Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted September 11, 2023, through September 14, 2023, East Norriton Dialysis 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 unannounced onsite Medicare recertification survey completed September 11, 2023, through September 14, 2023, East Norriton Dialysis 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 review of facility policy, observation (OBS) of treatments performed, and an interview with the interim Clinical Manager, the facility did not ensure that patient care staff removed gloves, performed hand hygiene, and donned clean gloves during discontinuation of dialysis with a central venous catheter (CVC) for one (1) of two (2) OBS (OBS #1), while accessing an AV (arterial-venous) fistula for two (2) of two (2) OBS (OBS 3 and 4), and during discontinuation of dialysis with an AV fistula for one (1) of two (2) OBS (OBS #5).
Findings include:
A review of facility policy on September 14, 2023, at approximately 9:00 A.M. revealed the following:
Policy #47806 titled "Access Assessment and Cannulation" states, "Assessment of Vascular Access: Prior to treatment, ask the patient to wash access area with soap per hand hygiene procedure. Wash access (per above) if patients unable to clean their access. Wash hands and don PPE... Look... Listen... Feel... Remove gloves and perform hand hygiene. Don new gloves... Perform skin antisepsis on one side at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection... Perform hand hygiene and don new gloves... Insert needle into previously prepped site... Remove gloves. Perform hand hygiene."
Policy # 47664 titled "Hand Hygiene" states, " Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water before and after direct contact with patients, entering and leaving the treatment area, before performing any invasive procedure such as vascular access cannulation or administration of 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, after contact with inanimate objects near the patient, when moving from a contaminated body site to a clean body site of the same patient, after contact with the dialysis wall box, concentrate, drain or water lines. "
Observation of the treatment area was conducted on September 11, 2023, from approximately 10:00 A.M. to 12:30 P.M. and September 13, 2023, from approximately 10:45 A.M. to 11:45 A.M. revealed the following:
OBS #1, Station #17, on September 11, 2023, at approximately 1:20 P.M., during discontinuation of dialysis with a CVC, EMP #1 (employee) was observed reinfusing the extracorporeal circuit and touching the dialysis machine. EMP #1 did not perform hand hygiene or don new gloves before disinfecting the CVC connections before disconnecting the blood lines and applying sterile port caps as required by facility policy.
OBS #3, Station #11, on September 11, 2023, at approximately 10:42 A.M., during access of an AV fistula, EMP #4 applied antiseptic to the access site. The patient bent their arm upward to adjust the blood pressure cuff, contaminating the access site. EMP #4 donned new gloves without performing hand hygiene and touched the dialysis machine. EMP #4 inserted the cannulation needles without performing hand hygiene, donning new gloves and reapplying antiseptic to the access site as required by facility policy.
OBS #4, Station #24, on September 11, 2023, at approximately 11:30 A.M., during access of an AV fistula, EMP #5 assessed the access site with a stethoscope and did not perform hand hygiene and don new gloves prior to applying antiseptic to the skin and inserting the cannulation needles as required by facility policy.
OBS #5, Station #3, on September 11, 2023, at approximately 10:05 A.M., during discontinuation of dialysis with an AV fistula, EMP #1 performed hand hygiene and donned clean gloves. EMP #1 gathered the patient ' s belongings, touched the dialysis machine and removed the dialysis needles without performing hand hygiene and donning new gloves as required by facility policy.
An interview with the interim Clinical Manager on September 13, 2023, at approximately 5:00 P.M. confirmed the above findings.
Plan of Correction:To ensure compliance the covering Clinic Manager (CM) or designee will in-service all direct patient care (DPC) staff on:
- Access Assessment and Cannulation
- Hand Hygiene
- Termination of Treatment Using a Central Venous catheter and Optiflux Single Use Ebeam Dialyzer
The meeting will focus on ensuring that hand hygiene is always performed per policy. This includes prior to donning gloves upon initiation and/or discontinuation of treatment hand hygiene must be completed. New gloves are to be donned before disinfecting the catheter connections, after assessing the access site and prior to cleaning the site, after touching the patient belongings and/or machine and after removing the patient needles.
Inservicing will be completed by October 10, 2023. All training documentation is on file at the facility.
The covering 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/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A Plan of Correction (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 covering 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: November 10, 2023
494.30(a)(1)(i) STANDARD
IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK
Name - Component - 00
Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory.
