1. When were regulations promulgated and when will hospitals be licensed for Medical Control Services?
  2. If an ambulance service has bases of operation in more than one EMS region, does it need an affiliation agreement with hospitals in each of these regions?
  3. How is an ambulance service "base of operation" defined?
  4. How do hospitals know that an ambulance service has multiple affiliation agreements, and what is each hospital responsible for with regard to that ambulance service?
  5. Can an ambulance service based in one EMS region get its affiliation agreement from a hospital based in another EMS region?
  6. If a hospital only has an affiliation agreement with an ambulance service for its ALS interfacility transfer work, to what degree does it have oversight responsibility for that service?
  7. Can an affiliate hospital oversee the work of its affiliated ambulance service when it is working in other regions?
  8. Can a hospital continue to have limited affiliation agreements with ambulance services for drug exchange only, while those ambulance services also have their main affiliation agreements with other hospitals? If so, does it have to meet all the regulatory requirements for medical control for such a limited affiliation agreement?
  9. If an affiliate hospital medical director is responsible for authorizing an EMT-Paramedic to practice, does this mean the state no longer licenses EMTs?
  10. Can an Affiliate Hospital Medical Director suspend or revoke an EMT-Intermediate's or EMT-Paramedic's certificationor authorization to practice? What effect would such an action have?
  11. How much of a liability is the Affiliate Hospital Medical Director undertaking for signing off on a Paramedic in one region, if he or she has no information regarding the practices of that Paramedic while working in another region?
  12. Under the Quality Assurance/Quality Improvement (QA/QI) system required to be provided by the affiliate hospital, does the Affiliate Hospital Medical Director need to review every single trip record for an ALS call by the affiliated ambulance service, or can he or she do a sampling? If a sampling is permissible, what is the required sampling?
  13. If a sampling of trip records are reviewed under the QA/QI system, and as a result an error is not captured in time to prevent a repeat error, is the affiliate hospital medical director or the hospital liable?
  14. What if EMTs deliver a patient to a hospital other than the affiliate hospital, and call that other hospital for on-line medical direction with regard to such a patient? Can they continue to do that under the new regulations?
  15. Do the new regulations apply to memoranda of understanding with Basic Life Support services?
  16. Do the QA/QI requirements apply to BLS services, or only to ALS?
  17. Can responsibility for skill competence and statistical compilation be delegated back to the ambulance service?
  18. Do all ALS-level ambulance services need to have affiliation agreements, or is the requirement limited to ALS-Paramedic level services?
  19. Is there a Department-approved template for affiliation agreements?

 

1. When were regulations promulgated and when will hospitals be licensed for Medical Control Services?

The amendments were promulgated effective February 23, 2007. However, until further notice the Department is extending the time for implementation of the Medical Control regulatory changes for hospitals. This is being done in order to give hospitals an opportunity to satisfactorily respond to Department comments regarding their submitted applications and supporting documents necessary for licensure as a Medical Control Service hospital. In the meantime, hospitals currently delivering medical control services to ambulance services can continue to do so. As a result, the OEMS deadline for implementation of the affiliation agreement changes in the EMS System regulations, most of which track these Hospital Licensure regulations changes for Medical Control, have similarly been extended until further notice.

2 . If an ambulance service has bases of operation in more than one EMS region, does it need an affiliation agreement with hospitals in each of these regions?

Yes. See 105 CMR 170.300(B).

3 . How is an ambulance service "base of operation" defined?

A base of operation for an ambulance service is a physical garage location.

4 . How do hospitals know that an ambulance service has multiple affiliation agreements, and what is each hospital responsible for with regard to that ambulance service?

The identities of each hospital with which an ambulance service has an affiliation agreement must be disclosed in each affiliation agreement. In addition, in these cases the affiliation agreements must address policies and procedures that set forth the duties and responsibilities of each affiliate hospital. See 105 CMR 170.300(A)(11).

5 . Can an ambulance service based in one EMS region get its affiliation agreement from a hospital based in another EMS region?

Yes. The regulations do not prohibit this for ambulance services with either all their bases of operation in a single EMS region, or with just a single base of operation. However, if an ambulance service has bases of operation in multiple EMS regions, then it is required to have an affiliation agreement with a hospital in each of these EMS regions.

