Or. Admin. Code § 333-700-0105

Current through Register Vol. 63, No. 11, November 1, 2024

Section 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)

(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 associates, 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 through 333-275-0180).

Or. Admin. Code § 333-700-0105

PH 7-2003, f. & cert. ef. 6-6-03; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12; PH 62-2024, minor correction filed 06/06/2024, effective 6/6/2024

Statutory/Other Authority: ORS 441.015 & 441.025

Statutes/Other Implemented: ORS 441.025