Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on November 21, 2024, Clearfield 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 completed on November 21, 2024, Clearfield 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(b)(2) STANDARD IC-ASEPTIC TECHNIQUES FOR IV MEDS Name - Component - 00 [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and
Observations:
Based on employee (EMP) interviews, observations (OBS), review of facility policy and an interview with the facility administrator, the facility failed to ensure staff/employees follow its policy for medication preparation for one (1) of two (2) medication preparation observations (OBS#1).
Findings include:
A review of policy, 1-06-01A "Preparation and Administration of Parenteral Medications (Non EPO, Non-Parsabiv) With All Dialyzer Types" on November 19, 2024 at approximately 11:00 AM states: ..."7. If the medication is in a vial, remove the vial cap, and clean vial stopper with an alcohol prep pad..."
Observation of the treatment area was conducted on November 20, 2024, from approximately 9:00 A.M. to 11:30 A.M.
OBS#1 was conducted on November 20, 2024 at approximately 9:20 A.M. Medication preparation performed by EMP#3. EMP#3 failed to utilize alcohol prep pad per policy and procedure and did not wipe the vial of Ferrlecit with alcohol or other antiseptic prior to entering the vial with a needled 10cc syringe. EMP#3 states "Since the vial is new and I just popped the seal I do not have to wipe with alcohol."
An interview with the facility administrator on November 20, 2024, at approximately 11:00 A.M. confirmed the above findings.
Plan of Correction:The Facility Administrator held mandatory in-services for all clinical teammates starting on 11/22/24. Surveyor observations were reviewed. Education included but was not limited to a review of Procedure 1-06-01A "Preparation and Administration of Parenteral Medications" with emphasis on but not limited to: 1) If medication is in a vial, remove vial cap and clean vial stopper with an alcohol prep pad. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet. The Facility Adminstrator or RN designee will conduct observational audits to verify medication preparation is compliant with policy, including but not limited to cleaning the vial stopper with an alcohol pad prior to withdrawing medication: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly infection control audits. Instances of non-adherence will be corrected immediately. The Facility Administrator 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.
494.80(a)(2) STANDARD PA-ASSESS B/P, FLUID MANAGEMENT NEEDS Name - Component - 00 The patient's comprehensive assessment must include, but is not limited to, the following:
Blood pressure, and fluid management needs.
Observations:
Based on review of policy, clinical records (CR) and interview with the facility administrator the clinic failed to ensure the nurse documented interventions for the patient leaving treatment more than 1 kg over the estimated dry weight, the clinic failed to ensure documentation of interventions for "abnormal findings" per policy, the clinic failed to ensure facility staff notified and documented that the nurse was notified if patient BP's recorded contained systolic greater than 180 mm/Hg or below 90 mm/Hg, the clinic failed to ensure patient received medications as prescribed by the physician, the clinic failed to ensure and document that the patient received the prescribed dialysis treatment time and the clinic failed to ensure all medications orders contained frequency and parameters for administration, the clinic failed to ensure physician was notified for two (2) of four (4) records reviewed (CR#2& CR#4). no CR4 data below
Findings include:
Review of Policy "1-03-08" TITLE: "PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT" completed on 11/5/2024 at approximately 11:00 AM revealed: PURPOSE: "To obtain and document baseline and ongoing inforamtion about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient's dialysis treatment, monitoring duringtreatment and for reviewing the patient's response to treatment and status prior to discharge... POLICY: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. a. Data collection includes butisnotnecessarily limited to:... ii. Measurement of Blood Pressure (BP); 1. Sitting and standing BP measurement required pre and post treatment (if patient unable to stand, document reason in patient electronic record or flow sheet)... PRE-TREATMENT DATA COLLECTION/ASSESSMENT; 4. 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... 10. If the dialysis prescription is not being met... the reason will be documented and the licensed nurse informed... 13. All findings, interventions and patient response will be documented in the patient's medical record... 16. If an abnormal finding or concern is identified post treatment, this needs to be reported to the licensed nurse... 17. Licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions or notification of physician is necessary prior to discharge of the patient from the facility... 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... Post-treatment: If patient is above or below 1 kg from the target weight... Blood Pressure: Pre-dialysis: Systolic greater than 180mm/Hg or less than 90mm/Hg... Blood Pressure-Intradialytic: Systolic greater than 180mm/Hg or less than 90mm/Hg... Blood Pressure Post Treatment: If the patient can stand: standing Systolic BP greater than 140mm/Hg or less than 90mm/Hg; If patient is not able to stand, document reason and sitting BP... Pre/Intra/Post Patient Reports/Complaints and/or teammate observation of:... Weakness or numbness... Changes in mobility, ambulation or reports of falls..."
