HospitalInspections.org

Based on record review and staff interview it has been determined that the hospital's governing body and medical staff failed to ensure that the ongoing program for quality improvement and patient safety is defined, implemented, and maintained.

Findings are as follows:

Surveyor review of Patient ID #1's medical record indicates that in October 2019, the patient underwent a laparoscopic cholecystectomy (several small incisions to remove the gallbladder) which converted to a laparotomy (an abdominal incison). The specimen, which was thought to be the patient's gallbladder, was sent to pathology for diagnosis and evaluation. The pathology report from 2 days later states there was no gallbladder tissue identified. The tissue was identified as renal parenchyma (kidney tissue). The results of these findings were discussed with the surgeon on that day.

During surveyor interview with the Clinical Quality Coordinator on 12/31/2019 at 12:10 PM, she stated that once she was notified of the incident she scheduled a "special" Medical Staff Performance Improvement Committee meeting to discuss this case. She stated the meeting was held on November 5, 2019, and, based on the committee recommendations a course of action was implemented effective 11/10/2019.

During surveyor interview with the Clinical Quality Coordinator on 12/31/2019 at 12:10 PM, she was unable to provide evidence that the course of action was implemented.

Based on medical record review and review of the Bylaws of the Medical Staff, Rules and Regulations of the Medical Staff (Approved by OLFH Board of Directors on 9/17/2017), it was determined that the hospital's medical staff failed to enforce the rules pertaining to the Bylaws for 6 of 12 patients. (ID #'s 1,7,8,9,10,11).

Findings are as follows:

A.
The Rules and Regulations of the Medical Staff, Section 9. The History and Physical Examination, states, in part:

"All history/physical exams may be performed up to and no more than 30 days prior to admissions. If the history and physical exam is greater than 24 hours and less than 30 days, the physician must update it and document that the history/physical exam is still current, that an appropriate assessment was completed on admission confirming the necessity for the procedure or care is still present; and that the patient's condition has not changed since the history/physical exam was originally completed.

b. Medical History and Physical Examination may include, but not limited to:

HISTORY
Chief Complaint, history of present illness, past medical history, medications allergies, family medical history, social history and review of systems.
PHYSICAL
General, vitals, HEENT, neck, cardiac, pulmonary, abdomen, extremities, skin...
ASSESSMENT AND PLAN"

1. Review of the medical record for Patient ID #7 revealed the patient presented for surgery in January 2020. Further review of the medical record revealed the H&P lacked, at a minimum, evidence of a chief complaint, family medical history, and social history.

During surveyor interview on 1/3/2020 at approximately 12:30 PM, the hospital's Risk Management Coordinator acknowledged that the above H&P lacked bylaws required documentation.

2. Review of the medical record for Patient ID #8 revealed the patient presented for surgery in December 2019. Further review of the medical record revealed that both the H&P dated 11/5/2019 and the updated H&P dated 12/12/2019, both lacked, at a minimum, evidence of past medical history, family medical history and social history.

3. Review of the medical record for Patient ID #9 revealed s/he presented for surgery in January 2020. Further review of the H&P completed on 1/2/2020 revealed an incomplete hand-written H&P document, which lacked, at a minimum, evidence of history of present illness, past medical history, medications and a review of systems.

4. Review of the medical record for Patient ID #10 revealed s/he presented for surgery in December 2019. Further review of the H&P dated 11/12/2019 revealed it lacked, at a minimum, a family medical history. The hand-written updated H&P dated 12/19/2019 was written on an "Interdisciplinary Progress Note" and was illegible to surveyor and marginally legible to the provider.

On 1/2/2020 at 10:00 AM, surveyor interviewed the surgeon who performed the above cases. He acknowledged that his hand-written notes are often illegible and that sometimes he has difficulty deciphering what he has written.

On 1/2/2020 at 2:50 PM, during an interview with the Chairman of Surgery and the Chairman of Medicine, both acknowledged that the hand-written documentation for Patient ID #'s 8, 9 and 10 does not meet the Bylaw criteria for documentation of a History and Physical.

5. Review of the medical record for Patient ID #11 revealed the patient presented for surgery in December 2019. Further review of the medical record revealed a H&P dated 1/2/2020, which was after the surgery was performed. This H&P lacked evidence of, at a minimum, family medical history, medications and social history.

During an interview with the Surgical Services Evidence Based Clinical Leader on 1/3/2020 at approximately 1:00 PM, she stated that there was no prior H&P in the medical record as it was "too old"; the chart was then "flagged" by the Medical Records Department and the physician was required to complete another H&P after surgery was performed.

The facility failed to provide evidence that the above patient's H&P's were performed according to the Bylaws of the Medical Staff.

B.
The Rules and Regulations of the Medical Staff, Section 1. Admission and Transfer of Patients, states, in part:

"J. General Patient Care: ...

(6.) A surgical operation shall not be performed without the informed written consent of the patient or his/her legal representative except in an emergency endangering the life of the patient."

Review of the medical record for Patient ID #1 revealed the written Consent to Operation indicated a Laparoscopic Cholecystectomy (several small incisions to remove the gallbladder) was to be performed. The Operative Note for Patient ID #1 indicates the surgeon performed a Laparoscopic Cholecystecotmy and a Laparotomy (an abdominal incision) during the procedure.

There lacked evidence that the patient was aware that an incision may be performed to complete the surgical procedure.

During surveyor interview with the surgeon on 1/2/2020 at 10:00 AM, he acknowledged that he neglected to include the possibility of converting the procedure to a laparotomy (open abdominal incision) when consenting the patient.

