N J A C A - Ambulatory Care Facility Licensure Standards

40 N.J.R. 702(a) January 22, 2008 RULE ADOPTION HEALTH AND SENIOR SERVICES SENIOR SERVICES AND HEALTH SYSTEMS BRANCH HEALTH FACILITIES EVALUATION AND LICENSING DIVISION OFFICE OF CERTIFICATE OF NEED AND HEALTHCARE FACILITY LICENSURE HUMAN SERVICES DIVISION OF ADDICTION SERVICES Readoption with Amendments: N.J.A.C. 8:43A Adopted Repeal and New Rule: N.J.A.C. 8:43A-19.7 Adopted Repeal: N.J.A.C. 8:43A-6.9 Manual of Standards for Licensing of Ambulatory Care Facilities Proposed: June 18, 2007 at 39 N.J.R. 2309(a). Adopted: December 10, 2007 by Fred M. Jacobs, M.D., J.D., Commissioner, Department of Health and Senior Services (with the approval of the Health Care Administration Board) (except as N.J.A.C. 8:43A applies to drug abuse treatment facilities) and December 11, 2007 by Jennifer Velez, Esq., Commissioner, New Jersey Department of Human Services (as N.J.A.C. 8:43A applies to drug abuse treatment facilities). Filed: December 21, 2007 as R.2008 d.24, with technical and substantive changes not requiring additional public notice and comment (see N.J.A.C. 1:30-6.3), with the proposed repeal of N.J.A.C. 8:43A-3.12 not adopted. Authority: N.J.S.A. 26:2H-1 et seq., specifically 26:2H-12.5; and Reorganization Plan No. 002-2004 (Governor McGreevey, February 5, 2004) 36 N.J.R. 1149(a) (March 1, 2004). Effective Date: December 21, 2007, Readoption; January 22, 2008, Amendments, Repeals, and New Rules. Expiration Date: December 21, 2012. Agency Note: N.J.A.C. 8:43A contains provisions applicable to ambulatory healthcare facilities, including drug abuse treatment facilities. Reorganization Plan No. 002-2004 (Governor McGreevey, February 5, 2004) 36 N.J.R. 1149(a) (March 1, 2004) transferred jurisdiction to implement statutory mandates addressing addiction services in New Jersey, including licensure of drug abuse treatment facilities, from the Department of Health and Senior Services to the Department of Human Services. The 40 N.J.R. 702(a) January 22, 2008 Department of Human Services is in the process of promulgating rules that would relocate and reestablish rules relating to addiction services within Title 10 of the New Jersey Administrative Code (hereinafter referred to as the "anticipated rulemaking"). Subsequent to the publication of the proposal that is the subject of this notice of adoption, the Commissioner of Human Services concurred in the readoption of the existing rules at N.J.A.C. 8:43A addressing licensure of drug abuse treatment facilities that are ambulatory care facilities, to ensure continuity of existing licensure standards for such facilities pending the conclusion of the anticipated rulemaking, and concurs in the adoption of the proposed readoption with repeals, amendments, and new rule, as reflected in this notice of adoption. N.J.A.C. 8:43A-26 contains provisions specifically applicable to drug abuse treatment facilities, and incorporates by reference N.J.A.C. 8:43A Appendix A, the Drug and Alcohol Admission Record. However, provisions applicable to drug abuse treatment facilities appear throughout N.J.A.C. 8:43A, such as at N.J.A.C. 8:43A-1.3, which contains definitions of terms used in N.J.A.C. 8:43A-26 and elsewhere throughout the chapter. Thus, the respective Commissioners' jurisdiction overlaps with respect to some provisions. Staff of both Departments will work cooperatively in connection with the anticipated rulemaking to ascertain which provisions of N.J.A.C. 8:43A can be proposed for deletion (and reestablishment as part of Title 10, as appropriate, in the anticipated rulemaking) as being applicable exclusively to drug abuse treatment facilities, and which should be retained as applicable to other types of facilities. Summary of Public Comments and Agency Responses: The Department of Health and Senior Services (Department) received comments from the persons and entities listed below. The numbers in parentheses following each comment correspond to the commenters listed below. 1. Gail Callandrillo, Vice President, Planning and Market Research, The Valley Hospital, Valley Health System, Ridgewood, NJ; 2. Diane DiGiulio, RN, MPA, Executive Director, New Jersey Kidney Stone Center, LLC, Manalapan, NJ; 3. John D. Fanburg, Esq., WolfBlock Brach Eichler, Roseland, NJ, on behalf of the Radiological Society of New Jersey; 4. Katherine Grant-Davis, President and CEO, New Jersey Primary Care Association, Inc., Hamilton, NJ; 5. Deborah Haggett, Administrator, Mid-Atlantic Stone Center, Marlton, NJ; 6. Eileen Kean, Esq., Director of Governmental Affairs, Medical Society of New Jersey, Lawrenceville, NJ; 7. Steven M. Lomazow, M.D., President, Neurological Association of New Jersey, Parsippany, NJ, on behalf of the American Academy of Neurology, the American Society of Neuroimaging, and the Neurological Association of New Jersey; 8. Richard Mackesy, Vice President, CentraState Healthcare System, Freehold, NJ; 9. Caswell L. Samms, Vice President of Finance and Planning, East Orange General Hospital, East Orange, NJ; 2 40 N.J.R. 702(a) January 22, 2008 10. Valerie Sellers, Senior Vice President, Health Planning and Research, and Jill Squiers, Assistant Vice President, Health Planning, New Jersey Hospital Association, Princeton, NJ; 11. James C. Wallace, Senior Vice President Advocacy and Institutional Advancement, Lourdes Health System, Camden, NJ. 1. COMMENT: A commenter states that it "represents the 19 Federally Qualified Health Centers (FQHCs) in New Jersey." The commenter states that in the past, N.J.A.C. 8:43A proved "quite burdensome for community health centers." The commenter states that it provided the Department with a position paper in August 2004, "advising of the problems that community health centers were having with current State licensing requirements for ambulatory facilities," and in which the commenter noted, "40 states do not license primary care sites preferring to spend their precious resources on other entities such as renal centers, surgical centers, and hospitals," and in which it "suggested that a task force be formed to . . . come up with recommendations for eliminating, reducing or development of tiered regulations for primary care sites." The commenter states that in its response to the position paper, "development of a task force was not approved and no changes were even considered. It is of no surprise that this issue continues to be problematic for the community health centers in New Jersey. Numerous meetings with the [Department] have not resulted in any changes to the regulatory requirements. In early 2007, the [commenter] was asked by the [Department] to submit any requested changes to the regulations for consideration prior to the regulation being readopted. . . [Not] one change that was recommended by the [commenter] was included. The [Department] chose instead to readopt the bulk of the regulations as is, with only technical amendments. This was a golden opportunity for the State of New Jersey to realign itself with regulatory agencies in other states, and make substantive changes to requirements that have been on the books for years. At this point, the same regulation that have been troublesome for the past [five] years are being proposed for readoption even though the [commenter has] commented that the regulation needed numerous changes and updates. The [commenter states] that the refusal of the [Department] to even review or consider any suggestions to these regulations is punitive to all ambulatory providers and the patients that they serve. In addition, the [Department] has not even begun to look at the problems imposed by the proliferation of clinics in retail stores. The services that they provide are nearly identical to those delivered at small primary care sites. These retail clinics have no regulations yet health centers are regulated under the same requirements used to oversee ambulatory surgical centers. This does not provide for equitable treatment." The commenter states that the Department should "consider exempting centers from the regulatory requirements that are currently in the regulations. Absent that, the [commenter] urges the [Department] to take the following actions with respect to . . . N.J.A.C. 8:43A . . . as those regulations apply to FQHCs: a. delete the requirements regarding general dental practice as they currently apply to FQHCs; 3 40 N.J.R. 702(a) January 22, 2008 b. revise the definition of 'operating room' to exclude a room that is specifically dedicated to one or more of the following: colposcopic or loop electrosurgical excision procedures[,] or cryosurgery; c. permit each FQHC to employ an administrator and structure its organization as the FQHC will best meet its operational needs, provided that the center conforms with current medical practice standards and federal grant requirements; d. permit each FQHC to designate its administrator as the administrator of an affiliated satellite and to designate an alternate contact in the event that the administrator is inaccessible; e. require that the director of nursing, or a person who holds a similar title, for an FQHC have at least one year of full-time experience, or its equivalent, in an ambulatory care setting, nursing, or nursing administration; f. delete the requirements governing discharge, transfer, and readmission of patients as they are currently applied to FQHCs, since the actions governed thereby are not applicable to these centers; g. permit the chief operating officer of an FQHC to designate a physician to serve as its medical director; h. permit each FQHC to satisfy the requirement of having a registered professional nurse who is director of nursing, or holds a similar title, on the premises during its hours of operation, by having another clinical professional or other qualified emergency medical services personnel on site during the hours of operation; i. permit each FQHC to satisfy emergency services and disaster plan requirements by meeting applicable requirements of The Joint Commission; j. permit each FQHC to satisfy the requirement of having a person with a health care background responsible for the direction, provision and quality of infection, prevention and control services by having a biannual review of the site by an infectious disease consultant or, if the center meets applicable requirements of The Joint Commission, having an infection control officer who is designated in accordance therewith; k. delete the requirements governing physical plans for new construction or alterations, since these plans must conform with local building codes, and undergo review and secure approvals by municipal government agencies; l. delete the requirement for FQHCs to maintain a separate room for washing dirty laundry for those centers that use only disposable laundry products; and m. require direct notification of each FQHC by the Department. . . of proposed and adopted regulations in writing, with new language identified by bold print and deleted language printed in italics." (4) RESPONSE: The Department disagrees with the commenter's assertion that N.J.A.C. 8:43A has been burdensome to all ambulatory care facilities. As stated in the Regulatory Flexibility Analysis on proposal, "the rules proposed for readoption and the proposed amendments, repeals and new rule establish the minimum standards necessary to ensure quality, uniformity, and professionalism in the provision and oversight of ambulatory care facility services and the construction of ambulatory care facilities in New Jersey." See 38 N.J.R. 2309(a), 2315 (June 18, 2007). 4 40 N.J.R. 702(a) January 22, 2008 With respect to community health centers specifically, the Department has recognized the importance of facilitating the appropriate distribution of Federally Qualified Health Centers (FQHCs) in New Jersey and has worked diligently with community health centers to improve the availability and accessibility of primary care services to those in need. Department staff members have worked diligently with FQHCs to find ways for them to comply timely with what are minimum standards of quality care. Department efforts toward this end include: A. Initiation of quarterly meetings with FQHCs to discuss licensing and inspection issues; B. Development of an agreement with the Department of Community Affairs (DCA) so that architectural staff of the Department can review and approve FQHC architectural plans on a priority basis, thereby enabling FQHCs to obtain local building permits without the time and expense of a DCA staff review; C. Initiation of a process through which FQHCs may initiate new sites and services by written attestation of compliance with licensing standards, thereby eliminating delays attendant to Department site inspection prior to approval; D. Assignment of a dedicated staff person in the Department's licensing unit to handle FQHC issues, questions, and licensing applications, thereby ensuring a more collegial, timely, and consistent approach to FQHC licensing; and E. Coordination of licensing assistance for FQHCs both within the Department and with the Department of Human Services for behavioral health services licensed by the latter. The Department has taken these extraordinary steps in recognition of the importance of primary healthcare services to medically underserved populations in New Jersey. The changes the commenter recommends would not provide the oversight that licensure implies and that the public expects. The commenter articulates no rationale for disparate licensure treatment of community healthcare centers and FQHCs. The licensing requirements provide minimum standards of quality of care that medically underserved community members, the core constituency of FQHCs, deserve, as much as others do. The Department's surveys of some FQHCs have found deficiencies relating to infection control, dental care, staffing, and physical plants. Implementation of the commenter's recommendations would undermine minimum standards to ensure quality of care. The commenter's recommendation "m" would impose a burden on the Department that exceeds the Department's rulemaking obligations established in the Administrative Procedures Act, N.J.S.A. 52:14B-1 et seq., and the rules promulgated pursuant thereto, the Rules for Agency Rulemaking, N.J.A.C. 1:30, to which the Department adheres in the conduct of rulemaking. N.J.A.C. 8:43A contains subchapters dedicated to specific categories of ambulatory care facility service delivery based on the unique attributes of the particular service, such as surgery, dialysis, and lithotripsy. However, the commenter's suggestion that the Department tailor general requirements for specific categories of ambulatory care facilities that are FQHCs is inappropriate to the issue of facilitating the availability and accessibility of quality primary care services in New Jersey. Members of the Department's licensing staff routinely work with potential health care providers, on a case-by-case basis, to facilitate the introduction of quality