QA Investigation Results

Pennsylvania Department of Health
DIALYSIS CLINIC, INC.
Health Inspection Results
DIALYSIS CLINIC, INC.
Health Inspection Results For:


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Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey completed December 13, 2019, Dialysis Clinic, Inc. 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 December 13, 2019, Dialysis Clinic, Inc. 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:




494.90(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, standing orders, and clinical records (CR) and staff interview (EMP), the facility failed to assess and/or manage patient's blood pressure for two (2) of five (5) in-center hemodialysis CR reviewed (CR2, CR3)

Findings Included:

Review of facility policies on 12/13/19 at approximately 1;30 PM revealed: "...HEMODIALYSIS TREATMENT READINGS...PURPOSE: To evaluate effectiveness of the dialysis treatment...and to provide for early detection of complications...PROCEDURE:...2. Normal parameters for hemodialysis will be established...For each parameter, guidance will be given regarding actions to take if readings fall outside the established parameters as follows:...b. The Physician will be notified of the following:...Blood Pressure Post Treatment Systolic <90 or >200; Diastolic >120 if symptomatic..."

Review of facility standing orders completed on 12/12/19 at approximately 11:05 AM revealed: "...HYPOTENSION/CRAMPS: If patient is hypotensive and/or symptomatic: May place patient in Trendelenberg...minimum UFR (ultrafiltration rate) PRN (as needed)...Normal saline Solution PRN...in 50-200 ml IV Bolus up to 500 ml...23.4 % Sodium Chloride solution may be administered...May adjust machine temperature up or down by 0.5 -1.0 degree Celsius...VITAL SIGNS...Blood Pressure - Notify physician if Systolic is < 90 or > 200 mmHg or Diastolic > 120 and symptomatic...Patients are to be evaluated and physician notified if above parameters are abnormal for this patient..."

Review of CR2 completed on 12/12/19 at approximately 12:50 PM revealed an admission date of 7/31/06. Eight in-center treatment flowsheets reviewed from 11/20/19 to 12/9/19 revealed:
12/2/19, "...Vital Signs (Post)...BP (blood pressure) Sit 202/91...Procedures, Complications, & Notes:...Chief Complaint (Post) Note: Deny Complaints..."
12/6/19, "...Vital Signs (Post)...BP Stand 207/89...BP Sit 206/84...Procedures, Complications, & Notes:...Chief Complaint (Post) Note: Deny Complaints..."
12/9/19, "...Vital Signs (Post)...BP Sit 202/76...Procedures, Complications, & Notes:...Chief Complaint (Post) Note: Deny Complaints..."
There was no documented evidence of physician notification in accordance with patient standing orders/facility policy and procedure for aforementioned patient treatment dates reviewed.

Review of CR3 completed on 12/12/19 at approximately 1:45 PM revealed an admission date of 8/15/17. Nine in-center treatment flowsheets reviewed from 11/20/19 to 12/9/19 revealed:
11/22/19, "...Time 12:57 PM...BP 88/43...Time 01:32 PM...BP 79/41...TX Complication: HYPOTENSION..."
11/30/19, "...Time 01:29 PM...BP 89/47...TX Complication: HYPOTENSION..."
12/6/19, "...Time 12:23 PM...BP 80/41...TX Complication: HYPOTENSION...12:29 PM BP 85/44..."
There was no additional documentation identified of interventions provided per facility standing orders to resolve hypotension complications for aforementioned treatment dates reviewed.

An exit conference was conducted on 12/13/19 at approximately 2:15 PM. facility clinical manager (EMP2) confirmed the above findings. EMP2 stated "...the patient interventions taken by staff should be documented...." EMP2 confirmed staff were to document patient interventions/treatments on the treatment flowsheets utilizing the facility electronic medical record system.














Plan of Correction:

1) Area Operations Director will be responsible to:
a) Present proposed Plan of Correction to Governing Body at the December 27, 2019 monthly meeting.

