HospitalInspections.org

Based on a review of a timeline of events (documented by hospital staff),
medical record review, documentation between the Chief of Surgery and hospital staff/Administration, policies and procedures, surgery schedule
and interviews and Review of Medical Staff Bylaws, Hospital Administration failed to document consideration of closure or suspending surgeries and procedures requiring sterile instrumentation in the Operating Room and/or Catheterization Lab until the problems identified in September 2016 (with autoclaves and a flash sterilizer not functioning correctly),were completely solved and patient safety was optimal. Regardless of the hospital's many attempts to correct the problems.
The rate of healthcare associated surgical site infections increased in September, October and November of 2016.

This deficient practice affected eight of nine sampled patients and had the potential to affect all patients who required surgery in the Operating Room.

Findings Include:

The problems with autoclaves and a flash sterilizer was evidenced by wet packs and staining. The hospital continued to use Flash sterilization, although policy revealed flash sterilization is for use in emergency situations only. The number of surgical site infections increased in September, but were not identified until October 2016. The number of hospital acquired surgical site infections also increased in October and November of 2016. Eight patients developed hospital acquired postoperative surgical infections


Review of Medical Staff Bylaws:

4. F. Duties of Department Chairs:

Each Department Chair is responsible for the following functions, either individually or in collaboration with Medical Center personnel:

1. all clinically related activities of the department...

12. to be responsible to the Board for the implementation of the Medical Center's quality assessment and performance improvement plan as it affects the Medical Staff...



See A -749

Based on a review of a timeline of events (documented by hospital staff), medical record review, documentation between the Chief of Surgery and hospital staff/Administration, policies and procedures, surgery schedule
and interviews, the hospital failed to prevent surgical patients from exposure to potential postoperative surgical infections by failing to suspend and /or stop surgeries in the Operating Room and or Catheterization Lab, when problems with autoclaves and one Intermediate Use Steam Sterilizer were identified beginning September 2016. As a result of this deficient practice multiple patients were identified by hospital staff as having healthcare associated surgical site infections. Thereby, exposing patients to hospital readmission(s), additional intravenous and oral antibiotics, additional surgery/surgeries and increased general anesthesia.

The hospital also failed to have an active member of the Medical Staff, with knowledge of infection control practices overseeing the Infection Control Committee and subsequent investigation after the problem with the autoclaves and Intermediate Use Steam Sterilizer were identified beginning September 2016 and an increase in healthcare associated surgical site infections were identified by the hospital.

See A- 749

Based on a review of a timeline of events (documented by hospital staff), medical record review, documentation between the Chief of Surgery and hospital staff/Administration, policies and procedures, surgery schedule
and interviews, the hospital failed to prevent surgical patients from exposure to potential postoperative surgical infections by failing to suspend and /or stop surgeries in the Operating Room and or Catheterization Lab, when problems with autoclaves and one Intermediate Use Steam Sterilizer were identified beginning September 2016. As a result of this deficient practice multiple patients were identified by hospital staff as having healthcare associated surgical site infections. Thereby, exposing patients to hospital readmission(s), additional intravenous and oral antibiotics, additional surgery/surgeries and increased general anesthesia.

The hospital also failed to have an active member of the Medical Staff, with knowledge of infection control practices overseeing the Infection Control Committee and subsequent investigation after the problem with the autoclaves and Intermediate Use Steam Sterilizer were identified beginning September 2016 and an increase in healthcare associated surgical site infections were identified by the hospital.

This deficient practice affected eight of nine sampled patients and had the potential to affect all patients who required surgery in the Operating Room and/or Catheterization Lab.

Definitions:

1. Sterilization: The complete elimination or destruction of all forms of microbial life. It is accomplished in the hospital by either physical or chemical processes. The principle sterilizing agents used are steam under pressure, dry heat, low temperature sterilization processes. (Hospital Policy and Procedure - ID: 1568731).

2. Critial Items: Involve a high risk of infection if such an item (surgical instruments) is contaminated with any microorganism, including bacterial spores...It is critical that objects that enter sterile tissue or the vascular system be sterile because any microbial contamination could result in disease transmission. (Hospital Policy and Procedure - ID: 1568731).

