HospitalInspections.org

Based on observation, interview and record review, the Governing Body failed to:


A. ensure patient received care in a safe and sanitary environment in 10 of 10 areas.
(Sterile Processing clean area, Clean Equipment room, Operating Room 1, Operating room 3, operating room 4, Crash cart, Difficult Intubation cart, Sterile processing instrument storage, Sterile processing supply storage (Wraps), Sterile processing autoclave room). The facility failed to:

Ensure that Surgical Instrument sets that contained implants (Screws and plates) were not released from the Sterile Processing department prior to the biological test resulting. There was no way to determine conditions were met to kill a specified amount of microorganisms for a sterilization process prior to releasing the implants to the operating room for surgery.

Ensure that a single use item was not re-sterilized. The facility was not following manufacturer instructions on the single use item. The facility was re-sterilizing Medtronic Endo-scrub sheaths used during nasal/sinus surgeries.

Ensure the facility was free from expired implants. There were two Ligaclip appliers used in general surgeries that were expired. One Ligaclip expired 4/2018, 7 months ago and one expired 7/2018, 4 months ago. Two uterine stents used in gynelogical surgeries were expired. One expired in 9/2018, 2 months ago. One expired 11/18/2018, 3 weeks ago.

Ensure that emergency supplies on the crash cart/difficult airway cart were not expired. An AED (Automatic Emergency Defibrillator) pad was observed stored on the crash cart that had expired 11/30/2018, 5 days ago. Naso/Oral endotracheal tubes x 11 observed on the difficult airway cart were expired. The expiration dates ranged from 11-2017 to 3-2018, a year ago.
Two Laryngo-Tracheal Atomization Device on the difficult airway cart were expired. Both packages expired 10-2017, 2 months ago.

Ensure facility followed manufacturer recommendations for shelf life on sterilized instruments. Surgical instruments were stored in central supply instrument room past the date of guaranteed sterilization date by manufacturer (4 months past date of sterilization guarantee)

Ensure that any surgical case, specifically implant cases, that required a return to surgery for complication or infection were identified and investigated.

Ensure that indwelling Foley catheter placements were done with aseptic technique and in accordance with accepted standards of practice.

Ensure there were no cardboard boxes in the OR's. There were corrugated cardboard boxes in the clean equipment room that stored Kidney Balloons (Sterile Supply) with other sterile supplies. Also, there were external shipping cardboard boxes stored next to protective cover sheets used in sterilization of surgical instruments and instrument tray wraps used to sterilize surgical instrument trays.

Ensure the facility was free from dirt and dust. The clean equipment room had multiple bins that stored surgical supplies coated in dust, dirt, and debris.

Ensure anesthesia laryngoscope blades stored on crash cart and difficult intubation cart were sanitized and stored according to the manufacturer instructions. Laryngoscope blades were sterilized in surgical peel packs and left undated. There was no way to tell how long the blades had been stored in the packs.

Ensure all expired supplies were removed from the clean equipment room.

Ensure autoclaves were clean and sanitary. Two autoclaves in the sterile processing room were covered with a brown/rust colored substance on all of the inside walls of the autoclave.

Ensure all walls in the operating room were free from chips and scrapes. The walls had multiple missing chips and scrapes that exposed sheetrock in OR #3.

Ensure the OR was free from rust and chips on the operating room table and wheel casters. The wheel casters in operating room #3 had chips missing in the protective coating and rust on the wheel casters.

Ensure the Sterile Processing clean room had splash guards for equipment stored in wire baskets. Sterile instruments/supplies were stored in a wire basket shelf with no splash guard exposing items to contamination from splashing when floor was mopped/cleaned.

Ensure the surgical staff wore protective attire in the surgical procedure to prevent contamination of the procedure from outside sources. The staff were observed in Operating room #1 during a surgical procedure not wearing shoe covers.

Ensure all medications and chemicals were dated with a beyond use date after opening:

Refer to tag A0144 and A0749 for additional information.




