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Tag No.: A0338
Based on interview and record review, the facility failed to ensure quality care was provided in accordance with the facility policy and procedure, for one patient (Patient 1), when:
1. Patient 1's abdominal and kidney/ureter/bladder x-ray (an imaging procedure) taken on August 26, 2022, indicating a retained foreign object (RFO), was not addressed in a timely manner (A 0353);
2. There was no documented evidence Patient 1's RFO was addressed when Patient 1 was discharged home on August 27, 2022 (A 0353); and
3. Patient 1's computerized tomography cystogram (an imaging procedure) of the pelvis taken on September 8, 2022, indicating the same RFO seen in Patient 1's x-ray on August 26,2022 (14 days before Patient 1's second surgery which was done to remove the RFO on September 27, 2022), was not addressed in a timely manner.
The cumulative effect of these systemic failures resulted in a delay in care provided to Patient 1 to meet his needs and to prevent further medical and surgical complications.
Tag No.: A0353
Based on interview and record review, the facility failed to ensure quality care was provided for one patient (Patient 1) in accordance with the facility policy and procedure, when:
1. Patient 1's abdominal and kidney/ureter/bladder (KUB) x-ray (an imaging procedure) taken on August 26, 2022, indicating a retained foreign object (RFO) was not addressed in a timely manner;
2. There was no documented evidence Patient 1's RFO was addressed when Patient 1 was discharged home on August 27, 2022; and
3. Patient 1's computerized tomography (CT) cystogram (an imaging procedure) of the pelvis taken on September 8, 2022, indicating the same RFO seen in Patient 1's x-ray on August 27, 2022 (14 days before Patient 1's second surgery which was done to remove the RFO on September 27, 2022), was not addressed on a timely manner.
These failures resulted in Patient 1 undergoing another surgical procedure on September 27, 2022, for the removal of the RFO, extensive adhesiolysis (a procedure performed to break up and remove adhesions), and small bowel resection (removal of part of the small intestine).
In addition, these failures resulted in Patient 1 suffering from surgical complications such as infection, pain, and delay in recovery, and could have led to the deterioration of the medical condition and/or death of the patient.
Findings:
During a record review conducted on January 17, 2022, Patient 1's "History & (and) Physical," dated August 16, 2022, indicated, "...Patient is here for pre-op visit: LAVH (laparoscopically assisted vaginal hysterectomy, a surgical procedure using a camera to guide the removal of uterus through the vagina), with salphingectomy (removal of the fallopian tube)...on 8/24/22 (August 24, 2022)..."
Patient 1's "Operative Report," dated August 24, 2022, indicated, "...surgeon (name of Physician 1)...Postoperative Diagnosis...fibroid uterus (noncancerous growth in the uterus) with adhesions between the uterus and bladder, bladder dome (part of the bladder) injury. Procedures performed: Laparoscopic-assisted abdominal hysterectomy, bilateral salphingectomy, repair of bladder dome...Assistant: (name of Physician 2)...Findings...mini-laparotomy (a smaller incision in the abdomen) performed to assist in dissection and removal of specimen..."
1. Patient 1's "Discharge Report," indicated a telephone order was received from Physician 1 on August 26, 2022, at 9:16 a.m., for Patient 1 to have an abdomen and KUB x-ray to rule out ileus (to determine if the cause was the inability of the intestine to contract normally) due to nausea and vomiting.
An untitled document, dated August 26, 2022, indicated, "Exams...Abdomen.../KUB...Findings consistent with a small bowel ileus versus early/partial small bowel obstruction. Radiopaque structure (dense structures which resist the passage of x-rays and would appear light or white in a radiographic image) along the right hemipelvis may represent a radiopaque sponge marker (most surgical sponges are detectable in the x-ray because of an incorporated radiopaque marker). Correlate clinically. Patient's (Patient 1) nurse (name of Registered Nurse [RN] 1) was informed of results on 1:35 p.m...Electronically signed by (name of Radiologist 1, a physician that specialized in diagnosing and treating injuries and diseases using radiology procedures) on 8/26/2022 at 1336 (1:36 p.m.)..."
Patient 1's "Multidisciplinary Notes," dated August 26, 2022, at 1:36 p.m., authored by RN 1, indicated, "...Spoke with radiologist regarding x ray abdomen, stated he couldnt (sic) get a hold of (name of Physician 1), provider to read report, sent text to provider..."
Patient 1's "Multidisciplinary Notes," dated August 26, 2022, at 5 p.m., authored by RN 1, indicated, "...Attempted to reach provider several times today via text and phone call, no response (three hours and 30 minutes since RN 1 received the call from Radiologist 1 regarding the x-ray results)...."
Patient 1's "Gynecology Progress Note," dated August 26, 2022, at 8:36 p.m., authored by Physician 1, indicated, "...Pt (Patient 1) had 3 (three) episodes of emesis this morning, s/p (status post, after) abd (abdomen) x-ray with postop ileus vs (versus) partial/early SBO (small bowel obstruction)...Diagnosis, Assessment & Plan...NPO (nothing by mouth)/IVF (intravenous fluid administered through the veins)...due to postop (after surgery) ileus (confirmed by x-ray on 8/26 [August 26, 2022])...Electronically signed by (name of Physician 1) on 8/26/22 at 2039 (8:39 p.m.)..."
There was no documented evidence Physician 1 was notified of Patient 1's abdomen/KUB x-ray which indicated an RFO.
There was no documented evidence Physician 1 addressed Patient 1's abdomen/KUB x-ray indicating an RFO.
During an interview on January 17, 2023, at 10:38 a.m., conducted with Radiologist 1, Radiologist 1 stated he was the one who read Patient 1's abdomen/KUB x-ray on August 26, 2022, which indicated a RFO consistent with the surgical sponge. Radiologist 1 stated he tried contacting Physician 1 who ordered the x-ray but was not able to get a hold of her. Radiologist 1 stated he called Patient 1's RN and informed the RN of the sponge inside Patient 1's abdomen. Radiologist 1 stated when there is a critical result of a patient, the result would be called to the ordering physician. Radiologist 1 stated if the physician was not able to be reached, the result would be reported to the patient's assigned RN.
During an interview on January 17, 2023, at 11:20 a.m., conducted with Physician 1, Physician 1 stated she was the surgeon of Patient 1 on August 24, 2022. Physician 1 stated on August 26, 2022, she was informed by the RN about Patient 1's nausea and vomiting. Physician 1 stated she ordered abdomen/KUB x-ray to rule out ileus. Physician 1 stated she did not receive report of the x-ray result from the radiologist.
Physician 1 stated she saw Patient 1 on the night of August 26, 2022. Physician 1 stated the RN told her the result of Patient 1's x-ray which was ileus vs (versus) SBO. Physician 1 stated she relied on what the RN told her about Patient 1's x-ray result. Physician 1 stated she did not read Patient 1's abdomen/KUB x-ray result. Physician 1 stated she should have looked at Patient 1's x-ray result and read it herself. Physician 1 stated if she had read Patient 1's x-ray result, she would have known of the RFO and she would have returned the patient to the operating room (OR) to remove the RFO. Physician 1 stated she would not have discharged Patient 1 with an RFO.