3. Nosocomial Infection Markers (NIMS): Possible healthcare acquired infection related to current hospitalization, previous hospital admission, or follow up after hospitalization (Definition documented on hospital's Infection Control Dashboard).

4. Healthcare-Associated Infections (HAIs): include central line-associated bloodstream infections, catheter-associated urinary tract infections, and ventilator-associated pneumonia. Infections may also occur at surgery sites,
(www.cdc.gov/hai/infectiontypes).

Findings Include:

A. Timeline:

A Review of timeline regarding problems in Central Sterile (documented by the Director of Surgical Service) includes:

"9/8: Water leak from below sterilizer # 2." (Sterilizer also referred to as an autoclave).

"9/9: "(Name of manufacturer of sterilizer) made repairs. # 2 leaked again."

"9/16: "(Name of Central Sterile employee) told me we had wet loads in both sterilizers."

"9/20: # 2 (sterilizer) still leaking and still have wet trays."

"9/23: Test loads....determine water pressure fluctuating in vacuum phase."

"9/26: Sterilizers down."

"9/27: Sterilizers down. Took instruments (name of offsite facility) to sterilize. CEO (Chief Executive Officer), Vice President of Patient Care Services, Manufacturer Representative and Director of Surgical Services meet for update."

"9/28, 9/29, 9/30: Sterilizers down." (not working per interview)

"11/11: More stains in trays. Took conference call from (Names of multiple hospital staff and Chief of Surgery (Medical Doctor). Suggested we change filters again. During an interview on 12/7/16 at 10:11 AM, the Director of Surgical Services / Employee Identifier (EI # 3) stated Central Sterile staff were placing "place papers called "Orthopedic Soaker Sheets" in the trays (used during sterilization process to wick moisture and prevent tears in the wraps). Light brown stains were seen on the paper sheets used in the hospital's sterilizer(s) and located in the Director's office by the state surveyor.

"11/14: Still getting stains after filters changed..."

"11/18: Ran test loads after units turned back on and had moisture and stains....steam separator was not turned on...Still had stains. (Sterilizer Manufacturer representatives) met with the Vice President of Patient Services and the Director of Surgical Services.

"11/19: "...ran dart test and both (sterilizers) were stained and the one from # 1 was wet." (DART: Daily Air Removal Test consists of a series of air removal and steam penetration barriers. A chemical indicator is located in the center of each pack. The test pack is placed directly into an empty steam sterilizer chamber. A uniform color change from yellow to black indicates that all the air was removed and replaced by steam, www.steris.com/products/chemical).

"11/21: ...Test loads ran...saw stains and wet items..."

"11/22: "...Bowie test on # 1 (sterilizer) had stains, # 2 bowie was good, but had water puddles in chamber. Ran test loads, still had stains and one item on # 1 had moisture in the wrap." (Bowie: test ensures materials processed in an autoclave have had adequate conditions for sterilization, https://consteril.com/autoclave-steam-sterilization-cycle-bowie-dick-test).

"11/28: "...New sterilizers arrived..."

"11/30: Staff reported wet load (presence of moisture) in flash (type of sterilizer) last night. Was called to flash this morning and had a wet load..."

"11/30: New sterilizers still having stains and wet loads."

"12/1: " (Name of Facility Director) and I spoke with (President of a thermo diagnostic company) about steam and results of the test from (name of sterilizer manufacturer). He said the brown stains sound like it is coming from instruments because we are not using R/O (reverse osmosis: a process in which dissolved inorganic solids (salts) are removed from a solution such as water (www.espwaterproducts.com/about-reverse-osmosis) or deionized water (water that has had almost all of its mineral ions removed, such as cations like sodium, calcium, iron, and copper, and anions such as chloride and sulfate, https://en.wikipedia.org) in the rinse cycle of the washer...Test results tell him Steam is picking up the residual on the instruments and turning back to tap water."

