Center for Dialysis Care, Shaker

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 29732 Based on observation, interview and policy review, the facility failed to ensure dialysis access sites remained uncovered during treatment, failed to ensure patients were educated about keeping access sites visible and failed to document monitoring of access sites every 30 minutes. This affected four (Patients #3, #4, #5 and #6) patients. This could potentially affect all patients at this facility. The census was 151. 1. During an observation on 12/09/24 at 7:40 AM to 8:45 AM, Patient #3 had the access site covered by a blanket. Review of the medical record for Patient #3 and treatment sheet dated 12/09/24 revealed from 6:52 AM to 7:52 AM there was no documentation the access site had been monitored. At 8:22 AM the access site was documented as visible. 2. During an observation on 12/09/24 from 7:40 AM to 8:45 AM, Patient #4 had the access site covered by a blanket. Review of the medical record for Patient #4 and treatment sheet dated 12/09/24 revealed from 7:05 AM to 8:36 AM there was no documentation the access site had been monitored. 3. During an observation on 12/09/24 at 8:30 AM, Staff J lifted the blanket covering Patient #5’s access site to check it, then replaced the blanket over the access site. Review of the medical record for Patient #5 and treatment sheet dated 12/09/24 revealed at 7:51 AM and 8:21 AM Staff J documented the access was covered by blanket but was checked by a technician. There was no documentation Patient #5 was educated on the risks of covering the access site or that an RN was notified. During an interview on 12/09/24 at 8:32 AM, Staff J confirmed the site was covered and stated the patient was asleep. 4. Review of the medical record for Patient #6 and treatment sheet dated 10/02/24 revealed from 6:07 AM to 7:30 AM, there was no documentation the access site was monitored. At 7:30 AM, the dialysis machine alarmed and the Patient Care Technician (PCT) noticed blood on the floor. A needed had dislodged from Patient #6’s access site. The treatment ended at 7:35 AM. Patient #6 was stable, and asymptomatic with blood pressure 131/80 and heart rate 92. The blood was not returned to Patient #6 due to air in the line. During an interview on 12/10/24 at 9:18 AM, Staff I confirmed there was no documentation Patient #6’s access site was monitored for one and a half hours prior to the needle dislodgement and confirmed the PCT was not re-educated on monitoring and documenting every 30 minutes. Review of the facility’s policy titled “Routine Intradialytic Monitoring”, effective 07/09/24, revealed the access site is uncovered and secure. When monitoring a patient that refuses to uncover their access the staff must educate the patient on the risks of a covered access at least once during the dialysis treatment and document the education and notify the registered nurse (RN). At least every 30 minutes during routine monitoring, uncover the access and check the safety of the site. Document the patient’s refusal to uncover the access at least every 30 minutes.”

“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: 29732 Based on record review, interview and policy review the facility failed to ensure the patient care technician (PCT) notified the registered nurse (RN) of consistent high blood pressures and failed to ensure the PCT notified the RN if the patient was one kilogram over or under the goal weight after dialysis treatment. This affected six (Patients #1, #4, #7, #8, #9 and #10) patients. Findings include: 1. Review of the medical record for Patient #7 and treatment sheet dated 10/05/24 revealed at 11:51 AM the blood pressure (BP) was 180/115. At 12:20 PM the BP was 182/115. At 1:19 PM the BP was 183/116. At 1:51 PM the BP was 185/116. There was no documentation the RN had been notified to assess the patient and medicate the patient. Review of the treatment sheet dated 10/10/24 revealed at 10:50 AM the BP was 186/120. At 11:19 AM the BP was 190/119. At 11:49 AM the BP was 193/124. At 12:19 PM the BP was 197/125. At 12:50 PM the BP was 200/125. At 1:21 PM the BP was 195/123. At 1:51 PM the BP was 198/126. There was no documentation the RN had been notified to assess the patient and medicate the patient. 2. Review of the medical record for Patient #8 and treatment sheet dated 10/02/24 revealed at 1:05 PM the BP was 198/97. At 1:18 PM the BP was 176/146. At 1:19 PM the BP was 183/109. At 1:46 PM the BP was 185/89. At 2:20 PM Patient #8 left with a BP 200/92. There was no documentation the RN had been notified to assess the patient and medicate the patient or that the patient left the facility with a BP of 200/92. 