OAR 333-700-0105
Minimal Service Requirements for an Outpatient Renal Dialysis Facility

The facility must provide dialysis services, as well as adequate laboratory, social, and nutritional services to meet the needs of the dialysis patient.

(1)

Outpatient Dialysis Services:

(a)

Staff-assisted dialysis services. The facility must provide all necessary dialysis services and staff required to perform dialysis.

(b)

Self-dialysis services. If the facility offers self-dialysis services, it must provide all medically necessary supplies and equipment and any other service specified in the facility’s patient care policies.

(2)

Laboratory Services: The facility must make available laboratory services (other than the specialty of tissue pathology and histocompatibility testing), to meet the needs of the dialysis patient. All laboratory services must be performed by an appropriately certified laboratory in accordance with federal and state regulations. If the facility furnishes its own laboratory services, these services must meet the applicable requirements established in state and federal regulations. If the facility does not provide laboratory services, it must make arrangements to obtain these services from a laboratory certified in the appropriate specialties and subspecialties of service.

(3)

Social Services: Social services shall be provided to patients and their families and shall be directed at supporting and maximizing the social functioning and adjustment of the patient. Social services must be furnished by a qualified social worker who has an employment or contractual relationship with the facility. The facility shall provide adequate social work coverage to ensure the needs of the patients are met. The qualified social worker is responsible for:

(a)

Conducting psychosocial evaluations;

(b)

Participating in team reviews of patient progress;

(c)

Recommending changes in treatment based on the patient’s current psychosocial needs;

(d)

Providing casework and group work services to patients and their families in dealing with the special problems associated with dialysis; and

(e)

Identifying community social agencies and other resources and assisting patients and families to utilize them.

(4)

Intentionally left blank —Ed.

(a)

Nutrition Services: Nutrition services shall be provided to the patients and the patient’s caregiver(s) in order to maximize the patient’s nutritional status. Each patient must be evaluated as to his/her nutritional needs by the attending physician and by a qualified dietitian who has an employment or contractual relationship with the facility.

(b)

The facility shall provide an adequate amount of dietitian coverage to ensure the needs of the patients are met. The dietitian shall be responsible for:

(A)

Conducting nutritional assessments of patients;

(B)

Participating in a team process in developing and reviewing patient care plans;

(C)

Recommending nutrition therapy with consideration of cultural preferences and changes in treatment based on the patient’s nutritional needs in consultation with the patient’s physician;

(D)

Counseling patients, patients’ families and significant others; and monitoring adherence to and response to nutrition therapy;

(E)

Referring patients for assistance with nutrition resources such as financial assistance, community resources or in-home assistance; and

(F)

Participating in Quality Assessment and Performance Improvement activities.

(5)

Self-dialysis Support Services: The facility furnishing self-dialysis training, upon completion of the patient’s training, must furnish (either directly, under agreement or by arrangement with another facility) the following services:

(a)

Surveillance of the patient’s home adaptation, including provisions for visits to the home or the facility;

(b)

Consultation for the patient with a qualified social worker and a qualified dietitian;

(c)

A record-keeping system, which assures continuity of care;

(d)

Installation and maintenance of equipment;

(e)

Testing and appropriate treatment of the water; and

(f)

Ordering of supplies on an ongoing basis.

(6)

Participation in Recipient Registry: The facility shall participate in a patient registry program with an Organ Procurement Organization (OPO) designated or redesignated for patients who are awaiting cadaveric donor transplantation.

(7)

Home Anemia Management:

(a)

Patient Monitoring: The facility, or the physician responsible for all dialysis-related services furnished to the patient, shall monitor the patient. This monitoring shall include:

(A)

Reviewing appropriate laboratory values;

(B)

Establishing the plan of care and monitoring the progress of the home anemia management therapy;

(C)

Determining that the patient or a caregiver who assists the patient in performing self-dialysis meets the following conditions:
(i)
Is trained by the facility to inject the anemia management drug;
(ii)
Is capable of carrying out the procedure;
(iii)
Is capable of reading and understanding the drug labeling; and
(iv)
Is trained in, and capable of observing, aseptic techniques.

(D)

Determining that the anemia management drug can be stored in the patient’s residence under refrigeration, and that the patient is aware of the potential hazard of a child’s having access to the drug and syringes.

(b)

The patient’s physician or facility must:

(A)

Develop a protocol that follows the drug label instructions; and

(B)

Make the protocol available to the patient to ensure safe and effective home use of the anemia management drug.

(8)

Medications:

(a)

Medications maintained in the facility shall be properly stored and safeguarded in enclosures of sufficient size that are not accessible to unauthorized persons;

(b)

Refrigerators used for storage of medications shall maintain appropriate temperatures for such storage and routine monitoring of these temperatures shall be documented;

(c)

Medications not given immediately shall be labeled with the name of the medication, the dosage prepared, the date and time, and the initials of the person preparing the medication. Expired medications must be disposed of appropriately; and

(d)

All medications shall be administered by licensed nurses, physician assistants, pharmacists, or physicians. Intravenous normal saline, intravenous heparin, and subcutaneous lidocaine may be administered as part of a routine hemodialysis treatment by dialysis technicians qualified according to Oregon Administrative Rules for Hemodialysis Technicians (OARs 333-275-0001 (Purpose) through 333-275-0180 (Fees)).

Source: Rule 333-700-0105 — Minimal Service Requirements for an Outpatient Renal Dialysis Facility, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-700-0105.

333‑700‑0000
Statement of Purpose 333‑700‑0004
Referenced Codes and Standards 333‑700‑0005
Definitions 333‑700‑0010
Application for Licensure 333‑700‑0015
Annual License Fee 333‑700‑0017
Application Review 333‑700‑0018
Approval of License Application 333‑700‑0019
Denial of License Application 333‑700‑0020
Expiration and Renewal of License 333‑700‑0025
Denial or Revocation of a License 333‑700‑0030
Discontinuance and Recommencement of Operation of Outpatient Renal Dialysis Facilities 333‑700‑0035
Return of Facility License 333‑700‑0040
Classification 333‑700‑0045
Hearings 333‑700‑0050
Adoption by Reference 333‑700‑0053
Complaints 333‑700‑0057
Investigations 333‑700‑0060
Surveys 333‑700‑0061
Violations 333‑700‑0062
Informal Enforcement 333‑700‑0063
Formal Enforcement 333‑700‑0064
Civil Penalties 333‑700‑0072
Waivers 333‑700‑0073
Outpatient Mobile Dialysis 333‑700‑0075
Administrative Authority and Management 333‑700‑0080
Quality Assessment and Performance Improvement 333‑700‑0085
Patient Care Plan 333‑700‑0090
Medical Records 333‑700‑0095
Medical Director of an Outpatient Renal Dialysis Facility 333‑700‑0100
Patient Care Staff 333‑700‑0105
Minimal Service Requirements for an Outpatient Renal Dialysis Facility 333‑700‑0110
Infection Control 333‑700‑0115
Patients’ Rights, Responsibilities and Family Education 333‑700‑0120
Facility Safety and Emergency Preparedness 333‑700‑0125
Reuse of Hemodialyzers and other Dialysis Supplies 333‑700‑0131
Physical Environment Requirements
Last Updated

Jun. 8, 2021

Rule 333-700-0105’s source at or​.us