Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on 10/28/2022, 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 10/28/2022, Dialysis Clinic Inc. was found to have the following standard level deficiencies that was/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)(i) STANDARD
IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT
Name - Component - 00
Routine Testing for Hepatitis B
The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit.
Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results.
Observations:
Based on a review of facility policies and procedures, medical records (MR) and staff (EMP) interviews, the facility failed to ensure hepatitis B core antigen (HBcAg) screening was performed per agency policy for patient (MR8).
Findings included:
Review of facility policies conducted on 10/28/2022 at approximately 10:10 AM revealed: PROCEDURE NO: 616.0 ...Hepatitis B: Evaluation and Monitoring PURPOSE: Provide guidelines for the evaluation and monitoring of patients and staff Hepatitis B status to prevent the transmission of Hepatitis B Virus (HBV) infection ...Total Hepatitis B Core Antibody (anti-
HBc): Appears at the onset of symptoms in acute Hepatitis B and persists for life. The presence of anti-HBc indicates previous or ongoing infection with Hepatitis B virus in an undefined timeframe. IgM Antibody to Hepatitis B Core Antigen (IgManti-HBc): Positively indicates recent infection with Hepatitis B virus (< 6 mos.) This indicates acute infection ...POLICY: Hepatitis Surveillance: Patients: 1. All new patients will have HBsAg, Anti-HBc (total), and Anti-HBs drawn upon admission and results known, to be accepted into the clinic. 2. All new patients will have HBsAg, Anti-HBc (total), and Anti-HBs drawn on the first day of treatment ... "
An initial request on for information from "ESRD CORE SURVEY DATA WORKSHEET #15 Vaccination information # of patient who received a complete series of Hepatitis B vaccine." Requested additional information concerning Hepatitis B status of patients was request from EMP1. EMP1 provided report "Immunization Summary-Multiple Patient " A request for any additional information pertaining to the Hepatitis B status of MR8 start of care 4/28/2001 with a primary diagnosis of Acute interstitial nephritis was requested from EMP1 on 10/26/2022.
During an interview with EMP1 on 10/27/2022 at approximately 8:50 AM confirmed, MR8 did not have an Anti-HBc (total) drawn upon admission and results known by staff per agency policy.
An exit interview was conducted on 10/28/2022 at approximately 2:30 PM with the administrator, nurse manager and technical manager which confirmed the above findings.
Plan of Correction:1. The Hepatitis B Core Antigen (HBcAg) screening was performed on 11/2/2022 for patient (MR8).
2. All RN staff will be re-trained on the facility's "Hepatitis B: Evaluation and Monitoring" policy #616.0 by 11/30/22 with emphasis that all new patients will have HBsAg, Anti-HBc (total), and Anti-HB's drawn upon admission.
3. All RN staff will review and sign acknowledgement of understanding of policy. A copy of the acknowledgement will be placed in the facility's education manual.
4. The Nurse Manager and/or Designee will audit the patient immunization summary report monthly for six (6) months to ensure that RN staff are following the policy with emphasis on HBsAg, Anti-HBc (total), and Anti-HB's being drawn on new patients upon admission (first day of treatment). The audit results will be reviewed at monthly QAPI meetings.
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 a facility observations tour (OBV), review of facility policy and procedures and staff (EMP) interview it was determined the facility failed to ensure disposal of expired medications for one (1) of one (1) facility tour.
Findings included:
A flash tour (OBV1) was conducted with EMP1 on 10/24/2022 at approximately 10:25 AM, observation of the emergency cart revealed, one (1) plastic bag with three (3) expired medication vials located in the emergency cart. The expired medication was as followed:
"Diphenhydramine vial 50mg/1mL Lot 090015 Exp 09/22"
An exit interview was conducted on 10/28/2022 at approximately 2:30 PM with the administrator, nurse manager and technical manager which confirmed the above findings.
Plan of Correction:1. The one (1) plastic bag containing three (3) expired vials of "Diphenhydramine vial 50mg/1mL Lot 090015 Exp. 9/22" was disposed of on 10/25/2022.
