Fmc - Richmond

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 44230 Based on observation and interview, the facility failed to ensure the chlorine test strips (used to determine total chlorine levels during hemodialysis treatments) were not expired in 1 of 1 facility reviewed. Findings Include: A policy titled “Storage of Supplies” indicated, but was not limited to: “Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired, contaminated or damaged...” During an observation on 06/04/2024 at 2:22 PM in the Home Therapy department, RPC EZ Chek Sensitive Total Chlorine Test Strips were found to have an expiration date of 05/31/2024. During an interview on 06/04/2024 at 2:30 PM, RN 4 indicated that the Patient Care Technician completed audits ensuring that all expired supplies/medications were discarded and recently found out he/she had not been doing this. All supplies past their expiration date are not to be used and are to be discarded appropriately.”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 48658 Based on observation, record review, and interview, the facility failed to ensure privacy and confidentiality in all aspects of treatment for 1 of 1 ESRD (End Stage Renal Disease) facility reviewed. Findings include: A policy titled “HIPAA Notice of Privacy Practices” indicated, but was not limited to: “We are required by law to...Make sure your PHI (Protected Health Information) (sic) is kept private...” On 06/04/2024 at 2:17 PM a document was observed posted to the Home Nurse’s closed door, visible from the hallway, titled “Patient insurance scans for May.” The document revealed PHI including the first and last names of 10 clinic patients. During an interview on 06/04/2024 at 2:39 PM, RN 4 indicated the names listed and posted on the office door were patient names. She also indicated that the office door is usually open instead of closed so it’s not as visible to the hallway and that most people can’t see that small of print.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 48658 Based on record review and interview, the facility failed to ensure the Pneumococcal immunization history were documented for 1 of 1 new admission patient records reviewed (Patient #3). Findings include: A policy titled “Pneumococcal Vaccine for Adults” indicated, but was not limited to: “Review vaccination status of all new patients to the facility...Patients should be offered pneumococcal vaccination on an annual basis, at minimum...the vaccine declination must be signed by the patient for each refusal and documented in the patient’s medical record...” The clinical record for Patient #3 was reviewed on 06/05/2024. The record failed to include documentation of Pneumococcal immunization status and documentation of Pneumococcal immunization offered to patient by facility. During an interview on 06/05/2024 at 8:55 AM, the Clinic Manager indicated she was unable to find any documentation in the clinical record indicating that Patient #3 had previously received or had been offered the Pneumococcal immunization. The expectation is that the facility is to obtain & review the immunization history of the patient and maintain that documentation within the clinical record. If the patient had not received the Pneumococcal immunization prior to admission to the facility, the immunization would be offered to the patient upon admission and that documentation maintained in the clinical record.”

“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: 48658 Based on record review and interview, the facility failed to maintain the physician ordered DFR (Dialysate Flow Rate) and BFR (Blood Flow Rate) aiding in maintaining the Kt/v (adequacy of dialysis) in 11 of 12 In-center hemodialysis record reviews. (Patient #1, #3, #4 #5, #6, #7, #8, #9, #10, #11, #15). Findings Include: 1. A policy titled “Patient Monitoring and Safety Checks During Hemodialysis Treatment” indicated, but was not limited to: “Monitor and document Machine Checks every 30 minutes or more frequently as needed but not to exceed 45 minutes...Verify dialysate lines are attached and in correct position and DFR, BFR, and UFR is set and functioning per treating physician order...” 2. The treatment record for Patient #1 indicated a Physician ordered DFR of 800 and a BFR of 450. The treatment record dated 05/29/2024 indicated a DFR of 500 and a BFR of 400 without a documented reason of change in the physician ordered prescription. The treatment record dated 06/03/2024 indicated a DFR of 500 for the first 2 hours of treatment and a BFR of 350 & 400 throughout the treatment without a documented reason of change in the physician ordered prescription. 