section .0100 – reserved for future codificaiton

Link to law: http://reports.oah.state.nc.us/ncac/title 10a - health and human services/chapter 14 - director, division of health service regulation/subchapter f/subchapter f rules.html
Published: 2015

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subchapter 14F- certification of cardiac rehabilitation

programs

 

section .0100 – reserved for future codificaiton

section .0200 – reserved for future

codification

 

section .0300 – reserved for future codification

 

section .0400 – reserved for future codification

 

section .0500 – reserved for future codification

 

section .0600 – reserved for future codification

 

section .0700 – reserved for future codification

 

section .0800 – reserved for future codification

 

section .0900 – reserved for future codification

 

section .1000 – reserved for future codification

 

SECTION .1100 – GENERAL INFORMATION: DEFINITIONS

 

10A NCAC 14F .1101        DEFINITIONS

The following definitions shall apply throughout this

Subchapter:

(1)           "ACLS-trained" means training that is

current in Advanced Cardiac Life Support, by the American Heart Association and

who has appropriate licensure to administer advanced cardiac life support.

(2)           "ACSM" means the American College of Sports Medicine.

(3)           "Article" means Article 8 of G.S. 131E.

(4)           "Cardiac Rehabilitation Program" has the

same meaning as the definition in the Article.

(5)           "Certification" has the same meaning as

the definition in the Article.

(6)           "DVRS" means the Division of Vocational

Rehabilitation Services, North Carolina Department of Health and Human

Services.

(7)           "Department" means the North Carolina

Department of Health and Human Services.

(8)           "Division" means the Division of Health

Service Regulation, North Carolina Department of Health and Human Services.

(9)           "ECG" means electrocardiogram.

(10)         "Graded exercise test" (GXT) means a multistage

test that determines a person's physiological response to different intensities

of exercise or the person's peak aerobic capacity.

(11)         "Maximal oxygen consumption" means the

highest rate of oxygen transport and oxygen use that can be achieved at a

person's maximal physical exertion, or functional capacity.  This is usually

expressed in METs.

(12)         "MET" means "metabolic

equivalent," a measure of functional capacity, or maximal oxygen

consumption.  One MET represents the approximate rate of oxygen consumption by

a seated individual at rest: approximately 3.5 ml/kg/min.  METs during exercise

are determined by dividing metabolic rate during exercise by the metabolic rate

at rest.

(13)         "Nurse Practitioner" means a currently

licensed registered nurse approved by the NC Board of Nursing and NC Medical

Board to practice medicine as a nurse practitioner under the supervision of a

physician licensed by the Board.

(14)         "Owner" means the legal owner of the

certified cardiac rehabilitation program.

(15)         "Physician" means an individual who is

licensed according to G.S. 90, Article 1, by the NC Medical Board to practice

medicine.

(16)         "Physician Assistant" means an individual

who is licensed and registered according to G.S. 90, Article 1, by the NC

Medical Board to practice medicine under the supervision of a physician

licensed by the Board.

(17)         "Premises" means "site."

(18)         "Program" means "Cardiac

Rehabilitation Program."

(19)         "Risk stratification model" means a method

of categorizing patients according to their risk of acute cardiovascular

complications during exercise as well as their overall prognosis.  Risk status

is related primarily to the type and severity of cardiovascular disease.  This

rating takes into account how well the heart pumps, the presence of heart pain

symptoms and/or changes in the electrocardiogram during exercise.  Guidelines

concerning medical supervision of patients in cardiac rehabilitation programs

which are based on risk stratification models are provided by: the American College of Cardiology, the American College of Physicians, the American Association of

Cardiovascular and Pulmonary Rehabilitation, the American Heart Association,

and the North Carolina Cardiopulmonary Rehabilitation Association.

(20)         "Simple spirometry" means an analysis of

air flow which provides information as to the degree and severity of airway

obstruction, and serves as an index of dynamic lung function.  It must include,

at a minimum, Forced Vital Capacity and Forced Expiratory Volume in 1 second.

(21)         "Site" means the facility in which the

cardiac rehabilitation program is held.

(22)         "Supervising physician" means a physician

who is on-site during the operation of the cardiac rehabilitation program.

