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Based on the manner and degree of the standard-level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 QAPI was out of compliance.

A-0283: Program Data. The hospital must use the data collected to - Identify opportunities for improvement and changes that will lead to improvement. Program Activities. The hospital must set priorities for its performance improvement activities that-- Focus on high-risk, high-volume, or problem-prone areas; Consider the incidence, prevalence, and severity of problems in those areas; and affect health outcomes, patient safety, and quality of care. The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained.

Based on observations, interviews and document review, the facility failed to ensure the quality assessment and performance improvement (QAPI) program implemented, measured and tracked performance improvement activities related to problem-prone areas. Specifically, the facility's QAPI program failed to implement and monitor preventive action related to the facility's Sterile Processing Department (SPD) in response to identified sterilization breaches and events in which bioburden was identified on surgical instruments. In addition, the QAPI program did not implement and monitor actions to prevent recurrence in response to events in which patient consents and History and Physicals (H&Ps) were not completed according to facility policy.

Based on observations, interviews and document review, the facility failed to ensure the quality assessment and performance improvement (QAPI) program implemented, measured and tracked performance improvement activities related to problem-prone areas. Specifically, the facility's QAPI program failed to implement and monitor preventive action related to the facility's Sterile Processing Department (SPD) in response to identified sterilization breaches and events in which bioburden was identified on surgical instruments. In addition, the QAPI program did not implement and monitor actions to prevent reoccurrence in response to events in which patient consents and History and Physicals (H&Ps) were not completed according to facility policy.

Facility policies:

The Safety, Infection and Quality Plan read, the facility will maintain an ongoing Safety, Infection and Quality Program which is designed to prevent, minimize and investigate risk events and to provide a safe and sanitary environment of care. All staff of the hospital are encouraged to identify opportunities for improvement. The program is a data-driven and proactive approach to quality improvement.

The program will develop mechanisms to detect and identify performance which is inconsistent with standards; collect data to determine the standards are being met; recommend corrective action which will bring performance into compliance with standards; plan follow-up studies to evaluate the effectiveness of the corrective action. The goals of the program include to improve overall patient care through systematic monitoring and evaluation; to ensure identification and solution of problems; to prevent adverse outcomes. Performance improvement is defined as a pro-active approach that continuously studies processes with the goal to prevent problems in care delivery.

The Incident/ Occurrence Reporting policy read, an incident is defined as any clinical or non-clinical occurrence which was not consistent with the routine care or operation of the organization. Incidents could involve patients, employees and medical staff members. Incidents could require higher level of review by supervisors and administration, and required trending and/or root cause analysis. An occurrence is defined as an event that deviated from the standards of care. It is the responsibility of all staff to immediately report events and/or incidents. The occurrence reporting process is used for facility improvement of the quality of patient care.

Follow-up will be conducted by the risk manager or their designee. Occurrence data will be analyzed, tracked and trended to ensure safe and effective patient care. Data will be shared at appropriate meetings including but not limited to Governance, Medical Staff, and Quality Safety and Infection Control.

The Decontamination and Cleaning of Contaminated Instruments policy read, proper care and cleaning helps safeguard instruments' function and effectiveness and reduces the likelihood of infections caused by instrument damage or malfunction. Surgical instruments shall be cleaned, handled and used according to the manufacturer instruction. Post procedure, all instruments opened on the sterile field require decontamination. Use approved enzymatic soak, spray gel or foam on instruments prior to transport. If utilizing manual cleaning method, complete the follow steps: refer to the manufacturer's instructions for instruments. In general soak the instrument in a tepid detergent bath for a minimum of ten minutes. This allows instrument soil to soften. The duration of the soak depends on the amount of soil on the instruments and how long the instruments have been allowed to dry.

The Point of Use: Cleaning and Decontaminating Instruments Prior to Sterilization policy read, preparation for decontamination of instruments should occur at the point of use and instruments should be cleaned and decontaminated as soon as possible after use. An approved pre-cleansing agent will be applied to instruments prior to transport. All surgical instruments should be cleaned and decontaminated according to the manufacturer's written IFU (instructions for use).

The History and Physical policy read, the H&P shall consist of chief complaint, history of present illness, allergies and medications, relevant social and family history, past medical history, review of systems and physical examination. A complete H&P must have been performed prior to but no longer than 30 calendar days of admission. If an H&P was not performed and documented within 30 calendar days of admission it must be performed and documented within 24 hours of admission. For patient undergoing procedures requiring sedation, general conscious or regional anesthesia, an H&P shall be performed within 24 hours prior to the procedure by a qualified medical provider. If a complete H&P was performed within 30 calendar days prior to the patient's admission, an update to the H&P shall be completed and recorded in the medical record within 24 hours of admission and prior to surgery.

The Consents policy read, informed consent consisted of an explanation of the nature and purpose of the recommended treatment or procedure; an explanation of the risks and benefits of a treatment or procedure; an explanation of the alternative with the risks and benefits of the alternatives; an explanation of the recuperative period which includes discussion of anticipated problems; and an explanation that the patient or representative is free to withdraw his or her consent.

A procedure specific consent must be used to document informed consent for the following: all surgical procedures performed under anesthesia care or IV sedation; selected procedures to include biopsies, endoscopies and spinal injections; exams or procedures requiring contrast. A separate written consent should be obtained for the use of Monitored Anesthesia Care, general, regional, spinal or epidural anesthesia, or IV sedation by the clinician administering the anesthesia.

Documenting consent: only consent forms meeting the below criteria will be accepted. The consent must be signed by the patient and/or legal representative and the attending physician. The type of information to be discussed and documented with the patient includes the procedures to be performed. Additional documentation to be documented on the consent includes the name of the responsible practitioner, signature of the patient and the date and time of signature, and signature of the provider and date and time of signature.

References:

The manufacturer's IFUs for the Mako TKA (Total Knee Replacement) Instrument Set read, prepare the detergent solution and fully immerse the instruments, allowing them to soak for a minimum of five minutes.

The IFUs for the Bausch and Lomb/ Storz Ophthalmic Instruments read, keep the instruments submerged in the cleaning solution for at least five minutes. If the instrument has lumens the lumens should be flushed using a syringe filled with 50 cc of warm distilled or deionized water as follows - place syringe tip into a beaker of warm (86 to 104 degrees F) distilled water and fill to the 50 cc mark. Force fluid through the lumen and repeat at least three times for each lumen. The cleaning solution should be changed before it becomes visibly soiled.

The IFUs for the V. Mueller Surgical Instruments read, Prepare the enzymatic/ neutral pH detergent solution utilizing drinking water with a temperature range of 81 to 111 degrees F. Immerse the device in the detergent solution and allow it to soak for a minimum of five minutes. For lumen devices, place the device in the open position and flush the device with a minimum of 50 ml of detergent solution. Repeat the flush process a minimum of 2 times for a total of 3 times. Rinse the device completely. For lumen devices, following the rinsing step place the device into the open position and flush the device with a minimum of 50 ml of treated water. Repeat the flush process a minimum of 2 times for a total of 3 times.

The IFUs for the Alcon Grieshaber Loading Forceps, which were included in the instrument sets for cataract surgeries, read, submerge instruments in deionized water for a minimum of five minutes.

The IFUs for the Hu-Friedy Dental Hand Instruments and Accessories read, Pre-Treatment: contaminated instruments must be cleaned as early as possible in the reprocessing process. Use an enzymatic cleaning and pre-soak for three to five minutes at 89.6 degrees F.

The IFUs for the Premier Dental Reusable Hand Instruments and Trachea Tubes read, if possible soiled devices should be placed in a holding solution (combined disinfectant/ enzyme solution) immediately after use and prior to cleaning.

The IFUs for the Integra/ Miltex Surgical and Dental Instruments read, keep instruments moist and do not allow blood and/or bodily fluids to dry on the instruments.

The IFUs for the Storz Surgical Laryngoscopes read, the use of non-sterile surgical instruments poses a risk of infection to patients. The following sterilization methods have been validated and approved for this medical device: steam sterilization in the fractionated prevacuum procedures. The medical device must be sterilized in its fully assembled state using the prevacuum procedure at 134 to 137 degrees C with a minimum exposure time of 4 minutes and maximum of 18 minutes.

1. The facility's QAPI program failed to implement and monitor performance improvement activities related to the Sterile Processing Department (SPD) in response to events related to inadequate cleaning and sterilization of surgical instruments (Cross Reference A-0749).

A. Document Review

a. Review of reported patient safety events revealed between 9/1/20 and 9/1/21 there were 34 reported events which involved sterile processing and contamination of surgical instruments. This included 20 events in which bioburden, such as bone, tissue, hair and bone cement were discovered on sterile instruments. Examples included:

i. On 10/16/20, staff entered an event report which read, instruments used in direct laryngoscopy procedures (a procedure to visualize the vocal cords and other structures in the throat) were only disinfected and cleaned by hand but were not sterilized. According to the event report, SPD staff stated the laryngoscopy instruments were washed and disinfected by hand but were not sterilized. The SPD staff member stated she had followed this process for the past year.

