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I. Based on observation, document review, and staff interviews, the acute care hospital's administrative staff failed to:

1. Ensure surgical services staff followed the manufacturer's recommendations to scrub surgical instruments prior to using an automated washer/disinfector to cleanse the instruments. Please refer to A-0749.

2. Ensure all surgical services staff completely covered their hair during surgical procedures. Please refer to A-0749.

3. Ensure all of the surgical services staff did not wear personal clothing items during surgical procedures or launder any personal clothing items in a hospital accredited laundry facility. Please refer to A-0749.

4. Ensure the surgical services staff tested the CidexOPA prior to each use in the endoscopy department. Please refer to A-0749.

The cumulative effect of these failures and deficient practices resulted in the hospital's inability to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. The hospital staff performed 993 surgical procedures in February 2018.


II. During the investigation of complaint 74655-C, the on-site survey team identified an Immediate Jeopardy (IJ) situation (a crisis situation that placed the health and safety of patients at risk) related to the Condition of Participation for Infection Control (42 CFR 482. 42). The hospital staff failed to ensure the surgical services staff adequately cleansed the surgical instruments prior to placing the instruments in the washer/disinfector.

While on-site, the survey team identified an Immediate Jeopardy (IJ) situation and notified the administrative staff on 3/27/18. The administrative staff promptly took action to remove the immediacy of the situation. The hospital staff removed the immediacy prior to the survey team exiting the complaint investigation when the administrative staff took the following actions:

a. the hospital staff re-educated the central sterile processing staff members regarding the need to manually clean/brush all instruments prior to packaging and sterilizing.

b. the hospital staff began reprocessing all of the surgical instruments in their inventory, initially focusing on the instruments needed for the next day's surgical procedures.

c. the hospital staff notified the surgeon leadership about the issues and changes in process.

d. the hospital staff educated the surgical services staff to check the sterilization date on all instrument packs, and not use any instruments sterilized prior to 3:00 PM on 3/27/18.

e. the hospital staff placed a red "X" on the tags of all instrument packs sterilized prior to 3:00 PM on 3/27/18 to prevent human error and staff accidentally using the instrument pack.

I. Based on document review, staff interviews, and observations, the hospital's surgical staff failed to ensure 2 of 2 observed staff members (Central Sterile Processing Technician A and the Sterile Processing Manager) cleaning dirty surgical instruments used brushes to clean the surgical instruments to remove any debris, as required by the instrument manufacturers instructions. Failure to clean the surgical instruments with brushes could potentially result in the surgical staff failing to remove all of the blood and other biological material from used surgical instrument prior to placing the instruments in an autoclave, preventing the autoclave from fully sterilizing the instruments, and potentially allowing bacteria or viruses to survive, potentially causing a life-threatening infection for the next patient. The hospital staff performed 993 surgical procedures during the month of February 2018.

Findings included:

1. During an interview on 3/21/18 at 2:35 PM, the Sterile Processing Manager stated the central sterile processing staff follow the manufacturer's instructions for use to direct how the staff cleanse the surgical instruments following a surgical procedure. The Sterile Processing Manager also stated the central sterile processing staff followed the AAMI (Association for the Advancement of Medical Instrumentation) and AORN (Association of peri-Operative Registered Nurses) standards for processing surgical instruments.

2. Review of the AAMI ST79:2017 standard, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, copyright 2017, revealed in part, "The device manufacturer's current written [instructions for use] should be ... followed." "The device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized ... The device labeling describes specific methods of cleaning and sterilization have been validated by the manufacturer.... If the device manufacturer specifies a specific brush or cleaning implement, the brush or an equivalent should be used...."

3. Review of the AORN Guidelines for Perioperative Practice, copyright 2018, revealed in part, "Brushes or devices of the correct size used in accordance with the brush or device manufacturer's [instructions for use] can facilitate cleaning of [channels in the devices]."

4. Observations on 3/21/18 at 11:05 AM revealed Patient #1 underwent a surgical procedure to remove their thyroid. The surgical procedure included the use of approximately 30 surgical instruments, including hemostats (a surgical clamp with serrated tips). The surgeon contaminated the hemostats with Patient #1's blood and tissue during the surgical procedure. Following the surgical procedure, the surgical staff took the contaminated surgical instruments to the decontamination area for cleaning in a cart.

