Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted April 22, 2024 through April 25, 2024, Fairmount Dialysis was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted April 22, 2024 through April 25, 2024, Fairmount Dialysis was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.30(a)(1) STANDARD IC-WEAR GLOVES/HAND HYGIENE Name - Component - 00 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.
Observations:
Based on observations (OBS) of the In-Center Hemodialysis Treatment Area, facility policies, and an interview with the administrator and manager of clinical services, the facility failed to follow its infection control policy related to hand hygiene during hemodialysis procedures for three (3) of eighteen (18) OBS: OBS #1, OBS #2, and OBS #3.
Findings include:
A review of Facility Policy: 1-05-01 Infection Control For Dialysis Facilities, conducted on April 22, 2024 at approximately 12:45 PM reads in part, "All teammates, physicians and non-physicians will perform hand hygiene....prior to gloving and immediately after removal of gloves....after patient and dialysis delivery system contact....before touching clean areas such as supplies, supply care and chairside keyboard/mouse....gloves should be changed when going from a dirty area or task to a clean area or task."
OBS #1, 04/22/204 at 11:35 AM: PF#1, Station #13 was observed to not perform hand hygiene after completion of Central Venous Catheter (CVC) exit site care and removal of gloves. OBS #2, 04/22/2024 at 11:40 AM: PF#1, Station #13 was observed, with gloved hands, attaching a syringe to a central venous catheter (CVC) hub in order to inject normal saline into the catheter. Upon removing the syringe from the hub, PF#1 proceeded to the chairside computer keyboard that is shared between two dialysis stations, with gloves still on and syringe still in hand, to document. Upon PF#1 leaving the computer station, PF#1 did not sanitize the chairside keyboard. A second employee, with ungloved hands, used the same keyboard for documentation. PF#1 was also observed to not sanitize his/her hands after removal of gloves once the hemodialysis treatment was initiated.
OBS #3, 04/22/204 at 12;10 PM; PF#2, Station #3 was observed removing an old CVC dressing and discarding the dressing, at which time PF#2 removed and replaced gloves without performing hand hygiene prior to donning the clean gloves.
An interview conducted with the administrator and manager of clinical services on April 24, 2024 starting at 2:00 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 05/01/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with emphasis on but not limited to: 1) All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene... b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact... e. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse. 2) Gloves should be changed when: i. When soiled with blood, dialysate or other body fluids ii. When going from a "dirty" area or task to a "clean" area or task. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet. The Facility Administrator will conduct infection control audits to verify teammates perform hand hygiene, glove wearing and glove changing per policy: daily for two (2) weeks, then weekly for two (2) weeks, then ongoing compliance will be monitored with monthly infection control audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed, until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.60 STANDARD PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT Name - Component - 00 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.
Observations:
Based on observations (OBS) of the In-Center Hemodialysis (ICHD) Treatment Area, the storage supply room, the peritoneal dialysis training room, an interview with the facility administrator and manager of clinical services, a review of facility policies, and a review of infection control documents, the facility failed to properly label a medication vial, and remove expired supplies from the above mentioned areas for four (4) of four (4): Observations (OBS): OBS#1, OBS#2, OBS#3, and OBS#4.
Findings include:
A review of Facility Policy: 1-05-01 Infection Control For Dialysis Facilities, conducted on April 22, 2024 at approximately 12:45 PM reads in part, "Supplies will be stored in a manner that maintains their integrity."
A review of Facility Policy: 1-06-1 Medication Policy, conducted on April 23, 2024 at approximately 8:30 AM reads in part, "Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured).... Each vial is labeled with the initials of the person opening the vial and the expiration date....All medications in the facility are checked monthly. Insulin and other medications with preservatives are dated and initialed once opened. All medications are checked monthly for expiration dates."
A review of infection Control Audits conducted on April 24, 2024 at approximately 10:30 AM found that medication/supply audits completed October 2023, November 2023, and February 2024 noted that no medications or supplies were expired.
Observation #1 took place in the In-Center Hemodialysis Treatment Area on April 22, 2024 from approximately 9:30 AM to 12:30 PM. The observation revealed the following:
Medication Preparation Area:
A multi-dose vial of Heparin 30,000 units in 30 ml (milliliters) found in cabinet #3 (moving from left to right since cabinets were not labeled) had been opened and approximately 10 ml of solution remained in the vial. There was no notation on the vial containing the initials of who opened the vial, nor the expiration date.
Forty-five (45) BD (Becton Dickinson) Eclipse Needles, 22 gauge (ga) x 1 1/2 inch lot number (#) 9052715 found in cabinet #1 (moving from left to right) had a use by date of 02/28/2024.
