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CINCINNATI, OH 45219

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on policy review, observations, interviews and medical record review it was determined the hospital failed to provide dialysis in a safe manner related to the failure to ensure access sites for two of six patients receiving dialysis were visible at all times. (Patient #15 and #16) The census was 17 acute hemodialysis patients.

Findings include:

Review of the policy and procedure titled "Patient Rights and Responsibilities", 015-03, originated 11/1992, reviewed and revised on 10/31/16 on page (4 of 5) under patient rights (#19) included patients have the right to receive care in a safe and secure setting.

Review of the medical records for Patient's #15 and #16 lacked documented evidence the access sites were being monitored every 15 minutes according to an interview by Staff A.

Observation of the dialysis unit on 07/06/17 at 10:35 AM revealed Patient #15 was hemodialyzing at station #1. The patient had a left arterial venous fistula in place and was lying on his/her left side. Patient #15's access site was covered with a blanket. There were no observations made of Staff K keeping the access site visible.

Observation of the dialysis unit on 07/06/17 at 10:45 AM revealed Patient #16 was hemodialyzing at station #3. The patient had a right upper arm graft and was lying on his/her right side. Patient #16's access site was covered with a blanket. There were no observations made of Staff M keeping the access site visible.

Interview with Staff B on 07/10/17 at 4:20 PM revealed we can try to keep the access sites uncovered, but the patients will cover themselves with a blanket because they get cold from the air conditioner blowing on them. Some of the patients will cover their face. The nurse should check at least every 15 minutes that the patient's access sites are uncovered.

Interview with Staff A on 07/01/17 at 4:30 PM revealed there is no policy and procedure in place to keep the patient's access sites uncovered.

This finding was confirmed with Staff B on 07/07/17 at the time of the interview at 4:20 PM and again prior to the exit conference.

NURSING SERVICES

Tag No.: A0385

Based on medical record review, facility policy review, staff interview, and review of Hemodialysis staffing and census sheets, the facility failed to ensure patients were administered a full hemodialysis treatment and failed to ensure the nursing service provided adequate staffing to meet the needs of acute hemodialysis patients. (A 392) The cumulative effect of these systemic practices resulted in the facility's inability to ensure that the patient's acute dialysis nursing needs were met.

STAFFING AND DELIVERY OF CARE

Tag No.: A0392

Based on medical record review, review of staffing/census sheets, staff interview, and facility policy review, the facility failed to ensure Patient #13 received the hemodialysis treatment for the duration ordered by the physician and failed to ensure the Hemodialysis Unit had adequate nursing staff to provide dialysis treatment to Patient #8 and #9. This affected three of 14 hemodialysis patients whose medical records were reviewed. The average census in the Hemodialysis Unit was 17.

Findings include:

1. Patient #13 arrived in the emergency department (ED) on 04/07/17 with a diagnosis of end-stage-renal disease (ESRD). The physician orders dated 04/07/17 was for the patient to hemodialyze for four hours. Review of the treatment flow sheet revealed the patient dialyzed for 210 minutes, a total of three hours and 20 minutes and not the four hours ordered.

Further review of the medical record for Patient #13 revealed the patient arrived in the ED on 04/14/17 with a diagnosis of ESRD. The physician orders for 04/14/17 was for Patient #13 to hemodialyze for four hours. The treatment flow sheet revealed Patient #13's dialysis treatment was initiated at 5:15 PM by Staff D and the dialysis treatment was terminated at 6:39 PM for a total of one hour and 24 minutes. The treatment flow sheet dated 04/14/17 lacked documented evidence as to why Patient #13's treatment was terminated early, or physician notification. There was no Against Medical Advice (AMA) form signed by the patient.

This finding was confirmed by Staff A on 07/11/17 prior to exit conference.

Review of the scope of service for the Hemodialysis Unit on 06/30/17 at 8:30 AM revealed the unit has six hemodialysis stations and equipment and staff to provide portable treatment elsewhere in the hospital. The scope of service revealed Hemodialysis is available 24 hours a day 7 days per week. Normal hours of operation are from 06:30 AM to 9:00 PM. The scope of service stated staffing for the Hemodialysis Unit is based on patient acuity and the number of treatments to be provided and the location of treatment.

Staff E, a Hemodialysis Charge Nurse, was interviewed on 06/30/17 at 01:15 PM. He/She stated although staffing is usually good, there are days that are "challenging." Staff E denied Hemodialysis staff are on call but explained facility union guidelines that state staff may be mandated for one hour after their scheduled work time. If staff are needed beyond that one hour, it must first be approved by the Chief Nursing Officer.

Staff E reported staff working beyond one hour in the past but since the new manager was hired in March, 2017, he/she informed staff they would no longer be working beyond one hour. Most Hemodialysis staff work from 06:30 AM to 7:00 PM. A smaller group of staff, primarily the staff trained to perform portable treatments, work from 9:00 AM to 9:30 PM. These staff can be mandated until 10:30 PM. Staff are not required to work on Sundays. A local agency is contracted to be on call when facility staff aren't working.

