Davita Hawley Lane Dialysis

“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: 44675 Based on observation, interview and review of facility policy, the facility failed to ensure the medication preparation remained clean and sanitary. The findings included: Observation on 1/22/24 at 11:00 AM identified several spots of sticky residue/tape debris throughout the edge of the clean medication preparation counter. There was a used face shield with a staff members name on it on the ledge of the clean medication preparation counter. Interview with the Clinical Coordinator and Clinical Services Specialist on 1/22/24 at 2:00 PM identified some staff place the medication labels of the edge of the counter when preparing medications. Subsequent to surveyor inquiry, she identified she will purchase an adhesive remover and clean the residue off the counters. Review of the medication policy directed an aseptic environment and aseptic technique is used when preparing medications. Review of the infection control for dialysis facilities policy directed clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled.”

“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: 44675 Based on observations, review of clinical records, interview, and policy review for one (1) of three (3) hemodialysis patients reviewed for hand hygiene (Patient #6), the facility failed to encourage hand hygiene post treatment per facility policy. The findings include the following: Patient #6 was admitted to the clinic with diagnoses that included End Stage Renal Disease. Review of the physician’s orders directed hemodialysis three times weekly for 3 hours and 30 minutes with a right upper arm arteriovenous fistula (AVF). Observation conducted on 1/17/24 at 11:56 AM identified Patient #6 at station #20 holding his/her access site post treatment with gloved hands. Patient #6’s gloves were removed and Staff Person #2 did not offer hand hygiene to Patient #6. At 12:10 PM, Patient #6 left the station, walked to the scale to weigh him/herself and failed to perform hand hygiene. Review of Patient #6’s treatment flowsheet dated 1/17/24 identified Patient #6’s treatment was terminated at 10:27 AM. It identified pressure was held to the access for greater than ten minutes. Review of the infection control policy directed patients to be encouraged to perform hand hygiene after treatment before leaving the treatment area.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 44675 Based on a review of clinical records, interview, and policy review for one (1) of three (3) hemodialysis patients reviewed for hepatitis vaccinations (Patient #3), the facility failed to ensure a patient susceptible to hepatitis B began vaccination series timely in accordance with facility policy. The findings include the following: Patient #3 was admitted to the clinic on 4/5/23 with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three times weekly for 3 hours with a left chest central venous catheter (CVC). Review of Patient #3’s hepatitis B antibodies dated 4/5/23 identified Patient #3’s antibodies were less than three (3) (antibodies less than 10 indicate that the patient is susceptible to hepatitis B). Review of Patient #1’s hepatitis vaccinations identified Patient #3 began the Energix series on 8/28/23 (approximately four and a half months after Patient #3 was identified as susceptible). Interview with the Clinical Coordinator on 1/18/24 at 12:30 PM identified Patient #3 started hemodialysis in another facility and transferred to the current facility in May 2023. She identified when reviewing his/her chart, she identified Patient #3 was not vaccinated against hepatitis B and started the series (approximately three months after Patient #3 transferred to the current clinic). She further identified the Energix series should have started in May when he/she transferred to the clinic. Review of the hepatitis B surveillance, vaccination, infection control measures and isolation guidance policy directed for all patients, hepatitis B serologic testing is drawn immediately upon admission to the facility and results should be known within seven days of admission. It identified for antibodies less than ten (10), the patient is susceptible and to offer the vaccination series. It further directed that results will be reviewed promptly to verify that patients are managed appropriately based on their testing results.”

“IC-HBV-TEST PTS/STAFF POST LAST DOSE CFR(s): 494.30(a)(1)(i) Hepatitis B Screening: Patients and Staff Test all vaccines [patients and staff] for anti-HBs 1-2 months after last primary vaccine dose. -- If anti-HBs is <10 mIU/mL, consider patient or staff member susceptible, revaccinate with an additional three doses, and retest for anti-HBs. -- If anti-HBs are =10 mIU/mL, consider immune, and retest patients annually. -- Give booster dose of vaccine to patients if anti-HBs declines to <10 mIU/mL and continue to retest patients annually. This Standard is not met as evidenced by: 44675 Based on a review of clinical records, interview, and policy review for one (1) of three (3) hemodialysis patients reviewed for hepatitis vaccinations, (Patient #1), the facility failed to ensure the patient’s hepatitis B antibodies were drawn post vaccination and a second series offered in accordance with facility policy. The findings include the following: Patient #1 was admitted to the clinic on 11/21/22 with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three times weekly for 3 hours with an arteriovenous fistula (AVF). Review of Patient #1’s hepatitis B antibodies dated 11/21/22 identified Patient #1’s antibodies were less than three (3) (indicating that the resident was susceptible to the hepatitis B virus). Review of Patient #1’s hepatitis vaccinations identified Patient #1 refused Energix (hepatitis B vaccination) three times in December of 2023. Patient #1 began his/her first Energix series (total of four doses over approximately six months) on 1/20/23. The last dose of Energix was administered on 7/19/23. Review of Patient #1’s hepatitis B antibodies dated 11/20/23 identified Patient #1’s antibodies were less than three (3) (more than four months after the series was completed). Review of Patient #1’s hepatitis B antibodies dated 1/8/24 identified Patient #1’s antibodies were less than three (3) (susceptible to hepatitis B). Interview with the Clinical Coordinator on 1/18/24 at 12:10 PM identified Resident #1’s hepatitis B antibodies were drawn late after completion of the first series but was not aware as to why. She identified she will discuss with Patient #1 further hepatitis vaccinations due to him/her not having immunity from hepatitis B after the yearly antibody test in January 2024 remained less than three (3). Review of the hepatitis B surveillance, vaccination, infection control measures and isolation guidance policy directed for an antibody less than ten (10) and core negative, the patient is susceptible to hepatitis B and to offer the vaccination series. It further directed to test all vaccinated patients for hepatitis B antibodies one (1) to two (2) months after the last full dose of the full vaccine series (adequate response is defined as greater than or equal to 10). It identified for antibodies less than ten (10), the patient is susceptible, and to revaccinate with an additional full series. It further directed that results will be reviewed promptly to verify that patients are managed appropriately based on their testing results.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 44675 Based on observations, review of clinical records, interview, and policy review for 1 of 3 hemodialysis patients observed for treatment initiation (Patient #7), the facility failed to ensure the integrity of products remained clean during pre-treatment catheter access care per facility policy. The findings include the following: Patient #7 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three times weekly with a central venous catheter (a catheter that leads into the heart for hemodialysis administration). Observation conducted on 1/22/24 at 10:56 AM identified Staff Person #1 was performing catheter care for Patient #7. Observation of the chairside table identified several pieces of pre ripped tape stuck onto the bedside table without a barrier between the tape and the table. Staff Person #1 used the pre ripped tape for Patient #7’s catheter. Interview with the Clinical Services Specialist on 1/22/24 at 2:00 PM identified tape and can be pre ripped but there must be a barrier between the chairside table and the pre ripped tape. Review of the central venous catheter with clearguard HD antimicrobial end caps procedure directed to use dialysis precautions and aseptic technique throughout the procedure. It further directed to set up a clean field with all appropriate supplies on a clean, moisture proof barrier.”