Fourteen (14) Vionex Healthcare Antiseptic Towlettes, lot # 1521 found in drawer #1 (moving from left to right) had a use by date of 06/01/2022.
Laboratory Area:
Forty-five (45) 6 ml NH Trace Elements Sodium Heparin vacutainers, lot # B22103HY, had a use by date of 04/10/2024.
One BD vacutainer urine cup kit contained a grey top vacutainer, lot # 1068759, expired 09/2022, and a red/yellow top vacutainer, lot # 1068759, expired 09/2022.
Twenty-five (25) orange top vacutainers, lot # 2291696, expired 03/31/2024.
Four (4) red top vacutainers, lot # 2278090, expired 02/29/2024.
Two (2) BD Bactec-Plus Aerobic/F Culture Vials, 30 ml, lot # 3152045, expired 03/5/2024 and 03/06/2024.
Five (5) Corning 15 ml centrifuge tubes, lot # 27320049, expired 10/05/2023.
Several COVID Lab Test Kits contained expired items including:
Kit #1: three (3) expired collection tubes, lot # 221801, expired 01/2024 and three (3) swabs, lot # 2025004, expired 10/31/2023. Kit #2: five (5) expired swabs, lot #2025004, expired 10/31/2023. Kit #3: five (5) expired swabs, lot # 2024042, expired 10/31/2023, four (4) swabs, lot # 2025004, expired 10/31/2023, a specimen transport bag #1 which contained 0.9% NS specimen tube, lot # 0063273, expired 02/28/2023 and one (1) swab lot # 2022105, expired 09/30/2023, and a second specimen transport bag which contained the same expired items as in specimen transport bag #1. Observation #2 took place in the ICHD Treatment Area and the Storage Area on April 22, 2024 from approximately 1:00 PM to 2:00 PM. The observations revealed the following:
The Emergency Evacuation Box located in the ICHD Treatment Area contained the following:
Thirteen (13) BD Safety-Lok 3 ml syringes, lot # 82666954, expired 09/30/2023.
Eight (8) 0.9% 10 ml Sodium Chloride Injection Syringes, lot # 0342165, expired 11/30/2023.
The Storage Room contained the following:
One unopened box (quantity of eight) of 1500 ml Baxter Dianeal Low Calcium Peritoneal Dialysis Solution with 2.5% Dextrose, lot # Y402668, expired March 2024.
Observation #3 took place in the ICHD Treatment Area on April 23, 2024 from 9:00 AM to 9:30 AM and found the following:
The Crash (emergency) Cart, Drawer #1, contained one bottle Nitroglycerin Sublingual Tablets, 0.4 mg (milligrams), lot # 17220136, expired 12/2023.
Observation #4 took place in the Peritoneal Dialysis Training Room on April 23, 2024 from 1:00 PM to 1:30 PM and found the following:
Two (2) 6 ml NH Trace Elements Sodium Heparin Vacutainers, lot # B22103HY, expired 04/10/2024.
Five (5) BD Eclipse Needles, 22 ga x 1 1/2", lot # 9052716, expired 02/28/2023.
Three (3) FlexiCap Disconnect Caps with Povodine-Iodine Solution, lot # 23D26h25, expired 03/28/2024.
An interview conducted with the administrator and manager of clinical services on April 24, 2024 starting at 2:00 PM confirmed the above findings.
Plan of Correction:The Facility Administrator held mandatory in-services for all clinical teammates starting on 05/1/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-06-01 "Medication Policy", Policy 1-08-02 "Obtaining Patient Lab Specimens", Policy 1-05-01 "Infection Control for Dialysis Facilities" and Policy 1-02-08 "Emergency Equipment Checks" with emphasis on but not limited to: A. Medications: 1) The Facility Administrator / designee is responsible for supervising the handling, storing, disposing, administering, and controlling of medications and performs monthly audit and inventory. 2) Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured)... Each vial is labeled with the initials of the person opening the vial and the expiration date. B. Lab supplies: 1) Teammates are to verify the expiration date on all laboratory specimen tubes prior to collection. Expired laboratory specimen tubes are not to be used and are to be discarded in the sharp's container. C. Infection control: 1) Supplies will be stored in a manner that maintains their integrity. 2) Expiration date and package integrity will be verified prior to use. D. Emergency equipment checks: 1) The following equipment checks will be performed by a licensed nurse teammate to verify the designated equipment is available and functional: Weekly: Emergency cart (crash cart) is clean, operational and supplies/medications have not expired. 2) In addition, the FA or designee will review the contents of the emergency evacuation kit(s) and replace missing or expired supplies at least monthly. The date and initials of the teammate checking the contents should be placed on a label outside the kit(s). Verification of attendance is evidenced by teammate's signature on the in-service sheet.