3. Review of the medical record for Patient #9 and treatment sheet dated 10/09/24 revealed at 6:30 AM, before treatment started, the BP was 188/105. It was retaken at 6:33 AM for a BP of 183/106. The RN was not notified. At 7:17 AM the BP was 183/103. At 7:46 AM the BP was 191/102. At 8:15 AM the BP was 180/103. At 9:47 AM the BP was 194/103 and continued this high until treatment ended at 10:53 with BP 187/100. There was no documentation the RN had been notified to assess the patient and medicate the patient or that the patient left the facility with a BP of 187/100. Review of the medical record for Patient #9 and treatment sheet dated 10/14/24 revealed at 8:09 AM the BP was 184/81. At 8:38 AM the BP was 187/95. At 9;08 AM the BP was 192/98. At 10:08 the BP was 195/106. At 10:38 AM the BP was 198/103. At 10:47 AM Patient #9 left with a BP 190/101. There was no documentation the RN had been notified to assess the patient and medicate the patient or that the patient left the facility with a BP of 190/101. 4. Review of the medical record for Patient #10 and treatment sheet dated 10/02/24 revealed at 11:38 AM the BP was 183/79. At 12:09 PM the BP was 201/86. At 12:38 PM the BP was 188/84. At 1:09 PM the BP was 190/84. At 1:39 PM the BP was 200/86. At the end of the treatment at 2:05 PM the BP was 202/93. There was no documentation the RN had been notified to assess the patient and medicate the patient or that the patient left the facility with a BP of 202/93. Review of the medical record for Patient #10 and treatment sheet dated 10/09/24 revealed at start of the treatment at 10:47 AM the BP was 185/91. At 11:16 AM the BP was 197/93. At 11:47 AM the BP was 208/101. At 12:47 PM the BP was 228/111. At 12:49 PM the BP was 219/107. At 1:18 PM the BP was 224/106. At the end of the treatment at 1:50 PM the BP was 220/110. There was no documentation the RN had been notified to assess the patient and medicate the patient or that the patient left the facility with a BP of 220/110. During an interview on 12/10/24 at 11:52 AM the Facility Manager confirmed these findings. Review of the agency policy titled “Patient Post Assessment and Check-Out”, effective 03/01/14 revealed after the treatment obtain the patient’s post-treatment weight. The PCT must notify the RN if the patient is 1 kilogram (kg) over or under the goal weight after the treatment. 5. Review of the medical record for Patient #1 and treatment sheet dated 10/23/24 revealed Patient #1 left 1.5 kg over their dry weight. There was no documentation the RN had been notified. 9. Review of the medical record for Patient #4 and treatment sheet dated 12/09/24 revealed Patient #4 left eight kg over the dry weight and 1.3 kg over the target weight. There was no documentation the RN had been notified. 10. Review of the medical record for Patient #7 and treatment sheet dated 10/10/24 revealed Patient #7 left 1.8 kg less than their dry weight. There was no documentation the RN had been notified. During an interview on 12/11/24 at 4:11 PM, Staff A and Staff I were made aware of these findings. Review of the facility policy titled “Severe Hypertension”, effective 03/18/21, revealed the PCT will notify the registered nurse (RN) of severe hypertension regardless of symptoms. The PCT will notify the RN when there are two consecutive instances of a systolic BP greater than 180 or two consecutive instances of a diastolic BP greater than 100. RN may give 0.1 mg Clonidine by mouth if ordered for persistent systolic pressure greater than 200 or diastolic pressure greater than 110. Notify physician after administration.”

“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: 29732 Based on observation, interview and policy review, the facility failed to ensure all bicarbonate cartridges were dated, timed, and initialed at the time it was placed on the machine. This could potentially affect all patients at this facility. The census was 151. 1. During an observation on 12/09/24 at 7:55 AM, the bicarbonate canisters were not labeled in stations 36, 37, 38 and 39. During an interview on 12/09/24 at 7:56 AM, Staff F confirmed the bicarbonate canisters were not labeled. 2. During an observation on 12/09/24 at 7:58 AM, the bicarbonate canisters were not labeled in stations 17, 18 and 19. During an interview on 12/09/24 at 7:59 AM, Staff G confirmed the bicarbonate canisters were not labeled. Review of facility’s policy titled “Solcart Cartridge - BBraun”, effective 12/09/15, revealed each bicarbonate cartridge must be dated, timed, and initialed at the time it is placed on the machine.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 29732 Based on observation, interview and policy review, the facility failed to ensure staff wore gloves and performed hand hygiene when touching patients or equipment; failed to ensure staff wore protective eyewear (goggles or face shield) whenever there is a potential for contacting blood, dialysate or other potentially infectious substances; and failed to clean and disinfect environmental surfaces and portable equipment between patients to prevent cross contamination. This had the potential to affect all patients at the facility. See V113, 115 and 116.”