According to follow-up documentation for the safety event, it was determined the manufacturer's Instructions for Use (IFUs) for the laryngoscopy instruments required low-temperature sterilization and the instruments had not been properly sterilized by SPD staff. The follow-up documentation read, unsterile equipment was used on multiple patients.

ii. On 2/24/21, staff entered an event report which read, bioburden (bone) was discovered in the tray of surgical instruments to be used for a total knee arthroplasty (a procedure to remove damaged tissue from the knee joint and replace it with an artificial surface). The sterile table in the operating room (OR) needed to be broken down and set up again, and two instruments needed to be sterilized via Immediate Use Steam Sterilization (IUSS, a rapid sterilization cycle which is not intended for routine sterilization of instruments).

iii. On 3/9/21, staff entered an event report which read, an ink pen was found in a sterile wrap under the container of a semi-rigid ureteroscope (a device passed through the urethra and bladder to examine the upper urinary tract) and the scope could not be used for the patient's case.

iv. On 5/24/21, staff entered an event report which read, cement was found on an instrument in the tray for total knee replacements. On the same date, a second event report was entered which read, bone was found in another total knee replacement instrument tray.

v. On 6/28/21, staff entered an event report which read, cement was found on instruments in three total knee replacement instrument trays. The table in the OR (operating room) needed to be broken down and set up again. When instruments were opened a second time, cement was found in another instrument tray and one of the instruments needed to be sterilized via IUSS.

vi. On 8/19/21, staff entered an event report which read, dried blood was found on two instruments after the patient's procedure began.

b. The facility provided the follow-up documentation for the above events related to SPD, which included the QAPI program's investigation and the preventive interventions implemented in response to the events. However, there was no evidence the QAPI program audited SPD processes to ensure instrument IFUs were followed; monitored for staff adherence once preventive interventions were implemented; or conducted additional investigation when the reports of inadequate cleaning and sterilization of instruments persisted. As example:

i. In the follow-up documentation for the event on 10/16/20 when it was identified instruments had been incorrectly sterilized and used in the care of multiple patients, the corrective action was SPD staff were educated on the correct process to sterilize the instruments. However, there was no evidence the QAPI program conducted monitoring or auditing to ensure the intervention was successful, nor did the QAPI program undertake further investigation to identify whether other instrumentation had been incorrectly reprocessed and used for patient care.

ii. In response to the event on 2/24/21 when bone was discovered in the instruments for a total knee replacement, the corrective action included new lighting was installed in the decontamination area and SPD staffing was increased. However, in the investigation documented for an event two weeks later on 3/9/21 when an ink pen was discovered in a ureteroscope tray, unresolved staffing issues were again identified as a potential contributing factor. The resolution comments read, multiple instrument sets had been wrapped by OR staff because the SPD area was short-staffed and the pen may have fallen out of an OR staff member's pocket.

iii. In the follow-up documentation for two events on 5/24/21 when cement and bioburden were found in multiple total knee replacement trays, the corrective actions included LED lighting had been installed in the decontamination area. This was documented three months after new lighting was identified as a corrective action for the similar event on 2/24/21, and there was no evidence the facility had conducted monitoring to identify whether the new lighting was a successful intervention.

The follow-up documentation for the 5/24/21 events read, other corrective actions included two inspectors for all orthopedic trays, decontamination at the point of use and a project to inspect and replace instruments for the orthopedic instrument trays.

iv. In response to the event on 6/28/21 when cement was identified in multiple total knee replacement instrument trays, the investigation revealed bioburden was not removed at the point of use and should have been identified when staff inspected the instruments prior to sterilization. This was in contrast to the corrective action identified one month earlier in response to the 5/24/21 event, which required point of use contamination and inspection of all orthopedic trays by two staff.

The recommended improvements for this event read, better lighting was implemented in decontamination and two inspectors were required for all orthopedic trays. There was no evidence the facility's QAPI program had conducted monitoring to demonstrate the new lighting installed several months prior was a successful intervention, nor was there evidence the facility audited SPD processes to ensure staff adhered to the required two inspectors for orthopedic trays.

v. After the event on 6/28/21 there were five additional reports reviewed for events in which bioburden or other forms of contamination were discovered in instrument trays. The corrective actions documented for these events continued to identify better lighting in decontamination and sterilization areas, increased staff in SPD and two inspectors for orthopedic instrument trays as the appropriate corrective interventions.

There was no evidence the facility's QAPI program tracked the identified interventions to ensure success, conducted additional monitoring in SPD to ensure staff's adherence to the identified interventions, or performed further analysis to determine why the identified interventions were not successful.

B. Observations

Observations revealed ongoing failures in SPD related to cleaning and sterilization of surgical instruments; specifically, staff's failure to adhere to the manufacturer IFUs and facility policy in point of use decontamination and manual cleaning to remove bioburden (Cross Reference A-0749).

a. On 9/14/21 at 12:30 p.m., observations of SPD Technician (Tech) #4 were conducted as she cleaned and reprocessed surgical instruments used in eye surgeries and orthopedic surgeries. During the observations, Tech #4 did not monitor the water temperature or the soak time when she manually cleaned surgical instruments in the decontamination room. Tech #4 stated she did not know the parameters for water temperature or soaking time according to the instrument IFUs. Tech #4 did not know how often the soaking water needed to be changed when manually cleaning instruments from multiple different surgical cases, and stated she would change the water when it became dirty.

According to the IFUs for the observed instruments, the manufacturer specified both temperature ranges and soak times for the instruments. In addition, the IFUs for the eye instruments specified the cleaning solution should be changed before it became visibly soiled. According to facility policy, the manufacturer's instructions were to be followed for manual cleaning and instruments were to be soaked for a minimum of 10 minutes to allow soil to soften.

b. On 9/17/21 at 9:30 a.m., an observation of SPD Tech (Tech) #7 was conducted as she cleaned surgical instruments used in dental surgeries. During the observation, two trays of dental instruments were brought into the decontamination room from the ORs. The instruments in both trays were dry and did not appear to have been sprayed with cleaning solution prior to transport from the ORs. SPD Tech #7 inspected the trays and confirmed neither had been sprayed at the point of use in the OR.

According to facility policy and the IFUs for the dental instruments, instruments were to be sprayed or moistened with enzymatic cleaner at the point of use prior to transport to SPD for reprocessing.

c. On 9/21/21 at 3:00 p.m., an observation of the Interim SPD Supervisor (Supervisor) #5 was conducted as he inspected eye instruments and prepared them for sterilization. Supervisor #5 stated he had observed the SPD tech manually cleaning and decontaminating the eye instruments in order to validate the instruments were cleaned correctly. When asked about the process to clean the lumens of the eye instruments, Supervisor #5 stated the SPD tech used 10-20 ml of detergent solution to flush each lumen one time.

Supervisor #5 then consulted the manufacturer's IFUs for the lumen eye instruments. He stated the IFUs specified staff were to flush the lumens with 50 ml of detergent solution rather than 10-20 ml, and further stated the lumens were to be flushed with detergent solution three times rather than once. Supervisor #5 confirmed the process the SPD tech performed to manually clean the eye instruments was not consistent with the instrument IFUs, and he stated the instruments would need to be cleaned and decontaminated again.

C. Interviews

Interviews revealed staff did not adhere to the corrective interventions implemented in response to multiple events related to SPD, specifically inspection of orthopedic surgical instruments by two inspectors prior to sterilization. Interviews with facility leadership further revealed there was no process to monitor the corrective actions in order to ensure improvement.

a. On 9/14/21 at 4:33 p.m., the Operating Room Director (Director) #1 was interviewed. OR Director #1 stated the facility had implemented several process improvements related to SPD in response to issues with bioburden on instruments. He stated facility leadership became aware of process issues related to SPD when staff reported an increase in events related to surgical instruments. OR Director #1 stated the process improvements included: replacing surgical instruments; fixing the lighting in the decontamination and sterilization areas; and educating staff to clean and decontaminate instruments at the point of use in the ORs.

OR Director #1 stated he focused on improving point of use cleaning because when he reviewed the events in which bioburden was found on instruments, he determined instruments were going to SPD soiled or dried. OR Director #1 stated he had performed observations to monitor point of use cleaning and ensure it was performed correctly, however, he was not able to provide evidence of this monitoring. He stated he had also instructed SPD staff not to accept instruments from the OR if they were dried or had bioburden on them. He stated this was discussed at a recent staff meeting and staff had reported instruments no longer came back to SPD dried out.

OR Director #1's statements were in contrast to observations in SPD, which revealed staff continued to transport contaminated instruments to SPD without spraying the instruments to prevent drying.

OR Director #1 stated in response to the events in which bioburden was discovered on instruments, he instructed SPD staff to have two people inspect the orthopedic instruments before sterilization. He stated this intervention was implemented to ensure instruments were thoroughly inspected after cleaning in order to identify bioburden, cement or other contaminants. However, OR Director #1 stated this intervention could not be consistently implemented because there were not enough staff in SPD to have two staff inspect all orthopedic instrument trays. He stated "about half of the time" there were enough SPD staff to ensure two staff members inspected the instruments; therefore, he did not enforce or monitor this instruction.

This was in contrast to the follow-up documentation for multiple events related to SPD and bioburden found on instrumentation in which the corrective action was documented as two inspectors were required for the orthopedic instrument trays.

OR Director #1 stated he investigated the event on 10/16/20 in which staff identified laryngoscope instruments were not sterilized correctly according to the IFUs and were used for multiple patient procedures. He stated he consulted the IFUs for the laryngoscopes and re-educated staff to the correct process to sterilize those instruments. However, OR Director #1 stated he did not perform any additional auditing or monitoring in SPD to ensure staff followed the IFUs to clean and sterilize the laryngoscope or any other instrumentation used in the facility.

OR Director #1's interview conflicted with the facility's QAPI Plan, which read when performance was inconsistent with standards the program, to recommend corrective action to bring performance into compliance with standards and plan follow-up studies to evaluate the effectiveness of the corrective action. In addition, it was not in alignment with the facility's occurrence reporting policy which read when events were reported, follow-up was to be conducted by the risk manager or designee and data was to be analyzed, tracked and trended to ensure safe and effective patient care.

b. On 9/15/21 at 10:45 a.m., the Infection Preventionist and Quality and Risk Manager (Manager) #2 was interviewed. (Manager) #2 stated the facility had identified ongoing concerns related to contamination of surgical instruments and became aware of the concerns when staff reported these events. Manager #2 stated, in particular, discovery of bone cement had been an ongoing issue, as it was difficult to identify once it dried on an instrument. She stated multiple actions were implemented in response to the events, including: an inspection of all orthopedic instruments for contaminated or rusty instruments; installing new lighting in the decontamination areas; ensuring point of use cleaning; and requiring two inspectors for the orthopedic instrument trays. She stated these actions were designated to OR Director #1 as he was the manager for the unit involved.

Manager #2 stated auditing to ensure these interventions were implemented and successful should have been carried out by OR Director #1. She stated she had not done any auditing or monitoring to ensure the success of the above interventions.

i. On 9/22/21 at 10:08 a.m., a second interview was conducted with Manager #2. Manager #2 stated it was important for staff in SPD to follow the manufacturer's IFUs to clean and sterilize surgical instruments. She stated it was an ongoing challenge to ensure SPD staff adhered to instrument IFUs and there had been continued events in which instruments were inadequately cleaned or bioburden was identified on instrumentation. She stated actions had been taken to address infrastructure barriers in SPD, such as lighting in the decontamination areas; however, she stated there were additional interventions which had not been implemented but were necessary to correct the ongoing issues in SPD, such as staff education and standardization of instruments.

Manager #2 stated when the QAPI program implemented corrective interventions in response to identified problems, there needed to be auditing or follow-up monitoring to determine whether the action was successful. She stated she believed monitoring had occurred in response to the continued events related to SPD, however, she was not able to provide any evidence of monitoring.

