902 KAR 20:275. Mobile health services.

 

      RELATES TO: KRS 216B.010-216B.131, 216B.990

      STATUTORY AUTHORITY: KRS 216B.042, 314.011(8), EO 96-862

      NECESSITY, FUNCTION, AND CONFORMITY: The administrative regulation establishing standards for mobile health services, 902 KAR 20:270, was found deficient by the Interim Joint Committee on Health and Welfare at its November 15, 1995, meeting. The finding of deficiency resulted from the lack of guidelines to coordinate the relationship between home IV therapy service and home health agencies. Legislation to establish such guidelines was not enacted during the 1996 Regular Session of the General Assembly. Therefore, pursuant to KRS 13A.333(1), 902 KAR 20:270 expired. KRS 216B.042 requires the cabinet to establish standards for health facilities and services, and authorizes it to promulgate administrative regulations. Without an administrative regulation establishing standards for mobile health services, the cabinet would be in violation of the legislative mandate expressed in KRS 216B.042. KRS 13A.333(6) prohibits an administrative body from promulgating an administrative regulation that is identical to or substantially the same as an administrative regulation that has expired. This administrative regulation is not identical to or substantially the same as 902 KAR 20:270, because:

      (1) Only the lack of guidelines to coordinate the relationship between home IV therapy services and home health services was found deficient;

      (2) This administrative regulation includes guidelines to coordinate the relationship between home IV therapy service and home health agencies; and

      (3) It is required by the legislative mandate of KRS 216B.042.

      Executive Order 96-862, effective July 2, 1996, reorganizes the Cabinet for Human Resources and places the Office of Inspector General and its programs under the Cabinet for Health Services.

 

      Section 1. Definitions. (1) "Certified radiation operator" means a person who has been certified pursuant to KRS 211.870 and 902 KAR 105:010 to 105:070 as an operator of sources or radiation.

      (2) "Computed tomography (CT) scanning" means a radiological diagnostic imaging procedure that shows cross sectional images of internal body structures.

      (3) "Governing authority" or "licensee" means the individual, agency, partnership, or corporation, in which the ultimate responsibility and authority for the conduct of the institution is vested.

      (4) "IV therapy" means the administration, by a registered nurse under the supervision of a licensed physician, of various pharmaceutical and nutritional products by intravenous, subcutaneous or epidural routes.

      (5) "IV therapy service" means pharmaceutical and nursing services, including direct hands-on care, limited to and necessary for the:

      (a) Preparation, dispensing and delivery of pharmaceutical and nutritional products and equipment; and

      (b) Related clinical consultation, training, and assessment or care incidental to initial start-up of IV therapy.

      (6) "License" means an authorization issued by the cabinet for the purpose of operating mobile health services.

      (7) "Lithotripter" means a noninvasive treatment technique that utilizes shock waves to shatter kidney stones.

      (8) "Magnetic resonance imaging (MRI)" means a diagnostic imaging modality which utilizes magnetic resonance, an interaction between atoms and electromagnetic fields, to project images of internal body structures.

      (9) "Other diagnostic and treatment services" means those health services which are determined to require licensure pursuant to KRS 216B.042 as a mobile health service.

      (10) "Qualified anesthesiologist" means a person who is a doctor of medicine or a doctor of osteopathy licensed to practice medicine and surgery and who is board certified or in the process of being certified by the American Board of Anesthesiology or the American Osteopathic Board of Surgery and who otherwise meets the criteria established by the mobile health service's governing authority.

      (11) "Qualified urologist" means a person who is a doctor of medicine or a doctor of osteopathy licensed to practice medicine and surgery and who is board certified or is in the process of being certified by the American Board of Urology or the American Osteopathic Board of Surgery and who otherwise meets criteria established by the mobile health service's governing authority.

      (12) "Registered nurse" means a nurse who is licensed to engage in registered nursing practice pursuant to KRS 314.041.

 

      Section 2. Scope of Operation and Services. Mobile health services provide medical services in various locations and in some instances utilize a specially equipped vehicle such as a van, trailer or mobile home. These services include mobile diagnostic imaging and examination services, mobile treatment services, and any other medical or dental services provided through the use of a mobile vehicle or performed at various locations.

 

      Section 3. Administration. (1) Licensee.

      (a) The licensee shall be legally responsible for the service and for compliance with federal, state and local laws and regulations pertaining to the operation of the service, limited to the scope of the service's certificate of need.