B. ensure they maintained an effective and ongoing quality assessment and performance improvement program. The facility failed to ensure they measured and analyzed adverse surgical events and implemented preventative actions in 9 of 24 sampled patients (Patient #'s 8, 9, 10, 12, 13, 14, 22, 23, and 24).

The facility failed to ensure an adverse event involving unsanitary practices being used to dry a surgical incision were addressed and corrective actions implemented.

The facility failed to ensure adverse events involving complications involving surgical removal and insertion of breast implants were addressed and preventative actions implemented. There were report of patients breast implants falling out and surgical incisions opening up. There were reports of surgical procedures being performed which were not listed on the practitioner's surgical privilege list.


The facility failed to ensure there was documentation that the quality program shared information about surgical returns with infection control for tracking and trending for potential infections. The facility failed to ensure that any surgical case, specifically implant cases, that required a return to surgery for complication or infection were identified and investigated.


Refer to tag A0286 for additional information.


C.ensure surgical privileges were delineated according to competencies for the types of surgical procedures that were being performed in 1 of 2 surgery departments (off-site campus).

The facility failed to ensure surgeons provided surgical services that they had privileges to perform. The surgeon performed surgical procedures which were not listed on his approved privileges form on 2 of 24 sampled patients (Patient #'s 12 and 14).

Patient #14 had a mastectomy 4 years ago and breast implants placed in 1 year ago from an outside surgeon. Staff #16 (facility' s surgeon) removed a breast implant on 09/04/2018. Attempted to place a larger breast implant in Patient #14 and changed his mind. The implant was removed and Patient #14's incision was closed. The procedures performed were not listed on the surgeon's approved privilege list. A request was made by surgery staff to administrative staff to check the surgeon's privileges and this was not done.

Patient #12 was 4 months post-operative for a mastectomy with insertion of breast implants and removal 1 month after that from another surgeon.

Patient #12 received breast implants during a surgery on 09/24/2018 by Staff #16 (facility' s surgeon).

Patient #12 returned on 11/12/2018 for surgery. Patient #12 had returned because one of her breast implants had fallen out in the shower and the other was bulging out through an opened incision. During the surgery on 11/12/2018, Patient #12 received removal of the old implants and new implants were placed in. The first assist was allowed to completely suture up one of the breast incision and this was not listed as a task she had privileges to perform.
The procedures performed were not listed on the surgeon's approved privilege list.



Ensure surgical assistants were not performing procedures which were not listed on their privileges. The surgical assistants were administering anesthetic injections and performing nerve blocks. This deficient practice was found in 4 of 24 sampled patients (Patient #'s 2, 3, 10 and 14).


Ensure ultrasound techs working in the surgery area had training and competencies related to the surgery area. The ultrasound tech received a needle stick during a surgical procedure. The surgeon used the same contaminated needle during a surgical procedure on Patient #11. The facility failed to put a system in place to prevent this from occurring again.




Refer to tag A0945 for additional information.

Based on observation, interview and record review the facility failed to ensure patients received care in a safe and sanitary environment in 10 of 10 areas. (Sterile Processing clean area, Clean Equipment room, Operating Room 1, Operating room 3, operating room 4, Crash cart, Difficult Intubation cart, Sterile processing instrument storage, Sterile processing supply storage (Wraps), Sterile processing autoclave room)


The facility failed to:

A. Ensure that Surgical Instrument sets that contained implants (Screws and plates) were not released from the Sterile Processing department prior to the biological test resulting. There was no way to determine conditions were met to kill a specified amount of microorganisms for a sterilization process prior to releasing the implants to the operating room for surgery.

B. Ensure that a single use item was not re-sterilized. The facility was not following manufacturer instructions on the single use item. The facility was re-sterilizing
Medtronic Endo-scrub sheaths used during nasal/sinus surgeries.