Manager #2 stated when trends or increased safety events were identified, the QAPI program performed a Root Cause Analysis (RCA) in order to identify contributing factors, implemented a plan of action and monitored the plan for outcomes and sustainability. Manager #2 stated an RCA had not been conducted in response to the multiple and ongoing events involving bioburden on surgical instruments.

c. On 9/14/21 at 5:49 p.m., the Chief Nursing Officer (CNO) #3 was interviewed. CNO #3 stated the event on 10/16/20, when staff identified the laryngoscopes were not sterilized according to the instrument IFUs, would be considered a sterilization breach. He stated there was no documentation of additional QAPI activities or investigation in response to the event. CNO #3 stated when the event was reported, it was entered as a "low-level incident," which caused the event to be closed without further investigation by the facility's QAPI or risk program. CNO #3 stated that, as of the date of this interview, the investigation had been reopened and 16 patients had been identified as potentially exposed to the unsterile instrument.

CNO #3 stated when the event was initially investigated and closed, the corrective intervention was staff training to the correct sterilization process for the instrument. He stated that had the event been properly investigated, the investigation would have included further interventions to prevent reoccurrence such as implementing process improvements, conducting audits of SPD and considering engineering controls.

2. The facility's QAPI program failed to implement, track and monitor performance improvement activities in response to multiple events in which surgical documentation, including patient consents and history and physicals (H&Ps), were reported to be incomplete or missing.

A. Document Review

a. Review of reported patient safety events revealed between the dates of 9/1/20 and 8/30/21, there were 18 events in which a patient consent form was found to be incomplete or unsigned. These included consents for surgical procedures and anesthesia. In addition, there were 37 events in which a H&P was absent, incomplete or not reviewed and updated on the date of surgery.

b. Medical record review revealed multiple patient records which lacked completed consents and/or H&Ps (Cross Reference A-0952, A-0955).

i. Review of the medical record for Patient #20 revealed on 7/19/21, the patient underwent a procedure to place a PICC (a peripherally inserted central catheter, a tube into the vein for intravenous medications or blood draws). The consent for the procedure did not have the name or description of the procedure documented on the consent form.

ii. Review of the medical record for Patient #21 revealed on 7/28/21, the patient underwent a left thumb arthroplasty (a surgery to replace part or all of the joint at the base of the thumb). The consent form for the procedure was not signed by Patient #21 or the provider who performed the surgery.

iii. Review of the medical record for Patient #22 revealed 8/20/21, the patient underwent a carpal tunnel release (a procedure to cut through the ligament of the wrist to relieve carpal tunnel pain). The consent form for the procedure was signed by the provider but was not signed by the patient.

iv. Review of the medical record for Patient #31 revealed on 5/24/21, the patient underwent a left knee arthroscopy and repair (a procedure to examine the knee joint) under general anesthesia. The medical record did not include a completed consent for anesthesia.

A patient safety event was entered on 6/1/21 in reference to Patient #31's medical record. The event report read, a signed anesthesia consent was missing and an email was sent to the provider with no response. There was no further documentation of follow-up to the reported event.

v. Review of Patient #35's medical record revealed on 8/20/21, the patient underwent a right carpal tunnel release. The procedure consent was signed by the provider but not by Patient #35 and did not include the patient's name or date of birth. In addition, the H&P completed on 8/20/21 lacked several elements including history of present illness, past medical history, a review of systems and physical examination, history of anesthesia complications and vital signs.

vi. Review of Patient #36's medical record revealed on 4/1/21, the patient underwent an epidural steroid injection for pain management. The consent for the procedure was signed by the provider but was not signed by Patient #36.

vii. Review of Patient #37's medical record revealed on 3/18/21, the patient underwent an incision and drainage of the right breast and expander removal. Review of the medical record revealed an H&P was completed on 2/1/21; however, there was no evidence the H&P was reviewed or updated with any pertinent changes within 30 days of the surgery in accordance with facility policy.

A patient safety event was entered on the same date in reference to Patient #37's medical record. The event report read the H&P was not present in Patient #37's chart on the date of the surgery. The follow-up documentation for the event report read an email with the facility's policy was sent to the provider for review.

viii. Review of Patient #38's medical record revealed the patient underwent a cricopharyngeal myotomy (a procedure in which a cut is made to divide a muscle around the esophagus) on 3/17/21. The medical record revealed an H&P was completed on 2/22/21. The H&P was subsequently reviewed by the provider and there were no changes from the original H&P; however, the review of the H&P was documented by the provider on 4/28/21, over a month after the patient's surgery.

c. The facility provided follow-up documentation for the investigation and actions taken in response to multiple patient safety events involving incomplete consents and H&Ps. According to the follow-up documentation, the corrective actions for the events included emails sent to the providers involved to reinforce the facility's policies related to completion of consents and H&Ps. In addition, the follow-up documentation for events entered in 2020 read the events were to be referred to the Medical Executive Committee (MEC) for further discussion and action.

i. The meeting minutes for the MEC meeting held on 10/20/20 were reviewed. According to the meeting minutes, a plan was discussed to address issues related to incomplete H&Ps. There was no discussion of incomplete consents noted in the meeting minutes.

ii. Meeting minutes for seven subsequent meetings of the MEC between November 2020 and September 2021 were reviewed. There was

Based on the manner and degree of the standard-level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42 Infection Prevention and Control and Antibiotic Stewardship Programs was out of compliance.

A-0749: The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on observations, interviews and document review, the facility failed to employ methods to prevent and control the transmission of infections within the facility. Specifically, the facility failed to ensure surgical instruments were cleaned, reprocessed and sterilized according to facility policy and the manufacturer's Instructions for Use (IFUs). The failures were identified in three of four observations of the Sterile Processing Department (SPD). In addition, the facility failed to ensure infection control practices were followed in the operating room (OR). Specifically, the facility failed to ensure multi-dose vials were not used in the OR and medication preparation in the OR was performed in accordance with facility policy and national guidelines during two of two procedures observed (Patient #11 and Patient #12).

A-0772: Leadership responsibilities. The infection preventionist(s)/infection control professional(s) is responsible for: The development and implementation of hospital-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines. Based on observations, interviews and document review, the facility's infection control professional failed to ensure oversight of the facility's Sterile Processing Department (SPD). Specifically, the infection control professional did not ensure a process was in place to sterilize surgical instruments according to the manufacturer's Instructions for Use (IFUs); did not prevent the routine use of Immediate Use Steam Sterilization (IUSS); and did not ensure sterilization breaches were investigated to prevent recurrence (Cross Reference A-0749).

Based on observations, interviews and document review, the facility failed to employ methods to prevent and control the transmission of infections within the facility. Specifically, the facility failed to ensure surgical instruments were cleaned, reprocessed and sterilized according to facility policy and the manufacturer's Instructions for Use (IFUs). The failures were identified in three of four observations of the Sterile Processing Department (SPD). In addition, the facility failed to ensure infection control practices were followed in the operating room (OR). Specifically, the facility failed to ensure multi-dose vials were not used in the OR and medication preparation in the OR was performed in accordance with facility policy and national guidelines during two of two procedures observed (Patient #11 and Patient #12).

Facility policies:

The Decontamination and Cleaning of Contaminated Instruments policy read, proper care and cleaning helps safeguard instruments' function and effectiveness and reduces the likelihood of infections caused by instrument damage or malfunction. Surgical instruments shall be cleaned, handled and used according to the manufacturer instruction. Post procedure, all instruments opened on the sterile field require decontamination. Use approved enzymatic soak, spray gel or foam on instruments prior to transport. If utilizing manual cleaning method, complete the following steps: refer to the manufacturer's instructions for instruments. In general, soak the instrument in a tepid detergent bath for a minimum of ten minutes. This allows instrument soil to soften. The duration of the soak depends on the amount of soil on the instruments and how long the instruments have been allowed to dry. Brush the instrument while it is in the soak bath. In the case of tubed devices, the lumens and channels should be brushed out as well. Rinse the instrument and assess the instrument for any remaining soil. If soil remains repeat the process.

The Point of Use: Cleaning and Decontaminating Instruments Prior to Sterilization policy read, preparation for decontamination of instruments should occur at the point of use and instruments should be cleaned and decontaminated as soon as possible after use. An approved pre-cleansing agent will be applied to instruments prior to transport. All surgical instruments should be cleaned and decontaminated according to the manufacturer's written IFU.

The Steam Sterilization policy read, items to be sterilized will be thoroughly cleaned and dried in accordance with the manufacturer's instructions. Follow the manufacturer's written instructions for package preparation, configuration and sterilization.

The Medication Management policy, last revised 10/19/20 read, multi-dose vials (MDV) used on more than one patient should be stored appropriately and must not enter the immediate patient treatment area. If multi-dose vials are brought into patient treatment areas, they will be considered single patient use.

The Safe Handling of Medication in the Perioperative Setting, revised 5/8/19 read, medications must never be stored on one's person such as in pockets or bags. Medications must only be taken into a patients' room who is receiving the medication. Safe handling of medications is applicable when taking care of single or multiple patients.

Single dose vials should be used whenever possible. If multi-dose vials must be used, do not keep (the vials) in the patient treatment area. Date and store MDV in accordance with infection control and or manufacturer recommendations. When a multi-dose vial is brought into a patient treatment area, it may be used on that patient only and must be discarded after use.

References:

The manufacturer's IFUs for the Mako TKA (Total Knee Replacement) Instrument Set read, Do not allow blood and/or bodily fluids to dry on the instruments. The decontamination process should begin immediately after the completion of the surgical procedure. Prepare the detergent solution and fully immerse the instruments, allowing them to soak for a minimum of five minutes. Thoroughly clean the devices using suitable soft bristle brushes. Pay particular attention to crevices and other difficult to clean areas until all soil has been removed.

Post Cleaning Inspection: before preparing for sterilization, all re-usable instruments should be inspected. All parts of the device should be checked for visible soil and/or corrosion. After cleaning, visually inspect devices under normal lighting for the removal of visible soil. Visually inspect for damage and functional anomalies.

