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Based on observation, interview, and record review, the hospital's Governing Body failed to ensure the following:
1. Ensure that there was an effective, hospital-wide quality assessment and performance improvement program (QAPI).
2. Ensure that an infection control program was well-organized and supported by all staff and departments.
3. Ensure that Surgical Services were well organized and services provided in accordance with acceptable standards of practice (AORN-Association of Operating Room Nurses-a national nursing organization with nationally recognized standards.) during surgical instrument processing. High level disinfection (to eliminate many or all disease causing germs) and sterilization of surgical instrument were not performed in a manner to ensure minimal risk of transmission of infectious agents. These deficient practices had the potential to affect the health and safety of all patients admitted to the hospital.

Findings:

1. The Governing Body did not ensure that the QAPI program was effective and well organized. (Refer to A-0263)

2. The Governing Body did not ensure that the infection control program was well-organized and supported by all staff and departments. (Refer to A-0747)

3. The Governing Body did not ensure that all sterile instruments and supplies were processed correctly to ensure their sterility. This failure resulted in an immediate jeopardy being called on September 3, 2014 at 1:55 PM. (Refer to A-0749)

4. The Governing Body did not ensure that Surgical Services were well organized and provided in accordance with acceptable standards of practice. (Refer to A-0940)

The cumulative effect of these systemic problems resulted in the hospital being unable to ensure the provision of quality health care in a safe environment.

Based on observation, interview and record review, the hospital's Quality Assessment and Performance improvement (QAPI) program failed to ensure the following:
1. Ensure that endoscopes (a long flexible instrument used to visualize the large intestine) were sterilized and disinfected according to the manufacture's instructions and infection control standards of practice (AORN-Association of Operating Room Nurses-a national nursing organization with nationally recognized standards).
2. Ensure that the facility examine the hospital's overall processes and system of cleaning and sterilization of surgical instruments. This resulted in an Immediate Jeopardy (IJ) situation called on September 3, 2014 and abated on September 5, 2014. These deficient practices had the potential to affect the health and safety of all patients admitted to the hospital.

Findings:

The hospital's Quality Assessment and Performance improvement program (QAPI) did not identify issues discovered during the improper cleaning and high level disinfection (to eliminate many or all disease causing germs) of endoscopes. These issues identified presented an opportunity to examine the hospital's overall processes of cleaning and sterilization of surgical instruments. As a result an immediate jeopardy was called on September 3, 2014 at 1:55 PM. The immediate jeopardy was abated when an acceptable corrective action plan was received on September 5, 2014 at 1:35 PM. (Refer to A-0309 and A-0749)

The cumulative effect of these systemic problems contributed to the hospital being unable to ensure the provision of quality health care in a safe environment.

Based on interview, the hospital's Quality Assessment and Performance improvement program QAPI) did not identify issues discovered during the improper cleaning and high level disinfection (to eliminate many or all disease causing germs) of endoscopes (a long flexible instrument used to view the large intestine) presented an opportunity to examine the hospital's overall processes of cleaning and sterilization of surgical instruments. This resulted in other instruments being cleaned and sterilized incorrectly, exposing patients and staff to an increased risk of transmission of infectious agents, refer to A-0749). The hospital's governing body did not ensure that the QAPI program facilitated the sharing of information and resources between the QAPI staff, staff of Surgical Services, and the Infection Control Committee in investigating issues regarding the cleaning and high level disinfection of endoscopes. This resulted in the potential for the patients to develop surgical site infections.

Findings:

1. During an interview with the Chief Executive Officer (who is also the Chief Financial Officer) was interviewed throughout the survey. He stated on two different occasions, during the QAPI meeting on September 5, 2014 at 9:15 AM and at the exit conference at 2:30 PM on the same day that the initial discovery of an error in endoscope processing was a "red flag" that other related processes should be looked at as well. He accepted some of the responsibility regarding not identifying an opportunity to examine the hospital's overall processes of cleaning and sterilization of surgical instruments, as well as sharing that responsibility with the QAPI, Infection Control and Surgical Services leadership.

