commenter's "feel[ing] that New Jersey patients have a right to know which health care facilities are using reprocessed [single-use medical devices]." The commenter provides no rationale as to why reprocessed devices are any different from any other medical equipment a licensed facility may purchase or use. Generally, the Department does not require facilities to make disclosures with respect to equipment they purchase or use. The data the Department collects will inform its future policymaking with respect to whether there are reasons relating to patient safety or health care quality to establish special requirements or rulemaking distinctions for reprocessed as opposed to new single-use medical devices. Finally, it appears that some or all of the requirements the commenter suggests the Department impose with respect to reprocessed single-use medical devices might be preempted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§301 et seq., ("FDC Act"), at §360k, as implemented by 21 CFR Part 808. 21 U.S.C. §360k provides in part that "no state or political subdivision of a state may establish or continue in effect with respect to a device intended for human use any requirement . . . which is different from, or in addition to, any requirement applicable under [the FDC Act] to the device, and . . . which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under [the FDC Act]. See Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006), cert. granted, 127 S. Ct. 3000 (June 25, 2007). 21 CFR Part 808 establishes the FDA's procedures and standards for the submission, review, and approval of applications for exemption from Federal preemption of state and local requirements applicable to medical devices on a device-by-device basis. For the foregoing reasons, the Department will make no change on adoption in response to the comment. 27. COMMENT: A commenter expresses that it "wholeheartedly supports" most of proposed amendments, repeals, and new rules. The commenter asserts that the definition of "a suicide attempt" is vague "but applies to all licensed facilities." The commenter appreciates "the invaluable benefit of performing detailed [root] cause analysis and addressing problems of risk in all such circumstances . . . the psychiatric facilities in the [State] will be greatly burdened by this standard. Because suicide attempts are a serious
concern in all psychiatric facilities as a 'primary symptom' of the conditions that [psychiatric facilities] treat, [psychiatric facilities take] steps to mitigate this risk as [they] attempt to address the underlying disorder that contributes to this behavior. Many of these facilities offer care to patients who have suicide on their minds often if not 100 [percent] of the time. Many . . . psychiatric patients will behave in ways that will put their health or lives at risk, whether or not this is a 'true' suicide attempt. The standard, because it does not discriminate on the seriousness of the outcome of the attempt, may reduce the willingness of programs to risk offering care to patients with behaviors (such as self mutilation or high risk activity) that could be interpreted as suicide or who are chronically suicidal or who have a history of past suicide attempts[,] due to the anxiety and the cost of the reporting standard. Moreover, without an outcome parameter on the behavior, many behaviors may be 'ambiguous' as to their intent and therefore create opportunity for dispute as to whether they are a 'suicide attempt' or not." The commenter recommends that the Department establish "two standards. All suicide attempts in facilities whose primary purpose is to the mentally ill should only conduct [root cause analyses] and report . . . event[s] that meet the 'serious adverse event' criteria of the other standards, or another outcome standard that captures significant events but limits the number in a clear way. For example, criteria could be included that requires reporting if resuscitation was needed, or the patient needed to be sent to an emergency room for medical stabilization, or admitted to a general acute care hospital. (Admission to a psychiatric hospital would not be discriminating.) These 'cases' would clearly eliminate the concern that an adolescent with superficial scratches or when routine evaluation and monitoring prevented a patient who was preparing to choke themselves or overdose on hoarded pills would need to be analyzed and then reported. Though near miss events that cause no harm may be indicators for change, it would be expected such facilities deal with these concerns in the regular course of business and may address this concern in other ways consistent with their mission such as a [Failure Mode Effects Analysis] project or near miss [root cause analysis]. For those facilities that do not make their primary mission the treatment of the mentally ill, all suicide attempts could be considered open for review." (8) RESPONSE: The Department thanks the commenter for its support of the proposed amendments, repeals, and new rules. The Department disagrees with the commenter's assertion that the meaning of "suicide attempt" is vague and that the proposed new rules would impose an undue burden on mental health facilities with respect to events that may be subject to characterization as suicide attempts. Proposed new N.J.A.C. 8:43E-10.6(a) and (j)3 would require facilities to report and conduct a root cause analysis with respect to "serious preventable adverse events." A facility's obligation to report events and to conduct a root cause analysis thereof depends on its preliminary finding that all of the following conditions are present: the event was an "adverse event" as proposed N.J.A.C. 8:43E-10.3 would define that term, that is, it was "an event that is a negative consequence of care that results in unintended injury or illness"; the event was a "preventable event" as proposed N.J.A.C. 8:43E-10.3 would define that term, that is, it was "an event that could have been anticipated and prepared against, but occurs because of an error or other system failure"; and the event was a "serious preventable adverse event" as proposed N.J.A.C. 8:43E-10.3 would define that term, that is, the event "results in death or loss of a body part, or disability or loss of bodily function lasting more than seven days or still present at the time of discharge from a health care facility." Thus, a patient's self-injury does not trigger a facility's obligations under proposed N.J.A.C. 8:43E-10.6 to report the event and conduct a root cause analysis unless the patient suffers harm to a
degree measured by an objective standard, and if the facility could have avoided the event. A facility is able to discern whether it has to report the event and conduct a root cause analysis without necessarily first determining the patient's intent, that is, to characterize the event as either an attempt at suicide or an accident. Proposed new N.J.A.C. 8:43E-10 would require only that the facility (1) ascertain whether it failed, or could have acted differently, to avoid occurrence of a patient's serious self-injury, and (2) analyze the event so the facility can act to prevent future occurrences. If a facility is aware of a patient's susceptibility to or propensity for self-injury and fails to prevent that injury, for example, by supervising the patient closely or by removing the patient's access to instrumentalities of harm, then it is appropriate for the facility to evaluate its shortcomings to identify the systems that contributed to the adverse event and implement measures to prevent future occurrences. This would apply regardless of whether a patient is truly suicidal, or has other characteristics that make the patient susceptible to self-injury. For example, a patient may be frail and elderly, have a physical condition, such as a tremor that impairs balance or grip, be developmentally disabled and/or cognitively incapacitated, or be just "accident prone." Any of these are conditions could enhance a patient's risk of self-injury, because they can cause, for example, difficulty holding sharp items or maintaining balance. All facilities have an obligation to prevent residents and patients from harming themselves, regardless of a patient's intent, if the facility can implement measures to prevent or avoid that harm. This responsibility exists regardless of the type of facility in which the incident may occur. The Department declines to establish "two standards" for the obligation to conduct root cause analyses based on facility type as the commenter suggests. The Department acknowledges that an ambiguous event that may be a suicide attempt poses difficulty with respect to how the facility is to report the event within the deadline proposed new N.J.A.C. 8:43E-10.6(b) would establish. A facility may have difficulty, upon its initial review of an event that may be a suicide attempt, in determining whether it is a "patient or resident protectionrelated event" pursuant to proposed new N.J.A.C. 8:43E-10.6(j) (reported using the checkboxes at Section B-5-E of the form at subchapter Appendix A), which addresses suicide attempts, or another type of event, such as a "care management event" pursuant to proposed new N.J.A.C. 8:43E-10.6(f) (reported at Section B-5-A of the form), which addresses, for example, harm due to improper drug dosages and medication errors, or an "environmental event" pursuant to proposed new N.J.A.C. 8:43E-10.6(g) (reported at Section B-5-B of the form), which addresses, for example, falls and restraint usage. Proposed new N.J.A.C. 8:43E-10.6(b)1 and (c)10 and 11 address this situation by authorizing facilities to submit partial reports when information necessary to make a complete report is unavailable to the facility, subject to later completion of missing information or correction of inaccurate information. Likewise, in the conduct of the root cause analysis, a safety committee needs to attempt to ascertain whether the event was unintended or patient-intended in order to develop recommendations to avoid similar occurrences in the future. If the committee is unable to determine with certainty the patient's intent with respect to the event during the root cause analysis, then the facility can develop concurrent recommendations "in the alternative," that is, recommendations that address avoidance of both intentional and unintentional patient self-injury under the circumstances. The form at proposed N.J.A.C. 8:43E-10 Appendix B accommodates this manner of reporting. For the foregoing reasons, the Department will make no change on adoption in response to the comment.
28. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.6(m), a commenter states, "To ensure that [Department] feedback is useful and to enable providers to promptly revise and resubmit the [root cause analysis], it is critical that any additional information be collected while memories are still fresh regarding the event. [The commenter believes] that a timeframe for [Department] response to [providers' submitted root cause analyses] would be helpful and should be included in [the new rules]." The commenter suggests revisions to proposed N.J.A.C. 8:43E10.6(m)2 that would require the Department to conduct a completeness review of root cause analyses "within 30 days" of receipt, return incomplete submissions "immediately," and that would bar the Department from seeking additional information or revision of the root cause analysis if the Department determines it to be "complete." (1) A commenter states that proposed new N.J.A.C. 8:43E-10.6(m) "is silent as to the timeframe for the Department to provide notice to the facility for acceptance of the [root cause analysis] or return for revision. While the [program within the Department responsible for implementation of the] Patient Safety Initiative has provided timely response to the [root cause analyses] to date, our experience with other sections of the Department not providing feedback or timely feedback does not provide a comfort level for this process. The dynamics of a [root cause analysis] are such that attempting to reconvene it months or years later would be impossible. [The commenter requests] a timeframe within which the Department will respond to the submitted [root cause analysis]. (2) RESPONSE: As the commenter's experience confirms, the Department is committed to prompt, timely review, and, as appropriate, follow-up and/or acceptance, of root cause analyses. The Department is cognizant of the need for finalization of these analyses while memories are fresh and before staff changes can occur that could make witnesses unavailable. While the Department's paramount concern is providing timely assistance to facilities in developing acceptable root cause analyses, the Department declines to limit the time in which it is to conclude its process of review and acceptance thereof, the length of which will depend on the nature of the event reported and the Department's own staffing constraints. Therefore, the Department will make no change on adoption in response to the comment. 29. COMMENT: A commenter states that reporting forms at N.J.A.C. 8:43E-10 Appendices A and B do not "include specific time frames and contact information. This would be very helpful to those completing the form." The commenter recommends, "The form should include specific time frames and contact information until it can be accessed and completed on-line." (8) RESPONSE: The Department will make no change on adoption in response to the comment. Facilities would be responsible for reporting to the Department using the forms at proposed new N.J.A.C. 8:43E-10 Appendices A and B by referring to proposed new N.J.A.C. 8:43E-10, particularly N.J.A.C. 8:43E-10.6, Reporting of serious preventable adverse events. Proposed new N.J.A.C. 8:43E-10.6 would provide applicable reporting deadlines at N.J.A.C. 8:43E-10.6(b) (for Appendix A) and (k) (for Appendix B); applicable telephone and telefacsimile numbers at N.J.A.C. 8:43E10.6(d), and the applicable mailing address at N.J.A.C. 8:43E-10.6(k)1. In addition, this information is available from the patient safety website at http://www.state.nj.us/health/ps/index.shtml. As provided at proposed new N.J.A.C. 8:43E-10.6(o), the forms are available for download from the Department's forms page at http://web.doh.state.nj.us/forms/ and at the program's web page at http://www.state.nj.us/health/ps/report.shtml.
