Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted July 29, 2024 through August 1, 2024, Buttonwood Dialysis was identified to have the following standard level deficiency that was determined to be in substantial 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:
494.62(d)(1) STANDARD ESRD EP Training Program Name - Component - 00 §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures.
Observations:
Based on a review of medical records (MR), facility policies, and an interview with the administrator, the facility did not follow its policy regarding the performance of quarterly fire safety/emergency/disaster preparedness drills for ten (10) of eleven (11) MR reviewed: MR#2, MR#3, MR#4, MR#5, MR#6, MR#7, MR#8, MR#9, MR#10, and MR#11.
Findings include:
A review of the following policies were conducted on July 31, 2024 at 8:00 AM:
Policy 4-07-01 The Facility Emergency Management Plan (ICHD, Home) states in part: "Emergency Management Plan Section b. Patients, ii. Quarterly, 1. Fire Safety Preparedness, 2. Emergency Take-off procedures."
Policy 5-01-21 Home Dialysis Monitoring and Ongoing Patient Education reads in part, The following need to be reviewed at least quarterly: Emergency/Disaster Preparedness."
A review of MRs was conducted on July 30, 2024 starting at 12:00 PM and again on July 31, 2024 starting at 8:00 AM. The admission date (AD) is indicated below.
MR#2 AD 07/27/2019 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 3rd quarter of 2024, nor in the 1st, 2nd, 3rd, or 4th quarters of 2023.
MR#3 AD 06/3/2020 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 1st, 2nd, 3rd, or 4th quarters of 2023.
MR#4 AD 11/07/2019 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 2nd quarter of 2024, nor in the 1st, 2nd, 3rd, or 4th quarters of 2023.
MR#5 AD 03/11/2022 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 3rd quarter of 2024, nor in the 1st, 2nd, 3rd, or 4th quarters of 2023.
MR#6 AD 08/29/2016 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 2nd, 3rd, or 4th quarters of 2023.
MR#7 AD 04/19/2021 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 1st, 2nd, 3rd, or 4th quarters of 2023.
MR#8 AD 04/02/2009 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 1st, 2nd, 3rd, or 4th quarters of 2023.
MR#9 AD 06/21/2019 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 1st, 2nd, 3rd, or 4th quarters of 2023.
MR#10 AD 08/07/2023 did not contain evidence that fire safety preparedness was reviewed with the patient at the time of admission, nor in the 4th quarter of 2023.
MR#11 AD 12/18/2020 did not contain evidence that quarterly fire safety preparedness drills were conducted in the 2nd quarter of 2024, nor in the 3rd and 4th quarters of 2023.
An interview conducted with the administrator and regional home program manager on August 1, 2024 starting at 10:15 AM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee will in-service all clinical teammates starting on 08/05/24. . Surveyor observations were reviewed. Education included but was not limited to a review of Policy 4-07-01 "Facility Emergency Management Plan (EMP)" and Policy 5-01-21 "Home Dialysis Monitoring and Ongoing Education"with emphasis on but not limited to: A. EMP: 1) the Facility Administrator or designee, is responsible to provide training for patients upon admission and quarterly: a. One drill to be conducted for each shift of patients. b. Include patient emergency takeoff procedure, policy: "Termination of Dialysis in an Emergency". Documentation of training will be kept in the patients charts, "Emergency Evacuation Acknowledgement Form" B. Home: 1) The following need to be reviewed at least Quarterly: Emergency/disaster preparedness. 2) Maintain information in the patient's medical record. Verification of attendance is evidenced by teammate's signature on the in-service sheet. The Facility Administrator or designee immediately completed a one hundred percent (100%) audit of patient emergency preparedness / fire drill documentation. Missing documentation for any patients, including for those identified by the surveyor was completed by 08/09/24. The Facility Administrator or designee will audit fire drill / emergency preparedness training documentation for three (3) quarters to verify compliance for all shifts of patients. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-adherence will be correctly immediately. The Facility Administrator or designee will review audit results with teammates during homeroom 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.
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted July 29, 2024 through August 1, 2024, Buttonwood 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:
494.60 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 Dialysis Storage Area, a review of facility policies, a review of infection control documents, and an interview with the administrator, the facility failed to remove expired supplies for one (1) of four (4)observations: OBS#4
Findings include:
A review of the following facility policies took place on July 30, 2024 starting at approximately 8:20 AM.
