HospitalInspections.org

Based on policy review, medical record review, and staff interview, it was determined the facility failed to:
1. Track sterilized surgical instruments used on patients.
2. Mitigate the risks associated with healthcare associated infections (HAI's) for one (#10) of ten patient medical records samples.

Findings included:

1. A review of the facility policy entitled, "Sterrad Sterilization", #SS.305-27, reviewed 03/2017, showed that the Surgical Services and Sterile Processing Departments (SPD) have the responsibility to provide and maintain a safe environment for the patient...the results of the sterilization test will be recorded in the assigned log and stored near the Sterrad in SPD (Sterrad systems uses low-temperature, hydrogen peroxide gas plasma technology to sterilize a wide range of instruments).

A review of all facility policies related to sterilization and disinfection of sterilized surgical instruments failed to reveal the presence of an instrument recall process.

A review of nationally recognized guidelines for the sterilization and disinfection of instruments used on patients revealed the following:
The Association for the Advancement of Medical Instrumentation (AAMI) recommends appropriate documentation and reporting practices that enable trackability of each facility-sterilized medical device to the patient on whom it was used.
The Safe Medical Devices Act of 1990 recommends that to ensure patient safety and compliance with reporting requirements, the health care facility should establish recall procedures to expedite the retrieval of processed items that are suspected to be nonsterile and to ensure adequate follow-up actions such as quarantine of the sterilizer, notification of physicians and affected clinical departments, and surveillance of patients. The recall order should include the following documentation:
a. include all items processed back to the last negative biological (Bl);
b. be immediately communicated to affected departments and followed by a written order;
c. identify by sterilization lot number the products to be recalled;
d. identify the persons or departments to whom the order is addressed;
e. require the recording, in terms of kind and quantity, of the products obtained in the recall; and
f. specify the action to be taken by the persons receiving the order (e.g., destruction or return of product).

An interview conducted on 04/12/18 at 3:15 PM with the facility SPD manager revealed the facility is not currently tracking sterilized instruments used on patients. The manager stated the sterilizer provides a lot number with every load but they do not keep a log or document the lot# in the medical record of the patient the instruments are used on. The manager stated they could track the instruments that are used on a patient but currently do not have a system in place.

2. A review Patient # 10's physician history and physical (H&P) documentation revealed the patient was admitted to the facility on 12/18/17 for a laminectomy and L4-S 1 spinal fusion.

On 12/30/17, Patient. #10 presented to the emergency department (ED) with complaints of fever, malaise, and low back pain for 1 day. The patient was noted to have a temperature of 101.7 degrees Fahrenheit (F). Radiology exams were ordered, as well as consultations for the surgeon and infectious disease. A review of the H&P physician documentation showed the patient was suspected to have sepsis, fever and elevated WBC's (a high white blood cell count usually indicates an increased production of white blood cells to fight an infection) and inflammatory markers. The physician's plan was to admit to the hospital for I.V. antibiotics and would culture if any drainage from the surgical site.

A review of the infectious disease (ID) physician consultation notes dated 01/01/18, showed the patient complained of drainage from the surgical site, as well as fever, malaise, and low back pain. The notes indicate the patient did not have any other complaints or evidence of an infectious process in any other body system. The patient's white blood cells (WBC's) were elevated above normal and CRP (inflammatory markers) were elevated at above normal. A urinalysis and chest x-ray were negative for infection. Documentation showed the lumbar surgical site was positive for serous drainage, tenderness, induration (an increase in the fibrous elements in tissue commonly associated with inflammation and marked by loss of elasticity and pliability). Continued review of the ID physician's assessment revealed the following: suspected early sepsis, with increased white blood cells secondary to postsurgical slow healing wound, lumbar fluid collection (3.6cm x 1.4 cm) seroma verses an abscess. A review of the CT scan and MRI confirmed the finding of the aforementioned fluid collection. The ID physician's plan was to continue empiric vancomycin, ceftriaxone, and rifampin, for a total of three antibiotics. The ID physician's note indicated the patient would need to be treated aggressively due to underlying hardware from the spine surgery. The ID physician recommended that the surgical site fluid drainage be cultured (a culture is a test to find germs, such as bacteria or a fungus, that can cause an infection). He also ordered a sensitivity test (checks to see which antibiotic will work best to treat the infection, reduce treatment time, and risk of toxicity to the kidneys).