“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: 29732 Based on observation, interview and policy review, the facility failed to ensure staff wore gloves and performed hand hygiene when touching patients or equipment. This had the potential to affect all patients and staff. The census was 152. 1. During an observation on 06/12/24 at 5:48 AM, Staff D put a patient on the dialysis machine at station 17. Without removing gloves or performing hand hygiene, Staff D used the computer. 2. During an observation on 06/12/24 at 6:04 AM, Staff F was working on the dialysis machine at station 6 without wearing gloves. On 06/12/24 at 8:25 AM, the Director of Clinical Operations was made aware of this finding. 3. During an observation on 06/17/24 at 10:37 AM Staff F assessed the patient in station 37, then removed gloves. Without performing hand hygiene, Staff F proceeded to use the computer. On 06/17/24 at 1:06 PM, the Director of Clinical Operations was made aware of these findings. Review of the facility policy titled “Personal Protective Equipment”, effective 12/13/2013, revealed wear gloves whenever there is a potential for contacting blood, dialysate, body fluids, other potentially infectious substances and when handling items or surfaces soiled with blood or body fluids. Change gloves when going from a “dirty” area to a “clean” area. Review of the facility policy titled “Hand Hygiene”, effective 05/04/2018, revealed staff must perform hand hygiene immediately after removing gloves.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 29732 Based on observation, interview and policy review, the facility failed to ensure staff wore protective eyewear (goggles or face shield) whenever there is a potential for contacting blood, dialysate or other potentially infectious substances. This could potentially affect all patients and staff. The census was 152. 1. During an observation on 06/12/24 at 5:46 AM, Staff C was putting in needles in the patient in station 26 without a face shield or goggles on. On 06/12/24 at 8:25 AM, the Director of Operations was made aware of these findings. 2. During an observation on 06/17/24 at 9:42 AM, Staff C was observed to put needles in the patient in station 29 without goggles or face shield. During an interview on 06/17/24 at 9:43 AM, the Facility Manager confirmed this finding. Review of the facility policy titled “Personal Protective Equipment”, effective 12/13/2013, revealed protective eyewear is defined as goggles or a face shield that provides shielding from top, bottom, and sides as well as front of the eyes. Prescription eye wear (glasses alone) is not considered protective eyewear. Wear protective eyewear whenever splashes, sprays, or droplets may come in contact with the eyes.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 29732 Based on observation, interview and policy review, the facility failed to clean and disinfect environmental surfaces and portable equipment between patients to prevent cross contamination. This could potentially affect all patients and staff. The census was 152. 1. During an observation on 06/12/24 at 6:08 AM, Staff F assessed the patient’s breath sounds in station 6 and did not clean the stethoscope afterwards. 2. During an observation on 06/12/24 at 6:34 AM, Staff H assessed the patient’s breath sounds in station 32 then placed the stethoscope back on the clean desk without cleaning it. During an interview on 06/12/24 at 6:36 AM, Staff H confirmed this finding. 3. During an observation on 06/17/24 at 9:47 AM, Staff C cleaned the dialysis chair without reclining it or opening the two sides of the chair. During an interview on 06/17/24 at 9:48 AM, the Facility Manager (FM) confirmed this finding. 4. During an observation on 06/17/24 at 9:55 AM, Staff Q used the thermometer on patient in station 36 then put it back in the clean area without disinfecting it. At 10:27 AM Staff Q used the same thermometer on patient in station 37 and replaced it in the clean area without disinfecting it. 5. During an observation on 06/17/24 at 10:03 AM, Staff F used a stethoscope on patient in station 36. Without disinfecting it, Staff F used the same stethoscope on the patient in station 45 at 10:17 AM. Again, without disinfecting the stethoscope, Staff F used it at 10:36 AM on the patient in station 37. 6. During an observation on 06/17/24 at 10:12 AM, Staff S used the thermometer on patient in station 45 then placed it in the clean area without disinfecting it. 7. During an observation on 06/17/24 at 10:14 AM, Staff L used the Hoyer lift on the patient in station 17, then returned it and plugged it in without disinfecting it. During an interview on 06/17/24 at 10:15 AM, the Facility Manager confirmed this finding. 8. During an observation on 06/17/24 at 10:55 AM, Staff T cleaned station 5, but did not clean the counter where the patient’s belongings had been. On 06/17/24 at 10:57 AM, Staff J was made aware of this finding. Review of the facility’s policy titled “Cleaning and Disinfection of Exterior Surfaces and Moveable Equipment”, effective 12/30/2013, revealed cleaning and disinfection of environmental surfaces, (including patient chair, dialysis equipment and adjacent tables) as well as any portable equipment (patient lift device, thermometers and stethoscopes) must be performed between patient treatments to prevent cross contamination. The procedure for cleaning the chair includes reclining the chair, wiping the space between each arm of the chair, and wiping the chase/shelf behind the chair. Review of the facility policy titled: Handling, Cleaning and Disinfection of Supplies”, effective 10/01/2013, revealed items taken into the dialysis station should be disposed of, dedicated for use only on a single patient or cleaned and disinfected before being taken to a common clean area or used on another patient.”

