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Based on interview and record review, the facility's Governing Body/Operating Board and Chief Executive Officer (CEO) failed to ensure the facility's operation was conducted in an effective, safe, and organized manner by failing to ensure:

1. The surgeons were informed when pathology results from ectopic pregnancy (occurs when a fertilized egg attaches itself outside of the uterus) surgical procedures were not the results expected or anticipated. (Refer to A0144 and A0347);

2. The surgical procedure the patient consented to was the surgical procedure performed. (Refer to A0144 and A0347);

3. The development, implementation and maintenance of an effective, ongoing, facility-wide, data-driven quality assessment and performance improvement (QAPI) program, in which the Governing Body (GB) ensured the program reflected the different department/services; and the program focused on indicators that improved health outcomes and the prevention of medical errors. (Refer to A0286 and A0308);

4. Patient 1's principal diagnosis of ectopic pregnancy of the left fallopian tube had the correct procedure code documented. In addition, the facility omitted diagnostic codes, including a complication code for Patient 1. (Refer to A0438, A0440 and A0465);

5. A diagnostic complication and the surgical procedure for Patient 16 were coded correctly. (Refer to A0438, A0440 and A0465); and,

6. The facility coding from October 2015 through August 2016, the retrieval of patient listings for codes Y62-Y69 (complications during surgical and medical care) accurately captured the complications of cases within this category. ( Refer to A0440).

7. The "Sterilization Consent Form" was completed prior to the surgical procedure, bilateral tubal ligation for sterilization, being performed. (Refer to A0466 and A0955);

8. The immediate post-operative reports were documented prior to the patient leaving the peri-operative department and the operative reports were complete and accurate. (Refer to A0959); and

9. Acknowledgement of a grievance was completed and written notice of the resolution to the patient's grievance was provided. (Refer to A0122 and A0123).

The cumulative effect of these systemic problems resulted in failure of the Governing Body/Operating Board to ensure patients were receiving quality care in a safe and effective manner.

Based on interview and record review, the facility failed to ensure:

1. Acknowledgement of a grievance was completed for a patient who filed a grievance. (Refer to A0122);

2. Written notice of the facility's resolution to the patient's grievance was provided. (Refer to A0123);

3. The surgeons were informed when pathology results from ectopic pregnancy (occurs when a fertilized egg attaches itself outside of the uterus) surgical procedures were not the results expected or anticipated. (Refer to A0144); and

4. The surgical procedure the patient consented to was the surgical procedure performed, and the patient was informed when the surgical procedure performed was not what she had consented to. (Refer to A0144).

The cumulative effect of these systemic problems resulted in failure to ensure patients were cared for in a safe manner and their rights were protected and promoted at all times.

On September 21, 2016, at 2:05 p.m., the Executive Director Ancillary Services (EDAS), the Director Patient Safety/Quality (DPSQ), and the Director Quality (DQ) were notified of the determination of an Immediate Jeopardy (IJ) situation to the health and safety of patients related to the surgeons not being notified of critical pathology results.

The facility developed a plan of correction, and the EDAS, the DPSQ, and the Clinical Director Pathology (Physician 2) were notified the plan of correction was accepted on September 21, 2016, at 4:45 p.m.

On September 22, 2016, at 1:25 p.m., implementation of the plan of correction was verified, and the Executive Director Ancillary Services was notified the Immediate Jeopardy was removed at 3:45 p.m.

Based on interview and record review, the facility failed to ensure acknowledgement of a grievance file on behalf of Patient 29 (by the patient's pediatrician) was completed for one of four sampled patients. This had the potential to result in a delay in the investigation of the grievance and a missed opportunity for improvement.

Findings:

On September 19, 2016, the facility's grievance log was reviewed.

On September 20, 2016, at 3:34 p.m., the grievance file for Patient 29 was reviewed with the Patient Safety Director (PSD) and the Risk/Patient Relations Manager.

Patient 29's grievance file indicated, on April 11, 2016, Patient 29's pediatrician called the facility regarding the care the facility provided to Patient 29 in the Emergency Department (ED). The pediatrician stated she treated Patient 29 on March 28, 2016, as a follow up per ED instructions. The facility treated the patient for a urinary tract infection but a urinalysis was not completed. The patient presented with fever, vomiting, diarrhea, coughing (times 1 week), and rhinorrhea (times 1 week). The pediatrician issues via the grievance questioned the following treatment:

1) Why was a urinalysis not completed, yet the facility treated/medicated the patient for a urinary tract infection.
2) Why did the facility not treat the patient for influenza? The pediatrician would like a phone call back from the Director of the ED.

During a concurrent interview with the PSD, she reviewed the grievance file and stated the initial letter, in response to the grievance,was not sent since he was not a relative and would be a violation of Health Insurance Portability and Accountability Act (HIPAA); and the grievance was referred to the Emergency Department Director but no follow up was done.

There was no indication the facility had conducted an investigation or sent a letter to the pediatrician with the facility's conclusion of the investigation (162 days after the pediatrician had filed a grievance). The grievance log indicated the case was still pending.

The facility policy and procedure titled "Patient Complaints and Grievances," revised/reviewed March 8, 2016, indicated "... 5.4. All grievances received by Patient Relations from a patient or his or her authorized representative shall receive an initial phone acknowledgement or written acknowledgement with seven (7) days. If the grievance is still in the process of being resolved, this will be communicated in the notification. If the resolution cannot be achieved within a seven (7) day period following the filing of a grievance, the patient shall be notified every 30 business days of the status of the issue and the expected resolution time frame."

Based on interview and record review, the facility failed to ensure written notice of the resolution to the complainant on behalf of Patient 29 grievance was provided for one of four patients (Patient 29). This resulted in the pediatrician not receiving a resolution to the grievance submitted.

Findings:

On September 19, 2016, the facility's grievance log was reviewed.

On September 20, 2016, at 3:34 p. m., the following grievance files were reviewed with the Patient Safety Director (PSD) and the Risk/Patient Relations Manager:

Patient 29's grievance file indicated, on April 11, 2016, Patient 29's pediatrician called the facility regarding the care the facility provided to Patient 29 in the Emergency Department (ED). The pediatrician stated she treated Patient 29 on March 28, 2016, as a follow up per ED instructions. The facility treated the patient for a urinary tract infection but a urinalysis was not completed. The patient presented with fever, vomiting, diarrhea, coughing (times 1 week), and rhinorrhea (times 1 week). The pediatrician issues via the grievance questioned the following treatment:

1) Why was a urinalysis not completed, yet the facility treated/medicated the patient for a urinary tract infection.
2) Why did the facility not treat the patient for influenza? The pediatrician would like a phone call back from the Director of the ED.

During a concurrent interview with the PSD, she reviewed the grievance file and stated the initial letter, in response to the grievance,was not sent since he was not a relative and would be a violation of Health Insurance Portability and Accountability Act (HIPAA); and the grievance was referred to the Emergency Department Director but no follow up was done.

There was no indication the facility had conducted an investigation or sent a letter to the pediatrician with the facility's conclusion of the investigation (162 days after the pediatrician had filed a grievance). The grievance log indicated the case was still pending.

The facility policy and procedure titled "Patient Complaints and Grievances," revised/reviewed March 8, 2016, indicated "... 5.4. All grievances received by Patient Relations from a patient or his or her authorized representative shall receive an initial phone acknowledgement or written acknowledgement with seven (7) days. If the grievance is still in the process of being resolved, this will be communicated in the notification. If the resolution cannot be achieved within a seven (7) day period following the filing of a grievance, the patient shall be notified every 30 business days of the status of the issue and the expected resolution time frame."

Based on interview and record review, the facility failed:

1. To ensure the surgeons were informed, when pathology results from ectopic pregnancy (occurs when a fertilized egg attaches itself outside of the uterus) surgical procedures, were not the results expected or anticipated for two sampled patients (Patients 1 and 16). This resulted in a delay in care and treatment for Patient 1's and 16's continued pregnancies, and had the potential to result in harm and possible death to the patients. In addition, this resulted in a delay in the notification to the surgeons that ectopic pregnancies for Patients 1 and 16 had not been resolved during the surgical procedures performed.

2. To ensure the surgical procedure the patient consented to was the same surgical procedure performed, and the patient was informed when the surgical procedure performed was not the same as the consent for one sampled patient (Patient 1). This resulted in Patient 1 having the right fallopian tube removed in error, another surgical procedure to remove the left fallopian tube ectopic pregnancy eight (8) days later, and Patient 1 not being able to conceive without In Vitro (eggs and sperm are brought together in a laboratory glass dish to allow the sperm to fertilize an egg) Fertilization in the future.

Findings:

1a. On August 3, 2016, and September 19, 2016, the record for Patient 1 was reviewed.

Patient 1, a 29 year old gravida (number of pregnancies) 3, para (number of pregnancies reaching viable gestation) 0, with a last menstrual period of June 10, 2016, presented to the facility Emergency Department (ED) on July 20, 2016, at 5:17 p.m., with the chief complaint of ectopic pregnancy as seen by ultrasound (type of imaging that uses high-frequency sound waves to look at organs and structures inside the body) in primary care physician's office.

On July 20, 2016, at 6:53 a.m., an ultrasound was performed to rule out an ectopic pregnancy and indicated "single ectopic pregnancy adjacent to left ovary in adnexal region."

The "ED Note - Physician" dated July 20, 2016, at 8:39 p.m., indicated Patient 1 had pelvic pain, was less than 20 weeks pregnant, Physician 1 (the ED on call Obstetrician) was notified, and Physician 1 accepted the patient as a surgical admission.

The "History and Physical" by Physician 1 dated July 20, 2016, at 9:22 p.m., indicated the diagnosis as ectopic pregnancy and laparoscopic left salpingectomy (surgical removal of a fallopian tube that is often related to tubal pregnancies), possible exploratory laparotomy would be performed.

The "Consent to Surgery or Special Procedure" dated July 20, 2016, at 9:15 p.m., and signed by Patient 1, indicated a "laparoscopic left salpingectomy, possible exploratory laparotomy" operation was to be performed.

The "Intraoperative Nursing Record," by Registered Nurse (RN) 1, dated July 20, 2016, at 11:03 p.m., indicated the procedure as a "Laparoscopic Salpingectomy (Left)," consents were verified, the procedure description modifier was "left," and a specimen was ordered.

The "Operative Report," by Physician 1, dated July 20, 2016, at 11:04 p.m., indicated the findings as "Left tubal pregnancy" and "Right distal hydrosalpinx (blocked fallopian tube filled with serous or clear fluid which may become substantially distended giving the tube a characteristic sausage-like shape)."

The "Pathology Specimen Accession Log" dated July 20, 2016, indicated the specimen as the "left fallopian tube," and the specimen was taken to pathology on July 21, 2016, at 7:30 a.m., by the Clinical Specialist Technician (CST).

The "Modified - Operative Report," by Physician 1, dated July 20, 2016, at 11:37 p.m., indicated the findings as "Right tubal pregnancy" and "Left fallopian tube with small distal hydrosalpinx."

Patient 1 was discharged from the facility on July 21, 2016, at 1:05 a.m., with instructions to follow-up with Physician 1 in two weeks.

During a telephone interview with RN 2, on August 11, 2016, at 8:01 a.m., she stated she received a telephone call from Physician 1, on July 21, 2016, first thing in the morning, and Physician 1 wanted RN 2 to "correct/change" the documentation on the "Intraoperative Nursing Record" for Patient 1's surgery from "Laparoscopic Salpingectomy (Left)" to "Laparoscopic Salpingectomy (Right)." RN 2 stated Physician 1 stated she had told RN 1, during surgery on July 20, 2016, the incorrect side and Physician 1 had actually removed the right fallopian tube. In addition, RN 2 stated Physician 1 requested she go to pathology and change the specimen label from "left fallopian tube" to "right fallopian tube."

The "Modified - Intraoperative Nursing Record," by RN 2, dated July 21, 2016, at 8:06 a.m. (9 hours after the surgical procedure), indicated the procedure as a "Laparoscopic Salpingectomy - Right."

On July 21, 2016, at 7:44 a.m., the laboratory/pathology order and specimen description was changed from left fallopian tube to right fallopian tube.

