Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on 8/28/2023, 8/30/2023 and 8/31/2023, Fresenius Medical Care Camp Hill 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 8/28/2023, 8/30/2023 and 8/31/2023, Fresenius Medical Care Camp Hill 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) 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, 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, for one (1) of two (2) 'Central Venous Catheter (CVC) Exit Site Care' observations (Observation #1); for one (1) of two (2) 'Cleaning and Disinfection of the Dialysis Station' observations (Observation #1); and for four (4) of four (4) treatment area observations. (Treatment Area Treatment Observation #1, #2, #3 and #4)
Findings:
A review was conducted of facility policy titled, 'Hand Hygiene' on August 28, 2023 at approximately 1:45 p.m. 'Hand Hygiene' policy, section, 'Policy' reads, "Hands will be...Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water...When...before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications, immediately after removing gloves, after contact with body fluids or excretion, mucous membranes, non-intact skin and wound dressings if hands are not visibly soiled..."
Observations conducted in the patient treatment area on August 28, 2023 between approximately 9:04 a.m. and 12:45 p.m. revealed the following:
Central Venous Catheter Exit Site Care Observation #1 : On 08/28/23 at approximately 11:06 a.m. while observing 'Central Venous Catheter Exit Site Care' observation #1 of 2, for patient #4, station #6, employee #4; employee #4 failed to perform hand hygiene after applying a sterile dressing to the CVC exit site and removing gloves.
Cleaning and Disinfection of the Dialysis Station Observation #1 : On 08/28/23 at approximately 10:13 a.m. while observing 'Cleaning and Disinfection of the Dialysis Station' observation #1 of 2, for station #6, employee #4; employee #4 failed remove gloves, perform hand hygiene and don clean gloves after emptying prime waste receptacle and prior to disinfecting the dialysis machine.
Treatment Area Treatment Observation #1 :On 08/28/23 at approximately 10:24 a.m. employee #4 failed to perform hand hygiene after removing gloves and prior to donning clean gloves.
Treatment Area Treatment Observation #2 :On 08/28/23 at approximately 10:25 a.m. employee #4 failed to perform hand hygiene after removing gloves and prior to donning clean gloves.
Treatment Area Treatment Observation #3 :On 08/28/23 at approximately 11:19 a.m. employee #4 left station # 6 with patient # 4, removed gloves, walked and picked up a new bag of saline solution. Employee # 4 failed to perform hand hygiene after removing gloves and prior to picking up a new bag of saline solution.
Treatment Area Treatment Observation #4 :On 08/28/23 at approximately 11:20 a.m. employee #4 left station # 6 with patient # 4, removed gloves, walked to supply cart and picked a item from the supply cart. Employee # 4 failed to perform hand hygiene after removing gloves and prior to picking up item from supply cart.
An interview with the facility Administrator on August 31, 2023 at approximately 2:00 p.m. confirmed the above findings.
Plan of Correction:V113 IC-Wear gloves/hand hygiene
The Clinical Manager (CM) or designee re-educated all the direct patient care (DPC) staff on the following policy: Hand Hygiene
Hand Hygiene Procedure
Changing the Catheter Dressing Procedure Cleaning and Disinfecting the Dialysis Station
Special emphasis will be placed on ensuring hand hygiene and glove changes in between tasks to prevent cross contamination and direct patient care staff are performing hand hygiene as per policy at all times. This includes after applying a new dressing to the catheter site, after emptying prime waste receptacle and prior to disinfecting the dialysis machine. The meeting will also review the importance of performing hand hygiene any time gloves are removed, before donning new gloves and prior to picking up clean supplies.
The in-servicing of staff will be completed by 9/13/23, with documentation of the training on file at the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time if compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A plan of correction (POC) audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
494.30(a)(4)(ii) STANDARD
IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL
Name - Component - 00
[The facility must demonstrate that it follows standard infection control precautions by implementing-
(4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-]
(ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.
Observations:
Based on a review of facility policy/procedure, treatment area observations, and an interview with the facility Administrator, the facility failed to ensure staff followed standard infection control precautions by emptying the prime waste receptacle prior to disinfecting the dialysis station for one (1) of two (2) observations of 'Cleaning and Disinfection of the Dialysis Station' (Observation #1).
