HospitalInspections.org

Based on interview and record review, the facility failed to develop, implement and maintain a quality assessment and improvement program that included the hospital's dialysis unit, resulting in failure to identify and correct gaps in the provision of comprehensive care for all dialysis patients served by the facility. Findings include:
See specific Tags:

A - 0308 Failed to comprehensively evaluate the performance of the Dialysis Contractor, failed to identify gaps in the provision of care for patients receiving dialysis in the facility, and failed to identify the scope of services provided by the dialysis contractor.

Based on interview and record review, the facility failed to comprehensively evaluate the performance of the Dialysis Contractor, failed to identify gaps in the provision of care for patients receiving dialysis in the facility, and failed to identify that the scope of services provided by the dialysis contractor did not meet facility expectations, resulting in the potential for less than optimal outcomes and the potential for missed care needs for all patients receiving dialysis in the facility including the potential transmission of Hepatitis B (HBV) infection to two (#13 and #14) exposed patients. Findings include:

On 10/10/18 at approximately 0930, Patient #1's inpatient dialysis treatment records were reviewed and revealed the inpatient Dialysis Unit staff did not follow the facility infection control policy for isolation of HBV positive patients or patients whose HBV status was unknown during dialysis treatment. (See A 0749.) They did not dialyze Patient #1 in isolation on 6/22/18 (first treatment) or on Patient #1's second treatment on 6/23/18 per the facility Infection Control policy for patients with unknown or positive HBV infection status. Patient #1's first Hepatitis B (HBV) positive laboratory result was an out-patient lab done at the facility on 3/27/18. A HBV laboratory test drawn on the day of Patient #1's first inpatient dialysis treatment on 6/22/18 was reported positive on 6/23/18. Patient #1 received two dialysis treatments in the main room with no isolation precautions, exposing two patients (#13 and #14) with unknown immunity status to possible HBV infection.

On 10/10/18 at approximately 1030 the Regional Administrator for the facility's dialysis contractor Staff V was interviewed and reported that his company's contract contract with the facility was to do dialysis treatments on a fee per treatment basis, and the responsibility for the inpatient dialysis unit belonged to the hospital.

On 10/10/18 at approximately 1045 the Chief Nursing Officer (CNO) Staff C and the Medical Director Staff A were questioned regarding the inpatient dialysis unit and both individually reported that they did not believe that the facility contract with the Dialysis provider was limited to simply providing dialysis treatments. Staff A and Staff C both reported that they believed that the contractor was responsible for the supervision, management and quality control of the dialysis unit and nursing care related to End Stage Renal Disease (ESRD). Staff A reported that inpatient dialysis was an "outsourced function".

On 10/11/18 at approximately 1000, the facility contract with the dialysis contractor was reviewed and revealed the title of the document was misleading. The contract was titled, "Outsourced Dialysis" and was dated 11/1/10. Contract language in the body of the contract was not clear as to the scope of services provided in the agreement, but referred to Appendix A. Appendix A delineated that the scope of services provided was limited to performance of dialysis treatments only, with a flat rate fee per treatment specified. The contract was renewed yearly since 1/11/10.

On 10/11/18 at approximately 1010, the Medical Director Staff A, the Regulatory Program Lead Staff B, the Chief Nursing Officer (CNO) Staff C and the Director of Nursing Staff F were interviewed and all stated that they did not realize that the services provided per the contract with the dialysis contractor were limited to performing the dialysis treatments on a fee per treatment basis. They all stated that they were surprised to learn that supervision and management of the dialysis unit and integrated care of the dialysis patient were the hospital's responsibility.

On 10/11/18 at approximately 1020, the facility Quality Assessment and Performance Improvement (QAPI) program and committee meeting minutes for 2017 and 2018 were reviewed with the Medical Director Staff A, the Regulatory Program Lead Staff B, the Chief Nursing Officer (CNO) Staff C and the Director of Nursing Staff F. There was no documentation that quality indicators for evaluating the performance of the facility's contracted dialysis provider were identified or that the contractor's performance was evaluated. Hospital monitoring of water quality provided by the hospital to the dialysis unit and environmental rounds (audits of environment) done twice yearly were the only things discussed regarding the dialysis unit in the QAPI meetings reviewed. There were no quality performance improvement projects related to the dialysis unit. There was no discussion documented or notation of any evaluation of the dialysis contractor's performance.