      (b) The licensee shall establish lines of authority and designate an administrator who will be principally responsible for the daily operation of the service. In the case of a service whose governing authority is comprised of more than one (1) licensed hospital, a separate administrator may be designated from each hospital to serve as the administrator of the service when it is being provided at the hospital where the designee is employed.

      (2) Policies. There shall be written administrative policies which the service follows covering all aspects of operation, including:

      (a) A description of organizational structure, staffing and allocation of responsibility and accountability;

      (b) A description of linkages with inpatient facilities and other providers;

      (c) Policies and procedures for the guidance and control of personnel performances;

      (d) A written program narrative describing in detail the service(s) offered, methods and protocols for service delivery, qualifications of personnel involved in the delivery of the services, and goals of the service(s);

      (e) A description of the administrative and patient care records and reports; and

      (f) Procedures to be followed in the storage, handling and administration of drugs and biologicals.

      (3) Personnel.

      (a) Medical director. The service shall have a medical director. The medical director shall be a licensed physician or dentist with specialized training and experience in, and responsibility for, all medical aspects of the service. In the case of a service whose governing authority is comprised of more than one (1) licensed hospital, a separate medical director may be designated from each hospital's medical staff to serve as the medical director of the service when it is being provided at the hospital where the physician is on staff. If a service operates only diagnostic examination equipment, and if the service is offered only to licensed hospitals, and if the employees of the service makes no medical assessment of the diagnostic patient data collected, then the service shall be exempt from the requirements of this paragraph.

      (b) The service shall employ, or provide for through a written contractual agreement, sufficient number of qualified personnel to provide effective patient care and all other related services. The licensee shall provide written personnel policies which shall be available to all employees, reviewed on an annual basis, and revised as necessary. If the staff-to-patient ratio does not meet the needs of the patients, the Division of Licensing and Regulation shall determine and inform the program administrator in writing how many additional personnel are to be added and of what job classification, and shall give the basis for this determination.

      (c) There shall be a written job description for each position which shall be reviewed and revised as necessary.

      (d) There shall be an employee health program for mutual protection of employees and patients including provisions for preemployment and periodic health examination, tuberculin test, and other appropriate tests.

      (e) Current personnel records shall be maintained for each employee which include the following:

      1. Name, address and Social Security number;

      2. Evidence of current registration, certification or licensure of personnel;

      3. Records of training and experience; and

      4. Records of performance evaluation.

      (4) In-service training. All personnel shall participate in ongoing in-service training programs relating to their respective job activities including thorough job orientation for new employees.

      (5) Medical records.

      (a) The service shall maintain medical records which contain at least the following:

      1. Medical and social history relevant to the service(s) provided, including data obtainable from other providers;

      2. Names of referring physician, if any, and physician's orders for special diagnostic services such as x-ray or CT scans;

      3. Description of each medical visit or contact, to include condition or reason necessitating visit or contact, assessment diagnosis, services provided, medications and treatments prescribed, and disposition made;

      4. Reports of all physical examinations, laboratory, x-ray, and other test findings relevant to the service(s) provided; and

      5. Documentation of all referrals made, including reason for referral, to whom patient was referred, and any information obtained from referral source.

      (b) Confidentiality of all patient records shall be maintained at all times.

      (c) Transfer of records. The service shall establish systematic procedures to assist in continuity of care where the patient moves to another source of care, and the service shall, upon proper release, transfer medical records or an abstract thereof when requested.

      (d) Retention of records. After patient's death or discharge the completed medical record shall be placed in an inactive file and retained for five (5) years or in case of a minor, three (3) years after the patient reaches the age of majority under state law, whichever is longer. Mammography and other radiology records shall be retained in accordance with federal requirements.

      (e) A specific location shall be designated by the mobile health service for the maintenance and storage of the service's medical records.

      (f) Provisions for storage of medical records in the event the mobile health service ceases to operate because of disaster, or for any other reason. The licensee shall safeguard the record and its content against loss, defacement and tampering.

 

      Section 4. Vehicle Requirements. (1) All vehicles used in the provision of a health service, as provided by the service's certificate of need, shall be kept, in optimum order with clean interiors and equipment.

      (2) The following standards shall apply only to those vehicles which the patient enters.

      (a) There shall be adequate heating and air-conditioning capability in both the driver and patient compartments.

      (b) There shall be a minimum of two (2) potential power sources for the vehicle. To insure an immediately available source of power in the event of a power failure, one (1) must be self-contained on the vehicle. The other source must be an exterior source of power hookup.