2) Nurse Educator will be responsible to:
a) Educate personnel on or before December 23, 2019 regarding:
i) "HEMODIALYSIS TREATMENT READINGS" policy focusing on actions to take if Blood Pressure readings fall outside established parameters
ii) CHRONIC HEMODIALYSIS STANDING ORDERS focusing on appropriate interventions, documentation, and notification of RN or physician in the treatment of blood pressures outside established parameters
b) Create audit checklist by December 23, 2019:
i) To monitor physician notification in accordance with standing orders and normal parameters
ii) To monitor that documentation exists to indicate interventions for episodes of blood pressures outside established parameters

3) Direct Patient Care Staff will be responsible to:
a) Notify the RN or physician if blood pressures are outside of established parameters as indicated in the "HEMODIALYSIS TREATMENT READINGS" POLICY and CHRONIC HEMODIALYSIS STANDING ORDERS
b) Document interventions for hypo or hypertensive episodes on the hemodialysis flowsheet

4) Charge Nurse or designee will be responsible to perform audits beginning December 24, 2019 as follows:
a) 100% of flowsheets will be audited daily for 2 weeks
b) If 100% compliant, 100% of one treatment day's flowsheets will be audited weekly for 2 weeks
c) If 100% compliant, 100% of one treatment day's flowsheets will be audited monthly X 3 months

5) Nurse Manager or designee will be responsible to:
a) Review and initial audits per audit schedule.
b) Document results of audits in QAPI and present findings to Governing Body monthly.

6) Governing Body will determine frequency of future audits based upon compliance.



494.90(a)(1) STANDARD
POC-ACHIEVE ADEQUATE CLEARANCE

Name - Component - 00
Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis.


Observations:


Based on a review of facility policy, clinical records (CR) and staff (EMP) interview, the facility failed to ensure treatments were delivered in accordance with the dialysis prescriptions ordered by the physician as specified in the patient plan of care for five (5) of five (5) in-center hemodialysis clinical records reviewed (CR1 - CR5).

Findings included:

Review of facility policy on 12/13/19 at approximately 1;30 PM revealed: "...HEMODIALYSIS TREATMENT READINGS...PURPOSE: To evaluate effectiveness of the dialysis treatment...and to provide for early detection of complications...PROCEDURE:...1. The following parameters will be monitored at a minimum of 30 minute intervals, with legible documentation in the following areas...d. Verify blood flow rate (BFR) is set to ordered BFR. Documentation must exist if ordered BFR is not obtained...

Review of CR1 completed on 12/12/19 at approximately 11:20 AM revealed an admission date of 10/19/18. Five in-center treatment flowsheets reviewed from 11/27/19 to 12/9/19 each with physician ordered BFR of 350 ml/min (millimeters/minute). Reviewed flowsheets revealed the following:
12/2/19 from 9:22 AM to 10:22 AM BFR at 340 ml/min. CR did not contain documented evidence of why BFR was not at rate as ordered.

Review of CR2 completed on 12/12/19 at approximately 12:50 PM revealed an admission date of 7/31/06. Eight in-center treatment flowsheets reviewed from 11/20/19 to 12/9/19 each with physician ordered BFR of 380 ml/min (millimeters/minute). Reviewed flowsheets revealed the following:
11/20/19 from 05:43 AM to 08:53 AM BFR at 390 ml/min. CR did not contain documented evidence of why BFR was not at rate as ordered.
11/25/19 from 05:58 AM to 08:53 AM BFR at 350 ml/min. CR did not contain documented evidence of why BFR was not at rate as ordered.
11/27/19 from 05:41 AM to 08:53 AM BFR at 360 ml/min. CR did not contain documented evidence of why BFR was not at rate as ordered.
11/30/19 from 05:42 AM to 08:23 AM BFR at 350 ml/min. CR did not contain documented evidence of why BFR was not at rate as ordered.

Review of CR3 completed on 12/12/19 at approximately 1:45 PM revealed an admission date of 8/15/17. Nine in-center treatment flowsheets reviewed from 11/20/19 to 12/9/19 each with physician ordered BFR of 350 ml/min (millimeters/minute). Reviewed flowsheets revealed the following:
11/20/19 from 10:20 AM to 01:24 PM BFR at 340 ml/min. CR did not contain documented evidence of why BFR was not at rate as ordered.
11/22/19 from 12:17 PM to 01:32 PM BFR at 340 ml/min. CR did not contain documented evidence of why BFR was not at rate as ordered.