N.J.A.C. 8:43E-10.7 Disclosure to Patient or Resident 30. COMMENT: With respect to proposed new N.J.A.C. 8:43-10.7(a), which requires disclosures to other persons when a patient or resident who is the subject of certain events is a minor or an incompetent adult, a commenter states, "As a tertiary care, inner city, safety net hospital with a trauma service, [the commenter] periodically cares for incompetent patient for whom [it has] been unable to determine or locate family or appropriate representative. What provisions are to be taking in these circumstances? (2) RESPONSE: Presumably, facilities that provide care to mentally incapacitated adults require informed consent to perform certain procedures and to undertake social decisionmaking, such as discharge planning. When mentally incapacitated persons have no apparent personal representative to assist them with this decisionmaking, facilities have standing as interested persons to commence guardianship proceedings pursuant to R. 4:86 of the Rules Governing the Courts of the State of New Jersey. This process also would be available for the appointment of a guardian to receive the notice N.J.A.C. 8:43E-10.7 would require. 31. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.7(d)1, which would establish the order of preference in facilities' selection of a family member for the disclosure proposed new N.J.A.C. 8:43E-10.7(a) would require, a commenter states, "Under the implementation of civil unions in the [State], should [proposed new N.J.A.C. 8:43E-10.7(d)1] not include "civil union partner" in the listing with spouse or domestic partner. (2) Also with respect to proposed new N.J.A.C. 8:43E-10.7(d)1, a commenter states, "Consistent with the new laws regarding civil unions (P.L. 2006, c. 103), [the commenter] suggests [proposed new N.J.A.C. 8:43E-10.7(d)1] be revised to include 'a partner in a civil union.' (1) RESPONSE: The commenters are correct. P.L. 2006, c. 103, approved December 21, 2006, requires recognition of civil union partners as holding the same rights as spouses. See, for example, N.J.S.A. 37:1-31, Legal benefits, protections, responsibilities of civil union couples equal to those of married couples, which provides in part: "Civil union couples shall have all of the same benefits, protections and responsibilities under law, whether they derive from statute, administrative or court rule, public policy, common law or any other source of civil law, as are granted to spouses in a marriage." And see N.J.S.A. 37:1-32, Legal benefits, protections, responsibilities of marrieds which apply in like manner to civil union couples; list not exclusive, which provides in part: "The following list of legal benefits, protections and responsibilities of spouses shall apply in like manner to civil union couples, but shall not be construed to be an exclusive list of such benefits, protections and responsibilities: . . .laws relating to emergency and nonemergency medical care and treatment, hospital visitation and notification, and any rights guaranteed to a hospital patient pursuant to P.L.1989, c.170 (C.26:2H-12.7 et seq.) or a nursing home resident pursuant to P.L.1976, c.120 (C.30:13-1 et seq.). . ." The Health Care Administration Board approved the notice of proposal on December 21, 2006, the same day the Governor approved the civil union law, P.L. 2006, c. 103. The Department filed the notice of proposal with the Office of Administrative Law shortly thereafter. The failure to revise the rule prior to publication to acknowledge the rights of civil union partners as the law requires occurred through administrative oversight and the Department regrets the omission. The Department will revise N.J.A.C. 8:43E-10.7(d)1 upon adoption to add civil union partners as persons with status equivalent to spouses and domestic partners for purposes of the rule.
N.J.A.C. 8:43E-10.8 Voluntary, Anonymous Reporting System 32. COMMENT: A commenter "applauds the Department for the careful crafting of" the proposed amendments, repeals, and new rules, and further states, "Notwithstanding [the commenter's] overall support of the intention of [the proposed amendments, repeals, and new rules], that is, to improve patient/resident safety through a systematic approach to the reporting of serious adverse events and near misses, [the commenter] has some reservations about this approach to their identification, notification and scrutiny. A reporting system can only be as accurate and complete as the reports it receives. [The commenter is] concerned that because this system is carried out in the workplace and because the workplace involving a small unit can not guarantee true anonymity, nurses (who historically do the most reporting of adverse events in health care institutions) may not report what they have done, barely avoided or seen, particularly when the adverse event or near miss involves another professional in a position of authority, if there is an overwhelming fear of impending job loss. The most ideal system for reporting and responding to serious adverse events and near misses may therefore still be awaiting development in a setting outside the health care institution where the potential for punitive action has been reduced." (10) A commenter expresses concern "about maintaining the anonymity of the healthcare provider who initiates a report [pursuant to N.J.A.C.] 8:43E-10.8. How will the Department take steps to protect the identity of an individual who reports an adverse event or near miss? The Department must make it clear that if an institution took any action, retaliatory in nature, there would be consequences for that institution also. This system, as proposed, must have that guarantee to be successful." (7) RESPONSE: The Department thanks the commenter for its support of the proposed amendments, repeals, and new rules. The Department acknowledges the commenters' concerns about protecting the anonymity of individuals who report serious preventable adverse events and near-misses pursuant to N.J.A.C. 8:43E-10.8. The Department does not intend to release voluntary, anonymous reports to facilities and anticipates facilities will adopt similar restrictions on dissemination of information, particularly with respect to nondisclosure of information that identifies the reporting individual. The Department is without the infrastructure to establish a forum to hear or participate in individual employment disputes. Other forums for such disputes exist. However, by maintaining open communication with stakeholders, such as the commenters, the Department will monitor licensees' compliance with the Patient Safety Initiative for indicia of retaliatory conduct, such as findings of fact and law from forums of competent jurisdiction, as well as anecdotal reports. The Patient Safety Act at N.J.S.A. 26:2H-12.25g(2) prohibits use of certain information developed by operation of the Act "in an adverse employment action." Should the Department determine that licensees are engaging in retaliatory activities that violate this provision or otherwise impede implementation of the Patient Safety Initiative, the Department would take enforcement and licensure actions as appropriate to maintain full compliance with the Act and its purposes. If faced with an industry-wide problem, the Department would ascertain whether amendments to the Act and/or the rules would be necessary and appropriate to address the problem. The Patient Safety Act is designed to encourage self-critical evaluation in a manner that prevents licensees from incurring the negative ramifications normally associated with acknowledgment of error. The Department has the representations of stakeholders who participated in the rulemaking
process that they intend to implement and comply with the Patient Safety Initiative in good faith with a view toward the enhancement of outcomes. Thus, licensees should have no reason to fear employees' reporting of errors. This in turn should reduce the inclination of licensees to engage in retaliatory conduct. Based on the foregoing, the Department will make no change on adoption in response to the comment. 33. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.8(b)1, which requires facilities "to prominently post" information concerning the voluntary, anonymous reporting system, a commenter states, "The number of items required to be posted on walls dilutes the effect of the message. Considering the message and availability organizations should have the option to post it in a manner and method [that] best reaches all of its employees, whether this is on physical wall space or an electronical intra/internet posting. (2) RESPONSE: The Department's paramount concern is that facilities provide employees and health care professionals with the required information regarding the voluntary, anonymous reporting system. The Department does not intend to prescribe the media facilities should use to provide this information to employees and health care professionals. The phrase "locations accessible to employees and health care professionals" at proposed new N.J.A.C. 8:43E-10.8(b)1 provides sufficient flexibility with respect to the methods facilities can use to disseminate the information; that is, it authorizes the posting of the required notice on facility walls and electronically. Facilities that use electronic posting as the means of dissemination must either ensure that all employees and health care professionals have access to the electronic system, or provide an alternate means of notice for those who do not have access to the electronic system. Moreover, in either situation, facilities must ensure that the notice holds a position of prominence that makes it likely all employees and health care professionals will see it. Based on the foregoing, the Department will make no change on adoption in response to the comment. 34. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.8(a), which authorizes employees and health care professionals practicing at a facility to submit anonymous reports of preventable adverse events not otherwise subject to mandatory reporting or near-misses, a commenter "suggests that the facility receive a copy of the anonymous report (of course omitting any identifying information) to facilitate the facility's ability to . . . maintain an 'internal tracking system of all reports of adverse events and near misses' pursuant to proposed N.J.A.C. 8:43E-10.4(d)3iii [and to] ensure that [the facility] can effectively conduct a review of the incident and change [its] policies and procedures to prevent future occurrences." The commenter suggests the Department revise proposed new N.J.A.C. 8:43E-10.8(a) to require the Department to "notify the facility within three business days of receipt of an anonymous report and . . . provide the facility with a copy of that report redacting any information that may identify the employee or healthcare professional who submitted the report." (1) RESPONSE: The Department believes that releasing copies of anonymous, voluntary reports to facilities will have a chilling effect on the Department's receipt of this information from facility employees and health care professionals practicing at a facility. Therefore, as stated above in response to a previous comment, the Department will not release copies of voluntary, anonymous
reports of adverse events or near-misses to health care facilities in which the events occurred. The Department will make no change on adoption in response to the comment. N.J.A.C. 8:43E-10.9 Confidentiality Protections and Restrictions on Disclosure and Use 35. COMMENT: A commenter states, "the protections concerning confidentiality and restrictions on the discovery of materials relating to reported events offered by [proposed new N.J.A.C. 8:43E-10.9] are important components . . . to ensure that serious preventable adverse events and other events are reported and investigated without fear of the information being used against the reporting facilities. [The commenter hopes] that the Department resists any efforts to weaken these important protections." (5) RESPONSE: The Department thanks the commenter for its support of proposed N.J.A.C. 8:43E-10.9. The Department agrees that the Act recognizes that robust and non-punitive review of serious preventable adverse events is a key to patient safety. This Act also recognizes the need to balance the interest in collaborative and confidential review of adverse events with the societal interest in appropriate access to consumer information. This section, consistent with the clear language of the Act, is an effort to strike that balance; however, the Department is committed to an ongoing discussion with interested persons of the proper means to facilitate the flow of consumer information while maintaining a non-punitive error reduction system. The Department will retain proposed N.J.A.C. 8:43E-10.9 on adoption and will otherwise operate in accordance with the authority the Patient Safety Act confers upon the Department. 36. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.9(b), a commenter states, "the protections from discovery should not be limited exclusively to the documents, materials or information developed during the process of self-critical analysis but should extend to any documents, material or information produced as a result of compliance with [proposed new N.J.A.C. 8:43E-10]." The commenter recommends that the Department revise proposed new N.J.A.C. 8:43E10.9(b) to extend the protections to documents, materials and information developed by a facility exclusively during the process of self-critical analysis "or thereafter as a result of the self-critical analysis." (1) RESPONSE: Proposed new N.J.A.C. 8:43E-10.9(b) is consistent with and to a great degree tracks the language of the Patient Safety Act at N.J.S.A. 26:2H-12.25g. A safety committee may review documents, such as policies and procedures, during the process of self-critical analysis, and the facility may revise its policies and procedures as a result of that analysis. However, the revision the commenter suggests would protect from access and disclosure the revised policies and procedures. This would result in an overbroad interpretation of the Patient Safety Act. Extending confidentiality protections to documents developed "thereafter as a result of the process of self-critical analysis," as the commenter suggests, may encourage facilities to classify otherwise discoverable documents, materials, and information as having been developed, for example, "for the purposes of patient safety," and to seek protection thereof from discovery under the guise of Patient Safety Act protections. The purpose of the Patient Safety Act and the protections it affords to documents, materials and information is not to shield from access and disclosure documents that otherwise would have been accessible were the Act not to have been enacted, but to protect the self-critical evaluation and root cause analysis development processes.