      (c) The vehicle shall be accessible to users with disabilities either through the use of a wheelchair lift or a ramp which complies with applicable American National Standards Institute (ANSI) requirements.

      (d) The vehicle shall have adequate and safe space for staff and examination procedures, as determined by the cabinet.

      (e) Equipment. Vehicles used in the provision of a health service, as provided by the service's certificate of need, shall have the following essential equipment:

      1. One (1) five (5) pound dry chemical fire extinguisher;

      2. One (1) first aid kit;

      3. Suction apparatus;

      4. Oxygen equipment (portable) including:

      a. One (1) "D" size oxygen cylinder;

      b. One (1) pressure gauge and flow rate regulator;

      c. Adaptor and tubing; and

      d. Transparent masks for adults and children. Nasal cannulas may be substituted.

      (f) Personnel. Each mobile health service vehicle shall at a minimum be staffed by one (1) person, who may also be the driver of the vehicle, who shall have the following qualifications:

      1. Red Cross Advanced and Emergency Care Certification, each with supplemental CPR instruction certified by the American Red Cross or the American Heart Association; or

      2. EMT-first responder certification; or

      3. EMT-A certification; or

      4. Licensure as a registered nurse, physician or dentist.

 

      Section 5. Requirements for Provision of Services. A licensed mobile health service shall comply with the requirements listed in Sections 3, 4, and 6 of this administrative regulation, the service's program narrative, and the additional requirements of this section which relate to the particular service(s) offered by the licensee.

      (1) Diagnostic services. Diagnostic services are those services which are performed to ascertain and assess an individual's physical health condition.

      (a) Diagnostic services, except for mammography services, shall be performed only on the order of a physician or advanced practice registered nurse as authorized in KRS 314.011(8).

      (b) The service shall prepare a record for each patient to include the date of the procedure, name of the patient, description of the procedures ordered and performed, the referring physician, the name of the person performing the procedure, the date and the name of the physician to whom the results were sent.

      (c) Diagnostic imaging services.

      1. Diagnostic imaging services are those services which produce an image, either through film or computer generated video, of the internal structures of a patient. These services include:

      a. X-ray;

      b. MRI;

      c. CT scanning;

      d. Ultrasound;

      e. Mammography;

      f. Fluoroscopy; and

      g. Other modalities using directed energy to gain statistical, physiological or biological diagnostic imaging information.

      2. Any mobile health service which provides diagnostic imaging services shall comply with the following:

      a. Equipment used for direct patient care shall be fully approved by the Federal Food and Drug Administration (FDA) for clinical use;

      b. There shall be a written preventive maintenance program which the service follows to ensure that imaging equipment is operative, properly calibrated, and shielded to protect the operator, patient, environment, and the integrity of the images produced. Recalibration of radiation producing and nonradiation producing instrumentation shall occur at least every six (6) months by biomedical service personnel and radiation producing instrumentation shall be recalibrated annually by a consulting health physicist.

      c. Diagnostic imaging services shall be provided under the supervision of a physician who is qualified by advanced training and experience in the use of the specific imaging technique for diagnostic purposes;

      d. Imaging services shall have a current license or registration pursuant to applicable Kentucky statutes and any administrative regulations promulgated thereunder;

      e. All Personnel engaged in the operation of imaging equipment shall be currently licensed or certified in accordance with applicable Kentucky statutes and administrative regulations;

      f. There shall be a written training plan for personnel in the safe and proper usage of the mobile imaging equipment and system;

      g. There shall be a physician's signed order which specifies the reason the procedure is required, the area of the body to be examined, and a statement concerning the condition of the patient which indicates why mobile imaging services are necessary; and

      h. There shall be sufficiently trained on-duty personnel with adequate equipment to provide emergency resuscitation services in the event of a patient emergency.

      (d) Other diagnostic services.

      1. Other diagnostic services are those services which are provided through the use of diagnostic equipment, and physical examination. These services include:

      a. Electrocardiogram services;

      b. Electroencephalogram services;

      c. Holter monitor services;

      d. Disability determination services;

      e. Pulmonary function services;

      f. Aphresis services;

      g. Blood gas analysis services;

      h. Echosonogrophy services; and

      i. Doppler services.

      2. Equipment used for direct patient care shall comply with the following:

      a. The licensee shall establish and follow a written preventive maintenance program to ensure that equipment shall be operative and properly calibrated;

      b. All Personnel engaged in the operation of diagnostic equipment shall have adequate training and be currently licensed or certified in accordance with applicable Kentucky statutes and administrative regulations; and

      c. There shall be a written training plan for the adequate training of personnel in the safe and proper usage of the equipment.

