Tenn. Comp. R. & Regs. 0720-33-.06

Current through October 22, 2024

Section 0720-33-.06 - BASIC SERVICES

(1) Medical Staff Services.

(a) Policies and procedures concerning services provided by the renal dialysis clinic shall be available for the treating and/or referring physicians.

(b) Each physician on the medical staff shall have a current license to practice medicine in the State of Tennessee.

(c) The governing body of a facility shall designate a medical director. The Medical Director shall:

1. Delineate the responsibilities of and communicate with treating and /or referring physicians to ensure that each patient receives medical care;

2. Arrange for the delivery of emergency and medical care when the patient's treating and/or referring physician or his/her designated alternate is unavailable;

3. Review reports of all accidents or unusual events occurring on the premises, identifying hazards to health and safety and recommending corrective action to the governing body;

4. Make periodic visits not less than quarterly, to the renal dialysis clinic to evaluate the existing conditions and make recommendations for improvements;

5. Review and take appropriate action on reports regarding significant clinical practices, guidelines and outcomes;

6. Oversee so that no infectious health conditions exist which would adversely affect patients;

7. Advise and provide consultation on matters regarding medical care, standards of care, surveillance and infection control;

8. Develop facility treatment goals which are based on review of aggregate data assessed through quality management activities;

9. Assure adequate training of licensed nurses and dialysis technicians;

10. Assure adequate monitoring of patients and the dialysis process; and

11. Ensure development and implementation of all policies required by this chapter.

(d) The members of the medical staff shall include nephrologists and other physicians with training or demonstrated experience in the care of end stage renal disease patients that consists, at a minimum, of having worked within the field of kidney dialysis for at least 12 months in the past five (5) years.

(e) If a Nurse Practitioner or Physician Assistant is utilized, such individuals shall meet the requirements established by the Board of Nursing (for a Nurse Practitioner) or the Board of Medical Examiners and its Committee on Physician Assistants (for a Physician Assistant).

(f) Medical staff.

1. Each patient shall be under the care of a physician on the medical staff.

2. The care of a pediatric dialysis patient shall be in accordance with this subparagraph. If a pediatric nephrologist is not available as the primary nephrologist, an adult nephrologist may serve as the primary nephrologist with direct patient evaluation by a pediatric nephrologist according to the following schedule:

(i) For patients two years of age or younger - monthly (two of three evaluations may be by phone);

(ii) For patients three to 12 years of age - quarterly; and

(iii) For patients 13 to 18 years of age - as needed or indicated.

3. At a minimum, each patient receiving dialysis in the facility shall be seen by a member of the medical staff monthly. Following the initial visit, at the option of the physician, a Nurse Practitioner or Physician Assistant may be utilized on an alternating basis every other month. Home patients shall be seen at least every three months. There shall be evidence of monthly assessment for new and recurrent problems and review of dialysis adequacy.

4. A physician on the medical staff or his/her designee shall be on call and available 24 hours a day to patients and staff.

5. Orders for treatment shall be in writing and signed by the prescribing physician. Routine orders for treatment shall be updated at least annually. Orders for treatment shall include treatment time, dialyzer, blood flow rate, target weight, medications including heparin, and specific infection control measures as needed.

6. If Nurse Practitioners or Physician Assistants are utilized:

(i) There shall be evidence of communication with the treating physician whenever the Nurse Practitioner or Physician Assistant changes treatment orders;

(ii) The Nurse Practitioner or Physician Assistant may not replace the physician in participating in patient care planning or in quality management activities; and

(iii) The treating physician shall be notified and direct the care of patient medical emergencies.

(g) Patient care plan.

1. A facility shall establish, implement, and enforce a policy whereby patient services are coordinated using an interdisciplinary team approach. The interdisciplinary team shall consist of the patient's primary dialysis physician, registered nurse, social worker, and dietitian.

2. The interdisciplinary team shall develop a written, individualized, comprehensive patient care plan that specifies the services necessary to address the patient's medical, psychological, social, and functional needs, and includes treatment goals.

3. The patient care plan shall include evidence of coordination with other service providers (e.g. hospitals, long term care facilities, home and community support services agencies, or transportation providers) as needed to assure the provision of safe care.

4. The patient care plan shall include evidence of the patient's (or patient's legal representative's) input and participation, unless they refuse to participate. At a minimum, the patient care plan shall demonstrate that the content was shared with the patient or the patient's legal representative.

