Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on October 20, 2023, Belle Vernon 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 completed on October 20, 2023, Belle Vernon Dialysis was identified to have the following 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:
494.90(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 reviews of medical records (MR), facility policy, and staff (EMP) interview, the facility failed to provide the necessary care and services to manage the patient's volume status for four (4) of five (5) in center dialysis records reviewed. (MR1-4)
Findings included:
Review of facility policy on October 19, 2023, at approximately 11:30pm revealed:
"...Policy: 1-03-08...TITLE: PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING, AND NURSE ASSESSMENT...PRE-TREATMENT DATA COLLECTION/ASSESSMENT, 4. Any abnormal findings o findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse...INTRADIALYTIC DATA COLLECTION/ASSESSMENT...9.... a. Vital signs and treatment monitoring, i. For non-nocturnal treatments is completed at least every thirty (30) minutes...10. If the dialysis prescription is not being met (including dialysis flow rate or change/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed., 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately...13. All findings, interventions, and patient response will be documented in the patient's medical record...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...Fluid Status: ...Post-treatment: If the patient is above or below1 kg from the target weight, Blood pressure: Pre-dialysis: Systolic greater than 180 mm Hg of less than 90 m Hg, Diastolic greater than or equal to 100 mm Hg, Blood Pressure-Intradialytic: Difference of 20 mm Hg increase or decrease from patient's last intradialytic treatment BP reading..."
Review of MR on 10/19/2023, between approximately 12:00pm and 2:30pm revealed:
MR1, admission date 10/6/2023, treatment dates reviewed 10/6/23-10/16/23.
10/9/23- Ordered Blood Flow Rate (BFR) 350. 1:07pm BFR 300, no documentation to reflect reason BFR not as ordered. 58 minutes between documented vitals and safety checks (1:33pm-2:31pm)
10/13/23- No documentation of vitals/safety checks from initiation of treatment at 1:07pm until 2:59pm (1 hour 52 minutes).
MR2, admission date 8/3/2020, treatment dates reviewed 10/2/23-10/16/23.
10/4/23- 12:30pm blood pressure (b/p) obtained by Patient Care Tech (PCT) 156/103. +22 points systolic and +23 points diastolic from previous b/p reading 134/80. No documented notification to licensed nurse per policy.
10/13/23- Patient specific pre-treatment b/p parameters 90-190/above 45. Documented pre-treatment b/p 200/104. No documentation reflecting notification to physician of pre-treatment b/p outside of parameters.
4:01pm b/p obtained by PCT 169/92. +23 points systolic from previous b/p reading 146/85. No documented notification to licensed nurse per policy.
5:31pm b/p obtained by PCT 164/86. -20 points systolic from previous b/p reading 184/101. No documented notification to licensed nurse per policy.
MR3, admission date 3/18/22, treatment dates reviewed 10/2/23-10/18/23.
10/2/23- Ordered BFR 450. 10:32am, 11:02am, 11:32am, 12:02am BFR 300, no documentation to reflect reason BFR not as ordered.
11:32am- b/p obtained by PCT 195/117. +34 points systolic from previous b/p reading 161/101. No documented notification to licensed nurse per policy.
12:02pm- b/p obtained by PCT 223/127. +28 points systolic from previous b/p reading 195/117. No documented notification to licensed nurse per policy.
10/13/23- Patient specific pre-treatment b/p parameters 90-220/50-120. Documented pre-treatment b/p 204/126. No documentation reflecting notification to physician of pre-treatment b/p outside of parameters.
Patient specific post-treatment b/p parameters 90-200/50-120. Documented post-treatment b/p 235/132. No documentation reflecting notification to physician of post-treatment b/p outside of parameters.
11:00am- b/p obtained by PCT 218/140. +35 points systolic and +23 points diastolic from previous b/p reading 183/117. No documented notification to licensed nurse per policy.
11:30am- b/p obtained by PCT 248/136. +30 points systolic from previous b/p reading 218/140. No documented notification to licensed nurse per policy.
2:00pm- b/p obtained by PCT 255/141. +20 points systolic from previous b/p reading 235/134. No documented notification to licensed nurse per policy.
10/16/23- Patient specific post-treatment b/p parameters 90-200/50-120. Documented post-treatment b/p 230/152. No documentation reflecting notification to physician of post-treatment b/p outside of parameters.
1:30pm- b/p obtained by PCT 214/126. +25 points systolic from previous b/p reading 189/114. No documented notification to licensed nurse per policy.
2:35pm- b/p obtained by PCT 255/141. +21 points systolic from previous b/p reading 235/134. No documented notification to licensed nurse per policy.
10/18/23- Patient specific post-treatment b/p parameters 90-200/50-120. Documented post-treatment b/p 176/121. No documentation reflecting notification to physician of post-treatment b/p outside of parameters.
MR4, admission date 10/12/22, treatment dates reviewed 10/4/23-10/16/23.
