Initial Comments:
Based upon the findings of an unannounced onsite Medicare recertification survey conducted November 4-6, 2020 and continued offsite November 9, 2020, Fresenius Kidney Care Lewistown 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 on-site unannounced onsite Medicare recertification survey conducted November 4-6, 2020 and continued offsite November 9, 2020, Fresenius Kidney Care Lewistown 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:
494.20 STANDARD
COMPLIANCE WITH FED/STATE/LOCAL LAWS
Name - Component - 00
The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements.
Observations:
Based on review of facility policy, Secretary of the Pennsylvania Department of Health Orders, and an interview with the facility Clinical Nurse Manager, facility failed to ensure staff followed established guidelines for COVID-19 employee screening for one (1) of one (1) 'COVID-19 Employee and Physician Screening Forms' (Screening Form #1).: failed to ensure staff followed established COVID-19 guidelines for wearing face coverings/face masks for one (1) of one (1) observations (Observation #1).
Findings:
A review was conducted of facility policy on November 9, 2020 at approximately 11:00 a.m. Policy 'Coronavirus Disease Screening and Infection Control Practices in Fresenius Kidney Care (FKC) Dialysis Clinics' 'Policy' states 'Patient, Visitor, Staff, Physician, and Physician Extender screening' states "All ...., staff, ...entering an FKC dialysis clinic must be screened for ongoing signs and symptoms of COVID-19 disease". "Screening Requirements: Daily monitoring of ......, staff, .... . Use the attached screening documents to record temperatures and perform screening of all ...., staff, ....". 'Related Policies and Procedures' list "FKC Staff and Physician Screening Tool".
Review of facility COVID-19 Employee and Physician Screening Forms conducted on November 5, 2020 at approximately 1:30 a.m. revealed the following:
Form #1: COVID-10 Employee and Physician Screening Forms were reviewed from September 1, 2020-November 4, 2020. Staff working schedules in the same time frame were also requested on November 5, 2020 at approximately 2:00 p.m.
Utilizing the Screening Forms and the working schedule of when the Biomed Technician (EF#4) was at this facility, there was no documentation of EF#4 being screened for COVID-19, according to facility policy, on November 2, 2020.
Utilizing the Screening Forms and the working schedule of when the facility Medical Director was at this facility, there was no documentation provided, while onsite, of the Medical Director being screened for COVID-19 according to facility policy, on October 2, 2020 and October 16, 2020. Documentation was sent November 6, 2020 at approximately 3:34 p.m. via email. The documentation included two separate COVID-19 Employee and Physician Screening Forms, dated "10/02" and "10/16", containing only one entry on each form, for the Medical Director. The Screening Form has a section at the top to list 'Facility Name' and 'Facility ID Number". These sections were left blank with no entries.
A review was conducted of facility policy on November 9, 2020 at approximately 11:00 a.m. Policy 'Coronavirus Disease Screening and Infection Control Practices in Fresenius Kidney Care (FKC) Dialysis Clinics' 'Policy' states "FKC Staff, Physician and Physician Extender PPE: In all FKC dialysis clinics, staff are required to wear the following PPE: All staff , ...... must wear ....facemask's". "Staff must always wear a facemask when in an FKC dialysis clinic .....". "Facemask's are always to be worn when staff are on the treatment floor, ....".
CDC (Centers for Disease Control and Prevention) 'Coronavirus Disease 2019 (COVID-19) 'Considerations for Wearing Masks' (Updated November 12, 2020) 'Who should wear a mask' states "Everyone 2 years of age and older should wear a mask in public settings and when around people who do not live in their household".
'Order of the Secretary of the Pennsylvania Department of Health Requiring Universal Face Coverings' (July 1, 2020) states "Accordingly, on this date, July 1, 2020 to protect the public from the spread of COVID-19, I hereby order: ...... Section #2: Face Coverings required. ..... individuals are required to wear face coverings if they are : (E) engaged in work, whether at the workplace or performing work off-site, when interacting in-person with any member of the public, working in any space visited by members of the public, ......, working in or walking through common areas, ....".
Observations conducted in patient treatment area on November 4, 2020, between approximately 8:30 a.m.-1:35 p.m. and on November 6, 2020 between approximately 8:25 a.m.-9:40 a.m. revealed the following:
Observation #1: On November 4, 2020 at approximately 8:35 a.m. employee #5 was observed walking into the treatment area from the rear employee entrance, not wearing a facemask. The facility Clinical Manager directed EF#5 to don a facemask. Per the Clinical Nurse Manager, "EF#5 was just reporting to work and starting her shift".
