Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on November 30, 2022 through December 2, 2022, Willow Grove 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 onsite unannounced Medicare recertification survey conducted on November 30, 2022 through December 2, 2022, Willow Grove 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 upon observation, policy and procedure review, and an interview with the facility administrator, it was determined the facility failed to ensure hand hygiene and donning of new gloves during initiation of graft/fistula for two (2) of two (2) observations (Observations #1 and #2).
Findings include:
A review of Procedure 1-04-01E titled "AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose" was reviewed on 12/1/22 at approximately 10:00 AM and states, "Have patient wash access site...perform hand hygiene. Put on PPE (personal protective equipment), please clean barrier under access extremity...clean the diaphragm of the stethoscope...perform inspection, auscultation and palpation...determine presence of bruit and thrill...determine direction of access flow..locate and palpate the needle cannulation sites...applying a 70% alcohol prep pad to each site...cleanse site by applying skin antiseptic...do not palpate insertion site once area has been prepped. apply a new tourniquet...Remove gloves, perform hand hygiene and put on clean gloves prior to cannulation..."
Observation of the treatment area was conducted on 11/30/22 from approximately 9:45 AM through 12:30 PM.
Observation #1. On 11/30/22 at approximately 10:37 AM, Patient Care Technician (PCT) #1 at station 2, was observed cleaning fistula/graft site then changing gloves without first performing hand hygiene prior to inserting cannulation needles.
Observation #2. On 11/30/22 at approximately 11:08 AM, RN 2 at station 9, was observed cleaning fistula/graft site then immediately inserting cannulation needles without first removing gloves, performing hand hygiene, and donning clean gloves.
An interview with the facility administrator on 12/2/22 at approximately 1:30 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/05/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with the emphasis on but not limited to: 1) teammates will wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. 2) Teammates will remove gloves and perform hand hygiene between each patient and / or station and between clean and dirty tasks. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator will conduct infection control audits to verify teammate compliance with hand hygiene between glove changes per policy: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control audit. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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 observations, facility policy, and an interview with the facility administrator, the facility failed to ensure that non-disposable items taken into the dialysis station were cleaned and disinfected before being used on another patient for one observation (Observation #3)
Findings include:
A review of policy, "Operation of Portable Myron L Conductivity Meter (D-1)" conducted on 12/2/22 at approximately 12:00 PM states, "The exterior of D1 meter should be cleaned with 1:100 bleach solution after collecting a sample from another dialysis delivery system to prevent cross contamination...the outside of the D-1 meter must be disinfected after use prior to returning the meter to the storage location..Procedure: when you are finished with the D1 meter, rinse thoroughly with dialysis quality water. Clean the exterior of the meter with 1:100 bleach solution and place meter in the clean storage location."
A review of policy, "Infection Control for Dialysis Facilities" conducted on 12/2/22 at approximately 12:00 PM states, "Non-disposable items are to be disinfected between patients...the outside surface of all equipment will wiped with a bleach solution prior to removal from treatment area..."
Observation of the clinical area was conducted on 11/30/22 from approximately 9:45 AM to 12:30 PM and again on 12/2/22 from approximatley 9:45 AM to 10:30 AM.
Observation #3: At 10:00 AM on 12/2/22, Patient Care Technician (PCT) #5 took Myron L meter to station #10 and placed meter on top of dialysis machine while obtaining sample for conductivity testing, then placed meter on top of station #7's dialysis machine while obtaining sample for conductivity testing and then returned meter to clean sink area. PCT did not sanitize meter prior to next use or between the two (2) dialysis stations.
An interview with the facility administrator on 12/2/22 at approximately 1:30 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/05/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with the emphasis on but not limited to: 1) Non-disposable items are to be disinfected between patients. 2) Items taken into the dialysis station will be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before taken to a common clean area or used on another patient. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct infection control audits to verify teammate compliance with cleaning and disinfecting non-disposable items between patient use or taken to a common clean area: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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 a review of facility policy and procedure, direct observation of staff (RN1), and staff interview, facility staff failed to conduct total chlorine testing as per facility policy and procedure for one (1) of one (1) staff observed (RN1).
Findings Included:
A review of facility policy and procedure conducted on 11/30/22 at approximately 2:15 p.m. Procedure 2-05-02H titled "Total Chlorine Test using RPC Ultra Low Total Chlorine Test Strip" states, "Procedure: Rinse the sample collections cup thoroughly with the water to be tested. Fill the sample cup to the line marked 100 ml with the sample. Remove one test strip from the foil package and dip it in the water sample for 60 seconds. While dipping the strip, move it back and forth at a constant gentle rate of approximately two, 1-2 inch wide stroked per second...remove the strip and shake once, briskly to remove excess water. Wait 20 seconds for the test strip to develop... After the 20 second wait period, immediately compare the strip color to the K 100-0118 color chart to determine the Total Chlorine level in the sample..."
