Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on September 11, 2023 through September 14, 2023, Saint Charles Way Dialysis was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on September 11, 2023 through September 14, 2023, Saint Charles Way 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 observations and an interview with the facility administrator, it was determined the facility failed to ensure proper disposal of expired medication for one (1) of one (1) observation. (Observation #1)
Findings include:
Review of Davita Incenter Hemodialysis Policies and Procedures Policy: 1-06-01: Title: Medication policy: " Notes: All nurses must be licensed by the state in which they are practicing " ; Purpose: " To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. " ; Policy: " 1. The Administrator/designee is responsible for supervising the handling, storing, disposing, administering, and controlling of medications and performs a monthly audit and inventory. " ; 13. " All open or unopened ampules and/or vials are stored ....Do not use any ampule or vial that has been stored improperly or has expired ... " ; 30. " All medications in the facility are checked monthly. All medications are checked monthly for expiration dates ... " ; 31. " Medications are ordered and replaced prior to expiration ... " ; 32. " Disposal of expired medications ... ...are removed from the treatment and inventory areas and disposed of per state/local regulations ... "
Observation #1: On 9/11/2023 at approximately 10:40 AM one (1) vial of Vancomycin with expiration date of 7/31/2023 found during review of medication station.
An interview with the facility administrator on September 14, 2023 at approximately 3:20 PM confirmed the above findings.
Plan of Correction:V143
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 10/04/23. 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) The Facility Administrator or designee is responsible for supervising the handling, storing, disposing, administering, and controlling of medications and performs a monthly audit and inventory. 2) All open or unopened ampules and/or vials are stored according to the manufacturer's directions. Do not use any ampule or vial that has been stored improperly or has expired. 3) All medications in the facility are checked monthly. Insulin and other medications with preservatives are dated and initialed once opened. All medications are checked monthly for expiration dates. 4) Medications are ordered and replaced prior to expiration. 5) Disposal of expired medications ... are removed from the treatment and inventory areas and disposed of per state/local regulations. Verification of attendance is evidenced by teammate's signature on the in-service sheet.
On 09/11/23, the Charge Nurse immediately and appropriately discarded the expired vial of Vancomycin which was identified by the surveyor. The Charge Nurse then completed a one hundred percent (100%) audit of medications in the facility and all medications were confirmed as current. Ongoing compliance will be monitored with the monthly infection control audit. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review the audit results with teammates during homeroom meetings and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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 review policies/procedures,weekly temperature logs of refrigerator/freezer and weekly cleaning log for oxygen concentrators the facility failed to ensure proper maintenance/functioning of equipment for three (3) of six (6) temperature logs (Observations #1-3) and nine (9) out of nine (9) weekly cleaning log for oxygen concentrators (Observations #1-#9)
Findings include:
Review of Davita incenter hemodialysis policies and procedures on September 18, 2023 at approximately 11:45 AM revealed: policy 1-06-06: title: medications requiring refrigeration: Purpose: " To provide guidance for the storage and management of medications requiring refrigeration. " Policy: " 3. The refrigerator is checked during facility normal operating hours, by a licensed nurse teammate or designee. Checks will be documented on the Medication refrigerator management log. A. Twice daily temperature checks ... " i. " Verify that the temperature remains between two (2) degrees Celsius and eight (8) degrees Celsius (thirty-six (36) degrees Fahrenheit and forty-six (46) degrees Fahrenheit. " ; d. " Temperature excursions and issues noted during daily check will be noted on log with actions taken and outcome(s) ... "
Review of Refrigerator/freezer logs on 9/14/23 between approximately 2:00 PM-2:30 PM and 9/15/23 between approximately 12:00 PM-1:30 PM revealed:
Observation (OBS) #1: Refrigerator #2: No documentation of a PM afternoon temperature checks on 7/6/23 and 7/15/23.
OBS # 2: No refrigerator number or identification for July 2023: No documentation of a PM afternoon checks on 7/6/23, 7/20/23 and 7/24/23.
OBS # 3: Refrigerator: Lab South: Refrigerator limits: thirty-six (36) degrees Fahrenheit to forty-six (46) degrees Fahrenheit. Temperature logged as thirty-five (35) on 7/5/23 but no documentation of action taken.
Review of Oxygen concentrator filter weekly cleaning logs on 9/14/23 between approximately 2:00 PM-2:30 PM and 9/15/23 between approximately 12:00 PM-1:30 PM revealed:
Observation (OBS) # 1: Oxygen concentrator filter weekly cleaning log # 1: No documentation of week 4 dated 7/29/23 and week 1 and week 2 of September (9/1/23 and 9/9/23).
OBS # 2: Oxygen concentrator filter weekly cleaning log # 2: No documentation of week 4 dated 7/29/23, week 4 of August (8/26/23), week 1 and week 2 of September (9/1/23 and 9/9/23).
