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Based on interview and record review the hospital failed to ensure two of 30 sampled patients had the following:
1) Patient 29's record had documented evidence of a patient being informed of a retained foreign object after surgical procedure; and
2) Patient 19's decision maker was informed of the cancellation for an invastive procedure.

These failures had the potential for Patient 29 and Patient 19 to not receive information necessary to exercise their rights as a patient and surrogate decision maker (Patient 19).

Findings:

1) Patient 29 was admitted to the hospital on 10/6/20 with diagnosis which included left leg pain per the facility Face Sheet.

A concurrent interview and record review of Patient 29's Operative Report, dated 10/12/20, was conducted with licensed nurse (LN) 25 . This report indicated Patient 29 had surgery and, "A broken screw and broken drill bit was left in bone ..." LN 25 stated it would have been the surgeon's responsibility to inform the patient if something was left behind. LN 25 further stated, "Don't see any patient disclosure from the surgeon." LN 25 stated no documented evidence that Patient 29 was informed of the broken screw and broken drill bit that was left in the bone.

The Surgeon was not available for interview.

A review of hospital facility policy and procedure titled, Responding To/Disclosure of Adverse Events, was conducted. The policy indicated, " ...Following an adverse event, a complete, accurate and factual description of pertinent clinical information related to the event should be entered into the patient's medical record ... All communications with the patient and family are also documented by the designated primary communicator ..."

Per the hospital policy LA region statuary reporting to external regulatory agencies with an effective date of 7/2018, "Disclosure of adverse event to patient or patients representative the patient or the party responsible for the patient, will be notified by risk management/ designee of the nature of the adverse event by the time the report to CDPH (California department of public health) is made. Such disclosures shall be reflected in the patients record. The patient or the party responsible for the patient shall not be provided with a copy of the report . The reports of CDPH should not be placed in the patient's medical record, but should be retained by risk management."



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2) Patient 19 was admitted to the hospital on 6/22/21 with a diagnoses to include failure to thrive, according to the facesheet.

Patient 19's facesheet, indicated, the patient's sister was the decision maker.

A record review as conducted on 7/13/21. Patient 19 was scheduled to undergo a transesophageal echocardiogram (TEE) , (a procedure to assess the structure and function of the heart).

Per the Cardiologist's note dated 7/12/21, "plan for TEE tomorrow...The benefits, risks, and alternatives of the procedure, as well as of moderate sedation (a drug induced depression of the consciousness), have been discussed in great depth with the patient's sister. She endorses that proceeding with this is what the patient would want."

On 7/13/21, the Anesthesiologist documented, the TEE was canceled due to a decline of Patient 19's respiratory status.

On 7/13/21, the procedure nurse documented the TEE was postponed and notified Patient 19's primary care physician.

There was no documentation in the patient's clinical record informing Patient 19's decision maker, of the TEE cancellation.

On 7/14/21 at 10 AM an interview was conducted with the Social Worker 1 (SW 1). The SW 1 acknowledged, notification to the patient's family member, should have been at the time of the cancellation.

Based on interview and record review the hospital failed to ensure they had a consistent methodology for collecting, analyzing, tracking, and trending that data, to ensure any safety of services and quality of care issues within the hospital were identified and corrected.

As a result, there was the potential for systemwide problems to go unnoticed and continue without resolution.

Findings

On 7/13/21, the survey team entered the facility for a complaint validation survey. The hospital administration, CEO, CNO, Director of Quality Management and the Patient Safety Director were present.

The survey team requested the hospital provide a list of all retained foreign objects identified by the hospital. The Director of Quality Management and the Patient Safety Director stated there had only been a single retained foreign object reported during the last year.

The team then asked for an alternative to the expected reported data, the hospital was asked to provide the team with a list of any and all patients that were coded and billed for a retained foreign object. The Director of Quality Management and the Patient Safety Director stated they were unable to gather that data, as it was an "overwhelming task."

On 7/14/21, the hospital provided the team with a list of incident reports involving retained foreign objects within the hospital and the ambulatory surgery center. This list of incident reports was generated by OR staff. This list included 38 incidents that included both near misses and true retained foreign objects. The hospitals reliance on staff filing incident reports to determine if there were issues with retained foreign objects in the main OR and in the ambulatory surgery center was informal, these incident reports were only reviewed by the OR department.