A review of the surgeon documentation dated 01/02/18 showed the surgeon canceled the order for a culture of the drainage from the surgical site. An interview with the RM revealed she could not ascertain why the surgeon would cancel the culture of the drainage from the surgical site when the hospitalist and infectious disease physicians recommended a culture to determine the pathogen and appropriate antibiotics based on the sensitivities. The patient was discharged home with a peripherally inserted central catheter (PICC) line for antibiotics. The patient was discharged with the following I.V. antibiotics; ceftriaxone and vancomycin. The antibiotic rifampin was ordered to be taken orally. The patient was discharged with three antibiotics for a suspected surgical site infection.

An interview performed on 04/12/18 at 11:25 AM with the facility Infection Preventionsit (IP) revealed that she was unaware that Patient #10 acquired a surgical site infection (SSI) after surgery at the facility. She also indicated that if a culture is not performed, the SSI might not be detected through normal surveillance for surgical site infections. The IP stated the facility has a very strong antimicrobial stewardship program that includes appropriate wound culturing and sensitivity of suspected infections for appropriateness of antibiotics given to patients.

A review of the physician H&P documentation showed Patient #10 was again admitted to the facility on 01/07/18 with complaints of 4 days of fevers up to 104 degrees (98.6 normal). The H&P indicated the patient had to discontinue the antibiotic vancomycin due to severe diarrhea. The patient was admitted for high fevers and possible incision and drainage by the orthopedic surgeon of the fluid collection located at the surgical site. Additionally, a nephrology physician was consulted due to suspected acute kidney injury from associated antibiotics.

A review of the nephrology (kidney) physician consultation documentation dated 01/09/18 showed the patient likely suffered an acute kidney injury due to vancomycin toxicity. Creatinine level (test of kidney function) on admission was 2.2 (high). The nephrologist's plan was to discontinue the vancomycin with the expectation kidney function would return to normal.

A review of the discharge (DC) summary physician documentation dated 01/12/19, showed the Patient #10 underwent I&D of the surgical site fluid collection. The final DC diagnosis included; acute kidney injury, abscess and fever. The patient was discharged on one oral antibiotic for the treatment of his hospital acquired surgical site infection.

Based on record review, facility policy and interview, it was determined the facility failed to ensure, immediately following surgery, a post operative report, describing techniques and findings for one [# 7] for ten sampled records reviewed.

Findings include:

A review of facility policy titled, "Operative Reports Documentation Requirements" page 1 item 4 states, A post-operative progress note is completed immediately post-operative for all surgical patients prior to the patient being transferred to the next level of care. Page 1 item 5 states, In addition, a surgical/procedure report is written or dictated after surgery and if immediately available after the procedure, with no delay whatsoever, it may suffice for the post-op progress note as well.

Patient #7 was admitted to facility on 04/11/2018 for elective inpatient surgical procedure.
A review of the intraoperative reports documents patient brought to surgical operating room at 10:30 AM,
Procedure safety time-out performed at 11:25 AM. Procedure start time at 11:30 AM. and Procedure stop time at 1:43 PM. Patient transferred to PACU [post anesthesia care unit] at 1:41 PM and transferred to inpatient bed at 2:11 PM.
A review of the Patient #7's medical record on 04/12/2018 at 3:00 PM with the Director of Post-Surgical Services and Operating Room Supervisor revealed the Patient #7's medical record did not document a post-operative progress note or a detailed operative report.

An interview on 04/12/2018 at 3:30 PM, with the Director of Post-Surgical Services confirmed the above findings