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Based on the severity of the deficiency related to patient rights that resulted in injury to a patient, the facility failed to substantially comply with this condition.

See A-0144

Based on observations, facility document review, and staff interviews, it was determined the facility staff failed to provide care in a safe setting for one (1) of fifteen (15) patients resulting in injury.

The findings include:

On July 22-28, 2020 the surveyor reviewed the medical record of Patient #11.

The medical record for patient #11 contained multiple entries of documentation related to the patient's port and its location. A history and physical form dated 04/24/2020 contained documentation that the patient had a port placed in December of 2016. Two (2) radiology reports dated 04/24/2020 and timed 6:40 PM and 7:16 PM indicated the patient had a left sided port.

A progress note by the physician on 04/25/2020 contained documentation that the patient's blood pressure was deteriorating and the family was called for an update. Per the progress note, the patient's family requested hospital staff to access the patient's port. The physician requested for the bedside Registered Nurse (RN) to access the port. The RN attempted to access the port in the right chest. The progress note contained documentation that the "RN re-evaluated and noted that patient's actual mediport was on the LEFT and easily accessed." A short time after the physician was called to the bedside for worsening hypoxia (decreased oxygen level) and hypotension (decreased blood pressure) and possible tension pneumothorax (accumulation of air in the chest that compresses the lungs). The progress note also contained documentation by the physician that the patient's pneumothorax was due to, "due to single lung ventilation vs trauma related to attempts at accessing port. [Family] explained that patient never had a port on the right chest." The progress note indicated that a mass on the right chest related to the patient's cancer was thought by the nurse to be a port; the actual port was located in the left chest.

A nursing note dated 04/24/2020 at 5:00 AM contained documentation that the patient was becoming increasingly unstable and that a nurse had attempted to access a mediport twice on the right side when the port was actually located on the patient's left side. A second RN checked the left side of the patient's chest and successfully accessed the port.

A physician progress note dated 04/27/2020 at 8:22 AM partially reads as follows, " "Chest Xray revealed large right tension pneumothorax. Required emergent chest tube placement ...Likely iatrogenic (caused by medical treatment) from attempted mediport placement on right side. Mediport is on left."

During an interview on July 24, 2020 at 8:00 a.m., Staff Member #16, the nurse on the unit who first attempted to access Patient #11's port, stated he/she had an in-service on port accessing in 2015 that included a return demonstration. Staff Member #16 stated he/she did not have a lot of experience with accessing ports, Staff Member #16 "did not get whole lot [of ports to access] in the ICU [intensive care unit]", and the ICU doesn't get the port accessing kits. Staff member#16 stated he/she didn't think a doctor's order was needed to access a port. Staff Member #16 stated that to determine the location of a port one would feel the upper chest of the patient and feel for two dots of the port. Staff Member #16 stated it was an emergency to access Patient #11's port and attempted to access a port on Patient #11's right chest wall one time. Staff Member #16 stated attempting to then draw blood to determine the right place, and when there was no blood return, the needle was removed. Staff Member #16 stated he/she then requested assistance from Staff Member #17, second staff nurse caring for the patient. Staff Member #16 stated that Staff Member #17 pulled back Patient #11's gown, Staff Member #17 saw that the port was on the left side of the patient's chest, and Staff Member #17 proceeded to access that port with success. Staff Member #16 stated that he/she did not check the chart to confirm the location of the port, but that someone else was checking the chart for the location. Staff Member #16 stated there was no documentation of the location of the port in the emergency room history and physical. Staff Member #16 also stated that the patient's family member advised the physician that Patient #11 had a port but the family failed to tell where the port was located.

During an interview on July 24, 2020 at 8:00 a.m., Staff Member #17 stated he/she had port access orientation that included accessing a port three times with an experienced and certified nurse as part of that orientation. Staff Member #17 stated he/she had ONS/ONCC Chemotherapy Biotherapy Certificate Course that was completed at the facility. Staff Member #17 stated that to determine the location of a port he/she would feel and touch the patient's skin. Staff Member #17 stated he/she had five years of experience in accessing ports.

During an interview on July 28, 2020 at 9:45 a.m., Staff Member #18, the Assistant Vice President of Quality, stated that the facility investigated this complaint about a nurse (Staff Member #16) incorrectly attempting to access a port on the right side of the patient's chest when the port was actually located on the left side of the patient's chest. Staff Member #18 stated that although the physician told the patient's family that this procedure may have resulted in the patient receiving a pneumothorax and requiring a chest tube, the facility's investigation determined that "the pneumothorax was not caused by the nurse trying to access the tumor" on the right side of the patient's chest. Staff Member #18 stated that it was up to the nurse's supervisor to determine how this event was going to be discussed/followed up with the nurse. As per Staff Member #18, the nursing supervisor was out on leave and could not be contacted for an interview.

The personnel file for Staff Member #16 contained a document "ICU SKILLS FAIR CHECK-OFFS: ICU SPECIALTY IV/IO COMPETENCY" that indicated the staff member was competent in accessing implanted ports. The competency was dated 4/28/15. The personnel file contained no documentation related to competency in accessing ports in the last five (5) years.

The personnel file for Staff Member #17 contained documentation of a current ONS/ONCC Chemotherapy Biotherapy Certificate Course. The personnel file failed to contain any documentation of competencies related to accessing a port to include a return demonstration.

During an interview on July 24, 2020 at 2:35 p.m., Staff Member #15, the Senior Director of Staff Development, stated that the ONS/ONCC Chemotherapy Biotherapy Certificate Course "does not specifically list accessing ports" and "doesn't say three specific attempts through a port" [specifically]. Staff Member #15 stated that training is conducted where needs are identified, and competencies that will be completed annually are chosen based on the yearly needs assessment.

