Title: Section 80.136 - Controlled substances for emergency medical services: purchasing, possessing, delivering, administering and safeguarding of controlled substances

80.136 Controlled Substances for Emergency Medical Services: Purchasing, possessing, delivering, administering, and safeguarding of controlled substances.

(a) Definitions:

(1) Ambulance Service means an individual, partnership, association, corporation, municipality or any other legal entity or subdivision, thereof, engaged in providing emergency medical care and the transportation of sick, or injured persons by motor vehicle, aircraft or other form of transportation to or from facilities providing hospital services.

(2) Medical Director means a New York State licensed physician who is responsible for authorizing treatment protocols and quality assurance activities for participating advanced life support agencies within an advanced life support system. The medical director of any advanced life support system with 10 or more advanced life support agencies and/or 100 or more advanced emergency medical technicians (AEMTS) shall designate associate physicians to provide quality assurance according to a plan submitted to and approved by the Emergency Medical Services Program.

(3) Agent means a person or persons certified as an emergency medical technician-critical care or emergency medical technician-paramedic who is appointed by an advanced life support agency, approved in writing by the medical director, and registered with the Department's Bureau of Narcotic Enforcement, to purchase, possess, and deliver controlled substances for use by an advanced life support agency.

(4) Advanced Life Support First Response Service means an organization which provides advanced life support care but does not transport patients.

(5) Advanced Life Support Agency (ALS Agency) means a certified ambulance service or certified advanced life support first response service which is authorized by the medical director of an advanced life support system to provide advanced life support care.

(6) Contracting Hospital means a hospital licensed as an Institutional Dispenser Class 3 which has a written agreement with one or more ALS Agencies to provide stocks of controlled substances to such services.

(7) Advanced Life Support System means an acute medical care system organized to provide advanced life support care on site or en route to a hospital in accordance with section 3031 of the Public Health Law.

(b)(1) A hospital licensed as an Institutional Dispenser Class 3 may:

(i) enter into a written agreement with an ALS Agency to provide, sell or deliver stocks of controlled substances, to such agency for use in an advanced life support system; or

(ii) enter into a written agreement with an ALS Agency to act as agent for such agency and supply a substock of controlled substances for use in the ALS Agency's response vehicles; and

(iii) provide only those controlled substances approved by the Department and the medical director.

(2) Only those ambulance services or advanced life support services meeting the conditions of and approved under this Part may possess, deliver or administer controlled substances.

(c) An ALS Agency and/or its agent shall:

(1) purchase, possess, deliver or cause to be administered only those controlled substances approved and listed by the Department and approved by the medical director of the advanced life support system;

(2) possess a certificate issued pursuant to article 30 of the Public Health Law;

(3) possess a class 3(c) institutional dispenser limited license from the Department, except that an ALS agency, owned and operated by a hospital, is exempt from obtaining a class 3(c) institutional dispenser limited license and shall:

(i) utilize the hospital's class 3 institutional dispenser license for the delivery of controlled substances for use in any authorized response vehicle;

(ii) maintain the ALS agency's controlled substances as part of the hospital's controlled substances substock;

(iii) have the hospital act as the agent for its ambulance service;

(iv) comply with all other sections of this Part;

(4) permit only a licensed physician or a person certified pursuant to Article 30 of the Public Health Law as an advanced emergency medical technician - critical care or advanced emergency medical technician - paramedic, and authorized by the medical director of the advanced life support system to receive or administer a controlled substance.

(d)(1) Any ALS Agency may be denied approval to purchase, possess, or deliver controlled substances upon a finding by the Department that the approval should be denied or revoked by reason of false statements in the application, failure to provide adequate safeguards against diversion of the controlled substances, or other good and sufficient reason such as an administrative determination that article 30 or 33 of the Public Health Law or a provision of Part 800 of this Title or of this Part was violated.

(e) Agents.

(1) An ALS Agency shall register an agent to purchase, possess, and deliver controlled substances, by making application to the Department.

(2) The Department shall issue such registration unless the Department finds that the application should denied by reason of false statements in the application, failure to provide adequate safeguards against diversion of the controlled substances, other good and sufficient reason such as an administrative determination that article 30 or 33 of the Public Health Law was violated, or conviction of one or more criminal offenses, as defined in section 800.3(ak), unless the applicant is found eligible after a balancing of the factors set out in Article 23-A of the Correction Law. In accordance with that Article, no application for registration shall be denied by reason of the applicant having been previously convicted of one or more criminal offenses unless (i) there is a direct relationship between one or more of the previous criminal offenses and duties required of the registration or (ii) registering the applicant would involve an unreasonable risk to property or the safety or welfare of a specific individual or the general public. In determining these questions, the department will look at all factors listed under New York State Correction Law section 753.

