902 KAR 20:074. Operation and services; outpatient health care center

Link to law: http://www.lrc.ky.gov/kar/902/020/074.htm
Published: 2015

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      902 KAR 20:074. Operation and services;

outpatient health care center.

 

      RELATES TO: KRS 194A.030(1),

211.842-211.852, 216B.010, 216B.015, 216B.040, 216B.042, 216B.045-216B.055,

216B.075, 216B.105-216B.131, 216B.176, 216B.177, 216B.990, Chapter 311, Chapter

314, 29 C.F.R. 1910.1030(d)(2)(vii), 42 C.F.R. 413.65, 42 U.S.C. 1320d-2

      STATUTORY AUTHORITY: KRS 194A.050(1),

216B.042, 216B.105

      NECESSITY, FUNCTION, AND CONFORMITY: KRS

216B.105 and 216B.042 require the Cabinet for Health and Family Services to

license and regulate health care facilities and health care services. This

administrative regulation provides licensure requirements for the operation of

and services provided by outpatient health care centers.

 

      Section 1. Definitions. (1)

"Campus" means the physical area on which the licensee's main

administrative building, other areas and structures are located as well as that

physical area located, immediately adjacent to and within 250 yards of the main

administrative building.

      (2) "Main provider" means a

licensed acute care hospital under which an outpatient health care center

functions as a subordinate and integral part, and which is under the same name,

ownership, and control as the outpatient health care center.

      (3) "Outpatient health care

center" or "center" means a licensed health care facility that

is designated in the Certificate of Need State Health Plan as a primary care

center with outpatient diagnostic and surgical services, and which is certified

by the Centers for Medicare and Medicaid Services under 42 C.F.R. 413.65 as a

provider-based institution, with permanent facilities on a single campus that

is operated under the supervision of an organized medical staff and is

comprised of service components for the provision of primary care, ambulatory

surgery, twenty-four (24) hour emergency care, and radiological and magnetic

resonance imaging "MRI".

 

      Section 2. Services. The center shall

provide component services that include primary care services, 24-hour

emergency services, diagnostic imaging including MRI, and ambulatory surgery

services on a single campus that is located in a county that has no hospital,

that has a population of 60,000 or more persons and that also is a

medically-underserved area as determined by the Secretary of the Federal Department

for Health and Human Services.

      (1) A primary care component shall

include the following services, which shall be provided in the center or shall

be arranged through other providers with which the center has linkage agreements

in accordance with Section 7 of this administrative regulation:

      (a) Basic health care services to

patients of all ages during normal hours of operation;

      (b) A variety of preventative,

diagnostic, and therapeutic services of sufficiently broad scope to provide for

the usual and expected needs of patients in all age groups;

      (c) Coordinated services for all other

health components in this administrative regulation; and

      (d) Services established in Section 8(1)

of this administrative regulation.

      (2) An ambulatory surgical care component

shall include:

      (a) Ambulatory surgical services that, in

the professional judgment of the surgeon and the facility's medical director,

may be safely performed in the outpatient setting on a patient whose recovery under

normal circumstances shall not require inpatient care, observation-hold, or

convalescence in excess of twenty-three (23) hours;

      (b) Follow-up care and services as

necessary for a surgical patient’s recovery; and

      (c) Services established in Section 8(4)

of this administrative regulation.

      (3) An emergency medical services

component shall include:

      (a) Twenty-four (24) hour emergency

medical treatment by a board certified or board eligible emergency room

physician seven (7) days per week;

      (b) A specific area for emergency

treatment that shall be located adjacent to an exterior entrance and is

immediately accessible to emergency transport vehicles;

      (c) Facilities sufficient to assure

prompt diagnosis, treatment, and stabilization of injuries and trauma; and

      (d) Services established in Section 8(2)

of this administrative regulation.

