Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed April 14, 2023, BMA Allentown was identified to be in compliance with the following requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage for End-Stage Renal Disease (ESRD) Facilities-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed April 14, 2023, BMA Allentown was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.30(a)(1) STANDARD
IC-WEAR GLOVES/HAND HYGIENE
Name - Component - 00
Wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station.
Observations:
Based on review of facility policy/procedure, observations, and an interview with the facility Clinical Nurse Manager, the facility failed to ensure the staff followed infection control protocols, included but not limited to, hand hygiene/don clean gloves, for one (1) of two (2) 'Discontinuation of Dialysis and Post Dialysis Care for AV Fistula or Graft' observations (Observation#1)
Findings include:
A review was conducted of facility policy/procedure on April 14, 2023 at approximately 10:30 a.m.
Policy 'Clinical Services' Termination of Treatment Using Arteriovenous Fistula or Graft and Optiflux Single Use Ebeam Dialyzer' (Setting: IC. IPS) Termination: Disconnecting the Patient' step (3) states "Disconnect the bloodlines from the needle lines and remove the needles according to the Post Treatment Needle Removal Procedure'.
Policy 'Clinical Services' 'Post Treatment Fistula Needle Removal' (Setting: IC. HT, IPS) 'Procedure' section (2) states "Person removing needles perform hand hygiene and don clean gloves."
Observations conducted in patient treatment area on 04/11/23 between approximately 8:15 a.m. -12:00 p.m. and on 04/12/23 between approximately 2:40 p.m. - 3:00 p.m. revealed the following:
Observation #1 of (2): During observation of 'Discontinuation of Dialysis and Post Dialysis Care for AV Fistula or Graft' on 04/11/23 at approximately 9:10 a.m., of patient #11, Employee #7 at station #23 did not perform hand hygiene/don clean gloves after reinfusing the extracorporeal circuit/disconnecting the bloodlines and before removing the needles.
An interview with the facility Clinical Nurse Manager on April 14, 2023 at approximately 11:15 a.m. confirmed the above findings.
Plan of Correction:The clinic manager (CM) or designee re-educated all the direct patient care (DPC) staff on the following policy:
- Termination of Treatment Using a Arteriovenous Fistula or Graft and Optiflux Single Use Ebeam Dialyzer
- Post Fistula Needle Removal
-
Special emphasis will be placed on ensuring that hand hygiene is performed per policy at all times. This includes completing hand hygiene and don new gloves after reinfusing the patient's blood at the end of treatment, disconnecting the bloodlines and prior to needle removal.
The in-servicing of staff will be completed by May 5, 2023, with documentation of the training on file at the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time if compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A plan of correction (POC) audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: June 2, 2023
494.30(a)(2) STANDARD
IC-STAFF EDUCATION-CATHETERS/CATHETER CARE
Name - Component - 00
Recommendations for Placement of Intravascular Catheters in Adults and Children
I. Health care worker education and training
A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections.
B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters.
II. Surveillance
A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site.
Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients.
VI. Catheter and catheter-site care
B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections].
Observations:
Based on a review of facility policy/procedure, observations, and an interview with the facility Clinical Nurse Manager, the facility failed to ensure that clinical staff maintain aseptic technique for the care of vascular accesses, including intravascular catheters for two (2) of two (2) 'Central Venous Catheter (CVC) Exit Site Care' and 'Initiation of Dialysis with Central Venous Catheter' observations (Observation #1, Observation #2).
Findings:
A review was conducted of facility policy/procedure on April 14, 2023 at approximately 10:30 a.m.
Policy 'Changing the Catheter Dressing Procedure' (Setting: IC, HT) 'Timing of Exit Site Dressing Change' states "Catheter exit site disinfection and dressing change is to be completed prior to cap and hub connector disinfection." 'Removal of dressing and inspection of Site' step (8) states "Discard dressing and remove gloves. Perform hand hygiene. 'Cleaning the Site' step (1) states "Perform hand hygiene and don clean gloves." Step (2) states "Remove swabstick from package by stick end without touching foam applicator ...."
