Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted January 22-24, 2024, Central Kittanning Dialysis Center 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 January 22 -24, 2024, Central Kittaning Dialysis Unit - Kittanning, was found 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 a review of facility policy/procedure, treatment area observations, interview with facility staff and an interview with the facility Administrator, the facility failed to ensure the staff followed infection control protocols, included but not limited to, performing hand hygiene/donning clean gloves prior to touching an electronic key pad when exiting dialysis clinic treatment floor and prior to entering "clean" supply area, for one (1) of one (1) observation.
Findings include:
A review was conducted of facility policies on 1/23/24 at approximately 3:15 p.m. to 4:00 p.m.: "Policy Number: G40 Infection Control ...Purpose: To decrease the potential for spread of infection within Innovative Renal Care and American Renal Associates (IRC/ARA) care centers.... POLICY: ...7. Gloves are required whenever caring for a patient or touching a patient's equipment or supplies..."
"Innovative Renal Care/American Renal Associates... PPE To Be Worn... Clinical Duties... Procedure: Touching Machine... Staff: Clinical... Gloves: (X)... Gown: (X)..."
Observations conducted in the patient treatment area on 1/23/24 between approximately
9:00 a.m. and 11:00 a.m. revealed:
Approximately 10:35 a.m. surveyor observed EMP #9, without wearing (PPE) personal protective equipment, touch dialysis machine #8 at station #4 while a patient (WB) was actively receiving dialysis treatment. EMP #9 touched the machine with bare hands without wearing gloves. EMP #9 proceeded to chart with an independent electronic key pad and computer system on wheels, that was not part of the dialysis machine, and then document in a facility log paper binder immediately after touching the active dialysis machine without performing hand hygiene.
Approximately 10:40 a.m. interview conducted with EMP #9 confirmed above findings. "I know I should've had gloves on and no I did not use hand sanitizer or wash my hands before documenting on seperate equipment."
Approximately 10:42 a.m. interview conducted with EMP #10 (facililty administrator) confirmed above findings. "Gloves should be worn and hand hygiene performed."
Plan of Correction:The governing body and management staff of this facility takes this deficiency statement very seriously and will ensure that these citations are corrected and that they remain in compliance. The governing body met on 01/30/2024 to review and approve the plan of correction and the tools that will keep approved plan in compliance. The in-services and tools are available for review in the facility.
V 113
An in-service was initiated to all Direct Patient Care (DPC) staff, including EMP#9 on 01/31/2024 by the Clinic Manager (CM) reinforcing performing hand hygiene, after each glove removal and wearing Personal Protective Equipment (PPE) to reduce the risk of cross contamination. Per policy G40 Infection Control "Gloves are required whenever caring for a patient or touching the patient's equipment or supplies." Also, per policy "Hands are always washed after gloves are removed and between patient contacts, as well as after touching blood, body fluids, secretions, excretions and contaminated items." Lastly per policy "The type of characteristics of personal protective equipment (PPE) used will depend upon the task and degree of exposure anticipated. To reduce the risk of cross contamination the following was discussed:
- PPE must be worn when there is a risk of splashing and spluttering of blood, such as when staff are in the treatment area when a patient is actively on the treatment machine.
- Gloves must be worn when touching a patients machine. It is unacceptable to touch the patients machine with bare hands.
- Hand hygiene must be performed after each glove removal, prior to donning a new pair of gloves and prior to continuing care of the patient or touching clean items such as the computer or documenting on paper.
The above items have been added to the monthly Infection Control (IC) Audit which will be done weekly for 8 weeks by an assigned Direct Patient Care (DPC) staff member. All breaks in Infection Control will be immediately addressed by the Clinic Manager. Additionally, The CM will spot check the treatment floor, weekly for 8 weeks, to ensure staff are wearing PPE and gloves when touching patient equipment and staff are performing hand hygiene after each glove removal, prior to donning gloves, and continuing care of the patient or touching clean items in the treatment area. A CM monitoring tool was developed to monitor this action. The Clinic Manager will ensure compliance through direct observation and review of the Infection Control Audits at least monthly prior to the Total Quality Management (TQM) meeting. All findings from the IC audit tool and CM monitoring tool will be addressed at the monthly TQM meeting, of which the medical director is a member, where additional action will be taken as deemed appropriate, such as additional training, continuing the weekly audits or if trends are identified, disciplinary action.
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 review of facility policy and procedure, chloraprep one-step manufacturer's directions for use (DFU), observation, and staff (EMP) interview, the facility failed to ensure staff (EMP # 3 and EMP #9) followed facility policy and procedure when caring for a patient's central venous catheter (CVC) for two (2) of two (2) observations.
(OBS#1 and OBS #2).
Findings included:
Review of facility policy and procedure "Procedure Number: IC05C CVC: Dressing Change" on 1/22/24 at approximately 2:00 PM revealed:
"...6. Depending on the type of catheter and patient's tolerance, the exit site may be cleaned disinfected with various products. Unless otherwise recommended by the catheter manufacturer, the Innovative Renal Care and American Renal Assocciates' (IRC/ARA) procedure for dressing changes will require cleanin and disinfection with one of the following, used per the manufacturer's instructions:
2% Chlorhexidine with alcohol..."