The Facility Administrator or designee immediately conducted an audit of all supplies and medications with expiration dates. The Facility Administrator directed teammates to immediately remove and appropriately discard all expired supplies and medications, [including unlabeled, open medication vials] and expired items identified by the surveyor. Ongoing audits will be conducted monthly by the Facility Administrator or designee per policy, who will also verify incoming stock is rotated as it arrives. Ongoing compliance will be monitored with the monthly infection control audit. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed, until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.80(d)(1) STANDARD PA-FREQUENCY REASSESSMENT-STABLE 1X/YR Name - Component - 00 In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- (1) At least annually for stable patients;
Observations:
Based on a review of medical records (MR), a review of facility policy, and an interview with the administrator and manager of clinical services, the facility failed to ensure that a revision of the plan of care was conducted annually for two (2) of seven (7) MR reviewed: MR#5 and MR#7.
Findings include:
A review of Facility Policy: 1-14-01 conducted on April 24, 2024 at approximately 8:00 AM reads in part, "A comprehensive reassessment of each patient and a revision in the plan of care will be conducted at least annually for stable patients."
A review of medical records was conducted on April 23, 2024 from 9:00 AM to 3:30 PM, and again on April 24, 2024 from 9:00 AM to 10:00 AM. The admission date is indicated below.
MR#5 Transfer to facility on 12/30/2019 found that the plan of care (POC) was updated annually on 05/20/2021 and 05/09/2022. The next POC update was completed on October 11, 2023. There was no annual POC update in the MR or provided by the facility for May 2023.
MR#7 Actual DaVita Start Date per the Patient Summary Report was 02/06/2023. The patient underwent peritoneal dialysis training at another DaVita facility and completed training in March 2023 at which time the patient was transferred to Fairmount DaVita for home peritoneal dialysis. An initial POC was not completed until 06/29/2023.
An interview conducted with the administrator and manager of clinical services on April 24, 2024 starting at 2:00 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designees held mandatory in-services for members of the Interdisciplinary Team (IDT) starting on 05/01/24. Surveyor observations were reviewed. Education included but was not limited a review of Policy 1-14-01 "Interdisciplinary Team (IDT) Patient Assessment and Plan of Care" emphasizing but not limited to: 1) A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: At least annually for stable patients. 2) Timing: One (1) year after the 90 Day reassessment or unstable reassessment. Ongoing annual reassessments will be completed 1 year after the annual re-assessment or unstable reassessment. Complete patient plan of care meeting within 15 days of the completion of the re-assessment and Plan of Care. Verification of attendance at the in-service will be evidenced by teammate's signature on the in-service sheet.
The Facility Administrator or designee will notify the IDT monthly of assessments / plans of care due dates. The Facility Administrator will conduct monthly audits on one hundred percent (100%) of patient assessments and plans of care for three (3) months to verify timely completion of annual assessments and plans of care. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with the IDT during Core Team Meetings, and with the Medical Director during monthly Quality Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.90(a)(1) STANDARD POC-MANAGE VOLUME STATUS Name - Component - 00 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;
Observations:
Based on review of facility policies and procedures, medical records (MR), hemodialysis (HD) treatment documentation, and an interview with the administrator and manager of clinical services, the facility did not address abnormal findings per the facility's policy for two (2) of five (5) HD MR's: MR#3 and MR#4.
Findings include:
A review of Facility Policy 1-03-08 Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment conducted on April 24, 2024 at approximately 9:00 AM reads in part, "Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment...The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation. Prescription components include but are not necessarily limited to:.....Blood flow rate (BFR). If the dialysis prescription is not being met the reason will be documented and the licensed nurse informed...abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary...abnormal findings fluid status: post treatment - if patient is above or below 1 kg from the target weight.....blood pressure (BP) post treatment: systolic BP less than 90 mm/Hg and diastolic BP less than 50 mm/Hg "
A review of medical records (MR) was completed on April 23, 2024 from approximately 9:00 am to 2:30 pm and on April 24, 2024 from approximately 9:00 am to 10:00 am. The admission date is indicated below.
MR #3: Admission Date: 06/21/2022. HD target weight orders were as follows: Target Weight: 80 kilograms (Kg);
Hemodialysis (HD) Treatment Records from 04/06/2024 to 04/18/2024 revealed the following:
04/09/2024: Pre-assessment nursing note on the flowsheet stated, "necessary fluid removal exceeds Ultra-Filtration Rate (UFR) prescription." Pre-treatment weight: 86.5 kg. Post-treatment weight: 86.4 kg.