Observations in the surgical decontamination area on 3/21/18 at 1:30 PM revealed Central Sterile Processing Technician (CSPT) A removed the contaminated surgical instruments used on Patient #1 from the cart. CSPT A took the contaminated instruments, opened the clamps and scissors, sprayed the instruments with water, and soaked the instruments in a cleaning solution. After soaking the instruments in a cleaning solution, CSPT A removed the instruments from the cleaning solution and sprayed the instruments with water. CSPT A then placed the instruments in a basket for an automated instrument washer (similar to a commercial dishwasher). CSPT A did not use a brush to scrub the serrated jaws of the hemostats, potentially leaving biological material from Patient #1's body in the serrations of the instruments' jaws.

5. Additional observations on 3/21/18 in the surgical decontamination area revealed:

a. At 2:07 PM, CSPT A removed several pairs of surgical scissors from the contaminated instrument carts from the operating rooms. CSPT A opened the jaws of the scissors, placed them in a basket, sprayed them off with water, and soaked them in a cleaning solution. CSPT A removed the scissors from the cleaning solution and sprayed them with water. CSPT A then placed the instruments in a basket for an automated instrument washer. CSPT A did not use a brush to scrub the jaws of the scissors, potentially leaving biological material in the jaws of the scissors.

b. At 2:22 PM, CSPT removed several surgical instruments from the contaminated instrument carts from the operating rooms. CSPT A opened the jaws of the instruments, placed them in a basket, sprayed them off with water, and soaked them in a cleaning solution. CSPT A removed the instruments from the cleaning solution and sprayed them with water. CSPT A then placed the instruments in a basket for an automated instrument washer. CSPT A did not use a brush to scrub the jaws of the instruments, potentially leaving biological material in the jaws of the instruments.

c. At 2:35 PM, the Sterile Processing Manager removed several surgical instruments from the contaminated instrument carts from the operating rooms. The Sterile Processing Manager opened the jaws of the instruments, placed them in a basket, sprayed them off with water, and soaked them in a cleaning solution. The Sterile Processing Manager removed the instruments from the cleaning solution and sprayed them with water. The Sterile Processing Manager then placed the instruments in a basket for an automated instrument washer. The Sterile Processing Manager did not use a brush to scrub the jaws of the instruments, potentially leaving biological material in the jaws of the instruments.

6. During an interview on 3/26/18 at 2:30 PM, the Executive Director of Surgical Services and Orthopedics stated that AESCULAP/B. Braun manufactured the instruments observed on 3/21/18.

7. Review of the AESCULAP/B. Braun document "care and handling of surgical instruments," revised 9/2015, revealed in part, "use appropriate-sized, soft nylon brushes to clean the instruments and their parts."

8. Further observations on 3/21/18 in the surgical decontamination area revealed:

a. At 2:26 PM, CSPT A removed a Stryker Heavy Duty Battery Powered surgical drill from the contaminated instrument carts from the operating rooms. CSPT A disassembled the Stryker surgical drill and used scrubbing to cleanse the exterior of the surgical drill. CSPT A retracted a retaining ring on the Stryker surgical drill and exposed several channels in the drill. CSPT A did not use a brush or other means to cleanse any potential contamination or pieces of the patient's body left in the channels.

b. At 2:35 PM, the Sterile Processing Manager removed a Stryker Heavy Duty Battery Powered surgical drill from the contaminated instrument carts from the operating rooms. The Sterile Processing Manager disassembled the Stryker surgical drill and used scrubbing to cleanse the exterior of the surgical drill. The Sterile Processing Manager retracted a retaining ring on the Stryker surgical drill and exposed several channels in the drill. The Sterile Processing Manager did not use a brush or other means to cleanse any potential contamination or pieces of the patient's body left in the channels.

c. At 2:42 PM, the Sterile Processing Manager removed a repaired Stryker Heavy Duty Battery Powered surgical drill from equipment the hospital received from the manufacturer. The Sterile Processing Manager disassembled the Stryker surgical drill and used scrubbing to cleanse the exterior of the surgical drill. The Sterile Processing Manager retracted a retaining ring on the Stryker surgical drill and exposed several channels in the drill. The Sterile Processing Manager did not use a brush or other means to cleanse any potential contamination, mechanical oils, or small metal shavings from the repair process.

d. At 2:50 PM, the Sterile Processing Manager removed four new sets Stryker Heavy Duty Battery Powered surgical drills from equipment the hospital received from the manufacturer. The Sterile Processing Manager disassembled the Stryker surgical drills and used scrubbing to cleanse the exterior of the surgical drills. The Sterile Processing Manager retracted a retaining ring on the Stryker surgical drills and exposed several channels in the drills. The Sterile Processing Manager did not use a brush or other means to cleanse any potential contamination, mechanical oils, or small metal shavings from the manufacturing process.

9. During an interview on 3/21/18 at 2:50 PM during the observations, the Sterile Processing Manager stated the new and repaired equipment should receive the same decontamination processing steps as a surgical instrument used in a surgical procedure on a patient.