Policy 5-06-01 Infection Control For Dialysis Facilities reads in part, "Supplies will be stored in a manner that maintains their integrity."
Observation #4 took place in the Water Treatment/Storage Area from 9:00 AM to 9:30 AM on 07/30/2024. The observation revealed the following:
Non-Injectable Catheter Caps, 3 boxes, each with a quantity of 100 were found to be expired: Box #1 contained 91 remaining caps, lot#1900070, use by date of 5/7/2022; Box #2 contained 100 caps, lot#1900070, use by date of 5/7/2022; Box #3 contained 100 caps, lot#2200078, use by date 5/6/2022.
Becton-Dickinson (BD) Microtainer Contact-Activated Lancet, 1 box with a quantity of 200 contained 90 remaining lancets, lot#y9MM8A2, expired 11/30/2023.
Actamedical Administration Infusion Sets Y-Site found 12 sets, lot#20210727, expired 07/26/2024.
Webcol Covidien Alcohol Prep Pads, 2 boxes, each with a quantity of 200 were found with a manufacturers date of 2013 on the boxes. Box #1 contained 124 remaining alcohol pads, lot#15F019462X; Box #2 contained 192 remaining alcohol pads, lot#15G200562X.
An interview conducted with the administrator and regional home program manager on August 1, 2024 starting at 10:15 AM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-service(s) for all clinical teammates starting on August 5, 2024. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 5-06-01 "Infection Control for Dialysis Facilities (PD)" with emphasis on but not limited to: 1) Supplies will be stored in a manner that maintains their integrity... Expiration date and package integrity will be verified prior to use. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. The Facility Administrator or designee immediately checked all supplies medications for expiration dates. Any supplies found expired were removed from inventory and appropriately disposed, including those identified in surveyor's observations on 08/01/24. The Facility Administrator or designee will monitor ongoing compliance 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 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, medical records (MR), hemodialysis (HD) treatment records, peritoneal dialysis (PD) treatment records, and an interview with the facility administrator, the facility did not address abnormal findings per the facility's policy and/or did not conduct post treatment nursing assessments for hemodialysis (HD) patients for three (3) of nine (9) HD MR reviewed: MR# 6, MR#7, and MR#9, and did not provide evidence that pertinent clinical data was captured for peritoneal dialysis (PD) patients for two (2) of two (2) PD MR reviewed: MR#10 and MR#11..
Findings include:
The following policies were reviewed on July 30, 2024 at 8:15 AM - 8:20 AM:
Facility Policy 1-03-08 Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment 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: Blood pressure (BP) intradialytic: systolic greater than 180 mm/Hg or less than 90 mm/Hg; diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg; Post treatment: systolic BP greater than 140 mm/Hg or less than 90 mm/HG; diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg; ....The licensed nurse will assess the patient prior to discharge. "
Facility Policy 5-01-29 Daily Home Treatment Record (Flowsheet) states in part, "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 below: a) the licensed nurse will review the patient's data via submitted Daily Home Treatment Records....d) the licensed nurse is responsible for end of month review for all Daily Home Treatment Records." The policy also contains a section on Abnormal Findings which reads in part, "...the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient's medical record....Fluid Status: if patient is above or below 2 kg from the target weight and if patient is using 4.25% (red) dialysate; Blood Pressure: Systolic greater than 150mm/Hg or less than 90mm/Hg, Diastolic greater than or equal to 100mm Hg; Temperature Pre/Post/PRN: Greater than 100 degrees Fahrenheit or 2 degree rise over baseline;" and "All Daily Home Treatment Records will be reviewed, attested to, and maintained as part of the patient's medical record."
A review of MRs was conducted on July 30, 2024 starting at 12:00 PM and again on July 31, 2024 starting at 8:00 AM. The admission date (AD) is indicated below.
MR#6 AD 08/29/2016. HD Treatment Records reviewed from 07/15/2024 to 07/26/2024 found the following:
07/15/2024: HD Treatment was initiated by the patient care technician (PCT) at 11:00 AM. Blood pressure (BP) was 209/103 at the start of treatment.