Policy 'Initiation of Treatment using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer' (Setting: IC, IPS) 'Prior to Initiation: Assessment and Machine Parameters' step (9) states ".... doff (remove) gloves, perform hand hygiene then don new gloves." 'Preparing the Catheter: Disinfection of the Catheter Connections, Heparin Removal, Flushing the Catheter and Heaprin Administration' step (1) states "Check to make sure catheter clamps are closed. Step (2) states "Remove cap from clamped arterial limb." Step (3) states "Using a sterile alcohol pad ....."
Observations conducted in patient treatment area on 04/11/23 between approximately 8:15 a.m. -12:00 p.m. and on 04/12/23 between approximately 2:40 p.m. - 3:00 p.m. revealed the following:
Observation #1: On 04/11/23 at approximately 8:55 a.m. while observing 'Central Venous Catheter Exit Site Care' observation #1, for patient #8, station #18; employee #6 did not remove gloves/perform hand hygiene/don clean gloves after removing the old dressing and prior to cleansing the area around the CVC exit site. Employee #6 did not complete the CVC exit site care and left CVC site exposed and initiated treatment. Employee #6 did not perform hand hygiene/don clean gloves prior to the initiation of dialysis.
The field placed under the CVC port made contact with the exposed site while employee #6 initiated dialysis treatment and attached sterile syringes to ports. The site was not cleansed again after contact.
Observation #2: On 04/11/23 at approximately 12:00 p.m. while observing 'Central Venous Catheter Exit Site Care' observation #2, for patient #3, station #23; employee #9 did not remove gloves/perform hand hygiene/don clean gloves after removing the old dressing and prior to cleansing the area around the CVC exit site. Employee #9 did not complete the CVC exit site care and left CVC site exposed and initiated treatment. Employee #6 did not perform hand hygiene/don clean gloves prior to the initiation of dialysis.
An interview with the facility Clinical Nurse Manager on April 14, 2023 at approximately 11:15 a.m. confirmed the above findings.
Plan of Correction:The clinic manager CM or designee re-educated all the direct DPC staff on the following policy:
- Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer
- Central Venous Catheter Exit Site Care
- Changing the Catheter Dressing Procedure
Special emphasis will be placed on ensuring that hand hygiene is performed per policy at all times. This includes completing hand hygiene and donning new gloves after removing the old catheter dressing and prior to cleansing the exit site. The meeting will also reinforce that the catheter exit site cannot be left exposed during the initiation of treatment and that the filed under the site must not make contact with the site. DPC staff will also be reminded that hand hygiene must be completed prior to the initiation of the treatment.
The in-servicing of staff will be completed by May 5, 2023, with documentation of the training on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAPI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: June 2, 2023
494.60(b) STANDARD
PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU
Name - Component - 00
The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.
Observations:
Based on a review of facility policy/procedure, manufacturers Directions for Use, equipment calibration documentation, and an interview with the facility Clinical Nurse Manager, it was determined the facility failed to ensure equipment was calibrated on an annual basis for one (1) of one (1) calibration logs reviewed (Log #1).
Findings include:
A review was conducted of facility policy/procedure on April 14, 2023 at approximately 10:30 a.m.
Policy ''Biomedical Support Services' (Settings: IC, IPS, HT) 'Mesa 90 XL Maintenance' 'Policy' states ".... A preventitive maintenance schedule must be established for annual recalibration of the meter sensor modules." 'Annual Maintenance' states "Each sensor module will be returned to MesaLabs or other company approved calibration lab annually for calibration."
'Daily Guard by Mesa Labs' '90 XL Meter Users Guide' section VII. 'Calibration Instructions' state "..... Note: Yearly factory calibrations are recommended on the conductivity/Temperature and Pressure sensor monitors. Factory calibration stickers are located on the sensor module and contain last known calibration date and calibration due date."
A review of the facility equipment calibration logs was conducted on 04/11/23 at approximately 11:00 a.m.
Log #1: The '90 XL-DCT Conductivity Module Dialysis Mesa Labs' calibration certificates for serial number DCT09112 and serial number DP308354 were reviewed. Documentation provided of calibrations being conducted on 11/02/22 with "Calibration Intervals: 12 months.". No documentation provided of calibration being conducted in 2021.