3. The treatment record for Patient #3 indicated a Physician ordered DFR of 800 and BFR of 400. The treatment record dated 05/22/2024 indicated a BFR of 350 after 30 minutes of treatment without a documented reason of change in the physician ordered prescription. The treatment record dated 05/24/2024 indicated a BFR of 300 for the first 33 minutes of treatment without a documented reason of change in the physician ordered prescription. The treatment record dated 05/29/2024 indicated a BFR of 375 after the first 25 minutes of treatment and lasting 36 minutes, without a documented reason of change in the physician ordered prescription. The treatment record dated 06/03/2024 indicated a DFR of 500 for the last 33 minutes of treatment without a documented reason of change in the physician ordered prescription. 4. The treatment record for Patient #4 indicated a Physician ordered DFR of 800 and BFR of 400. The treatment record dated 05/22/2024 indicated a DFR of 700 & 500 throughout treatment without a documented reason of change in the physician ordered prescription. The treatment record dated 05/29/2024 indicated a BFR of 375 the last hour of treatment without a documented reason of change in the physician ordered prescription. The treatment record dated 06/03/2024 indicated a BFR of 325 and 350 throughout treatment without a documented reason of change in the physician ordered prescription. 5. The treatment record for Patient #5 indicated a Physician ordered DFR of 800 and BFR of 400. The treatment record dated 05/31/2024 indicated a BFR of 350 after 49 minutes of treatment and for the remaining time of treatment, without a documented reason of change in the physician ordered prescription. 6. The treatment record for Patient #6 indicated a Physician ordered DFR of 800 and BFR of 400. The treatment record dated 05/30/2024 indicated a DFR of 600 and a BFR of 300 throughout the treatment, without a documented reason of change in the physician ordered prescription. 7. The treatment record for Patient #7 indicated a Physician ordered DFR Auto 2.0 and BFR 450. The treatment record dated 05/23/2024 a DFR of 700 and BFR of 400 for the last hour and 33 minutes of treatment without a documented reason of change in the physician ordered prescription. The treatment record dated 05/30/2024 indicated a DFR of 500 throughout the treatment, without a documented reason of change in the physician ordered prescription. The treatment record dated 05/30/2024 indicated a DFR of 600 and BFR of 400 throughout the treatment, without a documented reason of change in the physician ordered prescription. 8. The treatment record for Patient #9 indicated a Physician ordered DFR of 500. The treatment record dated 05/22/2024 indicated a DFR of 700 the first hour & 23 minutes of treatment without a documented reason of change in the physician ordered prescription. 9. The treatment record for Patient #10 indicated a Physician ordered DFR of 500. The treatment record dated 05/30/2024 indicated a DFR of 800 during treatment without a documented reason of change in the physician ordered prescription. The treatment record dated 06/01/2024 indicated a DFR of 700 & 800 during treatment without a documented reason of change in the physician ordered prescription. 10. The treatment record for Patient #11 indicated a Physician ordered BFR of 350. The treatment record dated 05/21/2024 indicated a BFR of 400 during treatment without a documented reason of change in the physician ordered prescription. The treatment record dated 06/04/2024 indicated a BFR of 400 during treatment without a documented reason of change in the physician ordered prescription. 11. The treatment record for Patient #15 indicated a Physician ordered DFR of 800 and BFR of 450. The treatment record dated 05/29/2024 indicated a DFR of 600 during treatment without a documented reason of change in the physician ordered prescription. The treatment record dated 05/31/2024 indicated a DFR of 600 during treatment without a documented reason of change in the physician ordered prescription. The treatment record dated 06/03/2024 indicated a DFR of 500 during treatment without a documented reason of change in the physician ordered prescription. The treatment record dated 06/03/2024 indicated a DFR of 500 during treatment and BFR of 350 the last 30 minutes of treatment without a documented reason of change in the physician ordered prescription. 44230 12. The treatment record for Patient #8 indicated a physician ordered DFR of 800. The treatment record dated 05/23/2024 indicated a DFR of 500 throughout treatment without a documented reason of change in the physician ordered prescription. 13. During an interview on 06/06/2024 at 9:45 AM, RN 6 indicated the facility expectation for staff is to document in the patient’s clinical record why DFR and /or BFR is changed to anything different than the rates ordered by the physician. 14. During an interview on 06/06/2024 at 4:25 PM, RN 1 indicated that it is the expectation of staff to contact the physician and document in the patient’s clinical record if changes are made to the DFR and/or BFR that is different than the physician’s order. She indicated that the floor staff change the rates sometimes in an effort to silence the dialysis machine alarm and that should not be happening.”

