Fresenius Medical Care Blairs

“Procedures for Tracking of Staff and Patients CFR(s): §403.748(b)(2), §416.54(b)(1), §418.113(b)(6)(ii) and (v), §441.184(b)(2), §460.84(b)(2), §482.15(b)(2), §483.73(b)(2), §483.475(b)(2), §485.542(b)(2), §485.625(b)(2), §485.920(b)(1), §486.360(b)(1), §494.62(b)(1). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(2) or (1)] A system to track the location of on-duty staff and sheltered patients in the [facility’s] care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the [facility] must document the specific name and location of the receiving facility or other location. *[For PRTFs at §441.184(b), LTC at §483.73(b), ICF/IIDs at §483.475(b), PACE at §460.84(b):] Policies and procedures. (2) A system to track the location of on-duty staff and sheltered residents in the [PRTF’s, LTC, ICF/IID or PACE] care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the [PRTF’s, LTC, ICF/IID or PACE] must document the specific name and location of the receiving facility or other location. *[For Inpatient Hospice at §418.113(b)(6):] Policies and procedures. (ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s) and primary and alternate means of communication with external sources of assistance. (v) A system to track the location of hospice employees’ on-duty and sheltered patients in the hospice’s care during an emergency. If the on-duty employees or sheltered patients are relocated during the emergency, the hospice must document the specific name and location of the receiving facility or other location. *[For CMHCs at §485.920(b):] Policies and procedures. (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For OPOs at § 486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. *[For ESRD at § 494.62(b):] Policies and procedures. (2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients. This Standard is not met as evidenced by: 46466 Based on observations, interviews and facility document review, the facility staff failed to maintain updated patient and staff information for tracking purposes in the event of a facility emergency evacuation. The findings include: During the facility flash tour on 1/23/24 at 12:40 p.m., an inspection of the facility’s emergency evacuation blue cart was conducted. There was a binder located on top of the blue cart that contained the facility’s “Emergency and Disaster Staff Contact Information Sheet”. It read “Update as needed - Annually review for completeness - Copy as needed to list additional staff.” The list was dated 2/27/2020 and did not include all of the current staff. A review of the “Emergency Disaster Patient Contact List - Verified” inside the same binder was last printed on 10/1/2022. An interview was conducted with Staff Member #1 (SM1) on 1/24/24 at 4:00 p.m. SM1 stated that in the event of an evacuation from the building, staff would take the blue evacuation cart. A review of the facility’s policy “Guidelines for Emergency Preparedness”, published 7/3/23, stated in part: “...Communication Plan. The facility must develop a communication plan for all patients (in-center and home). This plan includes the following: - Create and maintain staff, patient and facility emergency information contact lists...Quarterly, the CM will review and update: - The Emergency and Disaster Staff Contact Information Sheet. - The Emergency and Disaster Patient Contact Information Sheet...”. The findings were discussed with Staff Members #1 and #7 at the exit conference on 1/24/24 at 4:45 p.m.”

“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: 46466 Based on observation and document review, facility staff failed to perform hand hygiene after removing disposable gloves and failed to change gloves at appropriate times. The findings are: During observation of care provided to patients by dialysis staff on 1/23/24 and 1/24/24, the following breaks in infection control were noted: On 1/23/24 at 1:10 p.m., Staff Member #8 (SM8) was observed at a patient station touching the dialysis machine while wearing gloves. The dialysis machine next to SM8 began to alarm. SM8 removed SM8’s gloves, did not perform hand hygiene, regloved and touched the next dialysis machine. On 1/24/24 at 11:30 a.m., Staff Member #9 (SM9) was observed providing exit site care for a central venous catheter. After removing the dressing on the site, SM9 removed gloves and failed to perform hand hygiene before donning clean gloves. SM9 then removed tape from the catheter limbs (this area had not been cleaned) and continued with exit site care (to a clean area) without changing gloves. https://www.cdc.gov/handhygiene/providers/guideline.html retrieved 1/26/24 reads in part: “Healthcare personnel should use an alcohol-based hand rub or wash with soap and water for the following clinical indications: Immediately before touching a patient Before performing an aseptic task (e.g., placing an indwelling device) or handling invasive medical devices Before moving from work on a soiled body site to a clean body site on the same patient After touching a patient or the patient’s immediate environment After contact with blood, body fluids, or contaminated surfaces Immediately after glove removal.” The findings were discussed with Staff Members #1 at 3:00 p.m. and with Staff Members #1 and #7 at the exit conference on 1/24/24 at 4:45 p.m.”