An interview with the facility Clinical Nurse Manager on April 14, 2023 at approximately 11:15 a.m. confirmed the above findings.
Plan of Correction:V 403
To ensure compliance the Area Technical Operations Manager (ATOM) or designee will reeducate the CM and BMT on the following Fresenius Medical Care (FMC) policy and Operators Manual:
- Biomedical Support Services
- Daily Guard by Mesa Labs '90 XL Meter Users Gide'
Special emphasis will be placed on ensuring that all equipment is tested and calibrated per manufacturer's directions for use. This includes annual testing of the '90 XL-DCT Conductivity Module Dialysis Mesa Labs. The meeting will also review that the testing is documented in the facility calibration log upon completion. The ATOM will review the annual equipment testing and monitoring schedule with the biomedical technician (BMT).
In servicing will be completed by May 5, 2023. All training documentation is on file at the facility.
For ongoing compliance, the BMT and CM will review the results of all testing and calibrations when completed and review the results at the QAPI meetings. The ATOM will audit the testing and calibration of the equipment based on the calendar for six (6) months. At that time if compliance is observed the audits will then follow the monthly QAPI schedule with review at the monthly QAPI meetings. A POC specific audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: June 2, 2023
494.60(c)(4) STANDARD
PE-HD PTS IN VIEW DURING TREATMENTS
Name - Component - 00
Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement).
Observations:
Based on a review of facility policy, observations, and an interview with the facility Clinical Nurse Manager, the facility failed to ensure the vascular access site and bloodline connections were seen by staff members throughout the dialysis treatment for four (4) of four (4) treatment floor observations (Observation #1 - Observation #4)
Findings include:
A review was conducted of facility policy/procedure on April 14, 2023 at approximately 10:30 a.m.
Policy 'Safety Checks' (Setting: IC) 'Purpose' states "The purpose of this policy is to provide guidance on safety checks to prevent, detect, and treat complications." 'Policy' states "Safety checks will be performed pre treatment and every 30 minutes or more frequently as needed once the treatment has begun."
Observations conducted in patient treatment area on 04/11/23 between approximately 8:15 a.m. -12:00 p.m. and on 04/12/23 between approximately 2:40 p.m. - 3:00 p.m. revealed the following:
Observation #1: During treatment floor observations on 04/11/23 at approximately 8:35 a.m., patient #13, at station #24; The patients AV Graft access site was covered by a blanket from approximately 8:35 a.m. - 9:03 a.m. ( approximately 28 minutes).
Observation #2: During treatment floor observations on 04/11/23 at approximately 8:38 a.m., patient #2, at station #23; The patients AV Fistula access site was covered by a blanket from approximately 8:38 a.m. - 9:03 a.m. ( approximately 25 minutes).
Observation #3: During treatment floor observations on 04/11/23 at approximately 8:40 a.m., patient #12, at station #19; The patients AV Fistula access site was covered by a blanket from approximately 8:40 a.m. - 9:03 a.m. ( approximately 23 minutes).
Observation #4: During treatment floor observations on 04/11/23 at approximately 11:25 a.m., patient #8, at station #18; The patients CVC Catheter (tunneled thigh) access site was covered by a blanket from approximately 11:25 a.m. - 11:55 a.m. ( approximately 30 minutes).
An interview with the facility Clinical Nurse Manager on April 14, 2023 at approximately 11:15 a.m. confirmed the above findings.
Plan of Correction:
V 407
To ensure compliance, the CM or designee re-educated all the DPC staff on the following policy:
- Patient Assessment and Monitoring
- Safety Checks
The meeting will place special emphasis on ensuring that the patient's access site must be visible throughout their treatment. The meeting will also reinforce the importance of verification and documentation that the access is uncovered when monitoring the patient every 30-45 minutes.
All patients will receive re-education by the DPC staff on the need to keep their access uncovered during treatment for safety reasons. Documentation of the access training will be completed in the patient's clinical note.
The in-servicing will be completed by May 5, 2023, with documentation of the training on file at the facility.