      (4) A diagnostic imaging and MRI

component shall include:

      (a) Radiologic and magnetic resonance

imaging with permanent, fixed-site equipment licensed or registered pursuant to

KRS 211.842 to 211.852 and 900 KAR 6:050, but shall not include any services

for which a separate certificate of need is required;

      (b) Radiologic and imaging services shall

be provided in accordance with protocols established by the center, which shall

include a concise statement of the reason for the service; and

      (c) Services established in Section 8(3)

of this administrative regulation.

 

      Section 3. Administration and Operations.

(1) The licensee shall:

      (a) Be legally responsible for the center

and for compliance with federal, state, and local laws and administrative

regulations pertaining to the operation of the center;

      (b) Appoint a full-time administrator of

the center whose qualifications, responsibilities, authority, and

accountability shall be defined in writing and approved by the hospital governing

authority; and

      (c) Be responsible for and assure

compliance with this administrative regulation, and make immediately available

for public inspection at the center all licensure and complaint inspection

reports and plans of correction pertaining to the last three (3) year survey

period.

      (2) The administrator shall:

      (a) Be responsible for the daily

operations of the center and shall delegate that responsibility in his absence;

      (b) Assure the establishment and

implementation of written policies and procedures covering all aspects of the

center’s operation and, if appropriate, shall be consistent with the policies

and procedures of the main provider;

      (c) Serve as liaison between the center,

its medical staff, and the main provider;

      (d) Hold at least quarterly, component

and departmental staff meetings that shall include a discussion of

administrative and patient care standards;

      (e) Ensure that a sufficient number of

trained staff are available to meet the needs of all persons who receive

services in the center; and

      (f) Appoint a licensed physician to serve

as medical director who shall direct and coordinate all medical services and

oversee implementation of patient care standards and policies, who may serve as

the licensed physician in charge as established in Section 5(1)(a)1 of this

administrative regulation.

 

      Section 4. Policies and Procedures. (1)

Development of policies and procedures. The administrator shall assure development

or adoption and implementation of the following policies and procedures:

      (a) Administrative standards and policies

covering all aspects of the center's operation and specific to each component

part, including at least the following:

      1. A description of organizational

structure, staffing, and allocation of responsibility and accountability within

each component part;

      2. A description of referral linkages

with inpatient facilities and other providers;

      3. A description of the component

services provided by the center;

      4. Policies and procedures for the

guidance and control of personnel performance and quality assurance;

      5. Policies and procedures for creation

and maintenance of administrative and patient care records and reports;

      6. Policies for expense and accrual-based

revenue accounting system following generally-accepted accounting procedures;

      7. Policies and procedures governing the

use of aseptic techniques in all areas of the center;

      8. Policies and procedures for

sterilization of equipment and supplies;

      9. Policies and procedures for disposal

of patient waste and other potentially-infectious materials; and

      10. Policies and procedures for granting

and withdrawal of medical staff surgical privileges and privileges for the

administration of anesthetics.

      (b) Patient care policies and standards,

which shall be developed by staff physicians and other qualified professional

staff, for all medical aspects of the center including:

      1. Written protocols for standing orders,

rules of practice, and medical directives applying to each of the component services,

which shall be signed by the administrator and staff physician;

      2. Patient care policies and standards

for patients held in the center's holding-observation area;

      3. Patient care policies and standards

for primary care services;

      4. Patient care policies and standards

for emergency medical services;

      5. Patient care policies and standards

for ambulatory surgical services; and

      6. Patient care policies and standards

for diagnostic imaging and magnetic resonance imaging services; and

      (c) Patient rights policies which shall

be developed and assure that each patient is:

      1. Informed of the patient’s rights and

facility responsibilities, including procedures for handling patient

grievances;

      2. Informed of services available at the

center and any charges not covered under Medicare, Medicaid, or other

third-party payor arrangements;

      3. Informed of his medical condition,

unless medically contraindicated and documented in the medical record, and is afforded

the opportunity to participate in the planning of medical treatment, the right

to refuse treatment, and informed consent;

      4. Encouraged and assisted to understand

and exercise patient rights and the right to make grievances and receive a

response to a grievance;

      5. Assured confidentiality in treatment,

care, and records, and is afforded the opportunity to approve or refuse release

of records to any individual not involved in his care except as required by Kentucky

law or third-party payment contract; and

      6. Treated with consideration, respect, and

full recognition of his dignity and individuality, including privacy in

treatment, and in the care of his personal health needs.

