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Based on review of Penobscot Bay Medical Center ' s Governing Board meeting minutes, review of Performance Improvement Committee meeting minutes, review of the Risk Management Sub Committee meeting minutes, review of the hospital-wide Performance Improvement Program 2011 and interviews with the Chief Operating Officer and the Director, Quality, Risk & Safety on April 20 and May 18, 2011, it was determined that the hospital failed to have an effective governing body legally responsible for the conduct of the hospital as an institution as evidenced by:


1. The governing body failed to ensure that the Performance Improvement Program followed its mission and objectives consistently (Tag A0263);

2. The governing body failed to be totally responsible for the operations of the hospital (Tag A0267, Tag A0338 and Tag A0289):

3. The governing body failed to ensure that all medical staff requirements were met (Tag A0338);

4. The governing body failed to hold the medical staff accountable for the quality of care provided to patients (Tag A0338);and

5. The governing body failed to take action through the hospital's quality program to identify quality and performance problems ( Tag A0267 and Tag A0338).


The cumulative effects of these deficient practices resulted in this Condition of Participation being out of compliance.




BLAFL




Complaint Investigation -

#ME00011350 and #ME00011372

Based on review of Penobscot Bay Medical Center ' s Performance Improvement Program, review of Penobscot Bay Medical Center ' s OB/GYN Performance Improvement Indicators for 2011, review of Penobscot Bay Medical Center ' s OB/GYN Department meeting minutes for August 31, 2010, October 15, 2010, January 4, 2011 and draft minutes of April 5, 2011, review of medical records, and interviews with the Director, Quality, Risk & Safety, the Chief Nursing Officer, physicians, Obstetrical nurses, Chief of Radiology and the Vice President of Medical Affairs on April 20 and May 18, 2011, it was determined that the hospital failed to develop, implement and maintain an effective, ongoing hospital-wide, data driven quality assessment and performance improvement program that focused on indicators related to improving processes and systems as evidenced by:

1. The hospital failed to ensure that the scope of the hospital-wide Performance Improvement Program's requirements were met (Tag A0264 and Tag A0267);

2. The hospital failed to identify and develop quality indicators to measure and analyze aspects of performance that would improve care within the OB/GYN Department (Tag A0338 and Tag A0267);

3. The hospital failed to ensure that the hospital ' s governing body was responsible and accountable for ensuring full legal responsibility for the performance improvement program (Tag A0267);

4. The hospital failed to ensure that the governing body was responsible to see that an ongoing program for quality was implemented and maintained (Tag A0267);

5. The hospital failed to maintain a performance improvement program that addressed priorities for improvement and patient safety and that actions related to these were evaluated (Tag A0265 and Tag A0338); and

6. The hospital failed to ensure that the performance improvement activities tracked adverse patient events (Tag A0288).


The cumulative effects of these deficient practices resulted in this Condition of Participation being out of compliance.



BLAFL




Complaint Investigation -

#ME00011350 and #ME00011372

Based on review of the Penobscot Bay Medical Center Performance Improvement Plan on April 22, 2011,it was determined that there was no documented evidence that the plan had been followed consistently.

Findings include:


1. Penobscot Bay Medical Center Performance Improvement Plan was reviewed on April 22, 2011, it stated, "I. The Performance Improvement Program at Penobscot Bay Medical Center will provide a data-driven quality assessment and performance improvement program, including all departments, that focuses on indicators related to improved health outcomes, the prevention and reduction of medical errors, improved patient satisfaction and identifying potential and actual loss occurrences for the hospital............The Performance Improvement (PI) Program of the Penobscot Bay Medical Center (PBMC) will: 2. Provide mechanisms that track medical errors and adverse patient events, analyze their causes RCA's (Root Cause Analysis), implement preventive actions and provide feedback to support a culture of patient safety throughout PBMC."

2. During a telephone interview with the Director, Quality, Risk & Safety on April 21, 2011 at 10:30 a.m., she stated, "I did the Root Cause right after the event [Patient A]..I haven't written anything up yet."

3. During another telephone interview with the Director, Quality, Risk & Safety on April 21, 2011 at 12 noon, she stated, "I only do RCA's [Root Cause Analyses] on Sentinel Events." She added that this incident was not a Sentinel Event.






BLAFL




Complaint Investigation -

#ME00011350 and #ME00011372

Based on review of medical records, OB/GYN (obstetrical/gynecological) meeting minutes and interviews with key staff on April 20 and May 18, 2011, it was determined that there was no documented evidence that the hospital had tracked adverse patient events and developed processes to prevent further occurrences.

Findings include:


1. In the OB/GYN meeting minutes of January 4, 2011, Patient C's case was reviewed. The discussion stated, "....fundal height is subjective. If the patient is morbidly obese, the only benefit is to measure the same way each visit for consistency." There is no evidence that this patient's fundal height was recorded consistently, nor is there evidence in the minutes that a recommendation was made for developing a standard of practice.

2. Additionally, the minutes also stated that it was essential that the risks of morbid obesity be discussed with the patient. There is no evidence that an indicator and/or another measurement technique was developed to assess compliance.

