6 Colo. Code Regs. § 1011-1-15-6

Current through Register Vol. 47, No. 11, June 10, 2024

Section 6 CCR 1011-1-15-6 - PATIENT/CLINICAL FUNCTIONS

6.1 Hemodialysis Services

(A) A dialysis treatment clinic shall not provide outpatient hemodialysis treatment to a non end-stage renal disease patient without a referral for treatment from a board-certified or board-eligible nephrologist licensed as a physician in Colorado. When making the referral, the nephrologist and other licensed physicians who cared for the patient in the hospital shall use their professional judgment to determine when the patient no longer requires hospitalization and may receive outpatient dialysis.

6.1.1 Water Supply

(A) The clinic's water supply system shall be from a municipal water supply system or other system that meets the criteria established by the Department in Regulation No. 11 of the Water Quality Control Commission, Colorado Primary Drinking Water Regulations, 5 CCR 1002-11.

(B) Water used in hemodialysis procedures shall be further treated before use in dialysis machines. Dialysis treatment clinics shall follow a recognized method of treatment.

6.2 Clinical Laboratory

6.2.1 Clinical laboratory services shall be provided within the facility or by contract.

6.2.2 Contracted services shall meet the standards established herein.

6.2.3 Staffing and Organization

(A) The laboratory shall be under the supervision of a physician, certified in clinical pathology, either on a full-time, part-time, or consulting basis. The pathologist shall provide, at a minimum, monthly consultative visits.

(B) Emergency laboratory services shall be made available whenever needed.

(C) All laboratory work shall be ordered by a physician or a person authorized by law to use the results of such findings.

6.2.4 Facilities and Equipment

(A) There shall be adequate space within the facility for the laboratory.

(B) There shall be adequate storage space for supplies.

(C) Workbench space shall be ample, well lighted, and convenient to sink, water, and electrical outlets as necessary.

(D) All laboratory equipment shall be in good working order, be routinely checked and be precise in terms of calibration.

(E) A schedule of preventive maintenance shall be set up for all laboratory equipment.

6.2.5 Policies and Procedures

(A) A manual outlining all procedures performed in the laboratory shall be completed and readily available for reference.

(B) The conditions and procedures for referring specimens to another laboratory shall be in writing and available in the laboratory.

6.2.6 Clinical Laboratory Records

(A) A record of all preventive maintenance, repair, and calibration shall be kept on each item of laboratory equipment.

(B) A record system shall be established which ensures that laboratory specimens are adequately identified, properly processed, and permanently recorded.

(C) Duplicate copies of all reports shall be kept in the laboratory in a manner that permits ready identification and accessibility, for at least four years plus the current fiscal year.

6.3 Medical Records

6.3.1 Only members of the medical/house staff or other persons authorized by state law or regulation shall write or dictate medical histories and physical examinations.

6.3.2 A complete medical record shall be maintained on every patient registered in the dialysis treatment clinic. Each patient's record shall include:

(A) Sufficient information to properly identify the patient including clinic identification assigned to patient,

(B) Date and time of each treatment session,

(C) Original copies of any clinical test results including reports of tests referred to another laboratory,

(D) Initial diagnosis,

(E) Secondary diagnosis and complications as necessary, and

(F) Evidence of coordination or continuity of care 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.

6.3.3 All orders for diagnostic procedures, treatments, and medications shall be signed by the physician submitting them and entered in the medical record in ink, in type or electronically. The prompt completion of a medical record shall be the responsibility of the attending physician.

6.3.4 Authentication of the order may be by written signature, identifiable initials, computer key, or electronic verification.

6.3.5 Each dialysis treatment center shall provide a medical record room or other suitable medical record facility or area with adequate supplies and equipment. Medical records shall be stored safely to provide protection from loss, damage, and unauthorized use.

6.3.6 Medical records for individuals 18 years of age and older shall be preserved as original records, on microfilm or computer disc for no less than ten years from the most recent patient care usage, after which time records may be destroyed at the discretion of the clinic. Medical records for minors under the age of 18 shall be preserved for the period of minority plus ten (10) years.