04/11/2024: Pre-assessment nursing note on the flowsheet stated, "UF goal limited due to UF rate prescription; patient hypertensive; RN (registered nurse) to monitor. Pre-treatment weight: 84.9 kg. Post-treatment weight: 85.7.
04/13/2024: Pre-treatment weight: 88.7 kg. Post-treatment weight: 86.0.
04/16/2024: Pre-treatment weight: 85.3 kg. Post-treatment weight: 83.1 kg.
04/18/2024: Pre-treatment weight: 85.5 kg. Post-treatment weight: 83.8 kg.
For the above treatments, there were no notes in the electronic medical record for 04/09, 04/11, 04/13, and/or 04/18 addressing ongoing measures to address the lack of meeting the target weight of 80.0 kg. A note from the nurse practitioner on 04/16/24 addressed missed treatments altogether and the importance of the patient adhering to treatment days and times.
MR#4 Admission Date: 01/03/2023. Hemodialysis (HD) Treatment Records from 04/06/2024 to 04/18/2024 revealed the following:
04/18/2024: HD treatment was initiated at 6:19 AM and terminated at 9:34 AM. BP recorded on the treatment details flowsheet (intradialytic section) revealed that the patient's BP at 9:34 AM was 80/52. The nursing post assessment on the flowsheet recorded a sitting BP of 79/58. A standing BP was not recorded on the nursing post assessment. There was no notation by the nurse on the flowsheet nor in the electronic medical record addressing the hypotension.
An interview with the administrator and clinical services manager on April 24, 2024 starting at 2:00 PM confirmed the above findings.
Plan of Correction:The Facility Administrator held mandatory in-services for all clinical teammates starting on 05/01/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-08 "Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment" emphasizing but not limited to: [Pre-treatment data collection]: 1) Patient data will be obtained and documented by the patient care technician or licensed nurse. Data collection includes: Measurement of blood pressure, sitting and standing and intradialytic BP in the sitting/reclined or supine position and pre and post patient weight. 2) Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse ... If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. 3) Patient identity, prescription and machine settings are verified by teammates prior to initiation of treatment with the exception of blood flow rate (BFR) which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse by one (1) hour of treatment initiation along with the nursing assessment... including but not limited to ... Blood flow rate. [Intradialytic monitoring]: 4) Intra dialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes vital signs and treatment monitoring at least every 30 minutes. 5) If the dialysis prescription is not being met [including dialysis flow rate or change to/inability to obtain prescribed blood flow rate] the reason will be documented and the licensed nurse informed. [Post treatment]: 6) The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre dialysis findings. 7) If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 8) Licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility. 9) All findings, interventions and patient response will be documented in the patient's medical record. [Abnormal findings]: Blood pressure - Pre or post dialysis: Systolic less than 90 mm/Hg; Diastolic less than 50 mm/Hg. Fluid Status ... Post-treatment: If patient is above or below 1kg from target weight. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet.
The Facility Administrator and Clinical Coordinator will conduct audits to verify treatment documentation is accurate and complete, licensed nurse is notified of abnormal findings and appropriate interventions are implemented and documented by the licensed nurse: on twenty five percent (25%) of flow sheets daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed, until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.90(a)(1) STANDARD POC-ACHIEVE ADEQUATE CLEARANCE Name - Component - 00 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.
Observations:
Based on review of facility policies/procedure, medical records (MR), hemodialysis (HD) treatment documentation, and an interview with the administrator and manager of clinical services, the facility failed to ensure the blood flow rate (BFR) was administered per physician order for one (1) of five (5) incenter hemodialysis MR's reviewed (MR #3), and the facility failed to provide documentation that a patient requested early treatment termination for one (1) of five (5) HD MR's reviewed: MR#3.
Findings include:
A review of Facility Policy 1-03-08 Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment conducted on April 24, 2024 at approximately 9:00 AM reads in part, "Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment...The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation. Prescription components include but are not necessarily limited to:.....Blood flow rate (BFR). If the dialysis prescription is not being met the reason will be documented and the licensed nurse informed..."