ambulatory care services 5 40 N.J.R. 702(a) January 22, 2008 throughout the State. Specifically, the Department conducts a "functional review" pursuant to N.J.A.C. 8:43A-2.5(b) (proposed to be renamed from "preliminary conference"), to assist potential ambulatory care facility applicants in understanding the requirements of N.J.A.C. 8:43A. These reviews are useful for both potential providers and Department staff in familiarizing each other with the often-unique circumstances potential licensing locations implicate. While this individualized process is timeconsuming, it has proven itself necessary in many cases to reveal, as early as possible, the need for corrective measures or waiver applications that could remedy potential non-compliant licensing issues. The Department expects to continue this approach, as technological change provides increased opportunities to provide a greater array of health care services and settings (for example, retail clinics) that may seek special licensure considerations or exemptions. Entities that have approached the Department with respect to retail clinic operations have generally provided documentation showing that one or more private physicians own the retail clinic. This establishes that the clinic's operation consists of the private practice of medicine, over which the State Board of Medical Examiners in the Division of Consumer Affairs of the Department of Law and Public Safety, and not the Department, has jurisdiction. Therefore, the commenter is incorrect in stating that these entities are subject to no regulation, as they are subject to the oversight and rulemaking of that Board. The sharp increase in the number of ambulatory care facilities licensed in the State, including a significant increase in the number of FQHCs, suggests that N.J.A.C. 8:43A is not so burdensome as to preclude the establishment and operation of such facilities. Moreover, N.J.A.C. 8:43A-2.9 establishes a procedure by which facilities can apply to the Department for waiver of specific provisions of the chapter, provided that such a waiver would not endanger the life, safety, or health of patients or the public. Through judicious use of this provision, the Department has worked and will continue to work with prospective FQHCs to facilitate their licensure. For the foregoing reasons, the Department declines to make changes on adoption in response to the commenters' suggestions. 2. COMMENT: A commenter states that it "has advocated for several years for additional reporting, quality assurance and patient safety measures, all of which are already required for hospitals. . . In light of efforts by states and the federal government to enhance patient safety and healthcare quality, [the commenter] was very surprised to learn [ N.J.A.C. 8:43A was] proposed for readoption without incorporating substantive changes to ensure that patients are assured safe and quality care no matter where they access services." The commenter states, "there has been a dramatic increase in the number of ambulatory care facilities in New Jersey in the last decade . . . following deregulation in 1998. The number of free-standing facilities currently totals more than 600, with approximately 105 offering ambulatory surgery." The commenter states, "In New Jersey, the move from hospital-based care to ambulatory care facilities is demonstrated by an examination of the [uniform bill] (UB) data submitted by hospitals. Although the state does not collect claim and utilization 6 40 N.J.R. 702(a) January 22, 2008 data from ambulatory care centers, the negative effect following the establishment of such facilities can be seen in the decline in the number of hospital-based same day surgeries. In reviewing codes for 11 procedures commonly provided in an outpatient setting--such as cataract removal, colonoscopy and knee arthroscopy--the [commenter] found that the number of surgeries performed in hospital-based outpatient departments declined 20 percent between 2000 and 2005. It is presumed that these procedures moved from the hospital outpatient Department to an ambulatory surgery center, particularly considering the substantial increase in the number of facilities during that same period." The commenter states, "Considering the number of patient that seek care at ambulatory facilities [footnote omitted] and the increasing number of surgical procedures that are performed in non-hospital settings, [the commenter] established a task force in 2004 that examined issues related to ambulatory care, with a particular focus on quality and patient safety to ensure a level of safety for consumers. Over the course of two years, [the commenter]--at the direction of the task force--carefully researched existing requirements related to hospitals, ambulatory facilities and physicians' offices, as well as standards established by the leading national accrediting organizations for ambulatory care. The result is a comprehensive study of the variances between quality and reporting standards for each care setting." "[The commenter recognizes] that because [the commenter's] recommendations were not included as amendments in the proposal they cannot be adopted during this cycle of rulemaking. Consequently, [the commenter] requests that [the Department] continue to move forward with developing amendments for a new proposal before the end of the year. Although the [Department] has indicated in previous discussions that many of the [commenter's] concerns would be addressed by regulations implementing the Patient Safety Act, our analysis of those regulations finds that only one of [the commenter's] many recommendations is included. The Patient Safety Act . . . and the corresponding regulations proposed at N.J.A.C. 8:43E-10 are a necessary step toward increasing reporting and the evaluation of adverse events. However, there are additional measures that must be required of ambulatory care facilities to mitigate what is currently a dual standard of care. And while much rulemaking related to healthcare delivery in New Jersey has been put on hold pending the final report from Governor Corzine's Commission on Rationalizing Health Care Resources, it is [the commenter's] understanding that that the commission is almost focused exclusively on the financial stability of hospitals and is unlikely to address concerns related to quality and safety in ambulatory care facilities. Accordingly, [the commenter] believes [the Department] must act now to address the disparities in the level of oversight between hospitals, physician offices and ambulatory care centers. ... Uniform Bill Data and Report Cards [The Department] should convene task forces to develop 'report cards' to be provided to the public to assist [the public] in [its] decision-making as to where to access services. Ambulatory surgical centers should be the first facilities subject to public 7 40 N.J.R. 702(a) January 22, 2008 reporting. As least five states publish data related to facility usage and services: Idaho, Kentucky Maryland, Pennsylvania and Utah. The development of report cards would necessitate the adoption of uniform bill standards for ambulatory care facilities, which, unlike hospitals, are not required to use uniform bills or submit encounter[-]level data to the state. . . [The Department] already publishes report cards related to the following services and providers: Hospitals[,] Cardiac surgery[,] Nursing homes[, and] HMOs[. The Department should amend] licensing rules to require submission of uniform bills-similar to the UB04 (formerly UB92) used by hospitals--to the [Department], which would allow the reporting and tracking of utilization, reimbursement and referrals patterns by the Department. Ultimately [the Department] should develop report cards on individual facilities so that patients would have tools to assist them in their decisionmaking process." (10) RESPONSE: The Department agrees with the commenter's assertion that the Department needs to review ambulatory care facility reporting requirements and that patient safety must be the focus of all healthcare delivery and licensure activity. The Department has maintained, and expects to continue to maintain, a dialogue with hospital and ambulatory care facility stakeholders. The Department has convened a working group to evaluate disparities in the level of oversight that may exist among the various types of health care facilities the Department regulates and to develop, as appropriate, uniform requirements among all facility categories for information reporting, such as adverse events. Governor Corzine established Commission on Rationalizing New Jersey' Health Care Resources (Commission) by issuing Executive Order No. 39 (Governor Corzine, October 12, 2006), 38 N.J.R. 4529(a) (November 6, 2006), available at http://www.state.nj.us/infobank/circular/eojsc39.htm; see also http://nj.gov/health/rhc/index.shtml (Commission website). After the Commission issues its final report, the Department will reconvene stakeholders to review existing substantive reporting requirements for hospitals and ambulatory care facilities and the appropriateness of implementing measures in response to the Commission's report, such as establishing measures to gauge facility performance or issuing "report cards" similar to those the Department issues with respect to other types of facilities. 3. COMMENT: "Accreditation [The Department] should enforce existing licensing regulation to ensure that ambulatory care facilities are meeting at least a national minimum standard of performance for quality. A comprehensive review of standards implemented by accrediting agencies found many provisions addressing quality and safety that are not included in New Jersey's standards. Such certification would provide some level of assurance to the public that they have met at least a minimum standard of performance. Accrediting bodies are generally independent entities that establish standards for ensuring and continuously improving the safety and quality of care provided to the public at healthcare facilities. Most have a comprehensive accreditation process that evaluates, through on-site surveys, an organization's compliance with the standards. Additionally, on-site surveys conducted by accrediting agencies could relieve some 8 40 N.J.R. 702(a) January 22, 2008 oversight pressure on [the Department], which has indicated it does not have the resources to conduct regular inspections of facilities unless in response to a complaint." With respect to N.J.A.C. 8:43A-3.12(b), particularly the following sentence: "A full license shall not be issued upon expiration of the temporary license unless the report of the independent survey is submitted in accordance with this rule," the commenter recommends that until the Department "has promulgated amendments to the ambulatory facility licensing regulations, facilities should be required as a condition of licensure to seek accreditation from a nationally recognized accrediting agency that has deeming authority from CMS." (10) RESPONSE: N.J.A.C. 8:43A-3.12 requires ambulatory surgery facilities to report data and to adhere to auditing and certification requirements as part of the annual license renewal process. The proposal Summary indicates that the proposed repeal of N.J.A.C. 8:43A-3.12 stems from the statutory removal of ambulatory surgery services from the certificate of need requirement. Preliminary discussions arising from the work of the Commission indicate that changes to establish parity of the regulatory requirements applicable to ambulatory care facilities and hospitals may be appropriate to establish uniformity among these licensed facilities to ensure patient safety and quality of care. The Department anticipates further discussions with members of the regulated community and other stakeholders to address the final report and recommendations of the Commission. The Department anticipates addressing with these stakeholders the establishment of appropriate measures to reduce potential disparities in the levels of Department oversight of the various health care facilities the Department regulates to ensure quality of care and patient safety. Some of the measures the Department expects to address with these stakeholders include requiring uniformity among licensed facilities in data and adverse event reporting and auditing and certification, establishing outcome measures to gauge facility performance, and issuing report cards. Therefore, in response to the comment, and to maintain the status quo pending the conclusion of the Department's activities in response to the Commission's final report, the Department will not adopt the proposed repeal of N.J.A.C. 8:43A-3.12. An additional rationale for the Department's determination not to repeal N.J.A.C. 8:43A-3.12 is the Department's continued reliance on N.J.A.C. 8:43A-3.12(b) to require licensed ambulatory surgical facilities to provide a status report as to their compliance with the certification requirement in that subsection. The Department is evaluating alternatives to the annual survey process as a basis for the determination of licensure compliance. 4. COMMENT: "Adverse Event Reporting [The commenter's] task force recommends that facilities report events that jeopardize the health or safety of patient, including surgical site infection adverse drug reactions and a host of other events that hospitals currently are required to report. In fact, adverse event reporting provisions should be written in such a way as to capture any complication or unplanned outcome related to services provided in an ambulatory care facility. Patient Safety Act regulations would repeal [N.J.A.C.] 8:43A-3.8 and replace it with reporting requirements related to serious preventable events, but 9 40 N.J.R. 702(a) January 22, 2008 unplanned, emergent surgical complications are excluded from the definition of reportable surgical events. Moreover, while the Patient Safety Act rules will require the reporting of intra- and post-operative events that occur within 24 hours of surgery, there is no requirement to track outcomes beyond 24 hours or to monitor whether patients are admitted to a general acute care facility after being discharged from an ambulatory surgery center." The commenter recommends that the Department "add several elements to the definition of an adverse event to ensure that any complications must be reported, and ensure that complications arising more than 24 hours after surgery are included in the list of reportable events. Specifically, [the Department should require that] a report be made in any of the following circumstances: -- transfer of a patient to a general acute care hospital -- unplanned hospital admission -- any death occurring in an accredited facility or occurring within [30] days of a surgical procedure performed in an accredited facility -- untoward result of procedure such as infection, bleeding, wound dehiscence or inadvertent injury to other body structure -- cardiac or respiratory problems during stay at facility or within 48 hours of discharge -- medication event meaning patient death, serious disability or allergic reaction associated with a medication error (errors involving the wrong drug, wrong patient, wrong time, wrong rate, wrong preparation or worn route of administration) -- surgical event meaning surgery performed on the wrong body part, or on the wrong patient or retention of foreign objects in patient after surgery -- patient or family complaint -- equipment malfunction The American Association for Accreditation of Ambulatory Surgery Facilities and a new law in New York for office-based surgeries reflect many of these provisions." (10) RESPONSE: The changes suggested by the commenter relate to the proposed amendments, new rules and repeals to implement the Patient Safety Act that appears at 39 N.J.R. 314(a) (February 5, 2007), and are improperly submitted in response to this rulemaking. To the extent the commenter timely filed comments in response to that rulemaking, the Department will address them in the notice of adoption implementing that rulemaking. However, as a general response to the comment, as stated in response to previous comments, the Department will be reviewing the final report and recommendations of the Commission and will be meeting with stakeholders to respond to those recommendations. Among the issues the Department anticipates addressing with the stakeholders is the appropriateness of changes to establish parity in the regulatory requirements applicable to all licensed facilities as indicated to ensure patient safety and quality of care. Pending the conclusion of the Department's work in response to the final report and recommendations of the Commission, the Department will make no change on adoption in response to the comment. 