10. Review of the Stryker Battery Powered and Electric Heavy Duty Systems Care Instructions, effective, 4/21/17, revealed in part, "Manual removal of all gross soil is required." "Use suitable brushes ... to clean all surfaces." "Actuate all moving parts to clean hidden surfaces."

11. Review of the Steris Technical Data Monograph for the Reliance Vision Single Chamber Washer/Disinfector, copyright 2012, revealed the manual lacked instructions allowing the user to chose not to manually scrub surgical instruments to remove biological material prior to inserting the surgical instruments in the Washer/Disinfector, even if the instrument manufacturer's instructions required the hospital staff to manually scrub the surgical instruments.

11. During an interview on 3/26/18 at 2:30 PM, the Sterile Processing Manager and the Executive Director for Surgical Services and Orthopedics reviewed the manufacturers' instructions for cleaning the AESCULAP/B. Braun and Stryker Battery Powered and Electric Heavy Duty Systems Care Instructions. The Executive Director for Surgical Services and Orthopedics stated they taught the sterile processing staff to scrub the instruments with a brush, but acknowledged the observations of CSPT A and the Sterile Processing Manager failing to scrub the instruments with a brush. The Executive Director for Surgical Services acknowledged the manufacturers of the instruments required the surgical staff to cleanse the instruments, including the recessed channels, with a brush to remove any potential blood or body tissue from the instrument. The Executive Director for Surgical Services and Orthopedics stated, "no manufacturer is going to tell you that you don't need to scrub the instruments."


II. Based on observation, document review, and staff interview, the hospital staff failed to ensure 7 of 7 observed staff members (Anesthesiologist B, Surgeon C, Resident D, Medical Student E, Scrub Nurse F, Anesthesiologist G, and Surgeon H) wearing skull caps completely covered their hair. Failure to cover all of a staff member's hair could potentially result in bacteria on the staff member's hair entering the environment and potentially resulting in the patient developing a life-threatening surgical site infection. The hospital staff performed 993 surgical procedures during the month of February 2018.

Findings included:

1. During an interview on 3/26/18 at 2:30 PM, the Executive Director for Surgical Services and Orthopedics stated the hospital followed the AORN (Association of peri-Operative Registered Nurses) guidelines.

2. Review of the AORN Guideline Essentials Surgical Attire Quick View, copyright 2017, revealed in part, "Head Covering ... Completely cover your hair, scalp, sideburns, and the nape of your neck with a hood or head covering.... Uncovered hair and skin can harbor bacteria that can be dispersed into the environment."

3. Review of the Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017, published 5/3/17, revealed in part, "Wear a new, disposable, or hospital laundered head covering for each case, when entering the operating room. Ensure it fully covers all hair on the head and all facial hair not covered by the surgical mask."

3. Observations during Patient #1's surgical procedure on 3/21/18 revealed the following:

a. At 10:55 AM, Anesthesiologist B (a physician with specialized training in administering medication to render a patient unconscious for surgery) entered the operating room. Anesthesiologist B wore a skull cap. The skull cap consisted of a cap covering Anesthesiologist B's forehead and central part of Anesthesiologist B's hair. The skull cap did not cover the lower approximately one inch of Anesthesiologist B's hair on the side of Anesthesiologist B's head and the back of Anesthesiologist B's hair.

b. At 11:15 AM, Surgeon C entered the operating room. Surgeon C wore a skull cap. The skull cap consisted of a cap covering Surgeon C's forehead and central part of Surgeon C's hair. The skull cap did not cover the lower approximately one inch of Surgeon C's hair on the side of Surgeon C's head and the back of Surgeon C's hair.

c. At 11:15 AM, Resident D entered the operating room. Resident D wore a skull cap. The skull cap consisted of a cap covering Resident D's forehead and central part of Resident D's hair. The skull cap did not cover the lower approximately one inch of Resident D's hair on the side of Resident D's head and the back of Resident D's hair.

d. At 11:15 AM, Medical Student E entered the operating room. Medical Student E wore a skull cap. The skull cap consisted of a cap covering Medical Student E's forehead and central part of Medical Student E's hair. The skull cap did not cover the lower approximately one inch of Medical Student E's hair on the side of Medical Student E's head and the back of Medical Student E's hair.

e. At 10:55 AM, Scrub Nurse F entered the operating room. Scrub Nurse F wore a skull cap. The skull cap consisted of a cap covering Scrub Nurse F's forehead and central part of Scrub Nurse F's hair. The skull cap did not cover the lower approximately one inch of Scrub Nurse F's hair on the side of Scrub Nurse F's head and the back of Scrub Nurse F's hair.