“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: 29732 Based on observation, policy review and staff interview, the facility failed to ensure staff wore gloves when touching patients’ machines on two of three days of the survey. This could affect all patients receiving services from the facility. The census was 167. Findings include: Review of the facility policy titled, “Personal Protective Equipment,” effective 12/13/13, revealed staff were to wear gloves whenever there is a potential for contacting blood, dialysate, body fluids, mucous membranes, non-intact skin, other potentially Infectious substances and when handling Items or surfaces soiled with blood or body fluids. Change gloves when soiled, when going from a “dirty” task or area to a “clean” task or area, when moving from a contaminated body site to a clean body site; after touching one patient or their machine and before arriving to care for another patient or touch another patient’s machine, each time access site care is performed. 1. On 11/15/23 observations were made from 5:35 AM to 11:30 AM on Units 1, 2 and 3. At 6:57 AM Staff E was observed to touch the machine at station 6 with no gloves on. At 6:58 AM Staff E was observed to touch the machine at station 7 with no gloves on. At 7:00 AM Staff E was observed to touch the machine at station 9 with no gloves on. Interview on 11/15/23 at 7:05 AM with Staff E confirmed these findings. 2. On 11/16/23 at 11:16 AM Staff E was observed to have touch the machine in station 5 (dirty), touch the chair side computer (clean), then touch the machine and then the computer all with the same gloved hand. Interview on 11/16/23 at 11:19 AM with Staff U confirmed this finding. This deficiency represents non-compliance investigated under Substantial Allegation OH00147040.”

“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: 29732 Based on observation, policy review and staff interview, the facility failed to follow standard infection control precautions for cleaning and disinfection of contaminated surfaces, medical devices, and equipment on two of three days of the survey. This could affect all patients receiving services from the facility. The census was 167. Findings include: Review of the facility policy titled, “Cleaning and Disinfection of Exterior Surfaces and Movable Equipment,” effective 10/30/13, revealed cleaning and disinfection of environmental surfaces, (including patient chair, dialysis equipment, adjacent tables and work areas) as well as any portable equipment (oxygen concentrators and thermometers) must be performed between patient treatments to prevent cross contamination. The dialysis station will be completely vacated by the previous patient before cleaning, disinfection and set up is done for the next patient. Empty prime buckets, clean and disinfect with appropriate level of disinfectant. Do not rinse. Allow to air dry. Recline the chair and wipe the creases between the back of the chair and seat and space between each arm of the chair. Wipe the chase/shelf behind the chair. Use a low-level disinfectant cloth for each piece of equipment being removed from the station. Clean all surfaces. Immediately after cleaning, remove equipment from station and put back in the clean area. Allow equipment to air dry before using again. 1. On 11/15/23 observations were made from 5:35 AM to 11:30 AM on Units 1, 2 and 3. At 10:13 AM Staff K was observed to be setting up a machine in station 1 before the last patient left. At 10:20 AM Staff D was observed to not disinfect the oxygen concentrator before the next patient arrived. Interview on 11/15/23 at 10:22 AM with Staff D confirmed these findings. At 10:28 AM Staff L was observed to use a thermometer on the patient in station 15 and then return it to the clean area without disinfecting it first. Interview on 11/15/23 at 10:31 AM with Staff L confirmed this finding. At 10:40 AM Staff N was observed to clean the chair in station 39. Staff N did not recline the chair or open the sides of the chair. At 10:44 AM Staff N was observed to rinse the prime bucket from station 39 with tap water. Interview on 11/15/23 at 10:46 AM with Staff N confirmed these findings. At 10:48 AM Staff O was observed to clean station 45 but did not clean the