10 40 N.J.R. 702(a) January 22, 2008 5. COMMENT: "Length of Stay [The Department should ensure] that procedures performed at ambulatory care centers are consistent with the definition at [N.J.A.C.] 8:43A-1.3, which states ambulatory surgery generally does not require an overnight stay. The prohibition on overnight stays already applies to same-day surgical procedures performed at hospital outpatient departments ([N.J.A.C.] 8:43G-32.10). Additionally, such restrictions would be consistent with CMS, which excludes certain services from payment when performed at an ambulatory surgery center in an effort to limit covered procedures to only those that may be safely provided in the ambulatory care setting. Specifically, services that require an operation of more than 90 minutes to perform, or more than 90 minutes of anesthesia, or more than four hours of recovery time are all excluded ( 42 CFR §416.65(b)). Conversely, New Jersey does not limit the services that ambulatory care facilities may provide, so long as the service does not require a CN and the facility is licensed to provide it. The only limitation imposed by the State is found elsewhere in regulation, and states that a patient's admission may not last more than 24 hours." The commenter recommends that the Department amend N.J.A.C. 8:43A-1.3 "to state 'surgical procedures requiring the patient to remain in the facility beyond midnight of the day of treatment shall not be performed.' Because CMS restrictions only apply to Medicare reimbursement, New Jersey should adopt similar standards that would apply to all facilities, regardless of reimbursement source." (10) RESPONSE: N.J.A.C. 8:43G-32.10 establishes requirements applicable to hospitals with separate, designated units or services for medical same-day stays. N.J.A.C. 8:43G-32.10(b) defines same-day medical services as elective treatments, and diagnostic and non-surgical procedures, and does not apply to same-day surgical patients. Thus, these two categories of patients are not comparable. N.J.A.C. 8:43A12.1(b), which prohibits a patient from remaining in a facility for more than 24 hours, is an appropriate standard that the Department has consistently applied for decades without implicating significant quality of care issues. This existing standard permits facilities to cater to clients with impediments to their ability to schedule surgery (that is, limited sick and/or vacation time), by allowing facilities to extend the scheduling of cases into the evening and after the workday has ended. The Department's primary focus continues to be on a facility's compliance with licensing rules throughout their hours of operation rather than with an arbitrary regulatory curfew on patient surgery or recovery. The Department is willing to discuss this issue further with stakeholders and, in fact, has begun that process; however, for the reasons stated above, the Department will make no change on adoption in response to the comment. 6. COMMENT: "Transfer Agreements [The Department] should require ambulatory facilities to maintain agreements with neighboring acute care hospitals to provide back up services in the event of adverse reactions or other emergencies that the facility is unable to address. Written transfer agreements that contain specific elements required by [the Department] would ensure that all ambulatory facilities properly arrange for and notify hospitals of pending transfers, consistent with transfer arrangements required by [N.J.A.C.] 8:43A-24.3 regarding dialysis services and [N.J.A.C. 8:43A-]28.11 related to birth centers. When 11 40 N.J.R. 702(a) January 22, 2008 [the commenter] conducted its review of existing requirements across all providers, [the commenter] found that the Board of Medical Examiners has adopted more stringent standards for individual physician practices than what is currently required by the [Department] for ambulatory surgical facilities. For example, hospitals and physicians are required to establish transfer agreements that contain very specific provisions delineating each party's responsibility and under what conditions a patient may be transferred. However, none of that is required for ambulatory care centers, although general hospitals too often must serve as an emergency back-up when complications arise." The commenter recommends that the Department amend [N.J.A.C. 8:43A-3.1] to provide consistency with transfer requirements already in place for hospitals for both elective and emergent transfers" and that the Department specify "that the facility shall have a written agreement for services not provided directly by the facility, including a written transfer agreement with at least one general acute care hospital for the provision of back-up services. The transfer agreement must include, at a minimum: -- The clinical criteria for transfer consistent with the capacity of the referring facility. -- The responsibilities of the transferring and receiving physicians, including: The responsibility of the transferring physician to select the appropriate hospital, stabilize the patient and initiate transfer; Consultation with the receiving physician regarding non-emergent pretransfer diagnostic procedures and selection of mode of transport, equipment and personnel needed to [manage] patient care during transport; The responsibility of the receiving physician to ensure capability to provide needed care and document approval for the transfer. -- A patient may be transferred to another facility for only one of the following reasons, with the reason recorded in the patient's medical record: The transferring facility is unable to provide the type or level of medical care appropriate for the patient's needs, or The transfer is requested by the patient, or by the patient's next of kin or guardian when the patient is mentally incapacitated or incompetent. -- The transferring facility shall provide notification to the receiving hospital before transferring the patient. Documentation for the transfer shall be sent with the patient, with a copy or summary maintained by the transferring facility. The documentation shall include, when practicable: The informed consent of the patient or responsible individual 12 40 N.J.R. 702(a) January 22, 2008 The reason for the transfer The signature of the physician who ordered the transfer The condition of the patient upon transfer Patient information collected by the facility [ The name of the contact person at the receiving hospital [The commenter] also recommends that [the Department] require facilities to either transfer a patient from the facility to a hospital or discharged home no later than 12 hours after the patient is initially treated or stabilized. Such a provision would ensure ambulatory facilities safely transfer and/or discharge patients within a reasonable time frame and avoids the late transfer of patient to an acute care hospital after the patient's condition has deteriorated to the point that medical intervention by the hospital will not improve outcome. If a patient's medical condition is not stable enough to support a discharge or transfer, [the commenter] believes it could be indicative of complications or the failure to properly screen a high-risk patient to determine whether ambulatory care was appropriate." (10) RESPONSE: N.J.A.C. 8:43A-3.1 requires an ambulatory care facility to have a written transfer agreement for services the facility does not provide directly. The Department considers this an appropriate standard. The Department agrees with the commenter's assertion that some categories of ambulatory care facilities, may require a greater degree of specificity in their hospital transfer agreements to ensure access to a provider that offers a preferred treatment modality (such as access to kidney transplantation services with respect to facilities providing hemodialysis services). The Department does not agree with the commenter's assertion that the Department should require all ambulatory care facilities to maintain transfer agreements that are identical in the level of specificity to the level the Department requires hospitals to maintain. The disparate treatment is appropriate, particularly with respect to emergent transfers, to ensure that transferring facilities provide appropriate notification and patient-specific information to hospitals while avoiding the creation of needless paperwork that may impede the patient's treatment options. The Department disagrees with the commenter's suggestion that the Department establish a specific limit on the time in which a facility can transfer a patient, as this would impose an arbitrary standard that would be difficult to monitor or enforce. There is no evidence in the literature that such time limits affect patient outcomes. For the foregoing reasons, the Department will make no change on adoption in response to the comment. As with respect to the commenter's previous suggestions, the Department is willing to address these issues in the context of discussions with stakeholders the Department will convene after the Commission's issuance of its final report. 13 40 N.J.R. 702(a) January 22, 2008 7. COMMENT: "Medicaid and Charity Care [The Department] proposes to eliminate [ N.J.A.C.] 8:43A-3.12 because it references Medicaid and Charity Care volume thresholds that were required when ambulatory care facilities were subject to Certificate of Need rules. Because ambulatory facilities no longer need to go through the CN process, they are not provided with a list of access requirements with which they must comply. . . The elimination of CN for ambulatory facilities notwithstanding, [the commenter] believes [the Department] should enforce the requirement to submit an audited financial statement so that it may monitor the services provided to Medicaid and charity care patients in non-hospital[-]based facilities. Such information would assist the [Department] in evaluating access to care and the provision of services to the underserved should [the Department] undertake the development of a comprehensive Statewide health plan in the future. [The Department] understands the impact on access to care that can result from for-profit providers taking over services that have traditionally been provided by hospitals. After learning in 2005 that some hospitals sold their hospital-based renal dialysis program to for-profit groups, the [Department] required as a condition of its approval for ownership that a private dialysis company provide free care at the same level previously provided by the hospital. [The Department] indicates it will continue to examine access issues related to dialysis services prior to approving any additional transfers from a hospital to a non-hospital provider. Similarly, legislation supported by [the Department] would require ambulatory care facilities to provide up to 3.5 percent of their volume as an uncompensated care to uninsured patients. Both the regulatory and legislative action related to renal dialysis demonstrate the growing awareness of the need to ensure access to medically necessary healthcare services. (10) RESPONSE: As stated in response to previous comments, the Department will be reviewing the final report and recommendations of the Commission and will be meeting with stakeholders to respond to those recommendations. Among the issues the Department anticipates addressing with the stakeholders is the appropriateness of changes to establish parity in the regulatory requirements applicable to all licensed facilities as indicated to ensure patient safety and quality of care. For the reasons stated in response to the previous comments, pending the conclusion of the Department's work in response to the final report and recommendations of the Commission, the Department will not adopt the proposed repeal of N.J.A.C. 8:43A-3.12. 