The preliminary surgical pathology report on the "right fallopian tube" dated July 22, 2016, at 5:10 p.m., indicated "The initial sampling does not show changes for an ectopic pregnancy in this tube. The tube will be totally embedded, but additional sites for ectopic pregnancy should be considered."

The "Surgical Pathology Final Report" dated July 26, 2016, at 8:39 a.m., indicated "No villi or gestational changes are found with complete embedding of the tube. As mentioned in the Preliminary report, the possibility of an ectopic pregnancy at another site should be considered."

During a telephone interview with Physician 3, on September 19, 2016, at 10:30 a.m., he stated he tried to contact Physician 1, on July 22, 2016, in the early afternoon, by calling the physician's office and requesting a call back in regards to an "important finding" for Patient 1. Physician 3 stated he never spoke with Physician 1 in regards to the pathology findings of no pregnancy identified in the right fallopian tube.

During a telephone interview with Physician 1, on September 19, 2016, at 2:56 p.m., she stated:
- She had spoken with the patient about a left tubal pregnancy;
- Patient 1 had consented to a laparoscopic left salpingectomy;
- When they were in the Operating Room (OR), the left fallopian tube was removed/specimen being sent to pathology; and,
- She initially typed the operative note as left tubal pregnancy.

Physician 1 stated when she got home she realized she had removed the right fallopian tube and modified the operative report to indicate a right tubal pregnancy. In addition, Physician 1 stated she called the OR the next morning, and spoke with RN 2 to correct the "Intraoperative Nursing Record" to "Laparoscopic Salpingectomy (Right)," and to have the specimen label corrected to right fallopian tube.

Physician 1 stated she received the pathology results via facsimile on July 27, 2016 (one week after the initial surgical procedure). Physician 1 stated she was surprised that she had not received a telephone call from the pathologist when there was no pregnancy identified in the right fallopian tube. Physician 1 stated none of her office personnel remembered getting a telephone call from a facility pathologist and she did not receive a page from the facility pathologist.

Further review of Patient 1's record indicated Patient 1 presented to the facility ED on July 24, 2016 (Sunday), at 2:36 a.m., with the chief complaint of "pain around surgical site and gas."

The nursing "Triage Note" dated July 24, 2016, at 2:42 a.m., indicated Patient 1 had a laparoscopy for an ectopic pregnancy on July 20, 2016.

The "ED Note-Physician" dated July 24, 2016, at 6:08 a.m., indicated Patient 1 had a "laparoscopic cholecystectomy (surgical removal of the gallbladder) on Wednesday (July 20, 2016)."

Patient 1 was discharged from the facility on July 24, 2016, at 3:17 a.m. (total time at facility was 41 minutes).

In addition, Patient 1 presented to the facility ED on July 28, 2016, at 3:24 p.m., with the chief complaint of left lower abdominal pain, "ectopic pregnancy."

On July 28, 2016, at 4:19 p.m., a quantitative HCG test was performed which indicated Patient 1 was pregnant (result 21,311.0 mlU/ml - 6 weeks pregnant, 28 days after conception).

On July 28, 2016, at 5:57 p.m., an ultrasound was performed which indicated "There is a left adnexal ectopic pregnancy which was also reported on July 20, 2016," and the ectopic pregnancy was now "with a positive fetal heart (tone)."

The "Intraoperative Nursing Record" dated July 28, 2016, at 10:40 p.m., indicated Patient 1 underwent an operative laparoscopy for removal of the left fallopian tube and ectopic pregnancy. A specimen was sent to pathology (8 days after the left ectopic pregnancy was diagnosed).

The "Surgical Pathology Final Report" dated August 1, 2016, at 11:33 a.m., indicated "Chorionic villi present within fallopian tube, consistent with ectopic pregnancy."

1. b. On September 20, 2016, the medical record for Patient 16 was reviewed. Patient 16 was admitted to the facility through the Emergency Department (ED) on July 16, 2016, at 4:05 p.m., with a chief complaint of, "6 weeks preg [pregnant] lmp [last menstrual period]: 6/2016...blood in urine pain left groin..."

A blood test was performed on July 16, 2016, at 4:22 p.m., and indicated a Beta-human Chorionic Gonadotropin (B-hCG) level of 1970.0 which is indicative of approximately six weeks into a pregnancy.

The ED physician consulted with Physician 5, an obstetrician, on July 16, 2016, at 7:33 p.m. The ED physician's documentation regarding the consult with Physician 5 indicated, "...I then discussed with [Physician 5] the ob [obstetrician] doctor on call who came and evaluated the patient and felt it was an ectopic pregnancy and took the patient to the or [operating room]..."

According to the operative report, dated July 16, 2016, Physician 5 documented, "...preoperative diagnosis as, presumptive left tubal pregnancy and postoperative diagnosis as, left tubal pregnancy..." Physician 5 documented the description of the procedure as, "...Examination of the pelvis revealed a left tubal pregnancy that was readily visible...Attention was then directed to the tubal pregnancy. A linear salpingostomy [an opening up or look into a fallopian tube] was then performed...and the tubal pregnancy was able to be removed from the tube without any complications. The tissues were removed and the tube copiously irrigated and cleared of all clots and debris and no evidence of any ectopic remnant tissues were noted..." The Operative Report by Physician 5 indicated, "Finding: + [positive] left tubal pregnancy...normal left ovary. Normal right tube and ovary. Normal uterus..." The perioperative report indicated a specimen was collected.

The specimen log book in the perioperative area, indicated the specimen was picked up by the pathology department on July 18, 2016, at 7:48 a.m. The pathologist (Physician 2) finalized the report for the specimen on July 19, 2016, at 8:34 p.m. The pathology tissue request that accompanied the specimen indicated, "...Specimen description: Products of Conception...Pre-operative diagnosis: Left Tubal Pregnancy..." The pathology report finalized by Physician 2 indicated, "...Diagnosis, Products of conception: Predominantly blood clot and fibrin, No chorionic villi identified...Clinical Information, Pre-Operative diagnosis: Left tubal pregnancy...Specimen source, Products of conception..."

On September 21, 2016, at 10:25 a.m., Physician 2 was interviewed. Physician 2 stated, when an expected result of pregnancy tissue was not seen in a pathology report of tissues from a surgery to evacuate an ectopic tubal pregnancy, the surgeon should be called as soon as possible with the critical results. Physician 2 stated, "The concern is that the patient could still be pregnant."

On September 21, 2016, at 2:45 p.m., Physician 5 was interviewed. Physician 5 stated, he had the pathology report when he saw Patient 16 in his office a week after surgery and he understood the results to be, products of conception. According to an interview with Physician 2 on September 21, at 10:25 a.m., the pathology report listed, "products of conception" as the name of the tissue that was sent to the lab. The result of the examination of the tissue was indicated as, "predominantly blood clot and fibrin, no chorionic villi [human embryonic membrane] identified" Physician 5 stated, the facility did not call him with results of the pathology report.

Further review of Patient 16's record indicated, she returned to the Emergency Department at the facility on August 3, 2016, with a diagnosis of ectopic pregnancy. Ultrasound performed August 3, 2016, at 5:46 p.m., indicated, "...large complex mass in the left adnexa measuring 5.6 x 3.5 cm [centimeter]. The mass in the left adnexa present on today's examination is larger than the mass in the left adnexa on the comparison exam dated July 16, 2016...Of particular note, the beta hCG levels have risen from 1,970 on 7/16/2016 to 3,705. Please exclude ectopic pregnancy/incomplete evacuation of an ectopic pregnancy..."

Patient 16 underwent surgery by Physician 6, on August 3, 2016, for her ectopic pregnancy that had grown in size since her July 16, 2016, surgery (18 days prior) to the point of rupturing her left fallopian tube. Physician 6 removed the ectopic pregnancy along with the left fallopian tube.

On September 21, 2016, the facility's clinical laboratory policy titled, "Critical values," version June 24, 2016, was reviewed. The policy indicated, "...The pathologist makes a clinically critical diagnosis. Note: This critical diagnosis is made at the discretion of each individual pathologist. The pathologist notifies the physician responsible for the patient. The pathologist documents notification in the patient test report..."

On September 21, 2016, at 2:05 p.m., the Executive Director Ancillary Services (EDAS), the Director Patient Safety/Quality (DPSQ), and the Director Quality (DQ) were notified of the determination of an Immediate Jeopardy (IJ) situation to the health and safety of patients related to the surgeons not being notified of critical pathology results.

The facility developed a plan of correction, and the EDAS, DPSQ, and Clinical Director Pathology (Physician 2) were notified the plan of correction was accepted on September 21, 2016, at 4:45 p.m.

The plan of correction included:

a. Immediate communication to all Pathology Medical Staff, Laboratory Staff, Medical Staff Leadership, and Department of Surgery Staff (medical and nursing) in regards to the change in the facility policy and procedure of reporting, to the surgeon, by the pathologist or designee, when the expected result of an ectopic pregnancy was not identified in the pathology specimen.

b. Documentation in the record, of the surgeons' notification of the critical value, and if the initial notification was made by the designee, the pathologist follow-up with the surgeon.

c. Initiation of the chain of command if the surgeon cannot be reached.

On September 22, 2016, at 1:25 p.m., implementation of the plan of correction was verified, and the Executive Director Ancillary Services was notified the Immediate Jeopardy was removed at 3:45 p.m.

2. On August 3, 2016, and September 19, 2016, the record for Patient 1 was reviewed.

i. Patient 1, a 29 year old gravida (number of pregnancies) 3, para (number of pregnancies reaching viable gestation) 0, with a last menstrual period of June 10, 2016, presented to the facility Emergency Department (ED) on July 20, 2016, at 5:17 p.m., with the chief complaint of ectopic pregnancy as seen by ultrasound (type of imaging that uses high-frequency sound waves to look at organs and structures inside the body) in primary care physician's office.

On July 20, 2016, at 5:46 p.m., a quantitative HCG (human chorionic gonadotropin - a hormone produced in the body during pregnancy, measures the specific level of HCG in the blood) test was performed which indicated Patient 1 was pregnant (result 6,595 mlU/ml (Milli-International Units per Milliliter) - 5 weeks pregnant, 21 days after conception).

On July 20, 2016, at 6:53 p.m., an ultrasound was performed to rule out an ectopic pregnancy and indicated "single ectopic pregnancy adjacent to left ovary in adnexal region."

The "ED Note - Physician" dated July 20, 2016, at 8:39 p.m., indicated Patient 1 had pelvic pain, was less than 20 weeks pregnant, Physician 1 (the ED on call Obstetrician) was notified, and Physician 1 accepted the patient as a surgical admission.

The "History and Physical" by Physician 1 dated July 20, 2016, at 9:22 p.m., indicated the diagnosis as ectopic pregnancy and laparoscopic left salpingectomy (surgical removal of a fallopian tube that is often related to tubal pregnancies), possible exploratory laparotomy would be performed.

The "Consent to Surgery or Special Procedure" dated July 20, 2016, at 9:15 p.m., and signed by Patient 1, indicated a "laparoscopic left salpingectomy, possible exploratory laparotomy" operation was to be performed.

The "Intraoperative Nursing Record," by Registered Nurse (RN) 1, dated July 20, 2016, at 11:03 p.m., indicated the procedure as a "Laparoscopic Salpingectomy (Left)," consents were verified, the procedure description modifier was "left," and a specimen was ordered.

The "Operative Report," by Physician 1, dated July 20, 2016, at 11:04 p.m., indicated the findings as "Left tubal pregnancy" and "Right distal hydrosalpinx (blocked fallopian tube filled with serous or clear fluid which may become substantially distended giving the tube a characteristic sausage-like shape)."

The "Pathology Specimen Accession Log" dated July 20, 2016, indicated the specimen as the "left fallopian tube," and the specimen was taken to pathology on July 21, 2016, at 7:30 a.m., by the Clinical Specialist Technician (CST).

The "Modified - Operative Report," by Physician 1, dated July 20, 2016, at 11:37 p.m., indicated the findings as "Right tubal pregnancy" and "Left fallopian tube with small distal hydrosalpinx."

Patient 1 was discharged from the facility on July 21, 2016, at 1:05 a.m., with instructions to follow-up with Physician 1 in two weeks.

There was no documented indication in the record that the patient/patient's responsible party was informed which fallopian tube had been removed (left or right).

