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.