2. During an interview with the Director of Quality Assurance and Performance Improvement (QAPI) on September 5, 2014, at 9:15 AM, the Director of QAPI was unable to address the issues regarding cooperation between her staff and the Infection Control practitioner. She did not offer an explanation as to why the endoscope issues originally discovered did not lead to an assessment of other processes used in instrument cleaning and sterilization.

Based on observation, interview, and document review, the hospital failed to ensure an effective, active, system wide infection control program for the prevention, control, and investigation of infections and communicable diseases.
An immediate jeopardy was called on September 3, 2014 at 1:55 PM, in the presence of the hospital administrative staff, due to the facility's deficient sterile processing and disinfection practices under the Conditions of Participation for Infection Control.

The immediate jeopardy was abated on September 5, 2014 at 1:35 PM upon receipt of an acceptable corrective action plan. (Refer to A-0749)

The facility failed to ensure the following:

1. To provide an effective system-wide infection control program that includes effective communications. (Refer to A-0748)

2. To actively consider creation of policy and procedures based on Nationally Recognized Standards for infection control. (Refer to A-0748)

3. To include the governing body in the consideration of policy and procedures. Thus, failing to allow for the governing body to actively consider, adopt and provide appropriate active feedback and direction. (Refer to A-0748)


4. To include active surveillance to identify policies and procedures that are not implemented correctly in an active infection control program. (Refer to A-0748)

5. To provide surveillance to identify deficiencies in the staff knowledge regarding Infection Control concepts, policy and procedures. (Refer to A-0748)

6. That the sanitary condition of the Operating Suites environment was provided according to National Standards. (Refer to A-0748 and A-0749)

7. To provide effective monitoring and training to ensure staff were trained and competent to effectively sterilize surgical instruments packed in rigid containers. (Refer to A- 0749 )

8. To provide effective monitoring and training to ensure staff was trained and competent to effectively sterilize surgical hinged instruments. (Refer to A- 0749)

9. To provide training and monitoring systems to ensure staff is trained and competent to effectively monitor, identify, and pull from circulation; surgical instruments which are not effectively sterilized. (Refer to A- 0749)

8. . Failed to provide effective monitoring and training to ensure staff was trained and competent to effectively sterilize surgical hinged instruments. (Refer to A-0749)


The cumulative effects of these systemic problems resulted in the facility's inability to ensure an active, effective system-wide infection control program to prevent the spread of infection.

Based on observation, interview and document review, the hospital failed to provide an effective Infection Control program as evidenced by failure to have effective systems in place to ensure an active, effective, facility-wide infection control program. The hospital failed to ensure the following:

1. Integration of an active System-wide infection prevention and control program into the facility QAPI program when the hospital:

a. Failed to provide an effective system-wide infection control program that includes effective communications.

b. Failed to have in place a system to obtain multi-disciplinary input and guidance to develop and implement policy and procedures governing the prevention, and control of infections and communicable diseases.

c. Failed to create some policy and procedures based on the active consideration of nationally recognized standards.

d. Failed to provide a system for the governing body to consistently review and give consideration to Infection Control policy and procedures.

These failures had the potential to affect the health and safety of patients undergoing a surgical procedures in the hospital.

Findings:

1. On September 2, 2014 at 12:00 P.M., a review of a record titled, "Infection Prevention and Control plan" dated, March 13, 2014 revealed, that the hospital is not following the hospital's own policy related to the Infection Control Plan Design as stated on page 2 of the document. The policy showed the following:

"Systems are implemented to communicate ...surveillance data with the physicians and other independent practitioners ... staff.

In a review of a document titled "Cleaning and Sterilization of Colonoscopies (a long flexible instrument used to visualize the intestine) with the Auxiliary Water Channel" dated February 6, 2014, the document showed that an adverse event had occurred. The hospital had three colonoscopy scopes with an auxiliary water channel (a port that was the length of the instrument used for flushing water into the intestine). The sterile processing staff failed to disinfectant the colonoscopy scopes according to the manufacturer recommendations and the port had a brown discharge noted before a colonoscopy procedure. The three colonoscopy scopes were removed from service on February 13, 2014.