The IFUs for the Bausch and Lomb/ Storz Ophthalmic Instruments read, place the instruments into a clean basin filled with fresh neutral pH cleaning solution prepared according to the directions of the solution manufacturer. Keep the instruments submerged in the cleaning solution for at least five minutes. If the instrument has lumens, the lumens should be flushed using a syringe filled with 50 cc of warm distilled or deionized water as follows - place syringe tip into a beaker of warm (86 to 104 degrees F) distilled water and fill to the 50 cc mark. Force fluid through the lumen and repeat at least three times for each lumen. The cleaning solution should be changed before it becomes visibly soiled.

The IFUs for the V. Mueller Surgical Instruments read, Prepare the enzymatic/ neutral pH detergent solution utilizing drinking water with a temperature range of 81 to 111 degrees F. Immerse the device in the detergent solution and allow it to soak for a minimum of five minutes. For lumen devices, place the device in the open position and flush the device with a minimum of 50 ml of detergent solution. Repeat the flush process a minimum of 2 times for a total of 3 times. Rinse the device completely. For lumen devices, following the rinsing step, place the device into the open position and flush the device with a minimum of 50 ml of treated water. Repeat the flush process a minimum of 2 times for a total of 3 times. Following manual or automated cleaning, visually inspect the instrument for cleanliness. If visible soil remains, repeat the cleaning procedure until the device is thoroughly clean.

The IFUs for the Alcon Grieshaber Loading Forceps, which were included in the instrument sets for cataract surgeries, read, submerge instruments in deionized water for a minimum of five minutes.

The IFUs for the Hu-Friedy Dental Hand Instruments and Accessories read, Pre-Treatment: contaminated instruments must be cleaned as early as possible in the reprocessing process. Use an enzymatic cleaning and pre-soak for three to five minutes at 89.6 degrees F.

The IFUs for the Premier Dental Reusable Hand Instruments and Trachea Tubes read, if possible, soiled devices should be placed in a holding solution (combined disinfectant/ enzyme solution) immediately after use and prior to cleaning.

The IFUs for the Integra/ Miltex Surgical and Dental Instruments read, keep instruments moist and do not allow blood and/or bodily fluids to dry on the instruments.

The IFUs for the Storz Surgical Laryngoscopes read, the use of non-sterile surgical instruments poses a risk of infection to patients. The following sterilization methods have been validated and approved for this medical device: steam sterilization in the fractionated prevacuum procedures. The medical device must be sterilized in its fully assembled state using the prevacuum procedure at 134 to 137 degrees C with a minimum exposure time of 4 minutes and maximum of 18 minutes.

The Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice, 2019: Medication Safety, Recommendation V.i. and V.j. (Page 465) read, multi-dose vials should be used for only one patient when medication is prepared at the point of use. The collective evidence contains reports of infections being spread by use of a multi-dose vial for more than one patient. Multi-dose vials should be stored outside the immediate patient treatment area when possible.

1. The facility failed to ensure instruments and medical devices used for surgical procedures were cleaned, reprocessed and sterilized according to the IFUs to prevent and control the transmission of infection.

a. Observations revealed SPD staff were not knowledgeable of and did not adhere to the instrument IFUs and facility policy when performing point of use cleaning, manual cleaning and sterilization of surgical instruments.

i. On 9/14/21 at 12:30 p.m., observations of SPD Technician (Tech) #4 were conducted as she cleaned and reprocessed surgical instruments used in eye surgeries and orthopedic surgeries. During the observations, Tech #4 did not monitor the water temperature or the soak time when she manually cleaned surgical instruments in the decontamination room. Tech #4 stated she did not know the parameters for water temperature or soaking time according to the instrument IFUs. Tech #4 did not know how often the soaking water needed to be changed when manually cleaning instruments from multiple different surgical cases, and stated she would change the water when it became dirty.

At 2:30 p.m. SPD Technician (Tech) #10 was observed as he cleaned instruments used in eye surgeries. Tech #10 did not change the cleaning solution of detergent and water before soaking and manually cleaning a new set of eye instruments.

According to the IFUs for the observed instruments, the manufacturer specified both temperature ranges and soak times for the instruments. In addition, the IFUs for the eye instruments specified the instruments were to be placed into a clean basin filled with fresh neutral pH cleaning solution and the cleaning solution should be changed before it became visibly soiled. According to facility policy, the manufacturer's instructions were to be followed for manual cleaning and instruments were to be soaked for a minimum of 10 minutes to allow soil to soften.

ii. On 9/17/21 at 9:30 a.m., an observation was conducted of SPD Tech (Tech) #7 cleaning surgical instruments used in dental surgeries. During the observation, two trays of dental instruments were brought into the decontamination room from the ORs. The instruments in both trays were dry and did not appear to have been sprayed with cleaning solution prior to transport from the ORs. SPD Tech #7 inspected the trays and confirmed neither had been sprayed at the point of use in the OR.

According to facility policy and the IFUs for the dental instruments, instruments were to be sprayed or moistened with enzymatic cleaner at the point of use prior to transport to SPD for reprocessing.

iii. On 9/21/21 at 3:00 p.m., an observation was conducted of the Interim SPD Supervisor (Supervisor) #5 as he inspected eye instruments and prepared them for sterilization. Supervisor #5 stated he had observed the SPD tech manually cleaning and decontaminating the eye instruments in order to validate the instruments were cleaned correctly. When asked about the process to clean the lumens of the eye instruments, Supervisor #5 stated the SPD tech used 10-20 ml of detergent solution to flush each lumen one time.

Supervisor #5 then consulted the manufacturer's IFUs for the lumen eye instruments. He stated the IFUs specified staff were to flush the lumens with 50 ml of detergent solution rather than 10-20 ml, and further stated the lumens were to be flushed with detergent solution three times rather than once. Supervisor #5 confirmed the process the SPD tech performed to manually clean the eye instruments was not consistent with the instrument IFUs, and he stated the instruments would need to be cleaned and decontaminated again.

Supervisor #5 entered the decontamination room where SPD Technician (Tech) #8 was manually cleaning instruments. He informed Tech #8 the lumen eye instruments needed to be flushed with 50 ml of detergent solution a total of three times, and then flushed again with 50 ml of distilled water a total of three times. Tech #8 stated she was not aware of this requirement.

b. Review of patient safety event reports revealed an instrument used for direct patient care was not sterilized according to the manufacturer IFUs.

i. On 10/16/20, staff entered an event report which read, instruments used in direct laryngoscopy procedures (a procedure to visualize the vocal cords and other structures in the throat) were only disinfected and cleaned by hand but were not sterilized. According to the event report, SPD staff stated the laryngoscopy instruments were washed and disinfected by hand but were not sterilized. The SPD staff member stated she had followed this process for the past year.

According to follow-up documentation for the safety event, it was determined the manufacturer's Instructions for Use (IFUs) for the laryngoscopy instruments required low-temperature sterilization and the instruments had not been properly sterilized by SPD staff. The follow-up documentation read, unsterile equipment was used on multiple patients.

c. Review of reported patient safety events further revealed between 9/1/20 and 9/1/21 there were 34 reported events which involved sterile processing and contamination of surgical instruments. This included 20 events in which bioburden, such as bone, tissue, hair and bone cement were discovered on sterile instruments, specifically orthopedic and total knee replacement instruments. Examples included:

i. On 2/24/21, staff entered an event report which read, bioburden (bone) was discovered in the tray of surgical instruments to be used for a total knee arthroplasty (a procedure to remove damaged tissue from the knee joint and replace it with an artificial surface). The sterile table in the operating room (OR) needed to be broken down and set up again, and two instruments needed to be sterilized via Immediate Use Steam Sterilization (IUSS, a rapid sterilization cycle which is not intended for routine sterilization of instruments).

ii. On 5/24/21, staff entered an event report which read, cement was found on an instrument in the tray for total knee replacements. On the same date, a second event report was entered which read, bone was found in another total knee replacement instrument tray. The apparent cause statement in the follow-up documentation for the events read, the bone and cement had not been removed prior to sterilization.

iii. On 6/28/21, staff entered an event report which read, cement was found on instruments in three total knee replacement instrument trays. The table in the OR needed to be broken down and set up again. When instruments were opened a second time, cement was found in another instrument tray and one of the instruments needed to be sterilized via IUSS. The apparent cause stated in the follow-up documentation for the event read, bioburden should be removed at the point of use and in decontamination. If remaining, it should be found during inspection. There was a breakdown somewhere in these processes.

iv. On 7/13/21, staff entered an event report which read, when opening instruments for a total hip replacement on 7/12/21, there were two instances of bioburden discovered. One was a mass of tissue on the cord of a drill, the other was a piece of bone cement stuck to an instrument. Both trays required reprocessing. The apparent cause statement in the follow-up documentation for the event read, bioburden was not removed at the point of use or in decontamination and washing. Furthermore, the bioburden was not found at the time of inspection prior to entering the sterilizers. The documentation read, staff had been educated however issues related to bioburden on instruments continued.

v. On 8/19/21, staff entered an event report which read, dried blood was found on two instruments after the patient's procedure began.

vi. The safety event reports and follow-up documentation identified inadequate point of use cleaning, manual cleaning, and inspection prior to sterilization as factors contributing to multiple events in which bioburden was found on sterilized instrumentation. This was in contrast to facility policy and the manufacturer IFUs for orthopedic and other surgical instrumentation used at the facility, which specified the following: point of use cleaning or spraying was to occur to ensure blood and bioburden was not allowed to dry on instrumentation; soaking and manual cleaning were to occur to ensure soil was removed from instruments; and inspection was required prior to sterilization to ensure cleanliness.

d. Interviews revealed surgical instruments and devices were to be cleaned, reprocessed and sterilized according to the manufacturer's IFUs in order to prevent risk of infection to patients. Interviews also revealed if instruments were not adequately cleaned and were used for surgery, there was a risk to the patient of infection and other complications.

i. On 9/16/21 at 7:33 a.m., SPD Tech (Tech) #8 was interviewed. Tech #8 stated when she was trained to reprocess and sterilize surgical instruments, she was instructed to follow the manufacturer's IFUs. She stated it was important to refer to the IFUs because processes to clean and sterilize instruments could change over time.

Tech #8 stated elements of manual cleaning such as soaking times, the concentration of enzymatic solution, and the temperature of the detergent solution were all specified in the manufacturer's IFUs. She stated it was important to allow instruments to soak for a sufficient period of time to ensure the kill-time for the detergent was observed. Tech #8 stated instruments also could not be soaked for too long because the detergent could leave a residue on the instruments. She stated staff were to use a thermometer attached to the detergent dispenser to monitor the temperature of the water in the detergent solution. Tech #8 stated this was important because the manufacturer specified a temperature range in which the detergent was effective.