      3. Physical examination services shall be nonabusive and provided in a manner which ensures the greatest amount of safety and security for the patient.

      a. Protocols for diagnostic examinations shall be developed by the medical director.

      b. Personnel performing physical examinations shall have adequate training and be currently licensed or certified in accordance with applicable Kentucky statutes and administrative regulations.

      c. Personnel performing physical examinations shall be limited by the relevant scope of practice of Kentucky licensure.

      (2) Treatment services. Treatment services are those services provided to an individual who, because of a physical health condition, is in need of medical assistance for the attainment of their maximum level of physical function.

      (a) Mobile health clinic. A mobile health clinic is a health service providing both diagnostic and treatment services through the use of a mobile vehicle. A mobile health clinic may provide a wide range of diagnostic and treatment services on an outpatient basis for a variety of physical health conditions.

      1. Policies. The licensee shall develop patient care policies with the advice of a group of professional personnel that includes one (1) or more physicians and one (1) or more advanced practice registered nurses. At least one (1) member shall not be a member of the mobile health clinic staff. The policies shall include:

      a. A description of the services the mobile health clinic provides directly and those provided through agreement;

      b. Guidelines for the medical management of health problems which include the conditions requiring medical consultation and/or patient referral, and the maintenance of health records; and

      c. Procedures for review and evaluation of the services provided by the clinic at least annually.

      2. Personnel. The mobile health clinic shall have a staff that includes at least one (1) physician and at least one (1) advanced practice registered nurse. The clinic shall employ such other staff or ancillary personnel that are necessary to provide the services essential to the clinic's operation.

      a. The physician shall:

      (i) Be responsible for all medical aspects of the clinic and shall provide direct medical services in accordance with the Medical Practice Act, KRS Chapter 311. In addition, the physician shall provide medical direction, supervision, and consultation to the staff;

      (ii) In conjunction with the advanced practice registered nurse(s), participate in developing, executing, and periodically reviewing the mobile health clinic's written policies and services;

      (iii) Periodically review the mobile health clinic's patient records, provide medical orders, and provide medical care services to patients of the mobile health clinic; and

      (iv) Be present for consultation weekly, and be available within one (1) hour, through direct telecommunication for consultation, assistance with medical emergencies, or patient referral.

      b. The advanced practice registered nurse shall:

      (i) Participate in the development, execution and periodic review of the written policies governing the services the mobile health clinic provides;

      (ii) Participate with the physician in periodic review of patient health records;

      (iii) Provide services in accordance with mobile health clinic policies, established protocols, the Nurse Practice Act (KRS Chapter 314), and with administrative regulations promulgated thereunder;

      (iv) Arrange for, or refer patients to needed services not provided at the mobile health clinic; and

      (v) Assure that adequate patient health records are maintained and transferred when patients are referred.

      3. The mobile health clinic shall have linkage agreements or arrangements with each of the following:

      a. Inpatient hospital care;

      b. Physician services in a hospital, patient's home, or long-term care facility;

      c. Additional and specialized diagnostic and laboratory services that are not available at the mobile health clinic;

      d. Home health agency;

      e. Emergency medical services;

      f. Pharmacy services; and

      g. Local health department.

      4. The mobile health clinic shall carry out, or arrange for an annual evaluation of its total program, shall consider the findings of the evaluation, and take corrective action, if necessary. The evaluation shall include:

      a. The utilization of clinic services including at least the number of patients served and the volume of services;

      b. A representative sample of both active and closed clinical records; and

      c. The mobile health clinic's health care policies.

      5. The mobile health clinic shall develop and maintain written protocols, i.e., standing orders, rules of practice, and medical directives, which apply to services provided by the clinic and which explicitly direct the step-by-step collection of subjective and objective data from the patient. The protocols shall further direct data analysis, direct explicit medical action depending upon the data collected, and include rationale for each decision made. The protocols shall be signed by the staff physician.

      6. The Mobile health clinic staff shall furnish those diagnostic and therapeutic services and supplies that are commonly furnished in a physician's office or at the entry point into the health care delivery system. These include medical history, physical examination, assessment of health status, and treatment for a variety of medical conditions.