Observations:
Based on review of facility policy, observation, and interview with the interim Clinical Manager, the facility failed to ensure staff members wore the required personal protective equipment (PPE) to protect themselves when performing procedures during which spurting and spattering of blood might occur for one (1) of nineteen (19) observations (OBS) during the provision of care in the dialysis clinical area. (OBS #19)
Findings included:
Review of facility policy titled "Personal Protective Equipment" on September 14, 2023, at approximately 11:00 A.M. stated, "Personal protective equipment such as full face shield or mask and protective eyewear with full side shield, fluid-resistant gowns and gloves will be worn to protect and prevent employees from blood or other potentially infections materials to pass through to or reach the employee's skin, eyes, mouth or other mucous membranes, or work clothes when performing procedures during which spurting or splattering of blood might occur (e.g., during initiation or termination of dialysis, cleaning of dialyzers, or centrifugation of blood)..."
OBS #19, Station #23 on September 13, 2023, at approximately 1:10 P.M. EMP #4 was observed attending to a patient's central venous catheter (CVC) without wearing the required PPE (gown and face shield).
An interview with the interim Clinical Manager on September 13, 2023, at approximately 5:00 P.M. confirmed the above findings.
Plan of Correction:To ensure compliance the covering CM or designee will in-service all DPC staff on:
- Personal protective Equipment
The in-service will focus on the staff ensuring that they are wearing the appropriate personal protective equipment (PPE) when there is a risk of a possible blood splatter. This includes wearing a gown and face shield when attending to a patient's catheter.
Inservicing will be completed by October 10, 2023. All training documentation is on file at the facility.
The covering 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 covering 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: November 10, 2023
494.30(a)(1)(i) STANDARD
IC-IF TO STATION=DISP/DEDICATE OR DISINFECT
Name - Component - 00
Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient.
-- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient.
-- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient's station should be used only for that patient and should not be returned to a common clean area or used on other patients.
Observations:
Based on review of facility policy, observation (OBS) of treatments performed, and an interview with the interim Clinical Manager, the dialysis staff failed to clean equipment after use on a patient for one (1) of two (2) observations during initiation of dialysis with an AV fistula or graft. (OBS #2)
Findings include:
Review of facility policy titled "Access Assessment and Cannulation" on September 14, 2023, at approximately 11:00 A.M. stated, "Assessment of vascular access: 6. Listen:... Clean stethoscope after assessing patient..."
Observation of the treatment area was conducted on September 11, 2023, from approximately 10:00 A.M. to 12:30 P.M. and September 13, 2023, from approximately 10:45 A.M. to 11:45 A.M. revealed the following:
OBS #2, station #24 on September 11, 2023, at approximately 11:30 A.M. Employee (EMP) #5 was observed assessing the patient's fistula with a stethoscope. EMP #5 returned the stethoscope to the clean area in the center of pod #3 without cleaning the stethoscope.
An interview with the interim Clinical Manger on September 13, 2023, at approximately 5:00 P.M. confirmed the above findings.
Plan of Correction:To ensure compliance the covering CM or designee will in-service all DPC staff on:
- Access Assessment and cannulation
The in-service will focus on the staff ensuring that all non-disposal equipment is cleaned and disinfected after each use before being returned to the clean storage area. This includes stethoscopes.
Inservicing will be completed by October 10, 2023. All training documentation is on file at the facility.
The covering 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 covering 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: November 10, 2023
494.30(a)(4)(i) STANDARD
IC-HANDLING INFECTIOUS WASTE
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-
(i) Handling, storage and disposal of potentially infectious waste;
Observations:
Based on review of dialysis facility policy, observations (OBS) in the clinical area, and interview with the interim Clinical Manager, the dialysis facility staff failed to ensure the proper handling of potentially infectious waste for one (1) of two (2) observations (OBS #1).
Findings include:
Review of facility policy titled "Medical Waste Management Plan" on September 14, 2023, at approximately 11:00 A.M. stated, "All medical and potentially infectious (Bio-hazardous) waste storage bags shall be securely tied in containers and all containers shall be covered with a tight-fitting lid before being moved to a storage area for transportation..."
OBS #1, on September 11, 2023, from approximately 10:00 A.M. to 12:30 P.M. in the clinical area revealed the following:
Biohazardous waste containers located in the center of the pod areas #1 and #2 were observed with the lids in the open position during the entire observation period.
An interview with the interim Clinical Manager on September 13, 2023, at approximately 5:00 P.M. confirmed the above findings.
Plan of Correction:To ensure compliance the covering CM or designee will in-service all DPC staff on:
- Medical Waste Management Plan
The in-service will re-educate staff on ensuring that all bio-hazard waste container lids are closed when not in use.