“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: 33906 Based on observations, interviews and document review, it was determined the facility staff failed to follow infection control guidelines by failing to clean all non-disposable items at the dialysis station after each treatment for two (2) of two (2) observations. The findings were: On 1/23/24 the surveyor observed clean up and set up of two dialysis stations. At 2:01 p.m., the surveyor observed Staff Member #11 (SM11) cleaning dialysis Station #2. The surveyor noted SM6 failed to clean laminated papers hanging from the iv pole when cleaning the station. The surveyor asked SM11 if they had cleaned the laminated papers. SM11 confirmed they had not and told the surveyor they had not been told they needed to clean anything hanging from the iv pole when cleaning the station. At 2:10 p.m., the surveyor observed Staff Member #6 (SM6) cleaning dialysis Station #1. The surveyor noted SM6 failed to clean the BP cuff and tubing when cleaning the station. SM6 placed the unclean blood pressure cuff in a holder on the side of the dialysis machine. The surveyor asked SM6 at what point in the process of cleaning the station is the blood pressure cuff cleaned. SM6 stated it would be cleaned prior to using the cuff on the next patient. The surveyor asked SM6 “Isn’t that placing a contaminated blood pressure cuff on a clean machine?” SM6 agreed that it was and stated they hadn’t though of that. Facility Policy “Cleaning and Disinfecting the Dialysis Station” published 9/5/23 read in part: “Use a cloth wetted with 1:1000 bleach solution or EPA -approved disinfectant to clean and disinfect the dialysis station (chair/bed, tables, machine, television, IV pole, B/P cuff, hand sanitizer dispenser and holder, chaise wall behind chair.)” The above findings were discussed with Staff Member #1 at 3:00 p.m. on 1/24/24 and with Staff Members #1 and #7 at the exit conference at 4:45 p.m.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 46466 Based on clinical record review, staff interview and facility document review, the facility staff failed to (A) ensure patients were monitored during their treatments within forty-five (45) minutes; (B) ensure the Registered Nurse (RN) assessed patients within an hour of dialysis treatment; and (C) document notification of abnormally high and/or low blood pressure readings to the Charge RN per facility policy. The findings include: A review of treatment records for the sampled patients revealed the following: Patient #1 (Pt. #1): Six (6) treatment records were reviewed from 12/14/23 to 1/20/24. (A) Four (4) of the six (6) treatment records documented systolic blood pressures lower than 100 mm/Hg. The records failed to provide evidence that the RN was notified when these vitals were measured and documented in flowsheets on 12/14/23, 1/9/24, 1/11/24 and 1/16/24. (B) On 12/14/23, Pt.#1’s treatment record evidenced treatment monitoring at 7:51 a.m. The next monitoring was not completed again until 8:40 a.m. (C) On 12/14/23, Pt .#1’s treatment began at 7:42 a.m., the RN evaluation was documented at 10:10 a.m. On 1/16/24, Pt. #1’s treatment began at 9:21 a.m., the RN evaluation was documented at 11:11 a.m. Patient #2 (Pt. #2): Six (6) treatment records were reviewed from 1/8/24 to 1/22/24. (A) Four (4) of the six (6) treatment records documented systolic blood pressures greater than 180 mm/Hg and diastolic blood pressures greater than 100 mm/Hg. The records failed to provide evidence that the RN was notified, when these vitals were measured and documented in flowsheets on 1/8/24, 1/12/24, 1/15/24 and 1/22/24. (B) On 1/12/24, Pt. #2’s treatment record evidenced treatment monitoring at 1:03 p.m. The next monitoring was not completed again until 2:01 p.m. Patient #3 (Pt. #3): Six (6) treatment records were reviewed from 1/4/24 to 1/16/24. (A) Two (2) of the six (6) treatment records documented systolic blood pressures greater than 180 mm/Hg. The records failed to provide evidence that the RN was notified, when these vitals were measured and documented in flowsheets on 1/4/24 and 1/9/24. (B) On 1/11/24, Pt. #3’s treatment record evidenced treatment monitoring at 12:00 p.m. The next monitoring was not completed again until 1:02 p.m. Patient #5 (Pt. #5): Six (6) treatment records were reviewed from 1/8/24 to 1/22/24. (C) On 1/10/24, there was no documented RN assessment completed within one (1) hour of Pt. #5’s start of treatment. Patient #6 (Pt. #6): Six (6) treatment records were reviewed from 1/5/24 to 1/22/24. (A) Two (2) of the six (6) treatment records documented systolic blood pressures less than or equal to 100 mm/Hg. The records failed to provide evidence that the RN was notified, when these vitals were measured and documented in flowsheets on 1/5/24, and 1/17/24. (B) On 1/22/24, Pt. #6’s treatment record evidenced treatment monitoring at 1:07 p.m. The next monitoring was not completed again until 2:10 p.m. Patient #7 (Pt. #7): Six (6) treatment records were reviewed from 1/5/24 to 1/19/24. (B) On 1/19/24, Pt. #7’s treatment record evidenced treatment monitoring at 10:02 a.m. The next monitoring was not completed again until 11:05 a.m. Patient #8 (Pt. #8): Six (6) treatment records were reviewed from 9/26/23 to 10/7/23. (B) On 9/30/23, Pt. #8’s treatment record evidenced treatment monitoring at 11:35 a.m. The next monitoring was not completed again until 12:33 p.m. A review of the facility’s policy “Nursing Supervision and Delegation”, published 11/6/23, stated in part: “...Policy: The registered nurse must evaluate each patient preferably within an hour or according to state requirements...”. A review of the facility’s policy “Patient Assessment and Monitoring”, published 5/1/23, stated in part: “...During treatment: - Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations...1. Blood Pressure: Report to the nurse: - Systolic blood pressures greater than 180 mm/Hg. - Diastolic blood pressure greater than 100 mm/Hg. - Blood Pressure less than or equal to 100 mm/Hg systolic...”. The findings were discussed with Staff Members #1 and #7 at the exit conference on 1/24/24 at 4:45 p.m.”

