Fresenius Medical Care Decatur

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 30952 Based on review of the Alabama Department of Public Health for Rules for End Stage Renal Disease Treatment and Transplant Centers Chapter 420-5-5, medical record review, and staff interview, it was determined the facility failed to follow the Alabama State Licensure Rules for End Stage Renal Disease for reporting unusual occurrences to the State Survey Agency (SSA) including unscheduled transports to a hospital. This affected PI (Patient Identifier) # 1 and had the potential to affect the 33 patients served by the facility. Findings include: Rules of Alabama State Board of Health Alabama Department of Public Health Chapter 420-5-5 End Stage Renal Disease Treatment and Transplant Centers Amended December 18, 2007 page 7 420-5-5-.01 General (7) Unusual Occurrences Unusual occurrences which threaten the welfare, safety and health of patients, personnel or visitors shall be reported by the ESRD (End Stage Renal Disease) facility within 24 hours, either by telephone (and confirmed in writing), or by facsimile to the Alabama Department of Public Health, Division of Health Care Facilities, and other agencies/authorities as required. Examples of unusual occurrences include: misuse of medical devices or medications, defective devices, suspected cases of patient abuse or neglect, life threatening burns, fires or other catastrophic occurrences, medical conditions or deaths that occur as the result of unusual circumstances. Any acute event that results in a patient receiving emergency treatment must be reported. Emergency treatment includes unscheduled transportation to a hospital or receipt of cardiac life support from a hospital, ambulance service or rescue squad, or staff member. Also, to be reported are outbreaks of infectious disease or any condition in the facility, including the water treatment system, which would necessitate the temporary or long term closure of the dialysis facility (excluding inclement weather). 1. PI # 1 was admitted to the facility on 6/27/22 with diagnoses including End Stage Renal Disease, and Type Two Diabetes. Review of the Treatment Sheet dated 12/27/23 revealed PI # 1 was transferred from the facility to the hospital emergency department via emergency transport. Review of the SSA Unusual Occurrence (UO) on-line documentation submitted by ESRD facilities to the SSA revealed no documentation the facility reported PI # 1’s unplanned hospital transport to the SSA. Further review of the SSA ESRD UO online documentation revealed the facility had not reported any UO’s since opening in 2017. An interview was conducted on 1/10/24 at 9:00 AM with Employee Identifier # 1, Clinic Manager, who confirmed PI # 1 was transferred from the facility via emergency transfer to the hospital on 12/27/23. EI # 1 confirmed the facility failed to report PI # 1’s unscheduled transport and failed to report any UO’s to the SSA since opening in 2017.”

“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: 41624 Based on observations, review of facility policies and procedure, and interviews, it was determined the facility failed to ensure: 1. Staff performed hand hygiene after removing gloves per facility policy in two of four observations conducted for Central Venous Catheter (CVC) exit site care, including Patient Identifier (PI) # 1, PI # 10. 2. Staff performed hand hygiene after glove removal per facility policy in two of three observations conducted for initiation of dialysis with a CVC, including PI # 1, PI # 10. 3. Staff performed hand hygiene per facility policy in three of four observations conducted for parenteral (intravenous-IV) medication preparation and administration, including PI # 12, PI # 17, PI # 1. 4. Patients performed hand hygiene after holding exit sites prior to exiting the treatment area in one of three observations for discontinuation of dialysis and post dialysis access care with an AVF/AVG (arteriovenous fistula/graft), including PI # 2. 5. Staff performed hand hygiene after removing gloves per facility policy in two of three observations conducted for discontinuation of dialysis with a CVC, including PI # 11, PI # 1. 6. Staff followed facility policy for assessment of an AVF/AVG for initiation of dialysis in three of three observations conducted for access of an AVF/AVG during initiation of dialysis, including PI # 6, PI # 15, PI # 16. This had the potential to negatively affect the 33 patients who dialyze at the facility, staff, and visitors. Findings include: Facility Policy: Hand Hygiene Published: 11/6/23 Reference Number: 47664 Version: 8 Purpose The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination. Responsibility All staff, patients...must follow the same requirements for hand hygiene. Policy Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content... ...below identifies when hands should be washed specifically with soap and water or when alcohol-based hand rubs can be used: ...Before performing any invasive procedure such as vascular access cannulation or administration of parental medications. ...Immediately after removing gloves... ...When moving from a contaminated body site to a clean body site of the same patient. ...After contact with other objects within the patient station or treatment space. ...Hand Hygiene: Patients Patients should perform hand hygiene if able, prior to and after each dialysis treatment. ...Gloves must be provided to patients when performing procedures which risk exposure to blood or body fluids, such as...holding access sites post treatment to achieve hemostasis. To help ensure the prevention of cross contamination to their family members or other patients, hand hygiene must be performed... Facility Policy: Initiation and Termination of Treatment using a CVC Published: 7/5/22 Reference Number: 477265 Version: 4 Purpose The purpose of this policy is to provide direction on initiating and terminating a hemodialysis treatment... and a CVC. Background: ...The catheter exit site and hubs are the two primary sources for microorganism access which can result in a blood stream infection (BSI). Infection Control: - Hand hygiene must be performed per policy Hand Hygiene to prevent transmission of pathogenic microorganisms... Facility Policy: Access Assessment and Cannulation Published: 7/5/22 Reference Number: 45178 Version: 3 ...Background...The access must be prepared properly for needle placement to prevent bacteria from entering the bloodstream through the skin... Assessment of Vascular Access Follow the steps below... 