An interview with the facility Clinical Nurse Manager on November 6, 2020 at approximately 1:45 p.m. confirmed the above findings.
Plan of Correction:V101 Compliance with Fed/State/Local laws
Beginning 11/23/2020, the Clinical Manager (CM), or designee held staff meetings, elicited input, and reinforced the expectations and responsibilities of the facility staff on the following Policies & Procedures:
- FMS-CS-IC-II-155-221ACoronavirusDisease Screening and InfectionControl Practices in FreseniusKidney Care (FKC) Dialysis Clinics
- COVID-19 Employee and Physician Screening Form COVID-19
- FMS-CS-IC-II-155-080A - Personal Protective Equipment
Emphasis was placed on:
Ensuring all patients, visitors, staff, including Biomedical technician, physicians, and physician extenders entering the dialysis clinic must be screened for ongoing signs and symptoms of COVID-19 prior to admittance to the dialysis treatment floor.
Screening requirements includes daily monitoring of patients, visitor, staff, physician and physician extender temperature.
Screening requirements includes if the individual is presents or is experiencing flu-like symptoms or any combination of the following symptoms: cough, shortness of breath, difficulty breathing, fever >/=100.0 degrees Fahrenheit, chills, repeated shaking with shills, muscle pain, headache, sore throat, new loss of taste or smell, congestion or runny nose, nausea or vomiting, diarrhea.
Screening requirements includes if the individual is presents or is experiencing flu-like symptoms or any combination of the following symptoms: cough, shortness of breath, difficulty breathing, fever >/=100.0 degrees Fahrenheit, chills, repeated shaking with shills, muscle pain, headache, sore throat, new loss of taste or smell, congestion or runny nose, nausea or vomiting, diarrhea.
Facility will utilize screening documents to record temperature and screening of symptoms and close contact exposure. Ensuring there are no blank sections on the screening forms, all sections including facility name and facility ID number will be filled out.
Ensuring all staff are wearing a face mask upon entry to the FKC dialysis clinic and treatment floor.
The in-services will be completed on 11/27/2020 with documentation of the training on file at the facility.
For ongoing compliance, beginning 11/28/2020, the Clinical Manager or designee will conduct daily audits to ensure patients, visitors, staff, physicians, and physician extenders entering the dialysis clinic are screened and documentation is complete and all staff are wearing facemask upon entry to the dialysis unit and treatment floor until 100% compliance is observed. A POC specific auditing tool will be used for the audits. Once compliance is sustained, the Governing Body will decrease frequency to weekly for 4 weeks then resume regularly scheduled audits based on QAI calendar. Monitoring will be done through the Clinic audit checklist.
The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as
related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the
resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues. The QAI Committee is responsible to provide oversight, review findings, and take actions as appropriate. The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective
and is providing resolution of the issues.
Page: 2 of 9 - Fri Nov 20 10:27:40 EST 2020 External POC Report
Documentation of education, monitoring, QAI, and Governing Body is available for review.
The Clinic Manager is responsible for overall compliance. Completion Date: 12/4/20
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 review of facility policy, observations, and an interview with the facility Clinical Nurse Manager, the facility failed to ensure staff followed infection control protocols, included but not limited to, performing hand hygiene, for one (1) of one (1) 'Parenteral Medication Preparation and Administration' (Observation #1).
Findings include:
A review was conducted of facility policy on November 9, 2020 at approximately 11:00 a.m. Policy 'Medication preparation and Administration Procedure' section 'Medication Administration Procedure' step #1 states "Wash hands, Apply PPE (personal protective equipment)".
Observations conducted in patient treatment area on November 4, 2020, between approximately 8:30 a.m.-1:35 p.m. and on November 6, 2020 between approximately 8:25 a.m.-9:40 a.m. revealed the following:
Observation #1: On November 6, 2020 at approximately 9:30 a.m. during the 'Parenteral Medication Preparation and Administration' observation at station #10, patient #7, EF# 1 did not perform hand hygiene before donning new gloves after preparing patient medication and prior to administration of patient medication.
An interview with the facility Clinical Nurse Manager on November 6, 2020 at approximately 1:45 p.m. confirmed the above findings.