3. In the OB/GYN meeting minutes of January 4, 2011, Patient A's case was reviewed. The discussion regarding issues stated, " ....This was an emergency and such infant should be delivered in less than 30 minutes from decision time." There is no documented evidence that the infant was delivered within 30 minutes. In fact, the patient labored and was delivered via C-Section many hours later.

4. Additionally, the minutes under actions stated, " Form a focus group made up of OR [Operating Room], OB, Anesthesiology and nursing to review communication process." The Director of Quality, Risk & Safety stated on May 18, 2011 that this focus group had not met.

5. The meeting minutes of the OB/GYN Department of January 4, 2011 also stated that a review of the department by an outside group was recommended. The Director of Quality, Risk & Safety stated on April 20, 2011 that this review had been was requested. The draft report was received on May 7, 2011. The review of the report revealed that the report was not dated, the report was not signed and the report was on Penobscot Bay Medical Center letterhead. This surveyor obtained the name of the author of the report and contacted the writer by e-mail and telephone on May 12, 2011. The surveyor received a reply by return voice mail on May 12, 2011. The writer stated that he/she was at a conference but would call the surveyor back at break time. On May 23, 2011, the surveyor received a return call from the insurance reviewer. He/she stated that he/she was aware of incidents that had occurred in 2010 but was not focused on those events when he/she went there. He/she further stated that the visit was an annual visit based on a professional liability perspective. When asked why medical records were not reviewed, he/she stated that the visit and review was not focused on the events of 2010.

6. In the OB/GYN meeting minutes of August 31, 2010, Patient B's case was reviewed. The discussion stated, "CNW [Certified Nurse Midwife] ...stated that she should have admitted the patient to OB and re-examined her instead of sending the patient back to the ED [Emergency Department]....The members agreed that a system's issue has been identified due to this case. Conclusion: Monitoring pregnant women is best done on the OB unit and in the future all women with suspected renal colic will be admitted observation to the OB unit."

7. Additionally, under Action it stated, "[Physician C] to notify [Nurse Manager] of change in procedure." The Nurse Manager stated, " As of May 18, 2011, there was no change in procedure identified."

8. During an interview with the Nurse Manager of the OB/GYN Department on May 18, 2011, he/she stated, " My take on what was required of me was to review the policies in place. We did the review and made no changes."

9. A review of the quality file of the CNW was completed on May 18, 2011. The recommendation of the Chief of OB/GYN stated, " Case reviewed at OB/GYN Department meeting prompted discussion on appropriate venue for evaluation of a pregnant patient with pain at different gestional ages. A protocol will be forthcoming to optimize this process." As of May 18, 2011, there was no documented evidence of a new and/or revised protocol.

10. During an interview with the Vice President of Medical Affairs on May 18, 2011, he/she stated, "We cannot do a protocol or policy for everything that we do."





BLAFL




Complaint Investigation -

#ME00011350 and #ME00011372

Please see TAG A0267 for additional information regarding performance improvement activities that track, analyze and implement actions and mechanisms regarding adverse patient events.


BLAFL




Complaint Investigation -

#ME00011350 and #ME00011372

Please see TAG A0267 for additional information regarding actions taken aimed at performance improvement.



BLAFL




Complaint Investigation -

#ME00011350 and #ME00011372

Based on review of information provided, review of meeting minutes and review of a medical records, it was determined that the hospital failed to have an organized medical staff that was responsible for the quality of medical care provided to patients by the hospital, as evidenced by:


1. The Emergency Department Policy "Triage of the Obstetrical Patient" stated, "PROCEDURE...6. Vaginal bleeding - late in pregnancy (more than 20 weeks gestation). This may indicate placenta previa or placenta abruptio. a. Notify Maternity. b. Transfer to Maternity as quickly as possible on a stretcher. OR 7. Abdominal pain/cramping: no vaginal bleeding (more than 20 weeks gestation). Triage to Maternity. 1. Notify Maternity. 2. Arrange transport."

2. Patient B was evaluated in the ED. The Director, Quality, Risk & Safety agreed during an interview on May 18, 2011, that this was a violation of the policy.

3. During an interview with the CNW on May 18, 2011, he/she stated, " The ED called me and said should Patient B come to OB and I said no, please keep the patient and evaluate for kidney stones. I did not do an evaluation on OB..I should have but I had seen the patient that a.m. and figured it was the same issue." Additionally he/she stated, "If the patient had come to OB another vaginal exam would have been completed and the patient could have been prepared for the outcome."

4. The Director, Quality, Risk & Safety stated that the Nurse Midwife gave an order for Patient B to be evaluated in the ED but no documentation of the order was found in Patient B's medical record.

5. During an interview with the Nurse Midwife on May 18, 2011, he/she stated, "I received a call from the ED nurse asking if [Patient B] should be sent to OB. I said no, please keep her in the ED and evaluate for renal stones."