On Thursday, 06/15/17, three nurses worked from 09:00 AM to 9:30 PM performing portable dialysis treatments, one nurse worked as the charge nurse without an assignment, two nurses worked from 06:30 AM to 7:00 PM performing dialysis treatments in the unit, and the last two nurses worked from 06:30 AM to 5:00 PM performing dialysis treatments in the unit. Out of the eight nurses working, four were trained to perform portable dialysis treatments.

During the evening hours, one nurse was performing a portable dialysis treatment when another patient presented to the Emergency Department with a critical blood sugar greater than 600 and a critical potassium value of 6.7 (normal potassium is 3.6 - 5.2). The two nurses that worked until 5:00 PM had already left for the evening and one of those nurses was trained to perform portable treatments. The three nurses remaining that were trained to perform portable dialysis treatments were scheduled to work until 9:30 PM. All three nurses were currently performing portable treatments.

There was not another nurse to staff the case, so the patients were triaged and the decision was made to cut another treatment short to perform the urgent portable dialysis treatment.

2. Patient #8 presented to the Emergency Department on 06/13/17 at 8:29 PM with complaints of nausea and vomiting. The physician's History and Physical noted the patient had a medical history of end stage renal disease and was a brittle diabetic. The patient's blood sugar at 8:32 PM was determined to be critically high at 570. The patient's potassium was also elevated at 6. The patient's blood pressure on admission was 234/104.

A renal physician ordered the patient to receive a dialysis treatment for 3.5 hours on 06/15/17.

The dialysis treatment was initiated at 3:47 PM. A nursing note at 5:00 PM stated the patient was informed his/her treatment would be shortened. The patient's ordered 3.5 hour treatment was discontinued at 5:20 PM after 93 minutes.
A nursing note at 6:17 PM stated the patient became angry and ripped out his/her IV and informed staff he/she was ready to go home. The patient was discharged home against medical advice (AMA) at 9:00 PM.

3. Patient #9 presented to the Emergency Department from a nursing home on 06/15/17 at 12:51 PM with complaints of hyperglycemia with a blood sugar greater than 600. The patient was also noted to have a critical high potassium value of 6.7. Renal physicians planned for the patient to receive urgent hemodialysis.

The dialysis treatment was initiated at 6:56 PM and concluded at 8:56 PM.

Staff B, Executive Director of Transplant Services, was interviewed on 07/10/17 at 12:20 PM. Staff B was interviewed why an agency nurse was not called in to accommodate both patients. Staff B stated: "I don't have an answer." Staff B explained it wouldn't have been a problem for staff to call the agency nurse to perform the urgent dialysis treatment.

The agency contract was reviewed on 07/10/17 at 1:30 PM. Attachment 1 noted on call times and hourly rates. The attachment noted agency staff are on call Monday-Friday from 9:00 PM to 6:30 AM, Saturday from 5:00 PM to 6:30 AM, and Sunday from 6:30 PM to 06:30 AM.

Staff B was again interviewed at 3:45 PM and asked if facility Hemodialysis staff aren't required to work on Sundays, what happens if a patient needs hemodialysis between 06:30 AM and 6:30 PM on Sunday. Staff B reported the hours noted in the contract were typed in error. Staff B revealed although the hours don't reflect it, agency staff have been called in outside of the hours noted.

Staff B confirmed that there was an inadequate number of nurses on 06/15/17 to meet the needs of hemodialysis patients.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

Based on medical record review, facility policy review, staff interview and review of Hemodialysis machine daily maintenance logs, the facility failed to ensure dialysis staff bleached hemodialysis machines between patients that were positive for Hepatitis B and/or HIV and non positive patients potentially exposing five patients to Hepatitis B and HIV. The cumulative effect of this systemic practice resulted in the facility's inability to ensure infection control for all patients requiring acute dialysis services. The daily census for the Hemodialysis Unit was 17.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on medical record review, facility policy review, and staff interview, the facility failed to ensure dialysis staff bleached hemodialysis machines between patients that were positive for HIV and/or Hepatitis B and non Hepatitis B and non HIV patients potentially exposing five patients to Hepatitis B and HIV. This affected Patient #2, Patient #3, Patient #4, Patient #5, and Patient #7. The daily census for the Hemodialysis Unit was 17.

Findings include:

Review of the facility policy titled Environmental Cleaning in the Dialysis Unit on 06/30/17 at 10:00 AM revealed dialysis machines will be bleached after every Hepatitis B patient, after those with an unknown Hepatitis status or after those with HIV.

It was confirmed with Staff A and Staff B on 06/30/17 at 10:00 AM that a total of five patients were potentially exposed to Hepatitis B and/or HIV due to the dialysis machines not being bleached. It was further confirmed that every dialysis staff member, including contracted agency dialysis staff, are required to check a patient's laboratory results for their Hepatitis B and HIV status prior to administering a dialysis treatment.