Findings:
A review was conducted of facility policy titled, 'Prime Bucket Disinfection' on August 28, 2023 at approximately 2:00 p.m. 'Prime Bucket Disinfection' policy, reads, "Procedure: Step #1: Dispose of saline solution down any marked dirty sink or utility room hopper; Step #2: Clean all surfaces of the priming bucket; Step #3: Return clean priming bucket or approved receptacle to the machine"
The CDC 'Checklist: Dialysis Station Routine Disinfection' 'Part A: Before beginning routine disinfection of the dialysis station' includes but is not limited to "Ensure that the priming bucket has been emptied", ..........., "remove gloves and perform hand hygiene". Part B: Routine disinfection of the dialysis station-After the patient has left station' includes but is not limited to "Wear clean gloves". "Apply disinfectant to all surfaces in the dialysis station .....".
Observations conducted in the patient treatment area on August 28, 2023 between approximately 9:04 a.m. and 12:45 p.m. revealed the following:
*Note: Facility Procedure does not include "Emptying prime waste receptacle if present on the machine"/"Remove gloves, hand hygiene, don clean gloves" before "using disinfectant soaked cloth/wipe to visibly wet all machine ........" as listed in sequence on the 'Centers for Medicare & Medicaid Services ESRD Core Survey Version 1.6" surveyor observation form.
Observations conducted in the patient treatment area on August 28, 2023 between approximately 9:04 a.m. and 12:45 p.m. revealed the following:
Cleaning and Disinfection of the Dialysis Station Observation #1 :On 08/28/23 at approximately 10:13 a.m. while observing 'Cleaning and Disinfection of the Dialysis Station' observation #1 of 2, employee # 4 failed to empty prime waste receptacle after removing all bloodlines and disposable equipment and prior to disinfecting the dialysis station.
An interview with the facility Administrator on August 31, 2023 at approximately 2:00 p.m. confirmed the above findings.
Based on a review of facility policy/procedure, treatment area observations, and an interview with the facility Administrator, the facility failed to ensure expired items/supplies were discarded and replaced for one (1) of one (1) expired medication observations. (Observation #1).
Findings:
A review was conducted of facility policy titled, 'Expiration Dates Sterile Supplies'on August 28, 2023 at approximately 2:10 p.m. 'Expiration Dates Sterile Supplies' policy, reads, "Policy:...Sterile items will be checked before use to ensure that they have not expired. Approximately dispose of sterile items that have reached the expiration date."
Observations conducted in the patient treatment area on August 28, 2023 between approximately 9:04 a.m. and 12:45 p.m. revealed the following:
Expired Medication Observation #1: The following expierd items were observed in the medication drawer at the medication station: twenty-one (21) single use vials of Sodium Chloride 0.9% (18 mg per 2 mL) 2 mL vials, expired: 1/23
An interview with the facility Administrator on August 31, 2023 at approximately 2:00 p.m. confirmed the above findings.
Plan of Correction:V 122 – Revision
For immediate compliance, on 8/28/23 the expired 21 single use vials of Sodium Chloride 0.9% vials
were discarded. To ensure ongoing compliance the CM or designee will in-service all DPC staff on the following policies:
Cleaning and Disinfection of the Dialysis Station Priming Bucket Disinfection
Storage of Supplies
The meeting will focus on ensuring that all prime buckets are emptied, cleaned, and disinfected prior to the routine cleaning and disinfection of the dialysis station. The meeting will review that a 1:100 bleach wipe is used to clean all surfaces of the prime bucket before being placed back on the machine. The importance of ensuring that proper hand hygiene is being completed per policy will be reinforced during the meeting.
In servicing will be completed by 9/13/23. All training documentation is on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAPI schedule. A POC specific audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: 10/11/23
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 review of facility policy/procedure, treatment area observations, and an interview with the facility Administrator, the facility failed to ensure medications were labeled appropriately for for one (1) of one (1) medication observations. (Observation #1).
Findings:
A review was conducted of facility policy titled, 'Medication Preparation and Administration on August 28, 2023 at approximately 10:10 a.m. 'Medication Preparation and Administration' policy, reads, "Labeling Reconstituted Medication Solutions and Administration: All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of patient, date, time and initials of the person who prepared the medication..."