Review of CR's completed on 11/19/2024 between approximately 8:45 AM and 12:00PM revealed:
CR#2, Admit date: 1/11/2023; Mobility: walker; ambulates - no assistance needed.
Treatment date: 11/1/2024: Mobility: walker; ambulates - no assistance neededTarget weight prescribed - 74.5 kg - pre-weight recorded 72.3 kg(kilograms) post weight recorded 71.3kg. Standing BP not documented pre-treatment, standing BP not documented post-treatment. No documented interventions by nurse/no physician notification documented. Treatment date: 11/4/2024: Mobility: ambulates - no assistance needed; standing BP not documented post-treatment; No documented interventions by nurse/no physician notification documented. Treatment date: 11/6/2024: post weight documented 72.5kg - target weight prescribed 71.0kg; No documented interventions by nurse/no physician notification documented. Treatment date: 11/8//2024: post weight documented 73.7kg - target weight prescribed 71.0kg; No documented interventions by nurse/no physician notification documented. Treatment date: 11/11/2024: post weight documented 74.1kg - target weight prescribed 71.0kg; No documented interventions by nurse/no physician notification documented. Treatment date: 11/13/2024: Mobility: ambulates - no assistance needed; standing BP not documented pre-treatment; post weight documented 73.2kg - target weight prescribed 71.0kg; No documented interventions by nurse/no physician notification documented. Treatment date: 11/15/2024: post weight documented 72.7kg - target weight prescribed 70.0kg; No documented interventions by nurse/no physician notification documented.
CR#4, Admit date: 8/28/2024; Mobility: ambulates - no assistance needed. Treatment date: 11/11/2024: 11:31 AM - intra-dialytic BP documented 212/115mm/Hg; 11:41 AM clonidine 0.1 mg documented by RN as administered; clonidine orders do not contain parameters for administration or frequency; No documented interventions by nurse/no physician notification documented. Treatment date: 11/15/2024: 11:29 AM - intra-dialytic BP documented by PCT -181/95mm/Hg; 12:29 PM - intra-dialytic BP documented by PCT - 184/107mm/Hg; 12:59 PM - intra-dialytic BP documented by PCT - 193/106mm/Hg; 13:14 PM - RN documents patient complaint of Headache and administered Tylenol - no documentation of BP monitoring/check by RN; 13:29 PM - intra-dialytic BP documented by RN- 206/109mm/Hg; 13:31 PM - intra-dialytic BP documented by RN - 172/139mm/Hg clonidine 0.1 mg documented by RN as administered; clonidine orders do not contain parameters for administration or frequency; No documented notification to RN by PCT, no interventions by nurse/no physician notification documented.
Interview with the Facility Administrator completed 11/19/2024 at approximately 2:30PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-serviced for all clinical teammates starting on 11/22/24. 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 "PRN Order - Clonidine" revised 11/27/24, with emphasis on but not limited to: A. "Pre- Intra – Post Treatment Data Collection...": Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient's dialysis treatment, monitoring during treatment and for reviewing the patient's response to the treatment and status prior to discharge. 1) Patient data will be obtained and documented by the patient care technician or licensed nurse. Data collection includes but is not necessarily limited to: ii. Measurement of blood pressure, sitting and standing BP measurement required pre and post treatment (if patient unable to stand, document reason in the patient electronic record or flow sheet)... iv. Patient weight... 2) Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment ... 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: ... Treatment time, Target weight ... 3) 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. 4) 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. 5) Abnormal finding parameters or findings outside of any patient specific physician ordered parameters will be documented and 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. 6) All findings, interventions and patient response will be documented in the patients' medical record. 7) Additional documentation if applicable includes the following: ... Indication and patient response to PRN medication. 8) 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. 9) Licensed nurse will use their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician ... is necessary prior to discharge of the patient from the facility.
