Wisconsin Legislature: DHS 152.07(5)(b)

(d) A nurse;

(e) A dietitian; and

(f) A social worker.

(3) Services. The hospital housing the renal transplantation center shall:

(a) Be approved under ss. 50.32 to 50.39, Stats., and ch. DHS 124, meet all the requirements of 42 USC 1395x (e) and be a certified medicare provider;

(b) Be approved under 42 USC 1395rr (b);

(c) Have laboratory services approved for participation in medicare and under 42 CFR 493 (CLIA) available for cross-matching of recipient serum and donor lymphocytes for preformed antibodies by an acceptable technique on a 24-hour emergency basis. Other available laboratory services shall include:

1. Suitable maintenance of recipient sera and typing reagents;

2. Phenotyping for donors and recipients;

3. Updating and retyping for human lymphocyte antigens (HLA);

4. Screening of recipient sera for preformed antibodies with a suitable lymphocyte panel;

5. Testing the mixed lymphocyte cultures to determine cellularly defined antigens;

6. ABO blood grouping and typing;

7. Unusual pathogen culturing, fungal cultures, tissue cultures and tuberculosis cultures;

8. Immunofluorescence and electron microscopy;

9. Urine glucose, protein, and microscopy;

10. Complete blood count (CBC) and platelet count;

11. Blood gases and blood pH;

12. Serum calcium, potassium, phosphorous, and glucose;

13. Blood urea nitrogen (BUN), creatinine, serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT), lactic dehydrogenase (LDH) and prothrombin time; and

14. Spinal fluid and bone marrow exams;

(d) Have available other support services, including physical therapy, pharmacy, inhalation therapy, blood banking, dialysis, nerve conduction, cardiac catheterization, electroencephalography, diagnostic ultrasound, angiography and diagnostic radioisotopic scanning;

(e) Participate in a patient registry program; and

(f) Provide outpatient services for the evaluation, care and follow-up of renal transplantation patients.

(4) Physical design. In regard to physical design, the renal transplantation center shall:

(a) Provide a minimum of 10 beds to accommodate patients before and after transplantation; and

(b) Have rooms on the unit designed to provide isolation or segregation from patients with an infection or a communicable disease.

(5) Equipment and supplies. In regard to equipment and supplies, the renal transplantation center shall have:

(a) Donor kidney preservation equipment on the premises or available under arrangement or agreement, with donor kidneys preserved by currently acceptable medical methods; and

(b) Emergency resuscitation equipment available on the premises.

(6) Policies and procedures. In regard to policies and procedures, the renal transplantation center shall have:

(a) Unit policies and procedures which shall be in writing and updated at least annually. These policies and procedures shall relate to the operation of the unit and shall include infection control and emergency evacuation policies and procedures; and

(b) Patient care policies and procedures which shall be in writing and updated at least annually. These policies and procedures shall include the development of an individualized care plan for every patient, a list of patient rights and responsibilities and a grievance mechanism which is made available to all patients.

History: Cr. Register, June, 1988, No. 390, eff. 7-1-88; am. (3) (c) 13., Register, December, 1994, No. 468, eff. 1-1-95; correction in (3) (a) made under s. 13.92 (4) (b) 7., Stats., Register January 2009 No. 637.

DHS 152.08 Standards for renal dialysis centers and facilities.

(1) General. To be reimbursed by the CRD program, renal dialysis centers and free-standing and hospital-based renal dialysis facilities shall comply with the standards in this section.

(2) Staffing. A renal dialysis center shall have the following staff and a hospital-based renal dialysis facility or a free-standing renal dialysis facility shall make available the following staff directly, under arrangement or under agreement:

(a) A nephrologist;

(b) A vascular surgeon;

(c) Other physicians licensed in Wisconsin or, if employed by an ESRD unit approved under this chapter in a border state, in that state, with experience in the following specialties: cardiology, endocrinology, hematology, neurology, psychiatry, urology, orthopedics, pathology, pediatrics if children are under care, and radiology;

(d) A nurse;

(e) A dietitian; and

(f) A social worker.