"(First name of CEO) told me (EI # 3) to take instruments off site to be sterilized...Took two loads of instruments to (name of facility)...to run."

"12/2: Stains in trays ran at (name of outside facility). Had (name of staff) get distilled water...to rinse instruments and ran test load. Test load had stains and was wet. Spoke with (name of Facilities Director) and he was having someone come in to see what size DI unit we would need."


"12/4: Supervisor called about ability to do a fractured hip (from another facility). I told then we do not have the instrumentation ready..."


"12/5: Had stains on trays from (name of outside facility). Staff was seeing small stains that they really had to search to see. Prepared another load to go to (name of outside facility). I told them not to put the paper soaker sheets in the trays."

"12/5: Called (name of makers of the soaker sheets) to see it there was any possibility of paper reacting with chemicals. (Name of their technical expert) told me there is nothing in the paper that would react with other chemical to cause staining. He did say they do hear a lot from facilities because the paper is white and it does show any issues with steam quality or other things like staining from instruments."

12/5: (President of a thermo diagnostic company) arrived...I was showing him the staining from yesterday's instruments from (Name of outside facility), he said it was scorching from the high heat of the metal against the paper. But he did see older sheets, water stains..."

"12/6: Still some staining." (EI # 3 reports staining from loads run on 12/5/16).


B. Medical Record Reviews:

On 12/8/16 at 12:45 PM, the Infection Prevention Coordinator / Employee Identifier (EI # 1) confirmed the following patients (Patient Identifier # 1 though patient Identifier # 38) were identified by the hospital as having Surgical Site Infections (SSI). Meaning the infections were "hospital acquired."

1. Patient Identifier (PI) # 1:

Surgeon: EI # 2

Admission: 9/20/16 - 9/23/16.

Surgical Procedure 9/20/16: Left Total Knee Arthroplasty (Knee replacement surgery with prosthesis, www.mayoclinic.org).

Readmission to hospital: 9/28/16 - 9/30/16 due to copious (large) amount of drainage from incision.

Surgical Procedure 9/28/16: Deep Irrigation and Debridement (surgical removal of infected, dead or damaged tissue, https://en.wikipedia.org) of left knee under general anesthesia.

Readmission to hospital: 10/26/16 - 10/27/16.

Surgical Procedure 10/26/16: Deep irrigation and debridement left knee and exchange of polyethylene. The operative report (PreOperative History) - revealed PI # 1 had been off antibiotics for seven to ten days. Several days ago, PI # 1 began having increased pain, redness "over" the wound with some mild swelling, some erythema (redness) down the front of the leg and a very scant (small) amount of drainage from the distal incision (distal: distant from the main mass of the body, wikipedia.org).

11/8/16: Surgical Procedure: Placement of tunneled central venous catheter right internal jugular due to history of infected knee with need for long term intravenous access for antibiotics and blood draws


2). Patient Identifier (PI) # 2:

Admission: 9/27/16 - 9/28/16

Surgeon: EI # 8

Pre-operative Diagnosis: Severe Left Ventricular Dysfunction

Original Surgery Date: 9/27/16 - Implantation of Biventricular Cardioverter / Defibrillator (BICD: procedure for patients with severe left ventricular heart failure. Leads are attached in the right atrium, right ventricle and left ventricle. The BICD detects when the heart is beating at a faster than normal rate, and shocks it back to normal, www.cts.usc.edu).

Readmission to hospital: 10/14/16

Diagnosis: Suspected pacemaker pocket infection with sepsis (a life-threatening condition that arises when the body's response to infection injures its own tissues and organs, wikipedia.org).

Surgery: 10/14/16 Removed pacemaker.

Wound Culture: 10/14/16 - Positive for Klebsiella Pneumonia and Staph Aureus.

Blood Cultures x 2: 10/14/16 - Positive for Staph Aureus.

Discharge Date: 10/18/16

During an interview with the Infection Prevention Coordinator / EI # 1 on 12/8/16 at 12:45 the surveyor asked EI # 1 if she interviewed the surgeon (EI # 8) about this patient's surgical site infection and she said, "No. The autoclave issue was already identified."