On 10/11/18 at approximately 1200, Staff A reported that he had reviewed QAPI and Medical Executive committee minutes since 2014 and had not found any additional documentation. Staff A reported that the contract with the dialysis contractor had been signed by the hospital's parent corporate office and the previous Chief Operating Officer, and the current administration had not reviewed the contract appendices and noted the limits of the scope of provided services in the contract.

Based on interview and record review the facility failed to provide organized nursing services with nursing supervision and oversight of the dialysis unit, failed to have facility policies and procedures for nursing care of dialysis patients, and failed to implement the nursing process of identifying and responding to patient needs through assessment, care planning and documentation for patients with end stage renal disease receiving dialysis in the facility, resulting in the potential for unmet care needs and less than optimal outcomes for all 22 patients receiving dialysis in the facility. Findings include:

See specific Tags:

A 0386 - The facility failed to incorporate the inpatient dialysis unit into nursing organizational structure and identify nursing administrative authority and responsibility for the dialysis unit, and failed to develop, approve and implement nursing patient care policies and procedures for end stage renal disease and dialysis.

A 0396 - The facility failed to assess care needs related to end stage renal disease and dialysis treatment and develop and implement comprehensive nursing care plans

A 0398 - The Director of Nursing Service failed to provide supervision and performance evaluation of the non-employee nursing personnel in the dialysis unit.

Based on interview and record review, the facility failed to incorporate the inpatient dialysis unit into nursing organizational structure and identify nursing administrative authority and responsibility for the dialysis unit, and failed to develop, approve and implement nursing patient care policies and procedures for end stage renal disease and dialysis, resulting in the potential for less than optimal outcomes and missed care needs for all 22 patients receiving dialysis in the facility. Findings include:

On 10/11/18 at approximately 1000, the facility contract with the dialysis contractor was reviewed and revealed the scope of services provided was limited to performance of dialysis treatments only, with a flat rate fee per treatment specified.

On 10/11/18 at approximately 1010, the Chief Nursing Officer (CNO) Staff C and the Director of Nursing Staff F were interviewed and both stated that they did not realize that the contract with the dialysis contractor specified that the contractor only did dialysis treatments and nothing more. They all stated that they were surprised to learn that supervision and management of the dialysis unit and integrated care of the dialysis patient were the hospital's responsibility.

On 10/11/18 at approximately 1015 Staff C and Staff F were requested to provide documentation of Nursing management oversight by the facility, Nursing policies and procedures for patient care in the dialysis unit, Nursing policies and procedures for care of the patient with End Stage Renal Disease (ESRD) and documentation of administrative authority for the dialysis unit. Staff B and Staff F stated that there was no nursing management oversight or administrative authority done for the inpatient dialysis unit at this point because the facility management team was unaware that the dialysis unit was not an outsourced independent site, and not merely a hospital unit with contracted staff and equipment. When queried, Staff C and Staff F stated that the facility had or policies or procedures for the dialysis unit or for patients with ESRD because they believed the outsourced contractor was responsible for these. The only facility policy relating to ESRD was an Infection Control Policy, which was not consistently implemented (see A-0747) and there was no documentation that the facility conducted audits or monitoring of it's implementation in the dialysis unit.

Based on interview and record review the facility failed to assess care needs related to end stage renal disease and dialysis treatment and develop and implement comprehensive nursing care plans for six (#1, #5, #12, #13, #14, #15) of six dialysis patients reviewed out of a total of 22 patients receiving inpatient dialysis in the facility, resulting in the potential for unmet car needs and less than optimal outcomes for all 22 patients receiving dialysis in the facility. Findings include:

On 10/9/18 at approximately 1030 Patient #5's clinical record was reviewed with the Director of Nursing Staff F and revealed the following information: Patient #5 was a 74 year old female who was admitted to the facility on 10/1/18 with diagnoses including Acute Pulmonary Edema, End Stage Renal Disease (ESRD) and Hemodialysis. There were no Nursing assessments of care needs related to ESRD or dialysis, and no Nursing Care Plans or interventions for monitoring for or treatment of side effects and adverse events related to hemodialysis or alterations in health status related to ESRD.