Based on the foregoing, the Department will make no change on adoption in response to comment. 37. COMMENT: A commenter states, "While [the commenter believes proposed new N.J.A.C. 8:43E-10.9(c)] extends the protection to the [root cause analysis] teams, it would be beneficial to explicitly state this protection is extended to the [root cause analysis] teams, their meetings, investigations, discussions, deliberations, materials and work." (2) RESPONSE: The Department is unfamiliar with the entities to which the commenter refers by use of the term "root cause analysis teams." The Patient Safety Act establishes, and proposed new N.J.A.C. 8:43E-10.9 would establish, confidentiality protections and restrictions on disclosure and use applicable to documents, information and materials of a safety committee. Proposed new N.J.A.C. 8:43E-10.9(c) confirms that these confidentiality protections and restrictions on disclosure extend to members of the patient or resident safety committee. The commenter does not explain the role of "root cause analysis teams." Therefore, the Department is unable to respond to the commenter's concern. The Department will make not change on adoption in response to the comment. 38. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.9(c)2, a commenter states, "it will be very difficult to separate what an individual knew from [his or her] participation on the patient or resident safety committee versus knowledge [he or she] gained outside of that participation." The commenter recommends that the Department delete proposed new N.J.A.C. 8:43E10.9(c)2 "in its entirety." (1) RESPONSE: Proposed new N.J.A.C. 8:43E-10.9(c)2 allows persons to testify as to matters within their knowledge that was gained outside of their responsibility for or participation on the patient or resident safety committee. This is consistent with the Patient Safety Act at N.J.S.A. 26:2H12.25(h), which states that the Act is "not to be construed to increase or decrease" access to matters "if obtained from any source or context other than those specified in" the Act. A person may be part of the staff that observes the occurrence of a serious preventable adverse event, and may also serve on the safety committee. While it may be difficult to separate that person's observations and knowledge of an event from special knowledge the person may gain as part of the person's activities with respect to a safety committee, it is not impossible. It is appropriate that members with general knowledge of an event testify as to matters within their observation of that event when they are properly called upon to do so. The situation is similar to the careful analysis needed when an attorney must testify as a witness to an event in which the attorney simultaneously has an attorney-client relationship with a person interested in the matter. The court must distinguish between information the attorney has as a fact witness to an event from information the attorney may have obtained as a result of a privileged communication, but the attorney must nonetheless testify to facilitate the analysis. See, for example, In re Grand Jury Subpoena Issued to Galasso, 389 N.J. Super. 281 (App. Div. 2006), in which the Appellate Division stated: "A blanket motion to quash a subpoena ad testificandum is 'extremely inadvisable.' . . . An attorneywitness should appear and assert the privilege in response to specific questions. . . Then, the court, rather than counsel, can decide if the privilege applies . . . The burden is on the witness to justify the invocation of the privilege as to each question propounded . . . [Resolution] of the applicability of the privilege should abide a full record of the questions asked to which the privilege has been as-
serted. If a question . . . implicates the privilege, [the attorney] may, at that time, assert it in response to the specific question. That way, a clear record of the questions asked and the basis of appellant's objections may be created. In any event, [the attorney] is required to testify." [Citations omitted.] 389 N.J. Super. at 297-298. Thus, an attorney can be compelled to testify in a matter in which the attorney's client has an interest despite the attorney's concurrent knowledge of privileged information, and the court will decide whether the privilege applies to matters within the attorney's knowledge, on a question-by-question basis. Likewise, proposed new N.J.A.C. 8:43E-10.9(c)2 would anticipate that the court, or other entity presiding over a forum in which a committee member is to testify, would adjudicate on a question-by-question basis which matters or events are within the safety committee member's knowledge as a fact witness to an event, and which matters of which the member has knowledge by virtue of the member's participation in the safety committee and as to which the "privilege" applies. The Department declines to delete proposed new N.J.A.C. 8:43E-10.9(c)2 as the commenter suggests. The deletion of this provision could be construed to support an inference that the Department endorses a general or "blanket" abrogation of the responsibility of safety committee members to testify when called upon to do so in accordance with due process. Based on the foregoing, the Department will make no change on adoption in response to the comment. 39. COMMENT: A commenter states, "[proposed new N.J.A.C. 8:43E-10.9(e)] appears to have the effect of negating any type of protection afforded in the [Patient Safety Act]. Real change can only be accomplished in a non-punitive environment." (2) RESPONSE: Proposed new N.J.A.C. 8:43E-10.9(e) reiterates a concept the Patient Safety Act establishes at N.J.S.A. 26:2H-12.25h, and partially tracks the language of that provision (quoted in part above in response to a previous comment). Inasmuch as proposed new N.J.A.C. 8:43E10.9(e) is consistent with the Patient Safety Act, the Department disagrees with the suggestion that proposed new N.J.A.C. 8:43D-10.9(e) "negates" the protections the Patient Safety Act affords and will make no change on adoption in response to the comment. N.J.A.C. 8:43E-10.11 Other Reporting Requirements Unrelated to the Patient Safety Act 40. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.11, a commenter states, "this entire section should be stricken as outside of the scope, purpose and authority of the statute. In addition, many of the requirements are overly burdensome, overly broad and vague. For example, the requirements that an [ambulatory care facility] immediately notify the Department of the loss of heat or air conditioning pursuant to N.J.A.C. 8:43E[-]10.11(c)1, or of the loss or significant reduction of water, electrical power, or any other essential utilities necessary to the operation of the facility pursuant to N.J.A.C. 8:43E[-]10.11(c)2, are overly broad. If the section remains, the requirement that these incidents be reported should be limited to those occasions where a serious adverse event occurs, or at the very least, where patient care or safety is [affected]." (5) RESPONSE: The reporting requirements at proposed new N.J.A.C. 8:43E-10.11 would relocate from the several facility-specific chapters reporting requirements the Department establishes pursuant to its general authority to promulgate licensure standards for healthcare facilities under its jurisdiction pursuant to N.J.S.A. 26:2H-1 et seq., separate from or in addition to the rulemaking au-
thority the Patient Safety Act confers on the Department with respect to serious preventable adverse events. See the proposal Authority at 39 N.J.R. 314(a). The section heading of proposed new N.J.A.C. 8:43E-10.11, Other reporting requirements unrelated to the Patient Safety Act, serves to alert the regulated community to the nature of this rule. Proposed new N.J.A.C. 8:43E-10.11(c)1 and 2 would relocate existing provisions (proposed for deletion or repeal in the notice of proposal) that requiring reporting of these events applicable to some or all licensed facilities from the several facility-specific chapters to this chapter of general applicability, and would make the obligation to report these types of events uniform across all facilities. Inasmuch as some or all licensed facilities are obliged currently to report and routinely do report the types of events proposed new N.J.A.C. 8:43E-10.11 would collect in one rule, the Department disagrees with the commenter's assertion that proposed new N.J.A.C. 8:43E-10.11 is "overly burdensome, overly broad, and vague." Moreover, the Department disagrees with the commenter's suggestion that "the loss of heat or air conditioning . . . or . . . the loss or significant reduction of water, electrical power, or any other essential utilities necessary to the operation of the facility" do not implicitly affect patient care or safety. Therefore, the Department will make no change on adoption in response to the comment. 41. COMMENT: With respect to proposed new N.J.A.C. 8:43E-10.11(a)1, a commenter states, "the phrase 'related to' is too subjective and broad and should be deleted." (1) RESPONSE: As discussed in response to a previous comment with respect to the usage of "or related to" at proposed new N.J.A.C. 8:43E-10.6(a)2, the Department agrees that its use of "related to" at proposed new N.J.A.C. 8:43E-10.11(a)1 is overbroad, inasmuch as it has the potential to include every event that may happen at an adult and pediatric day health services facility or in a facility that provides services in a home-based setting, regardless of whether it is attributable to a facility's action or inaction. For the foregoing reasons, the Department will develop a rulemaking to appear in a future issue of the New Jersey Register to articulate with a greater specificity the nature of the events the facilities listed in proposed new N.J.A.C. 8:43E-10.6(a)2 would be required to report. 42. COMMENT: A commenter states its "[belief] that in its attempt to avoid redundant reporting requirements, the Department erred in not carrying forward into proposed new . . . N.J.A.C. 8:43E-10.11 . . . language in existing . . . N.J.A.C. 8:43-4.9(a)1, which, if omitted, will prove problematic for health care facilities and the Department alike." The commenter "objects to the more stringent standards to which long-term care facilities are held compared to hospitals in proposed new . . . N.J.A.C. 8:43E-10.11 . . . [Proposed new N.J.A.C. 8:43E-10.11(b)2] allows acute care facilities up to three hours after discovery of a reportable event to notify the Department. However, [proposed new N.J.A.C. 8:43E-10.11(b)3 requires that long-term care facilities provide the Department with telephonic notification 'upon the facility's discovery of the event' followed by written notification within 72 hours. [The commenter sees] no policy rationale for establishing different notification time periods." The commenter suggests "that the inconsistent requirements are the result of the inadvertent failure to carry forward into the proposed new rule existing language in current long-term care rules [at N.J.A.C. 8:36-5.10(a), 8:39-9.4(e)1 and 8:43-4.9(a)1], all of which require notification following 'three or more hours of interruption of physical plant services and/or other services essential to the
health and safety of residents.'" The commenter "believes that long-term care facilities should still be required to provide notification of such events to the Department after up to three hours, as is proposed for acute care facilities." The commenter states, "in the case of both long-term care facilities and acute care facilities, the proposed new rule makes no mention of how long certain prescribed types of events must last in order to be deemed reportable . . . We do not believe the Department would want to be notified every time, for example electrical power is interrupted for a mere ten minutes. [The commenter suggests] that [the Department] erred in not carrying forward into the proposed new rule the current rule provision requiring notification following three hours or more interruption of physical plant services essential to the health and safety of residents." (9) Another commenter states, "proposed N.J.A.C. 8:43E-10.11(b)2 and . . . 3 establish two different standards regarding reporting certain incidents [by defining] the term 'immediately' for acute care providers as 'no later than three hours after discover of the event' whereas for long-term care facilities, 'immediately' means 'upon the facility's discovery of the event.'" The commenter is "not sure why a different standard is being proposed based on provider type and [suggests] that there be one standard for all providers including long[-]term care facilities and assisted living facilities. That standard should be 'no later than three hours after discovery of the event.' [The] term 'acute care facilities' should be clarified to ensure that it includes general hospitals, rehabilitation hospitals, long[]term acute care hospitals and psychiatric hospitals." The commenter recommends that the Department add the following sentence at the end of proposed new N.J.A.C. 8:43E-10.11(b)3: "In the case of assisted living facilities, 'immediately' means telephonic notification of the Department no later than three hours after discovery of the event . . . followed by written notification within 72 hours." The commenter states, "the timeframes in [proposed new N.J.A.C. 8:43E-10.11(c)1 and 2] are inconsistent with timeframes in the current regulations regarding reportable events. For example, the hospital licensing regulations at N.J.A.C. 8:43G-5.6 require hospitals to report 'an unscheduled interruption for three or more hours of physical plant and/or clinical services essential to the health and safety of patients and employees.' Similarly, the current long[-]term care licensing regulations at N.J.A.C. 8:39-9.4(e)1 require facilities to report 'interruption for three or more hours of physical plant services and/or other services essential to the health and safety of residents.' [Proposed new N.J.A.C. 8:43E-10.11(c)1 and 2] would require hospitals, long[-]term care facilities and other facilities to report loss or interruptions of services even if they lasted only a couple of minutes. [The commenter believes] this is unnecessary and would urge the Department to revise proposed N.J.A.C. 8:43E-10.11(c) to make it consistent with current notification regulations [that require] reporting of interruptions of physical plant operations lasting three or more hours." The commenter specifically suggests adding the phrase "for three or more hours" at proposed new N.J.A.C. 8:43E10.11(c)1 and 2. (1) Another commenter "is concerned . . . about some . . . conflicts and inconsistencies between the new proposal and existing reporting requirements contained in other licensing regulations such as N.J.A.C. 8:39. For example, [proposed new N.J.A.C. 8:43E-10.11 would require] facilities to report a power outage 'immediately' . . . while the reporting procedure under N.J.A.C. 8:39-9.4 requires a power outage lasting 'three or more hours' to be reported. (4) A commenter states, "[existing N.J.A.C. 8:43G-5.6(a)1 requires] reporting of 'unscheduled interruption for three or more hours of physical plant and/or clinical services essential to the health and safety of patients and employees.' [Proposed new N.J.A.C. 8:43E-10.11(c)] does not provide a timeframe beyond which interruptions are to be reported." (2)