A review of Facility Policy 1-01-09 Prescribed Treatment Time Not Met conducted on April 24, 2024 at approximately 9:15 AM states in part, "Provides requirements for teammates to follow when a patient's treatment time is terminated early or extended; The RN will verify that a patient signs the Early Termination of Treatment Against Medical Advice Form any time the patient requests to terminate their treatment earlier than the prescribed run time...The RN will obtain the patient's signature on the Early Termination of Treatment Against Medical Advice form prior to the patient being rinsed back from their treatment. If unable to obtain the patient's signature prior to rinse-back, the RN will obtain the patient's signature on the form prior to the patient's departure from the facility. A RN must countersign all Early Termination of Treatment Against Medical Advice forms. A witness signature is required only if the patient refuses to sign the form. If a patient refuses to sign the Early Termination of Treatment Against Medical Advice form, the RN will document the patient's refusal with the words "patient refused" in the patient signature box along with the date. Under such circumstances, the RN will sign the form and will also obtain a witness' signature on the form... If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient's attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient's specific needs...Shortened/Early Termination of dialysis treatment includes all reasons the prescribed dialysis time is not met by 30 or more minutes....the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient's medical record....Fluid Status Post Treatment - if patient is above or below 1 kg from the target weight."
A review of medical records (MR) was completed on April 23, 2024 from approximately 9:00 am to 2:30 pm and on April 24, 2024 from approximately 9:00 am to 10:00 am. The admission date is indicated below.
MR #1: Admission Date: 06/21/2022. HD Orders were as follows: Blood Flow Rate (BFR) 450 ml/min; Ordered Maximum Ultra Filtration Rate (UF): 13.0 ml/kg/hr. Target Weight: 80 kilograms (Kg); Treatment Duration: 4.0 hours (h) 240 minutes (m).
Hemodialysis (HD) Treatment Records from 04/06/2024 to 04/18/2024 revealed the following:
04/09/2024: Treatment duration: 207 min (3h, 27m). Reason for early treatment termination: patient choice.
04/11/2024: BFR for the entire treatment time: 400 ml/min. Treatment duration: 181 min (3h, 1m). Reason for early treatment termination: patient choice.
04/13/2024: Treatment duration: 192 min (3h, 12m). Reason for early treatment termination: patient choice.
04/16/2024: BFR from 6:25 AM to 7:32 AM: 400 ml/min. BFR increased at 7:32 AM to 450 ml/min. Treatment duration: 209 min (3h, 29m). Reason for early treatment termination: patient choice.
04/18/2024: BFR for the entire treatment time: 400 ml/min. Treatment duration: 187 min (3h, 7m). Reason for early treatment termination: patient choice.
For the above treatments, there were no notes indicating the reason for the altered blood flow rate. There were no Early Termination of Treatment Against Medical Advice Forms found in the medical record for the above treatment dates. A review of notes in the electronic medical record for 4/9/24, 4/11/24, 4/13/24, and 4/18/24 did not address the reason for the change in blood flow rate, nor was there documentation addressing the shortened treatments. A note from the nurse practitioner on 04/16/24 addressed missed treatments altogether and the importance of the patient adhering to treatment days and times.
An interview with the administrator and clinical services manager on April 24, 2024 starting at 2:00 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 5/1/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-08 "Pre- Intra- Post Treatment Data Collection, Monitoring and Nursing Assessment" and Policy 1-01-09 "Prescribed Treatment Time Not Met" with emphasis on but not limited to: A. [Policy - Pre- Intra- Post]: 1) Patient identity, prescription and machine settings are verified by teammates prior to initiation of treatment. Prescription components include but are not necessarily limited to... Blood Flow rate... 2) If the dialysis prescription is not being met ... the reason will be documented and the licensed nurse informed. 3) The following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient's medical record... Fluid Status Post treatment: If the patient is above or below 1 kg from the target weight. B. [Policy - Prescribed Treatment Time...]: 1) The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time. 2) The RN will obtain the patient's signature on the Early Termination of Treatment Against Medical Advice form prior to the patient being rinsed back from their treatment. If unable to obtain the patient's signature prior to rinse-back, the RN will obtain the patient's signature on the form prior to the patient's departure from the facility. 3) An RN must countersign all Early Termination of Treatment Against Medical Advice forms. A witness signature is required only if the patient refuses to sign the form. 4) If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient's attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient's specific needs. 5) Shortened/Early Termination of the dialysis treatment includes all reasons the prescribed dialysis time is not met by 30 or more minutes. This includes but is not limited to: the late initiation of treatment with termination at scheduled time, early termination at the end of treatment and interruptions of dialysis during the treatment i.e. machine or access problems or use of the bathroom by the patient. 6) If a patient's treatment is shortened/early terminated, the RN will document the event in the patient's electronic health record. Documentation will include, as appropriate: the amount of time by which the treatment was shortened; a description of why the treatment was shortened; whether the patient's nephrologist was notified; a description of the follow-up medical orders provided by the patient's attending nephrologist (if any); a description of all other interventions planned to address the shortened treatment, including recommendations to the patient. 7) A completed copy of the Early Termination of Treatment Against Medical Advice form will be kept in the patient's health record. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet.