In a subsequent interview with the Quality Director and Infection Control Director, on September 2, 2014 at 3:05 PM, and in discussion of the event Titled, Cleaning and Sterilization of Colonoscopies with the Auxiliary Water Channel" dated, February 6, 2014. The director of Quality stated that the director of Infection Control was not notified of the event, "until the investigation was resolved." The Quality Director indicated an infection control issue may not be communicated to a formal committee to document challenges if the staff involved determines they can manage the challenge or fix the Infection Control issue.

The requested documentation of the event's formal communication up to the Governing Body was not provided.

2. On September 2, 2014 2:40 PM, during an interview with the Infection Control Director, a request for review of formal and informal environmental Infection Control surveillance documentation was made. The Infection Control Director indicated that formal or informal documentation was not available.

On September 4, 2014 at 3:00 PM, The Infection control Director indicated the facility relied on an informal process to communicate information the staff member considers non urgent IC issues. She stated, "if they see something that does not look right they will reach out to me."

On September 2, 2014 at 3:00 PM, in an interview with the Director of Quality and the Director of Infection Control. Both confirmed the communication and results of the Environmental Infection Control rounds were not always formally documented.

The Quality Director acknowledged the formal communications from Infection Control Committee to Quality, Med Exec and to Governing body does not always happen..

The requested documentation of the formal communication process up to the governing board regarding the Titled event, "Cleaning and Sterilization of Colonoscopies with the Auxiliary Water Channel." Dated February 6, 2014 was not provided.

A Concurrent review of a record titled, "Policies, Infection control program" revealed the facility is not following their own policy regarding the Infection Control Program for active surveillance. Under the subtitle, "Active Surveillance," dated, May 20, 2009 and referring to "house-wide" surveillance is a bulleted statement, "ICP or designee(s) will conduct infection control rounds throughout the organization to identify and correct practice or environmental issues."

Based on observation, interview, and document review the hospital failed to provide a functional and sanitary environment for the provision of surgical services in the following instances:

1. The facility failed to provide sterile supplies maintained in accordance with facility policy regarding, event-related sterility standards.

2. The facility failed to ensure re-usable surgical instruments were sterilized and stored in accordance with nationally recognized standards. AORN (The Association of PeriOperative Registered Nurses) was the nationally recognized standard the hospital identified as the standard they followed in absence of facility policy and procedure.

3. The hospital failed to ensure infection control surveillance was performed to ensure staff were following hospital infection control policies and procedures.

4. The hospital failed to ensure the Medical Staff (doctors, physician assistants and nurse practioners) were monitored for tuberculosis (TB-a bacterial disease of the lungs that is spread by inhaling droplets an infected person coughs into the air). The hospital did not require or collect results of the TB testing or have another process for assessing tuberculosis status of the Medical Staff.

These failures resulted in the potential for spread of infection among the Medical Staff, the hospital staff and patients.

An immediate jeopardy was called on September 3, 2014 at 1:55 PM, in the presence of the hospital administrative staff, due to the facility's deficient sterile processing and disinfection practices.

Findings:

An immediate jeopardy was called on September 3, 2014 at 1:55 PM, in the presence of the hospital administrative staff, due to the facility's deficient sterile processing and disinfection practices as follows:

Colonoscopy scopes (a long flexible instrument used to view the large intestine) were not being disinfected according to manufacturer's guidelines, resulting in the auxiliary water channel having a brown discharge.

Surgical instruments were not packaged in a way for the sterilant (chemical or steam used to sterilize surgical instruments and supplies) to reach all instrument surfaces.

The ineffective disinfection and sterilization of instruments and equipment could result in patients developing surgical site infections.

The immediate jeopardy was abated on September 5, 2014 at 1:35 PM, with administrative staff, upon receipt of an acceptable corrective action plan as follows:

Surgeries were postponed until the instruments were processed correctly.

All instruments were taken out of service until they were reprocessed.

The sterile processing staff were trained by a Certified Registered Central Service Technician in current practices of decontamination and reprocessing of instruments.

The five eye trays at Outpatient Surgery will be reprocessed.