During an interview on January 17, 2023, at 11:32 a.m., with RN 1, RN 1 stated she was the assigned RN to Patient 1 on August 26, 2022, dayshift (7 a.m. to 7 p.m.). RN 1 stated she remembered Patient 1 was complaining of nausea and was vomiting greenish color fluid. RN 1 stated Physician 1 ordered abdomen/KUB x-ray. RN 1 stated she received a call from the radiologist telling her of Patient 1's x-ray result. RN 1 stated she could not recall what the x-ray result was as told to her by the radiologist. RN 1 stated she did not remember the radiologist reported to her about Patient 1's x-ray result of the RFO. RN 1 stated she did not read Patient 1's abdomen/KUB x-ray result. RN 1 stated the radiologist would only call the patient's assigned RN when there is a critical result finding and the physician was not able to be reached. RN 1 stated when a patient's critical result was received, the RN would call the ordering physician to inform them of the critical result.
RN 1 further stated when the physician was unable to be reached, the chain of command (an organizational structure that would document how each member of a company reports to one another) would be followed and the charge nurse or the OR nurse manager would be informed to assist on who to contact next. RN 1 stated there was no documentation the chain of command was followed when RN 1 was not able to reach Physician 1 to inform her of Patient 1's x-ray result which was received from Radiologist 1.
During an interview on January 17, 2023, at 2:15 p.m., conducted with RN 2, RN 2 stated she was the assigned RN for Patient 1 on August 26, 2022, nightshift (7 p.m. to 7 a.m.). RN 2 stated when she received report from RN 1 regarding Patient 1, she remembered RN 1 telling her Radiologist 1 wanted to talk to Physician 1. RN 2 further stated it did not sound urgent or something she needed to follow up on. RN 2 stated RN 1 did not give her report on Patient 1's x-ray result and she did not review the x-ray result.
RN 2 stated Physician 1 came late at night to see Patient 1 on August 26, 2022. RN 2 stated she told Physician 1 the dayshift R was trying to get hold of her regarding Patient 1's x-ray result.
2. During a record review conducted on January 17, 2022, Patient 1's "Gyn (Gynecology) Discharge Summary," dated August 27, 2022, indicated, "...She (Patient 1) is doing well and wants to go home today. She had nausea and vomiting probably due to morphine (pain medication)...Hospital course: Laparoscopic hysterectomy complicated by bladder laceration (cut)...POst op course uncomplicated...Discharge to: Home...Electronically signed by (name of Physician 2) on 8/27/22 (August 27, 2022) at 2139 (9:39 p.m.)..."
There was no documented evidence Patient 1's abdomen/KUB x-ray on August 26, 2022, which indicated an RFO, was addressed prior to Patient 1's discharge from the facility.
During an interview on January 17, 2023, at 2:20 p.m., conducted with Physician 3, Physician 3 stated when a physician discharges a patient, there are criteria that needs to be checked to ensure the patient was safe for discharge. Physician 3 stated the physician should assess the patient based on the patient's medical condition and/or needs prior to discharging the patient. Physician 3 stated the physician should check any barriers for discharge to ensure a safe discharge for the patient.
Physician 3 stated for Patient 1, who had complaints of nausea and vomiting for which an x-ray was ordered to rule out ileus, the result should have been read and reviewed in its entirety prior to ordering the patient's discharge.
3. During a record review conducted on January 17, 2022, Patient 1's "Pre-Procedure Orders," dated September 7, 2022, indicated, "...CT cystogram...bladder injury..."
An untitled facility document, dated September 8, 2022, indicated, "...CT Cystogram Pelvis...Comparison: Abdominal x-ray from 8/26/2022 (August 26, 2022)...There is a radiopaque sponge marker along the anterior right lower abdomen...suggestive of retained surgical sponge consistent with Gossypiboma (surgical gauze or towel inadvertently retained inside the body following a surgery). (Name of the office manager) was informed of this result at 3:20 p.m., (name of Physician 1) is out of the office, (name of the office manager) will attempt to reach one of the other providers in the group and related (sic) finding...Electronically signed by (name of Radiologist 1) on 9/08/2022 (September 8, 2022) at 1526 (3:26 p.m.)..."
Patient 1's "Discharge Report," dated September 25, 2022, indicated, "...CT ABD (abdomen) & PEL (pelvis)...Reason: Abdominal Pain...Comment: LLQ (left lower quadrant) exquisite tenderness post op, known retained sponge. increased (sic) bradycar (bradycardia, slow heart rate [less than 60 beats per minute])..."
An untitled facility document, dated September 25, 2022, indicated, "...CT Abdomen and Pelvis...History: Acute onset diffuse abdominal pain with low heart rate...Comparison Study: CT pelvis September 8, 2022...Impression: Redemonstration of retained radiopaque sponge marker in anterior mid pelvis...This is consistent with Gossypiboma. Overall appearance is similar to previous exam...Verbal report was given to patient's ER (Emergency Room) physician (name of the physician) at 9/25/2022 (September 25, 2022) 3:17 PM (p.m.). Electronically signed by (name of Radiologist 2) on 9/25/2022 at 1519 (3:19 p.m.)..."
Patient 1's "Operative Report," dated September 27, 2022, indicated, "...Postoperative Diagnoses: Retained foreign body. Extensive adhesions of the small bowel...Operations Performed: Removal of foreign body, extensive adhesiolysis, small bowel resection...The abdomen was explored through a lower midline incision...A segment of laporatomy pad was identified...A segment of about 12 inches of bowel was removed..."
There was no documented evidence the CT cystogram result indicating RFO (the same RFO seen on Patient 1's x-ray on August 26, 2022) was communicated to the physician or other medical personnel.
During an interview on January 17, 2023, at 10:38 a.m., conducted with Radiologist 1, Radiologist 1 stated he was the radiologist who read Patient 1's CT cystogram on September 8, 2022. Radiologist 1 stated Patient 1's CT cystogram indicated sponge. Radiologist 1 stated it was the same RFO that he read on Patient 1's x-ray on August 26, 2022. Radiologist 1 stated, "it was very concerning," when he found out Patient 1's RFO was still in the patient when he read the CT result because it had been two weeks since the x-ray and the RFO was still inside Patient 1's body. Radiologist 1 further stated he tried to contact Physician 1 to inform her of Patient 1's CT result but the physician was out of the clinic. Radiologist 1 stated he spoke to the office manager who will contact someone regarding the result.
During an interview on January 17, 2023, at 11:20 a.m., conducted with Physician 1, Physician 1 stated she ordered CT cystogram for Patient 1 to check on the patient's bladder since there was a bladder injury from the patient's surgery on August 24, 2022. Physician 1 stated when Patient 1 had her CT cystogram on September 8, 2022, she was out of the office. Physician 1 stated when she returned to work on September 12, 2022, the Physician Assistant informed her of Patient 1's RFO from the CT cystogram result on September 8, 2022 (five days after the same RFO was identified from the CT cystogram). Physician 1 stated she immediately went to the Radiology Department (RD) to verify the RFO result. Physician 1 stated when she was in the RD, it was the first time she found out of Patient 1's RFO from patient's x-ray result on August 26, 2022 (18 days since the KUB result was out). Physician 1 stated she verified it was the same RFO identified on the patient's CT cystogram on September 8, 2022 (four days since the CT cystogram result).