Observations conducted in the patient treatment area on August 28, 2023 between approximately 9:04 a.m. and 12:45 p.m. revealed the following:
Medication Observation #1: Observation #1: On 08/28/23 at approximately 9:50 a.m. the following was observed within a drawer labeled "Heparin":
- One (1) 10 mL (milliliter) syringe with Heparin Sodium (porcine) 1,000 units/mL systemic Bolus 4, 000 units every treatment- the section on the label that read, "time" was left blank.
- One (1) 10 mL (milliliter) syringe with Heparin Sodium (porcine) 1,000 units/mL systemic Bolus 3, 000 units every treatment- the section on the label 'time' was left blank and section 'initials' was left blank.
An interview with the facility Administrator on August 31, 2023 at approximately 2:00 p.m. confirmed the above findings.
Plan of Correction:To ensure ongoing compliance the CM or designee will in-service all DPC staff on the following policies:
- Medication Preparation and Administration
The meeting will focus on ensuring open medications are labeled as per policy. This includes all medications in syringes not being administered immediately and shall be labeled appropriately with the name of the medication, route, dose, name of the patient, date, time and initials of the person who prepared the medication.
In servicing will be completed by 9/13/23. All training documentation is on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAPI schedule. A POC specific audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
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 a review of facility policy/procedure, treatment area observations, and an interview with the facility Administrator, the facility failed to ensure that clinical staff maintain aseptic technique for the care of vascular accesses, including intravascular catheters, for two (2) of two (2) 'Central Venous Catheter (CVC) Exit Site Care' observations (Observations # 1 and #2) and for one (1) of two (2) 'Initiation of Dialysis with Central Venous Catheter' observations. (Observation #2 )
Findings:
A review was conducted of facility policy titled, 'Central Venous Catheter Dressing Change' on August 28, 2023 at approximately 1:30 p.m. 'Central Venous Catheter Dressing Change' policy, section, 'Removal of Dressing and Inspection of Site' reads, "Note: The patient and Inpatient Services Staff must wear a mask for all procedures that require accessing the catheter to help prevent contamination by airborne nasal bacteria...Cleaning the Catheter Exit Site: Step 3. Using a gentle friction in a back-and-forth motion, clean the exit site with the antiseptic product. Begin in the center and continue outward two (2) inches in a concentric circle (see figure 1). Do this for 30 seconds and allow to dry..."
Observations conducted in the patient treatment area on August 28, 2023 between approximately 9:04 a.m. and 12:45 p.m. revealed the following:
Central Venous Catheter Exit Site Care Observation #1 : On 08/28/23 at approximately 11:06 a.m. while observing 'Central Venous Catheter Exit Site Care' observation #1 of 2, for patient #4, station #6, employee #4; employee #4 failed to cleanse area around the CVC exit site with antiseptic after removing old dressing and before applying a new sterile dressing
Central Venous Catheter Exit Site Care Observation #2 : On 08/28/23 at approximately 12:40 p.m. while observing 'Central Venous Catheter Exit Site Care' observation #2 of 2, for patient #6, station #7, employee #4; employee #4 failed to cleanse area around the CVC exit site with antiseptic after removing old dressing using a gentle friction in a back-and-forth motion, beginning in the center and continuing outward two (2) inches in a concentric circle for 30 seconds before applying a new sterile dressing and employee # 4 failed to ensure face mask was covering her nose throughout the procedure.
Initiation of Dialysis with Central Venous Catheter Observation #2 :On 08/28/23 at approximately 12:45 p.m. while observing 'Initiation of Dialysis with Central Venous Catheter' observation #2 of 2, for patient #6, station #7 employee #4; employee #4 failed to ensure face mask was covering her nose throughout the procedure.
An interview with the facility Administrator on August 31, 2023 at approximately 2:00 p.m. confirmed the above findings.
Plan of Correction:To ensure compliance the CM or designee will in-service all DPC staff on the following policies:
Changing the Catheter Dressing
Changing the Catheter Dressing Procedure Personal Protective Equipment
The meeting will focus on ensuring aseptic technique is followed and licensed staff is cleaning the central venous catheter (CVC) exit site with a 2% Chlorhexidine and 70% alcohol swab using a gentle back and forth friction, begin cleaning in the center of the exit site and continuing outward 2 inches in a concentric circle for 30 seconds. The meeting will review on ensuring face mask is worn appropriately, covering the nose throughout the procedure.
