Initial Comments:
Based on the findings of an unannounced incident investigation conducted on site on November 27, 2023 and off site November 28, 2023 and November 29, 2023, Callowhill Dialysis Center was identified as having the following standard level deficiency that was 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/procedure, medical records (MR), hemodialysis (HD) treatment records, and interviews with the facility administrator (FA) and Director of Clinical Services (DCS), the facility failed to follow its policy for monitoring vital signs, reporting and/or documenting abnormal findings pre, during and/or post HD, and documenting shortened HD treatments for one (1) of one (1) MR reviewed: MR#1.
Findings include:
A review of the facility's policy Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment (Policy: 1-03-08) on November 27, 2023 at approximately 10:00 AM reads in part,
"Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. Data collection includes ... measurement of BP (blood pressure), Heart or pulse rate;" "The nursing assessment will be performed and documented by a licensed nurse. The assessment includes the following components: review of patient reports, data collection, response to treatment."
"Pre-Treatment Data Collection/Assessment: any abnormal findings 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 ...the licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner if applicable) will be notified of any concerns that may preclude the initiation of dialysis. If there are no abnormal findings or concerns identified during the pretreatment data collection, the treatment may be initiated."
"Intradialytic Data Collection/Assessment: 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 .... Vital signs and treatment monitoring - for non-nocturnal treatments is completed at least every thirty (30) minutes ....Abnormal findings 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. The licensed nurse notifies the physician (or non physician practitioner if applicable) as needed of changes in patient status."
"Post Treatment Data Collection/Assessment: the PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre-dialysis findings. If an abnormal finding 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. Licensed nurse will use their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician is necessary prior to discharge of the patient from the facility."
"Abnormal Findings - any weight loss from last post weight .... Blood Pressure Pre-Dialysis: Systolic greater than 180 mm Hg or less than 90 mm Hg; Diastolic greater than or equal to 100 mmHg; Blood Pressure - Intradialytic: Difference of 20 mmHg increase or decrease from patient ' s last intradialytic treatment BP reading; Blood Pressure Post Treatment: Standing systolic BP greater than 140 mmHg or less than 90 mmHg; Standing diastolic BP greater than 90 mmHg or less than 50 mmHg; Sitting BP for patient ' s that cannot stand: Sitting systolic BP greater than 140 mmHg or less than 90 mmHg; Sitting diastolic BP greater than 90 mmHg or less than 50 mmHg; Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minutes or greater than 100 beats per minutes and/or an irregular heart beat."
A review of the facility's policy Prescribed Treatment Time Not Met (Policy 1-01-09) on November 27, 2023 at 2:30 PM reads in part,"The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time .....If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient's attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient's specific needs. Shortened/early termination of the dialysis treatment includes all reasons the prescribed dialysis time is not met by 30 or more minutes. This includes but is not limited to: the late initiation of treatment with termination at scheduled time, early termination at the end of treatment and interruptions of dialysis during treatment, i.e., machine or access problems or use of the bathroom by the patient; A copy of the Early Termination of Treatment form signed by the patient, if shortened voluntarily by patient, will be kept in the patient's health record. Additionally, if the patient's dialysis treatment is terminated 30 or more minutes prior to the ordered treatment length, the reason must be documented in the patient electronic health record at the time the treatment was terminated while reconciling/late reconciling the treatment times."
A review of twenty (20) hemodialysis (HD) treatment records (treatment detail reports) encompassing September 1, 2023 to November 2, 2023 took place on site November 27, 2023 from 10:00 AM to 3:00 PM, off site on November 28, 2023 from 9:00 AM to 11:00 AM, and November 29, 2023 from 8 AM to 9 AM. The start of care (SOC) is indicated below.