Inservicing will be completed by October 10, 2023. All training documentation is on file at the facility.
The covering 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 covering 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: November 10, 2023
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, observation (OBS) in the treatment area, and an interview with the interim Clinical Director, the facility failed to ensure medications were labeled appropriately for for one (1) of two (2) observations. (OBS #1).
Findings:
A review of facility policy titled, 'Medication Preparation and Administration" on September 14, 2023 at approximately 11:00 A.M. stated, "Labeling Vials: When preparing medications, if the vial is not used immediately in its entirety, the nurse or PCT (if allowed by state regulations), must place the date and time the vial was opened on the medication label along with their initials... Label any open multi-dose vial that is not immediately and store vial accordingly"
Observation of the treatment area was conducted on September 11, 2023, from approximately 10:00 A.M. to 12:30 P.M. and September 13, 2023, from approximately 10:45 A.M. to 11:45 A.M. revealed the following:
OBS #1, September 11, 2023, at approximately 11:45 A.M., an open bottle of Heparin 30,000 Units/30 ML (milliliters) was observed in the medication room with no date, time or initials noted on the bottle.
An interview with the interim Clinical Manager on September 13, 2023 at approximately 5:00 P.M. confirmed the above findings.
Plan of Correction:To ensure compliance the covering CM or designee will in-service all DPC staff on:
- Medication Preparation and Administration
The in-service will re-educate staff on ensuring that all vials of multi-dose medications, including heparin, are labeled per policy. This includes date, time the vial was opened and the initials of the staff member opening the vial.
Inservicing will be completed by October 10, 2023. All training documentation is on file at the facility.
The covering 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 covering 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: November 10, 2023
494.40(a) STANDARD
CARBON ADSORP-MONITOR, TEST FREQUENCY
Name - Component - 00
6.2.5 Carbon adsorption: monitoring, testing freq
Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours.
Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet.
Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L].
Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly.
Observations:
Based on review of dialysis facility policy, water testing logs, and interview with facility staff and the interim Clinical Manager, the facility staff failed to document water testing in accordance with facility policy.
A review of facility policy titled "Carbon Filtration Monitoring for Incenter Central Water Systems Policy" on September 14, 2023, at approximately 9:00 A.M. stated, "Tests Rationale: Total chlorine testing will be the only testing methodology used... Testing Locations and Frequency: What to Test: Worker Carbon Filter, When to Test: Prior to the initiation of the first patient treatment of the day and at a minimum of every four hours... Documentation: Routine Total Chlorine Testing will be documented in the approved electronic documentation system."
An interview with the Biomedical Technician on September 11, 2023, at approximately 1:00 P.M. revealed that the facility staff are required to document the water testing times in military time.
A review of the Post Worker Carbon Tank TLC-1 (54637) Water Testing Log was conducted on September 11, 2023, at approximately 12:35 P.M. Review of logs from March, 2023, through August, 2023, revealed the following:
Facility staff failed to document the testing in the military time format required on the following dates: what is the format?
March 11, 2023, test completion times were documented as 0315, 0640, 0959, and 0110 (should have been documented as 1310).
March 28, 2023, test completion times were documented as 0330, 0653, 1007, and 0145 (should have been documented as 1345).
March 30, 2023, test completion times were documented as 0330, 0653, 1009, and 0120 (should have been documented as 1320).
April 14, 2023, test completion times were documented as 0315, 0625, 0945, and 0100 (should have been documented as 1300).
April 20, 2023, test completion times were documented as 0345, 0700, 1020, and 0200 (should have been documented as 1400).
April 25, 2023, test completion times were documented as 0315, 0655, 1005, and 0125 (should have been documented as 1325).
April 26, 2023, test completion times were documented as 0315, 0634, 0930, and 0120 (should have been documented as 1320).
May 4, 2023, test completion times were documented as 0410, 0715, 1035, and 0145 (should have been documented as 1345).
May 12, 2023, test completion times were documented as 0315, 0644, 1000, and 1024 (should have been documented as 1324).
May 18, 2023, test completion times were documented as 0315, 0646, 1001 and 0119 (should have been documented as 1319).
June 7, 2023, test completion times were documented as 0345, 0640, 0956, and 0109 (should have been documented as 1309).
June 9, 2023, test completion times were documented as 0353, 0711, 1028, and 0140 (should have been documented as 1340).
July 19, 2023, test completion times were documented as 0350, 0700, 1007, and 0320 (should have been documented as 1320).