5. LOOK... 6. Listen... 7. Feel... 9. Remove gloves and perform hand hygiene. Don new gloves. Facility Policy: Medication Preparation and Administration Published: 2/6/23 Reference Number: 47488 Version: 9 Purpose To administer medications with the goals of staff and patient safety...and infection control. ...Infection Control: The following steps must be taken to ensure infection control: - Perform hand hygiene prior to accessing supplies, handling vials and IV (intravenous) solutions and preparing or administering medications... Facility Medication Preparation and Administration Procedure Published: 9/5/23 Reference Number: 47577 Version: 6 Purpose To provide direction for safely, therapeutically, and aseptically administering medications... Drawing Medications from a Vial ...1 Gather supplies: Medication vial Syringe Needle... Draw up medication in a clean area. Wash hands. 1. An observation of care was conducted on 1/8/24 at 9:20 AM with Employee Identifier (EI) # 3, Registered Nurse (RN) at station 17 for CVC exit site care on PI # 1. EI # 3 removed the old dressing over the CVC site, removed his/her gloves, and applied a new pair of gloves without performing hand hygiene per facility policy. EI # 3 then cleansed the CVC exit site, removed his/her gloves and without performing hand hygiene, re-applied new gloves and placed a new dressing over the CVC exit site. After placing the new dressing, EI # 3 removed his/her gloves and applied a new pair of gloves without performing hand hygiene. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1, Clinic Manager, who confirmed the staff failed to perform hand hygiene per facility policy for CVC exit site care. 2. An observation of care was conducted on 1/8/24 at 9:22 AM with EI # 3 at station 17 for initiation of dialysis with a CVC on PI # 1. EI # 3 applied new gloves without performing hand hygiene, initiated dialysis for PI # 1, then removed his/her gloves without performing hand hygiene. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1 who confirmed the staff failed to perform hand hygiene per facility policy. 3. An observation was conducted on 1/8/24 at 9:29 AM with EI # 5, RN, to observe preparation and administration of IV Korsuva (to treat severe itching) for PI # 12 after dialysis was discontinued at station 1. EI # 5 entered the medication preparation area but failed to perform hand hygiene prior to retrieving the medication, syringe, and needle used to prepare PI # 12’s IV medication. EI # 5 failed to perform hand hygiene prior to IV Korsuva preparation. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1 who confirmed the staff failed to follow the facility policy for hand hygiene prior to medication preparation. 4. An observation was conducted on 1/8/24 at 9:45 AM at station 7 during discontinuation of dialysis and post access care for an AVF/AVG. PI # 2 held his/her cannulation sites with a gloved hand until bleeding stopped, removed his/her glove, and exited the treatment floor without performing hand hygiene. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1 who confirmed staff failed ensure PI # 2 performed hand hygiene after holding his/her access site following glove removal, and before exiting the treatment area. 5. An observation was conducted on 1/8/24 at 9:55 AM at station 19 for discontinuation of dialysis with a CVC involving PI # 11. Before initiation of the discontinuation procedure, EI # 3 donned clean gloves without first performing hand hygiene. After the patient’s blood was returned to the patient, EI # 3 failed to remove gloves and perform hand hygiene before disconnecting CVC from bloodlines. When the procedure was complete, EI # 3 removed gloves but failed to perform hand hygiene. An interview was conducted on 1/10/24 at 9:00 AM with EI #1 who acknowledged the staff failed to follow the facility policy for hand hygiene during discontinuation of dialysis with a CVC. 6. An observation of care was conducted on 1/8/24 at 9:58 AM with EI # 8, Certified Clinical Hemodialysis Technician (CCHT), at station # 6 for access of AVF/AVG for initiation of dialysis on PI # 6. With gloves on, EI # 8 evaluated/palpated PI # 6’s AVF/AVG access site with his/her gloved hand, then without performing hand hygiene and applying new gloves, EI # 8 performed anti-sepsis using two alcohol pads to the cannulation sites wearing the same gloves. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1 who confirmed the staff failed to perform hand hygiene and change gloves prior to performing anti-sepsis per facility policy. 7. An observation was conducted on 1/8/24 at 10:01 AM with EI # 5, RN, to observe the preparation and administration of IV heparin at station 8 for PI # 17 after discontinuation of dialysis with an CVC. EI # 5 entered the medication preparation station but failed to perform hand hygiene prior to retrieving the IV medication, syringe, and needle to prepare the IV medication. EI # 5 prepared the IV heparin without first performing hand hygiene. EI # 5 entered station 8, donned gloves without first performing hand hygiene, then administered the IV heparin. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1 who confirmed staff failed to follow the facility policy and perform hand hygiene prior to medication preparation and administration. 8. An observation of care was conducted on 1/8/24 at 10:20 AM at station 4 with EI # 4, CCHT for AVF/AVG assessment for dialysis initiation. With gloves on, EI # 4 cleaned his/her stethoscope with an alcohol pad, evaluated PI # 15’s AVF sites with a stethoscope and palpation. Next EI # 4 applied the antiseptic using two alcohol pads to the access cannulation sites, then inserted the cannulation needles. EI # 4 failed to remove gloves, perform hand hygiene, and don clean gloves after cleaning the stethoscope and access evaluation and before access cannulation. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1, who verified staff must change gloves and perform hand hygiene after equipment cleaning, evaluation of the access, and prior to cannulation and treatment initiation with an AVF/AVG. 9. An observation of care was conducted on 1/8/24 at 10:32 AM at station 10 with EI # 7, CCHT, during PI # 16’s AVF/AVG assessment for initiation of dialysis. With gloves on, EI # 7 cleaned his/her stethoscope with an alcohol pad then evaluated PI # 16’s AVF sites using the stethoscope and palpation. EI # 7 applied antiseptic using two alcohol pads to the access sites then cannulated the access. EI # 7 failed to remove gloves, perform hand hygiene, and don clean gloves after cleaning the stethoscope, after access evaluation and before access antisepsis. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1 who verified staff must change gloves and perform hand hygiene after equipment cleaning and access evaluation. EI # 1 confirmed EI # 7 failed to follow the facility policy for hand hygiene during access of an AVF/AVG for initiation of dialysis. 10. An observation was conducted on 1/8/24 at 11:12 AM for CVC exit site care and initiation of dialysis with a CVC at station 19 involving PI #10. During exit site care, EI # 3 failed to perform hand hygiene before donning gloves at the initiation of the exit site care. EI # 3 moved from task to task, cleaned the CVC exit site, applied the new CVC dressing, removed the old gauze from catheter limbs, and cleaned the CVC hubs without removing gloves, performing hand hygiene, and donning new gloves. After completion of the exit site care, EI # 3 failed to remove gloves and perform hand hygiene before beginning the initiation of dialysis with a CVC. An interview was conducted on 1/10/24 at 9:00 AM with EI #1 who confirmed staff failed to follow the facility policy for hand hygiene during CVC exit site care and initiation of dialysis with a CVC. 11. An observation of care was conducted on 1/8/24 at 2:05 PM with EI # 3 at station 18 for discontinuation of dialysis with a CVC on PI # 1. EI # 3 applied gloves without performing hand hygiene, placed a clean field under the CVC ports, removed his/her gloves and applied new gloves without performing hand hygiene. EI # 3 then performed anti-sepsis to the CVC ports and removed his/her gloves but failed to perform hand hygiene after glove removal. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1 who confirmed the staff failed to perform hand hygiene per facility policy Initiation and Termination of Treatment using a CVC. 12. An observation of care was conducted on 1/8/24 at 2:08 PM with EI # 3 at station 18 for parenteral medication preparation and administration for PI # 1. EI # 3 entered the medication preparation area, applied gloves without performing hand hygiene, and gathered supplies needed including an MDV (multi-dose vial) of Heparin 30,000 units per 30 milliliters (ml), two syringes, and an alcohol prep pad. EI # 3 proceeded to draw up the medication, returned to station # 18, removed his/her gloves and applied new gloves without performing hand hygiene, and administered the medication. EI # 3 then removed his/her gloves and applied new gloves without performing hand hygiene. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1 who confirmed EI # 3 failed to perform hand hygiene per facility policy for medication preparation and administration. 13. An observation was conducted on survey day 3, 1/10/24 at 9:15 AM, at station 1 with PI #12. EI # 3 failed to perform hand hygiene before donning gloves and beginning parenteral medication preparation. After donning gloves, EI # 3 touched multiple surfaces in the medication preparation area including the refrigerator, keys, drawers, and clean supplies. Without changing gloves, EI # 3 prepared the IV medication, exited the med prep area, took the medication to station 1, and administered the medication to PI #12. After removing gloves, EI # 3 failed to perform hand hygiene. EI # 3 returned to the nurse station and retrieved clean supplies from the drawer without performing hand hygiene. An interview was conducted on 1/10/24 at 10:00 AM with EI # 1 who confirmed staff failed to follow the facility policy for hand hygiene during medication preparation and administration. 30952 49894”