(3) Such registration shall be valid for a period of two years and may be suspended or revoked upon a finding by the Department that the ALS Agency, agent, or its members have violated article 30 or 33 of the Public Health Law or any provision within Part 800 of this Title or any provision within this Part.

(4) Each ALS agency or its agent shall immediately notify the Department and the medical director of any change in the membership, employment, or contractual relationship with the designated agent or the dispensing hospital.

(5) Such registration shall be valid only for the ALS Agency and at the specified location(s) appointing the agent.

(6) An agent of an ALS Agency may deliver controlled substances, only for administration by their ALS Agency, to a licensed physician and individuals certified and authorized to administer controlled substances.

(f) Agents shall ensure that:

(1) Controlled substances shall be safeguarded properly and kept securely at the registered address on file with the Department;

(2) All stocks and/or substocks will be made available for inspection by authorized representatives of the Department;

(3) Access to controlled substances stocks shall be limited to the minimum number of individuals actually required to manage the administration, delivering and handling of such controlled substances efficiently;

(4) A plan is submitted to the Department for review, modification and/or approval that details the location(s) of all stocks or substocks, the safeguarding of, access to, and security standards for all controlled substances;

(5) A quality assurance plan for the administration of controlled substances is submitted to the Department; and

(6) Only a reasonable quantity of controlled substances as approved by the medical director is stored as substocks.

(g) Minimum security standards for ALS Agencies, their agents and all certified and authorized individuals:

(1) Any stock or substock of controlled substances shall be maintained in a secure manner and in compliance with this Part.

(2) Any stock or substock of controlled substances shall be stored in a locked cabinet of substantial construction at the location registered with the Department. The cabinet shall be stationary, be made of steel or other metal and be of sufficient size to store all controlled substances. This cabinet shall be limited to the storage of controlled substances, needles and syringes and associated records.

(3) Access to any stock or substock of controlled substances will be limited to the agent and require at least two locks with different keys.

(4) Any substock of controlled substances in an authorized response vehicle shall be stored as follows:

(i) When access to the patient compartment of an ambulance is kept locked at all times, controlled substances shall be secured in a locked cabinet using a key lock different than the patient compartment.

(ii) When the access to the patient compartment of an ambulance is not kept locked at all times or any other response vehicle is used, controlled substances must be secured in a locked box within a locked stationary cabinet under a two lock system using different keys.

(iii) The key(s) to access the cabinet where controlled substances are stored must be maintained under the direct control of a certified and authorized individual.

(iv) Controlled substances may be maintained in the direct possession and control of a certified and authorized individual at all times while such individual is on duty for the ALS Agency, however, at no time shall controlled substances be carried in any personal automobile.

(v) A written change of shift inventory for any substock shall be conducted when custody of controlled substances passes between certified and authorized individuals during a shift change.

(vi) Alternative forms of securing or maintaining controlled substances in authorized response vehicles are subject to the approval of the Department upon written application by the chief executive/operating officer of the ALS Agency. The application must describe the alternative methods, state reasons why the alternate method is necessary and fully describe procedures for safeguarding and controlling controlled substances and limiting access to certified and authorized individuals. (vii) Only individuals certified and authorized under this Part shall have access to controlled substances. If an agency operates at various times with different levels of personnel, all of whom are not certified and authorized, provisions shall be made to prohibit access to all controlled substances by persons who are not certified or authorized.

(h)(1) Controlled substances may only be administered pursuant to a physician's order or a protocol authorized by the medical director and approved by the Department pursuant to Article 30 of the Public Health Law and section 800.15 of this Title. A copy of the approved protocol shall be on file with the Department. Any change in such protocol shall be approved by the Department prior to being implemented.

(2) A certified and authorized individual making any administration of a controlled substance pursuant to a physician order or protocol order shall notify a medical control location to make a record of the administration as described in section 80.136(h)(3). Such notification shall be made during or immediately following the run.