As a requirement of employment, the Sterile Processing Supervisor will be required to maintain membership in a Professional Organization which provides current safety standards in sterile processing.

For the three colonoscopy scopes removed from service for improper cleaning, the manufacturer was contacted for proper cleaning process to reintroduce the colonoscopy scopes back into service.

The Director of Surgical Services has contacted a colonoscopy scope manufacturer's representative to schedule education for cleaning to include all water channels, with a return demonstration by sterile processing staff.

Instruments to be reprocessed will be monitored on a daily basis by the Sterile Processing Supervisor and Director of Surgical and Obstetrical Services. The Infection Control Preventionist will conduct random monitoring weekly.

The Supervisor of Sterile Processing and the Supervisor of Surgical Services will have competency validation completed by an individual qualified to attest to their competency.

Ongoing continuing education will be provided to the Central Sterile Processing Personnel at least three times a year. All Sterile Processing personnel will have their competency validated annually through observation and demonstration.


1. On September 3, 2014 at 1:45 PM, an observation with, The Chief Nursing Officer (CNO), the Infection Control Director and the Sterile Processing Supervisor (SPS) was made of surgical trays loaded and processed (Metal containers that surgical instruments and supplies are placed to be sterilized in a sterilizer. They are them wrapped in a package that prevents the sterile containers from being contaminated). The trays were not processed in accordance with AORN standards.

The following was opened and inspected:

A hysterectomy tray (instruments used for surgery to remove female reproductive organs), which was ready for transport to the OR.

The following was observed packed in the tray:

A stringer (typically a foot long, 3 rod device to assist with the positioning of instruments for sterilizing) held 23 sterile hinged instruments packed tightly together. Ten out of 23 hinged instruments' blades were closed and the tips layered across the bottom of the tray.

The sterilant (chemical or steam that sterilizes the instruments) would be unable to reach all instrument surfaces to sterilize them being packed too tightly together and the hinged instruments closed.

Wrapped in a blue towel were ten instruments spaced apart, then wrapped in a roll, and placed on top of the stringer. Additionally, two heavy sterile instruments were stacked on top of the stringer with metal to metal contact. The largest of the hinged instruments were packed in the middle of the stringer tightly. In the rigid tray placed around the instruments were five surgical blue towels.

In a concurrent interview, the SPS acknowledged the hysterectomy tray was representative of all rigid trays with hinged instruments. The SPS stated, "I have worked here for 20+ years and that is the way we have always done it." The Chief Nursing Officer and the Infection Control Director both acknowledged the trays were not consistent with the facility policy of following the AORN, a national nursing organization with nationally recognized standards.

(AORN) Recommendation IV: "Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents. ...Incorrect packaging may prevent sterilization from occurring. Inappropriate handling can lead to loss of package integrity. Incorrect packaging can make aseptic delivery of the contents to the sterile field difficult or impossible.

IV.c. Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces. Sterilant contact is necessary for sterilization to be achieved.

IV.e. Instruments composed of more than one part that can be disassembled should be disassembled unless the manufacturer's written (instructions)...specifies that disassembly is not required. Sterilization of assembled instruments can prevent exposure of some areas of the device to the sterilant.

IV.g. Towels placed within instrument sets should be lint-free, freshly laundered, and thoroughly rinsed by a health care-accredited laundry facility. Adequate rinsing reduces the risk of leaving chemical residues that could be transferred from the towels to instruments.28 Lint left on sterile instruments may be transferred to the surgical wound and may cause a foreign-body reaction.

IV.h. Items to be sterilized should be placed in the package or tray in an open or unlocked position.

2. On September 3, 2014 at 2:00 PM, in an interview while touring sterile supplies with the Sterile Processing Supervisor (SPS), the SPS was unable to verbalize the process of surveillance and/or quality checks for event related sterility, sterile instruments, and supplies.

During a concurrent observation, SPS acknowledged she could not identify instruments or supplies based on facility policy or a nationally recognized standard of event related sterility. She stated, " the facility follows AORN (a national nursing organization with nationally recognized standards).