      (2) Accessibility of policies and

procedures. Written policies and procedures shall be maintained in the facility

in a readily-accessible electronic format or a written manual that is available

and conveniently accessible to all staff employed in the component service.

 

      Section 5. Personnel and Qualifications.

(1) Personnel. The center shall have sufficient trained personnel to meet the

needs of each patient who presents for treatment at the center, which shall

include:

      (a) At a minimum, a core center provider

team to coordinate services for the component services, composed of at least

one (1) licensed physician in charge, who may also serve as the center’s

medical director and the physician in charge of emergency medicine; one (1)

full-time registered nurse, who shall provide services within the scope of

practice; and other nursing personnel, aides, and technicians as required to

meet the needs of the patients, as follows:

      1. A licensed physician shall be in

charge in the center twenty-four (24) hours a day, seven (7) days a week, who

shall be a physician in active practice and who shall be responsible for all

medical aspects of the center’s operation. The licensed physician in charge may

provide direct medical services in accordance with KRS Chapter 311.

      2. The center shall employ or have contractual

or other linkage agreements with other physicians as necessary to meet the surgical

needs of the center’s patients, and who shall be qualified to practice general

medicine (e.g., general practitioner, family practitioner, obstetrician/gynecologist,

pediatrician, and internist), and who shall hold at least courtesy staff

privileges at one (1) or more hospitals with which the center has a formal

transfer agreement.

      3. The registered nurse shall provide

nursing services within the scope of practice pursuant to KRS Chapter 314.

      (b) At a minimum, a core ambulatory

surgery component provider team composed of one (1) licensed physician in

charge; other licensed physicians, dentists, or podiatrists, as necessary to

meet the surgical needs of the center’s patients; an anesthesiologist or nurse

anesthetist; a full-time registered nurse; and other nursing personnel, aides,

and technicians as required to meet the needs of the patients, as follows:

      1. A licensed physician shall be in

charge of the ambulatory surgery component, and may also serve as the center’s

medical director. This physician shall be in active practice and shall either:

      a. Have surgical privileges at the

provider-based hospital or one (1) or more hospitals with which the center has

a formal transfer agreement; or

      b. Be a board-certified anesthesiologist

in active practice and be employed full time by the center or have a contract

to work full time at the center.

      2. Surgical procedures shall be performed

by physicians who are legally authorized to perform these procedures and have

been granted privileges by the center through its medical staff or governing

body.

      3. The ambulatory surgery registered

nurse shall be employed full-time and shall provide services within the scope

of practice pursuant to KRS Chapter 314.

      4. Other nursing personnel, aides, and

technicians shall be employed to meet the needs of the patients. A registered

nurse shall be available during the surgical procedure and if a patient is in

recovery for patient care in the operating or post-anesthesia recovery room.

      (c) At a minimum, the emergency medical component

shall be composed of a licensed physician, board certified in emergency

medicine or board eligible, who shall serve as director of emergency medicine;

at least one (1) full-time registered nurse; and other physicians and medical

staff who shall be available or on duty at all times for the emergency service,

as follows:

      1. A licensed physician shall be present

in the center twenty-four (24) hours a day, seven (7) days a week, shall serve

as director of emergency services and may also serve as the center’s medical

director. The director of emergency medicine shall assure creation and

implementation of patient care policies, and assure at least the following:

      a. Each patient presenting for or

requesting care shall be evaluated by a qualified physician or registered

nurse;

      b. Qualified medical personnel shall be

available to treat a patient presenting for or requesting emergency care;

      c. At least one (1) physician shall be

available on-site at all times to treat a patient;

      d. Establishment and maintenance of a

manual of policies and procedures for emergency and nursing care provided in

the emergency room;

      e. Nursing personnel shall be assigned to

or available to cover the emergency service at all times; and

      f. Diagnostic and treatment equipment, drugs,

and supplies shall be readily available for the provision of emergency services

and shall be adequate in terms of the scope of services provided.