During a telephone interview with RN 2, on August 11, 2016, at 8:01 a.m., she stated she received a telephone call from Physician 1, on July 21, 2016, first thing in the morning, and Physician 1 wanted RN 2 to "correct/change" the documentation on the "Intraoperative Nursing Record" from "Laparoscopic Salpingectomy (Left)" to "Laparoscopic Salpingectomy (Right)." RN 2 stated Physician 1 stated she had told RN 1, during surgery on July 20, 2016, the incorrect side and Physician 1 had actually removed the right fallopian tube. In addition, RN 2 stated Physician 1 requested her to go to pathology and change the specimen label from "left fallopian tube" to "right fallopian tube."

The "Modified - Intraoperative Nursing Record," by RN 2, dated July 21, 2016, at 8:06 a.m. (9 hours after the surgical procedure), indicated the procedure as a "Laparoscopic Salpingectomy - Right."

The preliminary surgical pathology report on the "right fallopian tube" dated July 22, 2016, at 5:10 p.m., indicated "The initial sampling does not show changes for an ectopic pregnancy in this tube. The tube will be totally embedded, but additional sites for ectopic pregnancy should be considered."

ii. Patient 1 presented to the facility ED on July 24, 2016 (Sunday), at 2:36 a.m., with the chief complaint of "pain around surgical site and gas."

The nursing "Triage Note" dated July 24, 2016, at 2:42 a.m., indicated Patient 1 had a laparoscopy for an ectopic pregnancy on Wednesday (July 20, 2016).

The "ED Note-Physician" dated July 24, 2016, at 6:08 a.m., indicated Patient 1 had a "laparoscopic cholecystectomy (surgical removal of the gallbladder) on Wednesday (July 20, 2016)."

Patient 1 was discharged from the facility on July 24, 2016, at 3:17 a.m. (total time at facility was 41 minutes).

There was no documented indication laboratory tests were performed, an ultrasound was done or the surgical case/preliminary pathology report from the laparoscopic salpingectomy was reviewed.

The "Surgical Pathology Final Report" dated July 26, 2016, at 8:39 a.m., indicated "No villi or gestational changes are found with complete embedding of the tube. As mentioned in the Preliminary report, the possibility of an ectopic pregnancy at another site should be considered."

iii. Patient 1 presented to the facility ED on July 28, 2016, at 3:24 p.m., with the chief complaint of left lower abdominal pain, "ectopic pregnancy."

On July 28, 2016, at 4:19 p.m., a quantitative HCG test was performed which indicated Patient 1 was pregnant (result 21,311.0 mlU/ml - 6 weeks pregnant, 28 days after conception).

On July 28, 2016, at 5:57 p.m., an ultrasound was performed which indicated "There is a left adnexal ectopic pregnancy which was also reported on July 20, 2016," and the ectopic pregnancy was now "with a positive fetal heart (tone)."

The "Intraoperative Nursing Record" dated July 28, 2016, at 10:40 p.m., indicated Patient 1 underwent an operative laparoscopy for removal of the left fallopian tube and ectopic pregnancy, and a specimen was sent to pathology (8 days after the left ectopic pregnancy was diagnosed).

The "Surgical Pathology Final Report" dated August 1, 2016, at 11:33 a.m., indicated "Chorionic villi present within fallopian tube, consistent with ectopic pregnancy."

During an interview with RN 5, on September 19, 2016, at 1:56 p.m., she stated Patient 1 was being cared for by RN 6 in the Post Anesthesia Care Unit (PACU), and she received two telephone calls from Physician 1 while Patient 1 was in the PACU following surgery on July 20, 2016. RN 5 stated the first telephone call from Physician 1 was in regards to the patient's blood type, and if the patient was Rh (Rhesus factor) negative would need RhoGam (Rho(D) immune globulin). RN 5 stated she received the second telephone call from Physician 1, on July 20, 2016, at 11:25 p.m., and Physician 1 stated she had actually removed the right fallopian tube not the left because when she visualized the tube the right needed to be removed. RN 5 stated she was instructed by the Physician to inform the patient and the patient's responsible party that the Physician would explain and discuss the surgery at the patient's follow-up office visit in two weeks. RN 5 stated she did not inform Patient 1/Patient 1's responsible party that Physician 1 had removed the right fallopian tube not the left fallopian tube.

During a telephone interview with Physician 1, on September 19, 2016, at 2:56 p.m., she stated:
- She had spoken with the patient about a left tubal pregnancy;
- Patient 1 had consented to a laparoscopic left salpingectomy;
- When they were in the Operating Room (OR), it was the left fallopian tube was removed/specimen being sent to pathology;
- She initially typed the operative note as left tubal pregnancy; and
- She had told Patient 1's responsible party after the surgery that the patient's left fallopian tube had been removed.

Physician 1 stated when she got home she realized she had removed the right fallopian tube and modified the operative report to indicate a right tubal pregnancy. Physician 1 stated the right fallopian tube was enlarged, and she really thought the right side was the tubal pregnancy. Physician 1 stated she did not have the ultrasound report with her when she went into surgery, and she thought it was unusual that the ultrasound report had not commented on the distal hydrosalpinx of the right fallopian tube.

In addition, Physician 1 stated she called the Post Anesthesia Care Unit (PACU) before Patient 1 was discharged from the facility, and requested the PACU RN inform the patient and the patient's responsible party that the tubal pregnancy was on the right side and the right fallopian tube had been removed. Physician 1 stated she called the OR the next morning, and spoke with RN 2 to correct the "Intraoperative Nursing Record" to "Laparoscopic Salpingectomy (Right)," and to have the specimen label corrected to right fallopian tube.

Physician 1 stated the first time she spoke with Patient 1/Patient 1's responsible party, in regards to removing the right fallopian tube, was on July 27, 2016 (one week after the initial surgical procedure), when she received the pathology results via facsimile, and she instructed the patient to return to the ED. Physician 1 stated she was surprised that she had not received a telephone call from the pathologist when there was no pregnancy identified in the right fallopian tube. Physician 1 stated none of her office personnel remembered getting a telephone call from a facility pathologist and she did not receive a page from the facility pathologist.

The facility Medical Staff Rules and Regulations, revised May 12, 2015, revealed "... A surgical operation shall be performed only on written, informed consent of the patient, or the parent, when the patient is a minor, or legal guardian. ..."

The facility policy and procedure titled "Event Reporting" reviewed/revised January 22, 2016, revealed "... Surgical or Invasive Procedure Events ... Surgery or other invasive procedure performed on the wrong site. ... When an unanticipated clinical outcome, complication or adverse reaction occurs during the delivery of patient care it is the primary responsibility of the physician who delivered care to communicate and provide information to the patient and/or patient's family/surrogate. ... "

The facility policy and procedure titled "Patients Rights and Responsibilities" reviewed/revised December 3, 2015, revealed "... The following are patient rights: ... Receive information about your health status, diagnosis, prognosis, course of treatment, prospects for recovery and outcomes of care (including unanticipated outcomes) in terms you can understand. You have the right to effective communication and to participate in the development and implementation of your plan of care. ..."


33801

Based on interview and record review, the facility failed to develop, implement, and maintain an effective, data driven, quality assessment performance improvement (QAPI) program by failing to ensure:

1. Performance improvement activities identified adverse patient events, analyzed their causes, and implemented preventive measures to prevent reoccurrence. (Refer to A0286);

2. Services furnished under contract or arrangement were included in the facility's quality assessment, performance improvement program. (Refer to A0308);

3. The accuracy of coding (assigning approved alpha and numerical codes for medical diagnoses and health procedures performed) records for assignment of International Classification of Diseases-10th revision - Clinical Modification and Procedure Coding System (ICD-10-CM & PCS, the national approved coding system for medical records) was monitored for accuracy. (Refer to A0297);

4.. Compliance with the Condition of Participation for Governing Body, by the identification of the deficient practices, or by ensuring interventions were in place to improve them. (Refer to A0043);

5. Compliance with the Condition of Participation for Patient's Rights, by the identification of the deficient practices, or by ensuring interventions were in place to improve them. (Refer to A0115); and

6. Compliance with the Condition of Participation for Medical Record Services, by the identification of the deficient practices, or by ensuring interventions were in place to improve them. (Refer to A0431).

The cumulative effect of these systemic problems resulted in existing problems throughout the facility to go unrecognized and uncorrected, and failure to ensure quality care and treatment was being provided in a safe and effective manner.

Based on interview and record review, the facility failed to ensure performance improvement activities identified adverse patient events, analyzed their causes, and implemented preventive measures to prevent reoccurrence.

The facility was informed on July 28, 2016, by Patient 1/Patient 1's responsible party of an adverse event which occurred on July 20, 2016, and involved a critical pathology result which was not directly communicated to the surgeon. In addition, on September 21, 2016, it was identified that the surgeon for Patient 16, on July 16, 2016, was not notified when a critical pathology result was obtained.

This failed practice resulted in the identification of immediate jeopardy related to the surgeons not being notified of critical pathology results, violations of patient's rights (refer to A0144), and the potential for harm or death to patients.

Findings:

During an interview with the Executive Director Ancillary Services (EDAS) and the Director Patient Safety/Quality (DPSQ), on September 20, 2016, at 1:25 p.m., they stated Laboratory/Pathology Services was a contracted service. They stated the Laboratory/Pathology Services had quality indicators but critical pathology results were not something the facility had monitored.

During an interview with Members of the Performance Improvement Committee (PIC), on September 22, 2016, at 9 a.m., when asked if there were any quality measures for the pathology service regarding critical values, they stated "no." They stated they were not aware until September 21, 2016, of the second event involving a critical pathology result, and had not implemented a procedure for the evaluation of pre and post operative discrepancies for pathology specimens.

A review of the performance improvement meeting minutes indicated there was no data being collected, reported, or analyzed for the reporting of critical pathology results.

Based on interview and record review, the facility failed to ensure the quality of contracted coding (assigning approved alpha and numerical codes for medical diagnoses and health procedures performed) services for accurate assignment of International Classification of Diseases - 10th revision - Clinical Modification and Procedure Coding System (ICD-10-CM & PCS, the national approved coding system for medical records) in four out of nine patient records reviewed, discharged from October 2015-August 2016.

This failure resulted in inaccurate coding of discharged inpatient records which had the potential to limit data gathering and case sampling to monitor facility effectiveness, safety of services and quality of care, as well as create errors of diagnostic and procedural coding for claims billing.

Findings:

In an interview with the Director of Health Information Management (DHIM), HIM Coding Director (HIMCD), HIM Trainer, Vice President of Revenue Cycle and the Therapy Services Director on September 20, 2016 at 9:47 a.m., the DHIM stated all the facility coding was not done in the facility and was done by an external vendor. Of the nearly 10,000 discharges per year, 80-85% of the coding was done by one vendor and the remaining coding work was done by a second vendor. The coding work, as submitted by the contracted coding vendor, was directed by the DHIM, and managed by the HIMCD.

For review of the coding, the DHIM stated that two coding audits were performed last year for the facility, and the DHIM and HIMCD were unaware of the results of recent audits. The DHIM stated there is a turnaround time with coding completed in one day after discharge.

A review of the facility policy "Coding and Documentation for Inpatient Services" section stated "To achieve consistency in the coding of diagnoses and procedure, coders must: Thoroughly review the entire medical record as part of the coding process in order to assign and report the most appropriate codes...Query the attending physician for documented confirmation of the condition when diagnoses or procedures are stated in other medical record documentation (nurses notes, pathology reports, radiology reports, laboratory reports...Use medical record documentation to attain specificity in coding, such as used the radiology report ..." The Coding Procedure also stated "Coders must not:...Misrepresent the patient's clinical picture through incorrect coding or adding diagnoses/procedures unsupported by the documentation for any reason."The policy stated the DHIM and the Director of Patient Financial Services were responsible to ensure compliance of the Coding Policy.

During an interview with the facility Governing Board on September 22, 2016, at 10:05 a.m., the group reported that the coding vendor contract was not reviewed by the committee. When asked about the complication cases that were missed and not trackable because of inaccurate coding, the board stated that an external consulting company had been consulted "two years ago ... when issues with coding were identified" and presently the "audit process...(needed) to be stepped up."