On September 3, 2014 at 2:30 PM, during an observation of bins containing stored processed sterile instruments and supplies, it was observed the instruments and supplies were not maintained in a manner consistent with the facility's stated policy of following AORN Standards. The following was observed:

Sample storage bin, measuring 2 ft by 2 ft. with packages which were viewed pushed into the bin space placing pressure on the packages.

A 2 ft. by 3 ft. shallow container with miscellaneous items. The miscellaneous items contained supplies and instruments which were out of date, some with opened packages.

SPS acknowledged, ten randomly sampled peel packs were observed, creased and crumpled. Three of the peel packs were yellowed with curled edges. The packages were stored in a mostly horizontal state allowing compression on the packages. SPS agreed she could not ensure the sterility of the surgical instruments and would remove them from circulation.


In a concurrent interview, the Chief Nursing Officer , Infection Control Director, and Sterile Processing Supervisor, all acknowledged the maintained condition of the supplies were not consistent with hospital policy of "Event Related Sterility" when processing and storing of sterile surgical instruments. The SPS indicated, in absence of a facility policy, the AORN, "Event Related Sterility", standard is applied.


The AORN Recommend standard states,

1. Sterile items shall be stored in a manner that reduces the potential for contamination
a. traffic through the area shall be controlled.
b. supplies shall be rotated so the oldest is used first.

2. When stored on open shelves, sterile items shall:
a. be positioned so that the packaging is not crushed, bent, compressed or punctured.

3. Sterile supplies shall be handled carefully.
a. Handle with clean hands.
b. Avoid dragging, sliding, crushing, bending, compressing, puncturing

On September 3, 2014 at 3:25 PM, in a tour of the outpatient surgery facility, during an observation, it was observed that five eye trays located in a sterile cabinet were found to have bio-burden (biological substance-such as blood or tissue) on the instruments.

In a concurrent interview, the Infection Control Director and the Sterile Processing Technician, acknowledged the hospital does not currently have a formal process to assure that the instruments are sterilized properly.

3. On September 4, 2014 at 3:30 PM, a record review was conducted. The Infection Control Director presented blank documents titled, " Infection Prevention and Control Departmental Assessment tools" in response to a request for the last quarter completed environmental surveillance tools .

In a concurrent interview, the Infection Control Director acknowledged consistent rounding or surveillance is not done. Completed tools were not provided by the hospital.

A review of a record titled, "Policies, Infection control program" revealed the facility is not following their own policy regarding the Infection Control Program for active surveillance. Under the subtitle, "Active Surveillance," dated, May 20, 2009, and referring to facility-wide surveillance is a bulleted statement, "Infection Control Practitioner or designee(s) will conduct infection control round throughout the organization to identify and correct practice or environmental issues."




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4. Nine Medical Staff credentialing/privileging files were reviewed on September 3, 2014 at 3:30 PM. None of the files contained any information regarding PPD results (Purified Protein Derivative used in skin tests to document exposure to tuberculosis), screening questionnaires or other measures of TB (tuberculosis) risk. The Director of Medical Staff Services was interviewed concurrently and stated measures of TB risk and exposure were not required by the hospital.

The CDC recommendations, "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005" state, "All HCWs (Healthcare workers) should receive baseline TB screening upon hire, using two-step TST (tuberculin skin test) or a single BAMT (Blood Assay Mycobacterium tuberculosis) to test for infection with M. tuberculosis."

Based on observation, interview and document review, the hospital also failed to ensure that surgical services were well organized. There was poor communication and cooperation between the surgical staff and other hospital departments such as Infection Control and Quality, refer to A-0309). The RN Director of Surgical Services did not seem fully aware of important issues within her department. This resulted in an inability for the hospital to ensure that patients undergoing surgery were treated according to the highest standards of care.

Findings:

1. The hospital's RN Director of Surgical Services and Ob/Gyn services was not knowledgeable about processes occurring in her department. (Refer to A-0942)

2. The hospital failed to ensure that sterile processing services were provided in accordance with high standards of practice. (Refer to A-0951)

The cumulative effect of these deficient practices increased the risk of infection and a poor surgical outcome for all surgical patients.