      2. Physicians employed by or under

contract with the center to provide emergency medical treatment shall be board

certified in emergency medicine or board eligible.

      3. Other nursing personnel, aides, and

technicians shall be available in the emergency department to meet the needs of

the patients who present for treatment.

      (2) Center staffing and qualifications.

In addition to the core service component staff requirements, the center shall

employ sufficient numbers of qualified administrative and medical personnel to

provide prompt and effective patient care and services, and shall assure at

least the following:

      (a) A written job description for each

position, which shall be reviewed and revised by the administrator as

necessary;

      (b) An employee health program for mutual

protection of employees and patients, including provisions for preemployment

and periodic health examination;

      (c) A tuberculosis skin test of each

staff member, which shall be implemented according to the following

requirements be documented in the employee's personnel record and which shall:

      1. A test shall be initiated on each new

staff member before or during the first week of employment. The results shall

be documented in the employee's personnel record within the first month of employment,

unless the employee documents a prior skin test of ten (10) or more millimeters

of induration, or is currently receiving or has completed nine (9) months of

therapy for latent tuberculosis infection (LTBI) or a course of multiple-drug

chemotherapy for tuberculosis;

      2. There shall be a two (2) step skin

testing for a new employee regardless of age whose initial test shows less than

ten (10) millimeters of induration, unless the employee can document that he

has had a tuberculosis skin test within one (1) year prior to his current employment;

      3. A staff member who has never had a

skin test result of ten (10) or more millimeters induration shall be skin

tested annually, on or before the anniversary of the last skin test;

      4. A staff member who has a skin test

result of ten (10) or more millimeters induration on initial employment or

annual testing shall receive a chest x-ray unless:

      a. A chest x-ray within the previous two

(2) months showed no evidence of tuberculosis; or

      b. The individual can document the

previous completion of a course of prophylactic treatment with Isoniazid. The employee

shall be advised of the symptoms of the disease and instructed to report to his

employer and to seek medical attention promptly if symptoms persist;

      5. The following shall be reported by the

center administrator to the local health department having jurisdiction immediately

upon becoming known:

      a. Names of staff who convert from a skin

test of less than ten (10) to a skin test of ten (10) millimeters or more

induration at the time of employment; and

      b. Chest x-rays suspicious for

tuberculosis;

      6. A staff member whose skin test status

changes on annual testing from less than ten (10) to ten (10) or more

millimeters of induration shall be considered to be recently infected with

Mycobacterium tuberculosis. A recently-infected person who has no sign or

symptom of tuberculosis disease on chest x-ray or medical history shall receive

preventative therapy with Isoniazid for six (6) months, unless medically

contraindicated, as determined by a licensed physician. Medication shall be

administered only upon the written order of a physician or other ordering

personnel acting within their statutory scope of practice. If an individual is

unable to take Isoniazid therapy, the individual shall be advised of the

clinical symptoms of the disease, and shall have an interval medical history

and a chest x-ray taken and evaluated for tuberculosis every six (6) months during

the two (2) years following conversation, for a total of five (5) x-rays; and

      7. A staff member who documents

completion of preventive treatment with Isoniazid shall be exempt from further

screening requirements; and

      (d) An employee file, which shall include

at least the following information for each employee:

      1. Name, address, Social Security number;

      2. Evidence of current professional

registration, certification, or licensure;

      3. Complete record of training,

experience, and in-service;

      4. Records of performance evaluation;

      5. Records of incidents and accidents in

which the employee was involved; and

      6. Documentation of current tuberculin

screening.