During a record review of facility coding from October 2015 - August 2016, the patient listing for ICD-10-CM complication codes Y62 -Y69 ("Complications during surgical and medical care"), failed to accurately identify complication cases as coded by the external vendor coders, in four of nine reviewed cases.

These failures in accuracy of diagnosis and procedure coding resulted in incomplete code capture (having all data gathered for cases of particular code assignments) and incomplete quality tracking of hospital complications.

Based on interview and record review, the facility failed to ensure services furnished under contract or arrangement were included in the facility's quality assessment, performance improvement program. This resulted in the facility and the Governing Body being unaware if quality services, under contractual agreements, were being provided to the patients/facility in a safe and effective manner.

Findings:

On September 20, 2016, the Performance Improvement Plan was reviewed.

There was an indication that four (4) of the facility's multiple contracted services had been reviewed.

There was no indication the quality of services provided under the medical records coding contracts, physician emergency services contract, temporary staffing agency contracts, or telemedicine services contract had been assessed and reviewed.

During an interview with the Executive Director Ancillary Services (EDAS) and Director Patient Safety/Quality (DPSQ), on September 20, 2016, at 1:25 p.m., when asked if an annual review of the quality of service provided by all contracted services had occurred, they stated the facility had reviewed the contracts for dialysis services, clinical laboratory services, wound care, and organ procurement. They stated the quality of services provided under the other facility contracts had not been assessed, reviewed or presented to the Governing Body for approval.

The facility policy and procedure titled "Contract and Document Control" reviewed/revised June 4, 2015, revealed "... Hospital shall evaluate and review annually all contract services and submit such review and evaluation to Medical Executive Committee and Governing Body for approval. ..."

Based on interview and record review, the facility failed to ensure the Medical Staff was organized and accountable to the Governing Body/Operational Board by failing to ensure:

1. The surgeons were informed, when pathology results from ectopic pregnancy (occurs when a fertilized egg attaches itself outside of the uterus) surgical procedures, were not the results expected or anticipated. (Refer to A0347); and

2. The surgical procedure the patient consented to was the surgical procedure performed, and the patient was informed when the surgical procedure performed was not what the patient had consented to. (Refer to A0347).

The cumulative effect of these practices increased the risk of substandard quality of care for all facility patients.

Based on interview and record review, the facility failed to ensure the Medical Staff was organized and accountable to the Governing Body/Operational Board by failing:

1. To ensure the surgeons were informed, when pathology results from ectopic pregnancy (occurs when a fertilized egg attaches itself outside of the uterus) surgical procedures were not the results expected or anticipated for two sampled patients (Patients 1 and 16). This resulted in a delay in care and treatment for Patient 1's and 16's continued pregnancies, and had the potential to result in harm and possible death to the patients. This resulted in a delay in the notification to the surgeons that ectopic pregnancies for Patients 1 and 16 had not been resolved during the surgical procedures performed.

2. To ensure the surgical procedure the patient consented to was the same surgical procedure performed, and the patient was informed when the surgical procedure performed was not the same as the consent for one sampled patient (Patient 1). This resulted in Patient 1 having the right fallopian tube removed in error, another surgical procedure to remove the left fallopian tube ectopic pregnancy eight (8) days later, and Patient 1 not being able to conceive without In Vitro (eggs and sperm are brought together in a laboratory glass dish to allow the sperm to fertilize an egg) Fertilization in the future.

Findings:

1a. On August 3, 2016, and September 19, 2016, the record for Patient 1 was reviewed.

Patient 1, a 29 year old gravida (number of pregnancies) 3, para (number of pregnancies reaching viable gestation) 0, with a last menstrual period of June 10, 2016, presented to the facility Emergency Department (ED) on July 20, 2016, at 5:17 p.m., with the chief complaint of ectopic pregnancy as seen by ultrasound (type of imaging that uses high-frequency sound waves to look at organs and structures inside the body) in primary care physician's office.

On July 20, 2016, at 6:53 a.m., an ultrasound was performed to rule out an ectopic pregnancy and indicated "single ectopic pregnancy adjacent to left ovary in adnexal region."

The "ED Note - Physician" dated July 20, 2016, at 8:39 p.m., indicated Patient 1 had pelvic pain, was less than 20 weeks pregnant, Physician 1 (the ED on call Obstetrician) was notified, and Physician 1 accepted the patient as a surgical admission.

The "History and Physical" by Physician 1 dated July 20, 2016, at 9:22 p.m., indicated the diagnosis as ectopic pregnancy and laparoscopic left salpingectomy (surgical removal of a fallopian tube that is often related to tubal pregnancies), possible exploratory laparotomy would be performed.

The "Consent to Surgery or Special Procedure" dated July 20, 2016, at 9:15 p.m., and signed by Patient 1, indicated a "laparoscopic left salpingectomy, possible exploratory laparotomy" operation was to be performed.

The "Intraoperative Nursing Record," by Registered Nurse (RN) 1, dated July 20, 2016, at 11:03 p.m., indicated the procedure as a "Laparoscopic Salpingectomy (Left)," consents were verified, the procedure description modifier was "left," and a specimen was ordered.

The "Operative Report," by Physician 1, dated July 20, 2016, at 11:04 p.m., indicated the findings as "Left tubal pregnancy" and "Right distal hydrosalpinx (blocked fallopian tube filled with serous or clear fluid which may become substantially distended giving the tube a characteristic sausage-like shape)."

The "Pathology Specimen Accession Log" dated July 20, 2016, indicated the specimen as the "left fallopian tube," and the specimen was taken to pathology on July 21, 2016, at 7:30 a.m., by the Clinical Specialist Technician (CST).

The "Modified - Operative Report," by Physician 1, dated July 20, 2016, at 11:37 p.m., indicated the findings as "Right tubal pregnancy" and "Left fallopian tube with small distal hydrosalpinx."

Patient 1 was discharged from the facility on July 21, 2016, at 1:05 a.m., with instructions to follow-up with Physician 1 in two weeks.

During a telephone interview with RN 2, on August 11, 2016, at 8:01 a.m., she stated she received a telephone call from Physician 1, on July 21, 2016, first thing in the morning, and Physician 1 wanted RN 2 to "correct/change" the documentation on the "Intraoperative Nursing Record" for Patient 1's surgery from "Laparoscopic Salpingectomy (Left)" to "Laparoscopic Salpingectomy (Right)." RN 2 stated Physician 1 stated she had told RN 1, during surgery on July 20, 2016, the incorrect side and Physician 1 had actually removed the right fallopian tube. In addition, RN 2 stated Physician 1 requested she go to pathology and change the specimen label from "left fallopian tube" to "right fallopian tube."

The "Modified - Intraoperative Nursing Record," by RN 2, dated July 21, 2016, at 8:06 a.m. (9 hours after the surgical procedure), indicated the procedure as a "Laparoscopic Salpingectomy - Right."

On July 21, 2016, at 7:44 a.m., the laboratory/pathology order and specimen description was changed from left fallopian tube to right fallopian tube.

The preliminary surgical pathology report on the "right fallopian tube" dated July 22, 2016, at 5:10 p.m., indicated "The initial sampling does not show changes for an ectopic pregnancy in this tube. The tube will be totally embedded, but additional sites for ectopic pregnancy should be considered."

The "Surgical Pathology Final Report" dated July 26, 2016, at 8:39 a.m., indicated "No villi or gestational changes are found with complete embedding of the tube. As mentioned in the Preliminary report, the possibility of an ectopic pregnancy at another site should be considered."

During a telephone interview with Physician 3, on September 19, 2016, at 10:30 a.m., he stated he tried to contact Physician 1, on July 22, 2016, in the early afternoon, by calling the physician's office and requesting a call back in regards to an "important finding" for Patient 1. Physician 3 stated he never spoke with Physician 1 in regards to the pathology findings of no pregnancy identified in the right fallopian tube.

During a telephone interview with Physician 1, on September 19, 2016, at 2:56 p.m., she stated:
- She had spoken with the patient about a left tubal pregnancy;
- Patient 1 had consented to a laparoscopic left salpingectomy;
- When they were in the Operating Room (OR), it was the left fallopian tube was removed/specimen being sent to pathology: and
- She initially typed the operative note as left tubal pregnancy.

Physician 1 stated when she got home she realized she had removed the right fallopian tube and modified the operative report to indicate a right tubal pregnancy. In addition, Physician 1 stated she called the OR the next morning, and spoke with RN 2 to correct the "Intraoperative Nursing Record" to "Laparoscopic Salpingectomy (Right)," and to have the specimen label corrected to right fallopian tube.

Physician 1 stated she received the pathology results via facsimile on July 27, 2016 (one week after the initial surgical procedure). Physician 1 stated she was surprised that she had not received a telephone call from the pathologist when there was no pregnancy identified in the right fallopian tube. Physician 1 stated none of her office personnel remembered getting a telephone call from a facility pathologist and she did not receive a page from the facility pathologist.

Further review of Patient 1's record indicated Patient 1 presented to the facility ED on July 24, 2016 (Sunday), at 2:36 a.m., with the chief complaint of "pain around surgical site and gas."

The nursing "Triage Note" dated July 24, 2016, at 2:42 a.m., indicated Patient 1 had a laparoscopy for an ectopic pregnancy on July 20, 2016.

The "ED Note-Physician" dated July 24, 2016, at 6:08 a.m., indicated Patient 1 had a "laparoscopic cholecystectomy (surgical removal of the gallbladder) on Wednesday (July 20, 2016)."

Patient 1 was discharged from the facility on July 24, 2016, at 3:17 a.m. (total time at facility was 41 minutes).

In addition, Patient 1 presented to the facility ED on July 28, 2016, at 3:24 p.m., with the chief complaint of left lower abdominal pain, "ectopic pregnancy."

On July 28, 2016, at 4:19 p.m., a quantitative HCG test was performed which indicated Patient 1 was pregnant (result 21,311.0 mlU/ml - 6 weeks pregnant, 28 days after conception).

On July 28, 2016, at 5:57 p.m., an ultrasound was performed which indicated "There is a left adnexal ectopic pregnancy which was also reported on July 20, 2016," and the ectopic pregnancy was now "with a positive fetal heart (tone)."

The "Intraoperative Nursing Record" dated July 28, 2016, at 10:40 p.m., indicated Patient 1 underwent an operative laparoscopy for removal of the left fallopian tube and ectopic pregnancy. A specimen was sent to pathology (8 days after the left ectopic pregnancy was diagnosed).

The "Surgical Pathology Final Report" dated August 1, 2016, at 11:33 a.m., indicated "Chorionic villi present within fallopian tube, consistent with ectopic pregnancy."

b. On September 20, 2016, the medical record for Patient 16 was reviewed. Patient 16 was admitted to the facility through the Emergency Department (ED) on July 16, 2016, at 4:05 p.m., with a chief complaint of, "6 weeks preg [pregnant] lmp [last menstrual period]: 6/2016...blood in urine pain left groin..."

A blood test was performed on July 16, 2016, at 4:22 p.m., and indicated a Beta-human Chorionic Gonadotropin (B-hCG) level of 1970.0 which is indicative of approximately six weeks into a pregnancy.

The ED physician consulted with Physician 5, an obstetrician, on July 16, 2016, at 7:33 p.m. The ED physician's documentation regarding the consult with Physician 5 indicated, "...I then discussed with [Physician 5] the ob [obstetrician] doctor on call who came and evaluated the patient and felt it was an ectopic pregnancy and took the patient to the or [operating room]..."

According to the operative report, dated July 16, 2016, Physician 5 documented, "...preoperative diagnosis as, presumptive left tubal pregnancy and postoperative diagnosis as, left tubal pregnancy..." Physician 5 documented the description of the procedure as, "...Examination of the pelvis revealed a left tubal pregnancy that was readily visible...Attention was then directed to the tubal pregnancy. A linear salpingostomy [an opening up or look into a fallopian tube] was then performed...and the tubal pregnancy was able to be removed from the tube without any complications. The tissues were removed and the tube copiously irrigated and cleared of all clots and debris and no evidence of any ectopic remnant tissues were noted..." The Operative Report by Physician 5 indicated, "Finding: + [positive] left tubal pregnancy...normal left ovary. Normal right tube and ovary. Normal uterus..." The perioperative report indicated a specimen was collected.