[Abnormal Findings]: 1) The following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient's medical record. a. Fluid status – Post-treatment: If patient is above or below 1 kg from the target weight. b. Blood pressure: Pre-dialysis: 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. c. 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. d. 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. If patient is not able to stand, document reason and sitting BP. e. Pre/ Intra / Post Patient Reports / Complaints / and / or teammate observation of: ... Weakness or numbness... Changes in mobility, ambulation or reports of falls...
B. PRN Order - Clonidine Revised: On 11/27/24, the Facility Administrator, Clinical Coordinator and Medical Director met to review the PRN Clonidine order currently entered for patients. The Medical Directed updated the order to include parameters for administration and frequency. The revised PRN Clonidine order was reviewed by all nurses during the in-services starting on 11/22/24, and includes these parameters: Give 0.1 mg orally every 60 minutes PRN for systolic pressure greater than 180 or diastolic pressure greater than 100. May hold for known intolerance / hypotension / undesirable side effects. Max dose is 0.3 mg per HD treatment. Call physician if unable to maintain Systolic BP less than 180 or Distolic BP less than 100 after max dose administered. Prescription changes were updated in the patients' order set effective 12/02/24. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will complete flow sheet audits to verify: a. any documentation of abnormal findings or prescription not met, [including but not limited to standing BP not taken with no documented reason and sitting BP; post weight above or below 1 kg difference from target weight], is also reported to the licensed nurse;
b. nurse response is documented, [including but not limited to indication and patient response to PRN medication, and / or notification of physician, as needed];
c. PRN Clonidine is administered as needed, per the revised order set with updated parameters effective 11/27/24.
All audits will be conducted using twenty-five percent (25%) of the treatment 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-adherence will be corrected immediately.
The Facility Administrator 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.
494.80(b)(1) STANDARD PA-FREQUENCY-INITIAL-30 DAYS/13 TX Name - Component - 00 An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session.
Observations:
Based on a review of clinical records (CR), facility policy, and an interview with the facility administrator, the agency failed to ensure that an initial comprehensive assessment was conducted on all new patients within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session for two (2) of four (4) CR's reviewed: (CR#2 and CR#3).
A review of Policy 1-14-01 conducted on 11/19/2024 at approximately 1:30 PM revealed: "TITLE: Interdisciplinary Team Patient Assessment and Plan of Care... ASSESSMENT: The facility's interdisciplinary team (IDT) consistsof, at a minimum, the patient or the patient's personal representative, a registered nurse, a physician or Non-Physician Practioner (NPP), ifallowed by state ESRD licensure regulations, treatingthe patient for ESRD, a social worker, and qualified renal dietitian per CMS... 4. A comprehensive assessment will be conducted on all new patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines..."
A review of Clinical Records was conducted on 11/19/2024 from approximately 8:30 AM to 11:30 AM.
CR#2 admit date: 01/11/2023 did not have the initial comprehensive assessment completed until 03/27/2023, 75 days after the beginning of the first dialysis session.
CR#3 admit date: 01/25/2023 did not have the initial comprehensive assessment completed until 03/27/2023, 61 days after the beginning of the first dialysis session.
An interview conducted with the facility administrator on 11/19/2024 at approximately 2:00 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates and the Interdisciplinary Team (IDT) starting on 11/25/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-14-01 "Interdisciplinary Team (IDT) Patient Assessment and Plan of Care" with emphasis on but not limited to: 1) The facility's interdisciplinary team (IDT) consists of, at a minimum, the patient or the patient's personal representative, a registered nurse, a physician or Non-Physician Practitioner (NPP), if allowed by state ESRD licensure regulations, treating the patient for ESRD, a social worker, and a qualified renal dietitian per CMS. 2) A comprehensive assessment will be conducted on all new patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines. Verification of attendance is evidenced by teammate's signature on in-service sheet. The Facility Administrator or designee will conduct an audit on all new patients' medical records to verify that initial patient assessment and plan of care documents are completed within thirty (30) days or thirteen (13) hemodialysis treatments per policy: monthly for three (3) months. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-adherence 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-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 facility policies, clinical records (CRs), interview with facility administrator, registered nurse (RN) interviews and Patient Care Technician (PCT) interviews, the facility failed to ensure treatments were delivered in accordance with the dialysis prescriptions ordered by the physician for four (4) of four (4) CRs reviewed (CR#1, CR#2, CR#3 and CR#4).