“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: 30952 Based on observations, review of facility policy and interviews, it was determined the facility failed to ensure staff wore required PPE (personal protective equipment) during care of patients who dialyzed with a CVC (Central Venous Catheter). This affected PI (Patient Identifier) PI #11, PI # 13, two of three observations of dialysis discontinuation with a CVC, and PI # 10, one of three observations of initiation of dialysis with a CVC and had the potential to affect the seven patients with CVC’s who dialyzed at the facility, and staff. Findings include: Facility Policy: Personal Protective Equipment (PPE) Published: 11/06/23 Reference Number: 47663 Version: 6 Purpose...to identify PPE and potential areas for use. Responsibility: Employees with potential exposure to hazardous chemicals, blood, or other potentially infectious material. ...Policy ...Employees shall use PPE in accordance with the type of patient contact expected and anticipated exposure... PPE including a full-side shield, or mask and protective eyewear with full side shield...must be worn to protect employees from blood or other potentially infectious materials...when performing procedures which spurting or spattering of blood might occur (...during initiation and termination of dialysis...). Findings include: 1. An observation was conducted on 1/8/24 at 9:55 AM at station 19, involving PI # 11. During discontinuation of dialysis with a CVC, EI (Employee Identifier) # 3, Registered Nurse (RN) failed to wear a face shield per facility policy. An interview was conducted on 1/10/24 at 9:00 AM with EI #1, Clinic Manager, who confirmed staff did not follow policy of the facility for wearing PPE. 2. An observation was conducted on 1/8/24 at 11:12 AM at station 19. During initiation of dialysis with a CVC involving PI #10, EI # 3 failed to wear a face shield per facility policy. An interview was conducted on 1/10/24 at 9:00 AM with EI #1 who confirmed staff did not follow policy of the facility for wearing PPE. 3. An observation was conducted on 1/8/24 at 4:36 PM at station 12 with RN, EI # 5 to discontinue a dialysis treatment with a CVC for PI # 13. EI # 5 was wearing the mask under his/her nose during the procedure. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1 who confirmed the face mask must be worn above the nose during termination of dialysis and staff failed to follow the facility policy for PPE use. 49894”

“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: 49894 Based on observations, review of facility policies, and staff interviews, it was determined that the facility failed to ensure unused medications taken to a patient station were disposed of and not taken back to a common area in one of one observation including PI (Patient Identifier) # 8. This had the potential to affect the 33 patients dialyzing at the facility. Findings include: Facility Policy: Dialysis Precautions Published: 1/4/12 Version 4 ...Policy Dialysis precautions will be followed by all employees with potential exposure to blood borne pathogens and other potentially infectious material in the dialysis setting. All employees will be educated regarding Dialysis Precautions ...as mandated by OSHA (Occupational Safety and Health Association) and recommended by the CDC (Centers for Disease Control). ...Clean Versus Dirty Area Clean Area: An area designated for clean and unused equipment, supplies, and medications. Dirty area: An area where there is potential for contamination with blood or body fluids and areas where contaminated or used supplies, equipment, ...are stored or handled. Clean areas should be clearly designated for the preparation and handling and storage of medications and unused supplies or equipment. Clean areas should be clearly separated from dirty areas where used supplies, equipment...are handled or stored. Facility Policy: Medication Preparation and Administration Published: 2/6/23 Reference Number: 47888 Version: 9 Purpose To administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control. Responsibility: Licensed Nursing Staff ...Infection Control ...Medications should be prepared in a clean work area away from dialysis patient stations and delivered separately to each patient. 1. An observation was conducted on 1/8/24 at 11:45 AM in which EI (Employee Identifier) # 3, Registered Nurse, took PI # 8 a cup of oral medications to the dialysis station. EI # 3 was holding a second medication cup labeled for another patient. After administering PI # 8’s oral medication, EI # 3 returned to the nurse’s station with the second medication cup in hand, placed the medication cup labeled for another patient, and taken to PI # 8’s dialysis station on the nurse desk. EI # 3 failed to ensure medications taken to the dialysis station were for the dedicated patient, and were delivered separately to the dialysis station, and not returned to a clean work area. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1, Clinic Manager, who confirmed the staff failed to follow the facility policy for medication administration.”

“IC-SINGLE USE VIALS CFR(s): 494.30(a)(1)(i) Intravenous medication vials labeled for single use, including erythropoietin, should not be punctured more than once. This Standard is not met as evidenced by: 49894 Based on observation, review of facility policy, and staff interview, it was determined that the facility failed to ensure an intravenous (IV) medication vial labeled for single use was discarded after use and not available for reuse on another patient. This had the potential to affect the 33 patients dialyzing at this facility. Findings include: Facility Policy: Medication Preparation and Administration Published: 2/6/23 Reference Number: 47488 Version: 9 Purpose To administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control. Responsibility: Licensed Nursing Staff ...Infection Control ...Discard single dose vials (SDV) after use. Never reuse for another patient. For single dose vials, never puncture the vial twice. 1. An observation was conducted on 1/8/24 at 12:57 PM of a SDV of Diphenhydramine in the medication drawer. The SDV was opened, dated, and initialed. Some of the medication had been withdrawn from the SDV vial which was placed back in the drawer for reuse. An interview was conducted on 1/9/24 at 11:30 AM with Employee Identifier (EI) #1, Clinic Manager, and EI # 2, Director of Operations, who confirmed SDV’s should be discarded after use.”