The Director of Quality Management and the Patient Safety Director were interviewed on 7/15/21 at 3:30 P.M. The Director of Quality Management and the Patient Safety Director were unsure of the retained foreign object definition, when the hospital needed to disclose this to the patient, and when it needed to be reported to the department. The Director of Quality Management and the Patient Safety Director stated that the hospital's Quality Improvement Committee had empowered the service line subcommittees to determine if there was a problem that needed to be elevated to the Quality Improvement Committee. The subcommittees were independently able to determine if an issue needed to be escalated to the Quality Improvement Committee. They had no criteria developed to inform the subcommittees about what was appropriate or required to be disclosed to the hospital's Quality Improvement Committee.

The hospital's Quality Improvement Committee had no plan or methodology for obtaining concerns within the main OR and the ambulatory surgery center for incidents that included a retained foreign object. The hospital did not develop a formal system of reporting a retained foreign object within the OR and ambulatory surgery center. There was no system used to identify a retained foreign object, there was no ability to track and trend what was indeed a retained foreign object or what was actually a near miss. The hospital did not collect and could not provide data on retained foreign objects. The hospital's Quality Improvement Committee relied solely on staff making an internal incident report, and on the OR subcommittee to report to them. There was a systemwide failure for the hospital's Quality Improvement Committee to gather, track and trend data for retained foreign objects within the hospital.

Based on interview and record review, the hospital failed to ensure the staff implemented its policies and procedures when:
1. Staff did not conduct pre and post pain assessments before and after pain medication administration for (2) out of 30 sampled patients (1, 7). As a result, there was a potential the patients' pain were not relieved.

2. Case Management staff did not revised, coordinated, and reevaluate a discharge plan for one of 30 sampled patients (15). As a result, Patient 15 was at risk for delayed discharge planning and a potential prolonged hospital stay.

Findings:

1 a. Patient 1 was admitted to the facility on 7/10/21 per the facility's face sheet. Patient 1 had a scheduled caesarian (a surgical procedure to deliver a baby) section but had a spontaneous vaginal delivery on 7/10/21.

On 7/13/21, a joint record review was conducted with Registered Nurse (RN) 1. Patient 1's medication administration record (MAR) indicated Patient 1 was given ibuprofen (a type of pain medication) on the following dates and times:

1) 7/11/21 at 7:45 P.M. for a pain level of 4 (on a numeric pain rating scale of 0-10: 0 for no pain and 10 for worst possible pain). There was no documentation Patient 1's pain level was reassessed after administration.
2) 7/13/21 at 12:37 A.M. There was no documented pain assessment prior to administration.
3) 7/13/21 at 9:21 A.M. There was no documented pain reassessment at the time of review.

On 7/13/21 at 3:12 P.M., a concurrent interview and record review with RN 2 was conducted. RN 2 stated she administered the ibuprofen orally, per the doctor's orders, to Patient 1 on 7/13/21 at 9:21 A.M. RN 2 stated she was supposed to reassess Patient 1's pain one hour after the administration of pain medication. RN 2 stated she should have documented if the patient had relief of pain after one hour.

Per the facility's policy and procedure titled Pain Standards revised 1/2019, " ...J. Ongoing Pain Assessment ...d. After each pain management intervention once sufficient time has elapsed for the treatment to reach peak effect: ...ii. Orally administered are expected to work in 60 minutes, therefore pain reassessment should take place in 60 minutes.



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1 b. Patient 7 was admitted to the facility on 7/2/21 for abdominal pain and a small bowel obstruction, per the facility's face sheet.

On 7/13/21 at 2:40 P.M., a joint record review and interview was conducted with registered nurse (RN) 7. Patient 7's MAR (medication administration record) indicated Patient 7 was given 0.4 milligrams of hydromorphone (a narcotic) intravenously on 7/13/21 at 5:51 A.M.

The pain assessments were then reviewed. On 7/13/21, there was no documented pain assessment prior to administration of the narcotic pain medication at 5:51 A.M.

RN 7 stated that there should be a pain assessment documented prior to the administration of a pain medication.

According to the facility's policy and procedure, Pain Standards, revised 1/2019, " ...J. Ongoing Pain Assessment ...1. Pain intensity and pain relief/comfort as reported by the patient will be reassessed and documented: ...c. Whenever the patient complains of pain or requested by provider ..."