Findings included: Review of facility policy on 11/18/2024 at approximately 9:00 AM revealed: "Policy: 1-03-08, TITLE: Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment... PURPOSE: To obtain and document baseline and ongoing information about the patient before, during and after dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient's dialysis treatment, monitoring during treatment and for reviewing the patient's response to the treatment and status prior to discharge... 3. Patient identity, prescription and machine settings re verified by teammate prior to initiation of treatment with exception of blood flow rate which is verified and documented when the order is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with nursing assessment...INTRADIALYTIC DATA COLLECTION ASSESSMENT... 9. Intradialytic monitoring and data collection which may be performed by the PCT or licensed nurse includes: a. vital signs and treatment monitoring...b. At a minimum, obtain and document the following:..iii. Blood and dialysate flows, arterial and venous pressures... 10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtained prescribed blood flow rate) the reason will be documented and the licensed nurse informed... 12. The licensed nurse notifies the physician as needed of changes in patient status. 13. All findings, interventions and patient response will be documented int the patient's medical record... 16. 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... 17. 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..."
Review of CRs conducted on 11/19/2024 from approximately 8:30 AM - 11:30 AM revealed the following:
CR#1, admitted on 10/7/2024. Treatment flowsheets reviewed revealed: Treatment date: 10/28/2024 - Blood Flow Rate (BFR) 250ml/min prescribed by physician; treatment initiated at 10:30 AM - BFR 350ml/min documented by PCT; 11:00 AM - BFR 350ml/min documented by RN; 11:30 AM BFR 350ml/min documented by PCT, 12:00 PM - BFR 350ml/min documented by PCT; 12:30 PM - BFR 350ml/min documented by PCT; 13:00 PM - BFR 350ml/min documented by PCT; 13:30 PM - BFR 350ml/min documented by RN; 13:55 PM treatment terminated - BFR 350ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 10/30/2024 - Blood Flow Rate (BFR) 250ml/min prescribed by physician; treatment initiated at 10:44 AM - BFR 350ml/min documented by PCT; 10:56 AM - BFR 350ml/min documented by RN; 11:26 AM BFR 350ml/min documented by RN, 11:56 AM - BFR 350ml/min documented by RN; 12:26 PM - BFR 350ml/min documented by RN; 13:26 PM - BFR 350ml/min documented by RN; 13:56 PM - BFR 350ml/min documented by PCT; 14:12 PM treatment terminated - BFR 350ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/1/2024 - Blood Flow Rate (BFR) 250ml/min prescribed by physician; treatment initiated at 10:34 AM - BFR 350ml/min documented by RN; 11:04 AM - BFR 350ml/min documented by PCT; 11:31 AM BFR 350ml/min documented by RN, 12:01 PM - BFR 350ml/min documented by PCT; 12:31 PM - BFR 350ml/min documented by PCT; 13:01 PM - BFR 350ml/min documented by PCT; 13:31 PM - BFR 350ml/min documented by PCT; 14:01 PM - BFR 350ml/min documented by PCT; 14:05 PM treatment terminated - BFR 350ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/4/2024 - Blood Flow Rate (BFR) 250ml/min prescribed by physician; treatment initiated at 11:05 AM - BFR 350ml/min documented by PCT; 11:35 AM - BFR 350ml/min documented by PCT; 12:05 PM BFR 350ml/min documented by PCT, 12:32 PM - BFR 350ml/min documented by PCT; 13:02 PM - BFR 350ml/min documented by PCT; 13:32 PM - BFR 350ml/min documented by PCT; 14:02 PM - BFR 300ml/min documented by PCT; 14:32 PM - BFR 300ml/min documented by PCT; 14:35 PM treatment terminated - BFR 300ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/6/2024 - Blood Flow Rate (BFR) 250ml/min prescribed by physician; treatment initiated at 13:14 PM - BFR 350ml/min documented by PCT; 13:34 PM - BFR 350ml/min documented by RN; 14:04 PM BFR 350ml/min documented by PCT, 14:31 PM - BFR 350ml/min documented by PCT; 15:01 PM - BFR 350ml/min documented by PCT; 15:31 PM - BFR 300ml/min documented by PCT; 16:01 PM - BFR 300ml/min documented by PCT; 16:31 PM - BFR 300ml/min documented by RN; 16:41 PM treatment terminated. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/8/2024 - Blood Flow Rate (BFR) 250ml/min prescribed by physician; treatment initiated at 11:02 AM - BFR 350ml/min documented by PCT; 11:30 AM - BFR 350ml/min documented by PCT; 12:00 PM BFR 350ml/min documented by RN, 12:30 PM - BFR 350ml/min documented by RN; 13:00 PM - BFR 350ml/min documented by RN; 13:30 PM - BFR 350ml/min documented by PCT; 14:00 PM - BFR 350ml/min documented by RN; 14:30 PM - BFR 350ml/min documented by RN; 14:33 PM treatment terminated - BFR 350ml/min documented by RN. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/13/2024 - Dialysis Flow Rate (DFR) 800ml/min prescribed by physician; treatment initiated at 11:01 AM - DFR 800ml/min documented by PCT; 11:30 AM - DFR 300ml/min documented by RN; 12:00 PM - DFR 300ml/min documented by PCT, 12:30 PM - DFR 300ml/min documented by PCT; 13:00 PM - DFR 300ml/min documented by PCT; 13:30 PM - DFR 300ml/min documented by PCT; 14:00 PM - DFR 300ml/min documented by PCT; 14:30 PM- DFR 300ml/min documented by RN; 14:37 PM treatment terminated. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders.