      (3) Personnel in-service training. Center

personnel shall participate in quarterly in-service training programs relating

to their respective job duties and activities, which shall include at least the

following:

      (a) Job orientation for new personnel and

recurring in-service training, including a requirement that each staff member

shall be knowledgeable of the center’s policies;

      (b) Quarterly in-service training for all

staff emphasizing professional competence, quality assurance, policy development;

and the physical, nutritional, environmental, and social components necessary

for effective health care;

      (c) Quarterly in-service training

pertaining to medical documentation and maintenance of medical records;

      (d) Reporting, identifying, and

preventing abuse and neglect of children and adults; and

      (e) Maintaining privacy and

confidentiality of patient-specific information and records.

 

      Section 6. Medical Records. (1)

Maintenance of records. The center or the main provider shall maintain a

medical record at the center for each patient to include at least the

following:

      (a) Medical and social history, including

data from other providers;

      (b) Description of each medical visit or

contact, including identification of the condition or reason for the visit or

contact, assessment performed, medical diagnosis, services provided,

medications and treatments prescribed, and disposition;

      (c) Reports of all laboratory, x-ray, and

other test findings;

      (d) Documentation pertaining to a patient

referred to the center for treatment, including the reason for the referral, to

whom the patient was referred, and information obtained from the referral

source;

      (e) Physicians’ orders, nurses’ notes,

and surgical and medical consent forms;

      (f) History and physical examination

record prior to surgery;

      (g) For surgical patients, the complete

medical record signed by the operating surgeon, including anesthesia record,

preoperative diagnosis, operative procedures and findings, postoperative diagnosis

and, if required, tissue diagnosis by a pathologist on specimens surgically

removed;

      (h) Charts, including records of

temperature, pulse, respiration, and blood pressure; and

      (i) Discharge summary completed at the

time of discharge which includes condition on discharge and post-treatment instructions

to the patient;

      (2) Confidentiality. Confidentiality of

patient records shall be maintained at all times;

      (3) Transfer of records. The center shall

establish systematic procedures to assist in continuity of care if the patient

moves to another provider of care, and the center shall, upon proper release,

transfer medical records or an abstract, if requested;

      (4) Attending signature. The attending

physician shall complete and sign the medical record of each patient as soon as

practicable after discharge, but not to exceed ten (10) days; and

      (5) Retention of records. Medical records

shall be maintained by the center for a period of five (5) years following the

last treatment, assessment, or visit made by the patient.

 

      Section 7. Linkage Agreements. The center

shall have linkages through written agreements.

      (1) Linkage agreements. Linkage

agreements shall be established with other providers of other levels of care

which may be medically indicated to supplement the services available in the center

and shall include:

      (a) Hospitals;

      (b) Emergency medical transportation

services in the service area;

      (c) In-patient care facilities; and

      (d) Other agreements as necessary.

      (2) Inpatient agreements. Linkage

agreements with inpatient care facilities shall incorporate provisions for:

      (a) Appropriate referral and acceptance

of patients from the center;

      (b) Provisions for appropriate

coordination of discharge planning with center staff; and

      (c) Provisions for the center to receive

a copy of the discharge summary for each patient referred to the center.

      (3) Transfer agreements. The written

transfer agreements shall include designation of responsibility for:

      (a) Transfer of information;

      (b) Provision of transportation;

      (c) Sharing of services, equipment, and personnel;

      (d) Provision of total care or portions

thereof in relation to facility and agency capability; and

      (e) Patient record confidentiality.

 

      Section 8. Provision of Services. The

center shall provide the following component services on its campus:

      (1) Primary care component. The center

shall provide at least the following services during scheduled hours of

operation that reasonably accommodate various segments of the population:

      (a) Medical diagnostic and treatment

services of sufficiently broad scope to accommodate the basic health needs of

all age groups;

      (b) Preventive health services of

sufficiently broad scope to provide for the usual and expected health needs of

persons in all age groups;

      (c) Educational offerings in the

appropriate use of health services, preventive health services, and health

maintenance;

      (d) Chronic illness management;

      (e) Laboratory, x-ray, and treatment

services shall be provided directly or arranged through other providers; and

      (f) Supplemental services may also be provided

for pharmacy, dentistry, optometry, nutrition, and counseling.