(23)         "Symptom-limited heart rate reserve" means

the difference between the symptom-limited maximal heart rate and the resting

heart rate.

(24)         "Vocational Questionnaire" means the

document used for vocational assessment.

(25)         "Vocational Rehabilitation Counselor"

means an individual who provides vocational rehabilitation counseling services.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

SECTION .1200 – CERTIFICATION

 

10A NCAC 14F .1201        CERTIFICATE

The named person(s) and the street address of the named

premises shall appear on the certificate.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A ncac 14F .1202        CERTIFICATION PROCESS

(a)  To initiate the certification process, an application

for certification shall be filed with the Department by the owner of the

cardiac rehabilitation services.

(b)  Application forms shall be available from the

Department, and each application shall contain at least the following

information:

(1)           legal identity of the owner-applicant;

(2)           name or names under which the facility or

services are advertised or presented to the public;

(3)           program mailing address;

(4)           program exercise site;

(5)           program telephone number;

(6)           ownership disclosure;

(7)           name of program director;

(8)           name of medical director; and

(9)           program hours of operation.

(c)  No applicant shall offer any cardiac rehabilitation

services described or represented as a "Certified Cardiac Rehabilitation

Program," unless the services have been certified in accordance with the

provisions of this Subchapter.

(d)  Except as otherwise provided in this Section, the

Department shall inspect and evaluate the program and premises identified in

the application and shall thereafter issue a certificate upon its determination

that the applicant has substantially complied with, and the program and the

services at the premises substantially met, the provisions of the Article and

this Subchapter.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .1203        CERTIFICATE RENEWAL

(a)  A certificate issued pursuant to the Article and this

Subchapter shall expire two years after the effective date but can be renewed

upon the successful re-evaluation of the program.  To initiate the renewal process,

an application for certification shall be filed with the Department by the

owner of the program.

(b)  Determination of compliance with the provisions of the

Article and this Subchapter for purposes of certificate renewal may, at the

discretion of the Department, be based upon an inspection or upon review of

requested information submitted by a program to the Department.

 

History Note:        Authority G.S. 131E-167; 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .1204        CERTIFICATION FOLLOWING PROGRAM CHANGES

(a)  The Department shall be notified, in writing, at least

30 days prior to the effective date, of any expected occurrences of the

following:

(1)           change in program ownership;

(2)           change in program name;

(3)           change of the premises in which a program

is conducted; and

(4)           the replacement or termination of

employment of the program director.

(b)  If a 30-day advanced written notification of any

occurrence enumerated in Paragraph (a) of this Rule is not possible, the

Department shall be notified immediately, by any reasonably reliable means of

notification, of such expected or completed occurrence, and written

notification shall follow immediately thereafter.

(c)  Upon the occurrences enumerated in Subparagraphs

(a)(1), (2), and (3) of this Rule, the owner of the program shall file with the

Department an application for certification, which, at a minimum, shall contain

the information specified in Rule .1202(b) of this Subchapter, and shall provide

such other documentation and information as requested by the Department.

(d)  The revised program shall be evaluated for compliance

with the provisions of the Article and this Section.  Evaluation may be based

upon inspection of the program or upon review of requested information

submitted by a program to the Department.  After a determination by the

Department that the program substantially complies with the provisions of the

Article and this Subchapter, a new certificate shall be issued.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .1205        INSPECTIONS

(a)  In accordance with G.S. 131E-167(c), inspection(s)

shall be made by the Department before a program is issued its initial

certification as a program defined in the Article.

(b)  The Department shall make or cause to be made such

other inspections of a program as it deems necessary in accordance with the

Article.  Circumstances which may be deemed to necessitate an inspection

include, but are not limited to:

(1)           change in program ownership;

(2)           change in program name;

(3)           change of the premises in which a program

is conducted;

(4)           the replacement or termination of

employment of the program director; and

(5)           investigation of complaints.

(c)  Inspections shall be announced or unannounced and may

be conducted any time during program business hours.  The purpose of any

inspection shall be discussed with the Program Director or designee during an

entrance conference.