RESPONSE: The Department proposed amendments at N.J.A.C. 8:36-5.10(a), 8:39-9.4(e), 8:43-4.9(a), and proposed to repeal existing N.J.A.C. 8:43G-5.6, to delete existing facility-specific requirements governing reportable events. Proposed new N.J.A.C. 8:43E-10.11 would rearticulate and collect the facility-specific reporting times in one rule. The Department agrees with the commenters' assertions that it would be appropriate to establish a uniform reporting time at proposed new N.J.A.C. 8:43E-10.11 applicable to all facilities to ensure consistency in the obligations of licensed facilities. The Department will develop a rulemaking to appear in a future edition of the New Jersey Register to establish a uniform reporting time for all facilities subject to the chapter to make the proposed definition of "immediately" for purposes of (c) and (d) applicable to all facilities. Likewise, for the reasons stated by the commenters, the Department agrees that physical plant and operational interruptions ought not to be reportable unless they pose a threat to life, health, or safety, or last longer than three hours. The Department will develop rulemaking to appear in a future issue of the New Jersey Register to establish that physical plant and operation interruptions are not reportable unless they pose a threat to life, health, or safety, or last longer than three hours. 43. COMMENT: A commenter compares the phrase "suspected criminal acts" used at proposed new N.J.A.C. 8:43E-10.11(a) with the phrase "alleged criminal acts" used at proposed new N.J.A.C. 8:43E-10.11(d), and states, "there is a difference between suspected criminal acts and alleged criminal acts, with the latter requiring more proof than a criminal act did in fact occur." The commenter suggests that the Department revise proposed new N.J.A.C. 8:43E-10.11(a) to replace the term 'suspected' for the term 'alleged' "to establish clarity and to ensure consistency within the proposed new rule." (9) RESPONSE: The Department agrees that the term "alleged" could be construed to establish a prerequisite to reporting that a law enforcement authority formally articulate a finding or "allegation" that a criminal act has occurred. Likewise, one might construe the term "suspected" to require a law enforcement authority to have first conducted an investigation and articulated a finding that a crime may have occurred. However, the difference between the two terms may not be as great as the commenter suggests, inasmuch as commonly available reference materials, such as dictionaries and thesauruses indicate that these are synonymous terms. Nonetheless, the Department agrees with the commenter's assertion that the Department should use consistent terminology to prevent the implication that it intends differences in meaning by the use of different terms. The Department intends only that the circumstances of an event suggest the potential for a finding of criminal activity surrounding or causing the event, but not to establish a prerequisite actual finding of criminal activity by a law enforcement authority. To ensure that the Department articulates a uniform standard that prevents these possible ambiguities, the Department will change proposed new N.J.A.C. 8:43E-10.11 on adoption to replace the terms "suspected" and "alleged" at N.J.A.C. 8:43E-10.11(a) and (d), respectively, with the term "potentially," to indicate that an event is reportable if it could, but might not, be associated with or the result of criminal activity, in the view of a lay person with reporting obligations under proposed new N.J.A.C. 8:43E-10. 44. COMMENT: A commenter states, "[proposed new N.J.A.C. 8:43E-10.11(d)] is . . . inconsistent with current regulation requiring facilities to report criminal acts to [the Department that] are also reportable to the police. [The commenter] recommends that [the Department revise proposed new N.J.A.C. 8:43E-10.11(d)] to be consistent with current regulations and clarify requiring reporting of serious alleged or suspected crimes. For example, both the hospital and long[-]term
care licensing regulation require reporting of 'all alleged or suspected crimes which endanger the life or safety of patients or employees, which are also reportable to the police department, and which result in an immediate on-site investigation by the police.' ( N.J.A.C. 8:43G-5.6(a)3 [applicable to] hospitals and N.J.A.C. 8:39-4.9(e)3 [applicable to] long[-]term care facilities)." The commenter recommends that the Department revise proposed N.J.A.C. 8:43E-10.11(d) to provide, in part, "criminal acts 'which are also reportable to the police Department, and which result in an immediate on site-investigation by the police' include . . ." (1) RESPONSE: The reporting requirements at proposed new N.J.A.C. 8:43E-10.11(d) are consistent in most respects with existing reporting requirements of N.J.A.C. 8:43G-5.6(a)3 proposed for repeal, and N.J.A.C. 8:39-4.9(e)3 proposed for amendment. As the commenter notes, existing N.J.A.C. 8:43G-5.6(a)3 proposed for repeal, and N.J.A.C. 8:39-4.9(e)3 proposed for amendment require the reporting of criminal acts that "result in an immediate on-site investigation by the police." This Department determined to omit this phrase at proposed new N.J.A.C. 8:43E-10.11(d) because the Department wants licensees to report all potentially criminal acts, and not only those that the police decide to investigate immediately or on site or at all. This is a matter that is beyond the control of either the Department or the licensee, and the Department does not want to use this factor as a criterion in determining whether an event is reportable. Proposed new N.J.A.C. 8:43E10.11(d) provides a nonexclusive list of examples of potentially criminal acts that are reportable events. Based on the foregoing, the Department will make no change on adoption in response to the comment. Federal Standards Statement 42 CFR §§483.13(c)(2) and (4) establish Federal standards governing the reporting of alleged violations involving mistreatment, neglect, and abuse, including injuries of unknown source and misappropriation of resident property, in nursing homes. The State is required under its contract with CMS to ensure that Medicare and/or Medicaid nursing homes follow the Federal reporting requirements and take required corrective actions, and to disclose to CMS the events reported by Medicare and/or Medicaid nursing homes. Nursing homes must comply with Federal requirements for participation in Medicare and/or Medicaid, including the reporting requirements set out in 42 CFR 483.13(c)(2) and (4). The Department acknowledges that these Federal reporting standards governing nursing homes participating in Medicare and/or Medicaid pre-empt State law with respect to the Department's disclosure in accordance with the requirements of its contract with CMS of confidential information related to events reported to the Department by nursing homes participating in Medicare and/or Medicaid. The adopted new rules would identify those facilities that qualify as Medicare and/or Medicaid nursing homes. The Act could be interpreted as creating a separate, parallel requirement for Medicare and/or Medicaid nursing homes to report certain events to the Department, separate from, and in addition to, the existing Federal requirement for them to report to the Department as CMS' contracted state survey agency. However, the Department has concluded that such parallel reporting would be burdensome to Medicare and/or Medicaid nursing homes and would not materially improve resident safety, since the plan of correction required under the Federal standards is functionally equivalent to a root cause analysis. Accordingly, the Department has chosen, instead, to deem Medicare and/or
Medicaid nursing homes that comply with the Federal reporting requirements as also complying with the requirements of the Act. Therefore, the adopted new rules would provide an exception from the requirements for reporting a serious preventable adverse event and for performing a root cause analysis of all serious preventable adverse events for Medicare and/or Medicaid nursing homes in compliance with the Federal reporting standards. Correspondingly, the Department is adopting amendments to existing reporting requirements at N.J.A.C. 8:39-9.4 only to the extent that they pertain to events required to be reported by adopted new N.J.A.C. 8:43E-10.11, which is unrelated either to the Act or to 42 CFR 483.13(c)(2) and (4). The adopted new rules at N.J.A.C. 8:43E-10.8 govern the disclosure of protected health information, acknowledging the patient or resident's right to request privacy protection for protected health information, in accordance with and subject to 45 CFR 164.522. The standard governing disclosure of protected health information, as set forth in the adopted new rules at N.J.A.C. 8:43E-10.8 meets, but does not exceed the requirements of 45 CFR 164.522. The Federal Patient Safety and Quality Improvement Act of 2005, Pub. L. No. 109-41 (Law), signed into law on July 29, 2005, establishes a voluntary system for confidential reporting of medical errors by health care providers to Federally certified patient safety organizations. Section 921(7)(B)(iii)(II) of the Law indicates it was not intended "to limit the reporting of information to a Federal, State, or local government agency for public health surveillance, investigation or other public health purposes or health oversight purposes." Thus, the Law does not supplant the requirements of CMS or the Act for mandatory reporting. The Federal Agency for Healthcare Research and Quality, the agency charged with implementation of the Law, has not yet proposed regulations implementing the Law. There are no other Federal standards applicable to the adopted new rules, amendments, and repeals. Full text of the adopted amendments and new rules follows (additions to proposal indicated in boldface with asterisks *thus*; deletions from proposal indicated in brackets with asterisks *[thus]*): (Agency Note: The text of N.J.A.C. 8:43A-3.8 below reflects the intervening adopted amendments effective June 18, 2007. See 39 N.J.R. 2309(a).) CHAPTER 36 STANDARDS FOR LICENSURE OF ASSISTED LIVING RESIDENCES, COMPREHENSIVE PERSONAL CARE HOMES, AND ASSISTED LIVING PROGRAMS 8:36-5.10 Reportable events (a) The facility shall notify the Department immediately by telephone at (609) 633-9034 or (609) 392-2020 after business hours, followed within 72 hours by written confirmation, of the following: 1. Termination of employment of the administrator, and the name and qualifications of his or her replacement; 2. Any elopements; and
3. Any suspected cases of resident abuse or exploitation, which have been reported to the State of New Jersey Office of the Ombudsman for the Institutionalized Elderly. (b) (No change.) CHAPTER 39 STANDARDS FOR LICENSURE OF LONG-TERM CARE FACILITIES 8:39-9.4 Mandatory notification (a)-(d) (No change.) (e) The facility shall notify the Department immediately by telephone at (609) 633-8981 or (800) 792-9770 after business hours, followed within 72 hours by written confirmation, of the termination of employment of the administrator or the director of nursing, and the name and qualifications of the proposed replacement. (f) The facility shall notify the State Office of the Ombudsman for the Institutionalized Elderly at (800) 792-8820) immediately of any suspected or reported resident abuse, neglect, or exploitation of residents aged 60 or older, pursuant to P.L. 1983 c. 43, N.J.S.A. 52:27G-7.1, and shall notify the Department immediately at the telephone numbers indicated in (e) above with respect to residents under the age of 60. (g) (No change in text.) CHAPTER 42 LICENSING STANDARDS FOR HOME HEALTH AGENCIES 8:42-3.8 Reportable events (a) The facility shall notify the Department immediately by telephone at (609) 292-5960), followed within 72 hours by written confirmation of the termination of employment of the administrator and/or the director of nursing, and the name and qualifications of his or her replacement. (b) (No change.) CHAPTER 42C HOSPICE LICENSING STANDARDS 8:42C-3.8 Reportable events (a) The hospice shall notify the Department immediately by telephone at (609) 292-5960 followed within 72 hours by written confirmation of the termination of employment of the administrator and/or the Director of Nursing, and the name and qualifications of his or her replacement. (b) (No change.)