Review of CR4 completed on 12/13/19 at approximately 9:40 AM revealed an admission date of 10/3/19. Nine in-center treatment flowsheets reviewed from 11/21/19 to 12/10/19 each with physician ordered BFR of 400 ml/min (millimeters/minute). Reviewed flowsheets revealed the following:
11/21/19 from 11:17 AM to 02:23 PM BFR at 350 ml/min. CR did not contain documented evidence of why BFR was not at rate as ordered.
11/23/19 from 11:18 AM to 01:48 PM BFR at 330 ml/min; from 02:17 PM to 02:47 PM BFR at 320 ml/min. CR did not contain documented evidence of why BFR was not at rate as ordered.

Review of CR5 completed on 12/13/19 at approximately 10:40 AM revealed an admission date of 9/21/13. Nine in-center treatment flowsheets reviewed from 11/21/19 to 12/10/19 each with physician ordered BFR of 380 ml/min (millimeters/minute). Reviewed flowsheets revealed the following:
11/21/19 from 06:55 AM to 08:25 AM BFR at 370 ml/min. CR did not contain documented evidence of why BFR was not at rate as ordered.
11/23/19 from 06:31 AM to 09:24 AM BFR at 360 ml/min. CR did not contain documented evidence of why BFR was not at rate as ordered.
11/29/19 from 06:06 AM to 08:55 AM BFR at 390 ml/min; from 09:24 AM to 09:55 AM BFR at 400 ml/min. CR did not contain documented evidence of why BFR was not at rate as ordered.
12/3/19 from 07:56 AM to 09:56 AM BFR at 360 ml/min. CR did not contain documented evidence of why BFR was not at rate as ordered.
12/5/19 from 08:22 AM to 09:52 AM BFR at 390 ml/min. CR did not contain documented evidence of why BFR was not at rate as ordered.

An exit conference was conducted on 12/13/19 at approximately 2:15 PM. facility clinical manager (EMP2) confirmed the above findings. EMP2 confirmed reasons for adjusting ordered blood flow rates should have been documented.











Plan of Correction:


1) Area Operations Director will be responsible to:
a) Present proposed Plan of Correction to Governing Body at the December 27, 2019 monthly meeting.

2) Nurse Educator will be responsible to:
a) Educate personnel on or before December 23, 2019 regarding:
i) "HEMODIALYSIS TREATMENT READINGS" policy focusing on verification that delivered Blood Flow Rate (BFR) is set to ordered BFR and if not, documentation exists to support rationale why it could not be obtained.
b) Create audit checklist by December 23, 2019:
i) To monitor that delivered BFR is at prescribed BFR
ii) To monitor that documentation exists to indicate reason for BFR outside of physician orders

3) Direct Patient Care Staff will be responsible to:
a) Document reasons why prescribed BFR was not achieved on the hemodialysis flowsheet

4) Charge Nurse or designee will be responsible to perform audits beginning December 24, 2019 as follows:
a) 100% of flowsheets will be audited daily for 2 weeks
b) If 100% compliant, 100% of one treatment day's flowsheets will be audited weekly for 2 weeks
c) If 100% compliant, 100% of one treatment day's flowsheets will be audited monthly X 3 months

5) Nurse Manager or designee will be responsible to:
a) Review and initial audits per audit schedule.
b) Document results of audits in QAPI and present findings to Governing Body monthly.

6) Governing Body will determine frequency of future audits based upon compliance.



494.170 STANDARD
MR-COMPLETE, ACCURATE, ACCESSIBLE

Name - Component - 00
The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility.


Observations:


Based on a review of facility policy, clinical records (CR) and staff (EMP) interview, it was determined the facility failed to ensure staff maintained complete and accurate medical records for the care provided and medications administered for one (1) of five (5) in-center hemodialysis CR reviewed (CR4).

