DIVISION OF HEALTH INFRASTRUCTURE PREPAREDNESS AND. Mobility Assistance Vehicle and Basic Life Support Ambulance Services

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1 HEALTH AND SENIOR SERVICES PUBLIC HEALTH SERVICES BRANCH DIVISION OF HEALTH INFRASTRUCTURE PREPAREDNESS AND EMERGENCY RESPONSE OFFICE OF EMERGENCY MEDICAL SERVICES Mobility Assistance Vehicle and Basic Life Support Ambulance Services Proposed Readoption: N.J.A.C. 8:40 Authorized By: Heather Howard, Commissioner, Department of Health and Senior Services (with the approval of the Health Care Administration Board). Authority: N.J.S.A. 26:2H-1 et seq., and 30:4D-6.4 and 6.6. Calendar Reference: See Summary below for explanation of exception to calendar requirement. Proposal Number: PRN Submit written comments by, 2009 to: Ruth Charbonneau, Director Office of Legal and Regulatory Affairs Office of the Commissioner New Jersey Department of Health and Senior Services PO Box 360 Trenton, NJ The agency proposal follows:

2 Summary N.J.A.C. 8:40, the Department of Health and Senior Services rules concerning pre-hospital basic life support (BLS) ambulance services and mobility assistance vehicle services, is scheduled to expire on June 7, 2009, pursuant to N.J.S.A. 52:14B-5.1. The Department has reviewed these rules and finds that they continue to be necessary, adequate, reasonable, efficient, understandable, and responsive to the purpose for which they were promulgated and is therefore proposing that they be readopted. The rules have been effective in regulating an industry that is changing rapidly in response to advances in medical understanding and technology. By filing this notice of proposed readoption prior to June 7, 2009, the chapter expiration date has been extended for 180 days to December 7, See N.J.S.A. 52:14B-5.1c. The Department will consider recommendations to amend Chapter 40 following readoption. Chapter 40, Interim Rules for Abortion Facilities Receiving Temporary Licensure, was adopted as Emergency Rule R.1974 d.215, effective August 5, See 6 N.J.R. 345(c) (September 5, 1974). Chapter 40, Interim Rules for Abortion Facilities Receiving Temporary Licensure, was repealed by R.1983 d.202, effective June 6, See 15 N.J.R. 308(a) (March 7, 1983), 15 N.J.R. 922(a) (June 6, 1983). Chapter 40, Manual of Standards for Licensure of Invalid Coach and Ambulance Services, was adopted as R.1985 d.192, effective April 15, See 16 2

3 N.J.R. 3127(a) (November 19, 1984), 17 N.J.R. 919(a) (April 15, 1985). Pursuant to Executive Order No. 66(1978), Chapter 40 expired on April 15, Chapter 40, Manual of Standards for Licensure of Invalid Coach and Ambulance Services, was adopted as new rules by R.1990 d.239, effective May 7, 1990, to expire on May 7, See: 22 N.J.R. 595(a) (February 20, 1990), 22 N.J.R. 1364(a) (May 7, 1990). Subsequent to expiration, the Executive Order No. 66(1978) expiration date for Chapter 40 was extended by gubernatorial waiver to January 31, See: 23 N.J.R. 2245(a) (August 5, 1991). Pursuant to Executive Order No. 66(1978), Chapter 40, Manual of Standards for Licensure of Invalid Coach and Ambulance Services, was readopted as R.1992 d.16, effective December 6, See: 23 N.J.R. 2566(a) (September 3, 1991), 24 N.J.R. 119(a) (January 6, 1992). Pursuant to Executive Order No. 66(1978), Chapter 40, Manual of Standards for Licensure of Invalid Coach and Ambulance Services, was readopted as R.1997 d.4, effective December 6, See: 28 N.J.R. 4198(a) (September 16, 1996), 29 N.J.R. 128(a) (January 6, 1997). Pursuant to Executive Order No. 66(1978), Chapter 40, Manual of Standards for Licensure of Mobility Assistance Vehicle and Ambulance Services, was readopted as R.1998 d.107, effective Janauary 23, See: 29 N.J.R. 4416(a) (October 20, 1997), 30 N.J.R. 648(a) (February 17, 1998). Chapter 40, Manual of Standards for Licensure of Mobility Assistance Vehicle and Ambulance Services, expired on January 23, Chapter 40, Mobility Assistance 3