Tech #8's interview was in contrast to observation and interview with Tech #4, as Tech #4 did not monitor or know the temperature and soaking time for manually cleaning contaminated instruments, and could not identify how often the water and detergent solution to soak instruments was to be changed.

ii. On 9/20/21 at 3:00 p.m., the Interim SPD Supervisor (Supervisor) #5 was interviewed. Supervisor #5 stated according to the facility's policy, SPD staff needed to follow the manufacturer's IFUs to reprocess instruments. He stated there were often instruments from multiple manufacturers in a single instrument tray, and if the instruments required different instructions, staff were to follow the most stringent instructions to reprocess the tray.

Supervisor #5 stated in order to ensure instrumentation was reprocessed correctly, it was necessary to review instrument IFUs, ensure SPD processes met the standards specified by the manufacturer and re-educate staff when standards were not met. He stated these steps had not yet been completed and were in process as of the date of this interview.

iii. On 9/14/21 at 4:33 p.m., the OR Director (Director) #1 was interviewed. Director #1 stated the facility's SPD followed standards from AORN and AAMI (the Association for Advancement of Medical Instrumentation), as well as the manufacturer IFUs for instruments.

Director #1 stated there was an increase in the number of events in which bioburden was found on surgical instruments. Director #1 stated in response to these events, he focused on improving point of use cleaning because he determined instruments were going to SPD soiled or dried. Director #1 stated he had performed observations to monitor point of use cleaning and ensure it was performed correctly; however, he was not able to provide evidence of this monitoring. He stated he had also instructed SPD staff not to accept instruments from the OR if they were dried or had bioburden on them such as blood or cement. He stated this was discussed at a recent staff meeting and staff had reported instruments no longer came back to SPD dried out.

Director #1's statements were in contrast to observations in SPD, which revealed staff continued to transport contaminated instruments to SPD without spraying the instruments to prevent drying. They also conflicted with the patient safety event report entered one month prior on 8/19/21, in which dried blood was found on two instruments which had already been cleaned and sterilized.

Director #1 stated he investigated the event on 10/16/20 in which staff identified laryngoscope instruments were not sterilized correctly according to the IFUs and were used for multiple patient procedures. Director #1 stated a staff member in the OR identified the laryngoscope was not being sterilized correctly when she asked for the instrument to use in a patient's procedure. He stated when the SPD staff informed the OR staff the instrument was washed and ready to use, the OR staff questioned whether the instrument needed to additionally be sterilized. Director #1 stated when staff then consulted the IFUs for the instrument, they determined it had not been sterilized according to the IFUs.

Director #1 stated in response to the event, he re-educated SPD staff on the correct process to sterilize the instrument. However, he stated he did not implement any further monitoring or rounding to validate whether staff followed the IFUs to sterilize the laryngoscopes or any other instruments.

Director #1 stated he was ultimately responsible to ensure instrument IFUs were available and followed for cleaning and sterilizing instrumentation. However, he stated there was no process in place to ensure IFUs were reviewed prior to reprocessing instruments, and stated this was a gap which needed to be fixed. Director #1 stated if staff did not know or were confused about the steps to reprocess an instrument they consulted the IFUs.

This was in contrast to observations in SPD of staff performing point of use and manual cleaning of surgical instruments in which staff were not aware of the required elements to clean instruments, including soak times, water temperature, the frequency to change the water and detergent solution, and the steps to flush instruments with lumens.

iv. On 9/22/21 at 10:46 a.m., Provider #6 was interviewed. Provider #6 stated he was an orthopedic surgeon who performed a high volume of surgeries at the facility. Provider #6 stated the facility had noticed an increase in reports of bioburden on instrumentation over the last year. He stated he was not certain why there were increased events involving bioburden on instruments, but it was possible the instruments were not being cleaned correctly in the OR before they were brought to SPD. Provider #6 stated the previous July he became concerned enough with the issue to halt a day of his surgeries.

Provider #6 stated when instruments were not cleaned adequately in SPD he became concerned about patient infections. He stated if a patient who underwent a total joint surgery developed an infection it was disastrous to the patient and often required hospitalization, long-term antibiotics and further surgeries. Provider #6 stated he was especially concerned with the events involving bioburden on instruments because a patient who underwent a total joint surgery the previous summer had developed an infection and he could not be certain it was not related to instrumentation.

v. On 9/22/21 at 10:08 a.m., Manager #2, the facility Infection Preventionist, was interviewed. Manager #2 stated it was necessary for staff in SPD to follow the manufacturer's IFUs to reprocess surgical instruments to ensure the instruments were cleaned and sterilized appropriately. She stated it was an ongoing challenge to ensure SPD staff adhered to instrument IFUs and there had been continued events in which instruments were inadequately cleaned or bioburden was identified on instrumentation. Manager #2 stated she did not believe there was a process in place to review instrument IFUs prior to reprocessing, or to ensure IFUs were available and followed.



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2. The facility failed to ensure MDVs were not stored and used in the immediate patient treatment area to prevent and control the transmission of infection.

A. Observations

a. On 9/14/21 at 10:08 a.m., observations of Patient #12's procedure were conducted.

i. During Patient #12's procedure, an opened and labeled MDV of Succinylcholine (a medication given to paralyze the body during intubation) was found on the anesthesiologist's medication cart. Anesthesiologist #9 stated the medication had been used on a patient earlier and she had labeled it to save if it was needed for another patient.

B. Interviews

a. On 9/14/21 at 4:35 p.m., an interview was conducted with OR Director (OR Director #1). OR Director #1 stated a MDV can be used in the OR but must be discarded after it was used on one patient. OR Director #1 stated if a MDV was used on more than one patient in the OR, there was a risk for cross contamination between patients.

The observation was in contrast to facility policy and nationally recognized guidelines which read, MDV should not be used in the immediate patient treatment area and should be discarded after single use in order to prevent the spread of infection.

3. The facility failed to ensure medications were prepared and administered in the OR according to facility policy and nationally recognized guidelines.

A. Observations

a. On 9/14/21 at 10:08 a.m., observations of Patient #12's procedure was conducted.

i. At 10:15 a.m., Anesthesiologist #9 was observed pulling up medication from the anesthesia cart. Anesthesiologist #9 labeled two syringes with the type of medication, her initials, the date and time. The anesthesiologist then placed the two labeled syringes filled with medication in her left chest scrub pocket.

b. On 9/14/21 at 10:53 a.m., observations of Patient #11's procedure was conducted.

i. During the observation of Patient #11's procedure, Anesthesiologist #9 was observed removing the two syringes prepared at 10:15 a.m. from her pocket and administering the medications to Patient #11.

ii. At 11:01 a.m., Anesthesiologist #9 was observed drawing up Fentanyl (a pain medication) and Versed (a medication used to make patients feel sleepy) into two syringes, labeling the syringes and then placing the syringes in her left chest scrub pocket. The rest of Patient #11's procedure was observed and Anesthesiologist #9 did not administer the medications in her pocket to Patient #11. At the end of the procedure, Anesthesiologist #9 was observed leaving the OR with Patient #11 and the two medication syringes in her chest scrub pocket.

B. Interviews

a. On 9/14/21 at 4:35 p.m., an interview was conducted with OR Director (OR Director #1). OR Director #1 stated the facility followed AORN guidelines for infection control practices at the facility. OR Director #1 stated medications were not to be pulled up for one patient in the operating room where another patient's procedure was being performed. OR Director #1 stated there was a risk for cross contamination and risk for administering medications to the wrong patient if medications were prepared during another patient's procedure. OR Director #1 further stated, there was a risk for cross contamination and spread of infection if a staff member carried syringes with medications in their scrub pockets.

b. On 9/22/21 10:08 a.m., an interview was conducted with the facility Infection Preventionist (Manager #2). Manager #2 stated staff members were not allowed to place medications in their pockets at any time since there could be other items in the pockets which could contaminate the syringe. Manager #2 additionally stated, by pulling up medications for one patient during another patient's procedure, raised numerous opportunities for breaches in infection control.

Based on observations, interviews and document review, the facility's infection control professional failed to ensure oversight of the facility's Sterile Processing Department (SPD). Specifically, the infection control professional did not ensure a process was in place to sterilize surgical instruments according to the manufacturer's Instructions for Use (IFUs); did not prevent the routine use of Immediate Use Steam Sterilization (IUSS); and did not ensure sterilization breaches were investigated to prevent recurrence (Cross Reference A-0749).

Facility policies:

The Safety Infection and Quality (SIQ) Program Plan read, the program was designed to prevent, minimize, control and investigate risk events and to provide a safe and sanitary environment of care. Infection prevention and control is part of the SIQ program. The Quality and Risk Manager and Chief Nursing Officer participate in the Association for Professionals in Infection Control and Epidemiology (APIC), Association of periOperative Nursing (AORN), and the International Association of Healthcare Central Service and Materials Management (IAHCSMM).

The plan referenced a resource from the Centers for Disease Control and Prevention (CDC) Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities.

The Infection Control Program read, the purpose of the program was to reduce the risk of infection and to ensure avoidable healthcare associated infections did not occur. Responsibility for the program was designated to the Infection Control Coordinator. Progress with the infection control program will be monitored by the Infection Control Coordinator.

The IUSS (Flash) Sterilization policy read, IUSS commonly referred to as Flash sterilization will be used only in selected clinical situations when instruments are needed immediately. This method will be used when no other option is available. IUSS should be performed only when the following conditions are met: the device and sterilizer's manufacturer's written IFU includes instructions for IUSS; the device manufacturer's written instructions are readily available and followed; items to be steam sterilized should be subjected to the manufacturer's decontamination process.

Documentation of cycle information and monitoring results should be maintained in a log to provide tracking of the IUSS items to the patient. Monitor sterilizer function with mechanical, chemical, and biologic monitors (Class 5 or Class 6 chemical indicator is recommended by AORN). Use a biological indicator to monitor sterilizer efficacy. Employees must demonstrate competency regarding sterilization, handling of instrument documentation, documentation and safety practices. Personnel who use IUSS to sterilize items for use in the perioperative setting will participate in quality assurance and performance improvement activities related to IUSS.