Plan of Correction:V113 IC-Wear gloves/hand hygiene
FRESENIUS KIDNEY CARE LEWISTOWN
Plan of Correction for Recertification
Provider Identification Number: 39-2866 Date of Survey: 11/9/20
Beginning 11/23/2020, the Clinical Manager (CM), or designee held staff meetings, elicited input, and reinforced the expectations and responsibilities of the facility staff on the following Policies & Procedures:
FMS-CS-IC-II-120-040A Medication Preparation and Administration
FMS-CS-IC-II-120-040C Medication Preparation and Administration Procedure FMS-CS-IC-II-155-090A Hand Hygiene
FMS-CS-IC-II-155-090C Hand Hygiene Procedure Emphasis was placed on:
Performing hand hygiene between donning and doffing of gloves.
Ensuring appropriate infection control implementation is practiced in between tasks to prevent cross contamination, including changing gloves and practicing hand hygiene before donning new gloves after preparing patient medication and prior to administration of patient medication.
The in-services will be completed on 11/27/2020 with documentation of the training on file at the facility.
For ongoing compliance, beginning 11/28/2020, Clinical Manager or designee will conduct daily audits on all shifts to ensure staff adherence to policy and procedure until 100% compliance is observed. A POC specific auditing tool will be used for the audits. Once compliance is sustained, the Governing Body will decrease frequency to weekly for 4 weeks then resume regularly scheduled audits based on QAI calendar. Monitoring will be done through the Clinic audit checklist.
The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as
related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the
resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues. The QAI Committee is responsible to provide oversight, review findings, and take actions as appropriate. The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective
and is providing resolution of the issues.
Documentation of education, monitoring, QAI, and Governing Body is available for review.
The Clinic Manager is responsible for overall compliance. Completion Date: 12/4/20
494.30(a)(4)(ii) STANDARD
IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL
Name - Component - 00
[The facility must demonstrate that it follows standard infection control precautions by implementing-
(4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-]
(ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.
Observations:
Based on review of medical records (MRs), facility policy, and an interview with the facility clinical nurse manager, it was determined the facility failed to ensure expired items were discarded for one (1) of one (1) observations (Observation #1).
Findings include:
A review was conducted of facility policy on November 9, 2020 at approximately 11:00 a.m. Policy 'Medication Preparation and Administration' 'Monitoring Expired Medications' states "Expired medications are to be discarded .....".
Observations conducted in patient treatment area on November 4, 2020, between approximately 8:30 a.m.-1:35 p.m. and on November 6, 2020 between approximately 8:25 a.m.-9:40 a.m. revealed the following:
Observation #1: On November 4, 2020 at approximately 11:00 a.m. the following expired items were observed in the treatment area medication refrigerator:
Eight (8) single dose 0.5 ml vials of Pneumovax 23 with an expiration date of 09/29/2020.
An interview with the facility Clinical Nurse Manager on November 6, 2020 at approximately 1:45 p.m. confirmed the above findings.
Plan of Correction:V122 IC-Disinfect surfaces/equip/written protocols
Beginning 11/23/2020, the Clinical Manager (CM), or designee held staff meetings, elicited input, and reinforced the expectations and responsibilities of the facility staff on the following Policies & Procedures:
FMS-CS-IC-II-120-040A - Medication Preparation and Administration Policy
Emphasis was placed on:
For immediate compliance, expired Pneumovax was discarded on 11/4/2020. Ensure all Registered Nurses return or discard expired medications per policy.
Ensure all Registered Nurses follow the end of month counting and inventory rotation, of all medications intended for use for patients.
Ensure all Registered Nurses check the expiration date of a vile or ampule before use for a patient.
The in-services will be completed on 11/27/2020 with documentation of the training on file at the facility.
For ongoing compliance, beginning 11/28/2020, Clinical Manager or designee will conduct Monthly audits utilizing facility specific audit tool for expired medications for 3 Months. The Governing Body will determine on-going frequency of the audits based on compliance. Once 100% compliance is sustained, monitoring will be done through the end of month inventory checklist and counting audit per the Quality Assessment Improvement Calendar, on a monthly basis.
The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as
related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the
resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues. The QAI Committee is responsible to provide oversight, review findings, and take actions as appropriate. The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective
and is providing resolution of the issues.
Documentation of education, monitoring, QAI, and Governing Body is available for review.