5. The patient care plan shall be developed within 30 days from the patient's admission to the facility and updated as indicated by any change in the patient's medical, nutritional, or psychosocial condition, or at least every six months. Evidence of the review of the patient care plan with the patient and the interdisciplinary team to evaluate the patient's progress or lack of progress toward the goals of the care plan, and interventions taken when the goals are not achieved, shall be documented and included in the patient's clinical record.

(2) Home Dialysis Training and Support Services.

(a) In addition to the other services contained in this chapter, a renal dialysis clinic may provide the following services:

1. Home dialysis training;

2. Home dialysis support services for those patients receiving home dialysis.

(b) Training Requirements.

Unless otherwise provided by this rule, a renal dialysis clinic providing home dialysis training shall ensure that the training will be conducted by a registered nurse having at least twelve (12) months of experience in providing nursing care and at least three (3) months of experience working in hemodialysis or peritoneal dialysis and that the registered nurse shall teach the following:

1. Full range of techniques associated with treatment modality selected, including but not limited to:

(i) Specific instructions on the use of the dialysis equipment to be used at home;

(ii) Procedures the patient is expected to use in order to perform the home dialysis;

(iii) Instructions on the use of supplies and equipment to achieve the physician's prescription; and

(iv) Anemia management.

2. Implementation of a nutritional care plan, provided however, a dietitian or nutritionist holding a valid license in this state may provide such training in lieu of a registered nurse;

3. Methods used to achieve and maintain emotional and social well-being, provided however, a licensed master's social worker, licensed advanced practice social worker, or licensed clinical social worker holding a valid certificate of registration or license in this state may provide such training in lieu of a registered nurse;

4. The detection, reporting, and management of potential dialysis complications, including water treatment problems;

5. The availability of support resources and how to access and use resources;

6. Self-monitoring health status, including recording and reporting health status information;

7. Handling medical and non-medical emergencies; and

8. Infection control precautions and proper waste storage and disposal procedures.

(c) Support Services. A renal dialysis clinic providing home dialysis training shall provide a patient with the following support services for the length of time that the patient is receiving home dialysis:

1. Periodic monitoring of the patient's home adaptation, including visits to the patient's home by facility personnel in accordance with the patient's plan of care;

2. Development and periodic review of the patient's individualized comprehensive care plan;

3. Patient consultation with members of the clinic's interdisciplinary team as needed;

4. Periodic monitoring of the quality of waters and dialysate used by home dialysis patients. The renal dialysis clinic shall correct the water quality if needed and arrange for backup dialysis until the water quality is corrected. All periodic monitoring of water quality and dialysate shall be performed in accordance with federal laws and rules (42 C.F.R. § 494.100(c)(v)); and

5. A review of self-monitoring data from the patient or patient's caregiver at least every two (2) months.

(d) Recordkeeping. As a part of the support services provided by the renal dialysis clinic, the clinic shall ensure that the individuals providing support services shall maintain records of the following:

1. Documentation that the patient or patient caregiver received home dialysis training before performing home dialysis;

2. Observations and inquiries of the patient's condition; and

3. Patient or patient caregiver's self-monitoring data.

(3) Nursing Services.

(a) Nursing services to prevent or reduce complications and to maximize the patient's functional status shall be provided to a patient and the patient's family or significant other.

(b) A full-time Nursing Manager shall be employed to manage the provision of patient care.

(c) A registered nurse shall be responsible for:

1. Conducting admission nursing assessments;

2. Conducting assessments of a patient when indicated by a question relating to a change in the patient's status or at the patient's request;

3. Participating in team review of a patient's progress;

4. Recommending changes in treatment based on the patient's current needs;

5. Facilitating communication between the patient, patient's family or significant other, and other team members to ensure needed care is delivered;

6. Providing oversight and direction to dialysis technicians and licensed practical nurses; and

7. Participating in continuous quality improvement activities.

(d) A charge nurse shall be on site and available to the treatment area to provide patient care during all dialysis treatments.

(e) If pediatric dialysis is provided, a registered nurse shall coordinate with a pediatric dialysis center that has a pediatric nephrologist on staff to provide care of pediatric dialysis patients younger than 14 years of age or smaller than 35 kilograms in weight.

(f) Sufficient direct care nursing staff shall be on-site to meet the needs of the patients.

(g) A facility shall provide a nursing station(s) to allow adequate visual monitoring of patients by nursing staff during treatment.

(h) A licensed nurse or dialysis technician shall evaluate each patient before and after treatment according to facility policy and the staff member's level of training. A registered nurse shall conduct a patient assessment when indicated by a question relating to a change in the patient's status or at the patient's request.

(i) The initial nursing assessment shall be initiated by a registered nurse at the time of the first treatment in the facility and completed within the first three treatments.