“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: 44230 Based on observation, record review, and interview, the facility failed to follow its policy ensuring that expired supplies were discarded for 1 of 1 Home Therapy Department Observations and that medications were properly secured and administered for 1 of 2 medication administrations observed. (Patient #16). Findings include: 1. A policy titled “Storage of Supplies” indicated, but was not limited to: “Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired, contaminated or damaged...” 2. A policy titled “Medication Preparation and Administration” indicated, but was not limited to: “All medications will be kept in a locked cabinet except when in use...” 3. A policy titled, “Special Considerations: Venofer” [Medication used to treat iron deficiency] What is venofer? indicated but was not limited to, “Venofer may be administered undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 ml of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session” ... “Venofer will be administered at a rate no faster than 100 mg ’ s over 2 minutes”. 4. During an observation on 06/04/2024 at 2:00-2:27 PM the following expired supplies and medications were found in the Home Therapy department: Exam room #1 & #2 hand sanitizer affixed to the wall indicated an expiration date of 01/2024. 1 bottle of blood leak test strips (used to detect a blood leak during hemodialysis) indicated an expiration date of 10/31/2023. 1 box of 50-count Ear-loop face masks indicated an expiration date of 03/31/2023. 1 box of 40 count Stay-safe caps (used to cap off peritoneal dialysis catheter to maintain sterility) indicated an expiration date of 05/31/2024. 1 bag of RPC EZ Chek Sensitive Total Chlorine test strips (used to test Total Chlorine levels during hemodialysis) indicated an expiration date of 05/31/2023. 79 Red/white top blood collection tubes indicated an expiration date of 05/31/2024 and 3 yellow top blood collection tubes indicated an expiration date of 08/31/2022. 5. During an observation on 06/04/2024 at 2:14 PM, the Home Therapy department medication cabinet was found to be unlocked/unsecured and unattended by the home therapy staff. The home therapy staff were observed to be in their office located across the hall from the unsecured/unlocked medications with their door slightly ajar, 1-2 inches, obstructing the view of the medications. The following medications were found in the unsecured cabinet: 1 opened bottle of Clonidine-Hydrochloride 0.1 mg (milligrams) tablets, 4 vials of Benadryl 50 mg/ml (milligrams per milliliters) (used to treat allergic reactions/itching), 1 vial of Heparin 30,000 units/30 ml (used to prevent blood clots in hemodialysis and fibrin formation in peritoneal dialysis), 2 vials of Venofer 50 mg/2.5 ml and 1 vial of Venofer 100 mg/5 ml (used to treat low iron levels). 6. During an observation on 06/07/2024 at 12:49 PM, RN 7 was observed drawing up 100 mg of Venofer and administering to Patient #16 via the venous medication port located on the hemodialysis blood lines. RN 7 administered the entire 100 mg dose of Venofer over 30 seconds. 7. During an interview on 06/04/2024 at 2:30 PM, RN 4 indicated that the secretary was in charge of ensuring that all expired supplies/medications were discarded and recently found out he/she had not been doing this. All supplies and medications past their expiration date are not to be used and are to be discarded appropriately. RN 4 further indicated that medications are not locked up during the day when staff are present and only secured prior to the staff leaving for the day.”