Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed December 9, 2022, Dialysis Clinic, Inc. 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 December 9, 2022, Dialysis Clinic, Inc. 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)(1) STANDARD
IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P
Name - Component - 00
The facility must-
(1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit;
Observations:
Based on direct observation and interview with staff (EMP), the facility failed to ensure restricted areas were maintained per facility designation.
Findings included:
During flash tour of facility on December 6, 2022, and ongoing observation while onsite conducting survey, concluded with observation on December 9, 2022, at 1:00pm surveyor observed double doors to supply room propped open with barrels of acid. Signage on doors read that the doors were to remain closed at all times.
December 9, 2022, at approximately 1:30pm surveyor confirmed doors to supply room propped open throughout survey with clinical manager who replied, "you are correct."
Exit interview on December 9, 2022, at approximately 2:30pm with Clinic Manager, Area Operations Director, Technical Manager, Nurse Educator, and Peritoneal Dialysis Nurse confirmed findings.
Plan of Correction:1) Area Operations Director will be responsible to:
a) Present proposed Plan of Correction to Governing Body at the December 20, 2022, monthly meeting.
2) Nurse Educator will be responsible to:
a) Educate personnel on or before December 28, 2022 regarding:
i) Need to secure integrity of medical supplies by closing supply room doors
b) Create and audit checklist to determine compliance with closing supply room door
3) Technical Manager or designee will be responsible to:
a) Order keypad lock for supply room door by December 21, 2022
b) Install keypad lock within 1 (one) week of receipt of lock (target receipt date is December 23, 2022).
4) Technical Manager or designee will be responsible to perform audits beginning December 29, 2022 as follows:
a) Daily for 2 weeks
b) If 100% compliant, Weekly for 2 weeks
c) If 100% compliant, Monthly for 2 months
5) Nurse Manager or designee will be responsible to:
a) Review and initial audits per audit schedule.
b) Document results of audits in QAPI and present findings to Governing Body monthly.
6) Governing Body will determine frequency of future audits based upon compliance.
494.30(b)(3) STANDARD
IC-STAFF REPORT IC ISSUES
Name - Component - 00
[The facility must-]
(3) Require all clinical staff to report infection control issues to the dialysis facility ' s medical director (see § 494.150 of this part) and the quality improvement committee.
Observations:
Based on direct observation and interview with staff (EMP), the facility failed to ensure medication refrigerator temperatures were maintained per agency policy.
Findings included:
Review of clinic policy on December 7, 2022, at approximately 2:00pm revealed: "...Refrigeration Guidelines...5. A temperature log must include the following information at minimum: ...b. Any temperature deviation from the stated parameters must include documentation of interventions and follow-up on effectiveness of intervention..."
Review of medication refrigerator temperature log on December 7, 2022, at approximately 10:00am revealed lab and medication refrigerator temperature parameters to be 40-42 degrees F (Fahrenheit.) Lab refrigerator temperature readings out of range 12/6/2022 at 3:00pm documented to be 38 degrees F. Medication refrigerator temperatures out of range 12/1/2022 at 5:20am documented to be 39 degrees F, 12/1/2022 at 3:10pm documented to be 38 degrees F, 12/2/2022 at 5:15am documented to be 39 degrees F, and 12/6/2022 at 3:05pm documented to be 39 degrees F. No interventions documented as per clinic policy.
Interview with Clinic Manager on December 7, 2022, at approximately 10:15am reveled knowledge of the deviation from parameters. "We were thinking that maybe it was because the refrigerator was open for medication count..." Confirms no interventions implemented.
Exit interview on December 9, 2022, at approximately 2:30pm with Clinic Manager, Area Operations Director, Technical Manager, Nurse Educator, and Peritoneal Dialysis Nurse confirmed findings.
Plan of Correction:1) Area Operations Director will be responsible to:
a) Present proposed Plan of Correction to Governing Body at the December 20, 2022, monthly meeting.
2) Nurse Educator will be responsible to:
a) Educate personnel on or before December 28, 2022 regarding the following Policies and Spreadsheets:
i) "Refrigeration Guidelines" including information regarding Stability of Medications during Excursions outside of normal range temperature and "Lab Refrigerator Temperature Log Spreadsheet" with instructions how to complete properly
ii) DCI Corporate Policy 1603 "Epogen Receiving and Storage" and its Attachment 1603A "Medication Refrigerator Temperature Log" and "Medication Refrigerator Temperature Log Interventions Spreadsheet" with instructions how to complete properly
b) Create audit checklist to monitor:
i) That documentation exists to support that interventions have been recorded on Medication Refrigerator Log when temperature deviates from the stated parameters
ii) To monitor that temperature of medication refrigerator is rechecked within 2 to 3 hours to determine effectiveness of intervention
3) Charge Nurse will be responsible to:
a) Ensure that Medication Refrigerator Log is completed at minimum twice per day
b) Ensure that interventions to out of range temperatures are recorded and monitored daily
4) Nurse Manager or designee will be responsible to perform audits beginning December 27, 2022 as follows:
a) Daily for 2 weeks
b) If 100% compliant, Weekly for 2 weeks
c) If 100% compliant, Monthly for 2 months
5) Nurse Manager or designee will be responsible to:
a) Review and initial audits per audit schedule.
b) Document results of audits in QAPI and present findings to Governing Body monthly.
6) Governing Body will determine frequency of future audits based upon compliance.
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