4. Observations during Patient #2's surgical procedure on 3/22/18 revealed the following:

a. At 9:12 AM, Anesthesiologist G entered the operating room. Anesthesiologist G wore a skull cap. The skull cap consisted of a cap covering Anesthesiologist G's forehead and central part of Anesthesiologist G's hair. The skull cap did not cover the lower approximately one inch of Anesthesiologist G's hair on the side of Anesthesiologist G's head and the back of Anesthesiologist G's hair.

b. At 9:27 AM, Surgeon H entered the operating room. Surgeon H wore a skull cap. The skull cap consisted of a cap covering Surgeon H's forehead and central part of Surgeon H's hair. The skull cap did not cover the lower approximately one inch of Surgeon H's hair on the side of Surgeon H's head and the back of Surgeon H's hair.

5. During an interview on 3/26/18 at 2:30 PM, the Executive Director for Surgical Services and Orthopedics acknowledged the staff members wore skull caps, that skull caps did not fully cover the staff members' hair, and the AORN standards required the staff members to fully cover their hair.


III. Based on observation, document review, and staff interviews, the hospital staff failed to ensure 2 of 2 observed staff members (Scrub Nurse I and Registered Nurse J) wore personal clothing items laundered in the hospital's laundry facility. Failure to launder personal clothing items in the hospital's laundry facility could potentially result in the clothing item becoming soiled with infectious material from a patient and if the staff launder the clothing item at home, potentially failing to remove or disinfect the infectious material on the clothing item, potentially transmitting the infectious material to another patient, who could develop a life threatening infection. The hospital staff performed 993 surgical procedures during the month of February 2018.

Findings included:

1. Observations during Patient #2's surgical procedure on 3/22/18 revealed the following:

a. Scrub Nurse I entered the operating room at approximately 09:00 AM. Scrub Nurse I wore a cloth bouffant style hair covering.

b. Registered Nurse (RN) J entered the operating room at approximately 9:00 AM. RN J wore a cloth bouffant style hair covering.

2. During an interview at the time of the observations, Scrub Nurse I stated they owned the cloth bouffant style hair covering. Scrub Nurse I wore the cloth bouffant style hair covering once, and took the cloth bouffant style hair covering home to wash it after wearing it once. The hospital staff did not provide a method for Scrub Nurse I to launder the cloth bouffant style hair covering in the hospital's laundry facility.

3. During an interview at the time of the observations, RN J stated they owned the cloth bouffant style hair covering. RN J wore the cloth bouffant style hair covering once, and took the cloth bouffant style hair covering home to wash it after wearing it once. The hospital staff did not provide a method for RN J to launder the cloth bouffant style hair covering in the hospital's laundry facility.

4. Review of the AORN Guideline Essentials Surgical Attire Quick View, copyright 2017, revealed in part, "If you wear personal clothing ... make sure it is covered completely by the scrub attire or has been laundered in a health care accredited facility." "Do not home launder your surgical attire."

5. Review of the policy "Surgical Attire," revised 3/2016, revealed the policy failed to address staff members wearing their own surgical attire, including hair coverings, and failed to address hospital laundering of the staff members' personal surgical attire.

6. During an interview on 3/26/18 at 2:30 PM, the Executive Director for Surgical Services and Orthopedics acknowledged the hospital allowed staff members to wear their own reusable cloth hair coverings. The staff members could only wear the reusable cloth hair covering once, and had to launder the reusable cloth hair covering in the staff members' personal laundry. The hospital did not provide access to a health care accredited laundry facility.


IV. Based on observation, document review, and staff interviews, the hospital staff failed to ensure the endoscopy staff tested 1 of 1 container of CidexOPA solution in the endoscopy area prior to each use. Failure to test the CidexOPA solution prior to each use could potentially result in the CidexOPA failing to possess the minimum effective concentration (MEC) of the active ingredient and failing to possess sufficient potency to effectively kill all the bacteria, fungi, and viruses potentially contaminating the endoscope. The hospital staff disinfected an average of 43 items per week using the CidexOPA in the endoscopy area.

Findings included:

1. Observations during a tour of the endoscopy unit on 3/22/18 revealed a large bucket of CidexOPA located in the reprocessing room of the endoscopy unit.

2. Review of the CidexOPA directions for use, not dated, revealed in part, "Use CidexOPA solution test strips ... before each use to detect the MEC."

3. Review of the document "Minimum Effective Concentration Log for Cidex Tank" for 1/2018, 2/2018, and 3/2018 revealed the staff only documented checking the MEC once per day.