On 10/10/18 at approximately 0930 Patient #1's clinical record was reviewed with the Director of Nursing (DON) Staff F and revealed the following information: Patient #1 was a 58 year old male who was admitted on 6/21/18 and discharged on 7/1/18. diagnoses included Human Immunodeficiency Virus (HIV)Infection, Acquired Immunodeficiency Syndrome (AIDS), End Stage Renal Disease (ESRD) with hemodialysis, Non-Hodgkin's Lymphoma, Neutropenia (white blood cell deficiency), Hypertension (HTN) and Epigastric Pain. An outpatient laboratory test result (lab) dated 3/27/18 and an inpatient lab result reported on 6/23/18 documented that Patient #1 had an Hepatitis B infection. Patient #1 Started Hemodialysis in the facility's inpatient dialysis unit on 6/22/18. Patient #1 had five hemodialysis treatments in the facility, on 6/22/18, 6/23/18, 6/26/18, 6/28/18 and on 6/30/18. Review of nursing care plans revealed no Nursing Assessments of care needs related to ESRD or dialysis, and no Nursing Care Plans or interventions for monitoring for or treatment of side effects and adverse events related to hemodialysis or alterations in health status related to ESRD. There were no nursing care plans for isolation during dialysis related to Hepatitis B (HBV) infection or for discharge planning for a patient with HBV infection on Hemodialysis.

On 10/10/18 at 1045 Patient #13's clinical record was reviewed with Staff F and revealed the following information: Patient #13 was a 66 year old female who was admitted on 7/2/18 with diagnoses which included ESRD and Hemodialysis. There were no care plans or Nursing Assessments of care needs related to dialysis.

On 10/10/18 at approximately 1100 Patient #14's clinical record was reviewed with Staff F and revealed the patient received dialysis treatment in the facility during June 2018 and had diagnoses which included ESRD and Dialysis. There were no care plans or Nursing Assessments of care needs related to dialysis.

On 10/11/18 at approximately 1120 Patient #12's clinical record was reviewed with Staff F and revealed the following information: Patient #12 was a 76 year old female who was admitted on 10/ 9 18 with diagnoses including Osteomyelitis of the left heel with Methicillin Resistant Staphylococcus aureus (MRSA - an antibiotic resistant germ), ESRD and Hemodialysis. There were no nursing assessments of care needs related to ESRD or dialysis, or Nursing care plans related to ESRD or Dialysis.

On 10/11/18 at approximately 1140 Patient #15's clinical record was reviewed with Staff F and revealed the following information: Patient #15 was a 85 year old male who was admitted into the facility on 10/08/18 with diagnoses which included acute on chronic ESRD. Patient #15 started hemodialysis in the facility on 10/10/18. There were no Nursing assessments or Nursing Care Plans related to Hemodialysis.

On 10/11/18 at approximately 1010, the Chief Nursing Officer (CNO) Staff C and the Director of Nursing Staff F were interviewed and stated that the facility had assumed that the inpatient dialysis unit was an independent outsourced entity and as such was responsible for assessing nursing care needs related to ESRD and Dialysis and creating Dialysis and ESRD related Nursing Care Plans and interventions. Staff C stated that now that the facility knew that the dialysis unit was actually an inpatient hospital unit under the hospital's authority, oversight and management, the hospital Nursing department would take responsibility for developing and implementing comprehensive individualized care plans that included ESRD and dialysis care problems and needs.

Based on interview and record review the Director of Nursing Service failed to provide supervision and performance evaluation of the non-employee nursing personnel in the dialysis unit, resulting in the potential for missed opportunities to improve quality of care for all 22 patients receiving dialysis in the facility. Findings include:

On 10/11/18 at approximately 1010, the Chief Nursing Officer (CNO) Staff C and the Director of Nursing Staff F were interviewed and both stated that they did not realize that the contract with the dialysis contractor specified that the contractor only did dialysis treatments and nothing more. They all stated that they were surprised to learn that supervision and management of the dialysis unit and integrated care of the dialysis patient were the hospital's responsibility. Staff C reported that the facility Nursing Department did not provide supervision and performance evaluation of the contracted nursing personnel in the dialysis unit because they had believed that the inpatient dialysis unit was an independent outsourced entity. Staff C reported that there was no Nurse Manager or facility Nursing Supervisor in charge of the inpatient dialysis unit.