8. COMMENT: "Ensuring the provision of quality care through regulatory oversight cannot and should not be limited solely to the hospital community since patients are treated across the healthcare continuum. Consumers should be assured that regardless of the setting in which they are receiving care, there is an independent agency that is monitoring and reporting on the quality of their care. A minimum standard of quality must be provided in any healthcare setting and should be a priority of providers and regulatory agencies charged with protecting the public. [The commenter believes] that with the increasing number of services offered in ambulatory care settings (both ambulatory facilities and physician offices), New Jersey 14 40 N.J.R. 702(a) January 22, 2008 must ensure that patient safety is the cornerstone of all healthcare delivered in the [State]. Indeed the pursuit of patient safety and consistently high quality services should be the priority of all healthcare organizations." (10) RESPONSE: The Department agrees with the commenter with respect to the importance of ensuring patient safety in all licensed health care facilities. The Department considers the readoption of this chapter with the proposed repeals, amendments, and new rule, in coordination with the proposed repeals, amendments, and new rules, to implement the Patient Safety Act at 39 N.J.R. 314(a) (February 5, 2007), as appropriate efforts toward this goal. 9. COMMENT: "The enhancement of healthcare quality and safety are at the forefront of both national and State efforts, with initiatives by the National Quality Forum and the Centers for Medicare and Medicaid Services leading the way. Increased reporting, oversight and transparency initiatives have been the focus of regulators, legislators and healthcare leaders across the nation. And yet in the five years since the regulations governing ambulatory care facilities were last adopted, [the Department] is making mostly technical changes to update contact information update for the [Department] and standards related to architecture and physical plants rather than taking this opportunity to promulgate meaningful requirements related to patient safety and healthcare quality. The [Department's] level of oversight of this industry--which in New Jersey numbers more than 600 facilities--is inconsistent with the national trend as well as initiatives in our neighboring states to improve quality and safety for patients regardless of where they access services. [The Department] should require ambulatory care facilities to adhere to the same level of reporting and oversight that is already required for hospitals, especially for ambulatory surgery facilities in which anesthesia is administered. At a minimum, [the Department] should increase the types of adverse events that must be reported to include emergency complications during surgery (the Patient Safety Act regulations at N.J.A.C. 8:43E-10 would exclude emergent complications from report), transfer of a patient to an acute care hospital and admission to a hospital following discharge from an ambulatory facility. Although [the Department] has indicated it does not have the funding or resources to conduct regular inspections, the Department is required to do so by regulation and should evaluate potential revenue sources that would allow it to visit facilities upon licensure renewal." (1, 8, 9, and 11) RESPONSE: The Department disagrees with the commenters' assertion that the Department has failed to update the content of N.J.A.C. 8:43A to be responsive to the protection of patient safety and service quality. As stated in the proposal Summary, the regulatory history of the chapter demonstrates that the Department has continuously reviewed N.J.A.C. 8:43A in the five years since the previous readoption of the chapter in 2002 to insure its responsiveness to healthcare trends and has worked with stakeholders to promulgate rulemaking that addresses surgery and anesthesia, infection control, renal dialysis and other services, and PACE organizations. Moreover, as the commenters implicitly acknowledge, ambulatory care facilities are subject to other chapters in Title 8 of the New Jersey Administrative Code, such as N.J.A.C. 43E, 15 40 N.J.R. 702(a) January 22, 2008 the rules of general applicability to all facilities the Department licenses. The Department has revised and updated, and continues to proposed revisions and updates to these rules, over the last five years. Moreover, contrary to the commenters' assertions, the Department is in the forefront among state health regulatory agencies implementing healthcare quality and safety initiatives. As the commenters acknowledge, a rulemaking proposal is pending that would implement the Patient Safety Act and would apply to ambulatory care facilities. See 39 N.J.R. 314(a) (February 5, 2007). The forum to take issue with the substantive content of that proposal is in comments the commenters may submit thereon, and is beyond the scope of this rulemaking. The Department's staff resources, or lack thereof, to inspect regulated facilities is not a topic that the Department can address by rulemaking, and is therefore beyond the scope of this rulemaking. The Department's ability to observe violations during routine inspections, as opposed to responding to complaints, is irrelevant to whether a facility's compliance with N.J.A.C. 8:43A establishes a minimum standard that ensure quality of care and patient safety. Because of the Department's ongoing revisions to the chapter to ensure its responsiveness to the public and the regulated community, the proposal to readopt N.J.A.C. 8:43A appropriately needed to address only those technical and substantive issues the proposal identifies. The larger systemic issue of appropriate regulatory parity among types of licensed facilities is among the topics the Commission has under discussion. As stated above in response to previous comments, after the Commission issues its final report, the Department will take appropriate measures to ensure that its regulatory scheme is consistent with statutory and executive mandates that may emanate from the Administration's and the Legislature's review of the report. 10. COMMENT: The commenter "appreciates the existing rules continue to be necessary, reasonable and responsive to the purposes for which they were promulgated. The rules proposed for [readoption] continue to provide the regulatory framework to protect patient care and employee health in the ambulatory care environment. [The commenter] supports the technical changes required to update the regulation. [The commenter] objects to N.J.S.A. 26:2H-18.57[,] which established the 'ambulatory care facility assessment.' Although [the commenter] believes ambulatory facilities should not be taxed, [the commenter recognizes] that this proposal is outside the scope of objection to an existing law. With that said, proposed [N.J.A.C.] 8:43A2.6(g) also creates new language applying to renewal of a facility license if the facility does not satisfy all ambulatory assessments allegedly in arrears. The tax burden placed upon an ambulatory facility is significant and substantial. [The commenter] believes the facility should be allowed to escrow a bond to cover the amount in discrepancy. Also if the amount is escrowed it should be held in an interest[-]bearing account. [The commenter] also objects to N.J.A.C. 8:43A-3.3[,] which amends the regulation regarding change of ownership of the facility. The business should be allowed to escrow a bond for potential tax liability pending the sale of the facility. In both 16 40 N.J.R. 702(a) January 22, 2008 scenarios it seems redundant to issue a conditional license when the assessment in dispute is escrowed." (6) RESPONSE: The Department thanks the commenter for its support for the rules proposed for readoption. The merit of N.J.S.A. 26:2H-18.57 is beyond the regulatory authority of the Department and beyond the scope of the proposal, and the Department makes no response to the commenter's objection to this statutory provision. The proposed amendments at N.J.A.C. 8:43A-2.6(g) and 3.3 address situation in which a facility's assessment is in arrears. The proposed amendments would not preclude escrowing a bond instead of cash when there is a dispute over the assessment amount owed, to expedite a facility sale or a license renewal, pending the resolution of the issue of the amount owed. In fact, the Department consented to the use of this device in at least one case. The Department has no objection to the placement of an escrowed amount into an interest-bearing account, provided all parties to the escrow understand that the Department is entitled to the accrued interest on its prorated share of the escrowed amount upon the resolution of the dispute and the release of the funds. Likewise, the Department would be entitled to receive interest accrued on its prorated share of a bond placed in escrow. The Department also does not consider the imposition of conditional licensure status on facilities whose licensure is in arrears and pending dispute to be redundant. When a facility elects to escrow, rather than to pay the Department, a duly imposed assessed amount in arrears, the designation of a facility as conditionally licensed to operate provides an accurate representation of a facility's status. A facility can avoid the Department's characterization of the facility as holding conditional licensure status by paying its assessment, challenging the amount owed, and seeking a refund. Typically, parties to a facility transfer condition the transfer upon the Department's issuance to the transferee of licensure in good standing and without condition. The use of conditional licensure ensures that both the transferor and transferee facilities remain obliged to ensure that resolution of liability for an assessment in arrears is part of the closing and finalization of the transfer, and that funds that change hands in the transfer address the unpaid arrears. The use of conditional licensure with accompanying escrow of the assessed amount is only appropriate when there is an actual dispute as to the amount of the assessment owed. N.J.A.C. 8:43-2.6 and 3.3 do not authorize the use of this mechanism when a facility merely objects in principal to the validity of N.J.S.A. 26:2H18.57. To countenance this situation would mean facilities could operate indefinitely under conditional licensure, theoretically waiting for the repeal or amendment of N.J.S.A. 26:2H-18.57. For the forgoing reasons, the Department will not make changes on adoption to N.J.A.C. 8:43-2.6 and 3.3 in response to the comment. 11. COMMENT: With respect to N.J.A.C. 8:43A-25.5, a commenter states that while its "radiographic room has an area of at least 250 square feet, it is not utilized as a procedure room. As such, [the commenter does] not have a handwashing facility within 17 40 N.J.R. 702(a) January 22, 2008 the room. There are however, two handwashing areas adjacent to the room. Since the room is only used for taking KUB x-rays and not utilized for invasive procedures, [the commenter does] not feel that a handwashing facility needs to be within the room since alcohol[-]based sanitizing gel is an accepted [Centers for Disease Control] (CDC) alternative. [The commenter] requests that radiographic rooms that are strictly used for diagnostic purposes, be exempt from the proposed regulation." (5) RESPONSE: As stated in response to a previous comment, the Department evaluates licensure compliance issues on a case-by-case basis and uses the American Institute of Architects "Guidelines for Design and Construction of Health Care Facilities" (AIA Guidelines) in its review of physical plant issues. Relevant to the scenario the commenter describes is a provision in the AIA Guidelines at section 5.5.8.3 that authorizes an exception to the requirement of hand washing facilities in procedure rooms if use of a room is limited to routine screening. The Department would consider this provision and other applicable provisions were the commenter to request a waiver in accordance with N.J.A.C. 8:43A-2.9. However, the Department can make no adjudication in response to the scenario the commenter describes until the commenter submits a formal waiver request. Inasmuch as the AIA Guidelines that the Department has incorporated by reference into the chapter appear to address the scenario the commenter describes, at least upon the Department's preliminary evaluation in the context of this rulemaking, the Department will make no change on adoption in response to the comment. 12. COMMENT: A commenter "endorses and commends the intent of [ N.J.A.C. 8:43A] to protect the health and safety of patients who receive ambulatory care services by establishing minimum rules and standards of care with which an ambulatory care facility must comply in order to be licensed to operate in New Jersey." (7) RESPONSE: The Department thanks the commenter for its support for proposed readoption. 13. COMMENT: A commenter requests that the Department amend N.J.A.C. 8:43A-25.2, and asserts that the amendments the commenter suggests "would increase the current standard of care and safety being provided to patients in . . . New Jersey." The commenter provides the history of its organization and describes it activities and membership. The commenter recommends that the Department amend N.J.A.C. 8:43A25.2(b)1 to add the following sentence: "If the facility provides neurodiagnostic imaging services, the medical director may be a neurologist, certified in neuroimaging, with a radiologist available who shall provide active participation in the facility's patient care programs." The commenter states, "While [the suggested] amendment speaks only to the abilities of certified Neuroimaging specialists, [the commenter does] not intend for [the suggested amendment] to preclude the privilege of other similarly well-trained physicians to provide imaging services within their scope of expertise." In support of the suggested revision, the commenter states "that Certified Neuroimaging specialists are by virtue of their training and experience qualified for and capable of assuming the responsibility of direction, provision, and quality of magnetic resonance imaging services provided to patients ( N.J.A.C. 8:43A-7.3). The on-site 18 40 N.J.R. 702(a) January 22, 2008 presence of Certified Neuroimaging specialists in a licensed facility not only complies with the intent of . . . N.J.A.C. 8:43A, this expanded presence increases the standards of patient care and safety relative to all diagnostic imaging services as the following statements will illustrate. Certified Neuroimaging specialists providing in-office ancillary diagnostic imaging are on-site and immediately available during most, if not all hours of facility operation. This assures that staffing schedules are implemented to ensure continuity of care to patients ( N.J.A.C. 8:43A-3.5) receiving not only magnetic resonance imaging services, but also appropriate neurological evaluation, care and treatment. Unlike radiologists, Neuroimaging specialists are able to coordinate and integrate the ambulatory diagnostic imaging service with subsequent, follow-up neurological services and other patient care services to provide a continuum of care for the patient. Further, they provide an enhanced system whereby, whenever possible, the patient is cared for by the same health care professionals. ( N.J.A.C. 8:43A-6.3, 13.) [The commenter] asserts that daily, on-site presence by an experienced and trained Neuroimaging specialist with in-depth knowledge of the patient offers an increased level of safety to the patient. [Certified] neuroimaging specialists are preeminently qualified to adhere to all standards of medical directorship in N.J.A.C. 8:43A-7.3 and. . . 