“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: 46466 Based on medical record and facility document review, the facility staff failed to follow physician’s orders for the prescribed dose of dialysis BFR (blood flow rate) and/or DFR (dialysate flow rate) for nine (9) of nine (9) in-center dialysis patients included in the sample. The findings included: Patient #1 (Pt. #1): The surveyor reviewed six (6) dialysis treatment records from 12/14/23 through 1/20/24. The treatment sheets evidenced an order for a BFR of 400 ml/min. On 12/14/23, the BFR was documented as 350. Pt. #1’s clinical record failed to contain evidence of documentation explaining why the BFR was not being administered as prescribed. Patient #2 (Pt. #2): The surveyor reviewed six (6) dialysis treatment records from 1/8/24 through 1/22/24. The treatment records evidenced an order for a BFR of 400 ml/min and a DFR of 500 ml/min. The treatment sheets evidenced the following: On 1/8/24, the DFR was documented as 800. On 1/10/24, the BFR was documented as 350. On 1/15/24, the DFR was documented as 800. On 1/17/24, the DFR was documented as 800. Pt. #2’s clinical record failed to contain evidence of documentation explaining why the BFR and/or DFR was not being administered as prescribed. Patient #3 (Pt. #3): The surveyor reviewed six (6) dialysis treatment records from 1/4/24 through 1/16/24. The treatment records evidenced an order for a BFR of 500 ml/min and a DFR of 800 ml/min. The treatment sheets evidenced the following: On 1/4/24, the BFR was 400 and the DFR was documented as 500. On 1/9/24, the BFR was 450 and the DFR was documented as 500. On 1/13/24, the BFR and DFR were not documented at all. Pt. #3’s clinical record failed to contain evidence of documentation explaining why the BFR and/or DFR was not being administered as prescribed. Patient #4 (Pt. #4): The surveyor reviewed six (6) dialysis treatment records from 1/4/24 to 1/20/24. The treatment records evidenced an order for a BFR of 500 ml/min and a DFR of 500 ml/min. The treatment sheets evidenced the following: On 1/20/24, the BFR was documented as 450 ml/min and the DFR was documented as 800 ml/min throughout the treatment. Pt. #4’s clinical record failed to contain evidence of documentation explaining why the BFR and DFR are not being administered as prescribed. Patient #5 (Pt. #5): The surveyor reviewed six (6) dialysis treatment records from 1/8/24 through 1/22/24. The treatment records evidenced an order for a DFR of 800 ml/min. The treatment sheets evidenced the following: On 1/19/24, the DFR was documented as 500. Pt. #5’s clinical record failed to contain evidence of documentation explaining why the DFR was not being administered as prescribed. Patient #6 (Pt. #6): The surveyor reviewed six (6) dialysis treatment records from 1/5/24 through 1/22/24. The treatment records evidenced an order for a BFR of 400 ml/min and a DFR of 500 ml/min. The treatment sheets evidenced the following: On 1/5/24, the BFR was 300 and the DFR was documented as 800. On 1/17/24, the BFR was documented as 300, 250 and 200. On 1/19/24, the BFR was documented as 300. On 1/22/24, the BFR was documented as 300. Pt. #6’s clinical record failed to contain evidence of documentation explaining why the BFR and/or DFR was not being administered as prescribed. Patient #7 (Pt.#7): The surveyor reviewed six (6) dialysis treatment records from 1/5/24 through 1/19/24. The treatment records evidenced an order for a DFR of 800 ml/min. The treatment sheets evidenced the following: On 1/5/24, the DFR was documented as 500. On 1/19/24, the DFR was documented as 500. Pt. #7’s clinical record failed to contain evidence of documentation explaining why the DFR was not being administered as prescribed. Patient #8 (Pt.