3). Patient Identifier # 3

Admission / Surgery Date: 9/20/16

Surgeon: EI # 9

Surgical Procedure: Robotic total Laparoscopic hysterectomy with bilateral
salpingectomies, cystoscopy, lysis of omental adhesions to anterior wall.

Discharge Date: 9/20/16

Readmission to hospital: 10/3/16

Readmission Diagnosis: Post operative hysterectomy pelvic abscess

Flagyl and Levaquin (antibiotics) administered intravenously (IV) 10/3-10/5/16

CT of Abdomen and Pelvis 10/3/16: Abscess identified.
(CT = computerized axial tomography, scan that reveals anatomic details of internal organs that cannot be seen in conventional x-rays, www.medicinenet.com).

Discharge Date: 10/5/16

During an interview on 12/8/15 at 1:30 PM, the Infection Prevention Coordinator / EI # 1 stated the physician who performed PI # 3's surgery was interviewed. Reportedly this physician's response to questions about the infection was, "Some issues were related to instrument sterilization."
EI # 1 stated this physician had no previous postoperative infections in the hospital.


4). Patient Identifier (PI) # 4:

Admission and Surgery Date: 9/20/16

Surgeon: EI # 9

Surgical Procedure: Robotic total hysterectomy with bilateral
salpingectomies, cystoscopy and lysis of adhesions

According to PI # 4's physician, PI # 4 was seen at another facility with a postoperative pelvic (as reported to the state surveyor by Infection Prevention Coordinator / EI # 1 on 12/8/16 at 1:45 PM). EI # 1 also stated the physician reported PI # 4's postoperative infection to the Director of Surgical Services).


5). Patient Identifier (PI) # 5:

Admission and Surgery Date: 10/7/16

Preoperative Diagnosis: Trimalleolar Fracture, right ankle.

Surgical procedure : Open Reduction Internal Fixation (ORIF) Right Ankle

Surgeon: EI # 2

Discharge Date: 10/7/16

Readmission to hospital: 10/20/16

Physician Notes: Cast removed in office yesterday. Copious (large amount) purulent (pus) drainage from wound, with erythema (redness) and warmth.

Readmission Diagnosis: Deep Ankle Infection, Status Post Deep ORIF Right Ankle

Surgical procedure: Deep Irrigation and Debridement, right ankle

10/21/16: Pre-debridement (surgical removal of infected, dead or damaged tissue, https://en.wikipedia.org) wound cultures positive for Staphylococcus Aureus (bacteria)

10/21/16: Post-debridement wound cultures positive for Staphylococcus Aureus

Surgical Procedures - Deep Irrigation and debridement x 3: 10/21/16, 10/23/16 and 10/25/16.

10/25/16: Surgical insertion of Groshong Catheter ( type of intravenous (IV) catheter used for central venous access. Used when long-term intravenous therapy is needed, en.wikipedia.org). Catheter to be used for 6 weeks of IV antibiotic treatment.

11/16/16: Follow up wound culture positive for Pseudomonas Auregonosa
(Right ankle abscess culture)

11/18/16 - Preoperative Diagnosis: Partial wound dehiscence, right ankle with exposed hardware (dehiscence: a surgical complication in which a wound ruptures along a surgical incision, https://en.wikipedia.org).

Surgical Procedure - 11/18/16: Irrigation and debridement, deep and hardware removal.

During an interview with the Infection Prevention Coordinator / EI # 1 on 12/8/16 at 2:00 PM), EI # 1 stated she reviewed PI # 5's case with the orthopedic surgeon. EI # 1 said, "Something is going on. I think he (name of orthopedic surgeon) thinks its the instruments." A problem with the sterilization process.