Based on observation, interview and record review, the facility failed to ensure staff adhered to infection control policies and failed to ensure that a sanitary environment was provided in the dialysis unit resulting in the potential for transmission of infections to all patients receiving dialysis. See specific tags:

- A 0749 - Failed to ensure that facility isolation policies were followed for two of four current inpatients on contact isolation precautions and one of one patients with hepatitis B infection on hemodialysis

Based on observation, interview and record review, the facility failed to ensure that facility isolation precautions were consistently followed for two of four current patients (#4 and #12) observed in contact isolation,and for one of one patients (#1) with Hepatitis B infection reviewed for Hepatitis B isolation during Hemodialysis, resulting in the potential transmission of infection to patients cared for by the staff involved and the potential for transmission of Hepatitis B infection to two discharged patients (#13 and #14) who were exposed to Patient #1 during dialysis treatment. Findings include:

On 10/9/18 from approximately 1030 to 1045 during an observation of Patient #4, contracted Hospice Nurse Staff O was observed in Patient #4's room with no protective gown or gloves (PPE - Personal Protective Equipment). A sign on the door of Patient #4's room identified that contact isolation precautions were necessary when entering the room. A cabinet with personal protective equipment (PPE) was located just outside the door of Patient #4's room.

On 10/9/18 at approximately 1040 Respiratory Therapist Staff N entered Patient #4's room without wearing a protective gown and disconnected Patient #4's breathing treatment and listened to the patient's lungs. Staff N was then interviewed after she left Patient #4's room at approximately 1043. Staff N said, "I don't touch anything when I take off a mask so I don't usually gown."

On 10/9/18 at approximately 1045 the Chief Nursing Officer Staff B was interviewed and stated, "I can't even speak to that." Review of Patient #4's clinical record at this time revealed Patient #4 was a 67 year old female who was admitted on 9/28/18 with a diagnosis of pneumonia and respiratory failure and history of cellulitis.

On 10/9/18 at approximately 1430 Staff B reported that he spoke to Patient #4's Hospice Nurse Staff O regarding her failure to wear PPE in a contact isolation room. Staff B said that when he asked Staff O why she didn't wear any gown or gloves in a contact isolation room he, "didn't like her answer."

On 10/9/18 at approximately 1530 during an observation of a dressing change on Patient #12's infected left heel wound by Staff Nurse T, Surgical Resident Physician Staff U entered Patient #12's room without a personal protective gown or gloves. A sign on the door of Patient #12's room identified that contact isolation precautions were necessary when entering the room. A cabinet with PPE was located just outside the door of Patient #4's room. Staff U was redirected by Staff C to leave the room and apply PPE before reentering. Staff U reentered Patient #12's room and notified patient #12 that her heel infection was not responding to antibiotics so she was scheduled for surgery the next day to have her leg removed below the knee (BKA).

On 10/9/18 at approximately 1600 Patient #12's clinical record was reviewed with Staff F and revealed the following information. Patient #12 was admitted into the facility on 10/9/18 with diagnoses which included left heel osteomyelitis with a multidrug resistant microorganism. Isolation precautions were ordered on admission.

On 10/10/18 at approximately 1100 the facility Infection Control Lead Staff D was interviewed and reported that gown and gloves were required before entering a room with contact isolation precautions. Staff D reported that staff including resident physicians were inserviced (educated) yearly on infection control and isolation precautions. Training records for Staff N, Staff O, and Staff U were reviewed and documented that they were educated on isolation precautions and PPE within the past 12 months.