#8): The surveyor reviewed six (6) dialysis treatment records from 9/26/23 to 10/7/23. The treatment records evidenced an order for a BFR of 400 ml/min and DFR of 500 ml/min. The treatment sheets evidenced the following: On 9/30/23, the DFR was documented as 800. On 10/3/23, the DFR was documented as 800. On 10/5/23, the BFR was documented as 350. On 10/7/23, the DFR was documented as 800. Pt. #8’s clinical record failed to contain evidence of documentation explaining why the BFR and DFR were not being administered as prescribed. Patient #9 (Pt. #9): The surveyor reviewed six (6) dialysis treatment records from 1/4/24 to 1/15/24. The treatment records evidenced an order for a BFR of 400 ml/min. The treatment sheets evidenced the following: On 1/12/24, the BFR was documented as 350. Pt. #9’s clinical record failed to contain evidence of documentation explaining why the BFR was not being administered as prescribed. On 1/24/24 at 3:30 p.m., Staff Member #1 (SM1) stated that on 1/13/24, the facility’s Electronic Medical Record System (EMR) “Chairside” was down. Staff had to document patient treatment monitoring on paper charting. SM1 provided the written documentation for Pt. #1. Pt. #1’s handwritten documentation did not include Pt. #1’s intradialytic BFR and DFR administered. A review of the facility’s policy “Patient Assessment and Monitoring”, published 5/1/23, stated in part: “...3. Machine Parameters and Extracorpeal Circuit - Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in the medical record if unable to meet prescribed blood flow. - Check dialysate flow rate setting is correct, and the prescribed flow is being delivered...4. Document any findings and interventions in the medical record...”. The findings were discussed with Staff Members #1 and #7 at the exit conference on 1/24/24 at 4:45 p.m.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 46466 Based on medical record review and facility document review, it was determined that facility staff failed to ensure the Plan of Care (POC) was signed by the patient. The findings included: Medical record review on 1/24/24, evidenced that one (1) of nine (9) medical records did not contain a signature of the patient. Patient #3 (Pt. #3)- POC (dated 5/30/23) failed to document Pt. #3’s signature or Pt. #’s refusal to sign. On 1/24/24, a signed copy of Pt. #3’s POC dated 5/30/23 was requested of Staff Member #1 (SM1), however, the signed POC was not provided to the surveyors prior to the exit conference. A review of the facility’s policy “Comprehensive Interdisciplinary Assessment and Plan of Care”, published 7/3/23, stated in part: “...Comprehensive Assessment Participation and Plan of Care Review...- The patient must sign the plan of care meant to acknowledge the information in the plan. If the patient chooses not to sign their plan of care, the reason for the refusal must be documented in the patient’s medical record...”. The findings were discussed with Staff Members #1 and #7 at the exit conference on 1/24/24 at 4:45 p.m.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 46466 Based on interviews, medical record review and facility document review, facility staff failed to report and document patient related safety events. The findings include: On 1/24/24 at 11:00 a.m., a review of Patient #6 (Pt. 6’s) medical record was conducted. The medical record documented on 1/8/24 at 2:00 p.m. “...Pt (patient) not alert to place or time. Pt began to have slurred speech while talking to dietician...Pt sent to (ER) per...FNP (Family Nurse Practitioner) via EMS...”. On 1/24/24 at 12:00 p.m., a review of the facility adverse event report for the last six (6) months failed to include Pt. 6’s adverse event in the report. On 1/24/24 at 12:15 p.m., an interview was conducted with Staff Member #1 (SM1) on the expectation of staff reporting an event, such as Pt. 6 experienced. SM1 stated that that Pt. 6’s incident should have been documented as an adverse event. SM1 stated that SM1 would have the nurse document it today. SM1 also verified that Pt. 6’s event was classified as a “safety event” per the facility’s policy. A review of the facility’s policy “Patient Safety Event Reporting and Documentation”, published 2/6/23, stated in part: “...Policy: When a Near Miss, Safety Event or Serious Safety Event occurs, staff are required to report, document, and review the event as noted in this policy. Staff are responsible for timely completion of these policy requirements...”. The findings were discussed with Staff Members #1 and #7 at the exit conference on 1/24/24 at 4:45 p.m.”