Physician 1 stated she saw Patient 1 in her clinic on September 13, 2022 (five days after the CT cystogram result which demonstrated the same RFO), and scheduled Patient 1's removal of the RFO to be performed on September 30, 2022. Physician 1 stated Patient 1 went to the Emergency Department (ED) on September 25, 2022, with the chief complaint of abdominal pain and low heart rate. Physician 1 stated Patient 1 was admitted. Patient 1's removal of the RFO was done earlier than scheduled on September 27, 2022, because of the patient's symptoms.
During an interview on January 18, 2023, at 9:35 a.m., with the Chief Medical Officer (CMO), the CMO stated he was made aware of Patient 1's RFO when the patient was in the ED because of the symptoms related to RFO. The CMO stated he spoke to Physician 1 and communicated to her that Patient 1's RFO should have been removed as soon as possible. The CMO stated Physician 1 told him a general surgery consult was needed for Patient 1's surgery because of possible adhesions caused by the RFO. The CMO stated he intervened and had a general surgeon perform the operation to Patient 1 on September 27, 2022, instead of September 30, 2022.
The CMO stated the facility was aware of the gaps which occurred on Patient 1's first surgery on August 24, 2022, from surgical counting (procedure of counting the surgical sponges and instruments in the operating room immediately after a surgery), to the physician not being informed of the RFO from the x-ray result, to the physicians not reading the x-ray result, and the physician discharging Patient 1 while not being aware of the x-ray result. The CMO stated if the surgical count was done correctly or the other gaps were addressed appropriately, Patient 1 would not have suffered from these complications.
During a review of the facility's policy and procedure (P&P) titled, "Critical Results and Critical Test Notification," dated October 27, 2021, the P&P indicated, "...Policy...To provide a mechanism to communicate timely and accurate critical results (tests and labs) to the appropriate clinician and/or medical staff...Procedure for Critical Values reporting...Outpatients: The personnel reporting the critical result must proceed as follows:
1. Notify the ordering physician when critical result is obtained...
2. If the physician cannot be reached within 30 minutes, provide the critical result information to the office RN.
3. After normal office hours, page the physician to report the critical values.
4. Ensure the physician or office RN reads back the test results to confirm accuracy...
Inpatients:
1. The personnel performing the test must proceed as follows when a critical result is exhibited...Notify the patient's assigned RN by phone when the test result is received...Ensure the RN reads back the test results to confirm accuracy.
2. The RN who receives the critical value or test result must proceed as follows...Notify the responsible physician when the critical value notification is received...If the responsible physician is not available within 30 minutes:
a. Contact an alternate physician responsible for care of the patient.
b. If the alternate physician is not available, contact section chair and follow through the chain of command...
Radiology Reporting Process...The Radiologist will call the results to the referring physician or the patient's nurse..."
During a review of the facility's document titled, "Medical Staff Bylaws," dated January 27, 2021, the document indicated, "...Purposes and Responsibilities of the Medical Staff...to provide patients with the quality of care that is commensurate with acceptable standards and available community resources...to collaborate with the Hospital in providing for the uniform performance of patient care processes throughout the Hospital...to serve as primary means of accountability to the Board of Trustees concerning professional performance of practitioners and others with Clinical Privileges authorized to practice at the Hospital with regard to the quality and appropriateness of health care...to adopt Rules and Regulations for the proper functioning of the Medical Staff, and the integration and coordination of the Medical Staff with the functions of the Hospital..."
Tag No.: A0385
Based on observation, interview, and record review, the facility failed to ensure the facility's policies and procedures were implemented when:
1. Adequate number of nurses was not maintained to provide needed patient care (A0392);
2. For Patient 1, the critical test result from abdominal and kidney/ureter/bladder (KUB) x-ray (an imaging procedure), indicating a retained foreign object (RFO, surgical sponge), was communicated to the physician (A 0398);
3. Appropriate Personal Protective Equipment (PPE, clothing or equipment worn to help prevent unnecessary exposure and spread of infectious diseases) was not worn while providing patient care inside the room of Patient 3 who was on contact precaution isolation (isolation precaution for patients with infection/s which could be transmitted by direct contact with the patient or indirect contact with environmental surfaces or patient care items in the patient's environment) (A 0398);
4. For Patient 35, the hospital's chain of command to notify a physician timely to obtain proper and appropriate care for the patient who needed immediate attention was not followed (A 0398);
5. For Patient 36, the physician was not notified of the patient's critical test results (A 0398);
6. For Patient 19, the physician was not notified when the patient's blood sugar (BS, normal BS level is 80 to130 milligram/deciliter [mg/dl, unit of measurement]) level was critically low (A 0398); and
7. For Patient 5, medications were not administered as ordered by the physician (A 0405).
The cumulative effect of these systemic failures resulted in the patients to not be provided safe and quality care to meet the patient needs.
Tag No.: A0392
Based on interview and record review, the facility failed to ensure adequate nursing staffing was maintained in accordance with the facility' policy and procedure.
This failure had the potential to impact the quality of care provided to the patients.
Findings:
During an interview on January 18, 2023, at 11:10 a.m., conducted with Registered Nurse (RN) 5, RN 5 stated when the unit was short staffed, medication administration to patients were delayed.
During a record review on January 19, 2023, at 11:30 a.m., conducted with the Assistant Chief Nursing Officer (ACNO), Patient 5's record was reviewed. The "History And Physical," indicated, "...Date of Admission: 1/10/2023 (January 10, 2023)...Chief Complaint: IR drain (Interventional Radiology drain, a tube inserted by the IR team to drain abscess) fell out, sepsis (life threatening infection) with recurrent diverticulitis (an inflammation or infection in one or more small pouches in the digestive tract) with diverticular abscess..."
The facility document titled, "PHA Order," indicated, "...Metronidazole (an antibiotic)...500 mg (milligram, unit of measurement)/100 ml bag...Route: IV...Q8H (every eight hours)...Start: 1/13/23 (January 13, 2023) - 2330 (11:30 p.m.)..."
Further review of the document indicated the following:
- Patient 5's Metronidazole was scheduled for January 14, 2023, at 11:30 p.m., and was administered on January 15, 2023, at 3:21 a.m. (a total of three hours and 51 minutes delay from the scheduled dose).
There was no documented evidence for the reason of delay for the patient's medication administration;
- Patient 5's Metronidazole was scheduled for January 15, 2023, at 7:30 a.m., and was administered at on January 15, 2023, 8:07 a.m. (a total of four hours and 46 mins from the last dose on January 15, 2023, at 3:21 a.m.);
On January 20, 2023, at 9 a.m., nurse assignment sheets were reviewed with the Chief Nursing Officer (CNO). The nurse assignment sheets for January 8, 2023, through January 16, 2023, for the day (7 a.m. to 7 p.m.) and night shift (7 p.m. to 7 a.m.) for Unit 1 were reviewed. The documents indicated the following:
- On January 8, 2023, night shift two registered nurses (RN)) were assigned five telemetry patients each;
- On January 9, 2023, day shift, two RNs were assigned five telemetry patients each, one RN was assigned six telemetry patients, and two RNs were assigned six medical-surgical (MedSurg) patients each;
- On January 15, 2023, night shift, two RNs were assigned five telemetry patients each and four RNs were assigned six MedSurg patients each; and
- On January 16, 2023, day shift, four RNs were assigned six MedSurg patients each.