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2. Patient 15 was admitted to the hospital on 7/8/21 with diagnoses that included a right tibial plateau fracture (a break in the top of the shin bone, at the knee) per the History and Physical dated 7/9/21. Per this same document, the physician had discussed with Patient 15 procedures and surgeries to be performed.

A review of a Case Management Note dated 7/9/21 was conducted with Quality Registered Nurse (QRN) 13. This document indicated: Assessment type: Admission; Anticipated changes related to illness: Inability to care for self; Concerns to be addressed: No discharge needs identified.

A review of the Operative Note, dated 7/9/21, was conducted with QRN 13. This note indicated Patient 15 had a list of procedures performed by the surgeon. Another Operative Note dated, 7/12/21, indicated Patient 15 had undergone another surgical procedure on 7/12/21. Per this same document, the surgeon wrote a postoperative plan for other procedures while Patient 15 was in hospital or in an outpatient setting.

There was no evidence of documentation by case management related to the second surgery or procedures for Patient 15, this was discussed with the healthcare team, the patient, and the family.

During an interview with the Case Management RN (CMRN) on 7/14/21 at 12:15 P.M., the CMRN stated discharge planning begins at admission and throughout the patient's stay at the hospital; case management's notes reflected what was the status of the patient especially if there was a change in condition. The CMRN further stated, for Patient 15, since there was a second set of procedures or surgery, a note from case management should have been completed for therapeutic discharge goals and for communication amongst disciplines and the family for continuity of care.

Per the hospital policy titled, Resource Management/Utilization Review Plan dated 10/18, "...Discharge Planning A. Effective discharge planning is an integral component in the provision of quality care and to insure the most appropriate utilization of healthcare resources throughout the continuum of care...C. The patient and family are integrally involved with the healthcare team in the assessment and planning for discharge..."

Based on interview and record review, the hospital failed to ensure an accurate documentation for an indication for x-ray (a type of imaging taken of the inside of the body) for one of 30 sampled patients (Patient 5).

As a result, there was a discrepancy on the documentation when the x-ray was actually conducted.

Finding:

Patient 5 was admitted to the facility on 9/14/20 with diagnoses which included biliary acute pancreatitis (inflammation of the pancreas) per the facility's face sheet.

On 7/14/21, a joint interview and record review was conducted with the interim Operating Room Manager (ORM). Per the Counts tab on Patient 5's electronic medical record dated on 9/14/20, xray was documented as "not taken." According to the document "Datix" provided by the facility to the survey team, on 9/14/20, Patient 5 had surgery and there was a possible count discrepancy of the surgical instruments. An x-ray was done at the end of the case to ensure there none left inside Patient 5.

On 7/14/21 at 3:40 P.M., an interview with the ORM was conducted. The ORM stated if an x-ray was conducted during the surgery, it would have been documented on the Counts tab. The ORM stated, "it was misdocumented."

Per the facility's policy titled Counts: Prevention of Retained Surgical Items, revised 6/2020, " ...Documentation ...1 ...2 ...vi ...Document that an intraoperative x-ray was taken, write the result of the intraoperative x-ray in the comments section ..."

Based on interview and record review, the hospital failed to implement their policy and procedure for 1 of 30 sampled patients (Patient 17). Patient 17's document for informed consent for a surgical procedure was not completed in accordance with the hospital's policy and procedure.

As a result, the hospital could not ensure Patient 17 and his family was provided with accurate consent information.

Findings:

Patient 17 was admitted to the hospital on 8/31/20 with diagnoses that included acute heart failure per the Intensive Care Unit History and Physical dated 8/31/20. Per this same document, Patient 17 had a pending CATH procedure (Cardiac catheterization- a procedure used to diagnose and treat certain heart/blood vessel conditions).

Per the Operative Note titled, Cardiac Catheterization Procedure Note, dated 8/31/20, Patient 17 had a list of procedures performed by the physician, and that Patient 17 tolerated the procedure well.

During a concurrent interview and record review with the Cath Lab Supervisor (CLS) on 7/15/21 at 10:35 A.M., the CLS stated documentation of informed consent was required for invasive procedures such as cardiac catheterization. The CLS also stated the usual practice was to check for a completed informed consent prior to each procedure. The informed consent for Patient 17 was signed by the spouse. However, there was no name of the physician who performed the procedure. The CLS confirmed the name of the physician who performed the procedure was not written on the informed consent. The CLS further stated, nursing should have followed up and ensured all elements of an informed consent were documented and completed.