During the direct observation of a total chlorine test on 11/30/22 at approximately 1:48 PM, RN1 was observed dipping the test strip in the sample water for approximately 20 seconds instead of the required 60 seconds. RN1 then immediately compared the test strip to the color chart. When surveyor asked how long he/she should swish the test strip in the water sample, RN1 stated that they will check the temperature of the water sample and then do approximatley 18 seconds swish time as the water temperature was approximately 79 degrees F. Surveyor then spoke with BioMed regional manager who stated that the manufacture of the test strips lists swish time dependent on water sample temperature but this is not what facility policy and procedure state.
An interview with Facility Administrator on 12/2/22 at approximately 1:30 p.m. confirmed the observed procedure was not conducted per the facililty policy.
Plan of Correction:The Facility Administrator or Biomed Technician held mandatory in-services for all clinical teammates responsible for total chlorine tests starting on 12/05/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 2-05-02H "Total Chlorine Test using RPC Ultra Low Total Chlorine Test Strip" with emphasis on but not limited to: 1) Rinse the sample collection cup thoroughly with the water to be tested. Fill the sample cup to the line marked 100 ml with the sample. 2) Remove one test strip from the foil package and dip it in the water sample for 60 seconds. While dipping the strip, move it back and forth at a constant gentle rate of approximately two, 1-2 inch wide strokes per second. 3) Remove the strip and shake once, briskly, to remove excess water. 4) Wait 20 seconds for the test strip color to develop... 5) After the 20 second wait period, immediately compare the strip color to the K100-0118 color chart to determine the Total Chlorine level in the sample. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet.
The Facility Administrator or designee will perform observational audits to verify total chlorine tests are completed accurately per policy: daily for two (2) weeks, then weekly for two (2) weeks, and monthly for two (2) months. Instances of non-compliance will be addressed immediately.
The Facility Administrator or biomed will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.90(a)(1) STANDARD
POC-MANAGE VOLUME STATUS
Name - Component - 00
The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient's volume status;
Observations:
Based on review of facility policies/procedures, dialysis treatment documentation, medical records (MR), and interview with facility adminstrator (FA), the facility failed to follow it's policy for reporting and documentation of abnormal findings during dialysis to the licensed nurse or physican for one (1) of seven (7) MR's reviewed, (MR #4).
Findings include:
Review of policy occurred on 12/1/22 at approximately 11:30 AM which revealed:
Policy 1-03-08 titled, "CWOW Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment" states, "Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. Data collection includes but is not necessarily limited to: measurement of patient temperature, measurement of blood pressure (BP)...heart or pulse rate...patient weight, respiration rate, patient's report of well-being..vascular access status...Intradialytic (during treatment) Data Collection/Assessment...abnormal findings or findings outside of any patient specific physician ordered paramaters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary....The license nurse notifies the physician..as needed of changes in patient status...Abnormal findings: Blood Pressure-Pre-Dialysis: systolic greater than 180mm/Hg or less than 90mm/Hg. Diastolic greater than or equal to 100mm/Hg. Blood Pressure-Intradialytic: difference of 20 mm/Hg increase or decrease from patient's last Intradialytic treatment BP reading..."
A review of MR's was conducted on 12/1/22 from approximately 9:30 am to 2:30 pm.
MR #4, Start of Treatment at current Facility: 9/16/20
Treatment Record for 11/21/22
1:31 PM- Intradialytic (during treatment) BP: 138/59
2:01 PM- Intradialytic BP: 86/49
2:31 PM- Intradialytic BP: 118/62
3:01 PM- Intradialytic BP: 135/44
3:31 PM- Intradialytic BP: 174/146
3:51 PM- Treatment terminated (completed) BP: 151/65
All documentation about blood pressures noted above was by the Patient Care Technician (PCT) and there was no documentation of License Nurse notification due to the abnormal findings above (low blood pressure, high blood pressure and multiple increases in BP) In addition, blood pressure was not rechecked until 30 minutes after abnormal findings. FA stated the PCT should have immediately re-taken the abnormal blood pressures and notified the license nurse of the findings.
An interview with the facility administrator on 12/2/22 at approximately 1:30 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 12/05/22. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-08 "Pre-Intra-Post treatment Data Collection Monitoring and Nursing Assessment" with emphasis on but not limited to: 1) Patient data will be obtained and documented by the patient care technician or a licensed nurse, and includes but is not necessarily limited to: Measurement of Blood Pressure (BP) 1. Sitting and standing BP measurement required pre and post treatment (if patient unable to stand, document reason in the patient electronic record or flow sheet) 2. Intradialytic BP in the sitting/reclined or supine position. 2) Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary. 3) The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 4) All findings, interventions and patient response will be documented in the patient's medical record... 5) ABNORMAL FINDINGS- Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient's medical record. Blood Pressure-Pre-Dialysis: systolic greater than 180mm/Hg or less than 90mm/Hg. Diastolic greater than or equal to 100mm/Hg. Blood
Pressure-Intradialytic: difference of 20 mm/Hg increase or decrease from patient's last Intradialytic treatment BP reading... Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct audits to verify documentation of abnormal data and notification of and response by the licensed nurse: on twenty five percent (25%) of the flow sheets daily each treatment day for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review the audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement Meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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