“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: 30952 Based on review of facility policy and procedures, observations, and interviews, it was determined the facility failed to ensure: 1. The Mixed Bleach Containers were labeled with the bleach solution strength per procedure. 2. The dialysis station was cleaned and disinfected according to facility policy and procedure in one of five observations for cleaning and disinfection of the dialysis station. This had the potential to negatively affect the 33 patients who dialyze at the facility. Findings include: Facility Procedure: Mixing Bleach Published: 8/25/2020 Version: 4 Procedure: Follow the steps...for mixing bleach: ...2. Pour measure amount of water into labeled opaque container. 2. Pour measure(d) amount of water... 3. Slowly pour measured amount of bleach into measured water... 4. Label opaque container with “Bleach Solution”, strength of solution, date, and time prepared... Facility Policy and Procedure: Cleaning and Disinfecting of the Dialysis Station Published: 09/05/2023 Reference Number: 47806 Version: 14 Purpose ...of this policy is to provide guidelines to prevent the spread of disease...maintain a clean. safe...environment for patients, staff, and visitors. ...Procedure Follow the steps below to disinfect the dialysis station after each dialysis treatment: ...3. Use a cloth wetted with 1:100 (one part bleach, 100 parts water) bleach solution...to clean and disinfect the dialysis station...machine, IV (intravenous) pole, B/P (blood pressure) cuff...chaise wall behind chair... 4. Clean all surfaces... 5...While wiping...wipe all surfaces of the machine... 1. On 1/8/24 at 9:10 AM, across from station 1, the surveyor observed one container labeled “spills” and one container labeled “clamps”. There was no label on the container for the strength of bleach solution. An interview was conducted on 1/8/24 at 9:15 AM, with EI (Employee Identifier) # 7, CCHT (Certified Clinical Hemodialysis Technician) who verbalized he/she prepared the bleach solution this day. EI # 7 confirmed the containers were not labeled with the bleach solution strength. 2. An observation was conducted on 1/8/24 at 10:12 AM to observe EI # 7 perform cleaning and disinfection of station 11. EI # 7 cleaned the dialysis machine but failed to disinfect the top section of the IV (intravenous) pole including the four IV hooks. EI # 7 cleaned the Hansen connector but failed to disinfect the Hansen hoses. EI # 7 cleaned the B/P (blood pressure) cuff lying in the dialysis chair and placed the cleaned B/P cuff in the wire basket on the side of the dialysis machine without first cleaning the inside of the wire basket. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1, Clinic Manager, who confirmed the staff failed to follow the facility policy for cleaning and disinfection of the dialysis station.”

“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: 49894 Based on observations, review of facility policy and interview, it was determined the facility failed to ensure staff: 1. Properly labeled and stored medications per facility policy. 2. Prepared and administered Parenteral (medications administered other than by oral route)/ Intravenous (IV) medications per facility policy. This deficient practice affected two of four observations for parenteral (IV) medication preparation and administration including Patient Identifier (PI) # 11, PI # 1, and had the potential to negatively affect the 33 patients dialyzing at this facility. Findings include: Facility Policy: Medication Preparation and Administration Published: 2/6/23 Reference Number: 47488 Version: 9 Purpose To administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control. ...Labeling Reconstituted Medication Solutions and Syringes - All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of patient, date, time, and initials of the person who prepared the medication... - Oral medications not being administered immediately must also be labeled as indicated above. ...Pre-drawing Medications Medications may be pre-drawn up to 4 hours prior to administration... ...Infection Control The following steps must be taken to ensure infection control. Perform hand hygiene prior to accessing supplies, handling vials...and preparing medications. ...Cleanse the diaphragm of a vial with alcohol prior to accessing the vial. If the vial is a multidose vial (MDV), cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle... Securement The following steps must be taken for the securement: All medications will be stored in a locked cabinet except when in use... 1. An observation was conducted on 1/8/24 at 9:00 AM of pre-drawn heparin syringes in a basket on the desk at the nurse’s station. The pre-prepared syringes had labels on them but did not include the time it was prepared or the initials of the preparer. Pre-prepared oral medications were on the desk in cups with a patient label, however no preparation time and no initials of the preparer were documented on the labels. These pre-drawn medications were not properly labeled and kept under the preparer’s control or in a locked designated medication storage area until delivery to the appropriate patient for administration. An interview was conducted on 1/10/24 at 9:00 AM with EI (Employee Identifier) #1, Clinic Manager, who confirmed staff did not follow the facility policy for medication preparation and administration. 2. An observation was conducted on 1/8/24 at 9:15 AM at station 19 involving PI # 11. Two heparin syringes were laying on the chairside table. The syringes were not labeled with the time of preparation or the preparer’s initials. At 9:55 AM, EI # 3, Registered Nurse, discontinued the patient’s dialysis and administered the heparin to PI # 11 via the CVC. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1, who confirmed staff failed to follow the facility policy for medication preparation and storage. 41624 3. An observation of care was conducted on 1/8/24 at 2:08 PM with EI # 3, to prepare and administer IV heparin at station 18 to PI # 1. EI # 3 obtained a MDV containing Heparin 30,000 units per 30 milliliters (ml), cleansed the diaphragm (septum) covering the vial with an alcohol pad, entered the septum with a clean needle attached to a 3-cc (cubic centimeter) syringe withdrawing 1.8 cc’s of heparin. EI # 3 then proceeded to access the septum of the MDV with a second needle attached to a 3-cc syringe and withdrew another 1.8 cc’s of heparin. EI # 3 failed to cleanse the septum of the MDV before accessing it with a needle each time per policy. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1 who confirmed EI # 3 did not follow facility policy when accessing the MDV.”