      (2) Emergency services component. The

center shall have written policies for operation of the emergency component and

shall assure the following:

      (a) A patient presenting for or requesting

emergency care shall be evaluated and triaged by a registered nurse or

emergency department physician in accordance with the center's formal operating

policies and procedures;

      (b) The physician, in conjunction with

the administrator and other medical staff, shall establish and maintain

policies and procedures for emergency and nursing care, which shall assure

that:

      1. Emergency services shall at all times

be under the direction of a licensed physician;

      2. Sufficient medical staff shall be

available and on site at all times to perform emergency medical care in

accordance with accepted standards of practice; and

      3. Current medical staff schedules and

telephone numbers shall be posted in the emergency treatment area;

      (c) Sufficient nursing and medical

personnel shall be assigned to or designated to cover the provision of

emergency services at all times;

      (d) Appropriate facilities shall be

provided to assure prompt diagnosis and emergency treatment for patients

requiring emergency care on arrival;

      (e) Adequate diagnostic and treatment

equipment, drugs, and supplies shall be readily available for the provision of

emergency services;

      (f) Adequate medical records shall be

kept for each patient seen in the emergency department, which shall include at

least:

      1. A log listing the patient visits to

the emergency department in chronological order, including:

      a. Patient identification;

      b. Means of arrival;

      c. Person transporting patient;

      d. Time of arrival;

      e. History of present complaint and

physical findings;

      f. Laboratory and x-ray reports, if

applicable;

      g. Diagnosis;

      h. Treatment ordered and details of

treatment provided;

      i. Patient disposition; and

      j. Record of referrals.

      2. Instructions to the patient or family

for those not admitted to the center; and

      3. Signatures of attending medical staff

member, and nurse if applicable.

      (3) Diagnostic imaging and MRI services.

The center shall have written policies for the operation of the component and

shall assure the following:

      (a) The center shall have diagnostic

radiology facilities currently licensed or registered pursuant to KRS 211.842

to 211.852, the Kentucky Radiation Control Act of 1978;

      (b) The center shall employ or contract

with a radiologist on at least a consulting basis to:

      1. Function as the director of the

department; and

      2. Interpret films requiring specialized

knowledge for accurate reading;

      (c) The center shall employ and have on

duty sufficient personnel to supervise and conduct services, including one (1)

certified radiation operator who shall be on duty or on call at all times;

      (d) Written policies and procedures

governing radiologic services and administrative routines that support sound

radiologic practices;

      (e) Signed reports shall be filed in the

patient's record, and duplicate copies kept in the department;

      (f) Radiologic services shall be

performed only upon written order of qualified personnel in accordance with

their scope of practice and the center's protocols and bylaws, and the order

shall contain a concise statement of the reason for the service or examination;

      (g) Reports of interpretations shall be

written or dictated and signed by the radiologist;

      (h) Only a certified radiation operator,

under the direction of medical staff, if necessary, shall use any x-ray

apparatus or material. Uses shall include application, administration, and

removal of radioactive elements, disintegration products, and radioactive isotopes.

A certified radiation operator under the direction of a physician may

administer medications allowed within his professional scope of practice and

the context of radiological services and procedures being performed; and

      (i) The radiology department shall be

free of hazards for patients and personnel. Proper safety precautions shall be

maintained against fire and explosion hazards, electrical hazards, and

radiation hazards.