10/4/23- 8:00am- b/p obtained by PCT 14/65. +28 points systolic from previous b/p reading 118/68. No documented notification to licensed nurse per policy.
10/11/23- 7:30am- b/p obtained by PCT 160/65. +31 points systolic from previous b/p reading 129/67. No documented notification to licensed nurse per policy.
9:51am- b/p obtained by PCT 129/71. -23 points systolic from previous b/p reading 152/68. No documented notification to licensed nurse per policy.
Interview with the Center Manager and Manager of Clinical Services on October 20, 2023, at approximately 2:00pm confirmed findings.
Plan of Correction:V 543
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 10/23/23. 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:
A. Pre-treatment Data Collection: 1) Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse, including but not limited to: ii Measurement of Blood Pressure (BP)... 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)... iv Patient weight...
2) Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: ... Blood flow rate; Dialysate flow rate... 3) Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse... If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. 4) The assessment is a nursing responsibility. The nurse will assess the patient pretreatment as warranted by the patient's condition. 5) The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner [NPP] if applicable) will be notified of any concerns that may preclude the initiation of dialysis.
B. Intra-dialytic data collection / assessment: 1) The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation. 2) Vital signs and treatment monitoring i. For non-nocturnal treatments is completed at least every thirty (30) minutes. At a minimum, obtain and document the following: blood pressure... blood and dialysate flows... fluid removal and / or replacement... 3) If the dialysis prescription is not being met (including dialysis flow rate or change to /inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed. 4) 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 judgment based on individual patient needs to determine if any clinical interventions are necessary. 5) The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 6) All findings, interventions and patient response will be documented in the patient's medical record.
C. Post treatment: 1) The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre-dialysis findings. 2) If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 3) Licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility.
D. Abnormal findings: 1) 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.
2) Fluid Status...Post-treatment- If patient is above or below 1 kg from the target weight. 3) Blood pressure: a. Pre dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg; Diastolic greater than or equal to 100 mm/Hg; b. Intradialytic: Difference of 20 mm/Hg increase or decrease from patient's last intradialytic treatment BP reading; Post dialysis: Standing / sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg, Standing / sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg... If patient is not able to stand, document reason and sitting BP. 4) Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct treatment records audits to verify timely nursing assessments, proper documentation of data collection, with appropriate notification of abnormal findings to nurse and response by nurse per policy on: twenty five percent (25%) of the treatment records daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits until facility is officially closed on 12/01/23. 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 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)(5) STANDARD
POC-VASCULAR ACCESS-MONITOR/REFERRALS
Name - Component - 00
The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement.
Observations:
Based on reviews of facility policy, observations (OBS), and staff (EMP) interview, the facility failed to ensure staff followed facility policy for Access of AV Fistula of Graft Initiation of Dialysis for three (3) of four (4) observations of Access of AV Fistula of Graft Initiation of Dialysis (OBS # 2, - #4).
Findings included:
Review of facility policy on October 19, 2023, at approximately 11:30pm revealed:
"...Procedure: 1-04-01E... TITLE: AV FISTLA OR GRAFT CANNULATION WITH NIPRO OR MEDISYSTEMS SAFETY FISTULA NEEDLES (SFN) AND ADMIISTRATION OF HEPARIN LOADING DOSE...13. Do not palpate insertion site once area has been prepped..."
Observations revealed:
OBS #2 conduced on 10/18/23 at approximately 10:45am at station #2. EMP #2 palpated insertion site after antisepsis.
OBS #3 conduced on 10/18/23 at approximately 11:40am at station #5. EMP #2 palpated insertion site after antisepsis.
OBS #4 conduced on 10/20/23 at approximately 10:40am at station #9. EMP #3 palpated insertion site after antisepsis.
Interview with the Center Manager and Manager of Clinical Services on October 20, 2023, at approximately 2:00pm confirmed findings.
Plan of Correction:V 550
The Facility Administrator or designee held mandatory in-services for clinical teammates starting on 10/23/23. Surveyor observations were reviewed. Education included but was not limited to a review of Procedure 1-04-01E "AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose" with emphasis on but not limited to: 1) Step 8: Locate and palpate the needle cannulation sites prior to skin preparation. 2) Step 10: While maintaining aseptic technique, prep each planned needle site by applying a 70% alcohol prep pad to each site using a circular rubbing motion, center out. 4) Step 11: While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular rubbing motion, moving from the center out and allow to dry. 5) Step 13: Do not palpate insertion site once area has been prepped. Rationale: Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation. 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 teammates are compliant with skin antisepsis prior to cannulation [cannulation site is not palpated after antiseptic is used] per policy: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly infection control audits until facility is officially closed on 12/01/23. Instances of non-compliance will be addressed immediately.
The Facility Administrator of designee will review audit results with teammates during homeroom meetings and with the Medical Director during monthly Quality Assessment Performance Improvement meetings known as Facility Health Meetings (FHM), with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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