Chapter DHS 152

DHS 152.07 DHS 152.07 Standards for renal transplantation centers.

DHS 152.07(1) (1) General. To be reimbursed by the CRD program, renal transplantation centers shall comply with the standards in this section.

DHS 152.07(2) (2) Staffing. A renal transplantation center shall have the following staff:

DHS 152.07(2)(a) (a) A transplant surgeon;

DHS 152.07(2)(b) (b) A nephrologist;

DHS 152.07(2)(c) (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, infectious disease, orthopedics, pathology, psychiatry, nuclear medicine, radiology, urology, immunology, anesthesiology, gastroenterology, vascular surgery, pediatrics if pediatric patients are under care, neurosurgery and cardiovascular surgery;

DHS 152.07(2)(d) (d) A nurse;

DHS 152.07(2)(e) (e) A dietitian; and

DHS 152.07(2)(f) (f) A social worker.

DHS 152.07(3) (3) Services. The hospital housing the renal transplantation center shall:

DHS 152.07(3)(a) (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;

DHS 152.07(3)(b) (b) Be approved under 42 USC 1395rr (b);

DHS 152.07(3)(c) (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:

DHS 152.07(3)(c)1. 1. Suitable maintenance of recipient sera and typing reagents;

DHS 152.07(3)(c)2. 2. Phenotyping for donors and recipients;

DHS 152.07(3)(c)3. 3. Updating and retyping for human lymphocyte antigens (HLA);

DHS 152.07(3)(c)4. 4. Screening of recipient sera for preformed antibodies with a suitable lymphocyte panel;

DHS 152.07(3)(c)5. 5. Testing the mixed lymphocyte cultures to determine cellularly defined antigens;

DHS 152.07(3)(c)6. 6. ABO blood grouping and typing;

DHS 152.07(3)(c)7. 7. Unusual pathogen culturing, fungal cultures, tissue cultures and tuberculosis cultures;

DHS 152.07(3)(c)8. 8. Immunofluorescence and electron microscopy;

DHS 152.07(3)(c)9. 9. Urine glucose, protein, and microscopy;

DHS 152.07(3)(c)10. 10. Complete blood count (CBC) and platelet count;

DHS 152.07(3)(c)11. 11. Blood gases and blood pH;

DHS 152.07(3)(c)12. 12. Serum calcium, potassium, phosphorous, and glucose;

DHS 152.07(3)(c)13. 13. Blood urea nitrogen (BUN), creatinine, serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT), lactic dehydrogenase (LDH) and prothrombin time; and

DHS 152.07(3)(c)14. 14. Spinal fluid and bone marrow exams;

DHS 152.07(3)(d) (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;

DHS 152.07(3)(e) (e) Participate in a patient registry program; and

DHS 152.07(3)(f) (f) Provide outpatient services for the evaluation, care and follow-up of renal transplantation patients.

DHS 152.07(4) (4) Physical design. In regard to physical design, the renal transplantation center shall:

DHS 152.07(4)(a) (a) Provide a minimum of 10 beds to accommodate patients before and after transplantation; and

DHS 152.07(4)(b) (b) Have rooms on the unit designed to provide isolation or segregation from patients with an infection or a communicable disease.

DHS 152.07(5) (5) Equipment and supplies. In regard to equipment and supplies, the renal transplantation center shall have:

DHS 152.07(5)(a) (a) Donor kidney preservation equipment on the premises or available under arrangement or agreement, with donor kidneys preserved by currently acceptable medical methods; and

DHS 152.07(5)(b) (b) Emergency resuscitation equipment available on the premises.

DHS 152.07(6) (6) Policies and procedures. In regard to policies and procedures, the renal transplantation center shall have:

DHS 152.07(6)(a) (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

DHS 152.07(6)(b) (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.

DHS 152.07 History 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 DHS 152.08 Standards for renal dialysis centers and facilities.

DHS 152.08(1) (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.