6. A Nursing Note which documented an assessment of Patient B performed in the ED by an OB nurse reported, "It was noted by the nurse a pad in the trash that appeared to have a bloody discharge. ED MD [Medical Doctor] states he was aware."

7. The Emergency Department Note for Patient B dated July 16, 2010 stated, " She states that the pain started a day or 2 before across her lower back and into the lower abdomen. She denied any uterine contractions or bleeding." There was no documentation of a speculum examination, nor any notation of vaginal bleeding or acknowledgement of a bloody pad."

8. A review of Patient B's History and Physical dictated by Physician A stated, "...She did report some vaginal discharge and in the the emergency room, began to experience some vaginal bleeding." There was no documentation in the ED Note of any vaginal bleeding.

9. Patient B was admitted to the OB unit and the nurses note dated 0100 7/17/10 stated, "Pt admitted to ob [obstetrics]unit with report of 10/10 pain r/t [related to] renal stones. Upon arrival to unit, assisted patient to bathroom. pt [patient]noted to have frank bloody discharge on pad. [Physician A] notified, and entered pt's room for assessment, vaginal exam, revealed 9 cm cervix, clear ROM occurred. Non-viable male infant delivered at 0048. Infant wrapped in warm blanket and cuddled by mother."

10. During an interview with the Director, Quality, Risk & Safety on May 18, 2011, she stated, " Even though the outcome would not have been different for [Patient B] and the baby, we should have done better by this patient."

11. A review of the OB/GYN Department meeting minutes of August 31, 2010, related to Patient B's case stated, " No quality issues." Additionally, there was no evidence that this committee recommended a review of the case by the Emergency physicians.

12. During an interview with the Director Quality, Risk & Safety, she stated, "We did a RCA and we determined that our existing policies were appropriate and that the staff had been educated."

13. A review of the OB/GYN Department meeting minutes and the ED meeting minutes by the hospital on May 18, 2011, revealed that from June 2010 to the present revealed there was no documented evidence of staff education related to the existing policies,nor could the hospital produce any evidence of staff training related to these policies.

14. Patient A's medical record stated that she presented to the hospital on August 14, 2010, and was diagnosed with abruptio placenta. A C-Section was performed on August 15, 2010. Patient A's initial hemoglobin was 12 fell to 6 after the surgery with a documented blood loss of 1000 cc.

15. During an interview with Physician A on May 18, 2011, he/she stated, "[Patient A's] medical record does not contain evidence of my medical decision making regarding the patient's anemia."

16. During an interview with Physician B on May 18, 2011, when asked what he/she would expect to see in a medical record regarding the medical decision making process, he/she stated that there should be clear documentation of that process.

17. A review of Patient A's case by the OB Physicians as documented in the minutes of the department dated January 4, 2011, stated, " No quality issues identified."

18. The OB/GYN Department meeting minutes of January 4, 2011 further stated that an one action was to form a focus group to review communication process.

19. During an interview with the Director, Quality, Risk & Safety on May 18, 2011, he/she stated, " The focus group has not met."

20. Please see TAG A0267 for additional information regarding the measurement, analysis, and tracking of quality indicators, including adverse patient events, and other aspects of performance that assess processes of care, hospital services and operations.


The cumulative effect of these deficient practices resulted in this Condition of Participation being out of compliance.





BLAFL




Complaint Investigation -

#ME00011350 and #ME00011372

Based on review of the Penobscot Bay Medical Center Medical Staff Rules and Regulations, review of Background Information, and interviews with key staff on April 20 and May 18, 2011, it was determined that the Medical Staff did not consistently adhere to their Rules and Regulations.

Findings include:

1. The Penobscot Bay Medical Center Medical Staff Rules and Regulations stated, "F. ON-CALL COVERAGE...The on-call physician is responsible for providing care to any PBMC patient needing such care in the following areas unless she personally arranges for an associate to care for the patient or personally arranges for appropriate transfer to another facility: 3. As required in the Emergency Service Department in accordance with Section "E" of these Rules and Regulations." Section E sated, "....The consulting physician must be physically present within 30 minutes of notification or as promptly as is possible under the circumstances if the condition of the patient, as determined by consultation between the Emergency Services Department and consultant, is deemed stable."

2. During an interview with the Director, Quality, Risk & Safety 20, 2011, she stated that Physician A arrived forty (40) minutes after she was called regarding Patient A. She further stated that the physician had child care issues and it was the weekend of the Rockland Boat Show and there was much traffic.

3. During an interview with Physician A on April 20, 2011, she stated, "I wasn't here in thirty (30) minutes. I think forty (40) minutes."

4. The information received from Patient A on April 13, 2011 stated, "8.14.2011 9:55 a.m. At 9:55 am when I was back in bed, a fetal monitor tracing was begun. [Physician A], the obstretrian on call, was not present. Both I and my aunt clearly recall the nurses informing them that [Physician A] had been contacted and was on his/her way but that [Physician A] would be delayed in arriving because [Physician A] had to find a babysitter for [Physician A's] child or bring his/her child to a babysitter."




BLAFL




Complaint Investigation -

#ME00011350 and #ME00011372