Review of manufacturer's directions for use on 1/22/24 at approximately 2:15 PM revealed: "ChloraPrep One-Step: 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol(IPA)... Directions... dry surgical sites (e.g. abdomen or arm): use gentle repeated back and forth strokes for 30 seconds. Allow to air dry approximately 30 seconds..."
OBS #1: CVC Exit Site Care performed on 1/22/24 at approximately 9:50 AM at station
#15 with EMP #3 revealed: EMP #3 cleansed exit site with chlora prep one-step swab stick applicator for less than 10 seconds and applied new dressing to site in less than 10 seconds after cleansing.
Interview conducted with EMP #3 at approximately 10:00 AM confirmed above findings. Surveyor asked EMP #3 how long is the cleanse time and then the dry time for CVC exit site care. EMP #3 responded "We only scrub the solution for about 5 (five) seconds. We let the area dry for 5 (five) seconds as well."
OBS #2: CVC Exit Site Care performed on 1/22/24 at approximately 10:35 AM at station #21 with EMP #9 revealed: EMP #9 cleansed exit site with chlora prep one-step swab stick applicator for less than 10 seconds and applied new dressing to site in less than 15 seconds after cleansing.
Interview conducted with EMP #9 at approximately 10:45 AM confirmed above findings. Surveyor asked EMP #9 how long is the cleanse time and then the dry time for CVC exit site care. EMP #9 responded "I scrub for about 10 seconds in a 'z' motion and then let it dry for about 5 (five) seconds."
Plan of Correction:V 147
An in-service was initiated to all DPC (Direct Patient Care) staff, including EMP#3 and EMP #9 on 01/31/2024 by the Clinic Manager (CM) regarding following manufacturer guidelines when disinfecting the Central Venous Catheter (CVC) site. Per policy IC05A CVC: Initiation & Discontinuation of treatment is states "Disinfect according to manufacturer's instructions." It was stressed during the in-service that all manufacturer guidelines must be followed for the type of disinfection used when cleaning the CVC site. Per the ChloraPrep manufacturer guidelines the site must be cleaned using a gentle, repeated back-and-forth stroke for 30 seconds. The site must be allowed to dry completely before placing the dressing over the site. This has been added to the monthly Infection Control (IC) Audit which will be done weekly, for 8 weeks by an assigned Direct Patient Care (DPC) staff member. All breaks in Infection Control will be immediately addressed by the Clinic Manager. Additionally, The CM will spot check the treatment floor, weekly for 8 weeks, to ensure all staff are following manufacturer guidelines ensuring the site is disinfected for 30 seconds. A CM monitoring tool was developed to monitor this action. The Clinic Manager will ensure compliance through direct observation and review of the Infection Control Audits at least monthly prior to the Total Quality Management (TQM) meeting. All findings will be addressed at the monthly TQM meeting, of which the medical director is a member, where additional action will be taken as deemed appropriate, such as additional training, continuing the weekly audits.
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 review of policy/procedure, observations and an interview with the Facility administrator the facility failed to ensure that medications were drawn up, prepared and labeled properly - facility not following policies for two (2) of two (2) observations made OBS #1 and OBS #2.
Findings include:
Review of policy completed on 1/22/24 at approximately 2:30 PM revealed:
"Policy Number: G48 Medications: "Handling, Administration, Storage & Disposal..."
"Purpose: To ensure safe:
preparation of parenteral medications
adminstration of medications to patients
Policy: Handling & Administration
... 4. Medications must never be left unsecured or unattended...
...14. Any medication drawn up before the time i is to be administered shall be labeled with:
patient name
medication name
dose of medication
date/time medication was drawn up
initials of nurse who drew up the medication..."
OBS #1 completed on 1/22/24 at approximately 10:20AM revealed eight (8) prefilled syringes in two (2) seperate locked drawers that did not contain labels with the time of preparation or initials of person who prepared/drawn up/filled the syringes.
An interview with the Facility Administrator completed on 1/22/24 at approximately 10:25 AM confirmed the above findings.
OBS #2 completed on 1/23/24 at approximately 9:15 AM revealed two (2) prefilled syringes in a locked drawer and did not contain labels with the name of the medication or the strength of the medication that was in the syringes.
An interview with the Facility Administrator completed on 1/23/24 at approximately 9:20 AM confirmed the above findings.
Plan of Correction:
V 715 (Please make sure MD signs in-service page)
An in-service was initiated to all Direct Patient Care Staff, including the Medical Director on 01/31/2024 by the Clinic Manager (CM) regarding the importance of labeling all prefilled syringes. Per policy it states, "Any medication drawn up before the time it is to be administer shall be labeled with: patient name, medication name, dose of medication, date/time medication was drawn up, initials of nurse who drew up the medication." It was stressed during the in-service that all pre-drawn medications must be labeled per the policy above and ensuring that the time, initials of person preparing medication, name of medication and strength of medication are documented on the syringe. To ensure compliance the Clinic Manager (CM) will spot check the medications drawer, weekly for 8 weeks, to ensure any pre-drawn medications are labeled per policy. A CM monitoring tool was developed to monitor this action. The clinic manager will ensure compliance through direct observation and use of the CM monitoring tool. The CM monitoring tool will be brought to the monthly Total Quality Management (TQM) meeting. All findings will be reviewed in the TQM meeting, of which the medical director is a member, where additional action will be taken as deemed appropriate such as continuing the weekly CM monitoring and/or disciplinary action.
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