OBS # 3: Oxygen concentrator filter weekly cleaning log # 3: No documentation of week 4 dated 7/29/23, week 4 of August (8/26/23), week 1 and week 2 of September (9/1/23 and 9/9/23).
OBS # 4: Oxygen concentrator filter weekly cleaning log # 4: No documentation of week 4 dated 7/29/23, week 4 of August (8/26/23), week 1 and week 2 of September (9/1/23 and 9/9/23).
OBS # 5: Oxygen concentrator filter weekly cleaning log # 5: No documentation of week 4 dated 7/29/23, week 4 of August (8/26/23), week 1 and week 2 of September (9/1/23 and 9/9/23).
OBS # 6: Oxygen concentrator filter weekly cleaning log # 6: No documentation of week 4 dated 7/29/23, week 4 of August (8/26/23), week 1 and week 2 of September (9/1/23 and 9/9/23).
OBS # 7: Oxygen concentrator filter weekly cleaning log # 7: No documentation of week 4 dated 7/29/23, week 4 of August (8/26/23), week 1 and week 2 of September (9/1/23 and 9/9/23).
OBS # 8: Oxygen concentrator filter weekly cleaning log # 8: No documentation of week 4 dated 7/29/23, week 4 of August (8/26/23), week 1 and week 2 of September (9/1/23 and 9/9/23).
OBS # 9: Oxygen concentrator filter weekly cleaning log # 9: No documentation of week 4 dated 7/29/23, week 4 of August (8/26/23), week 1 and week 2 of September (9/1/23 and 9/9/23).
An interview with the facility administrator on September 14, 2023 at approximately 3:20 PM confirmed the above findings.
Plan of Correction:V403
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 10/04/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-06-06 "Medications Requiring Refrigeration" and Policy 1-02-04A "Optional Oxygen Concentrator Filter Cleaning Log" with emphasis on but not limited to: A. Medication refrigerator: 1) The refrigerator is checked during facility normal operating hours, by a licensed nurse teammate or designee. Checks will be documented on the Medication Refrigerator Management Log. a. Twice daily temperature checks located on the Digital Data Logger (DDL) display at the beginning and end of the day. i. Verify that the temperature remains between 2° C and 8° C (36° F and 46°F)... c. A separate management log is maintained for each medication refrigerator present in the facility. d. Temperature excursions and issues noted during daily check will be noted on log with actions taken and outcome(s). B. Oxygen concentrator filter cleaning log: 1) On a weekly basis, the following will be performed:
a. Verify the unit is OFF before cleaning; b. Clean filter by removing it from the oxygen concentrator and washing it in a solution of warm water and a mild detergent. Then rinse the filter thoroughly
with warm water and towel dry. The filter should be completely dry before reinserting. Please refer to Operator's Directions for Use. Document on Oxygen Concentrator Filter Cleaning Log including facility name, facility number, concentrator manufacturer and concentrator serial number, along with date of cleaning, teammate signature and teammate initials. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct log audits to verify:
1) Temperature checks are completed for medication refrigerator / freezer per policy: daily for two (2) weeks and weekly for two (2) weeks; 2) Oxygen concentrator filters are cleaned weekly per policy: weekly for four (4) weeks. Ongoing compliance for both logs will be monitored with the monthly Facility Safety Tool audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review the audit results with teammates during homeroom meetings and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.60(c)(1) STANDARD
PE-PT CARE ENVIRONMENT-SUFFICIENT SPACE
Name - Component - 00
The space for treating each patient must be sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff.
Observations:
Based on observations and an interview with the facility administrator, it was determined the facility failed to ensure adequate space between clean sinks, sharps containers and dialysis chairs to prevent cross-contamination for three (3) observations (Observation #1-Observation #3).
Findings include:
Observation #1: On 9/11/2023 at approximately 10:15 AM station # 41 treatment chair was blocking clean sink. The clinic has five (5) treatment pods and each pod has at least one (1) clean sink and one (1) dirty sink located in the treatment pod. Station # 41 is located next to a clean sink thus the chair's location was preventing access to the clean sink.
Observation #2: On 9/11/2023 at approximately 10:20 AM Two (2) sharps containers on wheels were blocking clean sink at medication station.
Observation #3: On 9/11/2023 at approximately 10:30 AM station # 6 treatment chair was blocking clean sink. The clinic has five (5) treatment pods and each pod has at least one (1) clean sink and one (1) dirty sink located in the treatment pod. Station # 6 is located next to a clean sink thus the chair's location was preventing access to the clean sink.
An interview with the facility Administrator on September 14, 2023 at approximately 3:20 PM confirmed the above findings.