C. Ensure the facility was free from expired implants. There were two Ligaclip appliers used in general surgeries that were expired. One Ligaclip expired 4/2018, 7 months ago and one expired 7/2018, 4 months ago. Two uterine stents used in gynelogical surgeries were expired. One expired in 9/2018, 2 months ago. One expired 11/18/2018, 3 weeks ago.

D. Ensure that emergency supplies on the crash cart/difficult airway cart were not expired. An AED (Automatic Emergency Defibrillator) pad was observed stored on the crash cart that had expired 11/30/2018, 5 days ago. Naso/Oral endotracheal tubes x 11 observed on the difficult airway cart were expired. The expiration dates ranged from 11-2017 to 3-2018, a year ago.
Two Laryngo-Tracheal Atomization Device on the difficult airway cart were expired. Both packages expired 10-2017, 2 months ago.

E. Ensure facility followed manufacturer recommendations for shelf life on sterilized instruments. Surgical instruments were stored in central supply instrument room past the date of guaranteed sterilization date by manufacturer (4 months past date of sterilization guarantee)

F. Ensure that any surgical case, specifically implant cases, that required a return to surgery for complication or infection were identified and investigated.

G. Ensure that indwelling Foley catheter placements were done with aseptic technique and in accordance with accepted standards of practice.

H. Ensure there were no cardboard boxes in the OR's. There were corrugated cardboard boxes in the clean equipment room that stored Kidney Balloons (Sterile Supply) with other sterile supplies. Also, there were external shipping cardboard boxes stored next to protective cover sheets used in sterilization of surgical instruments and instrument tray wraps used to sterilize surgical instrument trays.

I. Ensure the facility was free from dirt and dust. The clean equipment room had multiple bins that stored surgical supplies coated in dust, dirt, and debris.

J. Ensure anesthesia laryngoscope blades stored on crash cart and difficult intubation cart were sanitized and stored according to the manufacturer instructions. Laryngoscope blades were sterilized in surgical peel packs and left undated. There was no way to tell how long the blades had been stored in the packs.

K. Ensure all expired supplies were removed from the clean equipment room.

L. Ensure autoclaves were clean and sanitary. Two autoclaves in the sterile processing room were covered with a brown/rust colored substance on all of the inside walls of the autoclave.

M. Ensure all walls in the operating room were free from chips and scrapes. The walls had multiple missing chips and scrapes that exposed sheetrock in OR #3.

N. Ensure the OR was free from rust and chips on the operating room table and wheel casters. The wheel casters in operating room #3 had chips missing in the protective coating and rust on the wheel casters.

O. Ensure the Sterile Processing clean room had splash guards for equipment stored in wire baskets. Sterile instruments/supplies were stored in a wire basket shelf with no splash guard exposing items to contamination from splashing when floor was mopped/cleaned.

P. Ensure the surgical staff wore protective attire in the surgical procedure to prevent contamination of the procedure from outside sources. The staff were observed in Operating room #1 during a surgical procedure not wearing shoe covers.

Q. Ensure all medications and chemicals were dated with a beyond use date after opening:

Refer to tag A0144 for additional information.


It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients having surgery in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death.

Based on observation, interview and record review the facility failed to:

A. ensure patient received care in a safe and sanitary environment in 11 of 11 areas (Sterile Processing Department, Clean Equipment room, Crash Cart, Difficult Airway Cart, Sterile Processing Instrument Storage Room, Operating Room 1, Operating room 3, Sterile processing supply storage, Pathology room in surgery, Sterile processing autoclave room, Sterile Processing Clean area).

It was determined that the deficient practice posed an Immediate Jeopardy to patient health and safety and placed all patients having surgery in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death.