(d)  Information deemed necessary by the Department to

evaluate compliance with the Article and this Subchapter, shall be made

available for inspection.  The information may include medical records,

personnel files, policies and procedures, program records, interviews with

program staff, interviews with patients, observation of the program in

operation, and any other information necessary to determine compliance.

(e)  Following completion of an inspection, an exit

conference shall be conducted with one or more representatives of the program's

management.  An oral summary of the findings shall be presented at the exit conference. 

The Department shall provide the program with a written report of the

findings.  The program shall have 10 working days from the receipt of the

report to respond with a plan of correction which describes the corrective

actions planned and taken to correct any cited deficiency(ies), the date each

deficiency was or will be corrected, and the date the program expects to be in

compliance with the provisions of the Article and this Subchapter.

 

History Note:        Authority G.S. 131E-169; 131E-170;

Eff. July 1, 2000.

 

10A NCAC 14f .1206        ADVERSE ACTION

(a)  Upon a determination that there has been a substantial

failure to comply with the provisions of the Article or the rules contained in

this Subchapter, the Department may, at its discretion, deny a new or renewal certificate,

suspend or revoke an existing certificate, or, as enumerated in Paragraph (c)

of this Rule, issue a provisional certificate.

(b)  Substantial noncompliance which has endangered, or has

a potential to endanger the health, safety, or welfare of any patient, shall be

cause for the denial, revocation, or suspension of a certificate.

(c)  Substantial noncompliance which does not endanger the

health, safety, or welfare of the patients being served may, at the discretion

of the Department, result in the issuance of a provisional certificate for a

period not to exceed six months.

 

History Note:        Authority G.S. 131E-168; 131E-169;

Eff. July 1, 2000.

 

SECTION .1300 – ADMINISTRATION

 

10A NCAC 14F .1301        STAFF REQUIREMENTS AND RESPONSIBILITIES

(a)  Each program shall be conducted utilizing an

interdisciplinary team composed of a program director, medical director, nurse,

exercise specialist, mental health professional, dietician or nutritionist,

supervising physician, physician assistant or nurse practitioner, and a DVRS or

other vocational rehabilitation counselor.  The program may employ, full-time

or part-time, or contract for the services of team members. Program staff shall

be available to patients as needed to perform initial assessments and to

implement each patient's cardiac rehabilitation care plan.

(b)  Individuals may perform multiple team functions, if

qualified for each function, as stated in this Rule:

(1)           Program Director - supervises program staff

and directs all facets of the program.

(2)           Medical Director B physician who provides

medical assessments and is responsible for supervising all clinical aspects of

the program and for assuring the adequacy of emergency procedures and

equipment, testing equipment, and personnel.

(3)           Nurse - provides nursing assessments and

services.

(4)           Exercise Specialist - provides an exercise

assessment, in consultation with the medical director, plans and evaluates

exercise therapies.

(5)           Mental Health Professional - provides

directly or assists program staff in completion of the mental health screening

and referral, if indicated, for further mental health services.

(6)           Dietitian or Nutritionist - provides directly

or assists program staff in completion of the nutrition assessment and

referral, if indicated, for further nutrition services.

(7)           Supervising Physician, Physician Assistant,

or Nurse Practitioner - medical person who is on-site during the operation of

programs that are not located within a hospital.

(8)           DVRS or other Vocational Rehabilitation

Counselor - screens patients who may be eligible for and interested in

vocational rehabilitation services, develops assessment and intervention

strategies, and provides other services as needed to meet the vocational

goal(s) of patients who may be eligible for and interested in services.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .1302        POLICIES AND PROCEDURES

The program director shall assure that written policies and

procedures are adopted by the program, approved by the medical director, and

available to and implemented by staff.  At a minimum, these policies and procedures

shall include the following areas:

(1)           admission of patients and orientation to the

program;

(2)           patient assessment, care planning, and

implementation of therapies;

(3)           patient follow-up evaluations, including progress

toward cardiac rehabilitation goals;

(4)           patient discharge;

(5)           medical records, in accordance with Rule .2002 of

this Subchapter;

(6)           orientation of all program personnel;