6.3.7 The clinic shall establish procedures for notifying patients whose records are to be destroyed before the destruction of such records.

6.3.8 The sole responsibility for the destruction of all medical records shall lie with the clinic involved but in no case shall records be destroyed before consultation with legal counsel.

6.4 Infection Control

6.4.1 The dialysis treatment clinic shall have a multi-disciplinary infection control committee charged with the responsibility of investigation and recommendations for the prevention and control of infection in the clinic.

6.4.2 The multi-disciplinary infection control committee shall be responsible for all clinic policies and procedures related to infection control including the following:

(A) The isolation of patients with specific infectious diseases and protective isolation of appropriate patients,

(B) The control of routine use of antibiotics and adrenocorticosteroids,

(C) The review and revision of clinic policies and procedures to ensure compliance with the governing board's chosen national standard for infection control.

(D) Presentation of orientation and in-service education programs on the control of infection, and

(E) The reporting of infectious diseases as required by applicable state and federal laws and regulations.

6.4.3 The dialysis treatment clinic shall implement policies and procedures to prohibit clinic personnel with a communicable or contagious disease from providing direct patient care when it can be determined that such contact might result in transmission of the disease.

(A) Meet at least monthly, and more frequently if the surveillance committee so indicates.

(B) Plan an agenda that includes:

(1) Review of significant features of the monthly report.

(2) Review of one major control policy (and related procedures) area each month in the light of newest available information and the clinic's current practice.

6.5 Dialyzer Regeneration

6.5.1 Regeneration shall not be permitted on dialyzers used for hepatitis antigen positive patients.

6.5.2 Prior to individual dialyzer regeneration, a physician shall inform the patient involved of the possible complications and hazards along with the possible benefits of such regeneration.

6.5.3 No patient shall be denied access to dialysis in the clinic as a result of that patient's refusal to permit regeneration of his or her dialyzer. The clinic shall document all instances where a patient refuses to permit regeneration.

6.5.4 Staffing and Training

(A) The clinic shall provide training for all personnel in the protocols and procedures for regeneration at the time of employment and at least annually thereafter.

(B) The clinic shall document the qualifications of the personnel responsible for the regeneration process along with the protocols for training said personnel.

6.5.6 Policies and Procedures

(A) The clinic shall establish polices to ensure the safety of employees when using disinfecting agents and procedures to address accidents and disinfectant spillage.

(B) Quality control procedures shall be established and documented in the facility procedure manual.

(C) The infection control committee, if one exists, shall approve all quality control procedures.

6.5.7 Quality Control

Quality control procedures shall include, but not be limited to, the following:

(A) Each dialyzer to be reused shall be clearly and indelibly labeled with the patient's name and other unique identifying information before the initial use.

(1) At each subsequent use, the label shall be checked by two (2) separate individuals, preferably the dialysis staff member and the patient.

(B) The number of uses shall be recorded in a reuse record maintained for each dialyzer and in the patient's permanent dialysis record.

(C) Water used to formulate cleaning solution and to rinse dialyzers shall be passed through a reverse osmosis membrane, ultra filtration membrane or a submicron filter (0.45 micron) which is appropriately maintained. This water shall contain less than 200 bacteria per ml., and shall be checked monthly by bacteriologic sampling of the source water outlet in the reprocessing area. If such sampling reveals bacterial counts that exceed this limit, the clinic shall implement corrective measures and do weekly sampling until the result returns to less than 200 bacteria per ml. The clinic shall maintain a record with the results of all samples.

(D) Each dialyzer shall be disinfected with an effective agent and each disinfection shall be documented. If formaldehyde is used as the disinfecting agent, there shall be a minimum concentration of 2% in both the blood and dialysate compartments, and the minimum exposure time shall be no less than 24 hours.

(E) Disinfection shall be monitored. All febrile reactions during dialysis with new or used dialyzers shall be documented in the patient's record.

(F) Blood and dialysate cultures shall be done on all patients experiencing febrile reactions. The results of those cultures shall be documented in the dialysis record.