      7. The mobile health clinic shall provide basic laboratory services essential to the immediate diagnosis and treatment of the patient, including:

      a. Chemical examinations of urine by stick or tablet methods or both (including urine ketones);

      b. Microscopic examinations of urine sediment;

      c. Hemoglobin or hematocrit;

      d. Blood sugar;

      e. Gram stain;

      f. Examination of stool specimens for occult blood;

      g. Pregnancy tests;

      h. Primary culturing for transmittal to a hospital laboratory or licensed laboratory; and

      i. Test for pinworms.

      8. The mobile health clinic shall provide medical emergency procedures as a first response to common life-threatening injuries and acute illness, and have available the drugs and biologicals commonly used in lifesaving procedures, such as analgesics, anesthetics (local), antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids.

      9. The clinic shall post in a conspicuous area at the entrance, visible from the outside of the clinic, the hours that emergency medical services will be available in the clinic, the clinic's next scheduled visit, and where emergency medical services not provided by the clinic can be obtained during and after the clinic's regular scheduled visits and hours of operation.

      (b) Mobile dental clinic. A mobile dental clinic is a health service providing both diagnostic and dental treatment services at different locations through the use of a mobile vehicle or equipment.

      1. Policies. The licensee shall develop patient care policies with the advice of a group of professional personnel that includes at least one (1) licensed dentist. These policies shall include:

      a. Guidelines which identify the dental problems which may not be performed in the mobile unit, and provisions for patient referral;

      b. Guidelines for the review and evaluation of the services provided by the clinic at least annually; and

      c. Guidelines for procedures to be followed in the event a patient has a medical emergency.

      2. Personnel. The mobile dental clinic shall have a staff that includes at least one (1) licensed dentist and at least one (1) dental assistant.

      a. The dentist shall:

      (i) Be responsible for all aspects of patient care in accordance with KRS Chapter 313 and any administrative regulations promulgated thereunder;

      (ii) Be present in the clinic at all times that a patient is receiving dental care; and

      (iii) Provide direct supervision to all staff involved in the delivery of services.

      b. The dental assistant shall:

      (i) Provide services in accordance with the mobile dental clinic policies and established protocols, KRS Chapter 313, and any administrative regulations promulgated thereunder; and

      (ii) Provide services only under the direct supervision of a licensed dentist.

      3. Equipment. The mobile dental clinics shall have the following equipment:

      a. X-ray units;

      b. Sterilizer;

      c. High-speed suction;

      d. Dental lights; and

      e. Emergency kit with the following drug types:

      (i) Antiallergenic;

      (ii) Vasodilators;

      (iii) Anticonvulsives; and

      (iv) Vasopressors.

      (c) Mobile lithotripter service. A mobile lithotripter service is a health service which provides for a noninvasive technique for removing kidney or ureteral stones through the use of a lithotripter at various hospital locations.

      1. Mobile lithotripter services may only be delivered on the grounds of the hospital utilizing the mobile lithotripter service.

      2. Lithotripsy services shall be performed only on the order of a physician.

      3. Lithotripsy services shall be provided under the supervision of a physician who is qualified by advanced training and experience in the use of lithotripsy treatment.

      4. The service shall prepare a record for each patient to include the date of the procedure, name of the patient, description of the procedures ordered and performed, the referring physician, and the name of the person performing the procedure.

      5. There shall be a physician’s signed order which specifies the reason the procedure is required, the area of the body to be exposed, and the anticipated outcome of treatment.

      6. Policies. A mobile lithotripter service shall develop patient care policies with the advice of a group of professional personnel that includes at least one (1) qualified urologist and one (1) qualified anesthetist. At least one (1) member shall not be a member of the mobile lithotripter service staff. The policies shall include:

      a. A description of how a patient will be transported between the hospital and the mobile lithotripter service;

      b. Procedures to be followed in the event a patient has a medical emergency;

      c. Guidelines for the review and evaluation of the service on an annual basis; and

      d. Policies and protocols governing the utilization and responsibilities of hospital staff in the delivery of lithotripter services.

      7. Personnel. The mobile lithotripter service shall employ at least one (1) lithotripter technician, and shall employ or make arrangements with the hospital utilizing the service for at least one (1) registered nurse, one (1) qualified urologist to be present in the unit during the delivery of lithotripsy services, and one (1) qualified anesthetist to be available for procedures requiring anesthesia.