(3) At any medical control location, the physician ordering or confirming the administration of a controlled substance shall make and maintain a record of such administration to include but not be limited to:

(i) physician name and signature;

(ii) date, time, and run identification;

(iii) patient name;

(iv) ALS Agency name;

(v) AEMT number and name;

(vi) patient's chief complaint and presenting problem;

(vii) name of controlled substance;

(viii) dosage and route of administration;

(ix) quantity administered; and

(x) receiving hospital name and record number.

(4) Each certified and authorized individual receiving an order or using a protocol to administer a controlled substance shall make a record of the administration to include but not be limited to:

(i) ordering physician identification;

(ii) date, time, and run identification;

(iii) patient name;

(iv) ALS Agency name;

(v) AEMT number and name;

(vi) patient's chief complaint and presenting problem;

(vii) name of controlled substance;

(viii) dosage and route of administration;

(ix) quantity administered, and

(x) receiving hospital name and record number.

The required record shall be the Department's Pre-hospital Care Report and any necessary supplement. A copy of the pre-hospital record shall become part of the patient's hospital record. Patient confidentiality shall be maintained at all times.

(5) A certified and authorized individual shall maintain an administration inventory record for all controlled substances. This record shall be returned to the agent before any controlled substances can be replenished.

(i) Recordkeeping Requirements.

(1) Agents shall keep records of all controlled substances obtained, purchased, delivered and administered.

(2) All purchase records, including date, quantity obtained and source shall be maintained in a separate file by date received.

(3) An inventory record shall be maintained and shall include the following:

(i) the name of the controlled substance;

(ii) the name of the manufacturer and lot number;

(iii) the strength of the controlled substance;

(iv) the total amount of controlled substance stock received;

(v) the name, address, and DEA registration number of the authorized person or hospital supplying the controlled substance stock;

(vi) the date the controlled substance stock was received;

(vii) the signature of the person receiving the controlled substance stock;

(viii) the date and the amount of the controlled substance delivered to a substock;

(ix) the signature of the agent who delivered the controlled substance substock;

(x) the signature of the certified and authorized individual receiving the controlled substance substock;

(xi) the vehicle identification number or location of substock; and

(xii) the remaining amount of controlled substance on hand.

(4) A separate record shall be maintained of all non-administered losses from any stock or substock with a brief statement describing the incident and signed by the certified and authorized individual and the agent.

(5) Partial doses remaining after the parental administration of a portion of an ampule or unit dose of a controlled substance may be destroyed and properly disposed of provided that:

(i) a notation is made on the administration record; and

(ii) the destruction is witnessed by a second certified emergency medical technician member of the ALS Agency, the agent, or other licensed health care provider.

(6) An administration record shall be kept for each substock. This record will indicate the substock location and/or the vehicle identification number, the name of each controlled substance, dose and quantities furnished to the substock and:

(i) date and hour of administration;

(ii) name of patient;

(iii) run and medical control information;

(iv) dose administered;

(v) balance on hand after each administration; and

(vi) the name and signature of the administering individual.

(j) All records pertaining to controlled substances shall be kept at the location registered with the Department by the ALS Agency for a period of five years and shall be readily available and produced promptly for inspection by authorized representatives of the Department.

(1) Within 30 days of June 30 and December 31 of each year, the ALS Agency shall submit a report for that six month period to the Department signed by the agent which report shall include the following:

(i) the name, address, and telephone number of the ALS Agency;

(ii) the Bureau of Narcotic Enforcement license number;

(iii) the agent's name;

(iv) the total amount of controlled substances received from the dispensing hospital;

(v) the total amount of controlled substances dispensed to personnel;

(vi) the total amount of controlled substances returned from personnel;

(vii) the total amount of controlled substances lost for any reason;

(viii) the total amount of controlled substances on hand at the end of the period; and

(ix) an actual physical inventory count of all controlled substances on hand.

(k) Responsibilities.

(1) All agents and members of an ALS Agency are under a continuing duty to report immediately to the Department and the medical director any loss, theft, or diversion of controlled substances.

(2) Agents and certified and authorized members of the ALS Agency are responsible for the proper safeguarding and handling of controlled substances, needles and syringes.

(3) The medical director of the advanced life support system authorizing the use and administration of controlled substances shall be accountable for the proper use and administration of the controlled substances and for maintaining a quality assurance plan and protocols approved by the Department.

(4) The chief executive/operating officer of the ALS Agency is responsible for the proper safeguarding, handling and accountability of controlled substances and for assuring that all reports and reporting procedures are carried out in accordance with this Part. The chief executive/operating officer shall not be relieved from any responsibility under this Part as a result of any delegation of responsibility.