The Facility Administrator or designee will conduct audits: 1) to verify teammates complete appropriate documentation on the treatment record and notify the RN concerning prescribed blood flow rate if parameters are not meeting treatment prescription, with appropriate RN intervention documented; 2) to verify the "Early Termination of Treatment against Medical Advice" form is signed by the patient and Registered Nurse when treatment times are not met on the treatment record as prescribed. Each audit series will be conducted on twenty five percent (25%) of the flow sheets daily for two (2) weeks then weekly for two (2) weeks then, then ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed, until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.100(b)(2),(3) STANDARD H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS Name - Component - 00 The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ' s medical record.
Observations:
Based on a review of medical records, facility policy, peritoneal dialysis (PD) documentation, and an interview with the administrator, clinical services manager, and home peritoneal dialysis training nurse, the facility failed to provide evidence of adequate home peritoneal dialysis (PD) monitoring for two (2) of two (2) PD patients: MR#6 and MR#7.
Findings include:
A review of Facility Policy: 5-01-21 conducted on April 24, 2024 at approximately 11:45 AM reads in part, "The peritoneal dialysis facility will retrieve and review treatment information submitted electronically, every seven (7) days from receipt of treatment level data. Based on what the patient submits, follow-up may be necessary and the patient's electronic health record will be updated to reflect any new information obtained."
A review of medical records was conducted on April 23, 2024 from 9:00 AM to 3:30 PM, and again on April 24, 2024 from 9:00 AM to 10:00 AM. The admission date is indicated below.
MR#6 Admit date 02/01/2024 completed home peritoneal dialysis (HPD) training on 03/06/2024. The patient was using Homechoice Claria Automated Peritoneal Dialysis system with Sharesource. Sharesource is a remote patient management system that allows healthcare providers to securely view their patient's recently completed home dialysis-related treatment data which is automatically collected after each peritoneal dialysis (PD) session. Healthcare providers can then act on this information by remotely adjusting their patients' home therapy prescription without requiring the patient to travel to the facility. The PD prescription dated 03/14/2024 contained orders for a target weight of 77.0 kg (kilograms). The treatment schedule was seven (7) days per week.
A review of forty-five (45) treatments via the Homechoice Claria Prescribed Versus Actual Reports from March 6, 2024 to April 22, 2024 found that the target weight was entered as 80.0 kg which is 3.0 kg difference from the physician order. There was no documentation as to the reason for the discrepancy. Further review of the Claria report found that it did not contain pre or post treatment weights or pre or post blood pressure (BP) measurements. Handwritten data requested from the patient and collected by the facility for 03/12/2024 and 03/13/2024 contained pre/post weights and pre/post BP, but they were the only additional notes provided to/by the facility regarding data collected pre and post treatment.
Nurses Notes recorded in the facility's electronic medical record revealed that on 03/11/2024, 3/12/2024, 03/14/2024, the home treatment record was reviewed by the home peritoneal training nurse (PDN), but there is no documentation pertaining to the reason for the absence of pre/post weights and pre/post BP measurements. A note on 03/18/2024 states, "spoke with pt regarding treatments" but no further detail was documented. A note on 04/09/2024 states, "evaluate weight (pre/post weight, target weight, body weight) but no further detail was documented. A home treatment review was documented by the PDN again on 04/17/2024, but there is no mention of the absence of weights or BP.
A Nurse Monthly Progress note from the PDN dated 03/14/2024 states "evaluate weight (pre/post-weight, target weight, body weight)" as an upcoming care activity due 04/08/2024. There was no documentation available on 04/08 addressing the above. A subsequent PDN nurses' note on 04/09 states, "Call placed to patient. Patient states that s/he was on his/her way out the door and would call nurse back at another time." The next PDN entry, dated 04/12, stated that patient "gets frustrated at times during treatment with machine," and that "patient concerns would be reviewed when s/he comes in for lab appointment on 04/17/2024." The PDN documentation on 04/17 notes that a home treatment review occurred, and that the patient was educated on reducing risk for peritonitis, but no further education is documented regarding the importance of obtaining weights and BP measurements.
The nurse monthly progress note contains PDN attestations for 03/08, 03/09, 03/10, 03/11, 03/12, and 03/13 stating that the "above treatments and medications have been completed as expected and that the patient has provided the necessary documented confirmation."
An interview was held with the medical director on April 24, 2024 at 8:00 AM. The medical director stated that the patient is new to PD and that the clinic continues to work with the patient. The medical director also noted that the patient will be attending clinic on April 25, 2024 at which time the above issues will be addressed with the patient.