The Decontamination and Cleaning of Contaminated Instruments policy read, proper care and cleaning helps safeguard instruments' function and effectiveness and reduces the likelihood of infections caused by instrument damage or malfunction. Surgical instruments shall be cleaned, handled and used according to the manufacturer instruction. Post procedure, all instruments opened on the sterile field require decontamination. Use approved enzymatic soak, spray gel or foam on instruments prior to transport. If utilizing manual cleaning method, complete the following steps: refer to the manufacturer's instructions for instruments. In general, soak the instrument in a tepid detergent bath for a minimum of ten minutes. This allows instrument soil to soften. The duration of the soak depends on the amount of soil on the instruments and how long the instruments have been allowed to dry.

The Point of Use: Cleaning and Decontaminating Instruments Prior to Sterilization policy read, preparation for decontamination of instruments should occur at the point of use and instruments should be cleaned and decontaminated as soon as possible after use. An approved pre-cleansing agent will be applied to instruments prior to transport. All surgical instruments should be cleaned and decontaminated according to the manufacturer's written IFU.

The Steam Sterilization policy read, items to be sterilized will be thoroughly cleaned and dried in accordance with the manufacturer's instructions. Follow the manufacturer's written instructions for package preparation, configuration and sterilization.

References:

The manufacturer's IFUs for the Mako TKA (Total Knee Replacement) Instrument Set read, prepare the detergent solution and fully immerse the instruments, allowing them to soak for a minimum of five minutes.

The IFUs for the Bausch and Lomb/ Storz Ophthalmic Instruments read, keep the instruments submerged in the cleaning solution for at least five minutes. If the instrument has lumens, the lumens should be flushed using a syringe filled with 50 cc of warm distilled or deionized water as follows - place syringe tip into a beaker of warm (86 to 104 degrees F) distilled water and fill to the 50 cc mark. Force fluid through the lumen and repeat at least three times for each lumen. The cleaning solution should be changed before it becomes visibly soiled.

The IFUs for the V. Mueller Surgical Instruments read, Prepare the enzymatic/ neutral pH detergent solution utilizing drinking water with a temperature range of 81 to 111 degrees F. Immerse the device in the detergent solution and allow it to soak for a minimum of five minutes. For lumen devices, place the device in the open position and flush the device with a minimum of 50 ml of detergent solution. Repeat the flush process a minimum of 2 times for a total of 3 times. Rinse the device completely. For lumen devices, following the rinsing step, place the device into the open position and flush the device with a minimum of 50 ml of treated water. Repeat the flush process a minimum of 2 times for a total of 3 times.

The IFUs for the Alcon Grieshaber Loading Forceps, which were included in the instrument sets for cataract surgeries, read, submerge instruments in deionized water for a minimum of five minutes.

The IFUs for the Hu-Friedy Dental Hand Instruments and Accessories read, Pre-Treatment: contaminated instruments must be cleaned as early as possible in the reprocessing process. Use an enzymatic cleaning and pre-soak for three to five minutes at 89.6 degrees F.

The IFUs for the Premier Dental Reusable Hand Instruments and Trachea Tubes read, if possible soiled devices should be placed in a holding solution (combined disinfectant/ enzyme solution) immediately after use and prior to cleaning.

The IFUs for the Integra/ Miltex Surgical and Dental Instruments read, keep instruments moist and do not allow blood and/or bodily fluids to dry on the instruments.

The IFUs for the Storz Surgical Laryngoscopes read, the use of non-sterile surgical instruments poses a risk of infection to patients. The following sterilization methods have been validated and approved for this medical device: steam sterilization in the fractionated prevacuum procedures. The medical device must be sterilized in its fully assembled state using the prevacuum procedure at 134 to 137 degrees C with a minimum exposure time of 4 minutes and maximum of 18 minutes.

The AORN Guideline to IUSS titled "When is it Acceptable to Use IUSS?" read, IUSS is acceptable only under the conditions detailed below: the item will be used immediately, terminal sterilization is not an option, and the manufacturer's written instructions for use for the device, sterilizer and sterilization container are readily available and followed.

The Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities, last updated May 2019, read, Flash sterilization is a modification of conventional steam sterilization. It is not recommended as a routine sterilization method because of the lack of timely biological indicators, absence of protective packaging, possibility for contamination of processed items during transport, and the sterilization cycle parameters are minimal. Do not use flash sterilization for convenience, as an alternative to purchasing additional instrument sets, or to save time. For sterilization of instruments and medical devices, follow the sterilization times, temperatures, and other operating parameters recommended by the manufacturers of the instruments.

Quality Control activities for sterile processing include the following: provide comprehensive and intensive training for all staff assigned to reprocess medical and surgical instruments. To achieve and maintain competency, review the written reprocessing instructions regularly to ensure they comply with the manufacturer's instructions. Compare the reprocessing instructions provided by the instrument manufacturer and the sterilizer manufacturer and resolve any conflicting recommendations. Conduct infection control rounds periodically in high-risk reprocessing areas. Document all deviations from policy.

1. The facility's infection control professional failed to ensure SPD staff cleaned, reprocessed and disinfected surgical instruments according to the instrument IFUs and facility policy (Cross Reference A-0749).

a. According to facility policy, surgical instruments were to be cleaned, handled, processed and sterilized according to the written manufacturer's IFUs.

b. Observations revealed SPD staff were not knowledgeable of and did not adhere to the instrument IFUs and facility policy when performing point of use cleaning, manual cleaning and sterilization of surgical instruments (Cross Reference A-0749).

i. On 9/14/21 at 12:30 p.m., observations of SPD Technician (Tech) #4 were conducted as she cleaned and reprocessed surgical instruments used in eye surgeries and orthopedic surgeries. During the observations, Tech #4 did not monitor the water temperature or the soak time when she manually cleaned surgical instruments in the decontamination room. Tech #4 stated she did not know the parameters for water temperature or soaking time according to the instrument IFUs. Tech #4 did not know how often the soaking water needed to be changed when manually cleaning instruments from multiple different surgical cases, and stated she would change the water when it became dirty.

According to the IFUs for the observed instruments, the manufacturer specified both temperature ranges and soak times for the instruments. In addition, the IFUs for the eye instruments specified the cleaning solution should be changed before it became visibly soiled. According to facility policy, the manufacturer's instructions were to be followed for manual cleaning and instruments were to be soaked for a minimum of 10 minutes to allow soil to soften.

ii. On 9/17/21 at 9:30 a.m., an observation was conducted of SPD Tech (Tech) #7 cleaning surgical instruments used in dental surgeries. During the observation, two trays of dental instruments were brought into the decontamination room from the ORs (operating rooms). The instruments in both trays were dry and did not appear to have been sprayed with cleaning solution prior to transport from the ORs. SPD Tech #7 inspected the trays and confirmed neither had been sprayed at the point of use in the OR.

According to facility policy and the IFUs for the dental instruments, instruments were to be sprayed or moistened with enzymatic cleaner at the point of use prior to transport to SPD for reprocessing.

iii. On 9/21/21 at 3:00 p.m., an observation was conducted of the Interim SPD Supervisor (Supervisor) #5 as he inspected eye instruments and prepared them for sterilization. Supervisor #5 stated he had observed the SPD tech manually cleaning and decontaminating the eye instruments in order to validate the instruments were cleaned correctly. When asked about the process to clean the lumens of the eye instruments, Supervisor #5 stated the SPD tech used 10-20 ml of detergent solution to flush each lumen one time.

Supervisor #5 then consulted the manufacturer's IFUs for the lumen eye instruments. He stated the IFUs specified staff were to flush the lumens with 50 ml of detergent solution rather than 10-20 ml, and further stated the lumens were to be flushed with detergent solution three times rather than once. Supervisor #5 confirmed the process the SPD tech performed to manually clean the eye instruments was not consistent with the instrument IFUs, and he stated the instruments would need to be cleaned and decontaminated again.

c. Review of reported patient safety events revealed between 9/1/20 and 9/1/21 there were 34 reported events which involved sterile processing and contamination of surgical instruments. This included 20 events in which bioburden, such as bone, tissue, hair and bone cement were discovered on sterile instruments. The follow-up documentation and investigation for the events identified multiple contributing factors, which included inadequate point of use decontamination and cleaning and lack of thorough inspection of cleaned instruments prior to sterilization.

d. Interviews revealed adherence to the manufacturer's IFUs was essential to adequate cleaning and sterilization of surgical instruments. Leadership interviews further revealed the infection control professional did not maintain oversight of SPD processes to ensure the manufacturer's IFUs were reviewed, available and followed to reprocess instruments.

i. On 9/16/21 at 7:33 a.m., SPD Tech (Tech) #8 was interviewed. SPD Tech #8 stated when she was trained to reprocess and sterilize surgical instruments, she was instructed to follow the manufacturer's IFUs. She stated it was important to refer to the IFUs because processes to clean and sterilize instruments could change over time. SPD Tech #8 stated elements of manual cleaning such as soaking times, the concentration of enzymatic solution, and the temperature of the detergent solution were all specified in the manufacturer's IFUs.

ii. On 9/20/21 at 3:00 p.m., the Interim SPD Supervisor (Supervisor) #5 was interviewed. Supervisor #5 stated that according to the facility's policy, SPD staff needed to follow the manufacturer's IFUs to reprocess instruments. He stated there were often instruments from multiple manufacturers in a single instrument tray, and if the instruments required different instructions, staff were to follow the most stringent instructions to reprocess the tray.

Supervisor #5 stated that in order to ensure instrumentation used at the facility was reprocessed correctly, it was necessary to review instrument IFUs, ensure SPD processes met the standards specified by the manufacturer and re-educate staff when standards were not met. He stated these steps had not yet been completed and were in process as of the date of this interview.

iii. On 9/22/21 at 10:08 a.m., the facility's Infection Preventionist (Manager) #2 was interviewed. Manager #2 stated one of the guiding principles for infection control in SPD was to follow the manufacturer's IFUs for reprocessing instrumentation. She stated this was important to ensure instruments were cleaned, disinfected and sterilized appropriately. She stated it was challenging to ensure SPD staff followed manufacturer IFUs to reprocess instruments and the facility had identified ongoing problems with bioburden and bone cement on sterilized instruments.

Manager #2 stated to her knowledge, there had been no review of the manufacturer IFUs for reprocessing instrumentation to identify whether SPD staff cleaned and sterilized instruments according to the IFUs. She stated she had not performed auditing or direct observation in the SPD to validate whether SPD processes were in alignment with the instrument IFUs. Manager #2 stated she believed there was a need for additional education and training for SPD staff to ensure they were knowledgeable on how to reprocess the instrumentation used at the facility.