CHAPTER 43 STANDARDS FOR LICENSURE OF RESIDENTIAL HEALTH CARE FACILITIES 8:43-4.9 Reportable events (a) The facility shall notify the Department immediately by telephone at (609) 633-8993 or (609) 392-2020 after business hours, followed within 72 hours by written confirmation of the following: 1. (No change in text.) 2. All residents who are missing for 24 hours; and 3. All suspected cases of resident abuse or exploitation that have been reported to the State of New Jersey Office of the Ombudsman for the Institutionalized Elderly and/or to the county welfare agencies. CHAPTER 43A MANUAL OF STANDARDS FOR LICENSING OF AMBULATORY CARE FACILITIES 8:43A-3.8 Reportable events (a) The facility shall report to the Department by telephone at (609) 588-7725 or at (609) 392-2020 after business hours, the resignation or termination of employment of the administrator, and the name and qualifications of the administrator's replacement within seven days of the resignation or termination. CHAPTER 43D STANDARDS FOR LICENSURE OF PEDIATRIC COMMUNITY TRANSITIONAL HOMES 8:43D-4.7 Reportable events and notification requirements (a) The facility shall notify the Department immediately by telephone at (609) 292-9900 or (800) 792-9770 after business hours, followed within 72 hours by written confirmation to the Department's Certificate of Need and Acute Care Licensure Program, of the following: 1. (No change in text.) 2. All residents who are missing for 24 hours; and 3. All suspected cases of resident abuse or exploitation that must also be reported to the Division of Youth and Family Services, Office of Institutional Abuse Investigation Bureau.
(b) The facility shall notify immediately the resident's family, guardian, and/or designated responsible person or community agency, and the Department, at the telephone numbers indicated in (a) above, after the occurrence of the following: 1.-2. (No change.) 3. All alleged or suspected crimes committed by or against residents as specified in N.J.A.C. 8:43E-10.6(a); 4.-5. (No change.) (c) (No change.) CHAPTER 43E GENERAL LICENSURE PROCEDURES AND STANDARDS APPLICABLE TO ALL LICENSED FACILITIES SUBCHAPTER 3. ENFORCEMENT REMEDIES 8:43E-3.4 Civil monetary penalties (a) Pursuant to N.J.S.A. 26:2H-13 and 14, the Commissioner may assess a penalty for violation of licensure rules in accordance with the following standards: 1.-11. (No change.) 12. For failure to implement a Certificate of Need condition of approval, $ 1,000 per day, which shall be assessed either from the date specified in the Certificate of Need for implementation of the specific condition of approval, if identified, or from the date on which the Certificate of Need was considered to be implemented; 13. For violations of rules governing the prohibition of mandatory overtime contained in N.J.A.C. 8:43E-8, $ 1,000 per violation, which may be assessed for each day noncompliance is found; 14. For failure of an entity licensed in accordance with N.J.S.A. 26:2H-1 et seq. to submit a serious preventable adverse event report to the Department in a timely fashion, as defined in N.J.A.C. 8:43E-10.6, the following, which shall be levied from the date following the date the report was due to be submitted to the Department until the date on which the report is received by the Department: i. $ 1,000 per day for general hospitals, with the maximum penalty assessed per event not to exceed $ 100,000; and ii. $ 250.00 per day for all other facilities, with the maximum penalty assessed per event not to exceed $ 25,000; and
15. For failure of an entity licensed in accordance with N.J.S.A. 26:2H-1 et seq. to disclose to a patient or resident, pursuant to N.J.A.C. 8:43E-10.7, a serious preventable adverse event that affected that patient or resident, the following: i. $ 1,000 for failure to disclose an event that the health care facility also failed to report, in a timely manner, to the Department; and ii. $ 5,000 for failure to disclose an event that the health care facility reported, in a timely manner, to the Department. (b)-(c) (No change.) SUBCHAPTER 9. (RESERVED) SUBCHAPTER 10. PATIENT OR RESIDENT SAFETY REQUIREMENTS AND REPORTABLE EVENTS 8:43E-10.1 Purpose (a) The purpose of this subchapter is as follows: 1. To implement the Patient Safety Act, N.J.S.A. 26:2H-12.23 through 12.25, to increase the safety of patients and residents in health care facilities by reducing the frequency and severity of preventable adverse events; and 2. To assure the Department receives timely notification of various events in health care facilities that may significantly affect their ability to continue to deliver health care services and/or may pose a danger to the life or safety of patients or residents, employees, medical staff or the public. 8:43E-10.2 Scope (a) This subchapter shall apply to all health care facilities licensed pursuant to N.J.S.A. 26:2H-1 et seq. and to State psychiatric hospitals operated by the Department of Human Services in accordance with the following: 1. For assisted living residences and comprehensive personal care homes licensed pursuant to N.J.A.C. 8:36, effective *[(12 months after the effective date of this subchapter)]* *March 3, 2009*; 2. For assisted living programs licensed pursuant to N.J.A.C. 8:36, effective *[(12 months after the effective date of this subchapter)]* *March 3, 2009*; 3. For long-term care facilities licensed pursuant to N.J.A.C. 8:39, effective *[(12 months after the effective date of this subchapter)]* *March 3, 2009*;
i. With respect to the mandatory reporting requirements found in N.J.A.C. 8:43E-10.6, Medicare and/or Medicaid nursing homes shall be deemed in compliance with N.J.A.C. 8:43E-10.6, provided they report in compliance with applicable Federal and State reporting statutes and regulations; 4. For home health care agencies licensed pursuant to N.J.A.C. 8:42, effective *[(180 days after the effective date of this subchapter)]* *August 30, 2008*; 5. For hospice care providers licensed pursuant to N.J.A.C. 8:42C, effective *[(180 days after the effective date of this subchapter)]* *August 30, 2008*; 6. For residential health care facilities licensed pursuant to N.J.A.C. 8:43, effective *[(12 months after the effective date of this subchapter)]* *March 3, 2009*; 7. For ambulatory care facilities licensed pursuant to N.J.A.C. 8:43A, effective *[(180 days after the effective date of this subchapter)]* *August 30, 2008*; 8. For adult and pediatric day health services facilities licensed pursuant to N.J.A.C. 8:43F, effective *[(12 months after the effective date of this subchapter)]* *March 3, 2009*; 9. For general, special, and psychiatric hospitals licensed pursuant to N.J.A.C. 8:43G, effective *[(the effective date of this subchapter)]* *March 3, 2008*; 10. For rehabilitation hospitals licensed pursuant to N.J.A.C. 8:43H, effective *[(the effective date of this subchapter)]* *March 3, 2008*; and 11. With respect to the following facilities operated or licensed by the Department of Human Services: i. For State psychiatric hospitals, effective *[(180 days after the effective date of this subchapter)]* *August 30, 2008*; and ii. For residential and outpatient substance abuse treatment facilities licensed pursuant to N.J.S.A. 26:2H-1 et seq., effective *[(180 days after the effective date of this subchapter)]* *August 30, 2008*. 8:43E-10.3 Definitions The following words and terms, as used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise: "Adverse event" means an event that is a negative consequence of care that results in unintended injury or illness, which may or may not have been preventable.
"Allergic reaction" means an abnormal immune response to a substance or allergen that does not normally cause a reaction and that results in a broad range of inflammatory responses. 1. Allergies are caused by inherited sensitivity or sensitivity acquired over time to a foreign substance. 2. Immediate reactions may be local, such as urticaria, angioedema, or systemic, such as severe bronchial obstruction, vasodilation, pulmonary edema, and shock. "Anonymous" means that information is presented in a form and manner that prevents the identification of the person filing the report. "Biologics" means therapeutics and products, including blood and vaccines, derived from living sources (such as humans, animals, and microorganisms). "Disability" means a physical or mental impairment that substantially limits one or more major life activities of an individual. 1. A physical impairment is any physiological disorder or condition, cosmetic disfigurement, or anatomical loss affecting one or more of the following body systems: neurological, musculoskeletal, special sense organs, respiratory (including speech organs), cardiovascular, reproductive, digestive, genitourinary, hemic, lymphatic, skin, and endocrine. 2. A mental impairment is any mental or psychological disorder, such as mental retardation, organic brain syndrome, emotional or mental illness, and specific learning disabilities. "Event" means a discrete, auditable, and clearly defined occurrence. "Health care facility" or "facility" means a health care facility licensed pursuant to P.L. 1971, c. 136, N.J.S.A. 26:2H-1 et seq. or a State psychiatric hospital operated by the Department of Human Services and listed in N.J.S.A. 30:1-7. "Health care professional" means an individual who, acting within the scope of her or his licensure or certification, provides health care services, and includes, but is not limited to, a physician, dentist, nurse, pharmacist or other health care professional whose professional practice is regulated pursuant to Title 45 of the Revised Statutes. "Health care system" means a licensed health care provider or entity that either owns and operates more than one licensed facility within the State or can document operational control over more than one licensed facility within the State, but is not a management company. "Hyperbilirubinemia" means bilirubin levels greater than 30 milligrams per deciliter. "Hypoglycemia" means a physiologic state in which the blood sugar falls below 60 milligrams per deciliter and physiological or neurological dysfunction begins. "Informed consent" means a process of communication between a patient and physician that results in the patient's written authorization or agreement to undergo a specific medical intervention.
