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Tag No.: A0130
Based on review of medical records, review of meeting minutes, review of policies and procedures, review of Medical Staff Bylaws and Medical Staff Rules and Regulations and interviews with key staff February 14-16, 2012, it was determined that the hospital failed to develop a system to ensure that the patient had the right to participate in the development and implementation of his or her care plan. This was evidenced by not being informed about the different standards of care followed by the locum tenens in the gastroenterology service and not being informed of the risks and benefits of the discontinuation of the patient's antithrombotic therapy.
Please see TAG A-0338 for additional information regarding the failure of system development to ensure that all patients received the same standard of care.
Tag No.: A0275
Based on review of medical records, review of meeting minutes, review of policies and procedures, review of Medical Staff Bylaws and Medical Staff Rules and Regulations and interviews with key staff February 14-16, 2012, it was determined that the hospital failed to utilize data collected to monitor the effectiveness and safety of services and quality of care. This was evidenced by a report of an adverse event happening as a result of different standards of care being utilized by locum tenens in the gastroenterology service.
Please see TAG A-0338 for additional information related to different standards of care being used by locum tenens in the Gastroenterology Department.
Tag No.: A0276
Based on review of medical records, review of meeting minutes, review of policies and procedures, review of Medical Staff Bylaws and Medical Staff Rules and Regulations and interviews with key staff February 14-16, 2012, it was determined that the hospital failed to identify opportunities for improvement and changes that will lead to improvement. This was evidenced by the Chief of the Gastroenterology Service not developing systems and orientation for locum tenens that provide care in his department.
Please see TAG A-0338 for additional information regarding the failure of the hospital to identify opportunities for changes that would lead to improvements within the Gastroenterology Department.
Tag No.: A0338
Based on review of medical records, review of meeting minutes, review of policies and procedures, review of Medical Staff Bylaws and Medical Staff Rules and Regulations and interviews with key staff on February 14-16, 2012, it was determined that the hospital failed to complete a credible and evidence-based review of the care and documentation, and failed to ensure that all members of the medical staff were adequately oriented to the hospital's standard of practice, as evidenced by:
Failure to complete a credible and evidence-based review of care and documentation
1. Per Patient A's medical record, Patient A underwent an elective colonoscopy on October 21, 2011 performed by a locum tenens gastroenterologist. Patient A was on lifelong aspirin, 81 mg. daily, after a cardiac stent procedure in 2004. The discharge instructions advised the patient to discontinue aspirin for 10 days.
2. According to the Chief of Gastroenterology, in an interview on February 15, 2012 and confirmed by the Vice President for Medical Affairs on the same day, the cardiologist from another hospital contacted the Chief of Gastroenterology at St. Joseph's Hospital with concerns that the discontinuation of Patient A's aspirin therapy by the locum tenens gastroenterologist had precipitated this patient's myocardial infarction seven days after the colonoscopy.
3. The 2009 Guidelines from the American Society of Gastrointestinal Endoscopy, "Management of antithrombotic agents for endoscopic procedures" stated, "... potential thromboembolic events that may occur with withdrawal of medication can be devastating, whereas bleeding after high-risk procedures, although increased in frequency, is rarely associated with any significant morbidity or mortality. Discussion with the patient and his or her prescribing physician before the procedure is invaluable to help determine whether antithrombotic agents should be stopped or adjusted in any particular patient."
4. During an interview on February 15, 2012, the Chief of Gastroenterology was asked for his opinion, based on the record, if the stopping of aspirin was appropriate. He said his practice, and those of "his office" were to continue aspirin in colonoscopy patients. He said it was the local standard to continue aspirin.
5. The case review by the Chief of Gastroenterology reads, "For management of aspirin, antiplatelet agents and anticoagulation before and post procedure, we follow the guidelines released in 2009 by the American Society of Gastrointestinal Endoscopy (Gastrointestinal Endoscopy 2009, Vo17, N6: 1 60-1 70), these guidelines recommend continuing aspirin before and after endoscopic procedures. However, they also state that it is finally the physician judgment to stop or continue this medication during the perioperative period after weighing the risks and benefits of his recommendations."
6. There was no documentation in Patient A's medical record of discussion of the risks and benefits with either the patient or his/her prescribing physician.
7. The Chief of Gastroenterology was asked during the same interview on February 15, 2012 if he thought the chart contained evidence of "the physician judgment to stop or continue this medication during the perioperative period after weighing the risks and benefits of his recommendations." The Chief of Gastroenterology said he could not answer because he did not see a discussion in the record of the decision making by the gastroenterologist. He further stated, "It [the record] did not say what it needed to say. I wasn't satisfied."
8. In spite of the American Society of Gastrointestinal Endoscopy published standards, the standard of practice identified by the Chief of Gastroenterology, and the lack of documentation noted by the Chief of Gastroenterology, the case review by the Chief of Gastroenterology concludes, "I cannot conclude that there was a violation of the standard practice."
9. Additionally, the St. Joseph ' s Hospital cardiologist, who was asked to review the case, stated during an interview on January 10, 2012, "...no matter what the patient should stay on baby aspirin...we encourage doctors to call us if they have questions regarding medications...we have someone in the office every day to answer questions."