      (4) Ambulatory surgical component

services. The center shall have written policies for the operation of the

component and shall assure the following:

      (a) The patient or the patient's legal

representative shall sign a written informed consent prior to all surgical

operations;

      (b) A medical history and physical

evaluation shall be performed and entered into the medical record no more than

thirty (30) days prior to surgery on a patient;

      (c) Pertinent preoperative diagnostic

studies and laboratory tests shall be performed and made a part of the medical

record prior to surgery. The preoperative diagnosis shall be recorded in the

medical record;

      (d) A patient shall be examined by a physician

immediately prior to surgery to evaluate the risk of anesthesia and of the procedure

to be performed, taking into account site of service, the invasive nature of

the procedure, and the need for extended postoperative recovery time or

monitoring;

      (e) The center shall employ a registered

nurse who shall serve as operating room supervisor;

      (f) A registered nurse shall be available

to circulate in the operating room at all times.

      (g) A list of physicians with surgical

privileges at the center and the privileges assigned to each by the medical

staff shall be on file;

      (h) The operating room shall have an

up-to-date operating room register;

      (i) The operating room shall have

medically-appropriate supplies and equipment available at all times to meet the

needs of the patients, including the following:

      1. Oxygen;

      2. Mechanical ventilator assistance

equipment including airways, manual breathing bag, and ventilator;

      3. Cardiac defibrillator,

      4. Cardiac monitoring equipment,

      5. Tracheostomy set,

      6. Laryngoscopes,

      7. Endotracheal tubes,

      8. Suction equipment; and

      9. Emergency medical equipment and

supplies specified by the medical staff;

      (j) The operating room shall have on

hand, or make arrangements for obtaining, an adequate supply of blood in a timely

manner to meet the needs of each patient;

      (k) Operating room administrative

regulations shall be posted;

      (l) Physicians' orders shall be in

writing and signed by the physician;

      (m) Except for cases requiring only local

infiltration anesthetics, a physician qualified to administer anesthesia, a

dentist qualified to administer anesthesia, or a registered nurse anesthetist

acting under the direction of the operating surgeon shall administer the anesthetics

and shall remain present during the surgical procedure and until the patient is

discharged to home or observation;

      (n) The patient’s attending physician

shall be responsible for assuring that tissue removed during surgery is

delivered to the center's pathologist and that an examination and report is made

on the tissue, if required by the center's written policies;

      (o) Voluntary interruption of pregnancy.

The center shall comply with the applicable Kentucky statutes, including KRS

311.710 to 311.810;

      (p) The center shall have written surgery

policies and protocols that shall include:

      1. Infection control policies addressing

the use of aseptic techniques and procedures for surgical patients;

      2. Protocols for sterilization of

surgical equipment and supplies;

      3. Protocols for disposal of patient

waste and other potentially-infectious materials;

      4. Protocol for obtaining pathological

examination of tissues removed during surgery; and

      5. Policies for granting and withdrawing

surgical privileges and privileges for the administration of anesthetics.

      (q) The center shall have the following

postanesthesia recovery services:

      1. At least one (1) postanesthesia

recovery unit;

      2. Adequate staff available in the

recovery unit so that no patient is left alone at any time;

      3. At least one (1) licensed physician shall

be present until all surgical patients are discharged;

      4. A registered nurse shall be present in

the recovery unit while a patient is recovering from anesthesia;

      5. A registered nurse shall be available

to the recovery unit at all times;

      6. A person staffing the postanesthesia

recovery unit shall be adequately trained in all aspects of postoperative and

postanesthetic care; and

      7. The recovery unit nurse shall record a

nursing note on the patient, noting the following:

      a. Postoperative abnormalities or

complications;

      b. Pulse;

      c. Respiration;

      d. Blood pressure;

      e. Presence or absence of swallowing

reflex;

      f. Cyanosis; and

      g. The general condition of the patient.

      (r) The ambulatory surgery component

shall assure the following equipment is available to the operating area:

      1. Suction machine;

      2. Stethoscope;

      3. Sphygmomanometer;

      4. Emergency crash cart;

      5. Necessary drugs; and

      6. Oxygen.

      (s) The surgical center shall provide

suitable accommodations for its patients, including:

      1. Adequate floor space, furnishings, bed

linens, and utensils, equipment, and supplies reasonably required for the

proper care and comfort of patients accommodated;

      2. Holding-observation and convalescent

accommodations within the following limitations:

      a. Holding-observation and convalescent

accommodations shall not exceed twenty-three (23) hours postadmission for

medical observation, recuperation, or convalescence in anticipation of discharge

to the patient's home;

      b. The decision to hold a patient shall

be the responsibility of a physician on the medical staff of the center, who

shall document the reason for and duration of the hold in the patient's medical

record and shall date and sign the entry; and

      c. A physician or registered nurse shall

be on duty at the center, if a patient is held in the center's accommodations beyond

regularly scheduled hours.