6). Patient Identifier (PI) # 6:

Admission and Surgery Date: 10/14/16

Surgeon: Employee Identifier (EI) # 2

Preoperative Diagnosis / Surgical Procedure: Right Total Knee Arthroplasty (Replacement)

Readmission to hospital: 11/1/16 (Identified by hospital as a Healthcare Associated Surgical Site Infection)

Readmission Diagnosis: Retinaculim tear right knee post traumatic
(Retinaculim: two fibrous bands of fascia crossing the front of the ankle, www.merriam-webster.com)

Surgical Procedure - 11/1/16: Irrigation and debridement deep and quad (quadriceps) tendon repair right knee

Pre-debridement wound cultures (final report) positive for Staphylococcus Intermedius on 11/4/16.

According to the Infection Prevention Coordinator / EI # 1, the patient's (PI # 6) surgery was initially scheduled for 10/10/16. The surgery was canceled because the surgical instruments were not sterile based on EI # 1's conversation with the Director of Surgical Services. (Interview with EI # 1 on 12/8/16 at 2:15 PM).


7). Patient Identifier (PI) # 7:

Admission and Surgery Date: 10/11/16

Surgical Procedure: Right Total Knee Arthroplasty (TKA, Replacement)

Surgeon: Employee Identifier (EI) # 2

Readmission to hospital: 11/1/16 (Identified by hospital as a Healthcare
Associated Surgical Site Infection (SSI) - infections may also occur at surgery sites...are an important threat to patient safety,www.cdc.gov/HAI/ssi.

History and Physical (H&P) 11/1/16: Persistent drainage since TKA two weeks ago...A recommendation was made for I & D (Irrigation and Debridement) under general anesthesia and cultures to see if there is an infection present....

Surgical Procedure 11/1/16: Right Knee Irrigation and Debridement (removal of all materials that may promote infection and impede healing. May be done with surgical instruments, www.medicinenet.com ).

Surgeon: Employee Identifier (EI) # 2

Wound cultures positive for: Staph epidermis

11/4/16 - 1:52 PM: Physician Progress Note: Consulted MD (Medical Doctor) in name of another city who agrees with plan - 6 weeks IV Vancomycin (antibiotic). No need for deep I & D.

11/4/16: Surgical insertion of Groshong Catheter for IV antibiotics.

During an interview on 12/8/16 at 2:20 PM, the Infection Prevention Coordinator / EI # 1 stated she did not discuss this case with the surgeon (EI # 2).


8). Patient Identifier (PI) # 8:

Admission and Surgery Date: 9/13/16: Right Total Knee Arthroplasty
(Replacement)

Surgeon: Employee Identifier (EI) # 2

Readmission to hospital: 10/21/16

Preoperative Readmission Diagnosis: Persistent Drainage Right Knee Arthroplasty (a surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses), www.uptodate.com).

Surgical Procedure Performed: Irrigation and Debridement Deep Right Knee, Poly Exchange (polyethylene exchange - remove prosthesis)

Postoperative Readmission Diagnosis: Deep Infection right Knee

Wound Cultures: Positive for Staph Intermedius and Staph Epidermis (Staphylococcus bacteria commonly found on the skin or in the nose. Usually, these bacteria cause no problems or result in minor skin infections. But staph infections can turn deadly if the bacteria invade deeper into your body, entering your bloodstream, joints, etc,www.mayoclinic.org/diseases.../staph-infections)

10/23/16: Physician Progress Note documented by EI # 2:
Culture growing staph...
Assessment: Deep prosthetic Infection Right Knee...for Groshong (Central Venous Catheter)...

Surgical Procedure 10/24/16: Insertion of Central Venous Catheter


Readmission to hospital: 11/11/16

Preoperative Readmission Diagnosis: Traumatic Retinaculum tear with Persistent Wound Drainage

Surgical Procedure 11/11/16: Deep Irrigation and Debridement and Retinaculum Repair Right Knee

11/11/16: Surgical Wound Cultures: Positive for Enterobacter Cloacae


C. Documented communication between the Chief of Surgery and hospital staff :

1). Date: 9/24/16 at 9:22 AM: (Between the Chief of Surgery and the Director of Surgical Services and the Central Sterile Manager).

Regarding: Autoclaves (a self-locking apparatus for the sterilization of materials by steam under pressure.medical-dictionary.thefreedictionary.com/autoclave).