MR #1 SOC 08/24/2017:
09/01/2023: Hemodialysis (HD) Treatment was initiated at 6:24 AM. Vital sign check by the PCT (patient care technician) recorded a heart rate (HR) of 58. Vital sign check did not occur again until 7:36 AM (37 minutes after the last check) at which time HR was 59. Vital signs recorded by the PCT at 8:06 AM and 8:32 AM documented a HR 58 on both occasions. There was no documentation as to the reason why the vital sign check after 6:24 AM was not obtained at least every 30 minutes per facility policy, nor was there documentation that the RN (registered nurse) was notified of a HR less than <60 per facility policy nor that the physician was notified at the time of the occurrence. At discharge, the HR was 70 standing and 72 sitting.
09/04/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 3 hours, 41 minutes. There was no documentation as to the reason for the shortened treatment nor was an Early Termination of Treatment Against Medical Advice Form present in the medical record (MR).
09/06/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 3 hours, 10 minutes. The HD treatment record states that the treatment was terminated for patient choice but there was no Early Termination of Treatment Against Medical Advice Form present in the MR nor was there evidence that the physician was notified of the shortened treatment time exceeding thirty (30) or more minutes per facility policy.
09/18/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 2 hours, 50 minutes. The HD treatment record states that the treatment was terminated for patient choice and there was an Early Termination of Treatment Form in the medical record, but there was no evidence that the physician was notified of the shortened treatment time exceeding thirty (30) or more minutes per facility policy.
09/22/2023: HD Treatment was initiated at 11:24 AM by the PCT at which time the BP was noted to be 202/91. There was no documentation that the RN was notified. At 1:02 PM, the PCT documented a BP of 192/80. BP was not checked again by the PCT until 1:47 PM (45 minutes after prior BP check) and found to be 202/80. There was no documentation as to the reason why the vital sign check after 1:02 PM was not obtained at least every 30 minutes per facility policy nor that the RN and/or physician were notified of the abnormal findings at the time. There was no documentation of any interventions concerning the elevated BP at the time of the occurrence. Treatment ended at 3:10 PM. The post HD treatment vital signs and the nursing assessment did not contain documentation of a standing blood pressure or heart rate even though the patient was noted to be ambulatory. Sitting BP was 175/83. There was no evidence that that the RN was notified at the time of the occurrence that the sitting systolic BP was > 140 mmHg per facility policy.
09/27/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 2 hours, 32 minutes. The HD treatment record states that the treatment was terminated for patient choice. There was an Early Termination of Treatment Form in the medical record, but there was no evidence that the physician was notified of the shortened treatment time exceeding thirty (30) or more minutes per facility policy. HD treatment was initiated at 11:58 AM. The HD pre-treatment, post-treatment vital sign section of the treatment record, and the pre or post HD nursing assessment did not contain documentation of a standing blood pressure or heart rate. The patient was noted to be ambulatory upon arrival to the facility. During the HD treatment at 1:03 PM, the PCT documented a HR of 41. There was no documentation that the RN was notified of a HR <60 per facility policy. At 1:25 PM (22 minutes later), the RN documented a manual HR of 70. HD treatment was terminated at 2:32 PM at which time the PCT documented a HR 51 on the intradialytic treatment record. There was no documentation that the RN was notified of the post treatment HR < 60 per facility policy, and/or the physician was notified at the time of the occurrence. Post treatment vital signs were not documented until 6:29 PM and the post HD nursing assessment was not completed until 6:31 PM.
09/29/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 3 hours, 41 minutes. There was no documentation as to the reason for the shortened treatment nor was an Early Termination of Treatment Against Medical Advice Form present in the medical record (MR).
10/02/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 2 hours, 50 minutes. The HD treatment record states that the treatment was terminated for patient choice and there was an Early Termination of Treatment Form in the medical record, but there was no evidence that the physician was notified of the shortened treatment time exceeding thirty (30) or more minutes per facility policy. Treatment was initiated at 11:40 AM. During the HD treatment, HR was 56 and 59 at 1:32 PM and 2:05 PM, respectively as documented by the PCT. There was no indication that the RN was notified of a HR < 60 per facility policy and/or the physician was notified at the time of the occurrence.