The specimen log book in the perioperative area, indicated the specimen was picked up by the pathology department on July 18, 2016, at 7:48 a.m. The pathologist (Physician 2) finalized the report for the specimen on July 19, 2016, at 8:34 p.m. The pathology tissue request that accompanied the specimen indicated, "...Specimen description: Products of Conception...Pre-operative diagnosis: Left Tubal Pregnancy..." The pathology report finalized by Physician 2 indicated, "...Diagnosis, Products of conception: Predominantly blood clot and fibrin, No chorionic villi identified...Clinical Information, Pre-Operative diagnosis: Left tubal pregnancy...Specimen source, Products of conception..."

On September 21, 2016, at 10:25 a.m., Physician 2 was interviewed. Physician 2 stated, when an expected result of pregnancy tissue was not seen in a pathology report of tissues from a surgery to evacuate an ectopic tubal pregnancy, the surgeon should be called as soon as possible with the critical results. Physician 2 stated, "The concern is that the patient could still be pregnant."

On September 21, 2016, at 2:45 p.m., Physician 5 was interviewed. Physician 5 stated, he had the pathology report when he saw Patient 16 in his office a week after surgery and he understood the results to be, products of conception. According to an interview with Physician 2 on September 21, at 10:25 a.m., the pathology report listed, "products of conception" as the name of the tissue that was sent to the lab. The result of the examination of the tissue was indicated as, "predominantly blood clot and fibrin, no chorionic villi [human embryonic membrane] identified" Physician 5 stated, the facility did not call him with results of the pathology report.

Further review of Patient 16's record indicated, she returned to the Emergency Department at the facility on August 3, 2016, with a diagnosis of ectopic pregnancy. Ultrasound performed August 3, 2016, at 5:46 p.m., indicated, "...large complex mass in the left adnexa measuring 5.6 x 3.5 cm [centimeter]. The mass in the left adnexa present on today's examination is larger than the mass in the left adnexa on the comparison exam dated July 16, 2016...Of particular note, the beta hCG levels have risen from 1,970 on 7/16/2016 to 3,705. Please exclude ectopic pregnancy/incomplete evacuation of an ectopic pregnancy..."

Patient 16 underwent surgery by Physician 6, on August 3, 2016, for her ectopic pregnancy that had grown in size since her July 16, 2016, surgery (18 days prior) to the point of rupturing her left fallopian tube. Physician 6 removed the ectopic pregnancy along with the left fallopian tube.

On September 21, 2016, the facility's clinical laboratory policy titled, "Critical values," version June 24, 2016, was reviewed. The policy indicated, "...The pathologist makes a clinically critical diagnosis. Note: This critical diagnosis is made at the discretion of each individual pathologist. The pathologist notifies the physician responsible for the patient. The pathologist documents notification in the patient test report..."

2. On August 3, 2016, and September 19, 2016, the record for Patient 1 was reviewed.

i. Patient 1, a 29 year old gravida (number of pregnancies) 3, para (number of pregnancies reaching viable gestation) 0, with a last menstrual period of June 10, 2016, presented to the facility Emergency Department (ED) on July 20, 2016, at 5:17 p.m., with the chief complaint of ectopic pregnancy as seen by ultrasound (type of imaging that uses high-frequency sound waves to look at organs and structures inside the body) in primary care physician's office.

On July 20, 2016, at 5:46 p.m., a quantitative HCG (human chorionic gonadotropin - a hormone produced in the body during pregnancy, measures the specific level of HCG in the blood) test was performed which indicated Patient 1 was pregnant (result 6,595 mlU/ml (Milli-International Units per Milliliter) - 5 weeks pregnant, 21 days after conception).

On July 20, 2016, at 6:53 p.m., an ultrasound was performed to rule out an ectopic pregnancy and indicated "single ectopic pregnancy adjacent to left ovary in adnexal region."

The "ED Note - Physician" dated July 20, 2016, at 8:39 p.m., indicated Patient 1 had pelvic pain, was less than 20 weeks pregnant, Physician 1 (the ED on call Obstetrician) was notified, and Physician 1 accepted the patient as a surgical admission.

The "History and Physical" by Physician 1 dated July 20, 2016, at 9:22 p.m., indicated the diagnosis as ectopic pregnancy and laparoscopic left salpingectomy (surgical removal of a fallopian tube that is often related to tubal pregnancies), possible exploratory laparotomy would be performed.

The "Consent to Surgery or Special Procedure" dated July 20, 2016, at 9:15 p.m., and signed by Patient 1, indicated a "laparoscopic left salpingectomy, possible exploratory laparotomy" operation was to be performed.

The "Intraoperative Nursing Record," by Registered Nurse (RN) 1, dated July 20, 2016, at 11:03 p.m., indicated the procedure as a "Laparoscopic Salpingectomy (Left)," consents were verified, the procedure description modifier was "left," and a specimen was ordered.

The "Operative Report," by Physician 1, dated July 20, 2016, at 11:04 p.m., indicated the findings as "Left tubal pregnancy" and "Right distal hydrosalpinx (blocked fallopian tube filled with serous or clear fluid which may become substantially distended giving the tube a characteristic sausage-like shape)."

The "Pathology Specimen Accession Log" dated July 20, 2016, indicated the specimen as the "left fallopian tube," and the specimen was taken to pathology on July 21, 2016, at 7:30 a.m., by the Clinical Specialist Technician (CST).

The "Modified - Operative Report," by Physician 1, dated July 20, 2016, at 11:37 p.m., indicated the findings as "Right tubal pregnancy" and "Left fallopian tube with small distal hydrosalpinx."

Patient 1 was discharged from the facility on July 21, 2016, at 1:05 a.m., with instructions to follow-up with Physician 1 in two weeks.

There was no documented indication in the record that the patient/patient's responsible party was informed which fallopian tube had been removed (left or right).

During a telephone interview with RN 2, on August 11, 2016, at 8:01 a.m., she stated she received a telephone call from Physician 1, on July 21, 2016, first thing in the morning, and Physician 1 wanted RN 2 to "correct/change" the documentation on the "Intraoperative Nursing Record" from "Laparoscopic Salpingectomy (Left)" to "Laparoscopic Salpingectomy (Right)." RN 2 stated Physician 1 stated she had told RN 1, during surgery on July 20, 2016, the incorrect side and Physician 1 had actually removed the right fallopian tube. In addition, RN 2 stated Physician 1 requested her to go to pathology and change the specimen label from "left fallopian tube" to "right fallopian tube."

The "Modified - Intraoperative Nursing Record," by RN 2, dated July 21, 2016, at 8:06 a.m. (9 hours after the surgical procedure), indicated the procedure as a "Laparoscopic Salpingectomy - Right."

The preliminary surgical pathology report on the "right fallopian tube" dated July 22, 2016, at 5:10 p.m., indicated "The initial sampling does not show changes for an ectopic pregnancy in this tube. The tube will be totally embedded, but additional sites for ectopic pregnancy should be considered."

ii. Patient 1 presented to the facility ED on July 24, 2016 (Sunday), at 2:36 a.m., with the chief complaint of "pain around surgical site and gas."

The nursing "Triage Note" dated July 24, 2016, at 2:42 a.m., indicated Patient 1 had a laparoscopy for an ectopic pregnancy on Wednesday (July 20, 2016).

The "ED Note-Physician" dated July 24, 2016, at 6:08 a.m., indicated Patient 1 had a "laparoscopic cholecystectomy (surgical removal of the gallbladder) on Wednesday (July 20, 2016)."

Patient 1 was discharged from the facility on July 24, 2016, at 3:17 a.m. (total time at facility was 41 minutes).

There was no documented indication laboratory tests were performed, an ultrasound was done or the surgical case/preliminary pathology report from the laparoscopic salpingectomy was reviewed.

The "Surgical Pathology Final Report" dated July 26, 2016, at 8:39 a.m., indicated "No villi or gestational changes are found with complete embedding of the tube. As mentioned in the Preliminary report, the possibility of an ectopic pregnancy at another site should be considered."

iii. Patient 1 presented to the facility ED on July 28, 2016, at 3:24 p.m., with the chief complaint of left lower abdominal pain, "ectopic pregnancy."

On July 28, 2016, at 4:19 p.m., a quantitative HCG test was performed which indicated Patient 1 was pregnant (result 21,311.0 mlU/ml - 6 weeks pregnant, 28 days after conception).

On July 28, 2016, at 5:57 p.m., an ultrasound was performed which indicated "There is a left adnexal ectopic pregnancy which was also reported on July 20, 2016," and the ectopic pregnancy was now "with a positive fetal heart (tone)."

The "Intraoperative Nursing Record" dated July 28, 2016, at 10:40 p.m., indicated Patient 1 underwent an operative laparoscopy for removal of the left fallopian tube and ectopic pregnancy, and a specimen was sent to pathology (8 days after the left ectopic pregnancy was diagnosed).

The "Surgical Pathology Final Report" dated August 1, 2016, at 11:33 a.m., indicated "Chorionic villi present within fallopian tube, consistent with ectopic pregnancy."

During an interview with RN 5, on September 19, 2016, at 1:56 p.m., she stated Patient 1 was being cared for by RN 6 in the Post Anesthesia Care Unit (PACU), and she received two telephone calls from Physician 1 while Patient 1 was in the PACU following surgery on July 20, 2016. RN 5 stated the first telephone call from Physician 1 was in regards to the patient's blood type, and if the patient was Rh (Rhesus factor) negative would need RhoGam (Rho(D) immune globulin). RN 5 stated she received the second telephone call from Physician 1, on July 20, 2016, at 11:25 p.m., and Physician 1 stated she had actually removed the right fallopian tube not the left because when she visualized the tube the right needed to be removed. RN 5 stated she was instructed by the Physician to inform the patient and the patient's responsible party that the Physician would explain and discuss the surgery at the patient's follow-up office visit in two weeks. RN 5 stated she did not inform Patient 1/Patient 1's responsible party that Physician 1 had removed the right fallopian tube not the left fallopian tube.

During a telephone interview with Physician 1, on September 19, 2016, at 2:56 p.m., she stated:
- She had spoken with the patient about a left tubal pregnancy;
- Patient 1 had consented to a laparoscopic left salpingectomy;
- When they were in the Operating Room (OR), it was the left fallopian tube was removed/specimen being sent to pathology;
- She initially typed the operative note as left tubal pregnancy; and
- She had told Patient 1's responsible party after the surgery that the patient's left fallopian tube had been removed.

Physician 1 stated when she got home she realized she had removed the right fallopian tube and modified the operative report to indicate a right tubal pregnancy. Physician 1 stated the right fallopian tube was enlarged, and she really thought the right side was the tubal pregnancy. Physician 1 stated she did not have the ultrasound report with her when she went into surgery, and she thought it was unusual that the ultrasound report had not commented on the distal hydrosalpinx of the right fallopian tube.

In addition, Physician 1 stated she called the Post Anesthesia Care Unit (PACU) before Patient 1 was discharged from the facility, and requested the PACU RN inform the patient and the patient's responsible party that the tubal pregnancy was on the right side and the right fallopian tube had been removed. Physician 1 stated she called the OR the next morning, and spoke with RN 2 to correct the "Intraoperative Nursing Record" to "Laparoscopic Salpingectomy (Right)," and to have the specimen label corrected to right fallopian tube.

Physician 1 stated the first time she spoke with Patient 1/Patient 1's responsible party, in regards to removing the right fallopian tube, was on July 27, 2016 (one week after the initial surgical procedure), when she received the pathology results via facsimile, and she instructed the patient to return to the ED. Physician 1 stated she was surprised that she had not received a telephone call from the pathologist when there was no pregnancy identified in the right fallopian tube. Physician 1 stated none of her office personnel remembered getting a telephone call from a facility pathologist and she did not receive a page from the facility pathologist.

The facility Medical Staff Rules and Regulations, revised May 12, 2015, revealed "... A surgical operation shall be performed only on written, informed consent of the patient, or the parent, when the patient is a minor, or legal guardian. ..."