"Kernicterus" means the medical condition in which elevated levels of bilirubin cause brain damage. "Low-risk pregnancy" means a pregnancy in a woman aged 18 through 39, with no previous diagnosis of essential hypertension, renal disease, collagen-vascular disease, liver disease, cardiovascular disease, placenta previa, multiple gestation, intrauterine growth retardation, smoking, pregnancy-induced hypertension, premature rupture of membranes, or other previously documented condition that poses a high risk of poor pregnancy outcome. "Medical device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease. "Medicare and/or Medicaid nursing homes" means a long-term care facility participating in Title XVIII (Medicare) and/or Title XIX (Medicaid) programs of the Federal Social Security Act (42 U.S.C. §§1396-1396v, subchapters XVIII and XIX). “Near-miss" means an occurrence that could have resulted in an adverse event, but the adverse event was prevented. "Neonate" means an infant in its first 28 days of life. "Patient or resident elopement" means a situation in which a registered or admitted patient or resident, excluding competent adults, leaves a health care facility without staff being aware that the patient or resident has done so. 1. In the case of a State-operated psychiatric hospital, patient or resident elopement shall be governed by the policies and procedures of the Department of Human Services with respect to elopement. "Pressure ulcer" means a skin ulcer that develops as a result of pressure on the skin. 1. "Pressure ulcer" does not include a skin ulcer that develops as a result of an underlying vascular etiology, including arterial insufficiency, venous insufficiency, and/or venous hypertension; or that develops as a result of an underlying neuropathy, such as a diabetic neuropathy. "Preventable event" means an event that could have been anticipated and prepared against, but occurs because of an error or other system failure. "Root cause analysis" or "RCA" means an in-depth analysis of a preventable adverse event that is designed to identify both direct and underlying causes of the event, in order to develop corrective actions that could reduce the potential for similar preventable adverse events in the future. "Serious preventable adverse event" means an adverse event that is a preventable event and results in death or loss of a body part, or disability or loss of bodily function lasting more than seven days or still present at the time of discharge from a health care facility.
"Spinal manipulative therapy" means all types of manual techniques, including spinal mobilization (movement of a joint within its physiologic range of motion) and manipulation (movement beyond its physiologic range of motion), regardless of their precise anatomic and physiologic focus or their discipline of origin. "Stage II pressure ulcer" means a pressure ulcer resulting in partial-thickness skin loss involving the epidermis or dermis. "Stage III pressure ulcer" means a pressure ulcer resulting in full-thickness skin loss involving damage or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. "Stage IV pressure ulcer" means a pressure ulcer resulting in full-thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structure such as tendon or joint capsules. "Surgery" means an invasive operative procedure in which skin or mucous membranes and connective tissue is resected, including minimally invasive procedures involving biopsies or placement of probes or catheters requiring the entry into a body cavity through a needle or trocar. 1. As used in this subchapter, "surgery" includes a range of dermatological procedures including biopsy, excision and deep cryotherapy for malignant lesions to extensive multiorgan transplant. 2. Surgery begins at point of surgical incision, tissue puncture, or insertion of an instrument into tissues, cavities or organs. 3. Surgery ends after the surgical incision has been closed and operative devices, such as probes, have been removed and counts have concluded, regardless of setting (recovery room or surgical suite.) "Toxic substance" refers to a chemical that is present in sufficient concentration to pose a hazard to human health. 8:43E-10.4 Patient or resident safety committee (a) Each facility shall establish a patient or resident safety committee, as applicable to the type of facility. 1. General hospitals shall establish a patient safety committee no later than *[(90 days after the effective date of this subchapter)]* *June 1, 2008*. 2. All other facilities shall establish a patient or resident safety committee no later than the *[operative]* *effective* date of this subchapter*,* applicable to the particular type of facility as set forth at N.J.A.C. 8:43E-10.2(a). (b) The purposes of the patient or resident safety committee are as follows: 1. To develop a patient or resident safety plan for the facility;
2. To conduct ongoing analysis and application of evidence-based patient or resident safety practices in order to reduce the probability of adverse events; and 3. To conduct analyses of near-misses and adverse events that occur within the facility, paying particular attention to serious preventable adverse events. (c) A facility shall comply with the following standards in establishing a patient or resident safety committee: 1. The patient or resident safety committee shall be comprised of at least the following individuals: i. A chairperson appointed by the chief executive officer (CEO) or administrator of the facility; ii. If the applicable licensing standards require the facility to have a medical director, then the medical director of the facility or equivalent position or the medical director's designee, who must also be a physician; iii. If the applicable licensing standards require the facility to have a chief nursing executive, a vice-president for nursing, or a director of nursing, then the chief nursing executive, vice-president for nursing, director of nursing of the facility or equivalent position or the designee of the chief nursing executive, vice-president for nursing or director of nursing, who must also be a nurse; and iv. The risk manager or other employee of the facility exercising primary responsibility for monitoring adverse events within the facility or the risk manager's designee. (1) For smaller facilities where there is no individual performing a separate risk management function, it is not necessary to have a separate risk manager represented on the committee; 2. When the nature of the facility and its staffing permits, the chairperson of the patient or resident safety committee shall also select ad hoc members for the patient or resident safety committee, based on the relevance of their job responsibilities and professional experience to the conduct of a root cause analysis of a specific adverse event or near-miss under investigation; 3. In the case of a facility that is part of a health care system that owns or operates multiple New Jersey facilities, the patient or resident safety committee may be operated at the system level, provided the following conditions are met: i. There is a representative from each New Jersey-licensed facility on the committee; and
ii. The system patient or resident safety committee ensures that each individual member facility's data related to patient safety remains distinctly identifiable; 4. The patient or resident safety committee shall not constitute a subcommittee of any other committee within a facility or health care system; 5. For all matters related to the patient or resident safety committee the chairperson of the patient or resident safety committee shall report directly to the CEO or other administrative head of the facility or system, unless the CEO is the chairperson; 6. The patient or resident safety committee shall meet at least quarterly, but may meet on a more frequent basis as needed and determined by the committee; and 7. The patient or resident safety committee shall document the proceedings of each meeting in minutes, which shall contain, at minimum, the following: i. The attendees at the meeting; ii. The date and time of the meeting; iii. A brief description of the issues discussed; and iv. The recommendations made by the committee. (d) To accomplish the purposes set forth in (b) above, the patient or resident safety committee shall perform the following activities: 1. Develop a written patient or resident safety plan for the facility, according to the requirements of N.J.A.C. 8:43E-10.5 no later than 180 days after the *[operative]* *effective* date of this subchapter*,* applicable to the particular type of facility as set forth at N.J.A.C. 8:43E10.2(a). i. There must be a facility-specific plan for facilities that are part of a health care system that employs a system patient or resident safety committee; 2. Review and revise, if appropriate, the patient or resident safety plan as often as the committee deems necessary, but at least once every three years; 3. Foster attitudes, beliefs, and behaviors supporting open communication within the facility about adverse events and near-misses by: i. Developing and implementing a training program for all professional and direct patient or resident care employees and medical staff enabling them to recognize and report to the patient or resident safety committee all serious preventable adverse events, as well as other adverse events and near-misses;
ii. Disseminating information to all employees and medical staff on the process for filing anonymous reports with the Department of near-misses and preventable events that are not serious preventable adverse events; and iii. Maintaining an internal tracking system for all reports of adverse events and near-misses that permits aggregation of the data and trend analysis; 4. Develop and recommend implementation of measures to minimize the risk of preventable adverse events; 5. Assure timely reporting to the Department or, in the case of a State psychiatric hospital, the Department of Human Services, of all serious preventable adverse events, in accordance with the requirements of N.J.A.C. 8:43E-10.6; 6. Review developments in evidence-based patient or resident safety practices appropriate to the services offered within the facility and recommend appropriate modification of facility policies and procedures to enhance patient or resident safety; 7. Except in the case of a Medicare and/or Medicaid nursing home, assemble an appropriate team to conduct a root cause analysis of every serious preventable adverse event, as well as at least one root cause analysis per year of a preventable adverse event that is not subject to mandatory reporting or of a near-miss reported to the patient or resident safety committee. i. Facilities, other than hospitals that do not belong to a health care system, may assemble a team of one and/or retain a consultant to perform the root cause analysis. ii. The patient or resident safety committee shall review the results of each root cause analysis and, as appropriate, recommend modification of facility systems, technology, policies or procedures to enhance patient or resident safety; 8. Analyze, on a quarterly basis, the aggregated data in the internal facility-specific tracking system to determine patterns of similar problems or events, which may otherwise not be detected by the patient or resident safety committee, in order to identify problems or events appropriate for further analysis; 9. Document whether the facility accepted, rejected, or modified the recommendations of the patient or resident safety committee for modifications in facility policies or procedures. i. In the case of rejection or modification of a recommendation, the patient or resident safety committee shall ensure that the documentation includes the rationale for the action taken; and 10. Monitor modified policies and procedures after implementation to determine the impact of the revised policies and procedures on preventable adverse events. 8:43E-10.5 Patient or resident safety plan
(a) Each facility shall develop, implement, and comply with a patient or resident safety plan that includes the following elements: 1. A process for facility staff to follow in reporting preventable adverse events and near-misses to the patient or resident safety committee. i. The reporting system established by the facility shall be accessible to facility staff at all times the facility is operating; 2. A process for conducting ongoing review and application of evidence-based patient or resident safety practices in order to reduce the probability of preventable adverse events; 3. Except for Medicare and/or Medicaid nursing homes, policies and procedures for the patient or resident safety committee to conduct root cause analyses of all serious preventable adverse events and annually at least one other preventable adverse event not subject to mandatory reporting, or a near-miss reported to the Committee. i. In selecting a case for root cause analysis of a near-miss or a preventable adverse event not subject to mandatory reporting, the patient or resident safety committee shall consider the seriousness of the resulting potential disability, observed trends or patterns, and the likelihood that a particular event would be repeated; 4. A process for monitoring the impact of changes recommended by the patient or resident safety committee and implemented by the facility; and 5. Policies and procedures for providing on-going training for facility personnel, including professional and direct patient or resident care employees and medical staff, as to the requirements of this subchapter and the facility's policies and procedures for assuring patient or resident safety. i. Current employees and staff shall undergo such training no later than one year following the operative date of this subchapter applicable to the particular type of facility as set forth at N.J.A.C. 8:43E-10.2(a). ii. New employees and staff shall undergo such training during the employee orientation. iii. The policies and procedures shall include a method for the facility to document that personnel have completed the required training. (b) The processes, policies, and procedures established pursuant to (a) above shall not eliminate or lessen a facility's obligation under applicable State licensure standards at Title 8 of the New Jersey Administrative Code or Federal Medicare Conditions of Participation to implement and maintain a continuous quality improvement program.