(7)           maintenance of personnel records which include job

descriptions, verification of credentials, continuing education and current

competencies;

(8)           use and orientation of volunteers;

(9)           communication with patient's referral and personal

physicians;

(10)         provisions for reporting and investigating

complaints and accidental events regarding patients, visitors and personnel

(incidents) and corrective action taken;

(11)         emergency procedures;

(12)         a preventative maintenance program to assure all

equipment is maintained in safe and proper working order and in accordance with

the manufacturer's recommendations; and

(13)         quality improvement program.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10a NCAC 14F .1303        CONTINUOUS QUALITY IMPROVEMENT

(a)  The cardiac rehabilitation program shall have an

ongoing Continuous Quality Improvement (CQI) program which identifies quality

deficiencies and addresses them with corrective plans of action, as indicated.

(b)  The CQI program shall evaluate the appropriateness,

effectiveness, and quality of the cardiac rehabilitation program, with findings

used to verify policy implementation, to identify problems, and to establish

problem resolution and policy revision as necessary.

(c)  The CQI program shall consist of an overall policy and

administration review, including admission and discharge policies, emergency

care, patient records, personnel qualifications and program evaluation.  Data

to be assessed shall include, at a minimum, the following:

(1)           number of patients in the program;

(2)           average length (weeks) patients are in the

program;

(3)           patient clinical outcomes;

(4)           adequacy of staff to meet program/patient

needs;

(5)           reasons for discharge; and

(6)           untoward events.

(d)  A sample of active and closed records shall be reviewed

at least semi-annually to assure program policies are followed and the program

is in compliance with the Article and the rules contained in this Subchapter.

(e)  Documentation of the CQI program shall include the

criteria and methods used to collect and analyze data, identification of

quality deficiencies, and any action(s) taken by the cardiac rehabilitation

program as a result of CQI findings.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

SECTION .1400 – PATIENT RIGHTS

 

10A NCAC 14F .1401        PATIENT RIGHTS

(a)  Prior to or at the time of admission, the program shall

provide each patient with a written notice of the patient's rights and

responsibilities.  The program shall maintain documentation showing that all

patients have been informed of their rights and responsibilities.

(b)  Each patient's rights shall include, at a minimum, the

right to:

(1)           be informed and participate in developing

the patient's plan of care;

(2)           voice grievances about the care provided,

and not be subjected to discrimination or reprisal for doing so;

(3)           confidentiality of the patient's records;

(4)           be informed of the patient's liability for

payment for services;

(5)           be informed of the process for acceptance

and continuation of service and eligibility determination;

(6)           accept or refuse services; and

(7)           be advised of the program's procedures for

discharge.

(c)  The program shall provide all patients with a telephone

number for information, questions or complaints about services provided by the

program.  The program shall also provide the Division Complaints Hotline number

or the Department of Health and Human Services Careline number or both.

(d)  The program shall investigate, within seven days,

complaints made to the program by the patient, the patient's family, or

significant other, and must document both the existence of the complaint and

the resolution of the complaint.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

SECTION .1500 – ADMISSION AND DISCHARGE

 

10A NCAC 14F .1501        ADMISSION AND DISCHARGE

(a)  All patients admitted to the program shall have a

referral from a physician.

(b)  Prior to discharging a patient, the interdisciplinary

team shall develop a discharge plan. At a minimum, the discharge plan shall

include instructions as to how to achieve or maintain the goals established in

the cardiac rehabilitation care plan.

(c)  Upon discharge from the program, a discharge summary as

outlined in Rule .2002(a)(10) of this Subchapter, shall be sent to the personal

or referring physician.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

SECTION .1600 – PATIENT ASSESSMENT

 

10a NCAC 14F .1601        PATIENT ASSESSMENT

(a)  Within five weeks of a patient's admission to the

program, the interdisciplinary team shall complete and document a cardiac

rehabilitation assessment.  At a minimum, the assessment shall include the

components specified in this Rule.