"...I have several concerns....

2. What is our (hospital) plan for breaking down the 'heavy' trays into ones less than 17 lbs (pounds)? ...

5. Have we communicated our plan with all the OR (Operating Room) personnel...?


2). Date: 9/28/16 at 3:24 PM: (Between the Chief of Surgery and Medical Staff / Physicians ):

"...I have been told neither autoclave is working...I have no time frame for fixing the current autoclaves..."


3). Date: 9/30/16 at 4:38 PM: (Between the Chief of Surgery and
Hospital Staff, Physicians and Hospital Administration)

Regarding: Autoclaves

"I am told the autoclaves and flasher have been fixed...here as evidence of problem and continued use of OR...Administration is moving forward with the purchase of new autoclaves and flasher..." (flash sterilization is a modification of conventional steam sterilization in which the flashed item is placed in an open tray or is placed in a specially designed rigid container to allow for rapid penetration of steam. Wrapped serialization is preferred. Correctly performed flash sterilization is an effective process for the sterilization of critical medical devices. Historically, flash sterilization is not recommended as a routine sterilization method because of the lack of timely biological indicators to monitor performance, absence of protective packaging following sterilization, possibility for contamination of processed items during transportation to the operating rooms, and the sterilization cycle parameters (i.e., time, temperature, pressure) are minimal,
https://www.cdc.gov/...sterilization).

4). Date: 11/11/16 at 8:00 PM: (Between the Chief of Surgery and hospital surgeons, anesthesiologist and a gastroenterologist).

"...we are still having issues with our autoclaves/sterilization process. We are now getting water stains on the paper that wraps the trays in the autoclaves. The stains were on almost every tray today. This means, technically, the instruments in the tray are not sterile...
You need to be aware that we have no guaranteed way to sterilize instruments at this time..."

D. Policies and Procedures:

1). Flash Sterilization and Use of Flashpacks

No policy number documented

Effective Date: 6/24/2003

"Reviewed: 7/7, 9/10"

"Recommendation: (Name of the Director of Surgical Services)"

Approval: No documentation.

Policy: Flash sterilization should be avoided whenever possible. Flash sterilization may be utilized only in emergency situations when no replacement instruments or implantable items are available.


2). Event Related Shelf Life Sterile Storage

Number: 412.06

Recommendation and Approval: No documentation

Effective Date: 10/1/2012

"Reviewed:" No documentation.

Policy: Sterility of items will be event-related... The integrity of the package will be the determining factor in establishing sterility of the enclosed items.

All items sterilized by Sterile Processing will be considered sterile unless the package/pack/tray/container is damaged or wet. Damage includes:

...Exposure to any type of moisture.


3. Infection Control and Prevention Plan:

"PolicyStat lD": 1981984

Last Revised: 12/7/2015

Next Review: 12/6/2016

Policy and Commitment: ..."The goal of the Infection Prevention Program is to reduce the acquisition and transmission of healthcare associated infections (HAIs)....

A. Program Description:

....Targeted studies shall be conducted on infections that are high-risk...

B. Infection Control and Prevention Program Responsibility:

- Developing a system for identifying, reporting, investigating and controlling infections....

- All hospital employees, in partnership with the Medical Staff are responsible for the safety, health and well being of all patients...

C. Risk Assessment:

- The identified risks for acquiring and transmitting infections are identified and prioritized.

Evaluation and Improvement:

The Infection Control / Safety Committee and Infection Control Coordinator have the responsibility for infection control activities throughout the facility. An active member of the Medical Staff, having knowledge of infection control practices and performance improvement methodologies participates and guides the committee on decisions for improvement of care through the prevention and control of infections.

- When evaluation identifies an area of concern, a specific problem...
the corrective action plan is formulated...and identifies the following:

1. What action is appropriate in view of the cause, scope and severity of the problem?
...3. Who or what is expected to change?...

- If immediate action is necessary, the Infection Control Committee, or its designee...has the authority to institute any...control measure, if there is reason to believe that any patient...is at risk.