A review of the medical record for patient ID #1 and interviews with staff indicated that the patient is a 37-year-old with a past medical history including, but not limited to, paraplegia secondary to a moter vehicle accident, chronic anemia (low blood values), hypertension (high blood pressure) and stage 3 chronic kidney disease. S/he was admitted to the hospital for possible acute cholecystitis (inflammation of the gallbladder). The patient was in the ICU for several days prior to being cleared for surgery and was transfused 2 units of blood in anticipation of the surgery, which was scheduled for 10/22/2019. The informed consent stated that the patient was undergoing a laparoscopic cholecystectomy (several small abdominal incisions to remove the gallbladder). During the surgical procedure the surgeon was unable to complete the surgery laparoscopically and converted the procedure to a laparotomy (an abdominal incision) with a Jackson Pratt drain (a drain used to remove fluids that build up in the body after surgery).

Further review of the medical record revealed that postoperatively the patient was transferred back to the ICU intubated, hypotensive and with ongoing bleeding of unknown etiology. The patient required 5-6 units of blood and platelets to maintain his/her hemoglobin and hematocrit. On day 2 post surgery the pathology department notified the surgeon that the specimen did not contain gallbladder, instead, it contained renal tissue indicating the presence of pyelonephritis (inflammation of the kidney from infection), which was now believed to be the site of infection. Urology had been involved in the patients care during this admission; given the specimen results they recommended treating the patient as having a partial nephrectomy.

The patient remained in the hospital until discharge on 12/6/2019. The discharge diagnoses included, but were not limited to,abdominal pain, sepsis and acute kidney injury superimposed on chronic kidney injury.

The physician failed to identify and remove the intended body part. This resulted in a condition level deficiency.

Based on record review and review of the hospital policy "Medical Staff Non-Compliance with Delinquent Medical Records", it was determined that the hospital failed to ensure that there was a complete history and physical examination (H&P), and an update, if applicable, in the medical record prior to surgery for 5 of 9 patients. (ID #'s 7,8,9,10,11).

Findings are as follows:

A review of the hospital policy " Medical Staff Non-Compliance with Delinquent Medical Records" states, in part:

III. Policy
"Medical record documentation shall be completed as outlined in the Medical Staff Bylaws and Rules and Regulations. This policy shall provide direction regarding those practitioners that routinely deviate from the intention of the Medical Staff Bylaws/Rules and Regulations."

IV. Definitions
"...History and Physical Content: Per 2014 Rules and Regulations; Section 9, (a), (b) will apply. Outline attached."

"Content of History and Physical (attached outline)
o Chief complaint
o History of present illness
o Past medical history
o Family medical history
o Allergies
o List of Medications (dose, route and frequency)
o Social history
o Review of systems
o Significant labs/testing results
o Physical Exam: General, vital signs, HEENT, neck, Cardiac, Pulmonary, Abdomen, Extremities, Skin
o Assessment and Plan of Care"

1. Review of the medical record for Patient ID #7 revealed the patient presented for surgery in January 2020. Further review of the medical record revealed the H&P lacked, at a minimum, evidence of a chief complaint, family medical history, significant labs/testing results and social history.

During surveyor interview on 1/3/2020 at approximately 12:30 PM, the hospital's Risk Management Coordinator acknowledged that the above H&P lacked required documentation.

2. Review of the medical record for Patient ID #8 revealed the patient presented for surgery in December 2019. Further review of the medical record revealed that the H&P dated 11/5/2019 and the updated H&P dated 12/12/2019, both lacked, at a minimum, evidence of past medical history, family medical history, significant labs/testing results and social history.

3. Review of the medical record for Patient ID #9 revealed s/he presented for surgery in January 2020. Further review of the H&P completed on 1/2/2020 revealed an incomplete hand-written H&P document, which lacked, at a minimum, evidence of history of present illness, past medical history, list of medications (dose, route and frequency) and a review of systems.

4. Review of the medical record for Patient ID #10 revealed s/he presented for surgery in December 2019. Further review of the H&P dated 11/12/2019, lacked, at a minimum, a family medical history and social history. The hand-written updated H&P dated 12/19/2019 was written on an "Interdisciplinary Progress Note" and lacked the same information.

On 1/2/2020 at 10:00 AM, surveyor interviewed the surgeon who performed the above cases; He acknowledged that his hand-written notes are often illegible and that sometimes he has difficulty deciphering what he has written.

On 1/2/2020 at 2:50 PM, during an interview with the Chairman of Surgery and the Chairman of Medicine, both acknowledged that the hand-written H&P's for Patient ID #'s 8, 9 and 10 do not meet the Bylaw criteria for documentation of a H&P.

5. Review of the medical record for Patient ID #11 revealed the patient presented for surgery in December 2019. Further review of the medical record revealed a H&P dated 1/2/2020, which was after the surgery was performed. This H&P lacked evidence of, at a minimum, family medical history, list of medications (dose, route and frequency) and social history.

During an interview with the Surgical Services Evidence Based Clinical Leader on 1/3/2020 at approximately 1:00 PM, she stated that there was no prior H&P in the medical record as it was "too old"; the chart was then "flagged" by the Medical Records Department and the physician was required to complete another H&P after surgery was performed.

The facility failed to provide evidence that the above patient's H&P's were performed according to policy.

Based on record review and staff interview, it has been determined that the hospital failed to properly execute informed written consent for 1 of 1 patients, ID# 1.

Surveyor review of the informed consent documentation for Patient ID #1 dated 10/22/2019 revealed an informed consent for a laparoscopic cholecystectomy (several small incisions to remove the gallbladder) to be performed. Further review of the Operative Note for patient ID # 1 revealed the surgeon performed a laparoscopic cholecystectomy and followed by an open cholecystectomy (an abdominal incision).

During an interview on 1/2/2020 at 10:00 AM with the physician that performed the surgery, he could not provide evidence that patient consented to the laparotomy.