(j) Each nurse shall have a current Tennessee license to practice nursing in good standing.

(k) Each nurse assigned charge responsibilities shall be a registered nurse and have six months experience in hemodialysis obtained within the last 24 months. A RN who holds a current certification from a nationally recognized board in nephrology nursing or hemodialysis may substitute the certification for the six months experience in dialysis obtained within the last 24 months.

(4) Pharmaceutical Services.

(a) The renal dialysis clinic shall have pharmaceutical services that meet the needs of the patients during dialysis and are in accordance with the Tennessee Board of Pharmacy statutes and rules. The governing body is responsible for implementing policies and procedures that minimize drug errors.

(b) All internal and external medications and preparations intended for human use shall be stored separately. They shall be properly stored in medicine compartments, including cabinets on wheels, or drug rooms. Such compartments, cabinets or drug rooms shall be kept securely locked when not in use, and the key must be in the possession of the supervising nurse or other authorized persons. Poisons or external medications shall not be stored in the same compartment and shall be labeled as such.

(c) Schedule II drugs must be stored behind two (2) separately locked doors at all times and accessible only to persons in charge of administering medication.

(d) Every renal dialysis clinic shall comply with all state and federal statutes and regulations governing Schedule II drugs.

(e) A notation shall be made in a Schedule II drug book and in the patient's nursing notes each time a Schedule II drug is given. The notation shall include the name of the patient receiving the drug, name of the drug, the dosage given, the method of administration, the date and time given and the name of the practitioner prescribing the drug, and shall be signed or initialed by the prescribing practitioner according to renal dialysis clinic policy.

(f) Medications not specifically limited as to time or number of doses when ordered shall be controlled by automatic stop orders or other methods in accordance with written policies. No Schedule II drug shall be given or continued beyond seventy-two (72) hours without a written order by the physician.

(g) Medication administration records (MAR) shall be checked against the physician's orders. Each dose shall be properly recorded in the clinical record after it has been administered.

(h) Preparation of doses for more than one scheduled administration time shall not be permitted.

(i) Medication shall be administered only by licensed medical or licensed nursing personnel or other licensed health professionals acting within the scope of their licenses, excluding medications as described in 0720-33-.04(12)(1).

(j) Unless the unit dose package system is used, individual prescriptions of drugs shall be kept in the original container with the original label intact showing the name of the patient, the drug, the physician, the prescription number and the date dispensed.

(k) Any unused portions of prescriptions shall be turned over to the patient only on a written order by the physician. A notation of drugs released to the patient shall be entered into the medical record. All unused prescriptions left in a renal dialysis clinic must be destroyed on the premises and recorded by a registered nurse. Such record shall be kept in the renal dialysis clinic.

(5) Laboratory Services. The renal dialysis clinic must maintain or have available, either directly or through a contractual agreement, adequate laboratory services to meet the needs of the patients. The renal dialysis clinic must ensure that all laboratory services provided to its patients are performed in a facility licensed in accordance with the Tennessee Medical Laboratory Act (TMLA), if located in Tennessee. All technical laboratory staff shall be licensed in accordance with the TMLA facility and shall be qualified by education, training and experience for the type of services rendered.

(6) Environmental services.

(a) Space and facilities for housekeeping equipment and supply storage shall be provided in each service area. Storage for bulk supplies and equipment shall be located away from patient care areas. The building shall be kept in good repair, clean, sanitary and safe at all times.

(b) The physical environment of the clinic shall be maintained in a safe, clean and sanitary manner. Any condition of the clinic site conducive to the harboring or breeding of insects, rodents or other vermin shall be prohibited. Chemical substances shall not be stored with or near food or medications.

(7) Medical Records.

(a) The renal dialysis clinic shall comply with the Tennessee Medical Records Act, T.C.A. §§ 68-11-301, et seq.

(b) The renal dialysis clinic must maintain a medical record for each patient. Medical records must be accurate, promptly completed, properly filed and retained, and accessible. The facility must use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries.

(c) All medical records, in either written, electronic, graphic or otherwise acceptable form, must be retained in their original or legally reproduced form for a minimum period of at least ten (10) years after which such records may be destroyed. However, in cases of patients under mental disability or minority, their complete facility records shall be retained for the period of minority or known mental disability, plus one (1) year, or ten (10) years following the discharge of the patient, whichever is longer. Records destruction shall be accomplished by burning, shredding or other effective method in keeping with the confidential nature of the contents. The destruction of records must be made in the ordinary course of business, must be documented and in accordance with the facility's policies and procedures, and no record may be destroyed on an individual basis.