(G) There shall be documentation of the addition of effective disinfectant concentrations in the dialyzer to be reused.

(H) Effective disinfectant removal from each dialyzer immediately prior to reapplication shall be documented. There shall be validation on a monthly basis regarding the effectiveness of the disinfectant removal.

(I) All other potentially toxic substances added during any part of the reprocessing procedure shall be removed and the removal documented by routine testing and/or validation studies, as appropriate.

(J) The effectiveness of the reprocessing procedure shall be documented before each subsequent use of each dialyzer.

(1) For hollow fiber dialyzers, a hollow fiber bundle volume (HFBV) of not less than 80% of the initial HFBV, measured at 0+10 mm of HG transmembrane pressure, shall be maintained.

(2) For parallel plate or coil dialyzers, small molecular clearance tests shall be performed during or after each use. Performance less than 90% of original capacity shall not be permitted.

(K) Blood leaks during the use of either new or reprocessed dialyzers shall be documented. If the blood-leak rate of used dialyzers exceeds that of new dialyzers, each used dialyzer shall be pressure-tested for possible blood compartment leak before reuse.

(L) Dialyzers shall be discarded unless the following criteria are met at the time the dialyzer is to be used on the patient:

(1) The dialyzer has no cracked or broken parts,

(2) The dialyzer appears clear and free of dissolved or residual blood manifest by a brownish or pinkish tinge, and

(3) Headers are visibly free of all but small peripheral clots.

6.5.8 Facilities

The clinic shall designate a separate room for dialyzer regeneration that meets all of the following criteria:

(A) Is equipped with a counter and counter sink unless equipped with an appropriate flushing system,

(B) Contains approved hand-washing facilities and storage cabinets,

(C) Contains separate clean and soiled areas. Regenerated dialyzers shall be maintained only in the clean area,

(D) Is ventilated with fresh air at a minimum rate of six (6) air changes per hour or locally exhausted. Air shall not be recirculated through the ventilating system except at those times when processing is not taking place,

(1) If general exhaustion of the room is selected, as opposed to local exhaustion, the site of exhaustion shall be, at a maximum, six (6) inches from floor level. (Note: formaldehyde gas is heavier than air.)

(E) Is lighted to a level of 50-foot candles throughout. Light levels at the work surfaces shall be 100-foot candles, and

(F) Contains storage space for supplies and regenerated dialyzers proportional to the number of patients in the unit.

6.5.9 Patient Care

(A) Admission Policies and Procedures

(1) The facility shall develop policies and procedures regarding patient admission criteria.

(2) A patient medical history and current health status information sufficient to determine appropriateness for admission shall be obtained and recorded prior to or on the date of admission.

(3) The receiving attending physician and designated registered nurse shall review each patient's records to determine the appropriateness of the admission.

(B) Patient Care Policies

The facility shall have written patient care policies relating to all areas of care, which are approved by the medical director and governing body. The patient care policies shall be reviewed periodically to determine effectiveness; a review that shall take place at least annually.

(C) Patient Care Plan

(1) Prior to any patient's first dialysis treatment, there shall be an initial nursing assessment to determine each patient's needs and ensure that safe, appropriate care can and will be provided until a patient care plan is developed.

(2) Within thirty (30) days of admission or 13 treatments, whichever is longer, the facility shall develop a written patient care plan that includes treatment goals.

(3) The care plan shall be individualized to reflect the patient's ongoing medical, psychological, social, dietary and functional needs. The care plan shall be reviewed and updated as indicated by any change in the patient's medical, nutritional or psychosocial status, or at least annually.

(4) All patient care plans 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 reviewed with the patient or the patient's legal representative.

(D) Medical Oversight and On-Call Coverage

(1) The facility shall ensure that the care of each dialysis patient is under the continuing oversight of a nephrologist.

(2) A nephrologist or licensed intermediate care provider with education and experience in the care of patients with acute and chronic kidney failure shall be on call during the facility's operating hours. A roster of on-call providers shall be posted at the nurses' station.

6 CCR 1011-1-15-6