1. Investigation and analysis, as well as the recommendation and monitoring of the implementation of related corrective actions, of preventable adverse events and near-misses shall fall within the jurisdiction of the patient or resident safety program rather than the continuous quality improvement program. 8:43E-10.6 Reporting of serious preventable adverse events (a) A health care facility shall report to the Department or, in the case of a State psychiatric hospital, to the Department of Human Services, every serious preventable adverse event that occurs in the facility. 1. The Department shall deem Medicare and/or Medicaid nursing homes that are otherwise compliant with applicable Federal reporting statutes and regulations, as well as with N.J.S.A. 52:27G-7.1 and N.J.A.C. 8:39, to be in compliance with (a) above, and shall not require facilities deemed compliant to file reports in accordance with this section. 2. Adult and pediatric day health care service*s* facilities and facilities that provide home-based services, that is, home health care facilities*[;]**,* hospice facilities*[;]**,* assisted living residences*[;]**,* comprehensive personal care homes*[;]**,* and assisted living programs, shall report only those serious preventable adverse events that are within the control of the facility or directly caused by, or related to, services of the facility. i. With respect to serious preventable adverse events related to health care services provided directly to residents of an assisted living residence, comprehensive personal care home or assisted living program by another health care facility, the facility directly providing the service shall report the event to the Department. (b) A facility shall notify the Department, or the Department of Human Services, as applicable, of the occurrence of an event subject to mandatory reporting, pursuant to (a) above, no later than five business days after the facility discovers*[, or should have discovered,]* the occurrence of the event. 1. If a facility does not have all the information required pursuant to (c) below for a complete report, the facility shall submit a partial report on a serious preventable adverse event within the time specified in (b) above, and shall then update this initial partial report as soon as the other information required pursuant to (c) below becomes available. 2. If a facility discovers an event subject to mandatory reporting pursuant to (a) above and the event occurred in a different facility, such as the erroneous retention of an object in the body after surgery, the facility that discovers the event shall notify the Department within the time specified in (b) above, but shall be exempt from the requirement to perform a root cause analysis of the event. i. If the facility that discovers the event knows the identity of the facility where the event occurred, the reporting facility shall include this information in its notice to the Department.
(c) A facility shall submit, pursuant to (a) above, the form provided at subchapter Appendix A, incorporated herein by reference, which includes the following information: 1. The facility name, license number, and address, and the name and title of the person submitting the report; 2. A brief description of the event, including the impact on the patient or resident; 3. The date and time the event occurred; 4. Where the patient or resident was when the event occurred; 5. The date and time the facility became aware of the event; 6. How the event was discovered; 7. The patient or resident's billing and medical record number, date of admission or ambulatory encounter, demographic information, and, for inpatients, whether the patient was admitted directly, by transfer, or through the emergency department; 8. The type of serious preventable adverse event, using the categories provided at (e) through (j) below; 9. The immediate corrective actions the facility took to eliminate or reduce the adverse impact of the event and to prevent future similar events; 10. If the facility previously submitted a partial report on the event pursuant to (b)1 above, the report number assigned to the prior report by the Department; and 11. If the facility previously submitted a report on the event containing incorrect information, the report number assigned to the prior report by the Department and the correct information. (d) Facilities shall report the information required pursuant to (c) above by means of telefacsimile using the form provided in subchapter Appendix A. 1. The telefacsimile number to which facilities are to submit event reports to the Department is (609) 530-4850. 2. The telephone number facilities may use to obtain additional information concerning the event report and form is (609) 530-7473. (e) Types of serious preventable adverse events include, but are not limited to, the categories listed in (f) through (j) below.
1. A facility shall report in the appropriate category events that are not specifically listed that meet the definition of a serious preventable adverse event. 2. Based on the types of services a facility provides, some categories may not be applicable; for example, surgical events could only occur at facilities that perform surgical procedures. 3. For purposes of this section, "associated with" means that it is reasonable to assume initially that the serious preventable adverse event was due to the referenced course of care; however, further investigation or a root cause analysis of the event may be needed to confirm or refute the presumed relationship. (f) Patient or resident care management-related events include, but are not limited to: 1. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with a medication error (such as errors involving the wrong drug, wrong dose, wrong patient or resident, wrong time, wrong rate, wrong preparation, or wrong route of administration); 2. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with a hemolytic reaction due to the administration of ABO/HLAincompatible blood or blood products; 3. Maternal death, loss of body part, disability or loss of bodily function lasting more than seven days or still present at discharge associated with labor or delivery in a low-risk pregnancy while in a health care facility; 4. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge associated with hypoglycemia, the onset of which occurs while the patient or resident is being cared for in the health care facility; 5. Death or kernicterus associated with failure to identify and treat hyperbilirubinemia in a neonate while the neonate is a patient in a health care facility; 6. Stage III or IV pressure ulcers acquired after admission of the patient or resident to a health care facility. i. Progression from stage II to stage III is excluded from the meaning of (f)6 above, provided that stage II was recognized and documented upon admission; and 7. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with spinal manipulative therapy provided in a health care facility.
(g) Environmental events include, but are not limited to: 1. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with an electric shock while being cared for in a health care facility. i. Events involving planned treatments, such as electric countershock (heart stimulation) or elective cardioversion, are excluded from the meaning of (g)1 above; 2. Incidents in which a line designated for oxygen or other gas to be delivered to a patient or resident contains the wrong gas or is contaminated by toxic substances and results in patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge; 3. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with a burn incurred from any source while in a health care facility; 4. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with a fall while in a health care facility; and 5. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days, or in the case of a non-residential health care facility, still present at discharge, associated with the use of restraints or bedrails while in a health care facility. (h) Product or medical device-related events include, but are not limited to: 1. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with use of generally detectable contaminated drugs, medical devices, or biologics provided by the health care facility, regardless of the source of contamination or product. i. For purposes of (h)1 above, "generally detectable" means capable of being observed with the naked eye or with the use of detection devices in general use; 2. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days, or in the case of a non-residential health care facility, still present at discharge, associated with the use or function of a medical device in patient or resident care in which the device is used or functions other than as intended, including, but not limited to, catheters, drains, and other specialized tubes, infusion pumps, and ventilators; 3. Intravascular air embolism that occurs while the patient or resident is in the facility.
i. Paragraph (h)3 above does not include deaths or disability associated with neurosurgical procedures known to present a high risk of intravascular air embolism; and 4. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with the use of a new or reprocessed single-use device in patient or resident care in which the device is used or functions other than as intended. (i) Surgery-related events include, but are not limited to: 1. Surgery initiated (whether or not completed) on a patient that is not consistent with the patient's documented informed consent, including, but not limited to, a surgical procedure intended for a patient "A" that is initiated on the wrong body part of patient "A," and a surgical procedure intended for another patient of the facility, but initiated on patient "A". i. Surgery-related events exclude emergent situations that occur in the course of surgery and as to which exigency precludes obtaining informed consent; 2. Retention of a foreign object in a patient after surgery, excluding objects intentionally implanted as part of a planned intervention, objects present prior to surgery that were intentionally retained, and retained broken microneedles; and 3. Intraoperative or post-operative (that is, within 24 hours) coma, death, or other serious preventable adverse event in any patient of an ambulatory surgery facility, in any hospital same-day surgery patient, or in any American Society of Anesthesiologists (ASA) Class I hospital inpatient; i. Paragraph (i)3 above includes all patient deaths, coma or other serious preventable adverse events in situations where anesthesia was administered, regardless of whether the planned surgical procedure was carried out. (j) Patient or resident protection-related events include, but are not limited to: 1. Discharge of an infant to the wrong person, excluding patient or resident abductions covered under N.J.A.C. 8:34E-10.11(b); 2. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days associated with patient or resident elopement; and 3. Patient or resident suicide or attempted suicide while in a health care facility. i. Paragraph (j)3 above does not include deaths or disability resulting from self-inflicted injuries that were the reason for admission to the health care facility. (k) A facility shall submit to the Department a root cause analysis of every serious preventable adverse event subject to mandatory reporting pursuant to (a) above no later than 45 days after
the submission of the initial report of the event using the form provided at subchapter Appendix B, incorporated herein by reference. 1. The mailing address to which facilities are to submit reports to the Department is: Patient Safety Initiative Health Care Quality Assessment Department of Health and Senior Services 25 Scotch Road, Suite 10 Ewing, NJ 08628-2500 2. The Department shall deem Medicare and/or Medicaid nursing homes that are otherwise compliant with applicable Federal reporting statutes and regulations, and with N.J.S.A. 52:27G-7.1 and N.J.A.C. 8:39, to be in compliance with (k) above, and shall not require facilities deemed compliant to file root cause analyses in accordance with this section. 3. State-operated psychiatric hospitals shall comply with the requirements for submission of RCAs set forth in policies and procedures of the Department of Human Services. (l) The root cause analysis performed by a facility in response to a report of an occurrence of a serious preventable adverse event may vary in substance and complexity, depending on the nature of the facility and the event involved, but shall include the following general components: 1. A description of the event, including when, where and how the event occurred and the adverse outcome for the patient or resident; 2. An analysis of why the event happened that includes an analysis not only of the direct cause(s) of the event, but also potential underlying causes related to the design or operation of facility systems; 3. The corrective action(s) taken for those patients or residents affected by the event; 4. The method for identifying other patients or residents or settings having the potential to be affected by the same event and the corrective action(s) to be taken; 5. The measures to be put into place or systematic changes needed to reduce the likelihood of similar events in the future; and 6. How the corrective action(s) will be monitored to assess their impact. (m) The Department shall: 1. Review an RCA to determine whether it satisfies the criteria in (l) above; and
2. Return an RCA that does not meet the criteria in (l) above to the facility for revision and shall not consider the RCA complete until the Department determines that the RCA meets the criteria in (l) above. (n) The Department anticipates the development of an Internet web-based electronic reporting system, but in the interim shall require facilities to submit event reports pursuant to (d) above and to submit root cause analyses pursuant to (k) above. 1. The Department shall provide notice to facilities on the reporting medium to be used, including telephone and facsimile numbers, e-mail addresses and/or web addresses. (o) Single copies of the forms provided at subchapter Appendices A and B, suitable for photocopying, are available upon request to the Patient Safety Initiative at the address set forth at subsection (d) above and are also available for download from the Department's Forms web page at http://web.doh.state.nj.us/forms and also from the program's web page at www.nj.gov/health/hcqo/ps. 8:43E-10.7 Disclosure to patient or resident (a) A health care facility shall ensure that a patient or resident or, in the case of a minor or incompetent adult, the patient's or resident's personal representative, guardian, parent, or other family member, as appropriate, and provided disclosure is permissible under applicable confidentiality law, is informed of the following: 1. Any serious preventable adverse event that affected the patient or resident; and 2. Any adverse event resulting from an allergic reaction that was not previously documented in the patient's or resident's medical history. i. In the case of an allergic reaction, a facility shall arrange that the patient or resident be informed of other circumstances, if known, in which the same allergic reaction might occur, and of known preventive measures, if any, and shall arrange that the patient or resident be advised to inform any health care professionals providing future care of the allergic reaction. (b) The patient's or resident's attending physician, the facility administrator, the facility's medical director or another health care professional authorized in accordance with facility policies shall make the disclosure required pursuant to (a) above within 24 hours of the time the facility discovers the event. (c) A health care facility shall ensure that a patient or resident or, in the case of a minor or incompetent adult, the patient's or resident's personal representative, guardian, parent, or other family member, as appropriate, is informed of the event or allergic reaction in the following manner: 1. In person, if the patient or resident is still in the facility;
2. By telephone, if the patient or resident has left the facility and the facility is unable to arrange a face-to-face meeting; or 3. By certified mail, if the facility is unable to contact the patient or resident by telephone. (d) If the patient or resident's attending physician determines that informing the patient or resident of the event would seriously and adversely affect the health of a patient or resident who is a competent adult, then the facility shall ensure that the attending physician, the facility administrator, the facility's medical director, or another health care professional authorized in accordance with facility policies informs a family member of the event, if a family member is available and can be so informed without violating any applicable confidentiality or privacy law. 1. In selecting a family member to whom to make the disclosure required pursuant to this subsection, the facility shall accord first preference to a spouse*, a partner in a civil union,* or *a* domestic partner, then to adult children or parents, and then to siblings. 2. The facility shall ensure that the attending physician documents in the patient or resident's medical record the basis of the determination that disclosure of the adverse event to the patient or resident would seriously and adversely affect the patient or resident's health. (e) Notwithstanding (a) through (d) above, the facility shall ensure that information concerning the serious preventable adverse event or allergic reaction is not disclosed to a family member who is not the guardian or who does not have a medical power of attorney, if the patient has prohibited disclosure of his or her protected health information, in accordance with and subject to 45 CFR §164.522, to any family members. (f) In disclosing information in accordance with (b) or (c) above, the facility shall ensure that the following information is recorded in the patient or resident's medical record: 1. The time, date, and individuals present when the disclosure was made, and the person to whom the disclosure was made; and 2. A statement that the occurrence of a serious preventable adverse event or adverse event related to an allergic reaction, as applicable, was disclosed. (g) The facility may request written acknowledgement from the patient or resident, or the patient or resident's parent, guardian, or family member, as applicable, that the patient or resident or family member received information about the serious preventable adverse event or an allergic reaction. 1. If a facility requests written acknowledgment, the facility shall advise the patient or resident, or the patient or resident's parent, guardian, or family member, as applicable, that signing the acknowledgement is voluntary and in no way constitutes either a release from liability by the patient or resident or an admission of liability on the part of the physician or health care facility.
