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902 KAR 20:275. Mobile health services


Published: 2015

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      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.)