The Clinic Manager is responsible for overall compliance. Completion Date: 12/4/20
494.40(a) STANDARD
SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL
Name - Component - 00
5.2.4 Softeners: auto regen/timers/salt/salt level
Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as "regeneration," which involves exposure of the resin bed to a saturated sodium chloride solution.
5.2.4 Softeners
Refer to RD62:2001, 4.3.10
Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration.
The face of the timers used to control the regeneration cycle should be visible to the user.
6.2.4 Softeners
Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated.
The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head.
Observations:
Based on review of facility policy, observations, water treatment log review, an interview with the ATOM (area technical operations manager), and an interview with the facility Clinical Nurse Manager, the facility failed to ensure the documentation of salt pellets filling at least half the brine tank, per policy, in the water treatment room for one (1) of one (1) observations (Observation #1) and for one (1) of one (1) water log reviews (Water Log Review #1).
Findings include:
A review was conducted of facility policy on November 9, 2020 at approximately 11:00 a.m. Policy 'Dealkalyzer' 'Monitoring of Dealkalyzer Operational Performance' 'Daily Requirements' state "Salt level and amount of salt added to brine tank. Note: Tank should be maintained at least half full."
Observations conducted in the Water Treatment room on November 4, 2020 at approximately 1:00 p.m revealed the following:
Observation #1: The Water treatment room was inspected on November 4, 2020 at approximately 1:00 p.m. There is a brine tank for the water softener and a brine tank for the Delakalyzer Tank. The brine tank for the Dealkalyzer Tank was approximately 1/8 full. A sign was posted on the Dealkalyzer Tank stating "Check brine tank daily to be sure the tank is at least half filled with salt, adding salt pellets if necessary".
Water Logs reviewed on November 5, 2020, at approximately 10:00 a.m. revealed the following:
Water Log Review #1: On November 5, 2020, at approximately 10:00 a.m. the Daily Water Treatment Logs were reviewed. The 'Water Pre-TX Opening' log contains a section to record salt level for the brine tank for the water softener. There is no section on the log to record salt level for the brine tank for the Dealkalyzer Tank.
An interview was conducted with the facility ATOM on November 6, 2020 at approximately 11:20 a.m. Per the ATOM, "There was no log kept prior to the survey for the brine tank for the Dealkalyzer Tank. The water logs will be updated to include a section to record salt level for the brine tank for the Dealkalyzer Tank".
An interview with the facility Clinical Nurse Manager on November 6, 2020 at approximately 1:45 p.m. confirmed the above findings.
Plan of Correction:V190 Softeners-auto regenerate/timers/salt lvl
Beginning 11/23/2020, the Area Technical Operations Manager (ATOM) or designee held staff meetings, elicited input, and reinforced the expectations and responsibilities of the facility staff on the following Policies & Procedures:
Dealkalyzer
FMC-CS-IC-II-140-126A Water Softener Emphasis was placed on:
Ensuring salt levels inside brine tanks will be maintained at a minimum of half full.
Ensuring DPC staff fills salt levels inside brine tanks at the appropriate level and documents date, time and quantity of salt added in the water treatment log.
Facility water logs will include documentation of salt level for the brine tank for the Dealkalyzer Tank.
The in-services will be completed by 11/27/2020 with documentation of the training on file at the facility.
For ongoing compliance, beginning 11/28/2020, the Clinical Manager or designee will conduct daily audit to ensure staff are adhering to policy and procedure for 2 weeks. A POC specific auditing tool will be used for the audits. Once compliance is sustained, the Governing Body will decrease frequency to weekly for 4 weeks then resume regularly scheduled audits based on QAI calendar. This will be monitored through the QAI Technical workbook.
The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as
related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the
resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues. The QAI Committee is responsible to provide oversight, review findings, and take actions as appropriate. The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective
and is providing resolution of the issues.
Documentation of education, monitoring, QAI, and Governing Body is available for review.
The Clinic Manager is responsible for overall compliance. Completion Date: 12/4/20
494.40(a) STANDARD
DIALYS PROPORT-MONITOR PH/CONDUCTIVITY
Name - Component - 00
5.6 Dialysate proportioning: monitor pH/conductivity
It is necessary for the operator to follow the manufacturer's instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient.
