Northern Montana Hospital Dialysis Unit

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 44769 Based on observation, interview and record review, the facility failed to maintain a sanitary environment in the storage room. This deficient practice had the potential to affect all patients receiving dialysis at the facility. Findings include: During an observation on 2/24/25 at 3:01 p.m., a 55-gallon, plastic drum of [Brand Name] liquid acid concentrate was observed in the storage room with the cap off and open. The top of the drum had dust, black particles and slivers of wood on the rim. During an observation on 2/24/25 at 3:03 p.m., the fluorescent light fixture in the dialysate storage room had multiple dead insects observed inside the cover. During an observation and interview on 2/26/25 at 9:56 a.m., staff member A stated the drums in the storage room were shipped to the facility that way, and she didn’t know why the drums were dirty or that the cap was off. A review of a facility policy titled, “Preparation, documentation and storage of Dialysis Bath,” with a last review date of 05/24, showed: “PROCEDURE: ... IV. STORAGE: A. Dialysate jugs shall be stored in a sanitary manner. 1. Dialysate jugs shall be stored in the designated room until the appropriate time for transporting to the treatment station for specific patient use. 2. Jugs shall remain capped/covered during transport and when not in use.””

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 44769 Based on observation, interview and record review, the facility failed to implement proper hand hygiene and aseptic techniques while initiating and discontinuing dialysis for 3 (#’s 8, 9, and 11) of 6 patients observed. This deficient practice had the potential to affect all patients receiving dialysis in the facility. Findings include: During an observation on 2/25/25 at 8:59 a.m., staff member J was observed disconnecting patient #9’s dialysis lines. Staff member J had disconnected one dialysis line and then removed a blanket off of patient #9 and carried it away from the station. Upon returning, staff member J disconnected the other dialysis line and placed the caps on patient #9’s central venous catheter without hand hygiene or changing her gloves. During an observation on 2/25/25 at 9:44 a.m., staff member J was observed performing settings on the hemodialysis machine without wearing gloves. Staff member J retrieved a thermometer from the supplies cart and checked patient #8’s temperature and cleaned the thermometer with an alcohol swab and returned it to the supplies cart. Staff member J then donned gloves, without performing hand hygiene, and cleaned patient #8’s fistula and inserted the cannulation needles. During an observation on 2/25/25 at 11:12 a.m., Staff member J performed hand hygiene, put on her face shield, donned gloves and then removed the caps from patient #11’s central venous catheter. A review of a facility policy titled, Infection Prevention/Hand Hygiene, with an effective date of 04/24, showed: “Policy: Effective hand hygiene reduces the incidence of health care-associated infections. ... PROCEDURE: Indications for Handwashing and Hand Sanitizer ... A. Indications for Alcohol-Based Hand Sanitizer If hands are not visibly soiled, an alcohol-based hand sanitizer may be used for routinely decontaminating hands in the following clinical situations: - Before having direct contact with patients. - Before inserting indwelling urinary catheters, peripheral vascular catheters, or other invasive devices that do not require a surgical procedure. ... - After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient. ...””