Based on interview the RN Director of Surgical Services did not have the experience or knowledge necessary to ensure the highest level of patient care. She was unable to provide a method for deciding when to involve the Infection Control (IC) Practitioner in the investigation of infection control related issues. She failed to involve the IC Practitioner regarding problems with proper cleaning and high level disinfection of endoscopes. The Director failed to provide sufficient oversight and supervision of staff involved in cleaning and disinfection/sterilization of endoscopes and surgical instruments. She did not have knowledge of the process for tracking pathological specimens that left the operating suite. This resulted in the hospital being unable to ensure that surgical patients were being treated according to the highest level of infection control and surgical care.

Findings:

In a review of a document titled "Cleaning and Sterilization of Colonoscopies (a long flexible instrument used to visualize the intestine) with the Auxiliary Water Channel" dated February 6, 2014, the document showed that an adverse event had occurred. The hospital had three colonoscopy scopes with an auxiliary water channel (a port that was the length of the instrument used for flushing water into the intestine). The sterile processing staff failed to disinfectant the colonoscopy scopes according to the manufacturer recommendations and the port had a brown discharge noted before a colonoscopy procedure. The three colonoscopy scopes were removed from service on February 13, 2014.


During an interview conducted during a tour of the operating room (OR) on September 3, 2014 at 8:20 AM, with the RN (Registered Nurse) Director of Surgical Services, she was asked about whether anyone from infection control was involved in the initial investigation of the endoscope issues. She stated that they were not because she did not think it was indicated. At that time, her department was focused on what was the reason for the endoscopes to have a discolored drainage and not on infection control issues. She was asked if the Infection Control Practitioner might have been able to assist at an early stage in determining if there were unrecognized infection control issues, the Director stated she hadn't thought of that. She was asked if she knew that the IC Practitioner would have liked a culture of the drainage, she stated she was not aware at that time. She was then asked how she would make the decision in this case, and other cases, on whether or not to involve the IC Practitioner if she didn't speak to the Practitioner for input and she did not have an answer. The Director was asked about a log of pathological surgical specimens (abnormal tissue that is removed during surgery) sent out of the OR for analysis. She said there was no log. She could not describe any alternative process for verifying that the specimens were identified and tracked. She could not answer. The surveyor later determined that the lab sent technicians to the OR to pick up these specimens and that the technicians would electronically log the specimens as received from the OR. She was questioned about humidity in the ORs. She was able to state the correct range and that there was an automated system but could not describe the process in which the OR humidity was tracked. She said an alarm would sound if the humidity was out of range but otherwise could not speak to the humidity monitoring process.

A policy dated 5/12 and entitled "Acquisition of specimens form the operating suite" was reviewed on September 4, 2014 at 11:45 AM. It stated that "tissue specimens ...transported to surgical pathology lab ...as soon as possible ...logged by histotechnicians when they are pick them up."

Based on observation, interview and document review, the hospital failed to ensure that sterile processing services were provided in accordance with high standards of practice (AORN-Association of Operating Room Nurses-a national nursing organization with nationally recognized standards). Endoscopes (a long flexible instrument used to view the large intestine) and surgical instruments were not processed in a manner to ensure the highest attainable level of cleanliness and sterility. These practices resulted in the potential for increased transmission of infectious agents to patients and staff.

Findings:

In a review of a document titled "Cleaning and Sterilization of Colonoscopies (a long flexible instrument used to visualize the intestine) with the Auxiliary Water Channel" dated February 6, 2014, the document showed that an adverse event had occurred. The hospital had three colonoscopy scopes with an auxiliary water channel (a port that was the length of the instrument used for flushing water into the intestine). The sterile processing staff failed to disinfectant the colonoscopy scopes according to the manufacturer recommendations and the port had a brown discharge noted before a colonoscopy procedure. The three colonoscopy scopes were removed from service on February 13, 2014.


The Medical Chief of Surgical Services and Ob/Gyn Services was interviewed on September 4, 2014 at 12:00 PM. He was aware of the incident and investigation regarding the initial event involving the cleaning of endoscopes. He was unaware that the process for other instruments, particularly those sterilized in rigid trays, was also not following proper technique.