Observations:
Based on reviews of facility policy, manufacturer recommendations, observations, and an interview with the Clinical Nurse Manager, the facility failed to ensure the staff followed infection control protocols which include, but not limited to, following the manufacturers recommendations for use of the phoenix meter for two (2) out of two (2) observations of the 'Preparation of the Hemodialysis Machine/Extracorporeal Circuit' (Observation #2-3).
Findings include:
A review was conducted of facility policy on November 9, 2020 at approximately 11:00 a.m. Policy 'Checking Conductivity and pH of Final Dialysate with the pHoenix XL Meter' 'Testing with pHoenix XL meter' 'Step 6' Action: "Rinse meter with RO (reverse osmosis) water after each measurement".
A review of manufacturer's recommendations for use of the phoenix meter was conducted on November 9, 2020 at approximately 11:00. Section (F) 'Taking Measurements' step #(4) states "Rinse the sample cup/tube thoroughly with treated water when finished". "Rinse the sample cup/tube thoroughly with treated water when finished".
Observations conducted in patient treatment area on November 4, 2020, between approximately 8:30 a.m.-1:35 p.m. and on November 6, 2020 between approximately 8:25 a.m.-9:40 a.m. revealed the following:
Observation #2: On November 4, 2020 at approximately 9:25 a.m., employee #1 was observed using the phoenix meter to check for conductivity and pH for station #9, for the dialysis treatment of patient #6. After using the phoenix meter, employee #1 failed to rinse the meter with treated (RO) water.
Observation #3: On November 6, 2020 at approximately 8:25 a.m., employee #5 was observed using the phoenix meter to check for conductivity and pH for station #10, for the dialysis treatment of patient #7. After using the phoenix meter, employee #5 failed to rinse the meter with treated (RO) water.
An interview with the facility Clinical Nurse Manager on November 6, 2020 at approximately 1:45 p.m. confirmed the above findings.
Plan of Correction:V250 Dialys proport-monitor pH/conductivity
Beginning 11/23/2020, the Clinical Manager (CM), or designee held staff meetings, elicited input, and reinforced the expectations and responsibilities of the facility staff on the following Policies & Procedures:
FMS-CS-IC-II-140-500C4 Checking Conductivity and pH of Final Dialysate with the pHoenix XL Meter
Emphasis was placed on:
Ensuring DPC staff are rinsing phoenix meter with RO water after each use.
The in-services will be completed by 11/27/2020 with documentation of the training on file at the facility.
For ongoing compliance, beginning 11/28/2020, Clinical Manager or designee will conduct daily audits on all shifts to ensure staff adherence to policy and procedure until 100% compliance is observed. A POC specific auditing tool will be used for the audits. Once compliance is sustained, the Governing Body will decrease frequency to weekly for 4 weeks then resume regularly scheduled audits based on QAI calendar. Monitoring will be done through the Clinic audit checklist.
The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as
related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the
resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues. The QAI Committee is responsible to provide oversight, review findings, and take actions as appropriate. The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective
and is providing resolution of the issues.
Documentation of education, monitoring, QAI, and Governing Body is available for review.
The Clinic Manager is responsible for overall compliance. Completion Date: 12/4/20
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 review of facility policy, medical records, and an interview with the facility Clinical Nurse Manager, it was determined the facility failed to ensure Intradialytic data collection/assessment was reported to the team lead/charge nurse, according to facility policy, for one (1) out of five (5) in-center hemodialysis medical records (MR) reviewed (MR#3).
Findings include:
A review was conducted of facility policy on November 9, 2020 at approximately 11:00 a.m. Policy 'Nursing Supervision and Delegation' 'Guidelines for PCT/LPN/LVN/RN: When to refer a patient to the team lead/charge nurse for further assessment' 'Blood Pressure' states "A systolic blood pressure greater than 180 mm/Hg and /or diastolic blood pressure greater than 100 mm/Hg at any time before, during, or after the treatment". policy 'Patient Assessment and Monitoring' 'Monitoring During Treatment' step (1) Blood Pressure' 'Action/Rationale' states "Report to the nurse: Systolic blood pressure greater than 180 mm/Hg, Diastolic blood pressure greater than 100 mm/Hg". 'Post Treatment' step (10 states "The direct patient care staff may obtain the following : Blood Pressure.... Ensure vital signs and overall condition are stable for discharge".
A review of medical records (MR) was conducted on November 6, 2020 between approximately 12:00 p.m.-1:45 p.m. revealed the following:
MR#3 Date of admission 12/18/2019:
Treatment flowsheet dated 10/23/2020 with a treatment time span of "8:35 a.m.- 12:07 p.m.".