The surveyor reviewed the facility's procedure titled, "LIPPINCOTT PROCEDURES - IMPLANTED PORT ACCESSING" reviewed by the facility on 11/20/2018 and approved by Clinical Practice Council vote, states in part: "Identifying type of port: ...Checklist for Identifying an Implanted Port: Check patient chart; Ask your patient; Feel for triangular shape; Feel for bumps on the septum ...Implementation: Review the patient's medical record to determine the type (such as a power-injectable device or single or double port) and the location of the implanted port, whether it has been previously accessed, and the patient's response to the procedure. If power injection will be performed using the implanted port, the non-coring Huber needle used to access the port must be identified as port-injection compatible. -Ensure that placement of the catheter tip has been confirmed. Verify the practitioner's order, if required by your facility ..."

The surveyor reviewed the document titled, "ICU SKILLS FAIR CHECK-OFFS: ICU SPECIALTY IV/IO COMPETENCY" dated 4/28/15. The document states in part: "Demonstration: Access/care of implanted ports: Review medical record and/or patient personal info (i.e., wallet card, verbal info) for information about the implanted port. Ensure confirmation of catheter tip placement (Xray for new admission). Verify order for the size and length of the needle ... Palpate and locate the septum of the port. If not already determined, feel for 3 protrusion "nubs" indicating a PowerPort. Also assess for 1 versus 2 septums. Assess for device rotation ..."

The hospital administration team acknowledged the above noted patient safety deficiency during the exit conference on 07/28/2020.

Based on facility document review and staff interviews, it was determined the medical staff failed to enforce its bylaws; specifically, the hospital's medical staff failed to ensure the death certificate was completed for each patient in (1) of (1) patient's death certificate reviewed in the survey sample. Medical record #11.

The findings include:

The medical record for patient #11 was reviewed in the hospital 07/22/2020 - 07/28/2020. The medical record for patient #11 contained documentation that the patient's date and time of death were 05/08/2020 at 12:52 PM.

On July 22, 2020 at 9:00 a.m., the surveyor received information from the Virginia Department of Health's Vital Records: Electronic Death Registration System (EDRS). This documentation contained evidence that the physician electronically signed Patient #11's death certificate on 5/14/20, six (6) days after the patient died.

A review of the facility's policy, Medical Staff Rules and Regulations: Article XIV Hospital Deaths and Autopsies: 14.1 Death and Death Certificates, states in part;
"(b) The medical certification of the cause of death within the death certificate will be completed and returned to the funeral director within 24 hours after death by the physician in charge of the patient's care for the illness or condition which resulted in death except when inquiry or investigation by the Office of the Chief Medical Examiner is required."

During a review of the Legislative Information System (LIS) Virginia Laws. Code of Virginia. Title 32.1. Health, Chapter 7. Vital Records, Article 4. Death Certificates and Out-of-State Transit Permits " § 32.1-263. Filing death certificates; medical certification; investigation by Office of the Chief Medical Examiner, states in part;

"The medical certification shall be completed and filed electronically with the State Registrar of Vital Records using the Electronic Death Registration System within 24 hours after death by the physician in charge of the patient's care for the illness or condition which resulted in death except when inquiry or investigation by the Office of the Chief Medical Examiner is required by §32.1-283 or 32.1-285.1, or by the physician that pronounces death pursuant to §54.1-2972."

Based on staff interview and document review, it was determined the facility failed to ensure that all equipment was inspected, tested and maintained to ensure its safety, availability and reliability. Specifically, the hospital failed to ensure maintenance was performed on its secondary morgue system, the Mopec MERC (Mortuary Enhanced Remains Cooling) system.

The findings were:

On 7/21/20 at 10:45 A.M., an interview was conducted with the Staff Member #9 (Director of Security and Parking). Staff Member #9 stated the facility has a Mopec MERC System that is used as a secondary cooling system when the facility's main morgue is full. Staff Member #9 stated the Mopec MERC system functions by placing a body in a bag, a pad containing a glycol solution is placed on top of the body, and the body is then placed inside a silver reflective. The glycol solution removes heat from the body, is sent through the machine to cool, and is then returned to the body via the pad. The pad is set to maintain the body at thirty-two (32) degrees fahrenheit. Staff Member #9 stated, "The system has been used quite a bit during the COVID pandemic. From mid-April to mid-May, it has been used approximately ten (10) times."

A document titled, "Portable Chiller, Instruction Manual, Air-Cooled Models", was provided by Staff Member #9 and reviewed by the surveyor on 7/21/20 and 7/27/20. Section 5.0 titled, "Maintenance" contained a subsection titled, "5.2 Periodic preventative maintenance" which listed ten (10) items to check and maintain on the system. On 7/21/20 at 1:00 P.M., the surveyor requested to review maintenance records on the Mopec MERC system, Staff Member #5 (Quality Consultant) stated, "I checked with Staff Member #9 and Staff Member #9 said there are no maintenance records available for the MERC units."

An additional interview was conducted on 7/21/20 at 1:50 P.M. with Staff Member #9 regarding the daily operation of the morgue and the Mopec MERC system. Staff Member #9 provided logs titled, "Morgue Checklists", which evidenced seven (7) line items the security department has to check in the morgue at the start of each shift. The surveyor asked for a log to show what, if any, items are checked on the Mopec MERC system at the start of each shift, Staff Member #9 was unable to provide a log for the Mopec MERC system. The surveyor requested to see documentation of temperatures specifically for the Mopec MERC system, Staff Member #9 stated, "We do not log a temperature for the MERC system when it is in use; only a variance in temperature (above forty degrees fahrenheit) would be reported to facilities."

The above noted equipment maintenance deficiency was acknowledged by the hospital management team during the exit conference on 07/28/2020.