“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: 41624 Based on observations, facility policy and procedures, and interview, it was determined the facility failed to ensure staff: 1. Cleaned the Central Venous Catheter (CVC) exit site according to facility policy. 2. Disinfected the CVC threads and hubs according to facility procedure. 3. Applied the CVC dressing according to facility policy. 4. Placed an underpad under the catheter limbs to protect work area and clothing per facility procedure. This affected four of four observations for CVC exit site care and included Patient Identifier (PI) # 1, PI # 10, PI #14, PI # 13, and one of three observations for initiation of dialysis with a CVC and included PI # 1 and had the potential to negatively affect all patients dialyzing with CVC’s. Findings include: Facility Procedure: Changing the Catheter Dressing Published: 5/2/22 Reference Number: 45664 Version: 7 Purpose The purpose of this policy is to provide instruction for cleaning the hemodialysis (HD) catheter exit site, changing the catheter dressing... Removal of Dressing and Inspection of Site ...Step 1: Place an underpad under catheter limbs to protect work area and clothing. ...Cleaning the Site Follow the steps below to clean the catheter exit site: ...2. Remove swabstick from package...2% (percent) Chlorhexidine and 70% alcohol (Chloraprep): Using gentle back and forth friction, clean the exit site...for 30 seconds and allow to dry a minimum of 30 seconds... If using povidone pad: Using gentle friction, disinfect the exit site...for 30 seconds... Applying the Dressing Follow the steps below to apply a dressing to the exit site: 1. Using aseptic technique, apply the catheter dressing over dry exit site... Facility Procedure: Initiation of Treatment Using a CVC and Optiflux Single Use Ebeam Dialyzer Published: 7/6/21 Version: 7 Purpose The purpose of this procedure is to provide direction initiating hemodialysis treatment using a CVC... Preparing the Catheter: Disinfection of the Catheter Connections... Follow the steps below to disinfect the catheter connections: Threads and end of the luer lock (hub) must be scrubbed with 70 % (percent) sterile alcohol pad... for 10-15 seconds and any time caps are removed ... (i.e.{that is} end of treatment...) to reduce risk of contamination. 1. During observations of care on 1/8/24 at 9:20 AM, the surveyor observed Employee Identifier (EI) # 3, RN (Registered Nurse) perform CVC exit site care for PI # 1 at station 17. During the procedure, EI # 3 cleansed the area around the exit site for 10 seconds with the Chloraprep swabstick, then immediately placed the sterile dressing over the site. EI # 3 failed to cleanse the exit site for 30 seconds and wait 30 seconds per policy for the site to dry before applying the dressing. 2. During observations of care on 1/8/24 at 9:22 AM, the surveyor observed EI # 3 initiate dialysis with a CVC for PI # 1 at station 17. During the procedure, EI # 3 removed the exterior cap to the venous (blue) hub and used an alcohol pad, making twisting motions around the hub sides and threads, for nine seconds. EI # 3 failed to scrub the venous hub sides and threads thoroughly with friction for 10-15 seconds, per procedure. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1, Clinic Manager, who confirmed the staff must clean the CVC exit site for 30 seconds during site care, wait 30 seconds for the site to dry before applying the dressing, and scrub each CVC hub for 10-15 seconds per procedure. EI # 1 confirmed the staff failed to follow facility policy and procedure for CVC site care and hub disinfection. 49894 3. An observation was conducted on 1/8/24 at 11:12 AM at station 19, with EI # 3 performing CVC exit site care for PI # 10. Before the start of the procedure, EI # 3 failed to place a clean barrier underneath the catheter limbs. EI # 3 scrubbed the CVC exit site with a chlorhexidine swab and allowed a 5 second drying time before placing a clean dressing. EI # 3 failed to allow the exit site to dry a minimum of 30 seconds per facility policy before dressing application. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1, who confirmed that the staff failed to follow the facility policy for CVC exit site care and dressing change. 30952 4. An observation of care was conducted on 1/8/24 at 11:50 AM at station 1 with EI # 5, RN, during CVC exit site care for PI # 14. EI # 5 removed the dressing surrounding the catheter limbs and the CVC exit site dressing. EI # 5 cleansed the CVC exit site with a chloraprep swabstick for 8 seconds and not for 30 seconds per facility procedure. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1 who confirmed staff failed to follow the facility procedure for CVC exit site care. 5. An observation of care was conducted on 1/8/24 at 12:10 PM at station 12 with EI # 5 during CVC exit site care for PI # 13. EI # 5 removed the dressing surrounding the catheter limbs and the CVC exit site dressing. EI # 5 cleansed the CVC exit site with povidone swabsticks, once for 13 seconds and once for 15 seconds, and not for 30 seconds per facility procedure. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1 who confirmed the staff failed to follow the facility procedure for CVC exit site care.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 30952 Based on observations, review of the manufacturer’s directions for use (DFU), facility policy and procedure, and interview, the facility failed to ensure staff followed the bloodline manufacturer’s DFU during dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing it through a filter) treatments by maintaining the arterial drip chamber (a pressure and air monitoring component of the dialysis bloodline tubing) fluid levels at the required fill level during one of two survey observation days. The failure to follow the manufacturer’s DFU affected three unsampled patients and had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 33 patients receiving incenter hemodialysis treatments at this facility. Findings include: Fresenius Medical Care Combiset True Flow Series Comibset Blood Tubing with Access Flow Reversing Connector twister) Instructions for Use ...Priming Precautions- ...5. Prime pre-pump arterial chamber 85 to 95 % full...post-pump arterial and venous chambers 65 to 75 % full. ...Dialysis Treatment Precautions- ...b. Maintain fluid level in drip chamber and adjust as needed... Facility Policy: Initiation of Treatment Using an Arteriovenous Graft or Fistula and Optiflux Single Use Ebeam Dialyzer Published: 07/06/2021 Version: 5 ...Final Machine Verification Prior to starting the blood pump, verify the following: ...5. The arterial chamber is 85-95% full... 1. Observations of the hemodialysis treatment area were conducted on 1/8/24 revealed the following: At 11:10 AM, at station 10, the arterial chamber fluid level was 25 % (percent). At 11:20 AM, EI (Employee Identifier) # 7, CCHT (Certified Clinical Hemodialysis Technician) confirmed the observation and adjusted the arterial chamber fluid level at station 10. 2. At 11:16 AM at station 4, the arterial chamber fluid level was less than 50 % full. At 11:23 AM, EI # 4, CCHT, confirmed the observation and adjusted the arterial chamber fluid level at Station 4. 3. At 11:17 AM at station 5, the arterial chamber fluid level was less than 25 % full. At 11:22 AM, EI # 4 confirmed the observation and adjusted the arterial chamber fluid level at Station 5. In an interview conducted on 1/10/24 at 9:00 AM, EI # 1, Clinic Manager, confirmed staff failed to ensure the arterial fluid levels were maintained at the correct levels.”