The nurse assignment sheets for January 8, 2023, through January 16, 2023, day and night shift for Unit 2, were reviewed and indicated on January 16, 2023, night shift, one RN was assigned five telemetry patients.
During a concurrent interview, the CNO stated the expectation would be the nurses are assigned four telemetry patients or five Med Surg patients each. The CNO stated if this was not the case, it was "not ideal." The CNO stated adequate staffing should be maintained for patient safety.
During a review of the facility's policy and procedure (P&P) titled, "Decentralized Staffing (Nurse Authority)," dated April 28, 2021, the P&P indicated,"...Patient care will be delivered...in a skill mix identified according to acuity...Registered nurses shall be assigned to every shift in nursing care areas according to patient census...it is the responsibility of the Unit Directors, Managers, and Charge Nurses to ensure that there are adequate levels of appropriate staff in sufficient quantities to staff their individual units on an ongoing basis...Staffing by Area...MedSurg...1:5...Telemetry...1:4..."
Tag No.: A0398
Based on observation, interview, and record review, the facility failed to ensure the facility's policies and procedures (P&P) were implemented for five patients (Patients 1, 3, 35, 36, and 19), when:
1. For Patient 1, the critical test result from abdominal and kidney/ureter/bladder (KUB) x-ray (an imaging procedure), indicating a retained foreign object (RFO) was not communicated to the physician.
This failure resulted in Patient 1 undergoing another surgical procedure on September 27, 2022, for the removal of the RFO, extensive adhesiolysis (a procedure performed to break up and remove adhesions), and small bowel resection (removal of part of the small intestine).
In addition, this failure resulted in Patient 1 suffering from surgical complications such as infection, pain, and delay in recovery, and could have led to deterioration of medical condition and/or death of the patient;
2. Appropriate Personal Protective Equipment (PPE, clothing or equipment worn to help prevent unnecessary exposure and spread of infectious diseases) was not worn by staff while providing patient care inside the room of Patient 3 who was on contact precaution isolation (isolation precaution for patients with infection/s which could be transmitted by direct contact with the patient or indirect contact with environmental surfaces or patient care items in the patient's environment).
This failure had the potential to spread infectious diseases to the other patients;
3. For Patient 35, the hospital's chain of command to notify a physician timely to obtain proper and appropriate care for a patient who needed immediate attention was not followed.
This failure had the potential to result in delayed care and treatment of the patient, which may negatively affect the patient's health and safety and may lead to prolonged hospitalization and/or death;
4. For Patient 36, the physician was not notified of the patient's critical test results.
This failure had the potential to result in delayed intervention and treatment of Patient 36 with laboratory results that required rapid clinical attention; and
5. For Patient 19, the physician was not notified when the patient's blood sugar (BS, normal BS level is 80-130 milligram/deciliter [mg/dl, unit of measurement]) was critically low.
This failure had the potential to result in a delay of treatment of Patient 19.
Findings:
1. During a record review conducted on January 17, 2022, Patient 1's "History & (and) Physical," dated August 16, 2022, indicated, "...Patient is here for pre-op visit: LAVH (laparoscopically assisted vaginal hysterectomy, a surgical procedure using a camera to guide the removal of uterus through the vagina), with salphingectomy (removal of the fallopian tube)...on 8/24/22 (August 24, 2022)..."
Patient 1's "Operative Report," dated August 24, 2022, indicated, "...Surgeon (name of Physician 1)...Postoperative Diagnosis...fibroid uterus (noncancerous growth in the uterus) with adhesions between the uterus and bladder, bladder dome (part of the bladder) injury. Procedures performed: Laparoscopic-assisted abdominal hysterectomy, bilateral salphingectomy, repair of bladder dome...Assistant: (name of Physician 2)...Findings...mini-laparotomy (a smaller incision in the abdomen) performed to assist in dissection and removal of specimen..."
Patient 1's "Discharge Report," indicated a telephone order was received from Physician 1 on August 26, 2022, at 9:16 a.m., for Patient 1 to have an abdomen and KUB x-ray to rule out ileus (to determine if the cause was the inability of the intestine to contract normally) due to nausea and vomiting.
An untitled document, dated August 26, 2022, indicated, "Exams...Abdomen.../KUB...Findings consistent with a small bowel ileus versus early/partial small bowel obstruction. Radiopaque structure (dense structures which resist the passage of x-rays and would light or white in a radiographic image) along the right hemipelvis may represent a radiopaque sponge marker (most surgical sponges are detectable in the x-ray because of an incorporated radiopaque marker). Correlate clinically. Patient's (Patient 1) nurse (name of Registered Nurse [RN] 1) was informed of results on 1:35 p.m...Electronically signed by (name of Radiologist 1, a physician that specialized in diagnosing and treating injuries and diseases using radiology procedures) on 8/26/2022 at 1336 (1:36 p.m.)..."
Patient 1's "Multidisciplinary Notes," dated August 26, 2022, at 1:36 p.m., authored by RN 1, indicated, "...Spoke with radiologist regarding x ray abdomen, stated he couldnt (sic, could not) get a hold of (name of Physician 1), provider to read report, sent text to provider..."
Patient 1's "Multidisciplinary Notes," dated August 26, 2022, at 5 p.m., authored by RN 1, indicated, "...Attempted to reach provider several times today via text and phone call. No response (three hours and 30 minutes since RN 1 received the call from Radiologist 1 regarding the x-ray results)...."
Patient 1's "Gynecology Progress Note," dated August 26, 2022, at 8:36 p.m., authored by Physician 1, indicated, "...Pt (Patient 1) had 3 (three) episodes of emesis this morning, s/p (status post) abd (abdomen) x-ray with postop ileus vs (versus) partial/early SBO (small bowel obstruction)...Diagnosis, Assessment & Plan...NPO (nothing by mouth) / IVF (intravenous fluid - fluid administered through the veins)...due to postop (after surgery) ileus (confirmed by x-ray on 8/26 [August 26])...Electronically signed by (name of Physician 1) on 8/26/22 at 2039 (8:39 p.m.)..."
There was no documented evidence Physician 1 was notified of Patient 1's abdomen/KUB x-ray result indicating a RFO.
There was no documented evidence Physician 1 addressed Patient 1's abdomen/KUB x-ray indicating a RFO.
During an interview on January 17, 2023, at 10:38 a.m., conducted with Radiologist 1, Radiologist 1 stated he was the one who read Patient 1's abdomen/KUB x-ray on August 26, 2022. Radiologist 1 stated Patient 1's abdomen / KUB x-ray on August 26, 2022, indicated a RFO consistent with the surgical sponge. Radiologist 1 stated he tried contacting Physician 1 who ordered the x-ray but was not able to get a hold of her. Radiologist 1 stated he called Patient 1's RN and informed the RN of the sponge inside Patient 1's abdomen on x-ray. Radiologist 1 stated when there is a critical result of a patient, the result would be called to the ordering physician. Radiologist 1 stated if the physician was not able to be reached, the result would be reported to the patient's assigned RN.