7.4(a), including participation in planning and budgeting for a diagnostic imaging service. Indeed, licensed neuroimaging sites previously grandfathered in. . New Jersey have 17 years, or more, of experience in these matters since prior to 1991." (7) RESPONSE: The Department understands the commenter to recommend that the Department authorize facilities subject to N.J.A.C. 8:43A-25.2 have as their medical directors neurologists certified in neuroimaging instead of, or as an alternative to, radiologists, when the practice involves neurodiagnostic imaging services. The Department further understands the commenter to be asserting that neurologists certified in neuroimaging can provide a level of care that is at least equivalent in quality to the level of care that radiologists provide. The Department assumes for purposes of this response that the commenter's representations are accurate with respect to how the presence of a certified neuroimaging specialist as medical director provides patient experience and outcomes that are at least equivalent to the services of a radiologist serving as medical director. Nonetheless, the changes the commenter suggests would be substantive and would require additional notice and opportunity for public comment, as they would require the establishment of new definitions and would broaden minimum licensure standards. In addition, the changes the commenter suggests would require the Department to consult with clinical experts to evaluate the validity of the commenter's representations with respect to the appropriateness of these changes in terms of their effect on patient experiences and outcomes. The Department periodically reviews existing requirements of N.J.A.C. 8:43A and changes thereto that are under Department consideration with a panel of technical experts and stakeholders in the clinical fields relevant to the matters under review. The Department will include the changes the 19 40 N.J.R. 702(a) January 22, 2008 commenter suggests among matters this workgroup will consider in an upcoming review and will invite the commenter, among other stakeholders, to participate in this process. Upon the conclusion of that review and consideration of the recommendations of the workgroup, the Department will propose rulemaking as appropriate. During that review, the Department will encourage the commenter and others to submit documentation of data, studies, and trends in other jurisdictions addressing commenter's suggestion, such as information related to cost, quality of care, and patient safety. 14. COMMENT: A commenter requests that the Department amend N.J.A.C. 8:43A-25.2(b)2 to authorize a facility providing magnetic resonance imaging to have a "subspecialty-certified imaging physician," as an alternative to having a radiologist, on staff and available during the facility's hours of operation and on the premises whenever contrast medium is being used. The commenter further requests that the Department add to this provision the following sentence: "All physicians with direct supervision of contrast administration responsibilities shall maintain current ACLS (advanced cardiac life support) certification." In support of this request, the commenter states that the American Academy of Neurology "defines a certified Diagnostic Neuroimaging specialist as a licensed physician who has completed a residency program in Neurology, and who has additional training, experience and competence in the standards of performance and interpretation of magnetic resonance imaging . . . of the head, spine, and peripheral nerves. Physicians are trained in the administration of contrast media and the recognition and emergency treatment of adverse reactions to contrast media. Neuroimaging training encompasses thorough knowledge of clinical neurology, neurophysiology, neuroanatomy, neurochemistry, neuropharmacology, and dynamics of cerebrospinal fluid circulation. Certified physicians possess special expertise in the quality control technical aspects [footnote omitted], and clinical applications of the diagnostic imaging modalities and techniques of neuroimaging." The commenter states, "that these certified neuroimaging specialists are qualified by virtue of their training and experience to assure immediate patient access to appropriate care in an emergency, both specific to this diagnostic imaging modality, and to all incidents arising from an adverse reaction to contrast. ... New Jersey patients should be permitted to benefit from the same unrestricted access to appropriate on-site care in an emergency as is being provided by qualified neuroimaging physicians in the rest of the country. There is a growing national shortage of radiologists and qualified subspecialty radiologists. The steady rise in outsourced, out-of-country interpretations as evidenced by the success of 'nighthawk' and now 'dayhawk' teleradiography offers substantiation of this phenomenon. Today, US radiologists often, necessarily, perform interpretations for multiple out-patient diagnostic imaging sites via teleradiography. As this technology use inevitably increases, the likelihood of on-site radiology presence decreases. Certified neuroimaging specialists performing in-office diagnostic imaging are able to fill 20 40 N.J.R. 702(a) January 22, 2008 this gap by being on-site and immediately available while assuring high standards of service, care and patient safety. [It] is in the patient's best interest, and in keeping with the intent of . . . N.J.A.C. 8:43A-25.2 . . . for neuroimaging specialists to continue to work together with their radiologic counterparts to assure the highest possible level of diagnostic imaging quality and safety. This continuing cooperative endeavor at a minimum includes mandatory, active participation by both radiologists and neuroimaging specialists in a licensed facility's programs as follows: [1 A] Patient Care Policy Program in compliance with N.J.A.C. 8:43A-6.2, to include developing, implementing, and reviewing written medical policies; written policies and procedures regarding emergency medical services; defining a medical emergency, approving the contents, locations, and frequency of checking contents, including expiration dates, of emergency kits or carts, equipment and supplies, and assigning responsibility for these checks (in compliance with N.J.A.C. 8:43A-15.3)[; 2 A] Program for Review of credentials and delineation of privileges, assigning duties based upon education, training competencies in compliance with N.J.A.C. 8:43A-7.4; continuing medical education requirements to include cultural awareness and competence in health care[; 3 A] Quality assurance program in compliance with N.J.A.C. 8:43A-18.1 and . . . 7.3(a)1[; 4 An] Infection prevention and control program in compliance with N.J.A.C. 8:43A-14.2[; 5] Reportable Events Policies in compliance with N.J.A.C. 8:43A-3.8, to further include compliance with up-to-date FDA recommendations to report serious adverse events related to . . . nephrogenic systemic fibrosis . . . to the FDA's MedWatch reporting system, and any required information reportable to the New Jersey State Board of Medical Examiners[; and 6] A Policy of compliance with all Federal, State, licensing and governing regulatory rules and regulations." The commenter states, "The vast majority of reactions to gadolinium contrast agents are classified as mild, (coldness at the injection site, nausea with or without vomiting, headache, warmth or pain at the injection site, paresthesias, dizziness, and itching). Reactions resembling an 'allergic' response are very unusual and vary in frequency from 0.004--0.7 percent (rash, hives, or urticaria; very rarely bronchospasm). Severe, life-threatening anaphylactoid reactions are exceedingly rare (0.001--0.01 percent) [citation omitted]. All require prompt recognition and treatment by a trained, experienced physician. The following examples may best serve to illustrate how the amendments we propose would increase the probability of successful response outcomes not only to an adverse reaction to contrast but to all potentially life-threatening events, such as seizure, stroke, or other central nervous system . . . or cardiovascular event. These potentially life-threatening events can occur during [magnetic resonance imaging] performed without contrast when a radiologist is not on the premises and a trained, experienced neurologist certified in neuroimaging is immediately available. Example 1. A patient is scheduled for [magnetic resonance imaging] of the spine without contrast in the neurologist's in-office ancillary, licensed ambulatory care facility. At the time of the study, a radiologist is available, perhaps performing needed teleradiography services at another center or hospital but is not on the premises. The neurologist (certified neuroimaging specialist) request that the patient's [magnetic 21 40 N.J.R. 702(a) January 22, 2008 resonance imaging] of the spine without contrast be done during his regular office hours, as the patient has a history of epilepsy with intractable seizures. The neurologist has already performed a comprehensive neurological evaluation and multi-system physical examination n the patient, obtained extensive past medical, social, [and] family history, documented all current medication and allergies, ordered condition-appropriate labwork and testing, initiated a treatment plan and a medication regimen, communicated with the patient's primary physician, and established a vital face-to-face, professional relationship with the patient and, quite often, also with the patient's family. During the [magnetic resonance imaging] of the spine without contrast, the patient has a breakthrough seizure. The decision: To assure optimum emergency care outcome for the patient, should the available radiologist be contacted, or should the immediately available, onthe-premises neurologist/certified neuroimaging specialist respond and provide immediate emergency care and neurological expertise specific to the patient's condition? The conclusion: To assure optimum emergency care outcome for the patient. . . the neurologist/certified neuroimaging specialist is most qualified to and should provide immediate emergency care. Example 2: In Example 1 above, substitute "[magnetic resonance imaging] of the brain with contrast" for "[magnetic resonance imaging] of the spine without contrast." The decision is, in fact, the same: To assure optimum emergency care outcome for the patient, should the available radiologist by contacted, or should the immediately available, on-the-premises neurologist/certified neuroimaging specialist respond and provide immediate emergency care and neurological expertise specific to the patient's condition? The conclusion is, in fact the same: To assure optimum emergency care outcome for the patient. . . the neurologist/certified neuroimaging specialist is most qualified to and should provide immediate emergency care. (7) RESPONSE: The Department assumes for purposes of this response that the commenter's representations are accurate with respect to how having a "subspecialtycertified imaging physician," as an alternative to having a radiologist, on staff and available during the facility's hours of operation and on the premises whenever contrast medium is being used, would provide patient experience and outcomes that are at least equivalent to having a radiologist on staff and available during the facility's hours of operation and on the premises whenever contrast medium is being used. The commenter does not appear to provide a supportive explanation for the commenter's request that the Department add the following sentence to N.J.A.C. 8:43A25.2(b)2: "All physicians with direct supervision of contrast administration responsibilities shall maintain current ACLS (advanced cardiac life support) certification." The Department will assume for purposes of this response that the suggestion would improve patient experience and outcomes. Nonetheless, as with the previous comment, the changes the commenter suggests would be substantive and would require additional notice and opportunity for public comment, as they would require the establishment of new definitions and would broaden minimum licensure standards. 22 40 N.J.R. 702(a) January 22, 2008 In addition, the changes the commenter suggests would require the Department to consult with clinical experts to evaluate the validity of the commenter's representations with respect to the appropriateness of these changes in terms of their effect on patient experiences and outcomes. As stated in response to the previous comment, the Department periodically reviews existing requirements of N.J.A.C. 8:43A and changes thereto that are under Department consideration with a panel of technical experts and stakeholders in the clinical fields relevant to the matters under review. The Department will include the changes the commenter suggests among matters this workgroup will consider in an upcoming review and will invite the commenter, among other stakeholders, to participate in this process. Upon the conclusion of that review and consideration of the recommendations of the workgroup, the Department will propose rulemaking as appropriate. During that review, the Department will encourage the commenter and others to submit documentation of data, studies, and trends in other jurisdictions addressing commenter's suggestion, such as information related to cost, quality of care, and patient safety. 15. COMMENT: A commenter states that the "American Lithotripsy Society [defined at N.J.A.C. 8:43A-29.3] was dissolved and no longer exists as such." The commenter, noting that N.J.A.C. 8:43A-29.5 requires radiologic technologists to obtain certification from the American Lithotripsy Society within one year of employment, states, "Certification may no longer be obtained through the American Lithotripsy Society." (2) RESPONSE: As of the filing of the notice of proposal, the American Lithotripsy Society continued to exist, along with its affiliated entity, the Urology Society of America, and continued to offer certification. However, the Department has since learned that the American Lithotripsy Society has discontinued operations. The Department is aware of no other program or organization that offers a similar certification program. Inasmuch as it would be impossible for members of the regulated community to comply, the Department will delete the requirement on adoption at existing N.J.A.C. 8:43A-29.5 that radiologic technologists obtain certification from the American Lithotripsy Society within one year of employment, and will delete the definition of this entity at existing N.J.A.C. 8:43A-29.3 as "ALS." If the Department becomes aware of another certification program addressing lithotripsy services, the Department will evaluate its appropriateness for purposes of conducting a future rulemaking to establish participation in the program as a requirement for persons performing these services. 16. COMMENT: A commenter states that the Department should amend N.J.A.C. 8:43A-29.9(a)5 to require that lithotripter inspection "be performed by a qualified person designated by the lithotripter manufacturer" rather than "pursuant to policies and procedures approved by the urologist." (2) RESPONSE: The existing standard at N.J.A.C. 8:43A-29.9(a)5 requires a quarterly inspection by "a qualified person in accordance with policies and procedures 23 40 N.J.R. 702(a) January 22, 2008 approved by the urologist" and requires documentation of all preventive maintenance and the maintenance of a service contract for the lithotripter according to manufacturer specifications. The Department developed the existing standard in consultation with a panel of experts that recommended inspection in conformance with specifications established in the lithotripter service contract as establishing an appropriate role for manufacturers, while ensuring practitioners retain oversight responsibility for the equipment they use. The Department has not experienced problems associated with this standard and will not make a change on adoption in response to the commenter's recommendation. 