(b)  Medical Assessment shall include:

(1)           cardiovascular evaluation as to present

diagnosis, therapy, and a discharge summary of the patient=s last

hospitalization; or

(2)           statement by referring physician as to

present diagnosis, and therapy;

(3)           resting 12-lead ECG;

(4)           medical record documentation prior to or

during the first exercise session of ECG, hemodynamic data, and the presence or

absence of symptoms, preferably determined by a graded exercise test.  A graded

exercise test shall not be required when deemed unnecessary by the patient's

attending or personal physician or the program's medical director;

(5)           fasting blood chemistry, as indicated, to

include total cholesterol, high density lipoprotein (HDL) cholesterol, low

density lipoprotein (LDL) cholesterol, triglycerides, and other comparable

measures; and

(6)           simple spirometry, if clinically indicated.

(c)  Physical Assessment shall include:

(1)           functional capacity as determined by measured

or predicted equivalents (METs);

(2)           height, weight, or other anthropometric

measures (i.e., body mass index, percent body fat, waist-to-hip ratio, girth

measurements);

(3)           current and past exercise history; and

(4)           physical limitations and disabilities that

may impact rehabilitation.

(d)  Nursing Assessment shall include:

(1)           coronary risk profile;

(2)           current symptoms such as angina or dyspnea,

and recovery from recent cardiac events;

(3)           presence of comorbidities;

(4)           assessment of medications; and

(5)           educational needs.

(e)  Nutrition Assessment shall include:

(1)           review of medical history;

(2)           eating patterns as measured by a food diary

or food frequency questionnaire;

(3)           fasting blood chemistries as described in

Subparagraph (b)(5) of this Rule;

(4)           anthropometric measures as described in

Subparagraph (c)(2) of this Rule;

(5)           behavioral patterns; and

(6)           identification of nutritional goals.

(f)  Mental Health Assessment shall include:

(1)           past history of mental illness including

depression, anxiety, or hostility or anger; and

(2)           present mental health functioning and need

for referral to a mental health professional.

(g)  Vocational Assessment shall include:

(1)           vocational questionnaire to determine

current vocational status, description of physical requirements of job, working

conditions, psychological demands as perceived by the patient; and

(2)           the need for vocational rehabilitation

services.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

SECTION .1700 – CARE PLANNING AND FOLLOW-UP EVALUATION

 

10A NCAC 14F .1701        CARE PLANNING

(a)  Within five weeks of a patient's admission to the

program, the interdisciplinary team shall develop a cardiac rehabilitation care

plan for the patient based upon assessments completed as required under Section

.1600 of this Subchapter.

(b)  The cardiac rehabilitation care plan, at a minimum,

shall include:

(1)           the patient's exercise therapy;

(2)           nutrition services, if indicated;

(3)           mental health services, if indicated;

(4)           vocational services if, indicated;

(5)           educational counseling;

(6)           cardiac rehabilitation goals; and

(7)           discharge planning.

(c)  Within six weeks of the patient's admission to the

program, a copy of the cardiac rehabilitation care plan shall be sent to the

patient's personal and referring physicians.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14f .1702        FOLLOW-UP EVALUATION

(a)  The interdisciplinary team members shall attend monthly

meetings for follow-up evaluation of patients' progress toward cardiac

rehabilitation goals. Changes to each patient's cardiac rehabilitation care

plan shall be made as needed based on continued evaluations. Any changes made

in the patient's cardiac rehabilitation care plan shall be recorded in the

medical record and sent to the patient's personal and referring physician(s).

(b)  If any staff member cannot attend, the reason for the

absence and the means of communicating information prior to and after the

meeting shall be documented.

(c)  The personal and referring physician(s) shall be

informed of any complication or change in patient status while in the program.

(d)  Progress notes shall be recorded in the patient's

medical record evaluating progress toward goals established from the plan of

care.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

SECTION .1800 – PROVISION OF SERVICES

 

10A NCAC 14F .1801        PERSONNEL

(a)  At least one ACLS trained and one other staff member

shall be present at the site during all program hours.

(b)  For cardiac rehabilitation programs that are not

located within a hospital or a hospital emergency resuscitation team is not

available to respond in an emergency, a supervising physician, physician

assistant, or nurse practitioner shall be on-site during all program hours.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .1802        EXERCISE THERAPY

(a)  The medical director, in consultation with program

staff, shall establish staff to patient ratios for exercise therapy sessions

based on medical acuity, utilizing an acceptable risk stratification model.

