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Based on a review of facility policy, review of medical record (MR), and interview with staff (EMP), it was determined that Croser-Chester Medical Center failed to follow their policy that require all patients be informed of their patient rights in advance of providing care for two of two medical records reviewed (MR1 & MR2).

Findings include:

Administrative Policy and Procedure, ADM-2E, Patient Rights and Responsibilities, last reviewed February 2016 revealed, "... Crozer-Keystone Health System (CKHS) is committed to notifying and educating our patients about their rights and responsibilities in order to deliver the highest quality of care in a transparent, collaborative setting. CKHS will display these rights and responsibilities in appropriate patient access and care areas and provide them to patients routinely. ... . Your Rights... 2. You have the right to be informed of your rights as a patient at the earliest appropriate time in the course of your hospitalization. ... . "

Review of MR1 and MR2 failed to reveal documented evidence that either patient had been given a copy of, or were informed of their Patient Bill of Rights during their inpatient admission.

An interview on January 12, 2017, at 10:00 AM with EMP4 and EMP5 confirmed that neither MR1 or MR2 contained any documentation that the patient had received a copy of their Patient Rights or were informed of their rights prior to receiving care.


An interview was conducted on January 12, 2017, at 1:40 PM with EMP6 confirmed that prior to providing care all patients are not given a copy of their Patient Rights. EMP6 also confirmed that the consent for treatment that all patients sign does not contain a statement that the patient was informed of their rights prior to receiving care.

An interview conducted on January 12, 2017, at 2:50 PM with EMP25 revealed that they did not provide patients with a copy of the Patient Rights when they register for Emergency Department services. Further interview revealed that EMP25 did not know where to obtain a copy if a patient would request a copy.

An interview conducted on January 12, 2017, at 3:00 PM with EMP27 in the Emergency Department revealed that they did not know where to get a copy of the Patient Rights if a patient requested a copy. EMP27 stated the patients are informed of their rights at Registration.


An interview conducted on January 12, 2017, at 3:10 PM with EMP1 confirmed that the facility did not have a process in place to provide outpatients with a copy of the Patient Rights prior to providing care. EMP1 also confirmed that no where in either inpatient or outpatient medical records was there documentation that patients were informed of their Patient Rights prior to receiving care.

Based on a review of facility policy, Personnel Files (PF), and interview with staff (EMP), it was determined that Crozer-Chester medical Center facility failed to ensure that Nursing staff participating in endoscopy procedures outside of the Endoscopy Suite were competent with endoscope use and disinfection for one of two Personnel Files reviewed (PF1).


Findings include:

A review of Infection Prevention & Control policy, Cleaning, Disinfection & Sterilization, last reviewed January 2016 revealed, "Crozer Keystone Health System Hospitals (CKHS) will appropriately clean, disinfect, and sterilize, when appropriate, all instruments, medical devices, and patient care equipment by approved methods published in established guidelines and in compliance with manufacturer's recommendations. ... . Semi-Critical Items: 1. Items that come into contact with mucous membranes or skin that is not intact; e.g. respiratory therapy and anesthesia equipment, endoscopes ... . 3. Semi-critical items require high-level disinfection. ... ."

An interview was conducted on January 12, 2017, at 11:15 AM with EMP3. EMP3 stated that they rely on nurses to verbalize if they have questions or concerns after being precepted. EMP3 confirmed that EMP12 was precepted by an OR Nurse with competencies for endoscope use and pre-cleaning during the first two PEG procedures that EMP12 assisted with. EMP3 stated that EMP12 did not verbalize any concerns during any of the eight PEG cases they assisted with and was found to handle the endoscope properly.


A review of PF1 revealed EMP12 was hired in May 2016 and had completed orientation for surgical procedures, which included assisting in PEG tube procedures. No documentation was found that EMP12 had competencies with endoscope use and cleaning. The Operating Room Nurse - Job Description revealed, "... prepares instruments/supplies for sterilization. ... ."