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 30952 Based on medical record (MR) review, and staff interview, it was determined the facility failed to follow the physician’s order for IV (intravenous) Vancomycin (an antibiotic used for the treatment of an infection) administration. This affected PI (Patient Identifier) # 1, one of one record reviews with an IV antibiotic order and had the potential to negatively affect the 33 patients who dialyze at the facility. Findings include: 1. PI # 1 was admitted to the facility on 6/27/22 with End Stage Renal Disease. Review of an Order Detail Report dated 12/8/23 revealed Vancomycin Hydrochloride (HCL) 1000 milligram (mg) IV (administer) during dialysis 3 times a week for 6 times (doses) for cellulitis (a bacterial skin infection). Review of the Treatment Sheet dated 12/8/23 revealed no documentation Vancomycin HCL was administered. Review of the Treatment Sheets dated 12/11/23, 12/13/23, 12/15/23, 12/18/23, 12/20/23 revealed a total of five doses of IV Vancomycin was administered. Review of the Treatment Sheet dated 12/23/23 revealed no documentation IV Vancomycin was administered. There was no documentation PI # 1 received the six doses of IV Vancomycin. An interview was conducted on 1/10/24 at 9:00 AM with Employee Identifier # 1, Clinic Manager who confirmed the MR documentation did not reveal PI # 1 received the six doses of IV Vancomycin ordered.”

“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: 41624 Based on medical record (MR) review, facility policies and procedure, and interviews with staff it was determined the facility failed to ensure treatments were administered: 1. Per the physician orders for Blood Flow Rate (BFR). 2. According to the facility policy and physician order for intravenous (IV) heparin administration delivery. 3. Per physician orders for the dialysate bath. This affected Patient Identifier (PI) # 3, PI # 1, PI # 2, three of five MR reviews, one of one heparin administration observations, including PI # 6, and one of five dialysis prescription verifications during the flash tour, including PI #11. This had the potential to affect the 33 patients who dialyzed at the facility. Findings include: Facility Policy: Patient Assessment and Monitoring Published: 05/01/2023 Reference Number: 45284 Version: 4 ...3. Machine Parameters and Extracorporeal Circuit Check machine settings and measurements: Check prescribed blood flow rate is being achieved or reason is documented in medical record if unable to meet prescribed blood flow rate. Facility Procedure: Pretreatment Safety Checks Procedure Published: 2/6/23 Version: 3 Predialysis Safety Checks Verify the following by two direct patient care staff members prior to treatment initiation: ...prescribed dialysate composition Facility Policy: Heparinization Published: 8/3/2020 Version: 4 Purpose This policy provides guidelines for adequate dosing and use of heparin in hemodialysis patients. ...Policy A physician order is required for all heparin doses and dose adjustments. ...Dose and Administration The physician must order the heparin dose and method of administration... Facility Policy: Medication Preparation and Administration Procedure Published: 9/5/23 Reference Number: 47577 Version: 6 ...Medication Administration Procedure: 7. Administer the medication via the appropriate route and/or port into the extracorporeal circuit. Facility Policy: Medication Preparation and Administration Published: 2/6/23 Reference Number: 47488 Version: 9 Medication Orders Medication orders must be administered with an order by a physician... Preparing and administering medications during Hemodialysis treatment ...Verify there is a physician order. ...Allowable Intravenous Administration Sites Administering Heparin The sites below are the appropriate sites for heparin administration. Drug: Heparin bolus (Pre-treatment) Route of Administration: IV Push...Fistula Needle or Catheter limb... 1. PI # 3 was admitted to the facility on 6/9/23 with a primary diagnosis of End Stage Renal Disease (ESRD). Review of the Orders Summary Report (OSR) revealed hemodialysis (HD) treatment orders dated 12/29/23 with a BFR of 400. Review of the Treatment Sheet (TS) dated 12/31/23 revealed the BFR was initiated at 400 at 5:28 AM then decreased to 350 at 5:58 AM. There was no reason documented why the BFR was 350 and not at 400 as ordered. Continued review of the TS dated 12/31/23 revealed the BFR was decreased to 300 at 7:01 AM. There was no reason documented why the BFR was 300 and not at 400 as ordered. Further review of the TS dated 12/31/23 revealed the BFR was decreased to 200 at 7:52 AM, then increased to 275 at 8:42 AM. The PCT (Patient Care Technician) documented PI # 3 was recannulated at 9:03 AM. The BFR was increased to 350 at 9:03 AM until end of treatment at 10:14 AM. There was no reason documented why the BFR was not at 400 as ordered. Review of the TS dated 1/3/24 revealed