“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: 32738 Based on findings during a tour on 01/17/24, the surveyors, while accompanied by the Clinical Coordinator, observed that the facility failed to maintain a safe, functional, and comfortable treatment environment. The findings include the following: 1.On 01/17/24 at 9:00 AM, the surveyors, while accompanied by the Clinical Coordinator observed two (2) of the Bi-carb storage shelves were rusted, not maintaining a clean and sanitary environment. 2. On 01/17/24 at 10:00 AM, the surveyors, while accompanied by the Clinical Coordinator observed the water room was unkept, with staining and splatter residue on the floor and walls, not maintaining a clean and sanitary environment.”

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 44675 Based on a review of clinical records, interview, and policy review for one (1) of three (3) hemodialysis patients reviewed for hemoglobin (Patient #2), the facility failed to ensure the patient’s hemoglobin was drawn weekly per physician’s direction. The findings include the following: Patient #2 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three times weekly for 3 hours and 30 minutes with a right chest central venous catheter (CVC). Review of Patient #’2 hemoglobin (responsible for delivering oxygen to the tissues of the body) labs identified the following: 1. On 11/15/23 Patient #1’s hemoglobin was 8.0 2. On 11/24/23 Patient #1’s hemoglobin was 6.6 3. On 11/27/23 Patient #1’s hemoglobin was 6.3 4. On 12/1/23 Patient #1’s hemoglobin was 7.5 5. On 12/15/23 Patient #1’s hemoglobin was 8.3 A nursing note dated 11/27/23 identified Patient #2’s hemoglobin was 6.6 and per the Nurse Practitioner, orders were received to increase Mircera to 100 mcg every two weeks, draw a stat hemoglobin and hemocue (measures hemoglobin in under one minute) that day and send Patient #2 to the emergency department post treatment. Review of NP #1’s note dated 11/29/23 identified Patient #2 went to the emergency department following the last treatment but did not receive a blood transfusion due to the hemoglobin being greater than seven. It further identified that the hemoglobin would be checked weekly. Review of the care plan dated 12/6/23 identified Patient #2 had a care plan for anemia with interventions that included Mircera increase, stool cards and weekly hemoglobin. Review of Patient #2’s hemoglobin’s after 11/27/23 identified the hemoglobin’s were drawn every two (2) weeks not weekly. Interview and record review with the Clinical Coordinator and Dietician on 1/19/24 at 12:30 PM identified the Mircera protocol draws hemoglobin every two weeks. She identified if a physician wants to monitor the hemoglobin weekly, a physician’s order would have to be put in for weekly hemoglobin’s. The Dietician identified the protocol overrides the physician’s orders and changes the labs back to the protocol. The Dietician further identified a one-time order would have to be entered for each week that the hemoglobin needs to be drawn. The Clinical Coordinator identified she was not aware that the protocol overrode the physician orders. She identified Review of Patient #’2 lab orders identified a lab order was put in on 11/29/23 for hemoglobin once a week and ended on 12/4/23. A lab order was then started on 12/5/23 for hemoglobin two times a month, which she identified was created by the protocol.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 32738 Based on observation, interview and review of facility policy, the facility failed to ensure the emergency evacuation carts (total of two) were locked and secured in accordance with facility policy. The finding included: During tour of the facility on 1/17/24 at 9:30 AM identified emergency box #1 and #2 were unsecured and unlocked. Observation of the facility on 1/18/24 at 10:00 AM identified emergency box #1 and #2 were unsecured and unlocked. Interview with the Clinical Services Specialist on 1/18/23 at 10:00 AM identified the emergency evacuation boxes should be locked. Review of the facility emergency management plan directed that the evacuation kit should be sealed with a breakaway lock and is only to be opened in the event of an emergency situation, monthly review, and/or the replacement of an outdated item.”