prime bucket. Interview on 11/15/23 at 11:02 AM with Staff O confirmed this finding. Staff O stated, “I do them all at once”. Staff O was observed at 11:04 AM to take the prime buckets from stations 42, 43 and 45 and pour straight bleach into them then rinse them with tap water. At 11:23 AM Staff P was observed to clean the prime bucket with a disinfectant wipe and then rinse it with tap water. At 11:30 AM Staff P was observed to clean station 29 but did not recline or open the sides of the chair and did not clean the oxygen concentrator in the station. Interview on 11/15/23 at 11:35 AM with Staff P confirmed these findings. Interview on 11/15/23 at 1:40 PM with Staff T confirmed the prime buckets were not to be rinsed with tap water. 2. On 11/16/23 at 10:50 AM Staff N was observed to clean station 27. Staff N did not clean the prime bucket or the counter behind the chair. On 11/16/23 at 11:09 AM Staff V was observed cleaning station 24 but did not clean the counter behind the chair. On 11/16/23 at 11:07 AM Staff N was observed to rinse the prime bucket with tap water. This deficiency represents non-compliance investigated under Substantial Allegation OH00147040.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 29732 Based on observation, policy review, and staff interview, the facility failed to ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules. This could affect all patients receiving services from the facility. The census was 167. Findings include: Review of the facility policy titled, “Medication Preparation and Administration,” effective 01/22/14, revealed all medications must have the septum cleaned with an alcohol prep pad prior to inserting a needle into the medication vial. All medications must be labeled with date, time, and initials on multi-use vials when opened. On 11/15/23 at 10:30 AM a bottle of Heparin was observed opened but not labeled with the time and date opened. Interview on 11/15/23 at 10:34 AM with Staff C confirmed this finding. On 11/15/23 at 11:10 AM Staff I was observed to draw up medication from a vial without cleaning the top first with an alcohol prep pad. Interview on 11/15/23 at 11:13 AM with Staff I confirmed this finding and threw the vial away. On 11/16/23 at 10:11 AM a multi-use Zemplar vial was observed on unit 2 to be opened but not labeled with date, time and initials. Interview on 11/16/23 at 10:14 AM with Staff I confirmed this finding. On 11/16/23 at 11:11 AM a multi-use Zemplar vial was observed on unit 1 to be opened but not labeled with date, time and initials. Interview on 11/16/23 at 11:12 AM with Staff U confirmed this finding. This deficiency represents non-compliance investigated under Substantial Allegation OH00147040.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 29732 Based on observation, policy review and staff interview, the facility failed to ensure patients were in view of staff during hemodialysis treatment to ensure patient safety during observations on the treatment floor on one of three days of the survey. This could affect all patients receiving services at the facility. The census was 167. Findings include: Review of facility policy titled, “AV Access Cannulation (Non Constant Site Cannulation),” effective 11/13/12, revealed for patient safety all access sites will be securely taped, anchored and visible throughout the treatment. Always keep the access uncovered. On 11/15/23 at 6:10 AM Patient #1 was observed to his the access site covered by a blanket. At 6:27 AM Staff I was observed to answer a machine alarm, look at Patient #1, and then walk away leaving the access site covered. On 11/15/23 at 6:23 AM the patient in station 6 was observed to have their access site covered by a blanket. At 6:53 AM Staff C was observed to talk with the patient and give a medication. Staff C then left leaving the access site covered. At 6:57 AM Staff E was observed to be at the machine at station 6 and walked away leaving the site covered. On 11/15/23 at 6:24 AM the patient in station 7 was observed to have their access site covered by a blanket. At 6:58 AM Staff E was observed to be at the machine at station 7 and walk away leaving the site covered. Interview on 11/15/23 at 7:05 AM with Staff E confirmed these observations.”