At 10:37 a.m., patients blood pressure was recorded as 187/94, Pulse 91, by EF#3 (patient care technician). The 'Comments' section stated "UF on, access visible, green AMP light, denies complaints, patient alert, patient denies needs". No documentation of EF#3 reporting hypertension to a registered nurse.
At 11:03 a.m., patients blood pressure was recorded as 181/87, Pulse 92, by EF#10 (patient care technician). The 'Comments' section stated "Green AMP light, denies complaints, access visible". No documentation of EF#10 reporting hypertension to a registered nurse.
At 12:06 p.m., patients blood pressure was recorded as 182/93, Pulse 99, by EF#3 (patient care technician). The 'Comments' section stated "Denies complaints, patient alert, treatment discontinued without problem, tx ended with no issues, no refill". No documentation of EF#3 reporting hypertension to a registered nurse.
At 12:11 p.m., 'Post-Dialysis Vitals and Evaluation', patients blood pressure was recorded as 189/88, Pulse 98, by EF#3 (patient care technician). No documentation of EF#3 reporting hypertension to a registered nurse.
Treatment flowsheet dated 10/30/2020 with a treatment time span of "8:33 a.m.- 12:20 p.m.".
At 12:04 p.m., patients blood pressure was recorded as 192/89, Pulse 96, by EF#10 (patient care technician). The 'Comments' section stated "Ended". No documentation of EF#10 reporting hypertension to a registered nurse.
At 12:20 p.m., patients blood pressure was recorded as 199/98, Pulse 93, by EF#3 (patient care technician). The 'Comments' section stated "Denies complaints, patient alert, treatment discontinued without problem, tx ended-no issues, no refill". No documentation of EF#3 reporting hypertension to a registered nurse.
At 12:23 p.m., 'Post-Dialysis Vitals and Evaluation', patients blood pressure was recorded as 187/87, Pulse 95, by EF#3 (patient care technician). No documentation of EF#3 reporting hypertension to a registered nurse.
An interview with the facility Clinical Nurse Manager on November 6, 2020 at approximately 1:45 p.m. confirmed the above findings.
Plan of Correction:V715 MD resp-Ensure all adhere to P&P
FRESENIUS KIDNEY CARE LEWISTOWN
Plan of Correction for Recertification
Provider Identification Number: 39-2866 Date of Survey: 11/9/20
On 11/20/2020, the Director of Operations (DO) and the CM is scheduled to meet with the Medical Director to discuss Medical Director Responsibilities as defined in the Conditions for Coverage. Emphasis placed on the Medical Director responsibilities to ensure staff adherence to policy and procedure as it relates particularly to the finding of the SOD.
The policies reviewed with the Medical Director are:
FMS-CS-IC-I-110-149A - Nursing Supervision and Delegation Policy FMS-CS-IC-I-110-131C - Patient Assessment and Monitoring
Documentation of the meeting with the Medical Director will be on file at the facility.
The Medical Director is informed at the meeting that the CM or designee will be re-educating the DPC staff on the policies.
Emphasis was placed on:
- Ensuring DPC staff refers to RN team leader or charge nurse if patient presents with a systolic blood pressure greater than 180 mm/Hg and /or diastolic blood pressure greater than 100 mm/Hg at any time before, during or after the patient's treatment.
- Notifying registered nurse (RN) and attending physician as necessary of all patient with hypertensive episodes or abnormal findings for further evaluation.
The in-services will be completed by 11/27/2020 with documentation of the training on file at the facility.
For ongoing compliance, beginning 11/28/2020, the Clinical Manager or designee will conduct daily audits of 10% of patient treatment sheets utilizing a developed Plan of Correction Auditing tool to verify adherence to policy and procedure until 100% compliance is achieved for 2 weeks. When 100% compliance is achieved, audits will continue weekly for 4 weeks. Once compliance is sustained, the Governing Body will then resume regularly scheduled audits based on QAI calendar. Monitoring will be done through the Clinic audit checklist.
The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as
related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the
resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues. The QAI Committee is responsible to provide oversight, review findings, and take actions as appropriate. The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective
and is providing resolution of the issues.
Documentation of education, monitoring, QAI, and Governing Body is available for review.
2020 External POC Report
The Clinic Manager is responsible for overall compliance. Completion Date: 12/4/20
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