On September 3, 2014 at 1:45 PM, An observation with, The Chief Nursing Officer (CNO), the Infection Control Director and the Sterile Processing Supervisor (SPS) was made of surgical trays loaded and processed. The trays were not processed in accordance with AORN standards.

The following was opened and inspected:

A hysterectomy tray (instruments used for surgery to remove female reproductive organs), which was ready for transport to the OR (operating room).

The following was observed packed in the tray:

A stringer (typically a foot long, 3 rod device to assist with the positioning of instruments for sterilizing) held 23 sterile hinged instruments packed tightly together. Ten out of 23 hinged instruments' blades were closed and the tips layered across the bottom of the tray.

The sterilant (chemical or steam that sterilizes the instruments) would be unable to reach all instrument surfaces to sterilize them being packed too tightly together and the hinged instruments closed.

Wrapped in a blue towel were ten instruments spaced apart, then wrapped in a roll, and placed on top of the stringer (a device that keeps hinged instruments in an open position). Additionally, two heavy sterile instruments were stacked on top of the stringer with metal to metal contact. The largest of the hinged instruments were packed in the middle of the stringer tightly. In the rigid tray placed around the instruments were five surgical blue towels.

In a concurrent interview, the SPS acknowledged the hysterectomy tray was representative of all rigid trays with hinged instruments. The SPS stated, "I have worked here for 20-plus years and that is the way we have always done it." The Chief Nursing Officer and the Infection Control Director both acknowledged the trays were not consistent with the facility policy of following the AORN, a national nursing organization with nationally recognized standards.

(AORN) Recommendation IV: "Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents. ...Incorrect packaging may prevent sterilization from occurring. Inappropriate handling can lead to loss of package integrity. Incorrect packaging can make aseptic delivery of the contents to the sterile field difficult or impossible.

IV.c. Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces. Sterilant contact is necessary for sterilization to be achieved.

IV.e. Instruments composed of more than one part that can be disassembled should be disassembled unless the manufacturer's written (instructions)...specifies that disassembly is not required. Sterilization of assembled instruments can prevent exposure of some areas of the device to the sterilant.

IV.g. Towels placed within instrument sets should be lint-free, freshly laundered, and thoroughly rinsed by a health care-accredited laundry facility. Adequate rinsing reduces the risk of leaving chemical residues that could be transferred from the towels to instruments.28 Lint left on sterile instruments may be transferred to the surgical wound and may cause a foreign-body reaction.

IV.h. Items to be sterilized should be placed in the package or tray in an open or unlocked position.

Based on interview and record review, the hospital failed to ensure that all patients undergoing general anesthesia underwent a complete post anesthesia evaluation according to current standards of anesthesia care. This resulted in the potential for harmful effects of general anesthesia to not be identified as early as possible, resulting in the possibility of patient harm.

Findings:

Current standards of anesthesia care indicate that a post anesthesia assessment should include the following elements:

Respiratory function, including respiratory rate, airway patency, and oxygen saturation;
Cardiovascular function, including pulse rate and blood pressure;
Mental status;
Temperature;
Pain;
Nausea and vomiting; and
Postoperative hydration.

Closed surgical records, both in and outpatient, were reviewed on September 4, 2014 at 9:40 AM. Seven records containing a post anesthesia assessment filled out and signed by the anesthesiologist or certified registered nurse anesthetist (CRNA). Five of these patients received general anesthesia (20, 21, 24, 25, 26) and two received monitored anesthesia care (a type of sedation monitored by an anesthesia professional but not involving full unconsciousness). The preprinted forms on each chart contained the first 4 elements of the Post Anesthesia Assessment above (respiratory function, cardiovascular function, mental status, and temperature) but did not contain nausea and vomiting, postoperative hydration or pain. None of these records had these missing elements written in by the anesthesia provider.

The Medical Director for Anesthesia was interviewed on September 4, 2014 at 12:40 PM. She agreed that nausea and vomiting, postoperative hydration and pain were not included on the form for post anesthesia assessment. She was unaware of the recent changes in the standard of anesthesia care but agreed to begin the process of adding these elements to the hospital's post anesthesia assessment form.