10/04/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 2 hours, 6 minutes. Documentation on the treatment record noted that the shortened treatment was due to patient choice, but there was no Early Termination of Treatment Against Medical Advice Form present in the medical record (MR) nor was there evidence that the physician was notified of the shortened treatment time exceeding thirty (30) or more minutes per facility policy. Treatment was initiated at 11:57 AM. At 12:02 PM, the PCT documented a: BP of 199/86; at 12:23 PM, a HR 59; at 1:19 PM, a HR 55. There was no evidence that the RN was notified of a HR < 60, an intradialytic systolic blood pressure increase of 20 mmHg from the patient's last intradialytic BP reading occurred, nor that any interventions were took place.
10/09/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 3 hours, 38 minutes. There was no documentation as to the reason for the shortened treatment nor was an Early Termination of Treatment Against Medical Advice Form present in the medical record (MR).
10/11/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 3 hours, 36 minutes. There was no documentation as to the reason for the shortened treatment nor was an Early Termination of Treatment Against Medical Advice Form present in the medical record (MR).
10/13/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 3 hours, 32 minutes. There was no documentation as to the reason for the shortened treatment nor was an Early Termination of Treatment Against Medical Advice Form present in the medical record (MR).
10/16/2023: HD treatment was initiated at 11:25 AM. At 1:03 PM, the PCT recorded a HR 39 with a notation to 'recheck.' A recheck at 1:12 PM (9 minutes later) found HR to be 69. There was no documentation that the RN was notified at 1:03 PM of a HR < 60 as per facility policy nor that any other interventions occurred.
10/23/2023: HD Prescribed Treatment Time was four (4) hours. Actual HD treatment time was 3 hours, 31 minutes. There was no documentation as to the reason for the shortened treatment nor was an Early Termination of Treatment Against Medical Advice Form present in the medical record (MR). HD Treatment was initiated at 11:23 AM at which time HR was 56 per PCT documentation. Repeat HR at 11:32 PM was 57. There was no documentation that the RN was notified of a HR < 60 as per facility policy nor that any other interventions occurred.
10/26/2023: HD Treatment was initiated at 6:16 AM. At 8:31 AM, the PCT recorded a HR 46. RN was notified at 9:01 AM (30 minutes later) at which time HR was 49. RN turned off ultrafiltration sometime after 9:01 AM. There was no documentation that the RN was notified at 8:31 AM of a HR < 60 as per facility policy.
10/28/2023: HD Treatment was terminated at 10:39 AM. Post Treatment standing BP at 10:30 AM was 210/54; sitting BP was 154/50. The standing BP was also noted in the post HD nursing assessment. There was no comment or documentation addressing the BP of 210/54, no indication that it was retaken prior to discharge, nor that any other interventions took place.
10/31/2023: HD Treatment was terminated at 10:31 AM. Post treatment vital signs contained a documented standing HR 54, and a sitting HR 73. The post HD nursing assessment noted the same findings, along with a comment of regular (heart) rate and rhythm. There was no indication that the HR 54 was addressed.
11/02/2023: HD Treatment was initiated at 6:31 AM. The PCT documented a BP 194/61. There was no evidence that the RN was notified of a SBP > 180 at the start of treatment per facility policy. Treatment was terminated at 10:31 AM. A HR of 54 was recorded on the intradialytic record by the PCT. There is no documentation on the intradialytic record/at the end of treatment that the RN was informed of a HR < 60 at the end of treatment. A late entry by the RN at 2:28 PM retrospectively addresses the interventions for the low heart rate.
An interview conducted with the Director of Clinical Services on November 27, 2023 at approximately 2:45 PM, and again with the Director of Clinical Services and Facility Administrator via conference call on November 28, 2023 confirmed the above findings.
Plan of Correction: V 543
A Governing Body meeting was held on 12/7/23 with the Medical Director, Facility Administrator and Regional Operations Director to review the results of the survey ending on 11/29/23. Plans of correction have been developed and initiated to correct identified deficiencies and to sustain compliance.