The CM or designee will perform daily audits on the DPC staff for 2 weeks. At that time if compliance is observed the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAPI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audits and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: June 2, 2023
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 a review of medical records, facility policy/procedure, and an interview with the Clinical Nurse Manager, the facility failed to ensure the staff followed facility procedure for early termination of treatment for five (5) of seven (7) medical records (MRs) reviewed (MR#1, MR#2, MR#4, MR#6, MR#7).
Findings include:
A review was conducted of facility policy/procedure on April 14, 2023 at approximately 10:30 a.m.
Policy 'Early Termination or Arriving Late for Treatment' 'Policy: Early Termination: "If a patient requests to leave treatment early: *The RN who evaluates the patient must document the rationale for early termination.....*The RN is responsible to notify the physician and document on the 'AMA' (Against medical advice) form.' 'Requirement Documentation- AMA Forms: AMA Forms are "Signed by the patient" and "Signed with each early termination event and filed in the patients medical record". 'Arriving Late' states "There may be times when a patients transportation is delayed and arrives late for their scheduled time. If patient arrives after their scheduled time for dialysis treatment start the patients treatment as soon as possible. Staff should do their best to accomodate the patients prescribed treatment time. If this is not possible ....the physician must be notified to review the time delay and determine the appropriate intervention. ......"
A review of medical records was conducted on April 13, 2023 between approximately12:30 p.m. - 3:30 p.m.
MR#1 Date of admission 03/18/23: Physician orders for Hemodialysis state treatment time "Scheduled Hours: 4:00 hours".
Patient treatment flow sheet date 04/06/23 reviewed. Flow sheet stated "Hours On: "03:47". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and the physician being notified.
Patient treatment flow sheet date 04/08/23 reviewed. Flow sheet stated "Hours On: "03:47". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
MR#2 Date of admission 07/28/18: Physician orders for Hemodialysis state treatment time "Scheduled Hours: 4:00 hours".
Patient treatment flow sheet date 03/28/23 reviewed. Flow sheet stated "Hours On: "03:35". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and the physician being notified.
Patient treatment flow sheet date 04/01/23 reviewed. Flow sheet stated "Hours On: "02:43". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
MR#4 Date of admission 12/28/22: Physician orders for Hemodialysis state treatment time "Scheduled Hours: 4:15 hours".
Patient treatment flow sheet date 03/28/23 reviewed. Flow sheet stated "Hours On: "04:03". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and the physician being notified.
MR#6 Date of admission 10/03/22: Physician orders for Hemodialysis state treatment time "Scheduled Hours: 4:00 hours".
Patient treatment flow sheet date 03/27/23 reviewed. Flow sheet stated "Hours On: "03:50". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and the physician being notified.
Patient treatment flow sheet date 03/29/23 reviewed. Flow sheet stated "Hours On: "02:31". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
Patient treatment flow sheet date 04/03/23 reviewed. Flow sheet stated "Hours On: "03:44". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
Patient treatment flow sheet date 04/05/23 reviewed. Flow sheet stated "Hours On: "03:27". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
MR#7 Date of admission 04/12/22: Physician orders for Hemodialysis state treatment time "Scheduled Hours: 4:30 hours".
Patient treatment flow sheet date 03/25/23 reviewed. Flow sheet stated "Hours On: "03:59". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and the physician being notified.
Patient treatment flow sheet date 04/01/23 reviewed. Flow sheet stated "Hours On: "04:02". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
Patient treatment flow sheet date 04/04/23 reviewed. Flow sheet stated "Hours On: "04:17". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
Patient treatment flow sheet date 04/07/23 reviewed. Flow sheet stated "Hours On: "04:06". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
An interview with the facility Clinical Nurse Manager on April 14, 2023 at approximately 11:15 a.m. confirmed the above findings.
Plan of Correction:V 543
To ensure compliance, the CM or designee re-educated all the DPC staff on the following policy:
- Early Termination or Arriving late for Treatment
- AMA Form
The meeting will place special emphasis on ensuring that any early termination of treatment is reported to the registered nurse (RN) prior to termination of the treatment and documentation of the RN notification. The meeting will also review that the RN must evaluate and determine the reason for the early termination with documentation and physician notification. The staff will be reminded that an Against Medical Advise (AMA) form must be signed by the patient any time treatment is ended early.