4 Vehicle and Basic Life Support Ambulance Services, was adopted as R.2004 d.217, effective June 7, See 35 N.J.R. 2010(a) (May 19, 2003), 36 N.J.R. 2795(a) (June 7, 2004). The rules proposed for readoption continue to establish uniform statewide licensure and operations standards for the delivery of mobility assistance vehicle (MAV) services and basic life support (BLS) ambulance services. Subchapter 1 continues to state the authority, scope and purpose, defined terms, and formal waiver procedures for the benefit of MAV and BLS providers. Subchapter 2 continues to provide rules for license applications, including general licensing information, licensure exceptions, track record review, licensure and administrative fees, and general vehicle inspection and provider audit information. Subchapter 3 continues to provide general administrative requirements, including rules for patient care reports, reportable events, insurance coverage, and maintenance of records. Subchapter 4 continues to provide general crewmember, equipment, and vehicle requirements, including minimum crewmember requirements, vehicle sanitation standards, vehicle temperature standards, and pneumatic testing standards. Subchapter 5 continues to provide specific mobility assistance vehicle service requirements, including required crewmembers, crewmember duties, patient transport duties, use of ramps and lifts, patient compartment requirements and dimensions, and two-way communications standards. Subchapter 6 continues to provide specific basic life support ambulance 4

5 service requirements, including required crewmembers, crewmember duties, basic equipment and supplies, rules for patient transport devices, and additional requirements for BLS ambulances providing emergency response, such as the oversight of a physician medical director. Subchapter 7 continues to define the scope of practice of EMT-Basics, to provide for enforcement actions including monetary penalities, license suspensions and revocations, and to notify providers of hearing procedures. This notice of proposed readoption is not required to be referenced in a rulemaking calendar since a public comment period of 60 days is being provided. See N.J.A.C. 1:30-3.3(a)5. Social Impact The rules proposed for readoption in N.J.A.C. 8:40 provide a system of control and regulation which ensures, to the extent practicable, that the delivery of MAV and non-volunteer BLS ambulance services is of the highest quality. The readoption of these provisions is essential to assure the public trust and confidence in the operations of MAV service providers and non-volunteer BLS ambulance service providers, in accordance with the purposes of the Medical Assistance and Health Services Act, N.J.S.A. 30:4D-6.4 and 6.6, and the Health Care Facilities Planning Act, N.J.S.A. 26:2H-1, et seq., respectively. Readoption of these 5

6 rules would continue to provide a uniform set of standards for the delivery of MAV and BLS ambulance services in the State of New Jersey. The social conditions which existed at the time of the original adoption of N.J.A.C. 8:40 still exist. There is a steady demand for MAV and BLS ambulance services. The past social effect of these rules has been to ensure uniform delivery of these services Statewide. This has resulted in better pre-hospital patient outcomes and in better transportation for wheelchair bound patients. The public has generally reacted favorably to the implementation of these rules. If these rules were not readopted, the uniform high quality delivery of MAV and BLS ambulance services would suffer, vehicle safety standards would decline, and some providers would operate without adequate medical equipment and supplies. Economic Impact The rules proposed for readoption would not impose any additional costs on the approximately 378 licensed providers that provide services governed by N.J.A.C. 8:40. The rules would continue to control and regulate approximately 291 BLS ambulance service and 163 MAV service providers. Approximately 76 providers are licensed to provide both BLS ambulance and MAV services. Costs are incurred by licensed entities in delivering BLS ambulance and MAV services, including, but not limited to, the purchase of vehicles, equipment, insurance, and labor. In addition, 6