(3) Services. A renal dialysis center or facility shall:

(a) Be approved under 42 USC 1395rr (b);

(b) Comply with all local ordinances, state rules and federal regulations relating to ambulatory medical care facilities, including but not limited to those for building, zoning, fire and safety, health and civil rights;

(c) Provide self-care dialysis training and kidney transplantation to all suitable patients either directly or under arrangement or agreement;

(d) Have laboratory services approved for participation in medicare and under 42 CFR 493 (CLIA) and available on a 24-hour emergency basis for dialysis-related tests. Laboratory services shall include:

1. Urine glucose and microscopy;

2. Complete blood count (CBC) and platelet count;

3. Prothrombin time;

4. ABO blood grouping, Rh typing and cross-matching;

5. Serum glucose, calcium, potassium, phosphorous and magnesium;

6. Blood urea nitrogen (BUN), creatinine, uric acid, serum glutamic-oxaloacetic transaminase (SGOT), lactic dehydrogenase (LDH) and alkaline phosphatase;

7. Blood pH and gases;

8. Pathogen cultures;

9. Tissue typing and spinal fluid analysis; and

10. Serum hepatitis screening;

(e) Maintain clinical records for each patient in accordance with professional principles; and

(f) Have available other support services, including physical therapy, pharmacy, inhalation therapy, blood banking, medical records and nuclear medicine.

(4) Physical design. In regard to physical design, a renal dialysis center or facility shall:

(a) Provide 80 square feet per patient bed to permit movement of emergency equipment;

(b) Have separate clean and sterile work areas to separate contaminated and soiled materials from the patient care area;

(d) Have adequate space for refrigerated and non-refrigerated storage, with separate facilities for food storage;

(e) Provide electrical connections at each dialysis station in accordance with federal and state electrical safety regulations;

(f) Have unit plumbing, including check cut-off valves and back-flow preventors, which assumes adequate incoming water pressure to conform to equipment requirements and to prevent back-flow from waste lines. Treated water shall be delivered through pipes of inert materials containing no copper;

(g) Provide appropriate means for disposal of solid waste, preferably by incineration;

(h) Provide a convenient toilet room with a toilet and wash basin for patient use only;

(i) Have a janitor’s closet within or adjacent to the unit; and

(j) Provide space for linen storage.

(5) Equipment and supplies. In regard to equipment and supplies, a renal dialysis center or facility shall:

(a) Have equipment available to sterilize items that require sterilization;

(b) Provide equipment in accordance with federal and state safety specifications and appropriately clean the equipment following each dialysis procedure;

(c) Provide treatment of water used for the dialysate to remove fluorides and prevent health hazards due to mineral content;

(d) Provide safeguards to ensure patient safety in the installation and maintenance of home dialysis equipment; and

(e) Have available cannulation trays, infusion pumps, intubation trays and emergency resuscitation equipment.

(6) Policies and procedures. In regard to policies and procedures, a renal dialysis center or facility shall have:

(a) Unit policies and procedures, in writing and updated at least annually. These policies and procedures shall relate to the operation of the unit and shall include infection control and emergency evacuation policies and procedures;

(b) Patient care policies and procedures, in writing and updated at least annually. These policies and procedures shall include the development of individualized long and short term patient care plans for every patient and a list of patient rights and responsibilities, including a grievance mechanism, which is made available to all patients; and

(c) Home dialysis and self-dialysis policies and procedures, in writing. The home or self-dialysis training unit shall develop additional policies and procedures, updated at least annually, to govern home dialysis and self-dialysis training and home analysis and self-dialysis activities. These policies and procedures shall include appropriate evaluation and surveillance of home dialysis and self-dialysis patients and equipment.

History: Cr. Register, June, 1988, No. 390, eff. 7-1-88; am. (3) (d) 6., Register, December, 1994, No. 468, eff. 1-1-95.

DHS 152.09 CRD program advisory committee.

(1) A CRD program advisory committee shall be established by the department and shall be given staff support by the department. The committee shall consist of 12 Wisconsin citizens, as follows:

(a) Four physicians, 2 of whom are nephrologists and the other 2 transplant surgeons;

(b) One dietician involved in ESRD patient care;

(d) One social worker involved in ESRD patient care; and

(e) Four public members.