the BFR ran at 300 from 5:37 AM to 6:34 AM, then increased to 400. There was no reason documented why the BFR was 300 the first 57 minutes of treatment and not at 400 as ordered. Further review of the TS dated 1/3/24 revealed the BFR was decreased to 300 at 8:28 AM until end of treatment at 9:40 AM. There was no reason documented why the BFR was 300 and not at 400 as ordered. An interview was conducted on 1/10/24 at 9:30 AM with Employee Identifier (EI) # 1, Clinic Manager (CM), who confirmed the staff failed to document why the BFR was not run at the ordered rate. 30952 2. PI # 1 was admitted to the facility on 6/27/22 with a primary diagnosis of ESRD. Review of the OSR revealed HD orders dated 10/20/23 for the BFR of 450. Review of the TS dated 1/3/24 revealed the BFR was 400 from treatment start at 9:29 AM to 1:03 PM. There was no reason documented why the BFR was 400 and not 450 as ordered. There was no physician’s order for BFR 400. Review of the TS dated 1/5/24 revealed the BFR was decreased to 350 at 11:30 AM and delivered at 350 until treatment end at 2:13 PM. There was no reason documented why the BFR was 350 and not 450 as ordered. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1 who confirmed there was no physician’s order for the BFR 400, and the BFR 350, and no reason was documented why the BFR was not 450 as ordered. 3. PI # 2 was admitted to the facility on 3/16/22 with a primary diagnosis of ESRD. Review of the OSR revealed HD orders dated 10/23/23 for the BFR of 400. Review of the TS dated 12/31/23 revealed the BFR was 450 from treatment start at 5:59 AM to 7:35 AM. There was no reason documented why the BFR was 450 and not 400 as ordered, and no physician order for BFR 450. In an interview conducted on 1/10/24 at 9:17 AM, EI # 1 confirmed there was no physician’s order for the BFR 450, and no reason was documented why the BFR was not 400. 49894 4. During the Flash Tour on 1/8/24 at 9:00 AM at station 19, the surveyor asked EI # 6, Certified Clinical Hemodialysis Technician (CCHT), to verify the prescription for PI # 11. PI # 11 was connected to a jug bath labeled 2K(Potassium) 3Ca (Calcium). The bath ordered was 2K 2.5Ca. EI # 6 verified that PI # 11 was being dialyzed with the wrong type of dialysate. An interview was conducted on 1/10/24 at 9:00 AM with EI #1, Clinic Manager, who confirmed the staff failed to follow the policy for verifying patient dialysate. 5. During a random observation of heparin administration on 1/8/24 at 10:15 AM at station 6, EI # 3 (RN) administered the heparin bolus for PI # 6 to the arterial chamber of the blood lines. Upon review of the patient’s heparin order, the heparin was not ordered to be given in the arterial chamber. EI # 3 stated that the physician had given a verbal order for the heparin to be given in the arterial chamber, however it was not documented. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1, who confirmed the staff did not follow the facility policy for heparin administration.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 41624 Based on observation, review of facility policy and procedure and interview, it was determined the facility failed to ensure staff performed AVF/AVG (arteriovenous fistula/graft) site preparation per facility procedure in one of three observations conducted for AVF/AVG access and initiation of dialysis, including PI (Patient Identifier) # 6. This had the potential to negatively affect all patients dialyzing at this facility with an AVF/AVG access. Findings include: Facility Policy and Procedure: Access Assessment and Cannulation Published: 7/5/22 Reference Number: 45178 Version: 3 ...Background...The access must be prepared properly for needle placement to prevent bacteria from entering the bloodstream through the skin... Policy: Evaluation and preparation of the access will be performed routinely prior to cannulation at each dialysis session. Skin Disinfection: Step 1: Disinfect cannulation site as follows using any of the disinfectants below: - 70 % (percent) isopropyl alcohol pad: Using gentle friction, clean the access site...for 30 seconds and allow to dry before cannulating... Step 2: Perform skin antisepsis on one site at a time, allow to dry and then cannulate. 1. An observation of care was conducted on 1/8/24 at 9:58 AM with EI (Employee Identifier) # 8, Certified Clinical Hemodialysis Technician (CCHT), at station 6 for access of AVF/AVG for initiation of dialysis on PI # 6. Using an alcohol pad, EI # 8 performed antisepsis to one site of the AVF/AVG for three seconds. EI # 8 then utilized another alcohol pad and performed antisepsis for three seconds to the second site. EI # 8 failed to perform antisepsis to each access site for 30 seconds per facility procedure. An interview was conducted on 1/10/24 at 9:00 AM with EI # 1, Clinic Manager, who confirmed EI # 8 failed to perform antisepsis of the cannulation sites per facility policy and procedure.”