The facility policy and procedure titled "Event Reporting" reviewed/revised January 22, 2016, revealed "... Surgical or Invasive Procedure Events ... Surgery or other invasive procedure performed on the wrong site. ... When an unanticipated clinical outcome, complication or adverse reaction occurs during the delivery of patient care it is the primary responsibility of the physician who delivered care to communicate and provide information to the patient and/or patient's family/surrogate. ... "

The facility policy and procedure titled "Patients Rights and Responsibilities" reviewed/revised December 3, 2015, revealed "... The following are patient rights: ... Receive information about your health status, diagnosis, prognosis, course of treatment, prospects for recovery and outcomes of care (including unanticipated outcomes) in terms you can understand. You have the right to effective communication and to participate in the development and implementation of your plan of care. ..."

The facility Medical Staff Rules and Regulations, revised May 12, 2015, revealed "... the responsibilities of each member of the Medical Staff include: Providing his/her patients with quality of care at the generally recognized professional level of quality and efficiency established by the Medical Center and the Medical Staff. ... Retaining responsibility within his/her area of professional competence for the continuous care and supervision of each patient in the Medical Center for whom he is providing services, or arranging for a suitable alternate to assure such care and supervision. ..."

Based on interview and record review, the facility failed to ensure the Condition of Participation for Medical Record Services was met by failing to ensure:

1. Patient 1's principal diagnosis of ectopic pregnancy of the left fallopian tube had the correct procedure code documented. In addition, the facility omitted diagnostic codes, including a complication code for Patient 1. (Refer to A0438, A0440 and A0465);

2. A diagnostic complication and the surgical procedure for Patient 16 were coded correctly. (Refer to A0438, A0440 and A0465); and,

3. The facility coding from October 2015 through August 2016, the retrieval of patient listings for codes Y62-Y69 (complications during surgical and medical care) accurately captured the complications of cases within this category. (Refer to A0440).

The cumulative effect of these systemic practices resulted in the failure of the facility to ensure delivery of statutory mandated compliance with the Federal regulations and ensure patients were receiving quality care in a safe and effective manner.


37295

Based on interview and record review, the facility failed to ensure the physicians accurately documented records for two sampled patients (Patients 1 and 16). This failed practice impacted the integrity and accuracy of those patients' electronic health records. This failure had the potential to result in missed opportunities to correctly document medical and surgical errors and to provide accurate communication to other health care providers.

Findings:

1. A review of Patient 1's record was conducted. Patient 1's Operative Report dated July 20, 2016, at 11:04 p.m., had modifications by Physician 1 which initially indicated, "Findings: Left tubal pregnancy." The initial operative report was not part of the patient's medical/legal record.

During a telephone interview with Physician 1, on September 19, 2016, at 2:57 p.m., the physician recounted that the error in the documentation of the Operative Report was realized after she left the facility. Within the hour following surgery, changes were made in the operative report from a computer at the physician's home, as shown on the report at 11:37 p.m. There was no indication the facility followed their policy and procedure for writing an addendum to an already dictated document in the record.

The original Intraoperative Nursing Record for Patient 1, dated July 20, 2016, at 11:03 p.m., indicated the procedure was a "Laparoscopic Salpingectomy (Left)." There was documentation that an operative "time out " was conducted at 10:16 p.m., with the patient verified, consent verified, and the operative site marking verified. The record was completed by the Registered Nurse (RN) 1.

The Intraoperative Nursing Record for Patient 1, indicated a modification to the record by RN 2 within the "Surgical Procedure" section occurred on July 21, 2016, at 8:06 a.m. The word "Left" was changed to "Right" on the original intraoperative nursing record. In changing these fields the remainder of the computer record automatically repopulated the surgical side sites, but left the author as RN 1.

The original intraoperative record now was no longer part of the record, only the modified version remained in the medical/legal record.

Upon further review of Patient 1's records, it was noted that RN 2 did not participate in the care of Patient 1 in the facility from the patient's ED admission on July 20, 2016, at 5:17 p.m. to the patient's discharge on July 21, 2016, at 1:05 a.m.

A review of the facility policy titled "Documentation and Authentication of Medical Records by Health Care Personnel" reviewed/revised November 3, 2015, indicated a signature "... Identifies the author or the responsible party who take ownership of and attest to the information contained in a record entry or document."

The policy further indicated, "Corrections to the electronic documentation may be by noting a document as "In Error" and re-documenting on a new electronic form, or by dictating an addendum to the original document."

A review of the facility policy titled "Medical Records: Composition, Management and Access" indicated in the Management of Medical Records "The medical staff and other health care professionals are responsible for the documentation in the medical record within required and appropriate time frames to support patient care...and all Medical Records...must be maintained in their entirety, and no document or entry may be deleted from the records ...Healthcare providers who are directly involved in the care of patient may access the full Medical Record in accordance with related policies..."

During an interview on September 19, 2016, at 9:55 a.m., with the Information Technology Informatics Director (ITID), he stated when physician entries were entered in the EHR the documentation was in a preliminary format and can be edited "until the record is signed and finalized." The record entries have timed notations at the end of each report. The ITID confirmed the inpatient medical record "never closes." When asked if patient care measurements such as vital signs could be changed after a patient had been discharged, he stated it would be possible to change the measurement as a late entry. If changed, the original entry would not be seen on the computer view of the record, and it cannot be seen by health information staff for release of information.

During a demonstration of how the EHR was used to access patient records on September 19, 2016, by the ITID, it was observed that the home screen in viewing a discharged patient record, under "New Order Entry" reflected the standard message, "You are currently viewing a discharged patient. Any order you place will apply to this encounter" appears for each discharged record.

2. Patient 16 had a salpingostomy (surgical incision into a fallopian tube) on July 16, 2016, for a "left tubal pregnancy, not ruptured," and a salpingostomy (surgical incision into a fallopian tube). The operative report was incorrectly dated July 17, 2016.


A further review of Patient 16's records, showed a second admission to the facility in which Patient 16 had surgery by Physician 6 on August 3, 2016.

The Operative Report of August 3, 2016, which was signed and verified on August 4, 2016, by Physician 6 documented a preoperative and postoperative diagnosis of "Failed salpingectomy for a ruptured ectopic pregnancy." The diagnosis should have documented a salpingostomy on July 16, 2016. The technical procedure was listed as "Laparoscopic right salpingectomy" with findings of "A 5 cm (centimeter) left ruptured ectopic pregnancy..."

A telephone interview was conducted with Physician 6, on September 22, 2016, at 11:30 a.m. As Physician 6 was reviewing the Operative Report, the physician was unable to explain the conflicting documentation in the Operative Report which indicated, "failed salpingectomy." Physician 6 stated the report, "should be failed salpingostomy." The procedure listed "right salpingectomy" which was actually a "left salingectomy."

Physician 6 further stated in the body of the report, "The right tube was adherent to the left pelvic wall, it should have stated the left tube was adherent to the left pelvic wall." Physician 6 stated she should have reviewed the operative report prior to authenticating it.

Based on interview and record review, the facility failed to ensure:

1a. Patient 1's principal diagnosis of ectopic pregnancy in the left fallopian tube (pregnancy
located outside of the uterus), had the correct procedure code documented. In addition, the
facility omitted diagnostic codes, including a complication code for Patient 1 which had the
potential for inaccurate claim billing; and,

b. A diagnostic complication and the surgical procedure for Patient 16 were coded correctly.

2. For facility coding from October 2015-August 2016, the retrieval of patient listings for
codes Y62 -Y69 (Complications during surgical and medical care), did not accurately
capture complication cases within this category.

These failures regarding the accuracy of diagnoses and procedure coding resulted in incomplete coding. This had the potential to create inaccurate and unreliable code reporting.

Findings:

1a. A review of Patient 1's record was conducted. The Coding Summary dated July 21, 2016, listed the International Classification of Diseases, 10th Revision, Clinical Modifications (ICD-10-CM, the approved coding system of diagnoses in hospitals) final principal diagnosis for Patient 1 as "Ectopic pregnancy, unspecified." No secondary diagnoses codes were listed.

The ICD-10-PCS (procedural coding system) for Patient 1 indicated "0UT64ZZ-Resection of Left Fallopian Tube, Percutaneous Endoscopic Approach." The procedure code should have indicated "0UT54ZZ" for the Right Fallopian Tube. The Current Procedural Terminology, version 4 (CPT-4, approved coding system for physician and outpatient claim billing) procedure code was "59151," which was incomplete as the correct side of the body, the right side, was not included in the code.

Documentation in the records from the Emergency Department, Operative Report, progress notes, Ultrasound Report, and Pathology Report were available to the facility staff as supporting documents for coding the medical record. The time stamp notation on Patient 1's record stamped by the coder showed "7/21/2016, 07:03 a.m." Coding the record at this time did not allow a viewing opportunity of the final pathology report, which was not completed at that time. There were also modifications in the medical record which reflected a surgical misadventure (per ICD-10-PCS) which should have been coded.

b. A review of Patient 16's record was conducted. The Coding Summary for July 16, 2016, did not list the correct site pertaining to the surgical CPT4 code for "laparoscopic treatment of ectopic pregnancy" which was located in the left fallopian tube. There was no diagnosis code for the misadventure (per ICD-10-PCS) of a failed extraction of a tubal pregnancy. The time stamp notation on the record by the coder showed "7/18/2016, 06:47 a.m." This did not allow an opportunity for the coder to view the pathology report.

A further review of Patient 16's record was conducted. The Coding Summary for August 4, 2016, listed the surgical procedure of "0UT54ZZ, Resection of Right Fallopian Tube, Percutaneous Endoscopic Approach." This Coding Summary should have been coded for the left fallopian Tube.

The time stamp notation on the record by the coder indicated "08/04/2016, 05:08 a.m.," which did not allow the viewing of the Final Operative Report entered by Physician 6 on August 4, 2016, at 6:48 a.m., or the final viewing of the pathology report on August 5, 2016. Further record review failed to show that a coding query to the physician (a formal review process) was done due to the contradictory wording in the Operative Report regarding the surgical site and the procedure performed.

Interviews were conducted with the Director of Health Information Management (DHIM), the Coding Director (CD), and the Health Information Management Training Coordinator (HTC) on September 20, 2016, at 9:47 a.m., who stated all facility coding is outsourced to an external vendor. Two coding audits were performed each year but the DHIM and CD were unaware of the results of recent audits.


A review of the current facility policy and procedure titled "Coding and Documentation for Inpatient Services" dated July 31, 2015, was conducted. The policy indicated "Diagnosis and procedures will be coded using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM)." The current accepted and approved coding system for diagnoses and procedures per the Centers for Medicare and Medicaid Services (CMS) should be ICD-10-CM & PCS which officially went into effect on October 1, 2015.

A review of the "Coding and Documentation for Inpatient Services" procedure section stated "To achieve consistency in the coding of diagnoses and procedure, coders must thoroughly review the entire medical record as part of the coding process in order to assign and report the most appropriate codes...Query the attending physician for documented confirmation of the condition when diagnoses or procedures are stated in other medical record documentation (nurses notes, pathology reports, radiology reports, laboratory reports...Use medical record documentation to attain specificity in coding, such as used the radiology report..."The Coding Procedure also stated "Coders must not...Misrepresent the patient's clinical picture through incorrect coding or adding diagnoses/procedures unsupported by the documentation for any reason."

2. During an interview with the Information Technology Informatics Director on September 19, 2016, at 9:55 a.m., the list of coded cases with the ICD-10-CM codes Y62-Y69 (Complications during surgical and medical care) were requested for the past year. The report listed seven cases.

During a record review of the seven cases on the Y62-Y69 listing for diagnostic complications caused during a hospital stay, two of the records were found to be coded incorrectly with complications not related to the facility. The two facility related complications of Patients 1 and 16 were not included on the list.

Based on interview and record review, the facility failed to fully document complications in the record for two patients (Patients 1 and 16) by failing to ensure:

A. Patient 1's record included documentation of a wrong site surgical procedure. This failure led to a delay in patient notification: and,


B. Patient 16's record reflected documentation which included a failed excision of a tubal pregnancy which resulted in a rupture of the fallopian tube eighteen days after the initial failed procedure necessitating a return to surgery.


The lack of documentation regarding surgical complications resulted in pain and suffering for these patients and failed quality assurance tracking of hospital complications.