17. COMMENT: With respect to the proposed definition of "employee" at N.J.A.C. 8:43A-1.3, a commenter states, "The proposed definition of 'employee' includes 'Persons who are in direct contact with patients or who provide patient care.' [The commenter] believes that this provision is vague and could be construed to encompass persons over [whom an ambulatory care facility] has no control or [with whom an ambulatory care facility has no] association. For example, 'persons who are in direct contact with patients or who provide patient care' could be read to include a patient's privately engaged caretaker who accompanies the patient to the [ambulatory care facility]. Reading the definition of 'employee' in conjunction with other provisions of the regulation could therefore lead to absurd results in matters of enforcement of those provisions. For example, [N.J.A.C.] 8:43A-3.7. . . requires [an ambulatory care facility] to provide screening testing for rubella and rubeola and other illnesses for employees. Accordingly, [the commenter believes] this provision should be amended to: 'Persons engaged by the ACF as employees or independent contractors, who are in direct contact with patients or who provide care' or alternatively, deleted from the proposed definition of ['employee'] altogether." (3) RESPONSE: The Department agrees with the commenter that the phrase "Persons who are in direct contact with patients or who provide patient care" is overbroad to the extent it could be construed to require facilities to oversee persons over whom facilities have no oversight ability, such as privately engaged caretakers, students, and independent contractors. The Department intends the proposed definition of "employee" and the facility oversight responsibilities it engenders to apply to individuals facilities engage to provide services that place those individuals in direct contact with patients. Inasmuch as facilities are without the ability or authority to require persons outside their direct employ to undertake the vaccination and other requirements the chapter requires of facility personnel, the Department will make a change on adoption to the proposed definition of "employee" at N.J.A.C. 8:43A-1.3 to provide that the definition means persons "a facility engages" who has direct contact with patients. 18. COMMENT: With respect to the proposed amendment at N.J.A.C. 8:43A25.5(a)1, a commenter believes "that because the area requirements for new equipment continually decrease as technology improves, the requirement of 'at least 250 square feet' [should] be deleted and instead the requirement should be that the room 'shall have an area that complies with the minimum equipment manufacturer specifications of the equipment used in the in the radiographic room(s). In addition, the use of the term 24 40 N.J.R. 702(a) January 22, 2008 'radiographic room' is unclear. For example, would a room in which there is a mammography machine be required to be not less than 250 square feet? In fact, there are many modalities utilized by radiologists [that] do not [require] this much space. For example, extremity [magnetic resonance imaging] units, by manufacturer specifications, do not require 250 square feet." (3) RESPONSE: The physical plant requirements at N.J.A.C. 8:43A, as proposed for readoption with amendments, repeals, and new rule, are generally consistent with industry standards set forth in the "Guidelines for Design and Construction of Health Care Facilities," 2006 Edition, issued by the American Institute of Architects. However, while the AIA Guidelines for magnetic resonance imaging equipment, for example, suggest a minimum standard ranging from 325 to 620 square feet, depending on the equipment vendor and magnet strength, N.J.A.C. 8:43A-25.5(a)1 requires as a minimum standard that facilities provide only 250 square feet. The licensure process considers physical plant issues on a case-by-case basis and considers a number of factors, such as vendor and magnet size, and potential alternatives depending on a potential facility's unique circumstances. With respect to new technologies that may require less space than standard equipment, such as extremity MRI, the requirement at N.J.A.C. 8:43A-25.5(a)1 establishing a minimum room size is useful to assure that equipment is housed in a designated area. The Department prefers to establish this minimum standard by rule and to work with applicants, preferably in the early stages of the licensure process, that is, during the functional review, to reach reasonable compromises and accommodations, to ensure that that the intent of the standard is achieved without imposing undue burden on potential providers. The Department is unaware of N.J.A.C. 8:43A-25.5(a)1 causing problems among potential and existing providers. For the foregoing reasons, the Department will make no change on adoption to N.J.A.C. 8:43A-25.5(a)1 in response to the comment. 19. COMMENT: A commenter states that N.J.A.C. 8:43A-25.5(a)11ii "should be amended to require a 'room, closet, or covered receptacle for the holding of soiled clinical material,' rather than requiring a full room. An ambulatory care facility does not need a 'room' to hold soiled clinical material. In addition, the [proposed amendment that would use the] new term 'clinical material' to replace 'linen'. . . is undefined . . . and its meaning is not entirely clear." (3) RESPONSE: The proposed readoption would retain the requirement for the holding of soiled clinical material in a room. The Department declined to propose to authorize holding of soiled clinical material in a storage space rather than in a closet or cabinetry, as N.J.A.C. 8:43A-25.5(a)11i would authorize for clean and sterile supplies. Soiled clinical material may consist of linen that the facility needs to send for cleaning, but it may also consist of other contaminated items that are disposable, such as paper garments and dressings. Facilities need to segregate these items in a manner that ensures that the clinical space is not exposed to them. The Department prefers to establish this minimum standard by rule and to work with applicants, preferably in the early stages of the licensure process, that is, during 25 40 N.J.R. 702(a) January 22, 2008 the functional review, to reach reasonable compromises and accommodations, to ensure that that the intent of the standard is achieved without imposing undue burden on potential providers. The Department is unaware of N.J.A.C. 8:43A-25.5(a)11ii causing problems among potential and existing providers. For the foregoing reasons, the Department will make no change on adoption to N.J.A.C. 8:43A-25.5(a)11ii in response to the comment. Federal Standards Statement The readopted rules and the adopted amendments, repeals, and new rule do not impose standards on ambulatory care facilities in New Jersey that exceed those contained in applicable Federal standards, therefore, an exceedance analysis is not required. The applicable Federal standards may be found at 42 CFR Part 416, for ambulatory care facilities, and at 42 CFR. §405.2100, Subpart V, for end-stage renal disease. Full text of the readopted rules can be found in the New Jersey Administrative Code at N.J.A.C. 8:43A. Full text of the adopted amendments and new rule follows (additions to proposal indicated in boldface with asterisks *thus*, deletions from proposal indicated in brackets with asterisks *[thus]*): 8:43A-1.1 Scope (a) This chapter applies to all health care facilities that provide ambulatory care services, including, but not limited to: 1. Primary care, hospital outpatient, ambulatory surgery, family practice, family planning, outpatient drug abuse treatment, chronic dialysis, computerized tomography, magnetic resonance imaging, extracorporeal shock wave lithotripsy, and radiological services; and 2. Abortion facilities, comprehensive outpatient rehabilitation facilities, and birth centers. (b) Ambulatory care facilities provide preventive, diagnostic, and treatment services to persons who come to the facility to receive services and depart from the facility on the same day. (c) The rules in this chapter constitute the basis for the licensure of ambulatory care facilities by the Department of Health and Senior Services. 26 40 N.J.R. 702(a) January 22, 2008 8:43A-1.3 Definitions The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise: ... "Addiction Professionals Certification Board of New Jersey, Inc." means the entity by that name for which the contact information is Addiction Professionals Certification Board of New Jersey, Inc., 1200 Tices Lane, Suite 104, East Brunswick, NJ 08816 (732) 249-1991, telefacsimile (732) 249-1559, www.certbd.com. ... "Ambulatory care facility assessment" means the annual assessment established by N.J.S.A. 26:2H-18.57, which applies to certain licensed health care facilities, which assessment the Department administers pursuant to N.J.A.C. 8:31A. ... "American Academy of Health Care Providers in the Addictive Disorders" means the entity by that name for which the contact information is American Academy of Health Care Providers in the Addictive Disorders, 314 West Superior Street, Suite 508, Duluth, MN 55802, (218) 727-3940, telefacsimile (218) 722-0346, www.americanacademy.org. "American Board of Medical Physics" means the entity by that name for which the contact information is American Board of Medical Physics, 12100 Sunset Hills Road, Suite 130, Reston, VA 20190-5202, (703) 481-5001, telefacsimile (703) 435-4390, www.acmp.org/abmp. "American College of Radiation Oncology" means the entity by that name for which the contact information is American College of Radiation Oncology, 5272 River Road, Bethesda, MD 20816, (301) 718-6515, telefacsimile: (301) 656-0989, www.acro.org. "American College of Radiology" means the entity by that name for which the contact information is American College of Radiology, 1891 Preston White Dr, Reston, VA 20191, (703) 648-8900, www.acr.org. "American Osteopathic Board of Radiology" means the entity by that name for which the contact information is American Osteopathic Board of Radiology, 119 East Second Street, Milan, MO 63556-1331, 800-258-AOCR (2627) or (660) 265-4011, telefacsimile (660) 265-3494, http://www.aocr.org/certification/index.asp. 27 40 N.J.R. 702(a) January 22, 2008 "Association for the Advancement of Medical Instrumentation" means the entity by that name for which the contact information is Association for the Advancement of Medical Instrumentation, PO Box 1211, Annapolis Junction, MD 20701-0211, (800) 877249-8226 or 240-646-7031, telefacsimile (301) 206-9789, www.aami.org. ... "Commissioner" means the Commissioner of Health and Senior Services. "Commission on Dietetic Registration" means the entity by that name for which the contact information is Commission on Dietetic Registration, 120 South Riverside Plaza, Suite 2000, Chicago, IL 60606-6995, (312) 899-0040 extension 5500 or toll-free (800) 877-1600 extension 5500, telefacsimile (312) 899-4772, www.cdrnet.org. "Commission on Radiation Protection" means the entity by that name that is in, but not of, the Department of Environmental Protection for which the contact information is Commission on Radiation Protection, PO Box 415, Trenton, NJ 08625-0415, (609) 984-5636, telefacsimile (609) 633-2210. ... "Construction guidelines" means the Guidelines for Design and Construction of Health Care Facilities, 2006 edition, incorporated herein by reference, as amended and supplemented, published by the American Institute of Architects, for which the contact information is the American Institute of Architects, 1735 New York Avenue NW, Washington DC 20006-5292, (800) 242-3837 or (202) 626-7541, telefacsimile (202) 626-7519, www.aia.org. ... "Coordinating Center for Health Information and Service" means the Coordinating Center for Health Information and Service of the Centers for Disease Control and Prevention (CDC) in the U.S. Department of Health and Human Services. This entity publishes the Morbidity and Mortality Weekly Report, for which the contact information is Morbidity and Mortality Weekly Report, Centers for Disease Control and Prevention, 1600 Clifton Rd., MS E-90, Atlanta, GA 30333, (404) 498-1150, telefacsimile (404) 498-2389, www.cdc.gov/mmwr. "Council on Social Work Education" means the entity by that name for which the contact information is Council on Social Work Education, 1725 Duke Street, Suite 500, Alexandria, VA 22314-3457, (703) 683-8080, telefacsimile (703) 683-8099, www.cswe.org. ... 28 40 N.J.R. 702(a) January 22, 2008 "Department" means the Department of Health and Senior Services. ... "Employee" means: 1. Full and part-time employees; 2. Persons *a facility engages* who are in direct contact with patients or who provide patient care; 3. Volunteer staff; and 4. Physicians and other clinical practitioners who are either salaried by the facility or have clinical privileges to provide medical care at the facility. ... "Healthcare Plan Review Unit" means the Healthcare Plan Review Unit within the Bureau of Construction Project Review in the Division of Codes and Standards of the Department of Community Affairs, for which the contact information is Healthcare Plan Review Unit, Bureau of Construction Project Review, Division of Codes and Standards, Department of Community Affairs, PO Box 817, Trenton, NJ 08625-0817, (609) 6338151. ... "Maternal and Child Health Consortium (MCHC)" means a voluntarily formed non-profit organization, consisting of all inpatient or ambulatory perinatal and pediatric care providers and related community organizations in a maternal and child health service region, as described at N.J.A.C. 8:33C. ... "Office of Acute Care Assessment and Survey" means the survey and inspections unit for acute care services within the Division of Health Facilities Evaluation and Licensing of the Senior Services and Health Systems Branch of the Department, for which the contact information is Office of Acute Care Assessment and Survey, Division of Health Facilities Evaluation and Licensing, Department of Health and Senior Services, PO Box 358, Trenton, NJ 08625-0358, (609) 292-9900. "Office of Certificate of Need and Healthcare Facility Licensure" means the health care facility licensing unit within the Division of Health Facilities Evaluation and Licensing of the Senior Services and Health Systems Branch of the Department, for which the contact information is Office of Certificate of Need and Healthcare Facility 29 40 N.J.R. 702(a) January 22, 2008 Licensure, Division of Health Facilities Evaluation and Licensing, Department of Health and Senior Services, PO Box 358, Trenton, NJ 08625-0358, (609) 292-5960, website address for forms: www.nj.gov/health/forms. "Office of the Ombudsman for the Institutionalized Elderly" means the unit of the same name within the Division of Elder Advocacy of the Department of the Public Advocate that investigates and responds to complaints of abuse, neglect and exploitation of individuals 60 years of age and older, who reside in licensed facilities within the State, both public and private, for which the contacted information is Office of the Ombudsman for the Institutionalized Elderly, Division of Elder Advocacy, Department of the Public Advocate, PO Box 852, Trenton, NJ 08625-0852, (877) 5826995. ... "Tuberculosis Program" means the Tuberculosis Program within the Communicable Disease Service of the Public Health Services Branch of the Department, for which the contact information is Tuberculosis Program, Communicable Disease Service, Public Health Services Branch, Department of Health and Senior Services, PO Box 369, Trenton, NJ 08625-0369, (609) 588-7522. 