On 10/10/18 at approximately 0930, Patient #1's clinical record was reviewed with the Chief Nursing Officer (CNO) Staff C and the Director of Nursing (DON) Staff F and the following information was revealed:

Patient #1 was a 58 year old male who was admitted on 6/21/18 and discharged on 7/1/18. Diagnoses included Human Immunodeficiency Virus (HIV)Infection, Acquired Immunodeficiency Syndrome (AIDS), End Stage Renal Disease (ESRD) with Hemodialysis, Non-Hodgkin's Lymphoma (cancer of the white blood cells), Neutropenia (white blood cell deficiency), Hypertension (HTN) and Epigastric Pain.

Patient #1's first Hepatitis B (HBV) positive laboratory result was an out-patient lab done at the facility on 3/27/18 and was ordered by Consultant Nephrologist Staff BB. Results indicated that Patient #1 had no antibodies (immunity) to HBV and was infected with the Hepatitis B virus. (HBV antigen positive). There is no indication that Staff BB ever followed up to see the results of the lab test he ordered. Patient #1 was not admitted to the facility during this time.

Patient #1 had an HBV lab test panel drawn on 6/22/18 (the first day of dialysis treatment in the facility). The test was ordered by Staff AA who was the patient's nephrologist. Staff AA stated that he was unaware of the results, which were available on the hospital electronic system on 6/23/18 at approximately 1023.

Physician progress notes from Patient #1's attending physician (Hospitalist) and his Infectious Disease Physicians (Staff Y and Staff Z) revealed they were aware that Patient #1 was infected with HBV on admission on 6/22/18. There was no documentation that they reported this to the Dialysis Unit or to the Infection Control Department. Staff Y documented on 6/22/18 that he discussed this with Patient #1's nephrologist Staff AA.

Review of the inpatient dialysis treatment records revealed Dialysis Unit staff did not follow the infection control policy. They did not dialyze Patient #1 in isolation on 6/22/18 (first treatment) or on Patient #1's second treatment on 6/23/18 per the facility Infection Control policy. Patient #1's laboratory results were posted 2 hours after Patient #1's second treatment. Patient #1 was dialyzed in isolation for the rest of his admission.

On 10/11/18 at approximately 0900 review of the dialysis treatment schedule for 6/22/18 and 6/23/18 revealed two patients (#13, #14) were exposed to Patient #1 during dialysis on these dates. Review of clinical records for these two patients revealed they were not tested for immunity (successful vaccination) to HBV infection.

On 10/10/18 at approximately 1230 Consultant Nephrologist Staff BB was interviewed and said that he could not remember Patient #1. Staff BB stated that he expected the lab to call him for abnormal test results. The facility medical Director Staff A who was present during this interview reported that HBV infection was not on the list of critical lab values that required the lab to telephone the physician. Staff A stated that physicians were responsible for checking the results of tests they ordered.

On 10/10/18 at approximately 1530 Patient #1's nephrologist Staff AA was interviewed by telephone and said that Staff Y never told him that Patient #1 was HBV positive. Staff AA was asked if he remembered ordering the HBV lab test for Patient #1. Staff AA stated that he expected to be notified of any significant abnormal lab test results. Staff AA reported that Patient #1 had exposed the other patients in the Dialysis Unit to HBV infection and they would need HBV post exposure testing and follow-up for six months. Staff AA said that it was a serious breach of infection control protocol not to dialyze a HBV positive patient in isolation.

On 10/11/18 at approximately 0830 Staff A, Staff C, Staff D (infection Prevention lead) and Staff F were interviewed and stated that they did not know that there was a violation of their isolation policy in the Dialysis Unit until it was brought to their attention during survey. They were unaware that an HBV positive patient was dialyzed in the main dialysis room (not in isolation) exposing two other patients.

On 10/11/18 at approximately 0835 the facility Infection Control Policy (revised 01/2016) was reviewed and revealed the following statements relating to isolation of patients with HBV infection in the inpatient Dialysis Unit:

"Hepatitis B (HBV) serological status of all patients is known before admission into the dialysis unit and is readily available to caregivers in the medical record."

"Patients with unknown or positive HBV status will have their treatment completed in a private room. A dedicated room is available for isolation."