The Facility Administrator or designee conducted mandatory in-services for all clinical teammates and visiting nurses starting on 11/29/23. 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" and Policy 1-01-09 "Prescribed Treatment Not Met" with emphasis on but not limited to:
A. [Policy] Pre- Intra- Post Treatment Data Collection, Monitoring and Nursing Assessment:
1. Pre-treatment: 1) 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... ii. Measurement of Blood Pressure (BP): a) 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). b) Intradialytic BP in the sitting/reclined or supine position. iii. Heart or pulse rate, noting also if the beat is regular or irregular. iv. Patient weight...2) 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. 3) Registered Nurse pre-treatment assessment will include, but not be limited to...vi. A physical assessment of the patient which includes...Apical heart rate and rhythm... Evaluation of volume status including edema. 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. 4) If there are no abnormal findings or concerns identified during the pretreatment data collection, the treatment may be initiated.
2. Intra-dialytic: 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) Intra-dialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: a. Vital signs and treatment monitoring i. For non-nocturnal treatments is completed at least every thirty (30) minutes. b. At a minimum, obtain and document: i. blood pressure and ii. Heart or pulse rate. 3) 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. 4) All findings, interventions and patient response will be documented in the patient's medical record.
3. 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.
4. 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. Abnormal Findings: Any weight loss from last post weight... Blood Pressure Pre-Dialysis: Systolic greater than 180 mm Hg or less than 90 mm Hg; Diastolic greater than or equal to 100 mmHg; Blood Pressure – Intra-dialytic: Difference of 20 mmHg increase or decrease from patent's last intradialytic treatment BP reading; Blood Pressure Post Treatment: Standing systolic BP greater than 140 mmHg or less than 90 mmHg; Standing diastolic BP greater than 90 mmHg or less than 50 mmHg; Sitting BP for patent's that cannot stand: Sitting systolic BP greater than 140 mmHg or less than 90 mmHg; sitting diastolic BP greater than 90 mmHg or less than 50 mmHg; Heart or Pulse Rate Pre/Intra/Post; Less than 60 beats per minutes or greater than 100 beats per minutes and/or an irregular heartbeat.
B. [Policy] Prescribed Treatment Time Not Met:
1. Completion of the Early Termination of Treatment Against Medical Advice Form (Policy 1-01-09A): 1) The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time. 2) The Registered Nurse (RN) will obtain the patient's signature on the Early Termination of Treatment Against Medical Advice Form prior to the patient being rinsed back from their treatment. If unable to obtain the patient's signature prior to rinse-back, the Registered Nurse (RN) will obtain the patient's signature on the form prior to the patient's departure from the facility.
2. Prescribed treatment time not met: 1) If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient's attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient's specific needs. 2) If a patient's treatment is shortened/early terminated, the RN will document the event in the patient's electronic health record. Documentation will include, as appropriate: The amount of time by which the treatment was shortened; A description of why the treatment was shortened; Whether the patient's nephrologist was notified; A description of the follow-up medical orders provided by the patient's attending nephrologist (if any); A description of all other interventions planned to address the shortened treatment, including recommendations to the patient. 3) Additionally, if the patient's dialysis treatment is terminated 30 or more minutes prior to the ordered treatment length, the reason must be documented in the patient electronic health record at the time the treatment was terminated while reconciling/late reconciling the treatment times. a. All available reasons must be reviewed and the most accurate reason must be selected. 4) The facility's Facility Administrator will verify that all shortened treatments are recorded and trended, and the Facility Administrator shall verify that such records are reviewed and discussed at the Facility Health Meetings (FHM), as appropriate.
Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct two audits:
A. To verify teammate documentation every thirty minutes of treatment data collection, including any abnormal findings, the notification of Registered Nurse regarding abnormal findings, [including but not limited to blood pressure and heart rate readings] and the appropriate response by the nurse to the findings, [including additionally, as needed notification of the physician and receipt of physician orders.]
B. To verify the "Early Termination of Treatment against Medical Advice" form is signed by the patient and Registered Nurse when treatment times are not met on the treatment record as prescribed.
Each audit series will be conducted on twenty five percent (25%) of treatment records: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored monthly with ten percent (10%) medical records audit. 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, along with a trending of shortened treatments. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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