Manager #2's interview was in contrast to the facility's Safety, Infection and Quality Plan and the Infection Control Program, which read the program was under the responsibility of the Infection Control Coordinator and the purpose was to control and investigate risk events, provide a sanitary environment of care, and reduce the risk of infection. Manager #2's interview also conflicted with the HICPAC guidelines for sterile processing which read quality control activities for sterile processing included comprehensive and intensive training for staff, review of the reprocessing instructions to ensure they complied with the manufacturer's instructions, and conduction of infection control rounds periodically in reprocessing areas.

2. The facility's infection control professional failed to ensure IUSS was performed according to facility policy and national standards for infection control and was not employed as a routine method of sterilization.

a. The facility's IUSS log was reviewed. Between the dates of 5/1/20 and 9/1/21, IUSS was documented a total of 10 times. However, on multiple occasions the documentation for IUSS use was incomplete according to facility policy. Examples included:

i. On 9/14/20 the SPD tech documented a trial retractor and inserter were processed on an IUSS cycle. The SPD tech did not document either a chemical or biological indicator was performed with the IUSS load. According to facility policy, staff were to document cycle monitoring results in the IUSS log to include mechanical, chemical or biological indicators, and a biological indicator was to be used to monitor sterilizer efficacy.

ii. On 9/25/20 the SPD tech documented a tonsil tray was processed on an IUSS cycle. The documented reason for IUSS was "Turnover." The SPD tech did not document either a chemical or biological indicator was performed with the IUSS load.

iii. On 8/4/21 the SPD tech documented an impactor was processed on an IUSS cycle. The documented reason for IUSS was unclear, as both "Received Unsterile" and "Turnover" appeared to be circled. The SPD tech did not document the type or duration of cycle used, the temperature of the cycle, or which operating room required the instrument. According to facility policy, the cycle information was to be documented on the IUSS log.

b. Review of the facility' sterilizer logs and patient safety event reports revealed multiple uses of IUSS which were not documented on the IUSS log according to facility policy.

i. On 6/28/21 a patient safety event was entered in reference to Patient #26's surgical case. According to the event report, bone cement was found on multiple instruments needed for the patient's total knee replacement surgery. The event report read, this lead to staff needing to "flash" one of the tibial impactors needed in the case. According to the facility policy, IUSS was commonly referred to as flash sterilization.

On review of the IUSS log, there was no documentation that IUSS was performed on this date. Review of the sterilization logs for 6/28/21 also did not include documentation of any instruments which were processed on an IUSS cycle.

ii. On 7/29/21, SPD staff documented an instrument called a Smile was processed on an IUSS cycle in Sterilizer #4. The reason for IUSS was documented as "Dropped." There was no patient sticker on the sterilization log to indicate the surgical case the instrument was used in. The IUSS log did not include documentation of the use of IUSS on this date.

iii. On 8/5/21, SPD staff documented an impactor was processed on an IUSS cycle in Sterilizer #3. The reason for IUSS was documented as "Drop on Floor." There was no patient sticker on the sterilization log to indicate the surgical case the instrument was used in, nor were there staff initials for the SPD tech who performed the IUSS. The IUSS log did not include documentation of the use of IUSS on this date.

iv. On 8/17/21, SPD staff documented an instrument called a Synthes piece was processed on an IUSS cycle in Sterilizer #3. The reason for IUSS was documented as "Needed ASAP- dropped or something." The IUSS log did not include documentation of the use of IUSS on this date.

c. Interviews revealed SPD staff did not document the use of IUSS on the sterilizer and IUSS logs according to facility policy and standards. Interviews further revealed the infection control professional and facility leadership did not maintain oversight of the use of IUSS to ensure it was performed according to facility policy and national standards.

i. Tech #8 stated IUSS was a shortened sterilization cycle which was only performed in Sterilizers #3 and #4. She stated IUSS was only to be used in emergency situations when there was no alternative option to obtain the instrument. Tech #8 stated IUSS was not to be used for convenience, or if the facility did not have a sufficient number of instruments for scheduled cases.

Tech #8 stated when IUSS was performed, it was to be documented on the IUSS log. She stated documentation for IUSS should include the patient's sticker because it was important to be able to trace the instrument processed on an IUSS cycle to the patient the instrument was used for. She stated it was also important to perform a biological indicator with the IUSS cycle and document the result from the indicator. Tech #8 stated staff were also to document the cycle information, the reason for IUSS, and the employee who performed the IUSS in the log.

Tech #8 stated it was important to track the use of IUSS to ensure sterilization parameters were met and the reasons IUSS was performed. She stated if a patient acquired an infection it was important to track the instruments used in the case, particularly if the instruments were sterilized on an IUSS cycle. She stated the separate IUSS log was maintained because IUSS was an emergency method of sterilization which did not meet the sterilization parameters recommended by the manufacturer IFUs.

Tech #8's interview was in contrast to review of the IUSS log and sterilization logs, which revealed on multiple occasions the use of IUSS was either incompletely documented or not documented at all in the IUSS log.

Tech #8 stated she would not run an entire tray of instruments through an IUSS cycle. She stated IUSS was intended for individual instruments but not for entire trays, because it was impossible to guarantee sterility if an entire tray was sterilized on an IUSS cycle. This conflicted to the documented use of IUSS on 9/25/20, when SPD staff documented a tonsil tray was sterilized on an IUSS cycle.

ii. On 9/14/21 at 4:33 p.m., the OR Director (Director) #1 was interviewed. OR Director #1 stated IUSS was only to be used in a truly emergent situation. He stated he had not reviewed the IUSS log in order to track the use of IUSS or ensure it was performed according to facility policy.

iii. On 9/15/21 at 10:45 a.m., the facility Infection Preventionist (Manager) #2 was interviewed. Manager #2 stated an IUSS log was maintained to track how often and under what circumstances IUSS was performed. She stated IUSS should be used rarely and only when urgently necessary.

Manager #2 stated she had not reviewed the facility's IUSS log. She stated she had been informed IUSS was not performed at the facility; however, she became aware IUSS was utilized when staff entered event reports which referenced the use of IUSS.

Manager #2 then reviewed the IUSS log. She stated it appeared there were numerous instances in which the rationale for IUSS was documented as the instrument was dropped. Manager #2 stated this led her to question whether the documentation on the IUSS log was an accurate reflection of why IUSS was being performed.

Manager #2 also reviewed the patient safety event report entered on 6/28/21, when cement was discovered on instruments needed for a case and an instrument needed to be flash sterilized. Manager #2 verified there was no documentation on the IUSS log to reflect use of IUSS on this date. She stated this led her to believe the use of IUSS was not being accurately documented and captured on the IUSS log.

iv. A second interview with Manager #2 was conducted on 9/22/21 at 10:08 a.m. Manager #2 stated she had not seen the IUSS log prior to the interview on 9/15/21. She stated it was important to review the use of IUSS to identify any trends in use and determine whether interventions were necessary to reduce the need for IUSS. Manager #2 stated the use of IUSS should have been reviewed, analyzed and presented at the facility's quarterly infection control meetings; however, she stated this had not occurred.

3. The facility's infection control professional did not ensure a sterilization breach was investigated and corrective action implemented in order to prevent recurrence (Cross Reference A-0749).

a. Review of patient safety event reports revealed a sterilization breach was identified in 2020 which potentially impacted multiple patients.

i. On 10/16/20, staff entered an event report which read, instruments used in direct laryngoscopy procedures (a procedure to visualize the vocal cords and other structures in the throat) were only disinfected and cleaned by hand but were not sterilized. According to the event report, SPD staff stated the laryngoscopy instruments were washed and disinfected by hand but were not sterilized. The SPD staff member stated she had followed this process for the past year.

According to follow-up documentation for the safety event, it was determined the manufacturer's Instructions for Use (IFUs) for the laryngoscopy instruments required low-temperature sterilization and the instruments had not been properly sterilized by SPD staff. The follow-up documentation read, unsterile equipment was used on multiple patients.

ii. The facility provided documentation of the review and investigation which occurred in response to the event on 10/16/20 when it was identified instruments had been incorrectly sterilized and used in the care of multiple patients. According to the documentation, the corrective action was SPD staff were educated on the correct process to sterilize the instruments. However, there was no evidence the infection control professional undertook further investigation to identify whether other instrumentation had been incorrectly reprocessed and used for patient care, to determine whether any infections or complications were associated with patient exposure to the unsterile instruments, or to implement infection control rounds in SPD to prevent recurrence.

This was in contrast to the facility's Safety, Infection and Quality plan and Infection Control Program, which read the Infection Control Program was under the responsibility of the Infection Control Coordinator and was designed to prevent and investigate risk events, provide a sanitary environment of care, and reduce the risk of infections. This also conflicted to the recommendations from HICPAC for quality control in sterile processing, which read reprocessing instructions should be reviewed regularly to ensure they complied with manufacturer's instructions and infection control rounds should be conducted periodically in high-risk reprocessing areas.

b. Interviews revealed the sterilization breach was not investigated according to facility processes.

i. On 9/14/21 at 4:33 p.m., the OR Director (Director) #1 was interviewed. OR Director #1 stated a staff member in the OR identified the laryngoscope was not being sterilized correctly when she asked for the instrument to use in a patient's procedure. He stated when the SPD staff informed the OR staff the instrument was washed and ready to use, the OR staff questioned whether the instrument needed to additionally be sterilized. OR Director #1 stated when staff then consulted the IFUs for the instrument, they determined it had not been sterilized according to the IFUs.

OR Director #1 stated in response to the event, he re-educated SPD staff to the correct process to sterilize the instrument. However, he stated he did not implement any further monitoring or rounding to validate whether staff followed the IFUs to sterilize the laryngoscopes or any other instruments. OR Director #1 stated to his knowledge, there was no effort to identify or notify any of the patients who were potentially exposed to the instrument.

ii. On 9/22/21 at 11:24 a.m., the facility Infection Preventionist (Manager) #2 was interviewed.
Manager #2 stated when the facility identified the laryngoscopes were not sterilized correctly, she did not conduct an investigation to determine the extent of the sterilization breach or to identify patients who were potentially exposed to the unsterile instruments. She stated she believed the instrument had only been used in six patient procedures.

Manager #2 stated she was uncertain of the process to review sterilization logs in order to identify which instruments were used in a patient's procedure and whether the instruments were sterilized correctly. She stated she did not review sterilization logs as part of her oversight of infection control at the facility, nor did she typically review sterilization of surgical instruments when she investigated surgical site infections.