07/17/2024: HD Treatment was initiated by the PCT at 11:00 AM. BP was 212/99 at the start of treatment. Subsequent BP recordings were: 246/93 (11:30 AM), 200/114 (12:00 PM), 157/51 (12:30 PM), 236/71 (1:01 PM), 205/90 (1:30 PM), 265/85 (2:01 PM), 160/67 (3:00 PM), and 158/66 (3:05 PM).
07/18/2024: HD Treatment was initiated by the PCT at 11:22 AM. BP was 217/111 at the start of treatment.
There was no evidence that the licensed nurse was notified about the elevated blood pressures during the 7/15, 7/17, or 7/18 HD treatments. There was no documentation on either the treatment details reports or in the electronic medical record by the licensed nurse regarding the elevated blood pressures, no evidence that the physician was notified of the consistently high BP's on 7/17, nor were any other interventions implemented to address the elevated pressures on 7/17.
MR#7 AD 04/19/2024. HD Treatment Records reviewed from 07/15/2024 to 07/26/2024 found that there were no post treatment nursing assessments documented on the treatment details reports for 7/15, 7/18, 7/19, 7/22, and 7/24.
MR#9 AD 06/21/2019. HD Treatment Records reviewed from 07/15/2024 to 07/26/2024 found that there were no post treatment nursing assessments documented on the treatment details reports for 7/22, 7/24, and 7/26.
MR#10 AD 08/07/2023. 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 06/21/2024 contained orders for a target weight of 94.0 kg. The Sharesource PD Treatment Records provided by the facility and reviewed for the time frame of 06/18/2024 to 07/22/2024 contained no recordings of pre or post patient weights, pre or post blood pressures, or patient temperatures.
MR#11 AD 12/18/2020. A review of the daily home treatment PD records documented by the patient, reviewed for the time frame of 05/16/2024 to 07/24/2024, contained no column to capture patient temperature and therefore, there was no evidence to support that the patient's temperature was monitored.
An interview conducted with the administrator and regional home program manager on August 1, 2024 starting at 10:15 AM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 08/05/24. 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" [In-center] and Policy 5-01-29 "Daily Home Treatment Record" [Home] with emphasis on but not limited to: A. Policy - In-center: 1) 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 component are confirmed by a licensed nurse by 1 hour of treatment initiation along with the nursing assessment. Prescripton components include but are not necessarily limited to:.....Blood fow rate (BFR). 2) 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. 3) Abnormal findings or findings outside of any patent specifc physician ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment based on individual patent needs to determine if any clinical interventons are necessary.. 4) Abnormal Findings: ... the following are considered abnormal findings and should be reported to the licensed nurse and documented on the patient's medical record. Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time ... [Blood Pressure: Pre dialysis]: ... Systolic greater than 180 mm/Hg (millimeter/Mercury) or less than 90 mm/Hg; Diastolic greater than or equal to 100 mm/Hg. [Blood Pressure -Intradialytic Systolic greater than 180 mm/Hg or less than 90 mm/Hg; Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg. [Blood Pressure Post Treatment]: If the patient can stand: Standing systolic BP greater than 140 mm/Hg or less than 90 mm/Hg; Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg. Sitting BP for patient's that cannot stand: Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg; Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg. 5) 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. 6) All findings, interventions and patient response will be documented in the patient's medical record. B. Policy – Home: 1) 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 below. a) The licensed nurse (RN/LPN/LVN) will review the patient's data via the submitted Daily Home Treatment Records...d) The licensed nurse is responsible for end of month review for all Daily Home Treatment Records. 2) Abnormal findings: the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient's medical record. [Fluid Status]: If patent is above or below 2 kg from the target weight and if patent is using 4.25% (red) dialysate. [Blood Pressure]: Systolic greater than 150mm/Hg or less than 90mm/Hg, Diastolic greater than or equal to 100mm Hg. [Temperature Pre/Post/PRN]: Greater than 100 degrees Fahrenheit or 2 degree rise over baseline. 3) All Daily Home Treatment Records will be reviewed, atested to, and maintained as part of the patent's medical record. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. The Facility Administrator or designee will complete flow sheet audits to verify any documentation of abnormal findings is also reported to the licensed nurse, and response is documented including but not limited to post treatement assessment, and physician notification as needed, per policy: on twenty five percent (25%) of the 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. 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 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-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 a review of medical records (MR), hemodialysis (HD) treatment records, facility policies, and an interview with the administrator, the agency failed to follow hemodialysis (HD) treatment physician orders for two (2) of eleven (11) records reviewed: MR#7 and MR#9.