In servicing will be completed by 9/13/23. All training documentation is on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAPI schedule. A POC specific audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
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 a review of facility policy/procedure, medical records (MRs), and an interview with the facility Administrator, the facility failed to ensure dialysis treatment was delivered per physician order/prescription for one (1) of five (5) MRs reviewed. (MR# 5)
Findings:
A review was conducted of facility policy titled, 'Unable to Achieve Prescribed Blood Flow Rate' on August 30, 2023 at approximately 10:00 a.m. 'Unable to Achieve Prescribed Blood Flow Rate' policy, reads, "Actions to Achieve Prescribed Blood Flow rate: Staff, patient and/or care partner should take the following actions to reduce the possibility of poor access blood flow: Position bloodlines in a way that keeps them from restricting flow kinking; ensure access and bloodline clamps have been appropriately opened/removed; properly cannulate access; avoid flipping needles; administer heparin, as ordered...Notification: Notify physician/extender if unable to achieve prescribed blood flow rate...Documentation: Document in patient's treatment record what action taken to address the inadequate blood flow and if unable to resolve. The nurse shall document any physician orders..."
MR review conducted on August 30, 2023 between approximately 10:00 a.m. and 3:00 p.m. revealed the following:
MR #5: Date of Admission: 5/3/2021. Physician ordered treatment blood flow rate (BFR) prescribed: 450.
- Flowsheet treatment date: 8/2/2023: BFR of 350 was documented during the entire length of treatment. No documentation of reason, actions taken, and of notifying physician of BFR not set according to physician order.
- Flowsheet treatment date: 8/4/2023: BFR of 350 was documented during the entire length of treatment. No documentation of reason, actions taken, and of notifying physician of BFR not set according to physician order.
- Flowsheet treatment date: 8/9/2023: BFR of 350 was documented during the entire length of treatment. No documentation of reason, actions taken, and of notifying physician of BFR not set according to physician order.
- Flowsheet treatment date: 8/11/2023: BFR of 350 was documented during the entire length of treatment. No documentation of reason, actions taken, and of notifying physician of BFR not set according to physician order.
- Flowsheet treatment date: 8/25/2023: BFR of 350 was documented during the entire length of treatment. No documentation of reason, actions taken, and of notifying physician of BFR not set according to physician order.
An interview with the facility Administrator on August 31, 2023 at approximately 2:00 p.m. confirmed the above findings.
Plan of Correction:By 9/13/23, the Director of Operations (DO) and the CM will meet with the Medical Director to review the Medical Director Responsibilities as defined in the Conditions for Coverage. The meeting also reviewed the following policies:
Nursing Supervision and Delegation Patient Assessment and Monitoring Medical Record Documentation Standards
Minutes of the meeting with the Medical Director will be on file at the facility for review.
The meeting will focus on the importance of the staff always following FMC policies. The meeting will review providing guidance to the registered nurse on his/her responsibilities for patient oversight including evaluation and verification of patient treatment prescriptions. Ensuring all physician treatment prescriptions contain specific orders or parameters for the BFR rate and is followed as prescribed. Reporting to Charge Nurse/Team Leader if the dialysis prescription order is not achievable or reporting to the attending Physician for further orders if the treatment prescription cannot be carried out as ordered. Ensuring physician is notified when the patient's prescribed BFR orders could not be met.
The Medical Director was informed at the meeting that the CM and the staff will receive education on the above policies by the CM or designee by 9/13/23.
All training documentation will be on file at the facility.
The Medical Director was informed that the CM or designee will perform daily audits of 10% of patient treatment sheets utilizing a developed Plan of Correction Auditing tool to verify adherence to policy and procedure related to physician prescriptions of BFR orders for 2 weeks. If compliance is noted, the audits will be completed 2 times/week for 2 weeks. If compliance is sustained, the audits will then follow the monthly QAPI schedule. A POC audit tool will be used for the audits.
The Medical Director was informed that staff found to be non-compliant will be re-educated and counseled.
To ensure ongoing compliance the CM will review the audit findings with the Medical Director weekly. The results and progress of the POC will be reviewed at the QAPI Committee monthly meeting. The QAPI committee will be responsible for further guidance and ongoing oversight.
|