i. The facility shall provide this advice orally at the time it makes the request, and the acknowledgment form shall state at the beginning, in easily readable print, that signing the acknowledgement is voluntary and in no way constitutes either a release from liability by the patient or resident or an admission of liability on the part of the physician or health care facility. (h) Notwithstanding N.J.A.C. 8:43E-10.9, the patient or resident's medical record, excluding the information required in accordance with (f) above, shall be available to the patient or resident upon request, subject to discovery, and admissible as evidence or otherwise disclosed in a civil, criminal, or administrative action or proceeding. 8:43E-10.8 Voluntary, anonymous reporting system (a) Employees and health care professionals practicing at a health care facility may submit an anonymous report to the Department or, in the case of a State psychiatric hospital, the Department of Human Services, regarding preventable adverse events that are otherwise not subject to mandatory reporting, as well as near-misses. (b) The facility shall inform employees and health care professionals practicing at the facility of their option to file such anonymous reports of preventable adverse events not subject to mandatory reporting or of near-misses. 1. The facility shall make this information available through patient or resident safety training programs and by prominently posting it in locations accessible to employees and health care professionals. 8:43E-10.9 Confidentiality protections and restrictions on disclosure and use (a) Documents, materials, and information received by the Department or the Department of Human Services, as applicable, in accordance with N.J.A.C. 8:43E-10.6 and 10.8 shall not be: 1. Subject to discovery or admissible as evidence, or otherwise disclosed in any civil, criminal or administrative action or proceeding; 2. Considered a public record under P.L. 1963, c. 73 ( N.J.S.A. 47:1A-1 et seq.), or P.L. 2001, c. 404 ( N.J.S.A. 47:1A-5 et seq.); or 3. Used in an adverse employment action or in the evaluation of decisions made in relation to accreditation, certification, credentialing, or licensing of an individual, which is based on the individual's participation in the development, collection, reporting or storage of information in accordance with P.L. 2004, c. 9 ( N.J.S.A. 26:2H-12.23 through 12.25). (b) Documents, materials, and information (including RCAs and minutes of meetings) developed by a health care facility exclusively during the process of self-critical analysis, in accordance with N.J.A.C. 8:43E-10.4, 10.5 or 10.6 concerning preventable events, near-misses and adverse events, including serious preventable adverse events, and any document or oral statement that constitutes the disclosure provided to a patient or resident or the patient or resident's family member
or guardian, in accordance with N.J.A.C. 8:43E-10.7, as well as the entry in the medical record related to such disclosure, shall not be: 1. Subject to discovery or admissible as evidence or otherwise disclosed in any civil, criminal or administrative action or proceeding; or 2. Used in an adverse employment action or in the evaluation of decisions made in relation to accreditation, certification, credentialing or licensing of an individual, which is based on the individual's participation in the development, collection or reporting or storage of information in accordance with P.L. 2004, c. 9 ( N.J.S.A. 26:2H-12.23 through 12.25). (c) The confidentiality protection and protection from discovery or introduction into evidence provided in this section shall also apply to any person who performs responsibilities for or participates in meetings of the patient or resident safety committee. 1. These persons shall not be required to testify as to any matters within the knowledge gained by the person as a result of responsibility for or participation on the patient or resident safety committee. 2. These persons shall be allowed to testify as to any matters within their knowledge that was gained outside of their responsibility for or participation on the patient or resident safety committee. (d) Subsections (a) through (c) above shall not be construed to limit the ability of a health care facility to take disciplinary action against a health care professional in a case in which the professional has displayed recklessness, gross negligence or willful misconduct or where there is evidence, based on similar cases known to the facility, of a pattern of significant substandard performance that resulted in serious preventable adverse events. (e) Subsections (a) through (c) above shall not be construed to increase or decrease, in any way, the availability, discoverability, admissibility or use of any documents, materials or information otherwise available from other sources merely because the documents, materials or information were presented during proceedings of the patient or resident safety committee. (f) Notwithstanding (a) through (c) above, if information submitted to or developed by the patient or resident safety committee provides a reasonable basis to suspect criminal behavior on the part of anyone employed by, on the medical staff of, or acting as an agent of, a health care facility, the facility shall report such information to the appropriate police authorities and, as applicable, to the Department in accordance with N.J.A.C. 8:43E-10.11(b). (g) Notwithstanding (b) above, the patient or resident safety committee may release deidentified aggregate trend data on preventable adverse events and near-misses, and a facility may file reports, analyses or plans required pursuant to this subchapter without violating this section or compromising the protections afforded by this section to the reporter of such information, the patient or resident safety committee and the underlying data.
(h) Notwithstanding (a) through (c) above, the Department, or, in the case of a State psychiatric hospital, the Department of Human Services, may use information derived from confidential reports in order to promote increased patient or resident safety, or to develop recommendations to facilities on "best practices" and other modalities for improving safety in the delivery of health care services. (i) To accomplish the purposes of (h) above, the Department or the Department of Human Services may: 1. Use the root cause analysis process for oversight purposes to require corrective action by a facility to avoid or reduce the likelihood of similar serious preventable adverse events in the future. i. The Department or the Department of Human Services, as applicable, shall reserve punitive enforcement action for those cases in which a facility has displayed recklessness, gross negligence or willful misconduct, or in which evidence exists of a pattern of significant substandard performance that has the potential for or actually results in harm to patients or residents. ii. Information derived from confidential reporting that is used for oversight of facilities shall continue to be maintained as confidential and shall not be subject to discovery, admissible as evidence, or otherwise disclosed in any civil, criminal or administrative action or proceeding, and shall not be considered a public record; 2. Use de-identified information to alert other health care facilities of potentially harmful practices that should be avoided or amended; and 3. Use aggregated, de-identified data to determine Statewide averages and trends in reported preventable adverse events and near-misses within New Jersey heath care facilities, based on the type of facility. i. Any report produced using this data shall not include information reflecting specific facilities or health care professionals, but shall merely constitute a trend analysis. 8:43E-10.10 Interagency sharing and use of confidential information (a) Information received by the Department or the Department of Human Services, as applicable, shall be shared with the Attorney General, who may use the information in accordance with N.J.S.A. 26:2H-12.23 through 12.25. (b) Information derived from confidential reporting that is used for oversight of health care professionals shall be maintained as confidential and shall not be subject to discovery, admissible as evidence, or otherwise disclosed in any civil, criminal or administrative action or proceeding, and shall not be considered a public record under P.L. 1963, c. 73 ( N.J.S.A. 47:1A-1 et seq.) or P.L. 2001, c. 404 ( N.J.S.A. 47:1A-5 et seq.) 8:43E-10.11 Other reporting requirements unrelated to the Patient Safety Act
(a) A health care facility shall immediately report to the appropriate police authorities all criminal acts or *[suspected]* *potentially* criminal acts that occur within a facility and pose a danger to the life or safety of patients or residents, employees, medical staff or members of the public present in the facility. 1. "Acts occurring within a facility" means, in the case of a home-based service, that is, services provided by home health care facilities, hospice facilities, assisted living residences, comprehensive personal care homes, and assisted living programs, acts related to events within the control of the facility or directly caused by or related to services of the facility. (b) A facility licensed in accordance with N.J.S.A. 26:2H-1 et seq. shall notify the Department immediately of the types of reportable events described in (c) and (d) below. 1. The Department anticipates the development of an Internet web-based electronic reporting system but shall, in the interim, require facilities to submit the notice required pursuant to (a) above by means of telephone, facsimile, or e-mail, or a combination thereof. i. The Department shall provide notice to facilities on the reporting medium to be used, including telephone and facsimile numbers, e-mail addresses and/or web addresses. 2. In the case of acute care facilities, "immediately" means no later than three hours after discovery of the event. 3. In the case of long-term care facilities, "immediately" means telephonic notification *[of]* *to* the Department *[upon the facility's discovery of the event]* at *[(609) 633-9034, or]* (609) 392-2020 *[after business hours,]* followed by written notification within 72 hours. (c) Examples of reportable events in the nature of physical plant and operational interruptions, include, but are not limited to, the following: 1. Loss of heat or air conditioning; 2. Loss or significant reduction of water, electrical power, or any other essential utilities necessary to the operation of the facility; 3. Fires, disasters, or accidents that result in injury or death of patients, residents or employees, or in evacuation of patients or residents from all or part of the facility; 4. A labor stoppage or staffing shortage sufficient to require the temporary closure of a service; and 5. Notices of a potential strike that a facility receives from an employee bargaining unit.
i. The report shall be accompanied by the facility's plan to continue service operations in the event the strike occurs. ii. Such a plan shall be considered proprietary, emergency and/or security information within the meaning of N.J.S.A. 47:1A-1.1 and therefore shall not be considered a "government record" subject to public access or inspection within the meaning of N.J.S.A. 47:1A-1 et seq. iii. In the event the strike is either averted or settled, the Department shall destroy all copies it has received of the facility's strike plan. (d) Examples of reportable events in the nature of *[alleged]* *potentially* criminal acts include, but are not limited to, the following: 1. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider; 2. Abduction of a patient or resident of any age; 3. Sexual assault on a patient or resident, staff member, or visitor within or on the grounds of a facility; and 4. Death or significant injury of a patient or resident, staff member, or visitor resulting from a physical assault that occurs within or on the grounds of the facility. (e) A health care facility shall report incidents of infectious and communicable diseases to the Department pursuant to N.J.A.C. 8:57.
APPENDIX A and B are available on the Patient Safety Initiative website at the link below: http://nj.gov/health/ps/documents/final_directions_march08.pdf
CHAPTER 43G HOSPITAL LICENSING STANDARDS SUBCHAPTER 6. ANESTHESIA 8:43G-6.10 Anesthesia continuous quality improvement (a)-(b) (No change.)