During an observation tour on December 5, 2018 after 9:30 am the following was observed:


STERILE PROCESSING DEPARTMENT

Review of "The steam sterilization record" revealed the following:
The record listed Load #1 to contain several orthopedic implants to include screws and plates. The biological test was noted to be out of the incubator at 8:40 am on 12-5-2018. Staff #21 was asked what time the instrument sets with the implants was released to the room. Staff #21 said approximately 7:30 am on 12-5-2018 when the sets came out of autoclave but prior to the biological test resulting. The instrument set was released to operating room for Patient #7. Staff #21 was asked if the facility routinely released sterilized implants prior to the biological test resulting. Staff #21 said it depended on when the case was scheduled, but if the case was early they would release the set when they needed.

Review of Patient #7 medical record revealed the following:

Patient #7 entered the OR (Operating Room) at 7:23 AM. The surgical case started at 7:48 am, 1 hour prior to the biological test resulting. The surgical case completed at 9:41 am. Review of the implant log noted on the OR record indicated multiple plates and screws on Patient #7.

Surgical Instrument sets that contained implants (Screws and Plates) were released from the Sterile Processing department prior to the biological test resulting. There was no way to determine conditions were met to kill a specified amount of microorganisms for a sterilization process prior to releasing the implants to the operating room for surgery.


Review of the Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79 2012 Guidelines revealed the following:


10.6 Routine load release

10.6.1 Process monitoring devices
Every sterilization load containing implants should be monitored with a POD containing a BI (an El challenge test pack). A Class 5 Integrating CI should be included in this PCD. Implants should be quarantined until the results of the BI testing are available (CDC, 2008).

10.6.3 Release criteria for implants

As with all cycles, an experienced, knowledgeable person should review the sterilizer chart or printout at the end of the sterilization cycle, as well as the results of other indicators that have been used to monitor the sterilization process. The load should be quarantined until the results of the BI testing are available (CDC, 2008).

Releasing implants before the El results are known is unacceptable and should be the exception, not the rule. When documented medical exceptions dictate (e.g., the need for trauma-related orthopedic screw-plate sets), it could be necessary to release an implantable device before the El results are known. In this case, the release of the device before the El results are known should be documented; the El result obtained later should also be documented. (See Annex L for examples of an implant log and an exception form.) It is critical that this
documentation be fully traceable to the patient. Emergency situations should be defined in written guidance developed in consultation with infection prevention and control, the surgeon, and risk management. Steps should be taken to reduce the frequency of emergency release of implantable items. For example, ongoing periodic reviews of the exception forms and implant logs could reveal consistent patterns of events that are causing emergency release and that could be corrected.

Staff #3, 15, and 21 confirmed the above finding.



CLEAN EQUIPMENT ROOM

A peel pack containing a sheath and tubing was observed in a bin re-sterilized that had been labeled Sharpsite #1880152. The peel pack was stored in the same bin with sterile supplies labeled Endo Scrub 2 Item #1912000, to be used with K. Storz Sharpsite AC 4 mm #1880152. The sterile supplies in the original manufacturer package were noted to have lot numbers and expiration dates.

Staff #15 confirmed the finding. Staff #15 was asked to identify what the items in the peel pack were that had been sterilized. Staff #15 confirmed they were Endo Scrub 2 sheath that had not been used on a previous surgical case so they had been re-sterilized. Staff #15 was asked what the manufacturer IFU (Instructions for Use) for Endo Scrub 2 listed as parameters for re-sterilizing. The facility did not have any IFU on site.

During a phone interview with Staff #22 on 12-7-2018 it was confirmed that item #1912000 was a disposable single use item. The item could not be re-sterilized.

The facility was not following manufacturer instructions on the single use item (Endo scrub 2). The facility was re-sterilizing Medtronic Endo-scrub sheaths used during nasal/sinus surgeries.


The clean equipment room had multiple bins that stored surgical supplies coated in dust, dirt, and debris. A build up of dust, debris was observed in bins that were holding sterile supplies (Surgical dressing) in the clean equipment room.