The in-servicing will be completed by May 5, 2023, with documentation of the training on file at the facility.
The CM or designee will perform daily audits on the DPC staff for 2 weeks. At that time if compliance is observed the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAPI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audits and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: June 2, 2023
494.90(a)(5) STANDARD
POC-VASCULAR ACCESS-MONITOR/REFERRALS
Name - Component - 00
The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement.
Observations:
Based on a review of facility policy/procedure, observations, and an interview with the facility Clinical Nurse Manager, the facility failed to ensure that the staff performed proper aseptic technique while initiating treatment for two (2) of two (2) 'Access of AV Fistula or Graft for Initiation of Dialysis' observations (Observation #1, Observation #2).
Findings include:
A review was conducted of facility policy/procedure on April 14, 2023 at approximately 10:30 a.m.
Policy 'Clinical Services' 'Access Assessment and Cannulation' 'Assessment of Vascular Assess' (Setting: IC, HT) 'Assessment of Vascular Access' Step (1) states "Prior to treatment, ask patient to wash area with soap per hand hygiene procedure. Wash access (per above) if patients unable to clean their access." Step (5) states "LOOK:......" Step (6) states "LISTEN:.....", Step (7) states "FEEL: ...", Step (9) states "Remove gloves and perform hand hygiene. Don clean gloves."
Policy 'Access Assessment and Cannulation' (Setting: IC, HT) 'Skin Disinfection' step (2) states .... Do not touch cannulation sites after skin disinfection."
Observations conducted in patient treatment area on 04/11/23 between approximately 8:15 a.m. -12:00 p.m. and on 04/12/23 between approximately 2:40 p.m. - 3:00 p.m. revealed the following:
Observation #1: On 04/11/23 at approximately 9:45 a.m., patient #9 at station #16, employee #9 began to initiate dialysis treatment. Employee #9 did not wash skin over access with soap and water or antibacterial scrub, prior to evaluating access site, nor verbally confirm that the patient had cleansed the access site.
Observation #2: On 04/11/23 at approximately 10:08 a.m., patient #10 at station #15, employee #9 began to initiate dialysis treatment. Employee #9 did not wash skin over access with soap and water or antibacterial scrub, prior to evaluating access site, nor verbally confirm that the patient had cleansed the access site. Employee #9 touched the access site after applying antiseptic. Employee #9 did not apply antiseptic to the skin over cannulation site after touching the site and prior to inserting cannulation needle.
An interview with the facility Clinical Nurse Manager on April 14, 2023 at approximately 11:15 a.m. confirmed the above findings.
Plan of Correction:V 550
The clinic manager CM or designee re-educated all the direct DPC staff on the following policy:
- Access Assessment and Cannulation
Special emphasis will be placed on verbally confirming that the patient washed their access prior to initiation of treatment. If the patient did not wash their access site when asked, the DPC must wash the access site with soap and water prior to evaluating the access site. The meeting will also review that the access site should not be touched after applying antiseptic.
The in-servicing of staff will be completed by May 5, 2023, with documentation of the training on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAPI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: June 2, 2023
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 medical records and an interview with the facility Clinical Nurse Manager, it was determined the facility failed to ensure physicians medication orders were administered as ordered for two (2) of seven (7) medical records reviewed (MR#3, MR#7) and failed to ensure the facility COVID-19 screening forms were completed per facility policy for one (1) of one (1) COVID-19 screening forms reviewed (Form #1).
Findings include:
Facility policy/procedure related to adhering to physicians orders was requested on 04/13/23 at approximately 11:30 a.m. No policy/procedure provided.
A review of medical records was conducted on April 13, 2023 between approximately12:30 p.m. - 3:30 p.m.
MR#3, Date of admission 09/12/22: 'Orders Summary Report' includes 'Midodrine HCI (Proamatine) 5 milligram oral pre dialysis every treatment." 'Start Date: 10/06/22.' 'End Date: 10/05/23.' 'Midodrine HCL (Proamatine) 5 milligram oral during dialysis PRN (as needed)." 'Start Date: 11/22/22.' 'End Date: 11/21/23.'