A telephone interview was conducted on January 17, 2017, at 3:00 PM with EMP12. EMP12 revealed they did not know that an endoscope could not be reused if it had only been pre-cleaned and did not understand that it required high level disinfection before reuse. EMP12 confirmed that they had been shown by a nurse preceptor the process for pre-cleaning the endoscopes and placing them in containers for return to Endoscopy during the first few PEG cases they assisted with, but that was the extent of their scope training. EMP12 stated they were not aware that additional scopes could be obtained from the Endoscopy Suite. EMP12 stated they never really felt competent with scope handling, even though they had done this several times on other PEG cases prior to January 7, 2017.

Based on a review of facility documents, Medical Records (MR) and interviews with staff (EMP) it was determined that Crozer Chester Medical Center failed to maintain a sanitary environment to avoid sources and transmission of infectious and communicable diseases by failing to follow their adopted policies for disinfecting endoscopes prior to reuse for one of two medical records reviewed (MR1 & MR2).

Findings:

Review of Infection Prevention & Control - Scope of Services revealed, "The Crozer-Keystone System has instituted an Infection Prevention & Control Program, which is part of a system-wide plan of continual improvement. The programs intent is to identify, prevent, control and reduce the incidence of nosocomial infections. The Crozer-Keystone System supports these activities, and provides the necessary resources to accomplish this undertaking. Crozer-Chester Medical Center/Springfield, Staffing - 1 FTE 1.0 Coordinator, Infection Preventionist. .... . Infection control policies & procedures reviewed at a minimum annually or as needed. ... Duties ... Perform annual risk assessment; yearly planning ... Consultation, evaluation & monitoring as appropriate for cleaning, disinfecting, sanitation & disposal products & processes ... The objectives of the Infection Prevention & Control Program are: ... To establish methods to monitor, evaluate and minimize the risk of transmission of infection to all patients, visitors and personnel. ... To preserve an active collaborative association with other departments in the Crozer Keystone Healthcare System. The goal of the Infection Prevention & Control Program is to insure a safe, healthy environment for all patients, employees, students, volunteers and visitors. This is accomplished through surveillance activities, isolation precautions, written infection control policies, continual staff education, and interaction with the Employee Health Department to establish appropriate treatment and prophylaxis protocols for employees. ... . Specified communicable diseases are reported to appropriate agencies. The infection Control Department adheres to all laws, standards, regulations and recommendations issued by federal, state and local authorities as well as other accrediting agencies. These include but are not limited to: CDC, NHSN, Joint Commission, OSHA, APIC, PA Dept. of Environmental Resources, PA State Health Dept., Healthcare Facilities Accreditation Program, PA Patient Safety Authority, Society for Healthcare Epidemiology of America. ... ."

Review of Infection Prevention and Control Authority Statement, effective January 1, 2016, revealed, "The Infection Prevention & Control Committee (1) shall have the authority to institute any appropriate control measures or studies when there is reasonably perceived danger to patients or personnel. All members of the medical or nursing staff are encouraged to alert the Infection Prevention & Control Department when issues relevant to hospital epidemiologies are perceived. Indicated surveillance modalities are to be directed through the auspices of the Infection Prevention & Control Department when issues relevant to hospital epidemiologies are perceived. Indicated surveillance modalities are to be directed through the auspices of the Infection Prevention & Control Department when issues relevant to hospital epidemiology are perceived. If a problem is identified, all individuals directly involved on a medical or nursing administrative level must be consulted as part of the solving team. Appropriate administrative and medical personnel must be contacted after appropriate actions have been determined (2) Final authority for implementation of these measures rests with the Epidemiology Service and the Chairman of the Infection Control Committee. ... ."

Review with EMP21 of the facility's 2016 Infection Prevention & Control Reporting Mechanisms and Modes revealed, "Surveillance Data Measured: Active Surveillance Testing Program for Methicillin-resistant Staphylococcus aureus (MRSA), Clostridium Difficile (c. diff), NHSN Defined Ventilator Associated Pneumonia (VAE), NHSN Defined Central Line Associated Blood Stream Infection (CLA-BSI), HNSN Defined Foley Associated Urinary Tract Infection, NHSN Defined Surgical Site Infections, Focused Surveillance for: Burn Treatment Center All organisms, Clusters, Hand Hygiene."