DHS 152.08(2) (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:

DHS 152.08(2)(a) (a) A nephrologist;

DHS 152.08(2)(b) (b) A vascular surgeon;

DHS 152.08(2)(c) (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;

DHS 152.08(2)(d) (d) A nurse;

DHS 152.08(2)(e) (e) A dietitian; and

DHS 152.08(2)(f) (f) A social worker.

DHS 152.08(3) (3) Services. A renal dialysis center or facility shall:

DHS 152.08(3)(a) (a) Be approved under 42 USC 1395rr (b);

DHS 152.08(3)(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;

DHS 152.08(3)(c) (c) Provide self-care dialysis training and kidney transplantation to all suitable patients either directly or under arrangement or agreement;

DHS 152.08(3)(d) (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:

DHS 152.08(3)(d)1. 1. Urine glucose and microscopy;

DHS 152.08(3)(d)2. 2. Complete blood count (CBC) and platelet count;

DHS 152.08(3)(d)3. 3. Prothrombin time;

DHS 152.08(3)(d)4. 4. ABO blood grouping, Rh typing and cross-matching;

DHS 152.08(3)(d)5. 5. Serum glucose, calcium, potassium, phosphorous and magnesium;

DHS 152.08(3)(d)6. 6. Blood urea nitrogen (BUN), creatinine, uric acid, serum glutamic-oxaloacetic transaminase (SGOT), lactic dehydrogenase (LDH) and alkaline phosphatase;

DHS 152.08(3)(d)7. 7. Blood pH and gases;

DHS 152.08(3)(d)8. 8. Pathogen cultures;

DHS 152.08(3)(d)9. 9. Tissue typing and spinal fluid analysis; and

DHS 152.08(3)(d)10. 10. Serum hepatitis screening;

DHS 152.08(3)(e) (e) Maintain clinical records for each patient in accordance with professional principles; and

DHS 152.08(3)(f) (f) Have available other support services, including physical therapy, pharmacy, inhalation therapy, blood banking, medical records and nuclear medicine.

DHS 152.08(4) (4) Physical design. In regard to physical design, a renal dialysis center or facility shall:

DHS 152.08(4)(a) (a) Provide 80 square feet per patient bed to permit movement of emergency equipment;

DHS 152.08(4)(b) (b) Have separate clean and sterile work areas to separate contaminated and soiled materials from the patient care area;

DHS 152.08(4)(c) (c) Provide space for instrument maintenance and storage;

DHS 152.08(4)(d) (d) Have adequate space for refrigerated and non-refrigerated storage, with separate facilities for food storage;

DHS 152.08(4)(e) (e) Provide electrical connections at each dialysis station in accordance with federal and state electrical safety regulations;

DHS 152.08(4)(f) (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;

DHS 152.08(4)(g) (g) Provide appropriate means for disposal of solid waste, preferably by incineration;

DHS 152.08(4)(h) (h) Provide a convenient toilet room with a toilet and wash basin for patient use only;

DHS 152.08(4)(i) (i) Have a janitor’s closet within or adjacent to the unit; and

DHS 152.08(4)(j) (j) Provide space for linen storage.

DHS 152.08(5) (5) Equipment and supplies. In regard to equipment and supplies, a renal dialysis center or facility shall:

DHS 152.08(5)(a) (a) Have equipment available to sterilize items that require sterilization;

DHS 152.08(5)(b) (b) Provide equipment in accordance with federal and state safety specifications and appropriately clean the equipment following each dialysis procedure;

DHS 152.08(5)(c) (c) Provide treatment of water used for the dialysate to remove fluorides and prevent health hazards due to mineral content;

DHS 152.08(5)(d) (d) Provide safeguards to ensure patient safety in the installation and maintenance of home dialysis equipment; and

DHS 152.08(5)(e) (e) Have available cannulation trays, infusion pumps, intubation trays and emergency resuscitation equipment.

DHS 152.08(6) (6) Policies and procedures. In regard to policies and procedures, a renal dialysis center or facility shall have:

DHS 152.08(6)(a) (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;

DHS 152.08(6)(b) (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

DHS 152.08(6)(c) (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.

DHS 152.08 History 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 DHS 152.09 CRD program advisory committee.