E. Review of Surgical Schedule:

A review of the surgical schedule revealed surgeries were performed beginning 9/1/16 through 11/30/16.

F). Interviews:

Interview on 12/6/16 at 1:50 PM with the Infection Prevention Coordinator / EI # 3:

During an interview on 12/6/16 at 1:50 PM the Infection Prevention Coordinator / EI # 3 was asked if the infections were specific to the OR and she said, "Yes." EI # 3 was also asked how possible hospital acquired infections are identified. EI # 3 stated the following sources are used to identify infections: name of automated surveillance system, daily "micro" report (identifies all cultures), Continuing Care Team (meets daily Monday - Friday) and reports all positive cultures for all patients in the hospital and Case Managers / Physicians notify EI # 3 of hospital readmissions.

EI # 3 was asked if she was aware of any problems in the OR in the past several months. EI # 3 said yes. "The problem started in September.
We did not identify patients until October (2016)." According to EI # 3 if an infection is identified, "I research."


Interview on 12/7/16 at 11:30 AM with Orthopedic Surgeon / Chief of Surgery / EI # 2:

During an interview on 12/7/16 at 11:30 AM the Orthopedic Surgeon / Chief of Surgery / EI # 2 confirmed he was aware of the problem in the OR (Operating Room). The state surveyor asked EI # 2 if any of his surgical cases were canceled because of the problem. EI # 2 said, "Yes, because we weren't able to sterilize our equipment." EI # 2 said the problem was "wet packs." The surgeon stated the "quick" sterilizer ("Quick" refers to Flash sterilizer also known as Immediate Use Steam Sterilization) was "used for 1- 2 instruments, but you are not going to flash an entire set of instruments for the holding area."

According to EI # 2 some of the patients (canceled surgeries) were in the holding area of the OR, but none of these surgical patients were given medications or anesthesia. The surgeon identified one patient who developed a postoperative infection. ( See medical record review for Patient Identifier / PI # 5).

EI # 2 was asked about his role as Chief of Surgery in relation to the problem with sterilization of surgical instruments. EI # 2 said, "I alerted them (surgeons /medical staff ) to potential staining. Not really staining. Scalding." EI # 2 identified staining as, "Brown spots on paper (paper used in bottom of specialized metal containers during sterilization process). Some felt it was an indication of wet packs; Not sterilized." The surveyor asked EI # 2 to verify his previous statement was correct and he replied, "Correct."

EI # 2 stated, " I am basically the liason between the surgeons and Administration." I advised the physicians, "We have issues; shouldn't book cases..We developed a secondary plan for other sterile processes like C -Sections...(cesareans sections - a surgical procedure used to deliver a baby through incisions in the mother's abdomen,www.mayoclinic.org/tests-procedures/c-section...)."

Interview on 12/7/16 at 12:30 PM with General Surgeon / EI # 7:

During an interview on 12/7/16 at 12:30 PM , General Surgeon / EI # 7, was asked if he was aware of any problems with autoclaves/sterilization of packs/surgical instruments in the OR. EI # 7 stated, "Flashing everything" results in a "twenty minute delay..." EI # 7 was asked if he canceled any cases since the problem was identified in September. He replied, "I've moved some cases." EI # 7 was asked if "moving" cases was done as a result of questionable sterility of surgical instruments. EI # 7 said, "No." It was because using flash sterilization takes longer, results in a delay and makes his day longer then usual. EI # 7 stated he has had no postoperative infections/hospital readmissions in 3.5 years.


Interview on 12/8/16 at 3:00 PM with Director of Surgical Services / EI # 3:

During an interview on 12/8/16 at 3:00 PM, the Director of Surgical Services / EI # 3, confirmed the OR was not closed when the problems with autoclaves/sterilization were identified in September 2016.