CR#2, admitted on 1/11/2023. Treatment flowsheets reviewed revealed: Treatment date: 11/1/2024 - Blood Flow Rate (BFR) 400ml/min prescribed by physician; treatment initiated at 9:29 AM - BFR 400ml/min documented by PCT; 9:59 AM - BFR 400ml/min documented by RN; 10:01 AM BFR 360ml/min documented by RN, 10:31 AM - BFR 360ml/min documented by PCT; 11:01 AM - BFR 360ml/min documented by PCT; 11:31 AM - BFR 360ml/min documented by RN; 12:01 PM - BFR 360ml/min documented by PCT; 12:31 PM - BFR 360ml/min documented by RN; 13:02 PM treatment terminated - BFR 350ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/11/2024 - Blood Flow Rate (BFR) 400ml/min prescribed by physician; treatment initiated at 9:29 AM - BFR 450ml/min documented by PCT; 9:59 AM - BFR 450ml/min documented by RN; 10:33 AM BFR 450ml/min documented by PCT, 10:59 AM - BFR 450ml/min documented by PCT; 11:29 AM - BFR 450ml/min documented by RN; 11:59 AM - BFR 450ml/min documented by RN; 12:29 PM - BFR 450ml/min documented by RN; 12:59 PM treatment terminated - BFR 450ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/15/2024 - Blood Flow Rate (BFR) 400ml/min AND cannulation with 15 guage needles prescribed by physician; treatment initiated at 12:20 PM - PCT documented 16 guage needles used to cannulate and BFR 350ml/min documented by PCT; 13:00 PM - BFR 350ml/min documented by PCT; 13:30 PM BFR 350ml/min documented by PCT, 14:00 PM - BFR 350ml/min documented by PCT; 14:30 PM - BFR 350ml/min documented by PCT; 15:00 PM - BFR 350ml/min documented by RN; 15:09 PM - BFR 350ml/min documented by RN; 15:10 PM treatment terminated - BFR 350ml/min documented by RN. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders.
CR#3, admitted on 1/25/2023. Treatment flowsheets reviewed revealed: Treatment date: 11/1/2024 - Blood Flow Rate (BFR) 400ml/min prescribed by physician; treatment initiated at 11:17 AM - BFR 450ml/min documented by PCT; 11:30 AM - BFR 450ml/min documented by RN; 12:00 PM BFR 450ml/min documented by PCT, 12:30 PM - BFR 450ml/min documented by PCT; 13:00 PM - BFR 450ml/min documented by PCT; 13:30 PM - BFR 450ml/min documented by PCT; 14:00 PM - BFR 450ml/min documented by RN; 14:30 PM - treatment terminated - BFR 450ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/6/2024 - Blood Flow Rate (BFR) 400ml/min prescribed by physician; treatment initiated at 11:23 AM - BFR 450ml/min documented by PCT; 11:36 AM - BFR 450ml/min documented by PCT; 12:00 PM BFR 450ml/min documented by RN, 12:30 PM - BFR 450ml/min documented by RN; 13:00 PM - BFR 450ml/min documented by PCT; 13:30 PM - BFR 450ml/min documented by RN; 14:00 PM - BFR 450ml/min documented by PCT; 14:30 PM - BFR 450ml/min documented by PCT; 14:38 PM - treatment terminated - BFR 150ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders.