1. Review of the medical record revealed Patient #1 presented to the Emergency Department on 05/27/17 at 11:14 PM with complaints of shortness of breath. A note on admission stated the patient told staff members he/she needed dialysis as it had been a week ago since his/her last hemodialysis treatment. Upon evaluation, the patient was found to be extremely tachypneic (abnormally fast or deep respirations), able to talk in short one word statements. The patient's respirations were noted to be in the 40's. The patient was also found to be hypoxic with an oxygen saturation of 70% on room air. The patient was intubated and transferred to the Medical Intensive Care Unit. A renal physician ordered the patient to receive a stat dialysis treatment at 01:38 AM. An agency dialysis nurse was notified of the ordered treatment. A physician's History and Physical noted the patient had a medical history of confirmed positive Hepatitis B surface antigen, Human Immunodeficiency Virus (HIV), and end stage renal disease. The laboratory history noted a positive HIV result in 04/08. The patient's laboratory results also noted a confirmed positive Hepatitis B surface antigen on 03/30/17 at 10:58 AM.

The pre-dialysis treatment data entered by the agency nurse noted the patient's Hepatitis surface antigen was unknown. The patient received a stat dialysis treatment from 03:30 AM to 07:05 AM on machine #225.

The Hemodialysis Unit Machine daily maintenance log for machine #225 was reviewed. A note in the comment section on 05/28/17 stated the machine needed to be bleached. The log noted that machine #225 was bleached by oncoming Hemodialysis staff.

A Hepatitis panel to determine the patient's Hepatitis B surface antigen status was drawn the morning of 05/29/17 by hemodialysis staff. The results revealed a confirmed positive Hepatitis B Surface Antigen at 10:31 AM. Despite the positive results, a hemodialysis nurse recorded in the patient's medical record at 1:06 PM that the patient was negative for Hepatitis B. The patient received his/her next dialysis treatment on machine #226 from 10:15 AM to 2:30 PM on 05/29/17 as ordered by a renal physician.

Review of the Hemodialysis Unit Machine daily maintenance log for machine #226 revealed the machine was not bleached.

2. Patient #2, a transfer from outside facility, received a dialysis treatment on 05/29/17 from 4:15 PM to 8:32 PM on the unbleached machine #226, potentially exposing Patient #2 to Hepatitis B.

The patient was discharged from the facility on 06/06/17. The medical record lacked documentation the patient was made aware of the possible exposure.

3. Patient #1 referenced above was dialyzed again on 05/30/17 at 9:30 AM on machine #228. The Hemodialysis Unit Machine daily maintenance log for machine #228 revealed the machine was not bleached.

4. Patient #3, admitted to the facility on 03/30/17 for a simultaneous liver and kidney transplant, received a dialysis treatment on 05/30/17 from 4:00 PM to 8:00 PM on machine #228. An attestation by the nephrology transplant attending physician on 06/09/17 noted the patient and his/her family were made aware of the possible exposure to Hepatitis B and the patient received a vaccination/immune globulin on 06/09/17.

5. Patient #4, also status post liver transplant on 12/25/16, was dialyzed on 05/31/17 from 10:15 AM to 1:10 PM on machine #228. The patient was discharged to another facility on 06/09/17. An addendum by the Hemodialysis Medical Director on 06/30/17, stated he/she spoke with the patient's case manager about the patient's potential exposure to Hepatitis B.

6. Patient #5, admitted to the facility on 05/15/17 with altered mental status, also received a dialysis treatment on 05/31/17 from 4:00 PM to 7:55 PM on machine #228.

Staff D was interviewed on 06/30/17 at 10:00 AM about the patient with the potential exposure to HIV. Staff D reported being unaware of the details of the incident but provided the name of the charge nurse that discovered the potential exposure (Staff E).

Staff E was interviewed on 06/30/17 at 11:45 AM. Staff E recalled being in charge of the Hemodialysis Unit on 06/03/17. Staff E reported always checking to see if any dialysis treatments took place during the night. Staff E stated, "I'm not saying there is anything wrong with the agency nurses but I like to check after they have given treatments just to make sure everything was okay." Staff E further described noting the patient dialyzed overnight being HIV positive. Staff E reported looking at the maintenance log for the machine the HIV patient was dialyzed on and noticing the machine had not been bleached. Staff E stated: "I saw the machine hadn't been bleached and a new patient was currently dialyzing on the same machine. It was too late to do anything." Staff E reported calling the agency nurse at home. When probed about the patient's HIV status the agency nurse admitted forgetting to check the patient's HIV status.

7. Patient #6 presented to the Emergency Department on 06/02/17 at 2:48 PM after being transferred from a local children's hospital with altered mental status. A nursing note at 4:23 PM stated a staff member from the children's hospital called to inform Emergency Department staff of a critical lab value ammonia of 401. The patient was intubated and admitted to the Medical Intensive Care Unit at 10:57 PM. A physician's History and Physical noted the patient was positive for HIV since 06/09. It was further noted the patient was diagnosed with acute renal failure. The patient was dialyzed on machine #229 for three hours as ordered by a renal physician.

8. Patient #7, a transplant patient, received a dialysis treatment on machine #229 at 07:30 AM. The medical record revealed the patient was informed of the possible exposure to HIV and the patient was ordered to receive 28 days of treatment.