(b)  If any patient has not had a graded exercise test prior

to the first exercise session, the patient's first exercise session must

include objective assessment of hemodynamic data, ECG, and symptom response

data.

(c)  Unless contraindicated by medical and laboratory

assessments or the cardiac rehabilitation care plan, each patient's exercise

therapy shall include:

(1)           mode of exercise therapy including, but not

limited to: walk/jog, aquatic activity, cycle ergometry, arm ergometry,

resistance training, stair climbing, rowing, aerobics;

(2)           intensity:

(A)          up to 85 percent of symptom-limited heart rate

reserve;

(B)          up to 80 percent of measured maximal oxygen

consumption;

(C)          rating of perceived exertion (RPE) of 11 to 13 if a

graded exercise test is not performed; or

(D)          for myocardial infarction patients: heart rate not

to exceed 20 beats per minute above standing resting heart rate if a graded

exercise test is not performed; and for post coronary artery by-pass graft

patients: heart rate not to exceed 30 beats per minute above standing resting

heart rate if a graded exercise test is not performed;

(3)           duration: up to 60 minutes, as tolerated,

including a minimum of five minutes each for warm-up and cool-down; and

(4)           frequency: minimum of three days per week.

(d)  The patient shall be monitored through the use of

electrocardiography during each exercise therapy session.  The frequency of the

monitoring continuous or intermittent shall be based on medical acuity and risk

stratification.

(e)  At two week intervals, the patient's adherence to the

cardiac rehabilitation care plan and progress toward goals shall be monitored

by an examination of exercise therapy records and documented.

(f)  The exercise specialist shall be responsible for

consultation with the medical director or the patient's personal physician

concerning changes in the exercise therapy, results of graded exercise tests,

as needed or anticipated (e.g. regular follow-up intervals, graded exercise

test conducted, or medication changes). Feedback concerning changes in the

exercise therapy shall be discussed with the patient and documented.

(g)  Diabetic patients who are taking insulin or oral

hypoglycemic agents for control of diabetes shall have blood sugars monitored

for at least the first week of cardiac therapy sessions in order to establish

the patient's level of control and subsequent response to exercise.  Cardiac

rehabilitation staff shall record blood sugar measurements pre- and

post-exercise.  Patients whose blood sugar values are considered abnormal for

the particular patient shall be monitored.  A carbohydrate food source or

serving shall be available.  Snacks shall be available in case of a

hypoglycemic response.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .1803        NUTRITION SERVICES

If indicated, based on the nutrition assessment and cardiac

rehabilitation care plan, each patient's program shall include the following

nutrition services:

(1)           interpretation and feedback on the patient's eating

patterns, blood chemistries, anthropometrics, and behavioral patterns;

(2)           identification of a therapeutic diet plan to

determine, at a minimum, a reasonable body weight, caloric, and fat intake;

(3)           patient counseling or behavior modification based

on the therapeutic diet plan and goals.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .1804        MENTAL HEALTH SERVICES

If indicated, based on the mental health assessment and

cardiac rehabilitation care plan, each patient's program shall include the

following mental health services:

(1)           feedback from mental health assessment to the

patient; and  

(2)           present mental health functioning and need for

referral to a mental health professional for evaluation or treatment.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .1805        VOCATIONAL REHABILITATION COUNSELING

AND SERVICES

(a)  The cardiac rehabilitation program shall have a written

agreement, with the local DVRS office or other vocational rehabilitation

counselor/services, which specifies the following:

(1)           The program shall administer a Vocational

Questionnaire to patients.

(2)           After administering the Vocational

Questionnaire, the program shall refer to the DVRS or other vocational

rehabilitation counselor/services patients who may be eligible for and desire

services.

(3)           The DVRS or other vocational rehabilitation

counselor shall provide feedback to the cardiac rehabilitation program

regarding the eligibility for DVRS or other vocational services of referred

patients.

(4)           The DVRS or other vocational rehabilitation

counselor shall provide progress reports for patients who are receiving DVRS or

other vocational rehabilitation services.