"Machines used for treatment on an HBV positive or unknown patient are cleaned after each treatment, including internal circuits. When the machine is no longer dedicated to an HBV positive patient, internal pathways of the machine are disinfected, external surfaces cleaned and disinfected, and the machine returned to general use."

Based on interview and record review, the facility failed to ensure that the discharge planning process provided communication and coordination of care with post-discharge providers for one (#1) of one Hepatitis B positive dialysis patients reviewed for discharge planning out of a total of 22 dialysis patients in the facility.
See specific tags:

A 0837 - Failure to provide necessary information on communicable disease infection to a post discharge dialysis provider

Based on interview and record review the facility failed to provide necessary information on communicable disease infection to a post discharge dialysis provider for one (#1) of one Hepatitis B positive Hemodialysis patients reviewed for discharge planning out of a total of 22 patients receiving inpatient dialysis in the facility, resulting in exposure to Hepatitis B infection of an unknown number of patients in the post-discharge dialysis unit. Findings include:

On 10/10/18 at approximately 0930, Patient #1's clinical record was reviewed with the Chief Nursing Officer (CNO) Staff B and the Director of Nursing (DON) Staff F and the following information was revealed:

Patient #1 was a 58 year old male who was admitted on 6/21/18 and discharged on 7/1/18. Diagnoses included Human Immunodeficiency Virus (HIV)Infection, Acquired Immunodeficiency Syndrome (AIDS), End Stage Renal Disease (ESRD) with Hemodialysis, Non-Hodgkin's Lymphoma (cancer of the white blood cells), Neutropenia (white blood cell deficiency), Hypertension (HTN) and Epigastric Pain.

Patient #1 had an Hepatitis B (HBV) laboratory (lab) test panel drawn on 6/22/18 which was reported as positive for Hepatitis B infection (HBV positive) on 6/23/18.

Physician progress notes from Patient #1's attending physician (Hospitalist) and his Infectious Disease Physicians (Staff Y and Staff Z) revealed they were aware that Patient #1 was infected with HBV on admission on 6/22/18. Patient #1's laboratory results were posted 2 hours after Patient #1's second inpatient dialysis treatment. Patient #1 was dialyzed in isolation for the rest of his admission.

Discharge instructions ("Clinical Summary") provided to Patient #1 at discharge on 7/1/18 and labeled "for your doctors" documented that Patient #1's diagnoses in hospital included AIDS, HIV infection, Urinary tract Infection, ESRD, Cholelithiasis (gallstones) and Non-Hodgkin's Lymphoma. There was no mention of HBV infection included in the discharge Clinical Summary diagnoses. Hospital Laboratory results listed in the discharge "Clinical Summary" included blood cell count results, blood clotting profile results and blood electrolyte results. There were no HBV results listed.

On 10/10/18 at approximately 1120 Case Management discharge planning notes from 6/22/18 through 7/1/18 were reviewed with the director of Outcomes Management (discharge planning) Staff G. Case management notes documented that Case Management staff were aware that Patient #1 tested positive for HBV infection during admission, but this was not reflected in the discharge plan or in his assessed discharge needs. Staff G was unable to provide documentation of any communication between the facility and the post discharge dialysis facility regarding Patient #1's hospital admission and his status at discharge. Review of the facility Policy on discharge planning revealed that instructions for communicating with post-discharge facilities only included skilled care facilities and rehabilitation facilities and did not include dialysis facilities.

On 10/10/18 at approximately 1530 Patient #1's nephrologist Staff AA was interviewed by telephone and said that the facility never told him that Patient #1 was HBV positive and that discharge paperwork and discharge instructions given to Patient #1 at discharge did not note that he was infected with HBV. Staff AA reported that Patient #1 had exposed the other patients in the Dialysis Unit to HBV infection and they would need HBV post exposure testing and follow-up for six months. Staff AA said that it was a serious breach of infection control protocol not to dialyze a HBV positive patient in isolation.

On 10/11/18 at approximately 0830 Staff A, Staff B, Staff D (infection Prevention lead) and Staff F were interviewed and provided documentation to prove that Patient #1's HBV infection was reported to the county health department on 6/29/18, but were unable to provide any documentation to indicate that Patient #1's post-discharge dialysis facility was notified.