During an interview on January 17, 2023, at 11:20 a.m., conducted with Physician 1, Physician 1 stated she was the surgeon of Patient 1 on August 24, 2022. Physician 1 stated on August 26, 2022, she was informed by the RN about Patient 1's nausea and vomiting. Physician 1 stated she ordered abdomen/KUB x-ray to rule out ileus. Physician 1 stated she did not receive report of the x-ray result from the radiologist. Physician 1 stated she saw Patient 1 on the night of August 26, 2022. Physician 1 stated the RN told her the result of Patient 1's x-ray which was ileus vs SBO. Physician 1 stated she relied on what the RN told her about Patient 1's x-ray result. Physician 1 stated she did not read Patient 1's abdomen / KUB x-ray result. Physician 1 stated she should have looked at Patient 1's x-ray result and read it herself. Physician 1 futher stated if she had read Patient 1's x-ray result, she would have known of the RFO and she would have returned the patient to the operating room (OR) to remove the RFO. Physician 1 stated she would not have discharged Patient 1 with a RFO.
During an interview on January 17, 2023, at 11:32 a.m., with RN 1, RN 1 stated she was the assigned RN to Patient 1 on August 26, 2022, dayshift (7 a.m. to 7 p.m.). RN 1 stated she remembered Patient 1 was complaining of nausea and was vomiting greenish color fluid. RN 1 stated Physician 1 ordered abdomen/KUB x-ray. RN 1 stated she received a call from the radiologist telling her of Patient 1's x-ray result. RN 1 stated she could not recall what the x-ray result was as told to her by the radiologist. RN 1 stated she did not remember the radiologist reported to her about Patient 1's x-ray result of the RFO. RN 1 stated she did not read Patient 1's abdomen / KUB x-ray result. RN 1 stated the radiologist would only call the patient's assigned RN when there is a critical result and the physician was not able to be reached. RN 1 stated when a patient's critical result was received, the RN would call the ordering physician to inform them of the critical result. RN 1 stated when the physician was unable to be reached, the chain of command (an organizational structure that would document how each member of a company reports to one another) would be followed.
RN 1 further stated there was no documentation the chain of command was followed when RN 1 was not able to reach Physician 1 to inform her of Patient 1's x-ray result received from Radiologist 1.
During an interview on January 17, 2023, at 2:15 p.m., conducted with RN 2, RN 2 stated she was the assigned RN for Patient 1 on August 26, 2022, nightshift (7 p.m. to 7 a.m.). RN 2 stated when she received report from RN 1 regarding Patient 1, RN 2 remembered RN 1 telling her Radiologist 1 wanted to talk to Physician 1. RN 2 further stated it did not sound urgent or something she needed to follow up on. RN 2 stated RN 1 did not give her report on Patient 1's x-ray result and she did not review the x-ray result. RN 2 stated Physician 1 came late at night to see Patient 1 on August 26, 2022. RN 2 stated she told Physician 1 the dayshift RN was trying to get a hold of her regarding Patient 1's x-ray result.
During an interview on January 18, 2023, at 9:50 a.m., with the Chief Nursing Officer (CNO), the CNO stated when a RN receives report of a critical result, the RN should notify the physician and document the date, time, name of the physician the result was given to, and the details of the result given to the physician. The CNO stated when the RN was not able to reach the physician, the chain of command should be followed.
The CNO further stated Patient 1's critical test result from the abdomen/KUB x-ray was not addressed in accordance with the facility's P&P.
During a review of the facility's P&P titled, "Critical Results and Critical Test Notification," dated October 27, 2021, the P&P indicated, "...Procedure for Critical Values Reporting...The personnel performing the test must proceed as follows when a critical result is exhibited...Notify the patient's assigned RN by phone when the test result is received...Ensure the RN reads back the test results to confirm accuracy...The RN who receives the critical value or test result must proceed as follows...Notify the responsible physician when the critical value notification is received...If the responsible physician is not available within 30 minutes...Contact an alternate physician responsible for care of the patient...If the alternate physician is not available, contact section chair and follow through the chain of command..."
2. During a concurrent observation and interview on January 18, 2023, at 11:35 a.m., conducted with the Director of Medical Surgical (DMS), Patient 3's room was observed to have an isolation sign on the door and a cart containing PPEs near the patient's room. Inside Patient 3's room, the Occupational Therapist was observed to be wearing an isolation gown, gloves, and mask, and a student nurse (SRN) was observed to be wearing gloves and mask.
The DMS was observed to proceed by Patient 3's door and called the SRN's attention for not wearing an isolation gown inside the patient's room. The SRN was observed to immediately run out of Patient 3's room, went to the PPE cart, and put on a gown. The SRN was observed to state she was inside Patient 3's room to check the patient's blood sugar and she forgot to wear the isolation gown before entering Patient 3's room. The SRN was observed to state she was aware the patient was on contact isolation precaution but did not know the reason for Patient 3's contact isolation.
The DMS was observed to state Patient 3 was on contact isolation precaution for Escherichia coli (E. coli, a type of bacteria) in the urine and appropriate PPE should be worn at all times before entering Patient 3's room.
During a record review on January 18, 2023, at 3:35 p.m., Patient 3's record was reviewed. The "History & (and) Physical," dated December 30, 2022, indicated Patient 3 was transferred from another facility complaining of right side flank pain and was found to have an acute kidney injury (kidney disorder).
The "Laboratory Inquiry Report," dated December 30, 2022, indicated Patient 3's urine culture was positive for E. coli.
An undated facility document titled, "Patient Assessment," indicated, "...(Name of Patient 3)...Safety/Risk...Isolation status: Contact..."
During a review of the facility's P&P, "Isolation & Standard Precautions," dated June 24, 2020, the P&P indicated, "...Contact Precautions...Personal Protective Equipment...Wear a gown every time you enter the patient's room..."
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3. A review of Patient 35's "History and Physical (H&P)," dated December 27, 2022, was conducted on January 19, 2023, at 11:30 a.m. The H&P indicated Patient 35 was admitted for shortness of breath. The "H&P" also indicated Patient 35 had a history of congestive heart failure (CHF, condition where heart cannot pump enough blood), chronic obstructive pulmonary disease (COPD, a lung disease that can cause difficulty breathing), and pulmonary fibrosis (a condition when lung tissue becomes damaged and scarred).
Review of Patient 35's "Multidisciplinary Notes," dated December 29, 2022, at 1:19 a.m., indicated, "...21:41 (9:41 p.m.) PT STATED FEELING HEAVY IN THE CHEST WITH DIFFICULTY BREATHING, VS (vital signs, which include heart rate, blood pressure [BP], temperature, blood oxygen level, and respiratory rate) WAS CHECKED, BP WAS IN THE 120'S. PROTOCOL ORDERS PUT IN FOR STAT (to be done immediately) EKG (electrocardiogram, a test to determine the heart rate and rhythm) AND LAB (laboratory test/s) TROPONIN (type of protein released into blood which could indicate heart damage). EKG SHOWS AFIB (atrial fibrillation, irregular heartbeat that can lead to blood clots in the heart)...ATTEMPTED TO REACH (Name of physician) 6 (six) TIMES, THROUGH ANSWERING SERVICE, PERSONAL PHONE AND LEFT MESSAGE FOR CALL BACK WITH NO RESPONSE. RAPID RESPONSE (RRT, hospital team called to assess and intervene if a patient is experiencing an acute decline in clinical status) WAS CALLED AT 22:53 (10:53 p.m.) (one hour and 12 minutes from the time patient had a change in condition at 9:41 p.m.) AND TOOK OVER CARE OF PT..."