A review of Infection Prevention & Control policy, Cleaning, Disinfection & Sterilization, last reviewed January 2016 revealed, "Crozer Keystone Health System Hospitals (CKHS) will appropriately clean, disinfect, and sterilize, when appropriate, all instruments, medical devices, and patient care equipment by approved methods published in established guidelines and in compliance with manufacturer's recommendations. ... . Semi-Critical Items: 1. Items that come into contact with mucous membranes or skin that is not intact; e.g. respiratory therapy and anesthesia equipment, endoscopes ... . 3. Semi-critical items require high-level disinfection. ... ."

An interview was conducted on January 12, 2017, at 11:00 AM with EMP13. EMP13 revealed that they functioned as the circulating nurse during the first patient's procedure on January 7, 2017, and had placed the soiled endoscope in the white container designated for soiled scopes, and that EMP12 was present and observed this. EMP13 stated that EMP12 was the circulating nurse during second patient's case and called EMP13 into the OR to assist as the irrigation portion of the endoscope was not working. EMP13 found it was missing a cap and fixed it and left the OR. EMP13 stated that EMP12 did not ask for any further additional assistance. EMP13 stated that they did not observe EMP12 take the dirty scope from the soiled container for use it in the second patient's case. At the end of the second patient's case when EMP13 and EMP15 relieved EMP12, they found two dirty scopes in the OR. EMP13 confirmed with EMP12 at that time that when the 2nd scope continued to have functional issues, EMP12 had used the dirty endoscope from the first patient on the second patient. EMP13 confirmed that EMP12 did not follow facility policy for proper disinfection of the endoscope before reuse.


A telephone interview was conducted with EMP12 on January 17, 2017, at 3:00 PM. EMP12 confirmed that on January 7, 2017, during the second patient's case, EMP10 continued to have difficulty with the endoscope and requested another scope. EMP12 stated they were not aware that additional endoscopes were available in the Endoscopy Suite, so they pre-cleaned the endoscope that had been used for the first patient's case and brought it to EMP10 who used it to complete the second patient's case. EMP12 also stated that they did not know that you could not reuse an endoscope if it was only pre-cleaned and did not understand what was involved in the high level disinfection process.

An interview conducted on January 12, 2017, at 3:10 PM with EMP21 revealed that, prior to the incident on January 7, no issues had been identified related to Operating Suite nursing staff inappropriately reusing scopes that had not received the required high level disinfection and therefore, no surveillance measures were in place at that time related to this issue. EMP21 confirmed that after review of MR1 and MR2 and interview with EMP12 it was confirmed that EMP12 did not follow the facility policy that required high level disinfection prior to using the dirty scope on the second patient on January 7, 2017.

Based on a review of facility policy, medical record (MR) and interview with staff (EMP), it was determined that Crozer-Chester Medical Center failed to follow their adopted policies for disinfecting endoscopes prior to reuse for one of two medical records reviewed (MR1 & MR2).

Findings include:

A review of Infection Prevention & Control policy, Cleaning, Disinfection & Sterilization, last reviewed January 2016 revealed, "Crozer Keystone Health System Hospitals (CKHS) will appropriately clean, disinfect, and sterilize, when appropriate, all instruments, medical devices, and patient care equipment by approved methods published in established guidelines and in compliance with manufacturer's recommendations. ... . Semi-Critical Items: 1. Items that come into contact with mucous membranes or skin that is not intact; e.g. respiratory therapy and anesthesia equipment, endoscopes ... . 3. Semi-critical items require high-level disinfection. ... ."

An interview was conducted on January 12, 2017, at 11:00 AM with EMP13. EMP13 revealed that they functioned as the circulating nurse during the first patient's procedure on January 7, 2017, and had placed the soiled endoscope in the white container designated for soiled scopes, and that EMP12 was present and observed this. EMP13 stated that EMP12 was the circulating nurse during second patient's case and called EMP13 into the OR to assist as the irrigation portion of the endoscope was not working. EMP13 found it was missing a cap and fixed it and left the OR. EMP13 stated that EMP12 did not ask for any further additional assistance. EMP13 stated that they did not observe EMP12 take the dirty scope from the soiled container for use it in the second patient's case. At the end of the second patient's case when EMP13 and EMP15 relieved EMP12, they found two dirty scopes in the OR. EMP13 confirmed with EMP12 at that time that when the 2nd scope continued to have functional issues, EMP12 had used the dirty endoscope from the first patient on the second patient. EMP13 confirmed that EMP12 did not follow facility policy for proper disinfection of the endoscope before reuse.