No PD treatments were recorded for April 6 and April 7, 2024. There was no documentation addressing the missed treatments.
MR#7 Start Date 02/06/2023. The patient was using Homechoice Claria Automated Peritoneal Dialysis system with Sharesource. The PD prescription dated 03/14/2024 contained orders for a target weight of 80.0 kg (kilograms). The treatment schedule was seven (7) days per week.
A review of fifty-two (52) treatments via the Homechoice Claria Prescribed Versus Actual Reports from March 1, 2024 to April 22, 2024 found that the target weight was entered as 76.0 kg which is 4.0 kg difference from the physician order. There was no documentation as to the reason for the discrepancy. Further review of the Claria report found that it did not contain pre treatment weights and/or pre treatment BP on the following dates: 03/03, 03/06, 03/08, 03/09, 03/11, 03/12, 03/16, 03/17, 03/19, 03/21, 03/22, 03/24, 03/25, 03/26, 03/28, 03/29, 03/31, 04/02,04/04, 04/06 to 04/10, 04/15 and 04/15. There were no post treatment weights or BP measurements recorded for any of the treatments on the Claria Report.
The nurse monthly progress note contains nurse attestations for 03/01, 03/02, 03/03, 03/04, 03/05, 03/06, 03/07, 03/08, 03/09, 03/10, 03/11, 03/12, 03/13 stating that the "above treatments and medications have been completed as expected and that the patient has provided the necessary documented confirmation." There is no documentation as to the reason for the missing data, i.e., pre/post treatment weights, pre/post treatment BP.
An interview with the administrator and manager of clinical services conducted on April 24, 2024 starting at 2:00 PM confirmed the above findings.
Plan of Correction:The Facility Administrator held mandatory in-services for all Peritoneal Dialysis (PD) teammates starting on 05/1/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 5-01-21 "Home Dialysis Monitoring and Ongoing Patient Education" and Policy 5-01-29 "Daily Home Treatment Record (Flowsheet)" with the emphasis on but not limited to: A. Home dialysis monitoring: 1) The Peritoneal Dialysis facility will: a. Document in the patient's medical record that the patient, the caregiver, or both have received and demonstrated an adequate comprehension of the training by reviewing home patient clinical records for evidence of compliance with their training. b. Retrieve, and review treatment information submitted electronically, every seven (7) days from receipt of treatment level data. Based on what the patient submits, follow up may be necessary and the patient's electronic health record will be updated to reflect any new information obtained... d. Maintain information in the patient's medical record. B. Daily home treatment record: 1) Purpose: To provide guidance for proper documentation of home peritoneal dialysis treatments and to collect data to assist in assessing the patient's response to peritoneal dialysis treatments. 2) As clinically applicable, all treatment data outlined on the Daily Home Treatment Record must be collected. Completed Daily Home Treatment Records must be reviewed to assist in evaluating the patient's progress and self-care decision-making process. This post-treatment data review will be verified by the Peritoneal Dialysis registered nurse documenting review in the medical record per guidance... b. If an abnormal finding(s) or concern is identified, the LPN/LVN will report to the RN. c. The RN will use their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary. 3) Abnormal findings: Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient's medical record. a. Within each category, definitions may be adjusted by a patient specific physician order. In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient's condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings. b. Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the Registered Nurse, and Nephrologist, as applicable. c. Fluid status: If the patient is above or below 2kg from the target weight. 4) All Daily Home Treatment Records will be reviewed, attested to, and maintained as a part of the patient's medical record. In the absence of Daily Home Treatment Records, the licensed nurse will review with the patient the importance of Daily Home Treatment Records, and the patient's responsibility to provide them and issue new paper flowsheets and provide instruction as applicable for electronic documentation. All of the above will be documented and attested to by the licensed nurse in the medical record. In addition, the patient's plan of care should address any problems with adherence to this requirement. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. Patients identified by the surveyor were referred to IDT for reassessment and update to plan of care as appropriate, to address target weights and treatment documentation, with updates by 05/31/24.
The Facility Administrator or designee will conduct audits on one hundred percent (100%) of the home treatment forms to verify all treatment data which is outlined on the daily treatment record is collected; PD nurse has reviewed; if abnormalities are noted, they will be documented in the clinical record and physician notified if applicable: monthly for three (3) months. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed, until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.140 STANDARD PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY Name - Component - 00 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility's staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility's staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions.
Observations:
Based on a review of the personnel file worksheet completed by the facility administrator, facility policy, Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens regulations, and an interview with the administrator, the facility failed to ensure that personnel qualifications were met for one (1) of fourteen (14) personnel listed on the worksheet: ID#11.