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 35356 Based on observation, interview and record review, the facility failed to ensure protection of clean patient equipment from cross contamination of blood-borne pathogens with the use of open lid biohazard containers with visible blood contamination; and failed to follow the manufacturer’s recommendation for the disinfectant used to clean contaminated surfaces. These deficient practices had the potential to serve as a vehicle for transmission of infectious disease and negatively impact the safety and wellbeing of all patients receiving care. Findings include: (1) Cross Contamination of Blood-Borne Pathogens During an observation on 2/26/25 at 10:25 a.m., nine-gallon red biohazard containers with clear plastic lids were observed with the lids open and popped upward. The containers had visible blood contamination around the outside of the open lids, and around the exposed rim of the containers. The biohazard containers were sitting between the patient’s chairs and the dialysis machines. The patient bloodlines and blood pressure cuff lines were running between the patient and the dialysis machine and touching the contaminated biohazard containers at station #s 4, 5, and 6. Between patient change-over of the stations the biohazard containers were not disinfected, and the visible blood contamination was not removed prior to the next patient. During an interview on 2/26/25 at 2:00 p.m., staff member A stated it was the expectation that any visible blood spills be cleaned/disinfected immediately and prior to the next patient utilizing the station. She stated efforts should be made to reduce the cross-contamination of blood-borne pathogens between patients. Review of the facility’s policy and procedure, titled, Infection Control and Prevention, Exposure Plan, with a review date of 6/2023, showed, “...Contaminated Equipment: Equipment that has become contaminated with blood or other potentially infectious materials shall be examined prior to servicing or shipping and shall be decontaminated as necessary (unless the decontamination of the equipment is not feasible) ...” A review of the facility’s policy and procedure titled, Guidelines of Care of Dialysis Patients with Active or Chronic Bloodborne Diseases, with a review date of 4/2023, showed, “...B. Care of Equipment. 3. Dialysis staff shall treat all blood and body fluids as potentially infectious and shall wear appropriate PPE (i.e., moisture resistant gowns, gloves, masks, face protection) while cleaning dialysis equipment or machines. 4. Clean thoroughly the exterior of the acidified bath connector bicarb holder with a bleach solution after each patient run. Any blood spilled on equipment or floor is to be immediately cleaned with bleach solution...” (2) Disinfectant During an observation on 2/26/25 at 9:00 a.m., a red bucket half full of clear liquid was sitting at the “dirty” sink area. There was no label indicating the contents of the bucket. During an interview and observation on 2/26/25 at 9:00 a.m., staff member G stated the red bucket contained a water and bleach solution for disinfection. Staff member G demonstrated that she filled the bucket with one clear plastic non-graduated disposable drinking cup with bleach. She stated she filled the red bucket to the white line (hard water mark on inside of the bucket) with water. She stated this was the solution they used to disinfect the patient stations. During an observation and interview on 2/26/25 at 9:10 a.m., staff member E stated staff were to use a clear plastic graduated cup and fill it up to the 180 milliliter line, then add two 1000 milliliters of water using the graduated measuring containers. During an observation and interview on 2/26/25 at 9:15 a.m., staff member G demonstrated with the non-graduated plastic cup the amount of bleach used in the bleach and water solution. When she filled the non-graduated cup with water to demonstrate the amount, it was approximately 160 milliliters. She stated that was less than the required amount of bleach for the solutions. A review of the facility’s policy and procedure titled, Guidelines of Care of Dialysis Patients with Active or Chronic Bloodborne Diseases, with a review date of 4/2023, showed, “...B. Care of Equipment. 2. The outer surface of the dialysis machine shall be meticulously cleaned with a I :9 bleach/water solution at the end of patient treatment...””

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 35356 Based on record review and interview, the facility failed to train new, and retrain existing staff, on required elements of infection control. This deficient practice had the potential to affect all dialysis patients. Findings include: Review of the facility’s personnel files showed staff members E, F, G, H, I, and J did not receive mandatory Exposure Control, hemodialysis related infection control training with the topics including, but not limited to: - Proper hand hygiene technique - Proper use of personal protective equipment (PPE) - Infection control practices recommended for hemodialysis units and Standard Precautions - Special precautions for hepatitis B positive patients - Proper infection control techniques for initiation, care, and maintenance of access sites - Modes of transmission for blood borne viruses, pathogenic bacteria, and other microorganisms as appropriate - Proper handling, preparation, and administration of parenteral medications maintaining aseptic technique; and - Proper methods to clean and disinfect equipment and environmental surfaces to minimize transmission of microorganisms. During an interview on 2/26/25 at 2:00 p.m., staff member A stated it was the expectation for staff to receive infection control training at hire and annually, thereafter.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 35356 Based on record review and interview, the facility failed to ensure staff received education and training on appropriate infection control measures for maintaining and accessing intravascular catheters during dialysis. This deficient practice had the potential to affect all patients with intravascular catheters to prevent catheter-related infections. Findings include: Review of the facility’s personnel files for intravascular catheter training and education on infection control showed staff members E, F, G, H, I, and J, did not receive education or training on infection control measures to prevent intravascular catheter-related infections. During an interview on 2/26/25 at 8:00 a.m., staff member A stated there was no documentation of infection control training and/education for intravascular catheter care and management. She stated new staff members were trained by the charge nurse.