      8. Lithotripsy equipment used for direct patient care shall comply with the following:

      a. Lithotripsy equipment shall be fully approved by the Federal Food and Drug Administration (FDA) for clinical use;

      b. The licensee shall establish and follow a written preventive maintenance program to ensure that equipment shall be operative, properly calibrated, properly shielded, and safe for the patient, operator, and environment;

      c. All Personnel engaged in the operation of diagnostic equipment shall have adequate training and be currently licensed, certified or registered in accordance with applicable Kentucky statutes and administrative regulations; and

      d. There shall be a written training plan for the adequate training of personnel in the safe and proper usage of the equipment; and

      e. There shall be sufficiently trained on-duty personnel with adequate equipment to provide emergency resuscitation in the event of a patient emergency.

      (d) Other treatment services, including IV therapy services, shall be performed only on the order of a physician.

      1. IV therapy shall only be performed by a registered nurse and shall be limited to nursing services which are required for the initial start-up of an IV therapy program.

      2. If nursing services are required which exceed the initial start-up of IV therapy, they shall be provided by an appropriately licensed agency to provide care under a physician’s plan of care.

      3. All services provided shall be under the supervision of a licensed physician.

      4. Policies. The licensee shall develop patient care policies with the advice of a group of professional personnel that includes one (1) or more physician(s) and one (1) or more registered nurse(s). At least one (1) member shall not be a member of the service's staff. The policies shall include:

      a. A description of the services provided;

      b. A requirement to inform patients of other in-home services which can be provided only by other appropriately licensed agencies;

      c. A requirement for a written common plan for treatment and coordination of treatment with other licensed health care providers servicing the patient, and immediate verbal communication between providers of revisions in the common plan shall be documented in the plan of treatment;

      d. Guidelines for the medical management of health problems which include the conditions requiring medical consultation or patient referral, and the maintenance of health records;

      e. Procedures for review and evaluation of the services provided at least annually; and

      f. Guidelines for patient and environment assessment.

      5. Personnel. The service shall have a staff that includes at least one (1) registered nurse. The service shall employ such other staff or ancillary personnel that are necessary and essential to the service's operation. The registered nurse shall:

      a. Participate in the development, execution and period review of the written policies governing the services provided;

      b. Participate with the physician in periodic review of patient health records;

      c. Provide services in accordance with established policies, protocols, the Nurse Practice Act (KRS Chapter 314), and with administrative regulations promulgated thereunder;

      (i) Arrange for or refer patients to needed services that cannot be provided by the service; and

      (ii) Assure that adequate patient health records are maintained and transferred when patients are referred.

      6. In-service training programs shall include instruction in:

      a. Use of equipment;

      b. Side effects and precautions of drugs and biologicals; and

      c. Infection control measures.

      7. The service shall carry out, or arrange for an annual evaluation of its total program, shall consider the findings of the evaluation, and take corrective action, if necessary. The evaluation shall include:

      a. The utilization of the service including at least the number of patients served and the volume of services;

      b. A representative sample of both active and closed records; and

      c. The service's health care policies.

 

      Section 6. Waste Processing. (1) Sharp wastes, such as broken glass, scalpel blades, and hypodermic needles, shall be segregated from other wastes and aggregated in rigid disposable containers immediately after use. Needles and syringes shall not be cut, dismantled, or destroyed after use, but shall be placed intact into a rigid container. The rigid containers of sharp wastes shall either be incinerated or disposed of in a sanitary landfill approved pursuant to 401 KAR 47:080.

      (2) The mobile health service shall establish a written policy for the handling and disposal of all pathological and microbiologic laboratory waste. Any incinerator used for the disposal of waste shall be in compliance with 401 KAR 59:020 or 401 KAR 61:010.

      (a) Pathological and microbiologic laboratory waste shall be placed in double impervious plastic bags and each bag shall be two (2) mils in thickness. A bag, when full, shall not exceed twenty-five (25) pounds. All bags shall be securely closed and a tag, which reads "INFECTIOUS WASTE" and identifies the mobile health service from which the waste is being removed, shall be attached to the bag in a conspicuous manner. These wastes shall be sterilized before disposal or be disposed of by incineration if they are combustible.

      (b) All unpreserved tissue specimens shall be incinerated off site.

      (3) The following liquids shall be disposed of by incineration or by sanitary sewer:

      (a) Blood;

      (b) Vaginal or cervical secretions or exudates;

      (c) Semen;

      (d) Cerebrospinal, synovial, pleurol, pericardial, peritoneal or amniotic fluids;

      (e) Saliva in dental procedures;

      (f) Fluids visibly contaminated with blood; and

      (g) Mixed fluids where any of the above may be involved. (23 Ky.R. 2645; Am. 2999; eff. 1-15-1997; TAm eff. 3-11-2011; TAm eff. 12-10-2012.)