Findings include:
A review of Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Fact Sheet was conducted on April 19, 2024 at approximately 2:30 PM. The fact sheet reads in part, "Hepatitis B virus (HBV) is a pathogenic microorganism that can cause potentially life-threatening disease in humans. HBV infection is transmitted through exposure to blood and other potentially infectious materials (OPIM) as defined in the OSHA Bloodborne Pathogens Standard, 29 CFR 1910.1030. Any workers who have reasonably anticipated contact with blood or OPIM during performance of their jobs are considered to have occupational exposure and to be at risk of being infected. An employer must develop an exposure control plan.... employers must make hepatitis B vaccination available to these workers.... employers must offer the vaccination series to all workers who have occupational exposure. Examples of workers who may have occupational exposure include, but are not limited to, healthcare workers...the vaccine must be offered at no cost to the worker and at a reasonable time and place."
A review of OSHA Bloodborne Pathogens Standard, 29 CFR 1910,1030 was conducted on April 19 2024 at approximately 3:00 PM. Standard 1910.1030b defines Occupational Exposure as "reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties. Standard 19.10.1030(c)(1)(i) states "each employer having an employee(s) with occupational exposure shall establish a written Exposure Control Plan designed to eliminate or minimize employee exposure." Section 1910.1030(f)(1)(i) states, "the employer shall make available the hepatitis B Vaccine and vaccination series to all employee who have occupational exposure." Section 1910.1030(f)(1)(ii)(A) states, "made available at no cost to the employee." Section 1910.1030(F)(1)(ii)(B) states, "made available to the employee at a reasonable time and place."
A review of Facility Policy 8-02-05 Training Program for New Patient Care Provider Teammates conducted on April 25, 2024 at 1:00 PM reads in part, "Specific training needs of the new DaVita teammate employed as a patient care provider are dependent on past dialysis experience and current knowledge base. Both the new non-experienced dialysis teammate and the new experienced dialysis teammate will complete modality specific requirements."
A review of Facility Policy 8-02-08 Auditing of Clinical Practice Requirements for Water and Dialysate Concentrate conducted on April 25, 2024 at 1:30 PM reads in part, "Initial training will be completed after new hire and annually thereafter."
A review of Facility Policy 8-02-03 Color Vision Evaluation conducted on April 25, 2024 at 2:00 PM reads in part, "Teammates who will be utilizing test kits or strips that relay on color differentiation for test results will be evaluated for ability to see color."
A review of the ESRD Core Survey Facility Worksheet: Personnel File completed by the administrator on 04/22/2024 found that information pertaining to Hepatitis Vaccine Acceptance/Declination, Competencies, Training in Emergency Preparedness and Infection Control, Water Testing and Color Blindness Testing was not provided for one employee listed as #11 on the worksheet- a per diem (as needed) registered nurse, date of hire: 10/01/2019.
The administrator was interviewed on April 24, 2024 at approximately 8:45 AM regarding the missing information on the worksheet. The administrator stated that the information is not available as it has been difficult to obtain the information from the employee since s/he works so infrequently, and that the facility has ongoing efforts to secure the information.
An interview with the administrator and manager of clinical services on April 24, 2024 at 2:00 PM confirmed the above findings.
Plan of Correction:The Facility Administrator held mandatory in-services for all clinical teammates starting on 05/1/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 8-02-01 "Teammate Qualifications, Licensure and Adequate Teammate Staffing" and Policy 8-02-03 "Color Vision Evaluation" with emphasis on but not limited to: A. Teammate qualification: 1) All dialysis facility teammates will meet applicable scope of practice, board and licensure requirements in effect in the State in which they are employed. 2) The dialysis facility's teammates (or contractors) will meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility's teammates (or contractors) will have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. B. Color vision evaluation: 1) Teammates/patients/helpers who will be utilizing test kits or strips that rely on color differentiation for test results will be evaluated for ability to see color. Color blindness testing is performed at time of hire. 2) Documentation of the color vision evaluation will be documented in the teammate's file and/or patient's medical record.
Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. The identified teammate will complete a color vision test prior to performing duties which require a color vision evaluation. Evaluation will be recorded and maintained in the teammate's file. The Facility Administrator will audit one hundred percent (100%) of teammate files to verify competencies and skills checklists are present and up to date by 05/30/24, including and not limited to color vision evaluation. Any missing or outdated items will be completed and placed in the teammate file. Going forward, the Facility Administrator of designee will perform teammate file audits quarterly to verify compliance. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed, until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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