8:43A-1.9 Qualifications of dietitians Each dietitian shall be registered or eligible for registration by the Commission on Dietetic Registration. 8:43A-1.11 Qualifications of drug counselors (a) Each drug counselor shall: 1. Be certified by the Addiction Professionals Certification Board of New Jersey, Inc.; 2. Be certified by the American Academy of Health Care Providers in the Addictive Disorders; 3.-5. (No change.) 8:43A-1.27 Qualifications of social workers (a) Each social worker shall be certified or licensed by the New Jersey State Board of Social Work Examiners and shall comply with the Social Workers' Licensing Act of 1991 (N.J.S.A. 45:15BB-1 et seq.) and amendments thereto and with all rules of the New Jersey State Board of Social Work Examiners. 30 40 N.J.R. 702(a) January 22, 2008 (b) Prior to the implementation by the Board of procedures for applying for certification or licensure, each social worker shall have a master's degree in social work from a graduate school of social work accredited by the Council on Social Work Education. 8:43A-2.2 Application for licensure (a) Any person, organization, or corporation desiring to operate an ambulatory care facility shall make application to the Commissioner for a license on forms prescribed by the Department, which are available from the Office of Certificate of Need and Healthcare Facility Licensure. (b)-(j) (No change.) (k) Each applicant for a license to operate a facility shall complete all information requested on the licensure application and may request the Office of Certificate of Need and Healthcare Facility Licensure to schedule an appointment to conduct a functional review of the application to review the conditions for licensure and operation, which request the Office shall grant. (l)-(m) (No change.) 8:43A-2.3 Types of services requiring a license (a) An ambulatory care facility shall provide neither the health care services listed at N.J.A.C. 8:43A-2.2(b) nor the other services to which N.J.A.C. 8:43A-32 applies unless the facility license indicates that the facility provides the service. (b)-(d) (No change.) (e) If a facility wishes to add any health care service during the annual licensure period, including any health care service not identified in (a) above, the facility shall obtain the authorization of the Office of Certificate of Need and Healthcare Facility Licensure prior to providing the additional service. 1. The Department shall base authorization upon compliance with this chapter, and may be contingent upon an on-site inspection by Department representatives. 2. This rule applies regardless of whether or not it is determined that a Certificate of Need is required. 8:43A-2.4 Newly constructed or expanded facilities (a) Any ambulatory care facility that intends to undertake any alteration, renovation, or new construction of the physical plant, whether a Certificate of Need is 31 40 N.J.R. 702(a) January 22, 2008 required or not, shall submit plans to the Health Plan Review Program of the Department of Community Affairs for review and approval or, in cases of existing construction where no Department of Community Affairs review is required, to the Office of Certificate of Need and Healthcare Facility Licensure for review to verify that the facility's physical plant is consistent with the licensure standards prior to the initiation of any work, in accordance with N.J.A.C. 8:43A-19. (b) (No change.) (c) Representatives of the Office of Acute Care Assessment and Survey shall conduct an on-site inspection of the construction of the physical plant to verify that the building has been constructed in accordance with the architectural plans approved by the Department of Community Affairs or, in cases of existing construction where no Department of Community Affairs review is required, to verify that the facility's physical plant is consistent with the licensure standards at N.J.A.C. 8:43A-19. 8:43A-2.5 Surveys and full or temporary license (a) When the written application for licensure is approved and the building is ready for occupancy, representatives of the Office of Acute Care and Survey shall conduct a survey of the facility to determine if the facility complies with the rules in this chapter. 1. (No change.) 2. The facility shall notify the Office of Acute Care Assessment and Survey of the Department when the deficiencies, if any, have been corrected, and the Office of Acute Care Assessment and Survey will schedule one or more resurveys of the facility prior to occupancy. (b) The Department may issue full or temporary licensure to a facility when the following conditions are met: 1. A functional review (see N.J.A.C. 8:43A-2.2(k)) for review of the conditions for licensure and operation, unless the Department determines functional review to be unnecessary, has taken place between the Office of Certificate of Need and Healthcare Facility Licensure and representatives of the facility, during which the Department will advise the facility representatives that the purpose of the temporary license is to allow the Department to determine the facility's compliance with N.J.S.A. 26:2H-1 et seq. and this chapter; 2.-4. (No change.) 32 40 N.J.R. 702(a) January 22, 2008 (c) No facility shall admit patients to the facility until the facility has the written approval and/or license issued by the Office of Certificate of Need and Healthcare Facility Licensure. (d)-(g) (No change.) 8:43A-2.6 Full license (a)-(f) (No change.) (g) The Department shall not renew a facility's license if the facility does not satisfy all ambulatory care facility assessments in arrears. 1. If a facility appeals an assessment in accordance with N.J.A.C. 8:31A-2.3, license renewal shall proceed if the licensee establishes an escrow account specifically dedicated to the payment of the assessment containing the amount of the unpaid assessment that is under appeal. 2. If the Department renews a license under the circumstances in (g)1 above, that license renewal shall be a conditional renewal that is conditioned upon payment of the assessment upon conclusion of the appeal (in addition to any other substantive licensure conditions the Department may require of a facility to meet other standards this chapter establishes). 8:43A-2.8 Surrender of license The facility shall notify each patient, each patient's physician, and any guarantors of payment at least 30 days prior to the voluntary surrender of a license, or as directed under an order of revocation, refusal to renew, or suspension of a license and shall return the license to the Office of Certificate of Need and Healthcare Facility Licensure within seven working days after the voluntary surrender, revocation, non-renewal, or suspension of the license. 8:43A-2.9 Waiver (a) (No change.) (b) A facility seeking a waiver of these rules shall apply in writing to the Director of the Office of Certificate of Need and Healthcare Facility Licensure. (c)-(d) (No change.) 33 40 N.J.R. 702(a) January 22, 2008 8:43A-3.3 Ownership (a) The licensee shall disclose the ownership of the facility and the property on which it is located to the Department, shall make proof of this ownership available in the facility or at a designated location, and shall report any proposed change in ownership to the Director of the Office of Certificate of Need and Healthcare Facility Licensing in writing at least 30 days prior to the change and in conformance with requirements for Certificate of Need applications. 1. The Department shall not approve a change in ownership if the facility's ambulatory care facility assessments are in arrears, unless and until the arrears are satisfied. 2. If a facility appeals an assessment in accordance with N.J.A.C. 8:31A-2.3, a change in ownership may proceed, as long as the licensee establishes an escrow account specifically dedicated to the payment of the assessment containing the amount of the unpaid assessment that is under appeal. 3. If the Department approves a change in ownership under the circumstances in (a)2 above, the approval shall be a conditional approval that is conditioned upon payment of the assessment upon conclusion of the appeal (in addition to any other substantive licensure conditions the Department may require of a facility to meet other standards this chapter establishes). (b) (No change.) 8:43A-3.4 Submission of documents and data (a) Upon the Department's request, a facility shall submit in writing any documents that this chapter requires to the Director of the Office of Certificate of Need and Healthcare Facility Licensing. (b) (No change.) 8:43A-3.7 Employee health (a) The policy and procedures manual of the facility shall include policies and procedures to ensure that physical examinations of employees are performed upon employment and subsequently and shall specify the circumstances under which other persons providing direct patient care services shall receive a physical examination and the content and the frequency of the examinations for employees and other persons providing direct patient care services. (b)-(c) (No change.) 34 40 N.J.R. 702(a) January 22, 2008 (d) The facility shall establish policies and procedures for the detection and control of the transmission of Mycobacterium tuberculosis that include, but are not limited to, developing a Tuberculosis Exposure Control Plan (TB plan), according to the guidelines set forth in "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005," incorporated herein by reference, as amended and supplemented, published in the Morbidity and Mortality Weekly Report, at MMWR 2005; 54 (No. RR-17) (December 30, 2005) published by the Coordinating Center for Health Information and Service, available at http://www.cdc.gov/mmwr/PDF/rr/rr5417.pdf and at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5417a1.htm, pursuant to the Occupational Safety and Health Act of 1970 Public Law 91-596, incorporated herein by reference as amended and supplemented. 1. For newly hired employees, the facility shall establish policies and procedures that will identify a new employee's baseline status of exposure to Mycobacterium tuberculosis and upon employment, the facility shall administer a two-step Mantoux tuberculin skin test, using five tuberculin units of purified protein derivative, to all employees. i. The licensee shall administer a second Mantoux test in one to three weeks after the first Mantoux test to employees with a "negative" (less than 10 millimeters of induration or less than five millimeters of induration if the individual is immunosuppressed) result following the first Mantoux skin test. ii. The licensee shall refer employees with a "positive" (greater than or equal to 10 millimeters of induration or greater than or equal to five millimeters of induration if the individual is immunosuppressed) result following either the first or second test for a medical evaluation to determine whether there is evidence of latent tuberculosis infection or active tuberculosis disease, which medical evaluation shall include, but not be limited to, a chest X-ray. (1) (No change in text.) iii. (d)1i and ii above are subject to the following exceptions: (1)-(4) (No change.) 2. The facility shall establish policies and procedures for the periodic screening of employees for Mycobacterium tuberculosis that contain at least the following requirements: i. The facility shall administer a Mantoux skin test to all tuberculin-negative employees at least annually; 35 40 N.J.R. 702(a) January 22, 2008 ii. The frequency of testing shall be determined by the level of risk assigned by the facility's TB plan; and iii. The facility shall maintain records of the results of employee Mantoux tuberculin testing. 3. Questions regarding tuberculosis control may be directed to: the Tuberculosis Program. (e) (No change.) 8:43A-3.8 Reportable events (a) The facility shall notify the Department immediately by telephone at (800) 792-9770 of any event occurring within the facility that jeopardizes the health or safety of patients or employees. Events that shall be reported to the Department include, but are not limited to, the following: 1.-4. (No change.) (b)-(c) (No change.) 8:43A-3.10 Information reportable to State Board of Medical Examiners (a)-(b) (No change.) (c) Notifications required by (a) above shall be provided within seven days of the date of the action, settlement, judgment, or award and shall be submitted on forms approved by the Department for that purpose. 1. The facility shall submit a completed supplemental form to the New Jersey State Board of Medical Examiners if so requested by the Board. *8:43A-3.12 Reporting requirements for ambulatory surgery facilities (a) As part of the annual licensure renewal process, all ambulatory surgery facilities shall submit to the Department's licensing program an audited statement that the facility has complied with the access requirements specified in the facility's certificate of need approval letter during the preceding licensure period. The audited statement shall include, but not be limited to, the following: 1. Total surgical case volume; 2. Surgical case volume for care provided to Medicaid-eligible and medically indigent persons, and its percentage of the total surgical case volume; 36 40 N.J.R. 702(a) January 22, 2008 3. The cost of providing surgical care to Medicaid-eligible and medically indigent persons, excluding costs associated with bad debt or partial payment for individuals who are not Medicaid-eligible or medically indigent, and its percentage of the total cost of providing care; and 4. A description of the facility's free-care and partial-pay programs, including criteria of eligibility for each. (b) As of July 15, 1996, each newly licensed ambulatory surgery facility shall submit to the Department the report of a survey of the facility performed by an independent accreditation organization approved by the Department. Such organizations shall be approved on the basis of their demonstrated ability to perform an operational survey using standards substantially equivalent to or exceeding the Federal Conditions for Coverage at 42 CFR Part 416. The survey shall be performed, and the report shall be submitted to the Department, within the 12 months immediately following receipt of a 12-month temporary license from the Department. A full license shall not be issued upon expiration of the temporary license unless the report of the independent survey is submitted in accordance with this rule. Ambulatory surgery facilities licensed prior to July 15, 1996 shall have until July 15, 1999 in which to be surveyed by an independent accreditation organization. Following submission of the initial report, each licensed facility shall submit a report of the most recent survey by an independent accreditation organization as part of the annual licensure renewal process. Such survey shall have been performed within three years of licensure renewal. The survey report shall include, but not be limited to, corrective actions recommended and/or undertaken. 