A review of Patient 35's "Rapid Response Note," dated December 28, 2022, at 11:50 p.m., indicated the RRT was called to the patient's bedside for A-fib. The note indicated Patient 35's heart rate was in the 180s (normal resting heart rate for adults is 60 to 80 beats per minute), systolic blood pressure in the 200s (first number of blood pressure reading which measures the pressure when heart beats, normal is 120), and oxygen level was at 89% (normal level is around 90% for some people with chronic lung disease).
On January 17, 2023, at 2:10 p.m., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated she would follow the chain of command if a physician was difficult to reach.
On January 19, 2023, at 1:48 p.m., an interview was conducted with the Nurse Manager (NM) 1. NM 1 stated staff should follow the chain of command if they cannot get in touch with the physician. NM 1 stated if the physician cannot be reached within 30 minutes, then staff should escalate chain of command. NM 1 further stated Patient 35's nurse should have followed the doctors' chain of command by trying to contact another physician involved in the patient's care.
A review of the facility's policy and procedure (P&P) titled, "Chain of Command - Patient Care Services," dated May 26, 2021, was conducted. The P&P indicated, "...It is the nurse's responsibility to communicate pertinent information and clinical concerns to the appropriate physician who has the authority to interpret and act on it, for the good of the patient...The medical staff chain of command will be used for patient care concerns in the order of...Another physician currently involved in the patient's hospital care...Patient care concerns include but are not limited to the following...Treatment plan concerns...Safety issues...The Nurse...If unable to reach the physician or patient care issue remains unresolved, consult with the charge nurse to review concerns...Discuss concern with another physician currently involved in the patient's care. If unsuccessful, notify the Manager, Director, or Liaison to utilize the Chain of Command until issue is resolved...
Chain of Command Algorithm...The Chain of Command will be followed under the following circumstances of patient care: Patient care management issues including but not limited to...Prescribed treatment plan or physician order...Life-threatening patient concerns...Safety concerns that may jeopardize the care/safety of a patient, family and/or employee..."
4. A review of Patient 36's "History and Physical (H&P)," dated November 28, 2022, was conducted on January 19, 2023, at 2:27 p.m. The H&P indicated Patient 36 was admitted for treatment of shock (a life-threatening condition when the body is not getting enough blood flow) following two cardiac arrests (heart suddenly stops beating).
A concurrent interview and record review, on January 20, 2023, at 11:35 a.m., was conducted with the Regulatory Compliance Manager (RCM). Review of Patient 36's "PCI Laboratory Report" for lactic acid (measures amount of lactic acid in the blood, normal is 0.4 to 2.0 millimoles per liter [mmol/L, unit of measurement], high levels can be fatal), from November 26, 2022, through November 27, 2022, indicated the following critical results were received by the licensed nurse:
- On November 26, 2022, at 5:29 p.m., lactic acid result was 7.8 mmol/L;
- On November 26, 2022, at 7:42 p.m., lactic acid result was 6.5 mmol/L; and
- On November 27, 2022, at 8:04 a.m., lactic acid result was 3.4 mmol/L.
The RCM stated there was no documented evidence the licensed nurses who received the critical test results notified Patient 36's physician.
An interview, on January 17, 2023, at 11:10 a.m., was conducted with Registered Nurse (RN) 3. RN 3 stated when a critical lab result is received the nurse should report the critical result to the physician within 15 minutes and document the notification in the patient's medical record.
An interview, on January 17, 2023, at 2:10 p.m., was conducted with RN 4. RN 4 stated a critical lab result should be reported to the physician within 15 minutes after receiving the call from lab.
An interview, on January 19, 2023, at 10 a.m., was conducted with the Nurse Manager (NM) 3. NM 3 stated critical lab results should be reported to the physician within 30 minutes and documented in the patient's electronic medical record.
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5. On January 9, 2023, at 11:30 a.m. an interview and concurrent record review was conducted with Nurse Manager 6 (NM 6). Patient 19's "History & (and) Physical- Adult," dated January 13, 2023, indicated, "...(Patient 19) presents with 2 (two) weeks of abdominal distention and bloating..."
The facility document titled, "Internal Medicine Prog. (Progress) Note," dated January 19, 2023, indicated, "...On 1/14 (January 14, 2023) pt (Patient 19) had rapid (RRT) called for ALOC (altered level of consciousness) and found unresponsive. He was noted to be hypoglycemic (with low blood sugar [BS]) with rightward gaze deviation...He was intubated (a breathing tube inserted through the airway) and transferred to the ICU (Intensive Care Unit, for critically ill patients) on 1/15 (January 15, 2023)...Diagnosis, Assessment & (and) Plan...Hypoglycemia (low blood suger)...Maintain blood glucose (sugar) 140-180...""
Patient 19's "PCI Laboratory Inquiry Report," dated January 19, 2023, indicated, "...GLUCOSE...39 (normal BS level is 80-130 mg/dl..."
There was no documented evidence Patient 19's physician was notified of Patient 19's critically low BS of 39.
NM 6 stated there was no documentation the physician was notified when Patient 19 had a low BS of 39 on January 19, 2023.
During a review of the facility's P&P titled, "Critical Results and Critical Tests Notification," revised August 2021, the P&P indicated, "...Registered nurses and Licensed Independent Practitioners ...Critical results are identified by the Medical Staff and require communication of the results...Communication of the critical results requires person to person communication and must not be left on a voice mail...A Critical Result: is a test result beyond the normal variation with a high probability or significant increase in morbidity and/or mortality...The RN who receives the critical value or test result must proceed as follows...Notify the responsible physician when the critical value notification is received, not to exceed 30 minutes...Documentation...The Physician Notification Screen in the electronic medical record is used to document physician notification of critical results or tests...The nurse receiving the critical result or test result must read back the result in its entirety to the reporting individual at the time the critical value is given...The nurse receiving the critical result will document time of call(s) and/or resolution if applicable..."
During a review of the facility's P&P titled, "Glycemic Control," reviewed February 2019, the P&P indicated, "...To ensure optimal glycemic control...Order sets are developed and approved by the medical staff for glycemic control...Hypoglycemic events...Hypoglycemia is defined as blood glucose below 70 mg/dl with or without symptoms...Notify physician STAT (immediately) for severe hypoglycemia for further instructions..."
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Tag No.: A0405
Based on observation, interview, and record review, the facility failed to ensure medications were administered as ordered by the physician, for one patient (Patient 5), in accordance with the facility's policies and procedures.
This failure resulted in medication administration errors and delay of treatment for Patient 5 which may lead to the patient's deterioration of medical condition and/or death.
