HospitalInspections.org

Based on review of facility provided documentation, and staff interview, the facility failed to ensure that for 1 of 5 patients (#1), the quality of medical care provided was done in a manner to ensure the best outcome for the patient.

The findings include:

Review of the medical record for Patient #1 revealed that the patient had an invasive procedure done at the bedside by Physician #2 without an informed consent, discussion of risks or benefits or possible alternative options. The physician was aware that the patient was anticoagulated prior to the procedure. See A347 for more specific information.

Based on clinical record review and staff interview the facility failed to provide quality medical care to 1 out of 5 patients sampled(#1). Failure of a physician to obtain an informed consent, discuss the appropriateness of an invasive procedure, the benefits versus the risks and the alternatives prior to performing the invasive procedure, may have prevented Patient #1 from suffering cardiac arrest and subsequent death.
The findings include:
Clinical record review on 01/12/2010 at 3:30pm revealed that Patient #1 underwent a invasive surgical procedure (supra pubic catheter placement) on 10/17/2009 at 12:00pm performed by Physician #2. Physician #2 failed obtain a signed informed consent to do the invasive procedure or to state on any document within the chart that he discussed the appropriateness of the procedure with the patient or with the patient's surrogate. The physician failed to document that he discussed any alternatives to a surgical procedure that might carry less risk. The physician failed to document within the chart that he discussed the risk and benefits of the procedure especially in consideration of the higher probability of bleeding due to the use of anticoagulants.
Nursing notes dated 10/17/2009 at 7:38pm stated that Patient #1 had a suprapubic catheter placed by Physician #2 at approximately 12:00pm after being "notified" of INR of 6.2 and "after several attempts". The staff nurse noted bleeding from the "penis and cath(eter) site, as well as into the catheter". The spouse of Patient #1, "was at the bedside throughout the procedure" .
Record review revealed a support team was called to the patient's room on 10/17/2009 at 3:45 due to altered mental status and respiratory distress. He was taken to cat scan for further evaluation and experienced cardiac arrest at 4:25pm. He was then transported to the critical care unit. The patient expired on 10/18/09 at 5:44pm.
Progress notes written by Physician #1 on 10/17/2009 at 6:10pm revealed the family of Patient #1 was informed that he/she was in "very poor condition" and "if we are able to bring him back, he may have severe brain damage". Progress notes written by Physician #1 on 10/18/2009 at 1:15pm revealed a questionable intra-abdominal bleed.
Progress notes written by Physician #3 on 10/17/09 at 10:00pm revealed "possible hemorrhage " and likelihood of death . Physician #3's Advanced Registered Nurse Practitioner (ARNP) on 10/18/2009 at 8:17am noted on a dictated report that Patient #1 was "hypovolemic with acute anemia". The cause of the anemia was "thought to be from suprapubic catheterization procedure which was performed earlier in the day with extended PT/INR values". The report went on to say "it was felt that the possibility of internal bleeding was great". Written progress notes on 10/18/2009 at 1:31pm revealed "status post suprapubic catheter with large volume bleed, massive transfusion in progress".
Further clinical record review revealed Patient #1 received 25 blood product transfusions from 10/17/2009 at 9:35pm through 10/18/2009 at 5:12pm with 24 of those blood transfusions occurring from 10/17/2009 at 9:35pm through 10/18/2009 at 10:40am.
The Case Manager (CM) notes dated 10/19/2009 at 10:37am made reference to physician #3's ARNP report in the case management report. It was noted that one of the medical impressions was that Patient #1 suffered from "acute anemia, status post insertion of suprapubic catheterization with extended INR/PT". It included "probable intra-abdominal hemorrhage and resultant hypovolemic shock".
Physician #4 stated on a report dated 10/19/2009 at 6:51am, "of note, there was an attempt at a suprapubic catheter and the patient had an INR of 6.1 at the time the suprapubic catheter was placed and pelvic ultrasound demonstrated what was thought to be consistent with a large hemorrhage in the right pelvis".
Physician #5 stated on a report dated 10/18/2009 at 1:31pm, "status post supra pubic cath(eter) with large volume bleed. Massive transfusion in progress". "Patient meets criteria in my opinion of brain death".
An autopsy was requested by Physician #4 who checked box #4 on the "Request for Autopsy" form stating "death occurring within 48 hours of an invasive procedure or surgery". In the Brief clinical summary box was written "admitted because of toxic megacolon (sepsis). Suprapubic catheter required; bleeding ensued (patient was anticoagulated). Patient #1 ' s autopsy report dated 10/22/2009 at 11:07am that revealed that the Final Anatomical Diagnosis stated " retropubic soft tissue and intra-abdominal hemorrhage " as #4 on a list of 10 with the first three pertaining to cerebral vascular occurrences.
On 01/13/2010 at 8:27am, an interview with the Risk Manager (RM) and Vice President of Quality revealed that they were aware that Patient #1 received a surgical procedure (supra-pubic catheter placement) performed by Physician #2 on 10/17/2009 at 12:00pm without an informed consent and in the presence of abnormal laboratory values (PT ( prothrombin time) was at 56.5 with a normal value range of 9.3-12.2 and an INR( international normalized ratio) 6.2 with a normal value range of 2.0-3.0) which are both alone and together known to greatly increase the risk of bleeding . The interview at that time also revealed that they were aware that there was a question of the patient suffering from hypovolemic shock.