2. All clinical staff will be in-serviced by 11/30/2022 on reviewing the expiration dates on all medications contained within the crash cart and the importance of disposing of any expired medications.
3. All clinical staff will review and sign acknowledgement of understanding. A copy of the acknowledgement will be placed in the facility's education manual.
4. Any member of the clinical staff responsible for completing the monthly check of medications within the crash cart will inform the Nurse Manager and/or Designee that the check has been completed. The Nurse Manager and/or Designee will then perform a recheck of the crash cart medications to ensure that no expired medications are present in the crash cart. The monthly recheck of medications will continue for six (6) months to ensure that clinical staff are meeting expectations and no expired medications are present within the crash cart. The results will be reviewed at monthly QAPI meetings.
494.100(b)(2),(3) STANDARD
H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS
Name - Component - 00
The dialysis facility must -
(2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and
(3) Maintain this information in the patient ' s medical record.
Observations:
Based on review of facility medical records, and staff (EMP) interview the facility failed to ensure home dialysis treatment records were reviewed for accuracy with post-treatment assessment documentation for determining if patients were following their treatment plans and/or having problems with their dialysis at home for one (1) of two (2) PD records reviewed (MR7).
Findings Included:
Review of the agency policy and procedures on 10/31/2022 at approximately 11:00 AM revealed, "PROCEDURE NO: 206.0...Daily Home Treatment Record PURPOSE: Provide guidelines for proper documentation of home peritoneal dialysis (PD) treatments and to collect data needed to assess the patient's response to PD treatments. SUPPORTIVE DATA ...The dialysis facility must retrieve, and review completed self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months and maintain this Information in the patient ' s medical record...POLICY...2. Each PD patient will be instructed to complete documentation of each treatment procedure on the Daily Home Treatment Record (See Attachment 206A or 206B) and/or by means of an electronic data card...4. Home training staff member will review completed Daily Home Treatment Records to assist in evaluation the patient's progress and self-care decision making process. This will assist staff in making changes to the plan of care if and when warranted or to focus retraining as needed..."
Review of MR7 completed on 10/27/2022 at approximately 12:25 PM revealed a start of care 11/27/2021. The history and physical received confirms " Office Visit 7/26/2021 ...Progress Note ...Problems ...4) Diabetes mellitus: Fair control ... " Review of the "(Agency) CURRENT MEDICATIONS BY CLASS" revealed "Group Name: ENDOCRINAL DRUG NAME...INSULIN GLARGINE (LANTUS) STRENGTH 100 U/ML, Dose 0.25 ML, Act. Ingred, 25 UNIT, Frequency QHS...Start Date 6/29/2022..." Also listed was "LINAGLIPTIN Strength 5MG, Dose 1 Tablet(s) ...Frequency daily ...Start Date 6/29/2022 ..."
Records review revealed "Amia Patient Clinical Data Report" most recently dated 8/8/2022 to 10/9/2022 reviewed by staff 10/10/2022. The records did not contain evidence of PD flow sheets recording data in the column "Blood Glucose (mg/dL) Pre, Post" No additional documentation was provided to confirm the staff conducting patient instruction/teaching for the missing information.
An exit interview was conducted on 10/28/2022 at approximately 2:30 PM with the administrator, nurse manager and technical manager which confirmed the above findings.
Plan of Correction:1. Home Dialysis Nurse reviewed orders for all home patients with diagnosis of diabetes. None contained orders for pre/post treatment glucose monitoring.
2. Home Dialysis Nurse will follow standing orders for glucose monitoring during training or clinic visit.
3. Home Dialysis Nurse will review physician orders for each home patient with diabetes to ensure that orders for monitoring glucose pre/post treatment are followed and documented on treatment sheet.
4. Treatment records will be edited to remove/include glucose testing results as ordered by the physician.
5. Initially, Home Dialysis Nurse Manager and/or designee will audit the flowsheets for home patients with a diabetes diagnosis for three (3) months to ensure that physician orders are being followed appropriately. If standards are met, the flowsheets will be audited quarterly for one year. The audit results will be reviewed at monthly QAPI meetings.
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