Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on June 28, 2021 through July 1, 2021, 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 conducted on June 28, 2021 through July 1, 2021, 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(a)(1)(i) STANDARD
IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS
Name - Component - 00
Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled.
When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station.
Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients.
Observations:
Based on observation during a tour of the facility, review of policy and procedure, and interview with the Facility Nurse Manager, it was determined, that the facility failed to maintain a functional treatment environment by storing expired medical supplies.
Findings include:
Review of policy titled, "Administration of Pneumococcal Vaccine" on July 1, 2021 at approximately 9:00 AM states, "Store unopened and open vials at 36-46 degrees Farenheit and all vaccine must be discarded after the expiration date..."
A tour of the Peritoneal dialysis medication area on June 28, 2021 at approximately 9:00 AM revealed:
1. The medication refrigerator contained eight (8) pneumococcal vaccines with an expiration date of 5/18/21.
An interview conducted with the Facility Nurse Manager on July 1, 2021 at approximately 11:00 am confirmed the above findings.
Plan of Correction:
The Nurse Manager met with the in-center nurses and home training nurses on 6/28, 7/7 & 7/8 to review
(1) Clinical Policy 9.36 "Administration of Pneumococcal Vaccine" in its entirety which includes the policy directive that all vaccine must be discarded after the expiration date." and (2) the PA DOH Deficiency Listing.
Completion date: 7/8/21
Going forward, (1) the three clinical areas' RNs (i.e., small 8 station side, the larger 24 station side and the home training area) will fill out a Monthly Medication / Supplies Expiry Date sheet with all medications listed with their expiration dates, the RNs' signature and date. These will be due to the Nurse Manager during the first week of every calendar month.
(2) The Nurse Manager or her designee (e.g., Education Coordinator) will monthly remind all nurses via DCI email to discard all outdated supplies or medications in their work areas and this will be reported to the monthly QAPI meetings for management oversite.
Completion date: 7/8/21
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 observation of the treatment area, facility policy, and an interview with the facility nurse manager, the facility did not follow its policy during the initiation of dialysis with a central venous catheter for one (1) of two (2) catheter initiation observations (OBS). OBS#2. and the facility did not follow its policy during the discontinuation of dialysis with a central venous catheter for one (1) of three (3) catheter discontinuation observations (OBS). OBS#3.
Findings include:
A review of policy "Central Venous Catheter (CVC) Exit Site Disinfection, Dressing Change and Preparation for Dialysis" was reviewed on June 29, 2021 at approximately 12:30 PM and states, "Purpose: to provide guidelines for the safe, aseptic central catheter exit site disinfection, dressing change and preparation to initiate hemodialysis..Procedure steps..10. With clean-gloved hands, remove old catheter dressing...remove gloves and discard. Perform hand hygiene. Apply new gloves. Clean exit site...11. perform hand hygiene and don new clean gloves. 12. Place a poly-lined towel drape or a sterile 4X4 under the first hub to create a field..13. Check to be sure both of the catheter's Y-extension tubes are clamped..14. Remove the securing tape...15. Prior to cap removal, disinfect the caps with alcohol pads and the part of the hub that is accessible and discard the pad..."
A review of policy, "Terminating Dialysis with an Internal Jugular Catheter." was reviewed on June 29, 2021 at approximately 12:30 PM and states, "Purpose: to provide guidelines to safely discontinue hemodialysis using a subclavian or internal jugular catheter (without introducing air or contaminates into the circulatory system)...Procedure steps...8. Clamp both Y-extensions of the catheter. 9. Place an open sterile 4X4 under the catheter. Create a sterile field...10. Recheck to be sure that both of the catheter's Y-extensions tubes are clamped. Disconnect blood lines..."
Observation of the treatment area was conducted on June 28, 2021 from approximately 9:15 AM through 11:00 AM and on June 29, 2021 from 9:00 AM through 10:00 AM.
OBS#2 at station #21 PCT#2 disinfected catheter hubs and initiated hemodialysis without first placing a clean field under the catheter hub prior to the procedure.
OBS#3 at station #19 PCT#7 removed the arterial limb bloodline line and the venous limb bloodline line prior to placing a clean under pad beneath catheter limbs leaving exposed uncapped limbs on patient's clothing.