Findings:

A. A review of Patient 1's record was conducted. The history and physical documented by Physician 1, dated July 20, 2016, at 9:16 p.m., indicated Patient 1 had a left adnexal pregnancy (a lump of tissue closely related to the uterus, such as located in the ovaries or fallopian tubes). Physician 1 indicated (she), "will proceed with LSC (laparoscopy-a surgical diagnostic procedure to view organs inside the abdomen with a fiber optic instrument), a left salpingectomy (surgical removal of a fallopian tube), a possible ex-lap (exploratory laparotomy, incision through any part of the abdominal wall)."

The "Consent to Surgery or Special Procedure" for Patient 1 dated July 20, 2016, at 9:15 p.m., indicated the operation Patient 1 consented to was a "laparoscopic left salpingectomy, possible exploratory laparotomy."

The original preliminary Operative Report by Physician 1, dated July 20, 2016, at 11:04 p.m., indicated the diagnostic/surgical findings as "Left tubal pregnancy" and "Right distal hydrosalpinx (a blocked fallopian tube filled with serous or clear fluid)." A specimen removed during the surgery was described as a, "Left fallopian tube."

The modified Operative Report dated July 20, 2016, at 11:37 p.m., was later modified by Physician 1 to, "Findings: Right tubal pregnancy" and "Specimens Removed: Right fallopian tube."

The preliminary pathology report which was signed and verified by Physician 3 on July 22, 2016, at 5:10 p.m., indicated "Preliminary Diagnosis Right fallopian tube (salpingectomy)." In addition, documented under the Preliminary Comment indicated, "The initial sampling does not show changes for an ectopic pregnancy (a pregnancy located outside of the uterus) in this tube ... additional sites for ectopic pregnancy should be considered. "

During an interview with Physician 1 on September 19, 2016 at 2:57 p.m., the physician stated she realized the documentation error on July 20, 2016, after leaving the facility, and corrected the operative report at 11:37 p.m. "from home." Physician 1 stated two phone calls were made to the recovery room nurse (RN 5) prior to the patient leaving the hospital. Physician 1 stated a third phone call was made on July 21, 2016, the next morning, to ask the Operating Room Charge Nurse (RN 2) to correct the pathology specimen label to read "right" fallopian tube.

During an interview with the recovery room nurse (RN 5) on September 19, 2016, at 1:56 p.m. RN 5 stated phone calls were received from Physician 1 on July 20, 2016, at 11:15 p.m., and at 11:25 p.m. RN 5 stated Physician 1 told her regarding Patient 1's surgery "the right side was done and not the left."

An interview was conducted with the nurse in the post anesthesia care unit, (RN 6), on September 22, 2016, at noon. RN 6 stated she received the patient in the recovery room from RN 1 who told her the procedure performed was a "left salpingectomy." RN 6 stated the phone calls from Physician 1 had been received by RN 5. RN 6 stated she gave the discharge instructions to Patient 1's spouse on July 21, 2016, at 1:15 a.m.

A review of Patient 1's records from facility visits on July 24, 2016, and July 28, 2016, to include progress notes, nursing notes, and pathology reports did not reflect the surgical complication which occurred during the wrong site surgery conducted on July 20, 2016.

B. A review of Patient 16's records was conducted. Patient 16 was admitted to the facility on July 16, 2016. Patient 16 was diagnosed with a left tubal pregnancy. Subsequently a left salpingostomy was performed. A complication during the admission which involved a failed extraction of a left fallopian tube pregnancy was not documented by Physician 5.

The Operative Report dated August 3, 2016, and completed on August 4, 2016, by Physician 5 indicated "left tubal pregnancy." The Pathology Report verified by Physician 2 on July 19, 2016, indicated "Diagnosis Products of conception ...no chorionic villi identified (indicated no products of conception were removed)."
There was no documentation to show that Patient 16 was notified of this pathology finding. Patient 16 returned to the Emergency Department on August 3, 2016, complaining of pain. Patient 16 subsequently had a second surgical procedure for a "left tubal pregnancy."

The final Operative Report by Physician 6 entered on August 4, 2016, at 6:48 a.m., reflected contradictory wording. The preoperative and postoperative diagnosis was, "Failed salpingectomy for a ruptured ectopic pregnancy (removal of a fallopian tube)," when a salpingostomy had been performed (an incision into a fallopian tube). The technical procedure was listed as "Laparoscopic right salpingectomy" which should have been a left salpingectomy. The report findings documented "a 5 cm (centimeter) left ruptured ectopic pregnancy..."In addition, the procedural description reflected contradictory documentation which indicated, "Right tube was cross clamped" and "the right tube was found to be adherent to the left pelvic sidewall."

Based on interview and record review, the facility failed to ensure the "Sterilization Consent Form" was completed prior to the surgical procedure, bilateral tubal ligation for sterilization, was performed for three of three sampled patients (Patients 2, 3, and 4). This resulted in surgical sterilization of Patients 2, 3, and 4, occurring without documentation of a completed, fully executed "Sterilization Consent Form."

Findings:

On September 19, the records for Patients 2, 3, and 4 were reviewed.

a. Patient 2 was admitted to the facility on September 19, 2016, with diagnoses including term pregnancy, repeat cesarean section (surgical, abdominal birth of an infant), and bilateral tubal ligation (fallopian tubes are clamped and blocked or severed, and considered a permanent method of sterilization and birth control).

The "Sterilization Consent Form (Non-Federally Funded)" dated June 2002 [current form in use is dated July 2007] had been signed by Patient 2 on July 19, 2016.

There was no indication the "Physician's Statement" had been completed and signed by the physician shortly before the sterilization operation had been performed.

b. Patient 3 was admitted to the facility on July 27, 2016, with diagnoses including term pregnancy, repeat cesarean section, and bilateral tubal ligation.

The "Sterilization Consent Form (Non-Federally Funded)" dated July 2007 had been signed by Patient 3 on July 5, 2016.

There was no indication the "Physician's Statement" had been completed and signed by the physician shortly before the sterilization operation had been performed.

c. Patient 4 was admitted to the facility on July 18, 2016, with diagnoses including term pregnancy, elective primary cesarean section and bilateral tubal ligation.

The "Sterilization Consent Form (Non-Federally Funded)" dated July 2007 had been signed by Patient 4 on May 5, 2016.

The "Physician's Statement" was incomplete and did not include the patient's name and date discussed with the patient.

During an interview with the Director Perioperative Services (DPOS) and the Director Perinatal Services (DPS), on September 21, 2016, at 3:15 p.m., they reviewed the records for Patients 2, 3, and 4, and were unable to find documentation of a completed "Physician's Statement" on the "Sterilization Consent Form (Non-Federally Funded)." They stated the "Sterilization Consent Form (Non-Federally Funded)" should be properly completed prior to a bilateral tubal ligation being performed.

The facility "Medical Staff Rules and Regulations" revised May 12, 2015, revealed "... A surgical operation shall be performed only on written, informed consent of the patient ... Before incision or procedure start, the support personnel, the Medical Staff member performing the procedure, and the anesthesia provider shall have as a team verified and documented in the patient's medical record their verification of: ... the adequacy of the consent for the proposed procedure ..."

Based on interview and record review, the facility failed:

1. To ensure when Physician 1 requested Registered Nurse (RN) 2 to modify an "Intraoperative Nursing Record" the modification occurred per facility policy and procedure for one sampled patient (Patient 1).

2. To ensure the "Intraoperative Nursing Record" accurately reflected the surgical specimens removed and ordered for three sampled patients (Patients 2, 3, and 4).

These failed practices resulted in inaccurate "Intraoperative Nursing Record(s)."

Findings:

1. On August 3, 2016, and September 19, 2016, the record for Patient 1 was reviewed.

Patient 1, a 29 year old gravida (number of pregnancies) 3, para (number of pregnancies reaching viable gestation) 0, with a last menstrual period of June 10, 2016, presented to the facility Emergency Department (ED) on July 20, 2016, at 5:17 p.m., with the chief complaint of ectopic pregnancy as seen by ultrasound (type of imaging that uses high-frequency sound waves to look at organs and structures inside the body) in primary care physician's office.

On July 20, 2016, at 6:53 a.m., an ultrasound was performed to rule out an ectopic pregnancy and indicated "single ectopic pregnancy adjacent to left ovary in adnexal region."

The "ED Note - Physician" dated July 20, 2016, at 8:39 p.m., indicated Patient 1 had pelvic pain, was less than 20 weeks pregnant, Physician 1 (the ED on call Obstetrician) was notified, and Physician 1 accepted the patient as a surgical admission.

The "History and Physical" by Physician 1 dated July 20, 2016, at 9:22 p.m., indicated the diagnosis as ectopic pregnancy and laparoscopic left salpingectomy (surgical removal of a fallopian tube that is often related to tubal pregnancies), possible exploratory laparotomy would be performed.

The "Consent to Surgery or Special Procedure" dated July 20, 2016, at 9:15 p.m., and signed by Patient 1, indicated a "laparoscopic left salpingectomy, possible exploratory laparotomy" operation was to be performed.

The "Intraoperative Nursing Record," by Registered Nurse (RN) 1, dated July 20, 2016, at 11:03 p.m., indicated the procedure as a "Laparoscopic Salpingectomy (Left)," consents were verified, the procedure description modifier was "left," and a specimen was ordered.

The "Operative Report," by Physician 1, dated July 20, 2016, at 11:04 a.m., indicated the findings as "Left tubal pregnancy" and "Right distal hydrosalpinx (blocked fallopian tube filled with serous or clear fluid which may become substantially distended giving the tube a characteristic sausage-like shape)."

The "Modified - Operative Report," by Physician 1, dated July 20, 2016, at 11:37 p.m., indicated the findings as "Right tubal pregnancy" and "Left fallopian tube with small distal hydrosalpinx."

Patient 1 was discharged from the facility on July 21, 2016, at 1:05 a.m., with instructions to follow-up with Physician 1 in two weeks.

The "Modified - Intraoperative Nursing Record," by RN 2, dated July 21, 2016, at 8:06 a.m. (9 hours after the surgical procedure), indicated the procedure as a "Laparoscopic Salpingectomy - Right."

The initial "Intraoperative Nursing Record" was no longer a part of Patient 1's medical legal record and was replaced by the "Modified" version.

During a telephone interview with RN 2, on August 11, 2016, at 8:01 a.m., she stated she received a telephone call from Physician 1, on July 21, 2016, first thing in the morning, and Physician 1 wanted RN 2 to "correct/change" the documentation on the "Intraoperative Nursing Record" from "Laparoscopic Salpingectomy (Left)" to "Laparoscopic Salpingectomy (Right)." In addition, RN 2 stated Physician 1 requested her to go to pathology and change the specimen label from "left fallopian tube" to "right fallopian tube." RN 2 stated she edited the original document and modified what was written under "Surgical Procedures - Main" for "Modifiers" from left to right side. RN 2 stated she did not realize when she made this modification it changed the entire document, and everywhere that said left was changed to right. RN 2 stated she did not ask what the procedure on the consent had been or what should have been removed versus what was removed. RN 2 stated she should not have edited the initial "Intraoperative Nursing Record," should not have changed/edited someone else's documentation, should have written a free text note/comment, should have notified her manager of the physician's request, and should have completed an incident report. RN 2 stated she was not sure of the facility's policy on modifying/editing the record.

During an interview with the Director Information Technology (DIT), on August 10, 2016, at 11:45 a.m., he stated the facility did not monitor/audit records for modifications that were made to the record. The DIT stated when a request was made for a printed copy of the record/medical-legal record, the printed copy would not include the original documentation only the latest modification/version. In addition, the DIT stated when viewing the record it would be difficult to impossible to tell what had been modified. The DIT stated the patient's encounter(s) never close, thus modifications to the patient's record could occur years later.

The facility policy and procedure titled "Documentation and Authentication of Medical Records by Health Care Personnel" reviewed/revised November 3, 2015, revealed "... Corrections to the electronic documentation may be by noting a document as "In Error" and re-documenting on a new electronic form, or by dictating an addendum to the original document. ..."

2. On September 19, the records for Patient 2, 3, and 4 were reviewed.

2a. Patient 2 was admitted to the facility on September 19, 2016, with diagnoses including term pregnancy, repeat cesarean section (surgical, abdominal birth of an infant), and bilateral tubal ligation (fallopian tubes are clamped and blocked or severed, and considered a permanent method of sterilization and birth control).