CR#4, admitted on 8/28/2024. Treatment flowsheets reviewed revealed: Treatment date: 11/11/2024 - Blood Flow Rate (BFR) 350ml/min prescribed by physician; treatment initiated at 11:30 AM - BFR 200ml/min documented by PCT; 12:01 PM BFR 150ml/min documented by RN, 12:26 PM - treatment terminated - BFR 150ml/min documented by RN. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders.
An interview with the facility administrator on 11/19/2024 at approximately 2:30 PM confirmed the above findings.
Plan of Correction:The Facility Administrator held mandatory in-services for all clinical teammates starting on 11/22/224. Surveyor observations were reviewed. Education included but was not limited to a review of Policy1-03-08 "Pre- Intra- Post Treatment Data Collection, Monitoring and Nursing Assessment" with emphasis on but not limited to: Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient's dialysis treatment, monitoring during treatment and for reviewing the patient's response to the treatment and status prior to discharge. 1) Patient identity, prescription and machine settings are verified by teammates 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 along with the nursing assessment ... Prescription components include but are not necessarily limited to: ... Blood Flow rate, Dialysate flow rate ... 2) Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: at a minimum, obtain and document the following: ... Blood and dialysate flows, arterial and venous pressures ... 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) The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 5) All findings, interventions and patient response will be documented in the patient's medical record. 6) 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. 7) Licensed nurse 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 prior to discharge of the patient from the facility. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet. The Facility Administrator or designee, including Patient Care Technicians or Registered Nurses will audit flow sheets to verify that documentation of abnormal findings, or prescription not being met, [including but not limited to blood flow rate and / or dialysate flow rate] is also documented as reported to the licensed nurse, and nurse response is documented, including but not limited to communication with physician as needed, per policy: on twenty five percent (25%) of flowsheets 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-adherence will be corrected immediately. The Facility Administrator 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 upon a review of facility policy, review of facility policy, review of employee(EMP)/staff schedule, treatment area observations (OBS), and an interview with the Nurse and Facility Administrator, the Medical Director failed to ensure staff stored and secured facility medications per policy, for one (1) of two (1) observations (OBS #1).
Findings include:
A review on 11/18/2024 at approximately 2:45 PM of Incenter Hemodialysis Policies & Procedures Davita Inc. revealed: Procedure: "1-06-01" Title: "MEDICATION POLICY... PURPOSE: To provide guidancefor medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications... POLICY... 11. All refrigerated medications... are to be locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate per state regulations..."
A review on 11/19/2024 at approximately 9:00 AM of the facility staffing/employee schedule revealed no licensed personnel were scheduled to work on 11/19/2024. Observations conducted in patient treatment area on 11/19/2024 between approximately 11:30 AM -12:30 PM revealed the following:
OBS #1 occurred on Tuesday, 11/19/2024, at approximately 12:20 PM revealed: medication preparation and storage drawers and medication refrigerator containing oral, intravenous and subcutaneous and sublingual medications were not locked or secured.
An interview with the facility administrator conducted on 11/19/2024 at approximately 12:35 PM confirmed the above findings. "We only have patients scheduled on Monday's, Wednesday's and Friday's, the medications should definitely be locked up at the end of business days on those days."
Plan of Correction:On 11/27/24, a Governing Body meeting with the Medical Director, Facility Administrator, Nursing Manager and Regional Operations Director was held to review the results of the survey ending on 11/21/24. 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. A plan of correction has been developed and initiated to correct the identified deficiency and to sustain compliance.
The Facility Administrator or designee held mandatory in-services for all for all clinical teammates starting 11/20/24. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-06-01 "Medication Policy" with emphasis on but not limited to: 1) All refrigerated medications ... are to be locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. Verification of attendance is evidenced by teammate's signature on the in-service sheet.
On 11/20/24, the medication cabinets were immediately locked upon hearing surveyor's observation. The Facility Administrator or designee will conduct medication audits to verify medications are locked at the end of the business day or if not under supervision by the licensed teammates: daily for two (2) weeks, then weekly for two (2) weeks, and monthly for two (2) months. Instances of non-adherence will be corrected 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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