An interview with the facility nurse manager on July 1, 2021 at approximately 11:00 am confirmed the above findings.
Plan of Correction:
The Nurse Manager met with the in-center nurses and CCHTs on 6/28, 7/7 & 7/8 to review:
(1) Clinical Policy 5.01 "Central Venous Catheter (CVC) Exit Site Disinfection, Dressing Change and Preparation for Dialysis" and Clinical Policy 5.04 "Terminating Dialysis with an Internal Jugular Catheter" in their entirety which includes the procedure directive to "Place a Poly-line Towel Drape or a sterile 4x4 under the (catheter) hubs to create a field." and also review (2) the PA DOH Deficiency Listing.
All clinical staff have had an opportunity to ask any relevant questions and have them answered.
Registered nurses will assist the Nurse Manager to oversee the compliance.
Completion date: 7/8/21
Going forward, the Nurse Manager or her designee will conduct monthly spot checks of dialysis initiation and termination of patients with internal jugular catheters to assure that a field is being created under the catheter hub by means of a sterile 4x4.
Results of the spot checks will be reported to the monthly QAPI meeting for management oversight.
Completion date: 7/8/21
494.80(a)(2) STANDARD
PA-ASSESS B/P, FLUID MANAGEMENT NEEDS
Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:
Blood pressure, and fluid management needs.
Observations:
Based on review of medical records (MR), facility policy and an interview with the facility's nurse manager, the facility did not follow its policy regarding vitals signs reporting for one (1) of seven (7) Incenter Hemodialysis MR's reviewed, (MR #1).
Findings include:
A review of "DCI Philadelphia Parameter Reporting Guidelines" on June 29, 2021 at approximately 12:00 pm states: "Blood Pressure pre (pre-treatment): Staff reports to charge nurse systolic greater than 200, Diastolic greater than 105. Charge Nurse reports to physican. Blood Pressure Intra (during treatment): staff reports to charge nurse greater or equal to 20mmHG decrease from prior BP check at any time during tx (treatment) or increase to greater than or equal to 180/100, charge nurse reports to physician yes. Blood pressure post (post treatment): staff reports to charge nurse systolic greater than 180, diastolic greater than 95, if unusual low BP, call MD if patient is dizzy or if loss of consciousness, charge nurse reports to physician yes if dizzy, syncope, or loss or consciousness..."
A review of MR's was conducted on 6/30/21 from approximately 9:00 am - 2:00 pm.
MR #1, Admission date: 11/15/202. Review of treatment sheets revealed the following:
On 6/17/2021 at 8:31 AM blood pressure was documented during treatment by PCT (patient care technician) to be 206/114, there was no documentation that the licensed nurse was notified.
On 6/22/2021 at 8:25 AM blood pressure was documented during treatment by PCT to be 195/111, there was no documentation that the licensed nurse was notified.
On 6/15/2021 blood pressure pre treatment was documented by PCT to be 245/144 (standing) and 232/142 (sitting), there was no documentation that the licensed nurse was notified.
On 6/26/2021 at 8:26 AM blood pressure was documented during treatment by PCT to be 172/124, there was no documentation that the licensed nurse was notified. At 9:57 AM blood pressure during treatment was documented by PCT to be 180/122, there was no documentation that the licensed nurse was notified.
An interview with the nurse manager on July 1, 2021 at approximately 11:00 AM confirmed the above findings.
Plan of Correction:
The Nurse Manager met with the in-center CCHTs on 6/28, 7/7 and 7/8 to review the DCI Philadelphia Parameter Reporting Guidelines. Specifically, the blood pressure guidelines to be reported to the registered nurse who, in turn may report to the physician.
The Nurse Manager stressed that it is important to not just speak to the RN or to the MD but to enter that information into the electronic dialysis flowsheet for accurate record-keeping, review and retrieval later, if needed.
Further, the Nurse Manager stressed that education of the patient regarding blood pressure when it is running high should include dietary salt and fluid intake, compliance with blood pressure medications ordered, not missing dialysis treatments and not signing off early for treatments.
Completion date: 7/8/21
Going forward, the Nurse Manager will review selected flowsheets for compliance with the parameter reporting guidelines, counsel clinical RNs & CCHTs, as needed and report her findings to the QAPI committee for management oversight.
Completion date: 7/8/21
|