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 35356 Based on observation, interview and record review, the facility failed to maintain a safe environment for patients by failing to label prefilled syringes with medication name, dose, patient name, preparer’s initials, date, and time; and failed to ensure all medications were stored in a locked and secure manner when not in use. These deficient practices have the potential to cause medication error and adverse drug events for all patients receiving care. Findings include: (1) Labeling of Pre-filled Medications During an observation on 2/26/25 at 10:15 a.m., two prefilled syringes were observed sitting on top of the nurses’ workstation on wheels. The prefilled syringes did not have labels. The prefilled syringes lacked the medication name, dose, patient name, preparer’s initials, date and time. During an interview on 2/25/25 at 10:25 a.m., staff member A stated the syringes were most likely lidocaine, since that was usually the only medication used in the one milliliter syringes. During an interview on 2/26/25 at 2:00 p.m., staff member A stated the expectation was to label all pre-filled medication syringes with the identifying information. Review of the facility’s policy and procedure, titled Preparation, Labeling, Administration and Documentation of Dialysis Medications, with a last reviewed date of 11/2024, showed: ...”after preparation the medication shall be appropriately labeled. The label shall indicate the following: a. Medication name b. Medication strength c. Patient name d. Medication dosage e. Bar code...” (2) Medications Stored in Secure Manner During an observation on 2/24/25 at 4:56 p.m., two multi-dose vials of Heparin were observed sitting on the counter next to the automated medication dispensing system. Two vials of multi-dose vials of Heparin were observed sitting on top of the nurses’ workstation on wheels and two more multi-dose vials of Heparin were observed sitting on the other nurses’ workstation on wheels adjacent to the other workstation. Patient care was completed for the day. During an interview on 2/24/25 at 4:56 p.m., staff member L stated the Heparin was not re-stocked in the automated medication dispensing system once it was pulled from the medication stock. During an observation 2/25/25 at 5:00 p.m., two multi-dose vials of Heparin were observed sitting on the counter next to the automated medication dispensing system. Two vials of multi-dose vials of Heparin were observed sitting on top of the nurses’ workstation on wheels and two more multi-dose vials of Heparin were observed sitting on the other nurses’ workstation on wheels adjacent to the other workstation. Patient care was completed for the day. During an interview on 2/26/25 at 2:00 p.m., staff member A stated the multi-dose vials of Heparin were most likely not locked back in the medication storage unit when not in use overnight. Staff member A stated it was the expectation that all medication be properly secured and locked in a secure manner when not in use. A request was submitted 2/26/25 at 8:00 a.m., for the facility’s policy and procedure for secure storage of medications. A policy and procedure which outlined the secure storage of medications was not provided by the end of survey.”

“PR-PRIVACY & CONFIDENTIALITY-RECORDS CFR(s): 494.70(a)(4) The patient has the right to- (4) Privacy and confidentiality in personal medical records; This Standard is not met as evidenced by: 35356 Based on observation, interview and record review, the facility failed to conceal personal medical information from the line of sight of patients and visitors of the facility for 2 (#2 and 12) of 12 sampled patients. This deficient practice affected all the patients utilizing the facility for dialysis treatment. Findings include: During an observation on 2/24/25 at 3:00 p.m., a binder with patient #2’s name and dialysis treatment records was observed sitting on top of the nurses’ station facing the entryway hallway. A patient in a wheelchair was sitting next to the nurses’ station. An environmental services staff member was observed cleaning the hallway next to the nurses’ station, in line of sight of the patient’s medical information. During an observation and interview on 2/24/25 at 4:00 p.m., the binder with patient #2’s medical information was still sitting on top of the nurses’ station facing the entryway hallway. Staff member L stated the binder was for patient #2 when he returns to the skilled nursing facility, so they know what he received at dialysis treatment that day. During an observation on 2/26/25 at 2:20 p.m., a binder with patient #2’s name and dialysis treatment records was observed sitting on top of the nurses’ station facing the entryway hallway. There was a newspaper and magazines sitting next to the patient’s binder for patients and visitors to read. During an observation on 2/26/25 at 4:00 p.m., a purple binder with patient #12’s name on the front and dialysis treatment records was observed sitting on the top of the nurses’ station facing the entryway hallway. During an interview on 2/26/25 at 2:00 p.m., staff member A stated patient healthcare information should be protected as much as possible for unauthorized access by other patients and visitors. Review of the facility’s policy and procedure titled, Dialysis Unit: Patient Rights, showed: “ ...This facility believes that every patient has the right to: ...Expect confidentiality of his/her records and to approve, or refuse, the release of medical information to any individual outside the facility. In certain cases, the law requires the release of records or information. In those cases, the consent by a patient will not be needed or requested. However, each patient retains the right to be notified when the records or information has been requested and will be released...””