Findings Included:

Review of facility policy on 12/13/19 at approximately 1;30 PM revealed: "...HEMODIALYSIS TREATMENT READINGS...PURPOSE: To evaluate effectiveness of the dialysis treatment...and to provide for early detection of complications...POLICY: While the patient is receiving a hemodialysis treatment, the nursing staff will perform routine monitoring (reading) of the patient's overall condition...PROCEDURE:...1. The following parameters will be monitored at a minimum of 30 minute intervals, with legible documentation in the following areas...o. Complications or symptoms that the patient is experiencing should be noted...q. Additional information information that occurs during treatment..."

Review of CR4 completed on 12/13/19 at approximately 9:40 AM revealed an admission date of 10/3/19. CR contained physician standing order "...MEDICATION THERAPY...For hypoglycemic reaction or a BG (blood glucose) <70 - Glucose 15 Gel (15g) Give one entire tube of gel. OR Glucose Tablets (4 gm) Give 1 -2 Tablets PO (by moth)..." Nine in-center treatment flowsheets reviewed from 11/21/19 to 12/10/19 revealed the following:
11/26/19, Medication given by registered nurse during treatment "...11:30 AM...GLUCOSE - 1 Tablet (s) PO PRN (as needed)...Procedures, Complications, & Notes:...MED GLUCOSE Was Effective: Yes..."
11/29/19, Medication given by registered nurse during treatment "...02:37 PM...GLUCOSE - 1 Tablet (s) PO PRN...Procedures, Complications, & Notes:...MED GLUCOSE note: bs (blood sugar) 74 (2:38 PM)..."
12/3/19, Medication given by registered nurse during treatment "...02:35 PM...GLUCOSE - 1 Tablet (s) PO PRN...Procedures, Complications, & Notes:...MED GLUCOSE note: bs 71 (2:38 PM)..."
12/10/19, Medication given by registered nurse during treatment "...01:41 PM...GLUCOSE - 1 Tablet (s) PO PRN...Procedures, Complications, & Notes:...MED GLUCOSE Was Effective: Yes...note: bs 71 (1:41 PM)..."
There was a lack documented evidence of additional nursing interventions in the aforementioned treatment flowsheet reviews, specifically, the patient complications precipitating the medication administration and/or patient complication resolution/non-resolution. Surveyor unable to discern if interventions were completed in accordance with patient medication therapy standing order and/or if physician was notified and plan of care was updated/individualized.

An exit conference was conducted on 12/13/19 at approximately 2:15 PM. facility clinical manager (EMP2) confirmed the above findings. EMP2 stated "...patient (CR4) has implanted device that takes his readings (BS levels)...informs the staff nurses...need to make sure everything is documented..."













Plan of Correction:

1) Area Operations Director will be responsible to:
a) Present proposed Plan of Correction to Governing Body at the December 27, 2019 monthly meeting.

2) Nurse Educator will be responsible to:
a) Educate Registered Nurses on or before December 23, 2019 regarding:
i) "HEMODIALYSIS TREATMENT READINGS" policy, "PRN MEDICATIONS" policy, and CHRONIC HEMODIALYSIS STANDING ORDRES focusing on including need for and effectiveness of PRN medications in documentation on the hemodialysis flowsheet
ii) Notification of physician if PRN medication is not effective as per CHRONIC HEMODIALYSIS STANDING ORDERS
b) Create audit checklist by December 23, 2019:
i) To monitor that documentation exists to indicate need for and effectiveness of PRN medications
ii) To monitor that physician was notified if PRN medication was not effective

3) Registered Nurses will be responsible to:
a) Document need for and effectiveness of PRN medications
b) Notify MD per CHRONIC HEMODIALYSIS STANDING ORDERS if prn medication is not effective

4) Charge Nurse or designee will be responsible to perform audits beginning December 24, 2019 as follows:
a) 100% of flowsheets will be audited daily for 2 weeks
b) If 100% compliant, 100% of one treatment day's flowsheets will be audited weekly for 2 weeks
c) If 100% compliant, 100% of one treatment day's flowsheets will be audited monthly X 3 months

5) Nurse Manager or designee will be responsible to:
a) Identify need to update individualized patient plan of care
b) Review and initial audits per audit schedule.
c) Document results of audits in QAPI and present findings to Governing Body monthly.

6) Governing Body will determine frequency of future audits based upon compliance.