(d) When a renal dialysis clinic closes with no plans of reopening, an authorized representative of the facility shall request final storage or disposition of the facility's medical records by the department. Upon transfer to the department, the facility relinquishes all control over final storage of the records and the files shall become property of the State of Tennessee.

(e) The renal dialysis clinic must have a system of coding and indexing medical records. The system must allow for timely retrieval.

(f) The renal dialysis clinic must have a procedure for ensuring the confidentiality of patient records. Information from or copies of records may be released only to authorized individuals, and the facility must ensure that unauthorized individuals cannot gain access to or alter patient records. Original medical records must be released by the facility only in accordance with federal and state laws, court orders or subpoenas.

(g) The medical record must contain information to justify admission, support the diagnosis, and describe the patient's progress and response to services.

(h) All entries must be legible, complete, dated and authenticated according to facility policy.

(i) All records must document the following:

1. Admitting diagnosis;

2. Documentation of complications;

3. Properly executed informed consent forms for procedures and treatments specified by facility policy, or by federal or state law if applicable, as requiring written patient consent;

4. All practitioners' orders, reports of treatment, medication records, radiology and laboratory reports, and vital signs and other information necessary to monitor the patient's condition.

(j) Electronic and computer-generated records and signature entries are acceptable.

(8) Nutrition services.

(a) Nutrition services shall be provided to a patient and the patient's caregiver(s) in order to maximize the patient's nutritional status.

(b) The dietitian shall be responsible for:

1. Conducting a nutrition assessment of a patient;

2. Participating in a team review of a patient's progress;

3. Recommending therapeutic diets in consideration of cultural or religious preferences and changes in treatment based on the patient's nutritional needs in consultation with the patient's physician;

4. Counseling a patient, a patient's family, and a patient's significant other on prescribed diets and monitoring adherence and response to diet therapy. Correctional institutions shall not be required to provide counseling to family members or significant others;

5. Referring a patient for assistance with nutrition resources such as financial assistance, community resources or in-home assistance;

6. Participating in continuous quality improvement activities; and

7. Providing ongoing monitoring of subjective and objective data to determine the need for timely intervention and follow-up. Measurement criteria include but are not limited to weight changes, blood chemistries, adequacy of dialysis, and medication changes which affect nutrition status and potentially cause adverse nutrient interactions.

(c) The collection of objective and subjective data to assess nutrition status shall occur within two weeks or seven treatments from admission to the facility, whichever occurs later. A comprehensive nutrition assessment with an educational component shall be completed within 30 days or 13 treatments from admission to the facility, whichever occurs later.

(d) A nutrition reassessment shall be conducted annually or more often if indicated.

(e) Each facility shall employ or contract with a sufficient number of dietitian(s) to provide clinical nutrition services for each patient.

(f) Nutrition services shall be available at the facility during scheduled treatment times. Access to services may require an appointment.

(9) Social services.

(a) Social services shall be provided to patients and their families and shall be directed at supporting and maximizing the adjustment, social functioning, and rehabilitation of the patient.

(b) The social worker shall be responsible for:

1. Conducting psychosocial evaluations;

2. Participating in team review of patient progress;

3. Recommending changes in services based on the patient's current psychosocial needs;

4. Providing case work and group work services to patients and their families in dealing with the special problems associated with end stage renal disease;

5. Except in the case of social workers providing service in correctional institutions, identifying community social agencies and other resources and assisting patients and families in utilizing them; and

6. Participating in continuous quality improvement activities.

(c) Initial contact between the social worker and the patient shall occur and be documented within two weeks or seven treatments from the patient's admission, whichever occurs later. A comprehensive psychosocial assessment shall be completed within 30 days or 13 treatments from the patient's admission, whichever occurs later.

(d) A psychosocial reassessment shall be conducted annually or more often if indicated.

(e) Each facility shall employ or contract with a sufficient number of social worker(s) to meet the psychosocial needs of the patients.

(f) Social services shall be available at the facility during the times of patient treatment. Access to social services may require an appointment.

Tenn. Comp. R. & Regs. 0720-33-.06

Original rule filed April 22, 2003; effective July 6, 2003. Amendment filed December 15, 2005; effective February 28, 2006. Amendment filed December 9, 2010 to have been effective March 9, 2011 was stayed for 28 days by the Government Operations Committee; new effective date March 29, 2011. Transferred from chapter 1200-08-32 pursuant to Public Chapter 1119 of 2022 effective 7/1/2022.

Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-11-202, 68-11-204, 68-11-206, and 68-11-209.