Plan of Correction:V404
The Facility Administrator or designee held mandatory in-services for all clinical teammate starting on 10/04/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 8-04-01 "Physical Environment" with emphasis on but not limited to: 1) the dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment. 2) The space for treating each patient will be sufficient to provide needed care and services, prevent cross contamination, and to accommodate medical emergency equipment and teammates. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct observational audits to verify space between clean sinks, sharps containers and dialysis chairs is adequate: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control audit. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review the audit results with teammates during homeroom meetings and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.80(a)(2) STANDARD
PA-APPROPRIATENESS OF DIALYSIS RX
Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:
(2) Evaluation of the appropriateness of the dialysis prescription,
Observations:
Based on review of policy, medical records (MR), and an interview with the facility administrator; the facility failed to ensure that the patient prescriptions were being implemented as ordered by the physician for three (3) out of fifteen (15) patient prescriptions reviewed (MR #6-7 and # 10).
Findings include:
A review was conducted of facility policy on September 14, 2023, at approximately 2:50 PM Policy:1-03-08 " Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment Policy section #2 " states: "The nursing assessment will be performed and documented by a licensed nurse ...., (a)(ii) Verification that machine safety checks have been completed and documented... (a)(iii) Verification of prescription including machine parameters". Section #3 states "Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment". "Prescription components include but are not necessarily limited to: (b) "Treatment time" (f) Blood flow rate". 'Intradialytic Data Collection/Assessment' section #12 states "The licensed nurse notifies the physician (or AHP if applicable) as needed of changes in patient status". Section # 13 states " All findings, interventions and patient response will be documented in the patients ' medical record".
Dialysis Regulatory and Ancillary Policies and Procedures: Policy: 3-02-03: Davita Inc.: Title: "PHYSICIAN ORDERS FOR PATIENT CARE" reviewed on 9/14/23 at approximately 2:50 PM revealed: "Purpose: To verify that orders are properly documented, transcribed, verified and implemented in a timely manner for patient care in Davita facilities and meet all Davita, federal and applicable state regulations."; Policy: General: A physician, in accordance with Davita medical staff bylaws, federal and state regulations, provides orders for patient care activities in one of the following ways: hand writes or electronically enters orders in the patient medical record. Gives verbal or telephone orders.; Orders must be received prior to the delivery of any treatment or service ordered.; non-licensed teammates may only transcribe written physician orders into a computerized system if signed in advance by the licensed physician. A Registered Nurse verifies the order entered in the computer against the written order in the chart before implementation.; All orders must be entered into the electronic medical record. All orders entered into the electronic medical record must be signed and dated by the ordering physician on any unsigned orders report or through eSignature within thirty (30) days."
On September 13, 2023 between approximately 1:40 PM and 3:00 PM and on September 14, 2030 between approximately 9:30 AM and 11:50 AM review of patient orders and dialysis treatment flow sheets revealed:
MR # 6: Physician orders dated: 8/31/23 "Blood Flow Rate (BFR) 400".
Treatment flow dated: 9/9/23 showed BFR: 350.
No documentation explaining the BFR difference from the prescribed BFR. No documentation showing the physician was notified.
MR # 7: Physician orders dated: 8/24/23 "Blood Flow Rate (BFR) 350".
Treatment flow dated: 8/30/23 showed BFR: 230 to 300.
No documentation explaining the BFR difference from the prescribed BFR. No documentation showing the physician was notified.
MR # 10: Physician orders dated: 8/24/23 "Blood Flow Rate (BFR) 400".
Treatment flow dated: 9/1/23 showed BFR: 300 to 350.
No documentation explaining the BFR difference from the prescribed BFR. No documentation showing the physician was notified.
An interview conducted with the facility administrator on September 14, 2023 at 3:20 PM confirmed the above findings.
Plan of Correction:V503
The Facility Administrator or designee held mandatory in-service(s) for all Clinical Teammates starting on (date). Surveyor observations were reviewed. Education included but was not limited to a review of Policy 3-02-03 "Physician Orders for Patient Care" and Policy 1-03-08 "Pre- Intra- Post treatment Data Collection, Monitoring and Nursing Assessment" with emphasis on but not limited to: A. Physician orders: 1) Purpose: To verify that orders are properly documented, transcribed, verified and implemented in a timely manner for patient care in DaVita facilities and meet all DaVita, federal and applicable state regulations. B. Pre- Intra- Post... 1) Patient identity, prescription and machine settings are verified by teammates prior to initiation of treatment with the exception of blood flow rate (BFR) which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within 1 hour of treatment initiation along with the nursing assessment. Prescription component include but are not necessarily limited to: treatment time... blood flow rate. 2) Intra dialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes vital signs and treatment monitoring at least every 30 minutes. 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. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet.
The Facility Administrator or designee will conduct audits to verify accurate and complete treatment documentation and timely nurse notification as required per policy: on twenty five percent (25%) of the treatment records daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored on the monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review the audit results with teammates during homeroom meetings and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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