Findings:
During an observation on January 18, 2023, at 11 a.m., conducted with Nurse Manager (NM) 4, Patient 5 was observed lying in bed, alert, and oriented. Patient 5 was observed to have an abdominal drain on the right upper part of his abdomen with thick yellow brown fluid drainage. Patient 5 was observed to have an intravenous (IV) antibiotic (metronidazole) infusing at 100 milliliter per hour (ml/hr) through the peripheral IV on her right hand.
During an interview on January 18, 2023, at 11:10 a.m., conducted with Registered Nurse (RN) 5, RN 5 stated when the unit was short staffed, patients' medication administration were delayed.
During a concurrent interview and record review on January 19, 2023, at 11:30 a.m., conducted with the Assistant Chief Nursing Officer (ACNO), Patient 5's record was reviewed. The "History And Physical," indicated, "...Date of Admission: 1/10/2023 (January 10, 2023)...Chief Complaint: IR drain (Interventional Radiology drain, a tube inserted by the IR team to drain abscess) fell out, sepsis (life threatening infection) with recurrent diverticulitis (an inflammation or infection in one or more small pouches in the digestive tract) with diverticular abscess..."
1. The facility document titled, "PHA Order," indicated, "...Metronidazole...500 mg (milligram, unit of measurement)/100 ml bag...Route: IV...Q8H (every eight hours)...Start: 1/13/23 (January 13, 2023) - 2330 (11:30 p.m.)..."
Further review of the document indicated the following:
- Patient 5's Metronidazole was scheduled for January 14, 2023, at 11:30 p.m., and was administered on January 15, 2023, at 3:21 a.m. (a total of three hours and 51 minutes delay from the scheduled dose).
There was no documented evidence for the reason of delay for the patient's medication administration;
- Patient 5's Metronidazole was scheduled for January 15, 2023, at 7:30 a.m., and was administered on January 15, 2023, at 8:07 a.m. (a total of four hours and 46 mins from the last dose on January 15, 2023, at 3:21 a.m.);
- Patient 5's Metronidazole was scheduled for January 18, 2023, at 7:30 a.m., and was administered on January 18, 2023, at 10:29 a.m. (a total of two hours and 59 minutes hours delay from the scheduled dose).
There was no documented evidence for the reason of delay for the patient's medication administration; and,
- Patient 5's Metronidazole was scheduled for January 18, 2023, at 11:30 p.m., and was administered on January 19, 2023, at 3:31 a.m. (a total of four hours and one minute delay from the scheduled dose).
There was no documented evidence for the reason of delay for the patient's medication administration.
There was no documented evidence the physician was notified for the multiple delayed administration of Metronidazole for Patient 5.
The ACNO stated when there was a delay in administering the medication, a reason should be documented and the physician should be notified.
The ACNO stated when there was a delay in medication administration, the following dose scheduled should be adjusted to ensure the appropriate dosing was followed in accordance to the physician's order.
The ACNO stated Patient 5's Metronidazole was not administered as ordered by the physician.
2. The facility document titled, "PHA Order," indicated, "...Zyvox (antibiotic) 600 mg/300 ml bag...Route: IV...Q12H (every 12 hours)...Start: 1/13/23 - 2300 (11 p.m.)..."
Further review of the document indicated the following:
- Patient 5's Zyvox was scheduled for January 16, 2023, at 11 a.m., and was administered on January 16, 2023, at 1:28 p.m. (a total of two hours and 28 minutes delay from the scheduled dose).
The reason for the delay was the medication not available per pharmacy.
There was no documented evidence the physician was notified for the delayed administration of Zyvox;
- Patient 5's Zyvox was scheduled for January 18, 2023, at 11 a.m., and was administered at on January 18, 2023, at 4:07 p.m. (a total of five hours and 7 minutes delay from the scheduled dose).
The reason for the delay was the medication not available per pharmacy.
There was no documented evidence the physician was notified for the delayed administration of Zyvox; and,
- Patient 5's Zyvox was scheduled for January 18, 2023, at 11 p.m., and was administered on January 18, 2023, at 10:18 p.m. (a total of six hours and 11 minutes from the last dose on January 18, 2023, at 4:07 p.m.).
The ACNO stated when there was a delay in administering the medication the physician should be notified.
The ACNO stated when there is a delay in medication administration, the following dose schedule should be adjusted to ensure the appropriate dosing was followed in accordance to the physician's order.
The ACNO stated Patient 5's Zyvox was not administered as ordered by the physician.
During an interview on January 19, 2023, conducted with the Pharmacy Operation Manager (POM), the POM stated Zyvox was a limited stock because it was not being used often.
The POM stated on January 16, 2023, the facility had several patients started on Zyvox and the stock ordered for Patient 5 was used and had to be reordered.
The POM stated on January 18, 2023, Zyvox was available and was delivered by the pharmacy to the nursing unit on January 18, 2023, at 6:22 a.m., for the 11 a.m. dose and at 1:23 p.m., for the 11 p.m. dose.
The POM stated the Zyvox should have been given as scheduled on January 18, 2023.
During a review of the facility's policy and procedure (P&P) titled, "Medication Administration," dated June 23, 2021, the P&P indicated, "...Medications shall be administered exactly as ordered by the physician...Medications must be administered within 60 minutes before or after the scheduled medication administration time...Any time outside of the parameters must have a reason code documented in the eMAR..."
During a review of the facility's policy and procedure (P&P) titled, "Medication Administration Times," dated August 24, 2022, the P&P indicated, "...For Nursing Personnel...Consult the Pharmacist whenever there is doubt regarding adequate time interval between the first dose and the next administration of the dosage...Administer medications accordingly..."
Tag No.: A0940
Based on observation, interview, and record review, the facility failed to ensure the facility's policy and procedure (P&P) for surgical count was implemented when:
1. For Patient 1, a retained foreign object (RFO) was discovered when the patient (Patient 1) had an abdominal and kidney/ureter/bladder (KUB) x-ray (an imaging procedure) on August 26, 2022 (A 0951); and
2. For Patient 12, a pocketed sponge counter (an item with pockets where each used surgical sponge would be placed) was not used during the surgical count during a surgical procedure on January 18, 2023 (A 0951).
The cumulative effect of these systemic failures resulted in the patients to not be provided safe and quality care to meet their needs.
Tag No.: A0951
Based on observation, interview, and record review, the facility failed to ensure the facility's policy and procedure (P&P) for surgical count was implemented for 2 patients (Patients 1 and 12), when:
1. For Patient 1, a retained foreign object (RFO) was discovered when the patient had an abdominal and kidney/ureter/bladder (KUB) x-ray (an imaging procedure) on August 26, 2022.
This failure resulted in Patient 1 having another surgical procedure on September 27, 2022, for the removal of the RFO, extensive adhesiolysis (a procedure performed to break up and remove adhesions), and small bowel resection (removal of part of the small intestine).
In addition, this failure resulted in Patient 1 suffering from surgical complications such as infection, pain, delayed in recovery and could have led to deterioration of medical condition and/or death of the patient; and,
2. For Patient 12, a pocketed sponge counter (an item with pockets where each used surgical sponges would be placed to be counted.
This failure had the potential to result in incorrect surgical count to be incorrect and had the potential for Patient 12 to suffer injury from a retained sponge.