(5)           The DVRS or other vocational rehabilitation

counselor shall attend monthly staff meetings in which eligible vocational

rehabilitation clients are discussed.  If the counselor cannot attend, the

reason for the absence and the means of communicating information prior to and

after the meeting shall be documented and attached to the staffing report.

(b)  The cardiac rehabilitation program must have written

documentation that feedback as described in Subparagraph (a)(3) of this Rule

and progress reports as described in Subparagraph (a)(4) of this Rule have been

communicated to the cardiac rehabilitation program by the DVRS or other

counselor and, if not, the reason(s) why.

(c)  If the program is not able to complete a written

agreement with the local office of DVRS or other vocational rehabilitation

counselor as outlined in Paragraph (a) of this Rule, the program shall have

documentation that specifies why such an agreement was not completed.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .1806        PATIENT EDUCATION

(a)  Each patient's cardiac rehabilitation care plan shall

include participation in the program's basic education plan.  At a minimum, the

education plan shall include the following topics:

(1)           basic anatomy, physiology, and

pathophysiology of the cardiovascular system;

(2)           risk factor reductions, including smoking

cessation and management of blood pressure, lipids, diabetes, and obesity;

(3)           principles of behavior modification

including nutrition, exercise, stress management and other lifestyle changes;

(4)           relaxation training offered at least once

per week by staff trained in relaxation techniques;

(5)           cardiovascular medications including

compliance, interactions, and side effects;

(6)           basic principles of exercise physiology,

guidelines for safe and effective exercise therapy, and guidelines for

vocational/recreational exertional activities;

(7)           recognition of cardiovascular signs,

symptoms and management; and

(8)           environmental considerations such as

exercise in hot or cold climates.

(b)  The educational program shall include individual or

group sessions utilizing written, audio, or visual educational materials as

deemed appropriate and necessary by program staff.

(c)  Each session shall be documented and presented on a

rotating basis such that each patient has access to all materials and classes

offered.

(d)  Documentation shall be included in each patient's

medical record to indicate which educational programs the patient attended.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

SECTION .1900 – EMERGENCIES

 

10A NCAC 14F .1901        EMERGENCY PLAN

A written plan approved and signed by the medical director

shall be established to handle any emergencies occurring on site while cardiac

rehabilitation services are being provided.  All areas of the premises

pertinent to program operation shall be included.  The plan shall address the

assignment of personnel and availability of equipment required in an emergency.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .1902        EMERGENCY EQUIPMENT

The following equipment and supplies must be available and

operable in the event of an emergency and must be maintained according to

manufacturer's recommendations:

(1)           suction equipment (portable);

(2)           defibrillator (portable);

(3)           intubation equipment;

(4)           medications;

(5)           oxygen tank supply;

(6)           regulator and mask for nasal cannula; and

(7)           communication system to access emergency medical

services.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .1903        EMERGENCY DRILLS

(a)  At least six patient emergency drills shall be

conducted each year and shall be documented.

(b)  Drill sites shall be rotated through all locations used

by patients while participating in program activities.

(c)  The drill documentation and effectiveness of emergency

drills shall be reviewed and signed by the medical director or supervising

physician.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

SECTION .2000 – MEDICAL RECORDS

 

10A NCAC 14F .2001        POLICIES AND PROCEDURES FOR MEDICAL

RECORDS

The program shall develop and implement policies and

procedures to include at least the following:

(1)           maintenance of a complete, accurate, and organized medical

record for each patient admitted to the program;

(2)           confidentiality of records;

(3)           accessibility of medical record information to the

patient, program staff, and non-employees; and

(4)           authentication of entries in medical records

including hard copy records and those kept in electronic medium such as

computerized records.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .2002        CONTENT OF MEDICAL RECORDS

(a)  The medical record shall contain at least the following

information:

(1)           patient identification data;

(2)           medical history and, when applicable,

hospital discharge summary;

(3)           graded exercise data, if available;

(4)           resting 12-lead ECG;

(5)           signed physician referral;

(6)           records of blood chemistry analyses;

(7)           signed informed consent to participate in

the program;

(8)           progress notes and response to the cardiac

rehabilitation care plan;

(9)           all records of each discipline's

participation in the patient's cardiac rehabilitation care plan;

(10)         a discharge summary which describes the

patient's progress while in the program, reason(s) for discharge, the

post-discharge plan, and follow-up as indicated;

(11)         miscellaneous clinical records developed

pursuant to the patient's course of treatment.