Findings include:
The following policies were reviewed on July 30, 2024 at 8:20 AM:
Facility Policy 1-03-08 Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment 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..."
Facility Policy 1-01-09 Prescribed Treatment Time Not Met states in part, "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. 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 shortened/early termination of treatment 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 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 treatment, i.e., machine or access problems or use of the bathroom by the patient. Reasons why a patient's treatment may be terminated early include, but are not limited to:.....patient choice. If a patient's treatment is shortened/early terminated, the RN will document the event in the patient's electronic health record.... A completed copy of the Early Termination of Treatment Against Medical Advice form will be kept in the patient's health record."
A review of MR was conducted on July 30, 2024 starting at 12:00 PM and again on July 31, 2024 starting at 8:00 AM. The admission date (AD) is indicated below.
MR#7 AD 04/19/2024. HD Treatment Orders started on 06/28/2024 included a blood flow rate (BFR) order of 350 mL/Min, and a HD treatment duration of four (4) hours). HD Treatment Records reviewed from 07/15/2024 to 07/26/2024 found the following:
7/18: HD Treatment was shortened and terminated after 3 hours and 19 minutes. Treatment was started at 6:37 AM and terminated at 9:56 AM. 7/19: BFR was 300mL/min for the entire treatment. BFR was started at 200 mL/Min at 3:53PM, then increased to 300 mL/Min at 4:02 PM where it remained until 7:02 PM. Treatment was shortened and terminated at 7:08 PM after 3 hours, 18 minutes 7/22: BFR was 300mL/min for the entire treatment. BFR was started at 300 mL/Min at 12:04 PM where it remained until 3:31 PM. HD Treatment was shortened and terminated at 3:15 PM after 3 hours, 11 minues. 7/24: BFR was 300mL/min for the entire treatment. BFR was started at 200 mL/Min at 11:22 PM, then increased to 300 mL/Min at 11:30 PM where it remained until the treatment end time at 15:10 PM. 7/26: BFR was 300mL/Min for the entire treatment. BFR was started at 300 mL/Min at 11:25 PM, where it remained until 2:01 PM at which time the BFR was increased to 350 mL/Min. Treatment was shortened and terminated at 2:43 PM after 3 hours, 18 minutes.
There were no notes addressing the reason for the discrepancy in BFR when compared to the physician treatment orders indicating that the BFR should be 350mL/min, nor were there any new physician orders changing the BFR for any of the above treatments. There were no early termination of treatment against medical advice forms contained in the medical record for the shortened treatments on 7/18, 7/19, 7/22 or 7/26.
MR#9 AD 06/21/2019. HD Treatment Orders started on 07/03/2024 included a HD treatment duration of four (4) hours. HD Treatment Records reviewed from 07/15/2024 to 07/26/2024 found that the HD treatment on 7/26 was terminated after 3 hours, 5 minutes. There was no early termination of treatment against medical advice form contained in the medical record for the shortened treatment.
An interview conducted with the administrator and regional home program manager on August 1, 2024 starting at 10:15 AM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 08/05/24. 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", Policy 1-01-09 "Prescribed Treatment Time Not Met" with emphasis on but not limited to: A. Policy "Pre- Intra- Post Treatment...": 1) 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. 2) The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to ... Blood flow rate ... 3) 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. 4) 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. 5) All findings, interventions and patient response will be documented in the patient's medical record. B. Policy "Prescribed Treatment Time Not Met": 1) [Completion of the Early Termination of Treatment Against Medical Advice form]: a) 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. b) 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. c) 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. 2) [Prescribed Treatment Time Not Met]: a) 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. b) 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. c) If a patient's treatment is shortened/early terminated, the RN will document the event in the patient's electronic health record. d) A completed copy of the Early Termination of Treatment Against Medical Advice form will be kept in the patient's health record. The Facility Administrator or designee will conduct audits: 1) to verify any documentation of abnormal findings including but not limited to inability to obtain blood flow rate], is also reported to the licensed nurse, and response is documented per policy: 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 (25%) of the flow sheets daily for two (2) weeks then weekly for two (2) weeks, then ongoing compliance will be monitored with the mothly 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 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.