Findings:
1. During an interview on January 12, 2023, at 10:30 a.m., conducted with Circulating Nurse (CN) 1 and Surgical Technician (ST) 1, CN 1 and ST 1 stated they were the staff during Patient 1's surgery on August 24, 2022, and they both performed the surgical counts. ST 1 stated a pre-surgical count was performed prior to starting Patient 1's surgery. ST 1 stated the pre surgical count was listed on a white board inside the OR room and if the surgeon needed additional instruments or sponges, it would be added to the white board and included in the counts. ST 1 stated Patient 1's surgery started as laparoscopic procedure but during the surgery, there was a bladder injury, and Physician 1 decided to do an open surgery (mini laparotomy). ST 1 stated they counted all the surgical sponges and they had all the sponges they counted except the one in the hand of Physician 1. ST 1 stated Physician 1 was holding a surgical sponge throughout Patient 1's surgery, as she likes to have one in her hand to use during the surgery. ST 1 stated it was the first time she assisted Physician 1 in a surgery and she was not used to having a surgeon holding a surgical sponge all throughout the surgery. ST 1 stated when they counted the surgical sponge that was in Physician 1's hand, they did not take it from her because she was still using it. ST 1 stated Physician 1 was still holding the surgical sponge after they completed the final surgical count.
CN 1 stated we counted everything during the surgical counts on Patient 1's surgery on August 24, 2022. CN 1 stated the dirty and blood soaked sponges were placed in a bin container and each sponge was counted by CN 1 and ST 1. CN 1 stated they counted the clean sponges, the ones which were not used for surgery, from the OR table by laying each down one by one as they counted them.
During a record review conducted on January 17, 2022, Patient 1's "History & (and) Physical," dated August 16, 2022, indicated, "...Patient is here for pre-op visit: LAVH (laparoscopically assisted vaginal hysterectomy, a surgical procedure using a camera to guide the removal of uterus through the vagina), with salphingectomy (removal of the fallopian tube)...on 8/24/22 (August 24, 2022)..."
Patient 1's "Operative Report," dated August 24, 2022, indicated, "...surgeon (name of Physician 1)...Postoperative Diagnosis...fibroid uterus (noncancerous growth in the uterus) with adhesions between the uterus and bladder, bladder dome (part of the bladder) injury. Procedures performed: Laparoscopic-assisted abdominal hysterectomy, bilateral salphingectomy, repair of bladder dome...Assistant: (name of Physician 2)...Findings...mini-laparotomy (a smaller incision in the abdomen) performed to assist in dissection and removal of specimen..."
Patient 1's "Discharge Report," indicated a telephone order was received from Physician 1 on August 26, 2022, at 9:16 a.m., for Patient 1 to have an abdomen and KUB x-ray to rule out ileus (to determine if the cause was the inability of the intestine to contract normally) due to nausea and vomiting.
An untitled document, dated August 26, 2022, indicated, "Exams...Abdomen.../KUB...Findings consistent with a small bowel ileus versus early/partial small bowel obstruction. Radiopaque structure (dense structures which resist the passage of x-rays. It appear light or white in a radiographic image) along the right hemipelvis may represent a radiopaque sponge marker (most surgical sponges are detectable in the x-ray because of an incorporated radiopaque marker). Correlate clinically. Patient's (Patient 1) nurse (name of Registered Nurse [RN] 1) was informed of results on 1:35 p.m...Electronically signed by (name of Radiologist 1, a physician that specialized in diagnosing and treating injuries and diseases using radiology procedures) on 8/26/2022 at 1336 (1:36 p.m.)..."
Patient 1's 'Operative Report," dated September 27, 2022, indicated, "...Postoperative Diagnoses: Retained foreign body. Extensive adhesions of the small bowel...Operations Performed: Removal of foreign body, extensive adhesiolysis, small bowel resection...The abdomen was explored through a lower midline incision...A segment of laparotomy pad was identified...A segment of about 12 inches of bowel was removed..."
During an interview on January 17, 2023, at 10:38 a.m., conducted with Radiologist 1, Radiologist 1 stated he was the one who read Patient 1's abdomen / KUB x-ray on August 26, 2022, which indicated a RFO consistent with the surgical sponge.
During an interview on January 12, 2023, at 10:02 a.m., conducted with the Vice President of Surgical Services (VPSS), the VPSS stated surgical counts were done three times. The first count would be prior to starting the surgical case, the second count would be just when the surgeon starts to close the surgical wound, and final count would be done at the end of the surgery.
The VPSS stated the Operating Room (OR) staff who did the surgical count for Patient 1's surgery on August 24, 2022, thought all the counts were correct, however it was not, when a retained surgical sponge was discovered in Patient 1's abdomen/KUB x-ray.
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2. On January 18, 2023, at 10:47 a.m., an observation of the final count during a surgical procedure was conducted with the VPSS and the Patient Safety Coordinator (PSC). CN 2 was observed laying out the dirty/used operating sponges on the instrument table as final counts were being conducted. A pocketed sponge counter was not observed to be used during the final count for the procedure.
On January 20, 2023, at 11:10 a.m., an interview was conducted with the Vice President of Quality (VPQ) and the Chief Medical Officer (CMO). They both stated the pocketed sponge counters are to be used in the operating room, during surgeries, at all times.
On January 20, 2023, at 11:40 a.m., an interview was conducted with the VPSS. The VPSS stated the pocketed sponge counters should have been used in the operating room, during surgeries, per policy. The VPSS stated the pocketed sponge counter was not used during the surgery which was observed on January 18, 2023, at 10:47 a.m.
A titled facility document, "OPERATING LIST", dated January 18, 2023, indicated, "...(name of Patient 12)...(name of Physician 4)...LAPAROSCOPIC CHOLECYSTECTOMY POSSIBLE OPEN (minimal invasive surgery to remove the gall bladder)..."
A titled facility document, "Op/Inv Proc (Operative Procedure) Note - Brief," authored by Physician 4 on January 18, 2023, at 11:06 a.m., indicated, "...Chronic cholecystitis (inflammation of the gall bladder)...Laparoscopic cholecystectomy..."
During a review of the facility's P&P titled, "Counts: Instruments, Sharps, Sponges," dated May 27, 2020, the P&P indicated, "...Policy...Counts are performed to account for all items and to lessen the potential for injury to the patient as a result of retained surgical item (RSI)...Sponges, sharps, and miscellaneous items on the operative field will be counted on every surgical/invasive procedures to prevent retention of a surgical item in the patient...The surgeon(s) and first assistant(s) should maintain awareness of all soft good, instruments, and sharps used in the wound during the course of the procedure...The surgeon does not perform the count but should facilitate the process by...communicating placement of surgical items in the wound to the perioperative team for notation on the whiteboard...
Notifying scrub person and RN circulator about the surgical items returned to surgical field after the count...
Safety concepts...Pocketed sponge counters will be used at all times. Sponges and/or white x-ray O.R. towels are placed in counter hangers as they are packaged...
Sponge counter bags should be used to collect sponges. These should be filled from the bottom up. At the end of the procedure, all sponges should be accounted for by placing each sponge in a pocket of the counter bag. This provides a verification that all sponges have been accounted for..."