The "Operative Report" dated September 19, 2016, indicated the technical procedure performed was a low transverse cesarean section and bilateral tubal ligation.

The "Order Sheet" dated September 19, 2016, indicated the placenta, right fallopian tube, and left fallopian tube specimens were ordered to be sent to pathology for routine analysis.

The surgical pathology final report dated September 20, 2016, indicated the placenta, right fallopian tube, and left fallopian tube were analyzed, both fallopian tubes were both completely transected, and no malignancy was seen.

The "Intraoperative Nursing Record" dated September 19, 2016, at 12:25 p.m., indicated Patient 2 had a cesarean section and a bilateral tubal ligation which started at 7:30 a.m., and the patient was out of the room at 8:35 a.m.

There was no documented indication on the "Intraoperative Nursing Record" that specimens were ordered.

b. Patient 3 was admitted to the facility on July 27, 2016, with diagnoses including term pregnancy, repeat cesarean section, and bilateral tubal ligation.

The "Operative Report" dated July 27, 2016, indicated the procedure performed as a repeat low transverse cesarean section and a bilateral tubal ligation.

The orders dated July 27, 2016, indicated the placenta, right fallopian tube, and left fallopian tube specimens were ordered to be sent to pathology for routine analysis.

The surgical pathology final report dated July 28, 2016, indicated the right fallopian tube, left fallopian tube, and the placenta were analyzed, the fallopian tubes were completely transected, and the placenta showed scattered subchorionic plaque.

The "Intraoperative Nursing Record" dated July 27, 2016, at 9:41 a.m., indicated Patient 3 had a repeat cesarean section with a bilateral tubal ligation which started at 7:27 a.m., and the patient was out of the room at 8:50 a.m.

There was no documented indication on the "Intraoperative Nursing Record" that specimens were ordered.

c. Patient 4 was admitted to the facility on July 18, 2016, with diagnoses including term pregnancy, elective primary cesarean section and bilateral tubal ligation.

The "Operative Report" dated July 18, 2016, indicated the procedure performed as an elective primary low transverse cesarean section and bilateral tubal ligation.

The orders dated July 18, 2016, indicated the placenta, right fallopian tube, and left fallopian tube were ordered to be sent to pathology for routine analysis.

The surgical pathology final report dated July 19, 2016, indicated the right fallopian tube, left fallopian tube, and the placenta were analyzed, the fallopian tubes were completely transected, and the placenta was unremarkable.

The "Intraoperative Nursing Record" dated July 18, 2016, at 7:20 p.m., indicated Patient 3 had a primary cesarean section with a bilateral tubal ligation which started at 7:30 a.m., and the patient was out of the room at 8:30 a.m.

The "Intraoperative Nursing Record" dated July 18, 2016, at 10:05 a.m., indicated "Specimens Ordered - n/a (not applicable)."

During an interview with the Director Perioperative Services (DPOS) and the Director Perinatal Services (DPS), on September 21, 2016, at 3:15 p.m., they reviewed the records for Patients 2, 3, and 4, and were unable to find documentation of specimens ordered on the "Intraoperative Nursing Record(s)." The DPOS stated the "Intraoperative Nursing Record" should include specimens ordered if specimen analysis was ordered and specimens were sent to pathology for analysis. The DPS stated, for Patient 4, she did not know why the nurse documented "n/a" for specimens ordered when specimen analysis was ordered and a final pathology report was obtained.

The facility policy and procedure titled "Documentation and Authentication of Medical Records by Health Care Personnel" reviewed/revised November 17, 2015, revealed "... The patient care process shall be documented by staff according to the established system. ..."

Based on interview and record review, the facility failed to ensure the sterilization consent form was completed prior to the surgical procedure, bilateral tubal ligation for sterilization, being performed for three of three sampled patients (Patients 2, 3, and 4). This resulted in surgical sterilization of Patients 2, 3, and 4, occurring without documentation of a completed, fully executed "Sterilization Consent Form."

Findings:

On September 19, the records for Patient 2, 3, and 4 were reviewed.

a. Patient 2 was admitted to the facility on September 19, 2016, with diagnoses including term pregnancy, repeat cesarean section (surgical, abdominal birth of an infant), and bilateral tubal ligation (fallopian tubes are clamped and blocked or severed, and considered a permanent method of sterilization and birth control).

The "Sterilization Consent Form (Non-Federally Funded)" dated June 2002 [current form dated July 2007] had been signed by Patient 2 on July 19, 2016.

There was no indication the "Physician's Statement" had been completed and signed by the physician shortly before the sterilization operation had been performed.

b. Patient 3 was admitted to the facility on July 27, 2016, with diagnoses including term pregnancy, repeat cesarean section, and bilateral tubal ligation.

The "Sterilization Consent Form (Non-Federally Funded)" dated July 2007 had been signed by Patient 3 on July 5, 2016.

There was no indication the "Physician's Statement" had been completed and signed by the physician shortly before the sterilization operation had been performed.

c. Patient 4 was admitted to the facility on July 18, 2016, with diagnoses including term pregnancy, elective primary cesarean section and bilateral tubal ligation.

The "Sterilization Consent Form (Non-Federally Funded)" dated July 2007 had been signed by Patient 4 on May 5, 2016.

The "Physician's Statement" was incomplete and did not include the patient's name and date discussed with the patient.

During an interview with the Director Perioperative Services (DPOS) and the Director Perinatal Services (DPS), on September 21, 2016, at 3:15 p.m., they reviewed the records for Patients 2, 3, and 4, and were unable to find documentation of a completed "Physician's Statement" on the "Sterilization Consent Form (Non-Federally Funded)." They stated the "Sterilization Consent Form (Non-Federally Funded)" should be properly completed prior to a bilateral tubal ligation being performed.

The facility "Medical Staff Rules and Regulations" revised May 12, 2015, revealed "... A surgical operation shall be performed only on written, informed consent of the patient ... Before incision or procedure start, the support personnel, the Medical Staff member performing the procedure, and the anesthesia provider shall have as a team verified and documented in the patient's medical record their verification of: ... the adequacy of the consent for the proposed procedure ..."

Based on interview and record review, the facility failed:

1. To ensure the immediate post-operative reports were documented prior to the patient leaving the Perioperative Department for three sampled patients (Patients 11, 12, and 13); and

2. To ensure the operative reports were complete and accurate for three sampled patients (Patients 2, 4 and 16).

These failures resulted in an inaccurate operative reports and important surgical information not being available to other hospital personnel having to provide care for these patients postoperatively.

Findings:

1. On September 21, 2016, the records were reviewed for Patients 11, 12, and 13.

Patient 11 was admitted to the facility on September 13, 2016, for lumbar back surgery by Physician 7. Patient 11's surgery finished at 7:19 p.m., on September 13, 2016, and Physician 7 documented the immediate post operative report on September 14, 2016 at 10:09 a.m., (over 14 hours after surgery ended).

Patient 12 was admitted to the facility on September 19, 2016, for surgical removal of a kidney by Physician 8. Patient 12's surgery finished at 11:58 a.m., on September 19, 2016, and Physician 8 documented the immediate post operative report on September 19, 2016, at 3:12 p.m., (over three hours after completion of surgery).

Patient 13 was admitted to the facility on September 19, 2016, for a knee replacement surgery by Physician 9. Patient 13's surgery finished at 10:50 a.m., on September 19, 2016, and Physician 9 documented the immediate post operative report on September 19, 2016, at 2:08 p.m., (over three hours after completion of surgery).

Patients 11, 12, and 13 went to the recovery room and then to an inpatient bed within the facility.

The immediate post operative notes, to include an explanation of the surgery performed and any complications, were not immediately available to other hospital personnel caring for these patients postoperatively.

On September 22, 2016, the facility policy titled, "Medical Record Completion Requirements" revised, November 3, 2015, was reviewed. The policy indicated,"...Operative reports shall be dictated/entered immediately by an Immediate Post Op Note. The full operative report is due within 24 hours of surgery..."

On September 22, 2016, the facility's Rules and Regulations, revised May 12, 2015, were reviewed. The section titled, "...Care Of Patients Undergoing Surgical Procedures...11. Operative reports shall be entered immediately. When the operative report is not placed in the medical record immediately, an operative progress note shall be entered in the medical record immediately after surgery to provide pertinent information for anyone required to attend the patient..."

On September 22, 2016, at 9:15 a.m., the Director of Health Information Management (DHIM) was interviewed. The DHIM stated, Post operative notes need to be done immediately, before the patient is moved to their next destination.

2a. Patient 2 was admitted to the facility on September 19, 2016, with diagnoses including term pregnancy, repeat cesarean section (surgical, abdominal birth of an infant), and bilateral tubal ligation (fallopian tubes are clamped and blocked or severed, and considered a permanent method of sterilization and birth control).

The "Operative Report" dated September 19, 2016, indicated the technical procedure performed was a low transverse cesarean section and bilateral tubal ligation.

The "Operative Report" did not delineate out which specimens were removed.

b. Patient 4 was admitted to the facility on July 18, 2016, with diagnoses including term pregnancy, elective primary cesarean section and bilateral tubal ligation.

The "Operative Report" dated July 18, 2016, indicated the procedure performed as an elective primary low transverse cesarean section and bilateral tubal ligation.

The "Operative Report" did not delineate out which specimens were removed.

During an interview with the Director Perioperative Services (DPOS) and the Director Perinatal Services (DPS), on September 21, 2016, at 3:15 p.m., they reviewed the records for Patients 2 and 4, and were unable to find documentation of specimens removed on the "Operative Report." The DPOS stated the "Operative Report" should have delineated which specimens were removed.

The facility's Medical Staff Rules and Regulations revised May 12, 2015, revealed "... Operative Procedure Reports ... Operative reports shall contain ... the specimens removed ..."

c. On September 20, 2016, the medical record for Patient 16 was reviewed. Patient 16 was admitted to the facility through the Emergency Department on July 16, 2016, at 4:05 p.m., with an impression of an ectopic pregnancy. The Emergency Department physician consulted with Physician 5, an obstetrician, on July 16, 2016, at 7:33 p.m. The Anesthesia Record indicated, surgery was July 16, 2016, beginning at 10:21 p.m., and ending at 11:05 p.m. The Operative Report by Physician 5 incorrectly indicated, a surgery date of July 17, 2016.

On September 21, 2016, at 2:35 p.m., Physician 5 was interviewed. Physician 5 stated, "the surgery was on the 16th, I dictated on the 17th and dictated the wrong date."

On September 22, 2016, the facility policy titled, "Documentation and Authentication of Medical Records by Health Care Personnel" revised November 3, 2015, was reviewed. The policy indicated, "...NOTE: Surgeries/procedures continuing past midnight shall be dated according to the date of induction of anesthesia, if applicable, or the date the surgery/procedure was initiated..."

On August 3, 2016, at 3:27 p.m., Patient 16 presented to the facility's Emergency Department with left lower abdominal pain. Physician 6 performed a laparoscopic left salpingectomy (removal of a left fallopian tube through small incisions) on Patient 16. The Operative Report indicated, "...Preoperative Diagnosis: Failed salpingectomy for a ruptured ectopic pregnancy..." The description of the procedure by Physician 6 indicated, "...The right tube, which was found to be adherent to the left pelvic sidewall..."

On September 22, 2016, at 11:30 a.m., Physician 6 was interviewed. Physician 6 stated, "salpingectomy is wrong, it should say salpingostomy." for pre and post diagnosis.

In regards to the right tube adhered to the left pelvic sidewall, Physician 6 stated, "Oh, I should have caught that, it should say left tube. Sometimes I sign the reports and I should catch the errors. I will go back and fix that."

On September 22, 2016, the facility's Rules and Regulations, revised May 12, 2015, were reviewed. The section titled, "...Operative Procedure Reports, a. Operative reports should be dictated by the primary surgeon immediately after surgery, and dated/signed by the surgeon. Operative reports shall contain the name of the primary surgeon and any assistants, indications and name of specific surgical procedure performed, type of anesthesia administered, complications if any, description of techniques and findings, the specimens removed, blood loss, prosthetic devices, grafts, tissues, transplants, or devices implanted if any, and the pre-operative and post-operative diagnosis..."


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