      (5) Physical and sanitary environment.

      (a) The condition of the physical plant

and the overall environment shall be maintained in such a manner that the safety

and well-being of patients, personnel, and visitors are assured.

      (b) There shall be an infection control

committee charged with the responsibility of investigating, controlling, and

preventing infections. This committee shall develop written infection control

policies that are consistent with Centers for Disease Control guidelines and

include:

      1. Prevention of disease transmission to

and from patients, visitors, and employees, including:

      a. Universal blood and body fluid

precautions;

      b. Precautions against airborne

transmittal of infections; and

      c. Work restrictions for employees with

infectious diseases;

      2. Use of environmental cultures. Culture

testing results shall be recorded and reported to the Infection Control Committee;

and

      3. Cleaning, disinfection, and

sterilization methods used for equipment and the environment.

      (c) The center shall provide in-service

education programs on the cause, effect, transmission, prevention, and

elimination of infections.

      (d) The center’s buildings, equipment, and

surroundings shall be kept in a condition of good repair, neat, clean, free

from accumulation of dirt, rubbish, and foul, stale, or musty odors.

      (e) Hazardous cleaning solutions,

compounds, and substances shall be labeled, stored in closed metal containers,

and kept separate from other cleaning materials.

      (f) The facility shall be kept free from

insects and rodents, and their nesting places, and entrances shall be

eliminated.

      (g) Garbage and trash:

      1. Shall be stored in areas separate from

those used for preparation and storage of food;

      2. Shall be removed from the premises

regularly; and

      3. Containers shall be cleaned on a

regular basis.

      (h) Sharp wastes:

      1. Sharp wastes, including needles,

scalpels, razors, or other sharp instruments used for patient care procedures,

shall be segregated from other wastes and placed in puncture-resistant

containers immediately after use.

      2. A needle or other contaminated sharp

shall not be purposely bent, broken, or otherwise manipulated by hand as a

means of disposal, except as permitted by Occupational Safety and Health Administration

guidelines at 29 C.F.R. 1910.1030(d)(2)(vii).

      3. A sharp waste container shall be

incinerated or shall be rendered nonhazardous.

      4. Nondisposable sharps, such as

large-bore needles or scissors, shall be placed in a puncture-resistant

container for transport to the Central Medical and Surgical Supply Department

in accordance with 902 KAR 20:009, Section 22.

      (i) Disposable waste:

      1. Disposable waste shall be placed in a

suitable bag or closed container so as to prevent leakage or spillage, and

shall be handled, stored, and disposed of in such a way as to minimize direct

exposure of personnel to waste materials.

      2. The center shall establish specific

written policies regarding handling and disposal of waste material.

      3. The following wastes shall receive

special handling:

      a. Microbiology laboratory waste

including a viral or bacterial culture, contaminated swab, or a specimen

container or test tube used for microbiologic purposes shall be incinerated,

autoclaved, or otherwise rendered nonhazardous; and

      b. Pathological waste including a tissue

specimen from a surgical or necropsy procedure shall be incinerated.

      (6) Utilization review and medical audit.

In order to determine the appropriateness of the services delivered, the center

shall establish procedures for the medical audit and utilization review of services

provided in the center. The center may use professional capabilities and

assistance obtainable from other agencies and sources. There shall be a written

plan for utilization review developed by the center including frequency of review

and composition of the body conducting the review. (32 Ky.R. 2407; 33 Ky.R.

814; 1083; eff. 10-13-2006.)