(b)  In the case of hard copy medical records, the following

shall apply:

(1)           the patient's name must be recorded on each

page of the record;

(2)           all entries in the records shall be legible

and authenticated with a signature, title, and date by the individual making

the entry; and

(3)           faxed entries, including orders, are

acceptable as long as a hard copy is incorporated in the medical record (note:

thermal paper faxes are not acceptable).

(c)  At its option, the program may maintain all or part of

its medical records in a form other than hard copy, such as electronic medium. 

Entries in such a record shall be authenticated according to program policies

and may include authentication measures such as personal computer entry codes

or electronic signatures.  However, when requested by the Division or other

State officials, the program must be able to produce a hard copy printout of

the record.

(d)  Medical record information may be stored, such as when

records are thinned or patients are discharged, in a form other than hard copy,

but the program must be able to produce a hard copy printout of the record if

requested by the Division or other State officials.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

SECTION .2100 – FACILITIES AND EQUIPMENT

 

10A NCAC 14F .2101        PHYSICAL ENVIRONMENT AND EQUIPMENT

(a)  The program shall provide a clean and safe environment.

(b)  Equipment and furnishings shall be cleaned not less

than weekly.

(c)  All areas of the facility shall be orderly and free of

debris and with clear traffic areas.

(d)  A written and documented preventative maintenance

program shall be established to ensure that all equipment is calibrated and

maintained in safe and proper working order in accordance with manufacturers'

recommendations.

(e)  There shall be emergency access to all areas a patient

may enter, and floor space must allow easy access of personnel and equipment.

(f)  Exit signs and an evacuation plan shall be posted and

clearly visible.  The evacuation plan shall detail evacuation routes for

patients, staff, and visitors in case of fire or other emergency.

(g)  No smoking shall be permitted in patient care or

treatment areas.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .2102        GRADED EXERCISE TESTING LABORATORY

If the program performs graded exercise testing, the

following facilities and equipment shall be available:

(1)           space for physical examination which allows for

visual privacy;

(2)           adequate space and temperature and humidity

controls for exercise as described under Rule .2101 of this Subchapter;

(3)           12-lead ECG equipment for recording the ECG during

exercise testing;

(4)           oscilloscope for ECG monitoring or continuous

recording;

(5)           treadmill, bicycle ergometer, or arm crank

ergometer;

(6)           blood pressure cuff and stethoscope;

(7)           emergency procedures, equipment, and supplies as

described in Section .1900 of this Subchapter; and

(8)           access to spirometer for pulmonary function

testing.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .2103        EXERCISE THERAPY

The following equipment shall be available and operable for

the provision of exercise assessment and therapy:

(1)           ECG and oscilloscope;

(2)           blood pressure cuff and stethoscope;

(3)           large clock with sweep second hand;

(4)           blood glucose testing equipment; and

(5)           equipment for the performance of anthropometric

measurements such as skinfold caliper, stadiometer, tape measure, and

physician's scale.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .2104        NUTRITION SERVICES

If provided on site, the following facilities and equipment

shall be available for the provision of nutrition services:

(1)           space that allows for confidential interviewing and

counseling;

(2)           nutrition guidelines and means of nutrient

analysis; and

(3)           educational materials, as deemed appropriate by the

program's dietitian/nutritionist, for patient distribution and use during

nutrition therapy counseling.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .2105        MENTAL HEALTH SERVICES

If provided on site, space shall be available for the

provision of the mental health services to allow for confidential interviewing

and counseling.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.

 

10A NCAC 14F .2106        VOCATIONAL REHABILITATION SERVICES

If provided on site, space shall be available for the

provision of vocational rehabilitation services to allow for confidential

interviewing and counseling.

 

History Note:        Authority G.S. 131E-169;

Eff. July 1, 2000.