Testing results were either omitted or incorrectly documented on the following dates:
April 3, 2023 test completion times were documented as 0330, 0643, 1321 (6 hours, 38 minutes between second and third test).
April 5, 2023, test completion times were documented as 0335, 0658, 1640 (9 hours, 42 minutes between second and third test).
May 13, 2023, test completion times were documented as 0654, 1006, 1262. No opening testing results documented.
May 14, 2023, test completion times were documented as 0315, 0852, 1300 (5 hours, 37 minutes between the first and second test, 4 hours, 8 minutes between the second and third test).
June 20, 2023, test completion times were documented as 0315, 0652, 1009. No testing was documented by 1409.
August 7, 2023, test completion times were documented as 0400, 0400, 0945, and 1300.
August 23, 2023, test completion times were documented as 0400, 0400, 0400, 1325.
An interview with the acting Clinical Manager on September 13, 2023, at approximately 5:00 P.M. confirmed the above findings.
Plan of Correction:To ensure compliance the covering CM or designee will in-service all DPC staff on:
- Carbon Filtration Monitoring for Incenter Central Water Systems
The in-service will re-educate staff on ensuring that the chlorine water testing is always completed per policy. This includes that the time of the testing is entered in military time. A review of the calculation of military time will also be reviewed at the meeting. The meeting will also reinforce that chloring testing must be completed every four (4) hours.
The staff will be informed that a timer for water testing will be located on the treatment floor and must be set every 4 hours to alert staff of the water testing.
Inservicing will be completed by October 10, 2023. All training documentation is on file at the facility.
The covering 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 covering 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: November 10, 2023
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 upon review of facility policy, medical records (MR), and an interview with the interim Clinical Manager, the dialysis facility failed to ensure in-center hemodialysis patient assessments, including blood pressures and machine parameters, were assessed and documented at minimum every 45 minutes, while on hemodialysis as per facility policy for five (5) of five (5) in-center hemodialysis Medical Records reviewed (MR#1, 2, 3, 4, and 5).
Findings include:
Review of facility policy titled "Patient Assessment and Monitoring" on September 14, 2023, at approximately 9:00 A.M. states, "During Treatment: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes or per state regulations... Machine Parameters and Extracorporeal Circuit: Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered..."
A review of MR conducted on September 12, 2023, from approximately 9:30 A.M. to 3:00 P.M. revealed the following:
MR#1, start of care July 24, 2023. Treatment records from August 25, 2023, through September 11, 2023, revealed the following:
No vital signs or dialysis machine settings documented on September 6, 2023, between 8:01 A.M. and 9:03 A.M., 1 hour, 2 minutes.
No vital signs or dialysis machine settings documented on September 8, 2023, between 8:01 A.M. and 9:38 A.M., 1 hour, 37 minutes.
No vital signs or dialysis machine settings documented on September 11, 2023, between 9:00 A.M. and 10:07 A.M., 1 hour, 7 minutes.
MR #3, start of care March 29, 2018. Treatment records from August 24, 2023, through September 9, 2023, revealed the following:
No vital signs or dialysis machine settings documented on September 5, 2023, between 9:40 A.M. and 10:35 A.M., 55 minutes.
MR #4, start of care July 6, 2023. Treatment records from August 22, 2023, through September 9, 2023, revealed the following:
No vital signs or dialysis machine settings documented on September 5, 2023, between 4:27 A.M. and 6:04 A.M., 1 hour, 37 minutes.
MR#5, start of care September 9, 2014. Treatment records from August 24, 2023, through September 9, 2023, revealed the following:
No vital signs documented on August 31, 2023, between 4:40 A.M. (on admission to the dialysis unit) and 5:30 A.M., 50 minutes.
No vital signs documented on September 5, 2023, between 6:02 A.M. and 7:23 A.M., 1 hour, 21 minutes.
No vital signs documented on September 9, 2023, between 7:02 A.M. and 8:03 A.M., 1 hour, 1 minute; and between 8:32 A.M. and 9:28 A.M., 56 minutes.
An interview with the interim Clinical Manager on September 13, 2023, at approximately 5:00 P.M. confirmed the above findings.
Plan of Correction:To ensure compliance the CM or designee will in-service all DPC staff on policy:
- Patient Assessment and Monitoring
Emphasis will be placed on ensuring that patient vital signs (VS) and machine parameters are assessed and documented every thirty (30) minutes, and not exceeding forty-five (45) minutes, per policy, while the patient is receiving treatment.
Inservicing will be completed by October 10, 2023. All training documentation is on file at the facility.
The covering 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 covering 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: November 10, 2023
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