494.150(c)(2)(i) STANDARD MD RESP-ENSURE ALL ADHERE TO P&P Name - Component - 00 The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;
Observations:
Based on a review of personnel files (PF), observations on the clinical unit, facility policies, and an interview with the administrator, the facility failed to provide evidence of following its policies related to hemodialysis (HD) access visibility for five (5) of twelve (12) observations at the following stations (STN): STN #15, STN#19, STN#5, STN#17, and STN#13, and cleansing of the HD access site for one (1) of two (2) observations: STN #23, and failed to provide evidence of following its policy related to tuberculosis (TB) screening for one (1) of three (3) PF's reviewed: PF#2.
Findings include:
The following policies were reviewed on July 30, 2024 at 8:15 AM to 8:20 AM:
Policy 1-03-08 Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment reads in part, "The vascular access site, blood line connections and the patient's face should be visible throughout the dialysis treatment."
Policy 1-04-01 Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) Vascular Access Care states in part, "Patient are encouraged to wash access extremity with soap and water upon arrival for dialysis, if able. If patient unable to wash site, patient care teammate will clean access extremity with skin cleansing agency and pat dry."
Policy 1-04-01E AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose reads in part, "Procedure: Have patient wash access site with appropriate antibacterial soap, if able. If patient unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent and pat dry. Rationale: Verifies that access extremity has been cleaned."
Observations on the dialysis treatment area took place on Monday, July 29, 2024 starting at 9:15 AM, and again on Tuesday, July 30, 2024 starting at 11:00 AM. The facility provided a patient seating chart/schedule for Monday-Wednesday-Friday (3 shifts), and Tuesday-Thursday-Saturday (2 shifts). The following situations were observed:
The patient located at Station #15 (MR#23) was observed on 07/29 at 10:05 AM to have a blanket covering the access site such that the access site was not able to be visualized.
The patient located at Station #19 (MR#4) was observed on 07/30 at 12:10 PM to have a blanket covering the access site such that the access site was not able to be visualized.
The patient located at Station #5 (MR#16) was observed on 07/30 at 12:20 PM to have a blanket covering the access site such that the access site was not able to be visualized.
The patient located at Station #17 (MR#24) was observed on 07/30 at 12:25 PM to have a gown covering the access site such that the access site was not able to be visualized. It appeared that the patient had put on a white gown backwards causing the patient's arms to be covered.
The patient located at Station #13 (MR#25) was observed on 07/30 at 12:30 PM to have a blanket covering the access site such that the access site was not able to be visualized. Of note, the schedule that was received on 7/29 did not have a patient seated at that location. The surveyor asked the FA which patient had been moved to station #13. It was determined to be MR#25.
MR#19 was observed to enter the HD unit at approximately 10:31 AM on 07/29. Upon entry, the patient weighed him/herself, then walked to STN #23 without washing his/her access site at the sink located at the entrance. PF#2 proceeded to apply antiseptic to the skin over the cannulation sites in preparation for cannulation without washing the skin over the access site first. PF#2 did not ask the patient if s/he had washed the skin over the access site when the patient entered the treatment area.
The Centers for Disease Control and Prevention (CDC) and the National TB Controllers Association released updated recommendations for Tuberculosis (TB) screening, testing, and treatment of health care personnel on May 17, 2019. These recommendations update the health care personnel screening and testing section of the 2005 CDC Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Settings. All health care personnel should be screened for TB upon hire (i.e., preplacement). TB screening is a process that includes: a baseline individual TB risk assessment, a TB symptom evaluation, and a TB test (e.g., a TB single blood assay test or a two-step tuberculin skin test (TST), and additional evaluation for TB disease as needed. Health care personnel with a positive TB test result should receive a symptom evaluation and a chest x-ray to rule out TB disease. Additional workup may be needed based on those results. All health care personnel should receive TB education annually. TB education should include information on TB risk factors, the signs and symptoms of TB disease, and TB infection control policies and procedures. (CDC/MMWR/May 17, 2019/Vol.68/No.19).