Interview on 12/8/16 at 3:10 PM with the Director of Surgical Services / EI # 3:
During an interview on 12/8/16 at 3:10 PM the Director of Surgical Services / EI # 3 was asked if Central Sterile staff place papers to wick moisture in containers used for sterilization of surgical instruments. EI # 3 stated papers are not needed if containers are dry. EI # 3 was asked if Central Sterile staff place papers in packs that are wrapped in blue covers prior to the sterilization process in the autoclaves. EI # 3 said, "Yes." The papers help prevent holes in the blue covers and wick moisture. Water is not acceptable in the packets because moisture inside can possibly wick contaminants from the outside.

EI # 3 said "water spots" are okay, but he looks at obvious stains and returns packs for sterilization. According to EI # 3, a small amount of water (Less than one tablespoon) is acceptable in vacuum sealed containers after the sterilization process.


Interview on 12/8/16 at 8:40 AM with the Infection Prevention Coordinator/ EI # 1:

During an interview on 12/8/16 at 8:40 AM, the Infection Prevention Coordinator/ EI # 1 stated when the hospital identifies a HealthCare Associated Surgical Site Infection, she conducts a case study and reviews the case with the physician.

Written response from the Director of Surgical Services / EI # 3 to questions from Quality Assurance Committee (received 12/13/16 at 4;30 PM):

Question (Q): Does staff document indicator results in the medical record or on the time out sheet?

Answer: (A): No.

Q: How did hospital ensure the sterility of packs and containers (containing surgical instruments) in September, October and November of 2016?

A: "We looked at all the parameters of sterilization: Pressure, Temperature and Time. These provide a means to ensure that appropriate parameters are met during a steam sterilization cycle. The sterilizer gives...a printout of these parameters...We never had a failure with the parameters being met per the printouts.

We run tests daily on each autoclave and "flash" sterilizer.

Bowie Dick (DART)...test..on the sterilizer, removing all the air...the DART test is in a challenge pack...with a test strip in the middle..strip should turn uniformly black. We never had a DART test to fail."

"Biological Test: ...the biological is in a challenge pack for the autoclaves and ran with the first load (container/packs of surgical instruments)..."

"Flash" sterilizers have a biological test run with an empty load without a challenge pack. After these biological tests have run through a sterilization cycle, they are placed in an incubator (device used to grow and maintain microbiological cultures...maintains optimal temperature, humidity and other conditions such as carbon dioxide and oxygen content of the atmosphere inside, wikipedia.org) with a control from the same lot number.
After three hours the control should show no growth. We never had a positive growth on a biological test."

"We also place chemical integrators (visual aids that show if an item has been subjected to the sterilization process, www.rdhmag.com) in the pack that give staff visual assurance the parameters are met. These integrators
change colors and we did not have any that did not pass."

Q: When concerns with sterility were noted, why did the hospital continue to perform elective surgeries?

A: "We used alternative methods of sterilization to process instruments that could be run in our plasma sterilizer (V-Pro). The V-Pro is able to sterilize instruments using low temperature sterilization, but it has limitation on volume and instruments with lumens. We also used our flash sterilizer because we were not having issues with it."

Q: Once a readmission (patient) related to a surgical site infection was identified, why was surgery not shut down?

A: "When the first SSI (Surgical Site Infection) was readmitted, it was during the first issues we had with out sterilizers at the end of September. Repairs had been made to our autoclaves...no wet packs...We (Hospital) did not see this problem reappear until around November 11, 2016."


Interview with Infection Prevention Coordinator/ EI # 1 on 12/15/16 at 9:43 AM:

According to EI # 1, the Hospital's Infection Control Dashboard report includes Nosocomial Infections Markers (NIMS). NIMS are possible healthcare acquired infections related to current hospitalization, previous hospital admission, or follow up after admission.

The following monthly reports reveal the number of NIMS that were determined to be healthcare acquired infections by EI # 1 and staff:

May 2016: Six respiratory related NIMS
Seven urine related NIMS
Three "other" NIMS: positive eye culture, positive throat
culture.

According to EI # 1 there were no Surgical NIMS/ Healthcare Associated Surgical Infections in May.

June 2016: One Surgical Site Infection / Healthcare Associated Infection

According to EI # 1 there was no trend identified.

July 2016: One Surgic