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Tag No.: A0115
Based on staff and family interviews and review of clinical records and policies, it was determined the hospital failed to protect and promote patients' rights. This resulted in the inability of the hospital to ensure patients' wishes were complied with and to render safe care. Findings include:
1. The hospital failed to ensure patients were allowed to make informed decisions regarding their care. Refer to A131 as it relates to the lack of informed consents prior to surgery.
2. The hospital failed to ensure patients were afforded an opportunity to develop advance directives. Refer to A132 as it relates to the lack of documentation of and the lack of opportunity to develop advance directives.
3. The hospital failed to ensure patients received care in a safe setting. Refer to A144 as it relates to the failure of the hospital to protect a patient from harm and the failure of the hospital to investigate incidents.
The cumulative effect of these systemic practices prevented patients from making informed decisions and compromised the hospital's ability to keep patients safe.
Tag No.: A0144
Based on staff and family interviews and review of medical records and policies, it was determined the hospital failed to ensure 1 of 1 deceased patient (Patient #7) whose record was reviewed, received care in a safe setting. This resulted in the inability of the hospital to ensure hospital staff and processes prevented injuries to patients. Findings include:
Patient #7 was a 93-year-old female who was admitted to the hospital on 6/04/09 for treatment of a fractured hip. The fracture was pathologic and had been noted on an outpatient CT scan on 6/01/09. Physician notes did not document why she was not admitted to the hospital until 6/04/09. She died in the hospital on 6/12/09.
When Patient #7 was admitted to the hospital on 6/04/09, her hemoglobin and hematocrit levels (tests for anemia) were mildly low at 11.7 and 34, respectively. (The tests stated reference values were 12-16 and 37-47). Her PT and INR (tests of the bloods ability to clot) were high at 125 and 13.3, respectively, preventing her blood from clotting rapidly. (The tests stated reference values were 10.8-13.4 and 2.0-4.0). She was given vitamin K on 6/04/09 and 6/05/09 to decrease her clotting times.
At 6:52 AM on 6/06/09, her PT and INR levels were still mildly elevated at 35.2 and 3.6, respectively. A physician order, dated 6/06/09, no time documented, but the order was noted by the nurse at 10:48 AM, was written for 4 units of fresh frozen plasma (FFP) "Now." The "Blood Transfusion Checklist" dated 6/06/09, stated the plasma was hung at 11:45 AM and finished at approximately 12:40 PM. The total volume Patient #7 received during this time was approximately 1000 ml with each bag containing approximately 250 ml of fluid. A "Nurse Note," dated 6/06/09 at 12:22 PM, stated "Second unit of FFP administered; VSS (vital signs stable)...Second unit is being administered 'wide open' and not on the pump...no problems noted." A "Nurse Note," dated 6/06/09 at 12:30 PM, stated "3rd unit of FFP administered...Pressure bag was used by personnel from surgery; bag infused over 5 minutes." A "Nurse Note," dated 6/06/09 at 12:37 PM, stated "4th unit was infused with use of pressure bag by surgical personnel; bag was infused over 5 minutes." Patient #7's PT and INR improved and she was taken to surgery. Before the surgery began and before anesthesia was administered, Patient #7 arrested. The "CODE BLUE DOCUMENTATION RECORD," dated 6/06/09, stated Patient #7 arrested at 1:16 PM. An "Anesthesia post resuscitation note...", dated 6/06/09, but not timed, stated Patient #7 was taken to the OR but before anesthesia was begun the patient became unresponsive. The note stated the Anesthetist attempted to intubate Patient #7 but was unable to do so. The note said a code blue, an alarm indicating the patient needed immediate resuscitation, was called and CPR was begun. Patient #7 was intubated and resuscitated. She was taken to the ICU and placed on a ventilator. The surgery was cancelled. Patient #7 remained on a ventilator until 6/09/09.
A progress note from the surgeon for 6/06/09 was not present in Patient #7's medical record. No explanation of the need to administer the FFP so rapidly was documented. A consultation report, dated 6/06/09, by the internist who cared for Patient #7 after her arrest stated "Because of the need for surgery, she was given 4 units of FFP in rapid sequence prior to surgery. Prior to surgery she decompensated from a respiratory standpoint and had evidence of respiratory distress, for which she was intubated, Code Blue was called because of concerns for the possibility of her being in PEA [pulseless electrical activity]. Dr. [name]...noted that he believed she was in PEA." The consultation stated Patient #7 was resuscitated. A physician's order, dated 6/05/09, stated not to resuscitate Patient #7 or give her blood products.
A progress note by the surgeon, dated 6/07/09, but not timed, stated "Labs and [chest x-ray] indicate fluid overload/[congestive heart failure]. At this point, she will need to manifest improvement in respiratory function before considering hip arthroplasty." A note by the surgeon, dated 6/08/09 but not timed, stated he had discussed the risks and benefits of surgery with Patient #7's family. He documented the internist "feels that she will recover & this is time to intervene with her hip. Family agrees that we should proceed with surgery. Family gives consent willingly & understands no guarantees." An explanation as to why the surgery needed to proceed before the patient was fully recovered from her congestive heart failure was not documented. A note by the internist clearing the patient for surgery was not documented. A consent for the hip surgery on 6/08/09, signed by the patient or her representative, was not present in the medical record. Patient #7 was taken back to surgery on 6/08/09 and the hip was repaired. She was successfully extubated on 6/09/09, however, she did not recover. She died on 6/12/09. The physician's "DEATH SUMMARY," dated 6/12/09, stated the cause of death was congestive heart failure and cardiogenic shock.
Several unsuccessful attempts to interview Patient #7's surgeon were made from 11/05/09 through 11/09/09 but he did not return the surveyors' calls.
The Performance Improvement Manager was interviewed on 11/6/09 at 8:35 AM. He stated that he had reviewed Patient #7's case on 7/08/09 and decided it did not need to be sent for physician peer review or other review. He said no other review of the case had been completed.
The hospital failed to protect Patient #7 from harm from transfusions, failed to ensure she had been cleared for surgery, failed to ensure an informed consent was garnered prior to surgery, and failed to investigate the events surrounding her death.