1. Licensure shall not be conditioned upon attainment by the ambulatory surgery facility of "accreditation" or "certification" or other such status granted by the independent accreditation organization.* 8:43A-12.20 Physical plant (a) New ambulatory surgical facilities shall comply with Chapter 3.7 (Outpatient Surgical Facility) of the construction guidelines. (b) (No change.) 8:43A-13.5 Medical records policies and procedures (a) (No change.) (b) A patient, the patient's legally authorized representative, or a third-party insurer as permitted by law may request or authorize, in writing, that a copy of the 37 40 N.J.R. 702(a) January 22, 2008 patient's medical record be provided to one of them or released to a third party. The ambulatory care facility or its subcontractor shall furnish a legible, written copy of the record at a fee based on actual costs. ("Legally authorized representative" within this section means spouse, domestic partner, civil union partner, immediate next of kin, legal guardian, executor, or an individual with power of attorney.) A copy of the medical record from an individual admission shall be provided within 30 days of request, in accordance with the following: 1.-5. (No change.) (c)-(d) (No change.) 8:43A-14.3 Infection prevention measures (a) Infection prevention activities shall be based on the Centers for Disease Control and Prevention Guidelines, and Hospital Infection Control Practices Advisory Committee (that is, HICPAC) recommendations listed below, incorporated herein by reference, as amended and supplemented: 1.-3. (No change.) 4. Guidelines for Preventing Health-Care-Associated Pneumonia, 2003: Recommendation of CDC and the Healthcare Infection Control Practices Advisory Committee, published in the Morbidity and Mortality Weekly Report at MMWR 2004; 53 (No. RR-3), published by the Coordinating Center for Health Information and Service, available at http://www.cdc.gov/mmwr/PDF/rr/rr5303.pdf and at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5303a1.htm; 5. Guideline for Hand Hygiene in Health-Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force, published in the Morbidity and Mortality Weekly Report at MMWR 2002; 51 (No. RR-16), published by the Coordinating Center for Health Information and Service, available at http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf and at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm; 6.-9. (No change.) (b) (No change.) (c) The Department shall allow facilities to diverge from the guidelines and recommendations listed at (a) above, provided that there is a sound infection control rationale based upon scientific research or epidemiologic data for the diversion. 38 40 N.J.R. 702(a) January 22, 2008 8:43A-15.1 Disaster planning (a) (No change.) (b) The licensee shall file the written, comprehensive emergency plan with the Department, and shall notify the Department when the plan is changed. 1. The licensee shall submit the plan to both municipal and county emergency management officials for their review. (c)-(f) (No change.) 8:43A-15.2 Drills, tests, and inspections (a) (No change.) (b) The facility shall perform semi-annual visual inspections and annual operational tests of the building's manual-pull alarm system and shall maintain documentation of inspections, test dates, locations of manual-pull alarms tested, persons testing the alarms, and results of the tests. (c)-(j) (No change.) 8:43A-16.2 Rights of each patient (a) Each patient receiving services in an ambulatory care facility shall have the following rights: 1.-8. (No change.) 9. To confidential treatment of information about the patient. i. Information in the patient's medical record shall not be released to anyone outside the facility without the patient's approval, unless another health care facility to which the patient was transferred requires the information, or unless the release of the information is required and permitted by law, a third-party payment contract, or a peer review, or unless the information is needed by the Department for statutorily-authorized purposes. ii. The facility may release data about the patient for studies containing aggregated statistics when the patient's identity is masked; 10.-14. (No change.) 39 40 N.J.R. 702(a) January 22, 2008 8:43A-16.3 Notice (a) The administrator shall provide all patients and/or their families upon request the name, addresses, and telephone numbers of the following offices with which complaints may be lodged: the Office of Acute Care Assessment and Survey and the Office of the Ombudsman for the Institutionalized Elderly. (b)-(c) (No change.) 8:43A-19.1 Physical plant general compliance for new construction or alteration (a) New buildings and alterations and additions to existing buildings for freestanding ambulatory care facilities shall conform with the New Jersey Uniform Construction Code, N.J.A.C. 5:23, and the construction guidelines. (b) New buildings and alterations and additions to existing buildings for ambulatory care facilities that are part of an acute care hospital shall conform with the New Jersey Uniform Construction Code, N.J.A.C. 5:23, and the construction guidelines. 8:43A-19.3 Plan submission; payment of review fees (a) Prior to any construction, plans shall be submitted for review and approval, in accordance with the provisions of this chapter, to the Healthcare Plan Review Unit. (b) (No change.) 8:43A-19.5 Provision for the handicapped Facilities shall be available and accessible to the physically handicapped pursuant to the Barrier-Free Subcode of the New Jersey Uniform Construction Code, N.J.A.C. 5:23-7. 8:43A-19.6 Common elements for ambulatory health care facilities All new ambulatory health care facilities, except small facilities addressed at N.J.A.C. 8:43A-19.7, shall comply with Chapter 3.1 (Outpatient Facilities) of the construction guidelines. 8:43A-19.7 Small ambulatory care facilities (a) For purposes of this section, "small ambulatory care facility" means a facility that provides ambulatory care services at which four or fewer workers use the space and equipment at any one time. 40 40 N.J.R. 702(a) January 22, 2008 (b) Chapter 3.3 (Small Primary (Neighborhood) Outpatient Facilities) of the construction guidelines applies to new small ambulatory care facilities. 8:43A-23.4 Primary care outpatient facilities New facilities that provide primary care services, except small facilities addressed at N.J.A.C. 8:43A-23.5, shall comply with Chapter 3.2 of the construction guidelines. 8:43A-23.5 Small primary care outpatient facilities (a) For purposes of this section, "small primary care outpatient facility" means a facility that provides primary care services at which four or fewer workers use the space and equipment at any one time. (b) Small primary care outpatient facilities may be located within existing commercial, residential, licensed child care, educational, or other types of buildings or may be small, freestanding, new or converted structures. (c) New small primary care outpatient facilities shall comply with Chapter 3.2 of the construction guidelines. 8:43A-24.10 Water treatment and dialysate (a) Water treatment equipment, water, and dialysate shall satisfy the requirements specified in the Association for the Advancement of Medical Instrumentation publications entitled, "Water treatment equipment for hemodialysis applications," RD62:2006, "Dialysate for hemodialysis," RD52:2004, "Hemodialysis systems," RD5:2003, and "Concentrates for hemodialysis," RD61:2000, incorporated herein by reference, as amended and supplemented. 1.-9. (No change.) 8:43A-25.4 Physical plant; computerized tomography and magnetic resonance imaging services (a) A new ambulatory care facility that provides computerized tomography or magnetic resonance imaging services shall comply with Sections 3.1-2.2 and 2.1-5.5 of the construction guidelines. (b) Existing facilities shall comply with these standards or the corresponding standards in effect at the time of construction, alteration, or approval. 41 40 N.J.R. 702(a) January 22, 2008 8:43A-25.5 Physical plant; radiological services (a) If radiological services are provided in a freestanding facility, the suite shall contain the following: 1. A radiographic room(s) that has an area of at least 250 square feet or greater as necessary to comply with equipment manufacturer specifications if the facility provides computerized tomography or magnetic resonance imaging services; 2. A film processing room, unless the facility exclusively uses digital technology; 3. A viewing area, unless the facility exclusively uses digital technology; 4. Film storage facilities for active, inactive, and unexposed film, unless the facility exclusively uses digital technology; 5.-7. (No change.) 8. Separate toilet rooms with handwashing facilities for staff, visitors, and patients; 9. Handwashing facilities that are within each procedure room or, with respect to magnetic resonance imaging procedure rooms, located immediately outside the procedure room, as specified by the equipment manufacturer; 10. (No change.) 11. Storage facilities, including at least the following: i. A room, closet, or cabinetry for storage of clean and sterile supplies; and ii. A room for holding of soiled clinical material; and 12. A housekeeping room that contains a service sink and storage for housekeeping supplies and equipment. 8:43A-29.3 Definitions The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise: ... *["ALS" means American Lithotripsy Society. The American Lithotripsy Society is a voluntary membership organization dedicated to addressing all issues regarding the 42 40 N.J.R. 702(a) January 22, 2008 management and treatment of stone disease including aspects of lithotripsy as a treatment modality for urinary stone disease.]* ... 8:43A-29.5 Qualifications of radiologic technologists Each radiologic technologist shall be licensed by the New Jersey State Department of Environmental Protection *[and shall be certified by the American Lithotripsy Society within one year of employment.]*. 8:43A-30.3 Radiation therapy oncology services staff qualifications (a) (No change.) (b) In order to be qualified under this subchapter, a radiation oncologist shall be certified by the American Board of Radiology in general radiology, radiation oncology or therapeutic radiology prior to 1976; or certified by the American Board of Radiology or the American Osteopathic Board of Radiology in radiation oncology since 1976 or actively engaged in the process for certification by the American Board of Radiology or the American Osteopathic Board of Radiology. 1. (No change.) 2. Upon application made to the Department by the physician, a waiver of the requirement of board certification shall be granted to a radiation oncologist who is licensed by and in good standing with the New Jersey Board of Medical Examiners as of September 18, 2000. i. If granted, the waiver shall remain for the duration of the applicant's career unless the applicant fails to maintain his or her status of good standing with the New Jersey Board of Medical Examiners. ii. If the applicant fails to maintain good standing with that Board, the waiver shall automatically become null and void. iii. Physicians falling out of good standing, and subsequently achieving good standing status, shall be eligible to reapply for a subsequent waiver, provided the applicant shall show cause why a subsequent waiver should be approved. (c) (No change.) (d) All radiological physicists in the radiation oncology facility shall be qualified to insure that Cobalt-60 units and other energy units are calibrated and used properly. 43 40 N.J.R. 702(a) January 22, 2008 (e) For the purposes of this subchapter, qualified radiological physicists means one who: 1. (No change in text.) 2. Does not meet the criteria in (e)1 above, but whose petition for recognition as a "qualified radiological physicist," as defined at N.J.A.C. 7:28-14.2, has been granted by the Commission on Radiation Protection. (f) To obtain recognition as a "qualified radiological physicist" within the meaning of (e)2 above, the individual shall submit a written petition to the Commission on Radiation Protection that contains sufficient information about the individual's educational, professional, clinical, technical, employment and/or any other relevant experience, and shall adhere to such other procedures and requirements that the Commission may prescribe. 1. The Commission may approve any such petition based on its determination that the individual demonstrates competence to act as a qualified radiological physicist. 8:43A-30.6 Radiation oncology services supplies and equipment (a)-(b) (No change.) (c) All single-unit facilities shall have dual photon energy equipment with electron capability. (d) New or replacement machines shall, at a minimum, provide greater than or equal to 10 MV photon energy level capability and greater than or equal to 10MeV electron energy level capability unless another machine already exists at that facility with these capabilities. 8:43A-30.7 Radiation oncology services quality improvement methods (a) (No change.) (b) New and existing radiation oncology facilities shall have and maintain accreditation by the American College of Radiology or the American College of Radiation Oncology. 8:43A-30.9 Independent verification of radiation oncology equipment calibration (a) (No change.) 44 40 N.J.R. 702(a) January 22, 2008 8:43A-32.3 Waiver requests (a) If a licensing applicant believes that certain requirements of this chapter do not apply to the service proposed, then the applicant may request a waiver from those specific standards by following the process outlined at N.J.A.C. 8:43A-2.9. (b) Waiver forms are available from the Office of Certificate of Need and Healthcare Facility Licensure. 45