An interview conducted on January 12, 2017, at 3:10 PM with EMP21 confirmed that after review of MR1 and MR2 and interview with EMP12 it was confirmed that EMP12 did not follow the facility policy that required high level disinfection prior to using the dirty scope on the second patient on January 7, 2017.

A telephone interview was conducted with EMP12 on January 17, 2017, at 3:00 PM. EMP12 confirmed that on January 7, 2017, during the second patient's case, EMP10 continued to have difficulty with the endoscope and requested another scope. EMP12 stated they were not aware that additional endoscopes were available in the Endoscopy Suite, so they pre-cleaned the endoscope that had been used for the first patient's case and brought it to EMP10 who used it to complete the second patient's case. EMP12 also stated that they did not know that you could not reuse an endoscope if it was only pre-cleaned and did not understand what was involved in the high level disinfection process.

Based on a review of facility documents, and interviews with staff (EMP) it was determined that Crozer-Chester Medical Center failed to follow their adopted protocol and failed to adopt a written policy related to the process of obtaining additional endoscopes when performing procedures outside of the Endoscopy Suite for one of two procedures performed (MR1).

Findings include:


Crozer Keystone Health Care System, Standards of Care Manual, Perioperative Services, Pre Cleaning & Disinfecting of Endoscopes and Endoscoping Assessories, last reviewed May 15, 2016, revealed, "... Purpose: to establish acceptable standardized procedures for decontamination of the flexible endoscopes and it's accessories following the patient use and prior to reuse. Who May Perform: Registered Nurses (RNs), Endoscopy technicians, Sterile Processing Department (SPD) technicians. ... . Procedure: ... 5. Pre-clean ... 11. Transport the endoscope to the reprocessing area in a covered container. ... . 21. All staff will have direct visualization of scope cleaning competency every 6 month. ... ."


A tour of the outpatient Endoscopy Suite at 1:30 PM with EMP6 and EMP1 revealed that the two scopes used for the cases on January 7, 2017, were determined to be fully functional when returned to the Endoscopy Suite for high level disinfection. No malfunctions were identified. EMP6 also confirmed that on January 7, 2017, there were two high level disinfected upper endoscopes in the Endoscopy scope room that were ready for use and could have been procured.

An interview at 1:45 PM with EMP24 revealed that they have a protocol to obtain clean scopes when the Endoscope Suite is closed, as on weekends like Saturday, January 7, 2017. The OR staff can access the Scope Room and obtain additional scopes that have had high level disinfection from the scope closet. EMP24 explained that after use, the endoscopes are to be placed in the white plastic containers with biohazard designation on the lid and returned to the Endoscopy Suite for reprocessing. Both EMP6 and EMP24 stated that there were plenty of clean scopes available to the OR staff on January 7, 2017, that could have been obtained. EMP6 and EMP24 confirmed that this protocol is not in writing.

Based on a review of facility policy, medical records (MR) and interview with staff (EMP), it was determined that Crozer-Chester Medical Center failed to follow their policy to assure that an Operative Report was completed immediately following a procedure for one of two medical records reviewed (MR1).

Findings include:

Medical Record Department, MRD-2-2, review date January 27, 2013, Discharge Record Review Deficiency Analysis. "... III. ... 5 ... (c) the operative report is to be dictated immediately following surgery. ... ."


A review was conducted on January 12, 2017, at 9:30AM of MR1which failed to reveal an Operative Report for the procedure performed on January 7, 2017.


An interview on January 12, 2017, at 10:15 AM with EMP4 and EMP5 confirmed that MR1 did not contain an Operative Report. EMP5 further stated that the surgeon who had performed the procedure on January 7, 2017, (EMP10) failed to follow the policy.