Manager #2 stated she had discussed SPD processes with OR Director #1, however she stated beyond those discussions she had not conducted audits or direct observations of SPD since the sterilization breach was identified on 10/16/20.

Manager #2's interview was in contrast to the facility's infection control program, which read under the responsibility of the Infection Control Coordinator the purpose of the program was to ensure avoidable healthcare associated infections did not occur. It also conflicted with the recommendations from HICPAC for quality control in sterile processing, which read infection control rounds should be conducted periodically in reprocessing areas.

iii. On 9/14/21 at 5:49 p.m., the Chief Nursing Officer (CNO) #3 was interviewed. CNO #3 stated the event on 10/16/20, when staff identified the laryngoscopes were not sterilized according to the instrument IFUs, would be considered a sterilization breach. He stated there was no documentation of additional investigation in response to the event. CNO #3 stated when the event was reported, it was entered as a "low-level incident," which caused the event to be closed without further investigation by the facility's infection control professional. CNO #3 stated that, as of the date of this interview, the investigation had been reopened and 16 patients had been identified as potentially exposed to the unsterile instrument.

CNO #3 stated when the event was initially investigated and closed, the corrective intervention was staff training to the correct sterilization process for the instrument. He stated that had the event been properly investigated, the investigation would have included further interventions to prevent recurrence, such as conducting audits of SPD.

Based on the manner and degree of the standard-level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.51 Surgical Services was out of compliance.

A-0952: Prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies: A medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration, and except as provided under paragraph (b)(1)(iii) of this section. Based on interviews and document review, the facility failed to ensure patients received an updated and complete History and Physical (H&P) exam prior to their procedure according to facility policy in three of eight focused reviews of medical records (Patients #35, #37, and #38).

A-0955: A properly executed informed consent form for the operation must be in the patient's chart before surgery, except in emergencies. Based on interviews and document review, the facility failed to ensure patients signed informed consents prior to a procedure being performed in 6 of 38 medical records reviewed (Patient #20, #21, #22, #31, #35, #36).

Based on interviews and document review, the facility failed to ensure patients received an updated and complete History and Physical (H&P) exam prior to their procedure according to facility policy in three of eight focused reviews of medical records (Patients #35, #37, and #38).

Findings include:

Facility policy:

The History and Physical policy read, the H&P shall consist of chief complaints, history of present illness, allergies and medications, relevant social and family history, past medical history, review of systems and physical examination. A complete H&P must have been performed prior to but no longer than 30 calendar days of admission. If an H&P was not performed and documented within 30 calendar days of admission it must be performed and documented within 24 hours of admission. For patients undergoing procedures requiring sedation, general conscious or regional anesthesia, an H&P shall be performed within 24 hours prior to the procedure by a qualified medical provider. If a complete H&P was performed within 30 calendar days prior to the patient's admission, an update to the H&P shall be completed and recorded in the medical record within 24 hours of admission and prior to surgery.

1. The facility failed to ensure H&P examinations were completed prior to patients' procedures.

A. Document Review

a. Medical record review revealed multiple patient records which lacked completed H&Ps.

i. Review of Patient #35's medical record revealed on 8/20/21, the patient underwent a right carpal tunnel release. The H&P completed on 8/20/21 lacked several elements including history of present illness, past medical history, a review of systems and physical examination, history of anesthesia complications and vital signs.

ii. Review of Patient #37's medical record revealed on 3/18/21, the patient underwent an incision and drainage of the right breast and expander removal. Review of the medical record revealed an H&P was completed on 2/1/21; however, there was no evidence the H&P was reviewed or updated with any pertinent changes within 30 days of the surgery in accordance with the facility policy.

A patient safety event was entered on the same date in reference to Patient #37's medical record. The event report read the H&P was not present in Patient #37's chart on the date of the surgery. The follow-up documentation for the event report read an email with the facility's policy was sent to the provider for review.

iii. Review of Patient #38's medical record revealed the patient underwent a cricopharyngeal myotomy (a procedure in which a cut was made to divide a muscle around the esophagus) on 3/17/21. The medical record revealed an H&P was completed on 2/22/21. The H&P was subsequently reviewed by the provider and there were no changes from the original H&P; however, the review of the H&P was documented by the provider on 4/28/21, over a month after the patient's surgery.

The lack of H&Ps in the medical records reviewed were in contrast to the facility policy which read, an H&P must have been performed 30 days or less prior to the procedure. If an H&P was not performed and documented within 30 days, one must be performed and documented within 24 hours prior to the procedure by a qualified medical provider. If a complete H&P was performed within 30 calendar days prior to the patient's admission, an update to the H&P was to be completed and recorded in the medical record within 24 hours of admission and prior to surgery.

b. Review of reported patient safety events revealed between the dates of 9/1/20 and 8/30/21, there were 37 additional events in which an H&P was absent, incomplete or not reviewed and updated on the date of surgery.
B. Interviews

a. On 9/15/21 at 3:36 p.m., an interview was conducted with the Director of Perioperative and Inpatient Services (Director) #11. Director #11 stated an H&P was an examination performed by the provider regarding the patient's medical history and was completed prior to a procedure. Director #11 stated it was important for an H&P to be completed prior to surgery to ensure the patient was safe to proceed with surgery and review any present medical conditions. Director #11 stated if a medical emergency occurred during the procedure and an H&P exam was not completed prior to surgery, there was a risk to the patient if the provider did not know of the patient's pre-existing medical conditions.

b. On 9/22/21 at 10:46 a.m., Provider #6 was interviewed. Provider #6 stated he was one of the surgeons at the facility and treated a high volume of patients at the facility. He stated he was also a member of the facility's Governing Board, which was responsible to oversee the activities of the facility's Quality and Performance Improvement (QAPI) program and the Medical Executive Committee. Provider #6 stated he was not aware of any problems related to missing or incomplete H&Ps.

Based on interviews and document review, the facility failed to ensure patients signed informed consents prior to a procedure being performed in 6 of 38 medical records reviewed (Patient #20, #21, #22, #31, #35, #36).

Findings include:

Facility policy:

The Consents policy read, informed consent consists of an explanation of the nature and purpose of the recommended treatment or procedure; an explanation of the risks and benefits of a treatment or procedure; an explanation of the alternative with the risks and benefits of the alternatives; an explanation of the recuperative period which includes discussion of anticipated problems; and an explanation that the patient or representative is free to withdraw his or her consent.

A procedure specific consent must be used to document informed consent for the following: all surgical procedures performed under anesthesia care or IV sedation; selected procedures to include biopsies, endoscopies and spinal injections; exams or procedures requiring contrast. A separate written consent should be obtained for the use of Monitored Anesthesia Care, general, regional, spinal or epidural anesthesia, or IV sedation by the clinician administering the anesthesia.

Documenting consent: only consent forms meeting the below criteria will be accepted. The consent must be signed by the patient and/or legal representative and the attending physician. The type of information to be discussed and documented with the patient includes the procedures to be performed. Additional documentation to be documented on the consent includes the name of the responsible practitioner, signature of the patient and the date and time of signature, and signature of the provider and date and time of signature.

1. The facility failed to ensure informed consents were completed by the provider and signed by the patient prior to a procedure.

a. Medical record review revealed multiple patient records which lacked completed and signed informed consents.

i. Review of the medical record for Patient #20 revealed on 7/19/21, the patient underwent a procedure to place a PICC (a peripherally inserted central catheter, a tube into the vein for intravenous medications or blood draws). The consent for the procedure did not have the name or description of the procedure documented on the consent form.

ii. Review of the medical record for Patient #21 revealed on 7/28/21, the patient underwent a left thumb arthroplasty (a surgery to replace part or all of the joint at the base of the thumb). The consent form for the procedure was not signed by Patient #21 or the provider who performed the surgery.

iii. Review of the medical record for Patient #22 revealed on 8/20/21, the patient underwent a carpal tunnel release (a procedure to cut through the ligament of the wrist to relieve carpal tunnel pain). The consent form for the procedure was signed by the provider but was not signed by the patient.

iv. Review of the medical record for Patient #31 revealed on 5/24/21, the patient underwent a left knee arthroscopy and repair (a procedure to examine the knee joint) under general anesthesia. The medical record did not include a completed consent for anesthesia.

A patient safety event was entered on 6/1/21 in reference to Patient #31's medical record. The event report read, a signed anesthesia consent was missing and an email was sent to the provider with no response. There was no further documentation of follow-up to the reported event.

v. Review of Patient #35's medical record revealed on 8/20/21, the patient underwent a right carpal tunnel release. The procedure consent was signed by the provider but not by Patient #35 and did not include the patient's name or date of birth.

vi. Review of Patient #36's medical record revealed on 4/1/21, the patient underwent an epidural steroid injection for pain management. The consent for the procedure was signed by the provider but was not signed by Patient #36.

b. Review of reported patient safety events revealed between the dates of 9/1/20 and 8/30/21, there were 18 events in which a patient consent form was found to be incomplete or unsigned. These included consents for surgical procedures and anesthesia.

Review of medical records and patient safety event reports revealed facility policy was not followed which read, a procedure specific consent must be used to document informed consent for the following: all surgical procedures performed under anesthesia care or IV sedation; selected procedures to include biopsies, endoscopies and spinal injections; exams or procedures requiring contrast. A separate written consent should be obtained for the use of Monitored Anesthesia Care, general, regional, spinal or epidural anesthesia, or IV sedation by the clinician administering the anesthesia. The consent must be signed by the patient and/or legal representative and the attending physician.

B. Interviews

a. On 9/15/21 at 3:36 p.m., an interview was conducted with the Director of Periop and Inpatient Services (Director) #11. Director #11 stated a consent was a document which was an agreement between the provider and the patient undergoing a procedure. Director #11 stated the signed patient consent was supporting evidence the procedure and the risks of the procedure had been reviewed with the patient prior to the procedure. Director #11 stated there was a risk to the patient if an informed consent was not signed, which included the possibility the patient did not know the risks and benefits of the procedure being performed.

b. On 9/22/21 at 10:46 a.m., Provider #6 was interviewed. Provider #6 stated he was one of the surgeons at the facility and treated a high volume of patients at the facility. He stated he was also a member of the facility's Governing Board, which was responsible to oversee the activities of the facility's Quality and Performance Improvement (QAPI) program and the Medical Executive Committee. Provider #6 stated he was not aware of any problems related to missing or incomplete informed consents.