“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: 29732 Based on observation, policy review and staff interview, the medical director failed to ensure all policies and procedures relative to patient care and safety are adhered to by all individuals who treat patients in the facility for seven of nine patients reviewed (Patient #3, #5, #6, #7, #9, #10, and #12). This could affect all patients receiving services from the facility. The census was 167. Findings include: Review of the facility’s policy titled “Safety Initiative - Time Out” effective 10/14/2015, revealed the patient care provider (PCP) will set the machine parameters per the physician’s hemodialysis orders. In order to ensure patient safety, the dialysis technician (DT) and registered nurse (RN), Licensed Practical Nurse (LPN), or approved and trained DT will double check the accuracy of the machine settings and all aspect of the patient’s care by performing a Time Out before treatment initiation. Treatment cannot be initiated until the Time Out process had been completed and documented. The PCP will verify the treatment parameters are set as ordered using the Time Out Checklist as a guide. Documentation in the electronic medical record (EMR) must be completed prior to the initiation of treatment. Review of the facility policy titled, “Routine Intradialytic Monitoring,” effective 03/17/23, revealed routine monitoring is documented in real time in the EMR and late documentation (over 60 minutes after data collection) must be noted. 1. On 11/16/23 Staff N was observed to start Patient #12’s dialysis treatment at 11:01 AM but did not call for the registered nurse (RN) sign on/Time Out. Staff C was observed to do the safety verification check after Patient #12 had started their dialysis treatment. Interview on 11/16/23 at 11:03 AM with Staff A, who was standing at the nurses’ station, confirmed Staff N started the dialysis treatment for Patient #12 before the RN did the safety check. Review of Patient #12’s medical record and treatment sheet dated 11/16/23 revealed Staff C documented the safety verification check at 10:59 AM when the treatment started at 11:01 AM. Interview on 11/16/23 at 3:35 PM with Staff A confirmed this was not correct. He stated Staff C did the safety check after the treatment had started. Staff A stated it must be when the staff documented it in the computer. Staff A confirmed Staff C documented the safety check before doing it. Further review of Patient #12’s medical record and treatment sheet dated 11/16/23 revealed the Staff C documented two intravenous (IV) medications and one medication by mouth was given at 2:43 PM when the dialysis treatment ended at 1:30 PM. It was also documented Patient #12’s blood pressure at 11:01 AM at start of treatment was 205/119, at 12:00 PM Patient #12 had a blood pressure of 155/125, and at 12:31 PM the blood pressure was 162/135. There was no documentation that Staff C addressed the or notified the physician. Review of the standing orders for Patient #12 revealed that Clonidine 0.1 milligrams (mg) was ordered as needed for high blood pressure. Review of the Initial Assessment and Standing Orders revealed Clonidine 0.1 mg as needed for high blood pressure >200 systolic or >110 diastolic (persistent). Notify Physician after administration. Interview on 11/20/23 at 7:35 AM with Staff C confirmed she did not document a late entry when she documented giving the medications to Patient #12 at 2:43 PM on 11/16/23 when the treatment ended 1:30 PM. Staff C stated, “I should have, my mistake”. Staff C also stated that Patient #12 regularly comes in with high blood pressures. She stated she usually gave the patient an hour to see if it came down. Staff C stated there was a Clonidine (used to lower blood pressure) standing order but Patient #12 always refused it. Staff C confirmed documentation did not show Clonidine was offered. 2. Review of Patient #3’s record revealed on 11/03/23 the registered nurse (RN) documented the verification safety check on Patient #3 at 4:02 PM. The patient’s treatment started 6:16 AM (10 hours and 14 minutes late) On 11/13/23 the RN documented the verification safety check on Patient #3 at 6:30 AM, after the treatment started at 6:18 AM (12 minutes late). 3. Review of Patient #5’s record revealed on 11/03/23 the RN documented the verification safety check on Patient #5 at 6:33 AM, after the treatment started at 5:46 AM (47 minutes late). On 11/08/23 the RN documented the verification safety check on Patient #5 at 5:42 AM after the treatment started at 5:30 AM (12 minutes late). On 11/10/23 the RN documented the verification safety check on Patient #5 at 5:51 AM after the treatment started at 5:35 AM (16 minutes late). On 11/13/23 the RN documented the verification safety check on Patient #5 at 5:39 AM after the treatment started at 5:30 AM (nine minutes late). 4. Review of Patient #6’s record revealed on 11/06/23 the RN documented the verification safety check on Patient #6 at 3:56 PM after the treatment started at 12:12 PM (three hours and 44 minutes late). 5. Review of Patient #7’s record revealed on 11/13/23 the RN documented the verification safety check on Patient #7 at 1:19 PM after the treatment started at 12:16 PM (one hour and three minutes late). 6. Review of Patient #9’s record revealed on 11/13/23 the RN documented the verification safety check on Patient #9 at 1:41 PM after the treatment started 11:41 AM (two hours late). 7. Review of Patient #10’s record revealed on 11/08/23 the RN documented the verification safety check on Patient #10 at 2:42 PM after the treatment started 2:25 PM (17 minutes late). Interview on 11/15/23 at 4:30 PM with Staff A confirmed the RN’s documented the verification safety checks after the treatments started which did not follow the facility’s policy. This deficiency represents non-compliance investigated under Substantial Allegation OH00147040.”