6 . If a hospital only has an affiliation agreement with an ambulance service for its ALS interfacility transfer work, to what degree does it have oversight responsibility for that service?

The hospital would need to work out the parameters of its role as an affiliate hospital to that ambulance service with the service's other affiliate hospital(s), in the policies and procedures referenced in the answer to question 4 above.

7 . Can an affiliate hospital oversee the work of its affiliated ambulance service when it is working in other regions?

The hospital would need to work out the parameters of its role as an affiliate hospital to that ambulance service with the service's other affiliate hospital(s), in the policies and procedures referenced in the answer to question 4 above.

8 . Can a hospital continue to have limited affiliation agreements with ambulance services for drug exchange only, while those ambulance services also have their main affiliation agreements with other hospitals? If so, does it have to meet all the regulatory requirements for medical control for such a limited affiliation agreement?

Hospitals and ambulance services may continue to enter into agreements limited to setting the terms of drug exchange. However, these are not affiliation agreements, and should not be so named. Because they are not affiliation agreements for medical control, the regulatory requirements for medical control do not apply.

9 . If an affiliate hospital medical director is responsible for authorizing an EMT-Paramedic to practice, does this mean the state no longer licenses EMTs?

No. The Department of Public Health's Office of Emergency Medical Services continues to certify (equivalent of licensure) EMTs at all levels - Basic, Intermediate and Paramedic. In addition to that certification, Advanced Life Support EMTs - Intermediates and Paramedics - need to be authorized to practice by their affiliate hospital medical director. Affiliate hospital medical directors have since July 2003 had the responsibility to authorize the ALS EMTs of their affiliate ambulance services under the EMS System regulations for affiliation agreements. See 105 CMR 170.020, "Authorization to Practice" definition, and 105 CMR 170.300(A)(2).

10 .Can an Affiliate Hospital Medical Director suspend or revoke an EMT-Intermediate's or EMT-Paramedic's certificationor authorization to practice? What effect would such an action have?

Affiliate Hospital Medical Directors cannot suspend or revoke an EMT's certification - the Department of Public Health certifies EMTs, and only it can suspend or revoke an EMT's certification. An Affiliate Hospital Medical Director can suspend or revoke an ALS-level EMT's authorization to practice. This means the EMT can no longer work for that ambulance service under the affiliation agreement that names that Affiliate Hospital Medical Director. The EMT remains a certified EMT and may work elsewhere. The Affiliate Hospital Medical Director must notify the Department within 48 hours of suspending or revoking an EMT's authorization to practice, and the Department will commence an investigation. See 105 CMR !30.1503(A)(3) and 105 CMR 170.795.

11 . How much of a liability is the Affiliate Hospital Medical Director undertaking for signing off on a Paramedic in one region, if he or she has no information regarding the practices of that Paramedic while working in another region?

Any answer on liability for Affiliate Hospital Medical Directors begins with the fact that MGL c. 111C, the state's EMS statute, offers broad liability protection for physicians who provide medical oversight for EMS, as long as they act in good faith. See MGL c. 111C, section 20, and the Department's Advisory explaining that protection, on-line at: http://www.mass.gov/Eeohhs2/docs/dph/emergency_services/physician_liability.pdf pdf format of physician-liability.pdf .

Second, that said, Affiliate Hospital Medical Directors who are responsible for oversight of ALS-level EMTs, which includes authorization to practice, must ensure the policies and procedures worked out with the ambulance service's other affiliate hospital(s) include provisions for the physicians to get the information they need to make appropriate oversight decisions. In addition, affiliation agreements must contain a procedure by which the ambulance service will notify the Affiliate Hospital Medical Director of Department disciplinary action against any EMT employed by the ambulance service. See 105 CMR 170.300(10). Finally, since all suspensions or revocations of an EMT's authorization to practice must be reported to the Department, pursuant to 105 CMR 130.1503(A)(3), any Affiliate Hospital Medical Director can check with the Department if he or she has any reason to question an EMT's history.

12 . Under the Quality Assurance/Quality Improvement (QA/QI) system required to be provided by the affiliate hospital, does the Affiliate Hospital Medical Director need to review every single trip record for an ALS call by the affiliated ambulance service, or can he or she do a sampling? If a sampling is permissible, what is the required sampling?