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 44769 Based on interview and record review, the facility failed to sustain the prescribed dose of dialysis for 1 (# 3) of 4 sampled patients. This deficient practice resulted in inadequate dialysis. Findings include: A review of patient #3’s “Hemodialysis treatment information” sheet dated 2/25/25, showed a Blood Flow Rate (BFR) order for 400. Time stamps of 5:16 a.m., 5:45 a.m., 6:15 a.m., 6:45 a.m., 7:15 a.m., and 7:45 a.m., showed a BFR of 315, resulting in two hours and 34 minutes of inadequate dialyzing. During an interview on 2/26/25 at 2:58 p.m., staff member A stated that was an error for running the correct BFR order for patient #3 on 2/25/25.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 35356 Based on observation, interview and record review, the facility failed to ensure patient medical records accurately reflected that the physician ordered dialysis treatment was the same as the dialysate bath provided to the patient during dialysis for 1 (#10) of 12 sampled patients. This deficient practice had the potential to cause patients to receive the wrong dialysate and may result in inadequacy of the treatment provided. Findings include: During an observation on 10/24/25 at 4:26 p.m., a clear plastic jug with a red spout, had a label which showed, “[patient #10] K2”. The sign above the station where the jugs were stored showed: “K2/CA++ 2.5” (“K2 dialysate” in dialysis refers to a dialysate solution that contains a potassium concentration of 2 milliequivalents per liter (mEq/L) and “CA 2.5 dialysate” in dialysis refers to a dialysate solution containing a calcium concentration of 2.5 milliequivalents per liter (mEq/L)). During an interview on 2/26/25 at 2:00 p.m., staff member A stated the jug labeled for patient #10, for K2, contained K2/CA 2.5, dialysate bath which was the dialysate solution patient #10 was receiving for his dialysis treatments. Review of patient #10’s physician orders, dated 11/5/24, showed, “change dialysate from K3 to K2.” During an interview on 2/26/25 at 2:00 p.m., staff member A stated the facility’s bulk supply of dialysate for K3 contained CA 2.25, and the K2 contained CA 2.5. She stated if the patient’s order was for a different concentration of calcium than what was in the bulk supply, the patient’s dialysate jug would need to be individually “spiked” to achieve a different calcium concentration. She stated patient #10’s dialysate jug was not “spiked” with additional calcium. Review of patient #10’s physician orders, dated 2/26/25, showed, “Bath: 2K/CA 2.25.” This order was different than what the patient was receiving. During an interview on 2/26/25 at 3:30 p.m., staff member A stated patient #10 was receiving the dialysate bath of K2/CA 2.5. She stated he was not receiving a dialysate bath of K2/CA 2.25, as on his orders. She said when the patient’s order changed from the K3/(CA 2.25) to the K2/(CA 2.5), whoever entered the order into the patient’s chart, may have entered the wrong order for the CA. She stated the patient should be receiving K2/CA 2.5. She stated the expectation was the treatment orders for the prescribed dialysate bath would reflect what the patient was receiving.”