10. In spite of the conflicting opinions from the review of the case, the Chief of Gastroenterology stated in an interview on February 15, 2012 that he had not considered discussing the case with the cardiologist to reconcile the cardiologist's opinion with his own opinion.
11. During an interview on February 15, 2012, the Chief of Gastroenterology stated that there had been no discussion about this case, or discussion of the local standard at the Surgical Services Department meetings as of February 15, 2012.
12. During an interview on February 16, 2012, the Vice President of Medical Affairs stated, "there was no reconciliation between the two opinions" and "there was inadequate documentation (in the record) regarding the decision that we made." He stated that it was his opinion that the 2009 National standard was not violated, but the local standard of care was violated.
13. During an interview with the Chief of Gastroenterology on February 15, 2012, he was asked what had changed as a result of this case and stated, "I discussed it with my group...need to improve documentation...have done nothing yet."
14. A review of the Peer Review Committee meeting minutes for a year and review of the Surgical Services Meeting minutes for a year, documented no discussion of this colonoscopy case by the Medical Staff and, therefore, no performance improvement measures put into place.
Failure to ensure that all members of the medical staff are adequately oriented
15. The locum tenens gastroenterologist who had performed Patient A's colonoscopy was on the St. Joseph Hospital Medical Staff from April 22, 2011 through December 31, 2011 according to hospital credentialing and privileging files.
16. The Hospital provided a sample orientation checklist to the Endoscopy Unit, but the Hospital could not provide a copy of the checklist indicating that this locum tenens gastroenterologist underwent an orientation.
17. During an interview on February 15, 2012, the Chief of Gastroenterology said that he did not have time to orient locum tenens physicians to the standards of his practice, even though they are covering his practice, because they "are not here long enough." In regard to the orientation of this particular locum tenens gastroenterologist, he further stated, "No time...he was only here a week."
18. During an interview with the Vice President of Medical Affairs on February 16, 2012, he said that "locum tenens physicians add risk." In reference to whether locum tenens physicians should be aware of local standards of practice, he stated, "it was not clear to the locum what was expected." The Vice President of Medical Affairs also stated, "I feel the failing here is how we deal with locums...we have to be sure that they know what we expect."
19. After the interview on February 16, 2012, the Vice President of Medical Affairs provided the survey team with the draft of a new policy which discussed orientation and expectations for locum tenens physicians. In spite of Chief of Gastroenterology's statement that he did not have time to orient locum tenens physicians, this draft policy stated that the locum tenens physicians must be "certified as adequately oriented by either the Department Chair, the Service Leader, the Lead Physician or the Vice President of Medical Affairs."
The cumulative effect of these deficient practices resulted in this Condition of Participation not being met.
Tag No.: A0701
Based on facility tours and interviews with key personnel on February 14- 16, 2012, it was determined that the facility failed to maintain a safe and sanitary environment.
Findings include:
1. During a tour of the Emergency Department on February 14, 2012, the following was found;
Bay 4 had gouged walls, and tape residue present
Bay 6 had gouged and soiled walls
Bay 7 had a cracked door jamb
Bay 8 had gouged and cracked walls, a cabinet door was de-laminated, the cabinets had areas that were de-laminated, and there was tape residue present. The floor tiles were cracked in the adjacent hallway.
Room 9 had gouged walls, the laminate surfaces had de-laminated, there was tape residue present inside cabinet doors, the inside drawers were visibly soiled, and there was a hole in the wall.
Room 11 had chipped floor tiles, and the cabinets were de-laminated. The soiled utility room cabinets were de-laminated. The bathroom had cove moulding that was not attached to the wall. The floor tiles in the nurses ' station were cracked.
These findings were confirmed with the Emergency Department Administrator during an interview on February 14, 2012.
2. During a tour of the Surgical Services Department on February 14, 2012, the following was found:
Operating Room 1 and 4 have trash containers with rusty castors
Operating Room 2 has a trash container with rusty castors, a stool with a torn vinyl seat, the clean operating table has tape residue present, and the wooden door was gouged. Clean suction tubing was noted to be dangling on the floor. The tubing was immediately discarded.
The floor under Autoclave #4, in the sterile core was visibly soiled and dusty.
These findings were confirmed with the Surgical Services Department Administrator on February 14, 2012.
3. During a tour of the Surgical Services Department on February 15, 2012, the following was found: Room 5 has a trash container with rusty castors.
4. During a tour of Central Sterilization on February 15, 2012, a rusty metal under sink cabinet was present and utilized.
5. During a tour of the print shop on February 15, 2012, it was noted that 3 (three) extension cords were in use.
6. During a tour of the Diabetes Center on February 15, 2012, 37 (thirty-seven) vacutainers were noted to be expired.
7. During a tour of the dietary food storage area on February 15, 2012, three (3) dented cans were found. These cans contained food for patient consumption.
8. During a tour of the facility on February 14, 2012, the following was found: stained ceiling tiles were observed in room 543, outside room 377, and at the ED ambulance entrance. In room 403, an unprotected fluorescent lighting unit was present. In Room 371, a rusty metal window sill was observed. In room 377, two (2) bolt holes were present in the floor.
9. These findings were confirmed with the Facilities Director during the facilities tours February 14-16, 2012.