7 BLS ambulance service providers must purchase medical supplies and equipment, such as bandages, bag valve masks, and suction machines. The rules proposed for readoption would continue to require providers to maintain patient records and report unusual occurrences to the Department. Since N.J.A.C. 8:40 was adopted on June 7, 2004, many providers have switched to electronic patient care reporting, which reduces the costs associated with purchasing, storing, and recycling paper. The readoption of these rules would not affect the cost of licensed services to the public or to the State. Failure to readopt these rules may result in providers using expired medicine and/or supplies, carrying insufficient insurance, or using unsafe vehicles, all of which would negatively impact the quality of MAV and BLS ambulance services. Federal Standards Statement The proposed readoption is mandated by N.J.S.A. 26:2H-1, et seq., and 30:4D-6.4 and 6.6. These rules are not subject to any Federal standards or requirements. Therefore, a Federal standards analysis is not required. Jobs Impact The rules proposed for readoption have not had and would not have an impact in the generation or the loss of jobs in the State. 7

8 Agriculture Industry Impact The rules proposed for readoption have not had and would not have an impact on the State s agriculture industry. Regulatory Flexibility Statement The proposed readoption would continue to affect approximately 11 New Jersey hospitals that operate MAV and/or BLS ambulance services, which are not considered small businesses as defined in the Regulatory Flexibility Act, N.J.S.A. 52:14B-16, et seq., because each hospital employs more than 100 employees. The proposed readoption would continue to affect the approximately 367 additional licensed providers, of which the Department estimates that 250 are small businesses as defined in the Regulatory Flexibility Act, N.J.S.A. 52:14B-16, et seq. The Department estimates that each of these 250 small businesses generally employs at least 10 people. Therefore, a regulatory flexibility analysis is required. The estimated 250 licensed providers that are small businesses include approximately 87 MAV service providers, 126 BLS ambulance service providers, and 37 providers that are licensed to provide both MAV and BLS ambulance services. The rules proposed for readoption would continue to require all of these providers to comply with certain record keeping, reporting and compliance requirements, discussed above in the Summary and the Economic Impact Statement. BLS ambulance service 8

9 providers would continue to comply with these requirements by completing patient care reports for each patient treated, reporting unusual occurrences to the Department by telephone and in writing, ensuring that vehicles are equipped and maintained according to N.J.A.C. 8:40, and maintaining employee records at the provider s principal place of business. MAV service providers would continue to comply with these requirements by completing run reports for each patient transported, reporting unusual occurrences to the Department by telephone and in writing, ensuring that vehicles are equipped and maintained according to N.J.A.C. 8:40, and maintaining employee records at the provider s principal place of business. N.J.A.C. 8:40 could not be designed to lessen the impact of record keeping, reporting and compliance requirements on small businesses without creating unacceptable disparities in the quality of MAV and BLS ambulance services. Differing compliance, reporting requirements, or timetables that take into account resources available to small businesses would not further the purposes for which N.J.S.A. 26:2H- 1 et seq., and 30:4D-6.4 and 6.6 were enacted. Similarly, performance rather than design standards would not be responsive to the purposes for which these statutes were enacted. It would not ensure high quality MAV and BLS ambulance services to exempt small businesses from all or part of the rules, because any deviations from the rules would endanger the public health, safety and welfare. It would not be appropriate, for example, to exempt small businesses from meeting minimum 9

10 crewmember requirements or vehicle safety requirements because this would result in a lower quality of care for patients. The readoption of the record keeping, reporting and compliance requirements in N.J.A.C. 8:40 is required to provide the public benefit of uniform, high quality MAV and BLS ambulance services. Smart Growth Impact The rules proposed for readoption have not had and would not have an impact on the achievement of smart growth and implementation of the State Development and Redevelopment Plan. Housing Affordability Impact The rules proposed for readoption have not had and would not have an impact on the costs associated with housing because the rules only apply to providers of MAV and BLS ambulance services. Smart Growth Development Impact The rules proposed for readoption have not had and would not have an impact on housing production because the rules do not apply to housing. Full text of the rules proposed for readoption may be found in the New Jersey Administrative Code at N.J.A.C. 8:40. 10