4. During an interview at the time of the tour, Endoscope Technician K stated they only tested the CidexOPA for the MEC once per day, before the first time they used the CidexOPA for the day.

5. During an interview at the time of the tour, the Endoscopy Manager acknowledged the manufacturer's directions required the endoscopy staff to test the CidexOPA prior to each use.

Based on observation, document review, and staff interviews, the hospital staff failed to remove Chloraprep saturated linens under the patient prior to placing draping material over the patient during a surgical procedure using electrocautery. Failure to remove Chloraprep saturated linens under the patient could potentially result in the alcohol in the Chloraprep solution evaporating and creating flammable fumes, potentially igniting and causing a surgical fire when the surgeon used an electrocautery device. The hospital staff performed 993 surgical procedures during February 2018.

Findings included:

1. Observations during Patient #1's surgical procedure on 3/21/18 at 11:19 AM revealed a surgical staff member positioned Patient #1's head so that Patient #1's neck was hyperextended. The surgical staff member used Chloraprep (a solution of chlorhexidine gluconate and isopropyl alcohol, both disinfectants used to kill bacteria and viruses, tinted orange and also extremely flammable) to kill bacteria and viruses on Patient #1's skin prior to the surgical procedure. The surgical staff member applied the Chloraprep solution to Patient #1's neck. The Chloraprep solution ran down Patient #1's neck and onto the sheets under Patient #1's neck and shoulders. The surgical staff waited the manufacturer recommended 3 minutes for the Chloraprep to dry on Patient #1's skin and then placed sheeting material over Patient #1's body to prepare for Patient #1's surgery.

The surgical staff members did not place sterile gauze or another material under Patient #1's neck and shoulders prior to using the Chloraprep solution. The surgical services staff did not change the linens under Patient #1 prior to starting the surgical procedure. The surgical procedure involved Surgeon C using electrocautery (a device that stops blood vessels from bleeding by using electricity the blood vessel to heat up very hot) multiple times during the surgical procedure.

Observations following Patient #1's surgical procedure on 3/21/18 at approximately 13:15, after the surgical staff finished the surgical procedure, revealed an orange stain on the sheets underneath Patient #1's neck, indicating the Chloraprep solution dripped down Patient #1's neck and pooled into the sheets under Patient #1.

2. Observations during Patient #2's surgical procedure on 3/22/18 at 9/25 AM revealed Surgical Nurse J raised Patient #2's left foot off the surgical bed and began applying Chloraprep to Patient #2's left foot. The Chloraprep solution began dripping down Patient #2's left foot and onto the sheets underneath Patient #2's foot. The Chloraprep solution saturated the sheets under Patient #2's foot, creating an approximately 4 inch diameter pool of Chloraprep that soaked completely through the sheets and down to the surgical bed underneath. The surgical staff waited the manufacturer recommended 3 minutes for the Chloraprep to dry on Patient #2's skin and then placed sheeting material over Patient #2's body to prepare for Patient #2's surgery.

The surgical staff did not place towels or additional surgical linens under Patient #2's foot prior to applying the Chloraprep solution. The surgical staff did not change the linens under Patient #2's foot prior to beginning the process of placing surgical sheeting material over Patient #2's foot, and trapped the liquid Chloraprep solution under the surgical sheeting during the surgical procedure. Surgeon H used electrocautery multiple times during the surgical procedure.

Observations following Patient #2's surgical procedure on 3/22/18 at 10:25 AM revealed the sheet under Patient #2's left foot contained an approximately 4 inch diameter orange spot, in the same location the Chloraprep dripped onto the sheet prior to the surgical procedure.

3. Review of the policy, "Preoperative Skin Antisepsis," revised 8/2017, revealed in part, "Consult manufacturer's recommendations for each individual type of prep solution used."

4. Review of the manufacturer's directions for Chloraprep solution, issued 10/2006, revealed in part, "Flammable. Keep away from fire or flame. To reduce risk of fire: ... do not drape or use ignition source (e.g. cautery ...) until solution is completely dry ... do not allow solution to pool ... remove wet material from prep area." "Whenever prepping the neck area, place towels under each side to absorb excess solution.... Remove any wet materials, drapes, and gowns before draping." "While waiting for Chloraprep to dry: Do not drape. Check for pooled preparation. Use sterile gauze to absorb pooled solution. Do not blot. Allow solution to dry. Remove all wet materials." "When Chloraprep solution is dry: Begin draping only after solution is dry and all solution-soaked materials are removed."

5. During an interview on 3/26/18 at 2:30 PM, the Executive Director for Surgical Services and Orthopedics acknowledged the findings.