The following facility policy was reviewed on July 31, 2024 at 8:00 AM:
Policy 4-06-05 Tuberculosis Monitoring and Follow-Up reads in part, "If exemption criteria for TST is not met, the following testing options are available: Baseline TST using a two step Purified Protein Derivative (PPD) Mantoux test (a second TST repeated one to three weeks after the first, if the initial test is negative. A second TST is not needed if the teammate can show documented TST results from any time during the previous 3 months; a single TST will be administered and represents the second stage of two-step testing."
A review of PF's was conducted on July 31, 2024 starting at approximately 12:20 PM. The date of hire (DOH) is indicated below.
PF#2 DOH 11/13/2023 did not contain any evidence of completion of a two-step TST or a QuantiFERON blood study upon hire.
An interview with the administrator and regional home program manager on August 1, 2024 starting at 10:15 AM confirmed the above findings.
Plan of Correction:A Governing Body meeting with the Medical Director, Facility Administrator, Nursing Manager and Regional Operations Director was held on 08/05/24, to review the results of the survey ending on 08/01/24. The Governing Body reviewed Policy COMP-DD-017 "Medical Director Qualifications and Responsibilities" with the Medical Director, who acknowledges that he/she is responsible to ensure all policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and non-physician providers. Plans of correction have been developed and initiated to correct identified deficiencies and to sustain compliance. The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 08/05/24. Surveyor observations were reviewed. Education included but was not limited to a review of policies outlined below. Verification of attendance at the in-service is evidenced by teammate's signature on the in-service sheet. 1. [Visible access]: Policy 1-03-08 "Pre- Intra- Post Treatment Data Collection, Monitoring and Nursing Assessment" with emphasis on but not limited to: 1) Intradialytic treatment monitoring and data collection includes, Vital signs completed at least every thirty (30) minutes. 2) The vascular access site, blood line connections and the patient's face should be visible throughout the dialysis treatment. The Facility Administrator or designee will conduct daily observational audits to verify teammates are confirming patient's access site, face and bloodline connections are visible throughout the dialysis treatment: daily for two (2) weeks, then weekly for two (2) weeks, then ongoing monthly during infection control audits. Instances of non-adherence will be addressed immediately. Patients refusing to keep access, bloodline connection or faces visible will be re-educated by the physician. Care conferences will be scheduled with the Interdisciplinary team and the patient to develop individual plans of correction. 2. [Cleanse access extremity]: Policy 1-05-01 "Infection Control for Dialysis Facilities"and Policy 1-04-01E "AV Fistula or Graft Cannulaton with Nipro or Medisystems Safety Fistula Needles (SFN) and Administraton of Heparin Loading Dose" with emphasis on but not limited to: A. Infection control: 1) Patients and caregivers will be encouraged to a. Wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis. B. AV Fistula or Graft Cannulation: 1) Have patient wash access site with appropriate antibacterial soap, if able. If patient unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent and pat dry. Rationale: Verifies that access extremity has been cleaned. The Facility Administrator or designee will conduct observational audits to verify teammates are encouraging patients to wash hands and access extremity upon entering the treatment area and patients are doing so: daily for two (2) weeks, then weekly for two (2) weeks, then monthly for two (2) months. Instances of non-adherence will be addressed immediately. 3. Policy 4-06-05 "Tuberculosis Monitoring and Follow-Up" with emphasis on but not limited to: 1) Testing options ... c. If exemption criteria for TST is not met, the following testing options are available: i. Baseline TST using a two-step Purified Protein Derivative (PPD) Mantoux test (a second TST repeated one to three weeks after the first if the initial test is negative). Test results will be recorded on the Teammate Health Monitoring Record. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet. The Facility Administrator will audit one hundred percent (100%) of new teammate's medical records monthly for two (2) months to verify screening is completed and documentation recorded per policy. Instances of non-compliance will be addressed immediately. The Medical Director will review progress of teammate education, results of audits, and adherence to this plan of correction during monthly Quality Assurance and Performance Improvement meetings known as Facility Health Meeting. 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 if applicable to achieve sustained compliance. Supporting documentation will be included in the meeting minutes. The Facility Administrator on behalf of the Governing Body is responsible for compliance with this plan of correction.
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