The QA/QI system needs to include, at a minimum, "regular" review of trip records and other statistical data pertinent to the EMS service's operation, "in accordance with the hospital's own QA/QI standards and protocols." If the hospital's QA/QI standards and protocols call for less than 100% review, then that would apply to trip record review as well. See 105 CMR 170.300(A)(4).

13 . If a sampling of trip records are reviewed under the QA/QI system, and as a result an error is not captured in time to prevent a repeat error, is the affiliate hospital medical director or the hospital liable?

If the sampling is in accordance with the hospital's own QA/QI standards and protocols, and the QA/QI system has been operated in good faith, then the Affiliate Hospital Medical Director's action falls under the protection of MGL c. 111C, §20's broad liability protection, as explained in answer to question 11 above. Please note that this same statutory provision applies to hospitals providing medical control to ambulance services as well.

14 . What if EMTs deliver a patient to a hospital other than the affiliate hospital, and call that other hospital for on-line medical direction with regard to such a patient? Can they continue to do that under the new regulations?

The new regulations do not prohibit this from occurring. On-line medical direction may be delegated by the affiliate hospital to physicians at another hospital. See 105 CMR 170.300(C). It is simplest for an affiliate hospital to ensure quality if the ambulance service calls the affiliate hospital for on-line medical direction. If an ambulance service does call another hospital with which it does not have an affiliation agreement, but this hospital itself is licensed to provide medical control and there is a written agreement in place with the affiliate hospital, its physicians are deemed to have met the qualifications requirements for such physicians under 105 CMR 130.1504 of the regulations. However, if the non-affiliate, receiving hospital is not licensed to provide medical control, this hospital is not authorized to provide on-line medical direction, although the non-affiliate, receiving hospital may be linked into a call for medical direction placed to the affiliate hospital. In any event, the Affiliate Hospital is ultimately responsible for overseeing QA/QI for the service with which it has the affiliation agreement.

15 . Do the new regulations apply to memoranda of understanding with Basic Life Support services?

No. See 105 CMR 170.300, and 105 CMR 130.1501.

16 . Do the QA/QI requirements apply to BLS services, or only to ALS?

Sometimes, BLS services may voluntarily enter into full affiliation agreements with hospitals, even though under the regulations, only ALS level services are required to have them. See 105 CMR 170.300(A). In any case in which an agreement is entered into between a hospital and a BLS-level ambulance service, whether an MOU or an affiliation agreement, the terms of the agreement control, including any terms set out regarding QA/QI. Thus, because these regulations do not specifically apply to a category of ambulance service that is not required to have affiliation agreements in the first place, enforcement of any terms would be a matter between the parties to the agreement rather than by the Department.

17 . Can responsibility for skill competence and statistical compilation be delegated back to the ambulance service?

The regulations do not prohibit this. The affiliate hospital is required to "ensure" that there is a process for skill maintenance and review available to the EMS personnel employed by the affiliated ambulance service. See 105 CMR 130.1502(H). However, please note that the hospital cannot delegate back to the ambulance the responsibility for remedial training that the regulations require be provided specifically in the hospital's emergency department, operating rooms or skill laboratories. See 105 CMR 130.1502(I).

18 . Do all ALS-level ambulance services need to have affiliation agreements, or is the requirement limited to ALS-Paramedic level services?

All ALS level services, both at the Intermediate and Paramedic level, are required to have affiliation agreements for medical control.

19 . Is there a Department-approved template for affiliation agreements?

The Department does have a template that includes the current regulatory minimum elements required for affiliation agreements between hospitals and ambulance services for medical control pursuant to 105 CMR 130.1501-1504 (Hospital Licensure regulations regarding Medical Control Services) and 105 CMR 170.300 (EMS System regulations). As with any contract, all parties should seek the advice of their legal counsel prior to signing. The Department offers a draft template only as a starting point, and not as a substitute for the development and legal review of a comprehensive affiliation agreement. The best practice with regard to affiliation agreements, as with all contracts, is that they be negotiated and developed by the parties - in this case, hospitals and ambulance services - tailored to their particular circumstances, and reviewed by their respective attorneys or legal departments. Please refer to the website under Medical Control Service, Template Affiliation Agreement.

Last Updated: 03-30-2010