Patient treatment flowsheet dated 03/28/23 'Description' 'Midodrine HCL (Proamatine)' 'Administered prescribed:' "No; Unable to administer as prescribed."
Patient treatment flowsheet dated 03/30/23 'Description' 'Midodrine HCL (Proamatine)' 'Administered prescribed:' "No; per algorithm."
Patient treatment flowsheet dated 04/06/23 'Description' 'Midodrine HCL (Proamatine)' 'Administered prescribed:' "No; unable to administer as ordered."
There are two (2) physician orders for Midodrine HCL (Proamatine) 5 milligram oral. One order states to be administered every treatment and the second order states Midodrine HCL (Proamatine) 5 milligram oral to be administered PRN (as needed).
No documentation provided of notifying the physician of prescribed medication not being administered as ordered.
MR#7, Date of admission 09/12/22: 'Orders Summary Report' includes 'Midodrine HCI (Proamatine) 5 milligram oral pre dialysis every treatment." 'Start Date: 12/17/22.' 'End Date: 12/16/23.'
Patient treatment flowsheet dated 03/21/23 'Description' 'Midodrine HCL (Proamatine)' 'Administered prescribed:' "No; Unable to administer as prescribed."
Patient treatment flowsheet dated 04/04/23 'Description' 'Midodrine HCL (Proamatine)' 'Administered prescribed:' "No; Administration variance."
No documentation provided of notifying the physician of prescribed medication not being administered as ordered.
A review was conducted of facility policy/procedure on April 14, 2023 at approximately 10:30 a.m.
Policy 'Clinical Services' 'Guidance on Dialyzing and Infection Control Practices during a COVID-19 Endemic in Fresenius Kidney Care (FKC) Dialysis Clinics' 'Patient, Visitor, Staff, Physician, and Physician Extender Screening' states "Regardless of COVID-19 vaccination and or booster status, all patients, visitors, staff, physicians, and physician extenders entering an FKC dialysis clinic must be screened for ongoing signs and symptoms of COVID-19 disease." .... Completed screening forms must be maintained in a secure location within all FKC dialysis clinics for twelve months ..."
A review of the COVID-19 screening forms was conducted on 04/11/23 at approximately 1:00 p.m.
Form #1: The 'COVID-19 Patient and Visitor Screening Form' (s) reviewed from 03/27/23 - 04/11/23. The form contains (4) sections: Temperature, symptom questions, close contact with a COVID-19 + person, and direct contact with COVID-19 + person while not wearing PPE. The screening forms dated 03/27/23, 03/29/23, 03/30/23, and 04/11/23 were incomplete and all of the listed questions were not completed.
An interview with the facility Clinical Nurse Manager on April 14, 2023 at approximately 11:15 a.m. confirmed the above findings.
Plan of Correction:By April 28, 2023, the Director of Operations (DO) and the CM will meet with the Medical Director to review the Medical Director Responsibilities as defined in the Conditions for Coverage. The meeting also reviewed the following policy:
- Physician Order Documentation
- Guidance on Dialyzing and Infection Control Practices during a COVID-19 Endemic in Fresenius Kidney Care Dialysis Clinics
The Medical Director will be informed at the meeting with the DO and CM that the DPC staff receive re-education of the above policies with the focus on the
importance of the staff always administering the physician ordered medications. The DPC staff meeting also reviewed the need to ensure that all questions on the Covid-19 Patient and Visitor Screening Forms are completed and the answers documented.
To ensure compliance, the CM or designee will in-service all DPC staff on the above policies. The in-service will provide re-education on ensuring that all physician medication orders are always adhered to. If the medication order is unable to be administered, the reason why and notification of the physician must be documented in the medical record. The meeting will also review that the Covid 19 screening for all staff, patients and visitors, physician and physician extenders is still in effect. All questions on the Covid 19 screening form must be completed in its entirety and the forms maintained in the unit for twelve (12) months.
The inservice will be completed by May 5, 2023, with documentation on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAPI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results weekly with the Medical Director and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: June 2, 2023
|