There were two Ligaclip appliers used in general surgeries that were expired. One Ligaclip expired 4/2018, 7 months ago and one expired 7/2018, 4 months ago. Two uterine stents used in gynelogical surgeries were expired. One expired in 9/2018, 2 months ago. One expired 11/18/2018, 3 weeks ago.

There were corrugated cardboard boxes in the clean equipment room that stored Kidney Balloons (Sterile Supply) with other sterile supplies. Also, there were external shipping cardboard boxes stored next to protective cover sheets used in sterilization of surgical instruments and instrument tray wraps used to sterilize surgical instrument trays.

There were two boxes of expired surgical sutures. One expired 7-31-2018, 4 months ago and one expired 9-30-2018, 2 months ago.

A Photon Blade used in surgery to enhance illumination of blue dye in procedures was found expired 9-15-2018, 3 months ago.

Eight Endometrial suction catheters were found with expiration dates that ranged from 9-2017, over one year ago to 10-2018, 2 months ago.


Review of ANSI/AAMI ST79:2017 revealed the following:
"11.1 Sterile Storage
Sterile items should be stored under environmentally controlled condition that reduces the potential for contamination ...
Supplies should be removed from external and web-edged shipping container before transport to any restricted area ..."


CRASH CART/DIFFICULT AIRWAY CART

An AED (Automatic Emergency Defibrillator) pad was observed stored on the crash cart that had expired 11/30/2018, 5 days ago. Naso/Oral endotracheal tubes x 11 observed on the difficult airway cart were expired. The expiration dates ranged from 11-2017 to 3-2018, a year ago. Two Laryngo-Tracheal Atomization Device on the difficult airway cart were expired. Both packages expired 10-2018, 2 months ago.

KY Lubricating jelly found that expired 11/2018, 5 days ago. Safety Intravenous catheters with Expiration dates, 2-2018, 9 months ago and 12-2018, 1 year ago. Blunt Plastic Cannula expired 1-2018, 11 months ago. Safety IV Catheters found expired 2-2018, 9 months ago.

Anesthesia laryngoscope blades stored on crash cart and difficult intubation cart were sanitized and stored according to the manufacturer instructions. Laryngoscope blades were sterilized in surgical peel packs and left undated. There was no way to tell how long the blades had been stored in the packs.

An oxygen flowmeter in the crash cart was not covered or labeled. There was no way to determine if it was clean or dirty.


STERILE PROCESSING INSTRUMENT ROOM

Surgical instruments were stored in central supply instrument room past the date of guaranteed sterilization date by manufacturer (4 months past date of sterilization guarantee)


Review of IFU for Halyard Sterilization wrap revealed the following:

"Additional real time testing also supports maintenance of package sterility for Halyard Quick check and Halyard one step for:

1 year following pre-vacuum steam and EO
1 year following sterrad"

Review of IFU for Cardinal Health Sterilization Pouches revealed the following:

"Real time test supports maintenance of package sterility for 6 months after steam sterilization and 24 months after EO sterilization"

Review of the facility policy titled, "Guidelines for Infection Control" with a final approval date of 3/13/2018 revealed the following:

"Shelf Life will be defined as event related in that sterilized items are considered sterile unless there is loss of integrity of sterile packaging." The policy did not follow the manufacturer recommendations.



OR DEPARTMENT RETURN TO SURGERY LOGS/OCCURRENCES


Review of the Return to Surgery log revealed the following:

Patient #12

11-12-2018 Bilateral breast reconstruction with Bilateral implants
11-28-2018 Bilateral Mastectomy Simple

Patient #22

7-26-2018 Mastectomy Simple Left
8-21-2018 Mastectomy Simple Left

Patient #23
9-10-2018 Bilateral Modified Radical Mastectomy
10-8-2018 Incision and Drainage of Left Breast

Patient #24
5-22-2018 Mastectomy Simple
6-14-2018 Incision and Drainage of Left Breast

Patient #8
8-9-2018 Bilateral Modified Radical Mastectomy
9-4-2018 Reconstruction Breast with implant Bilateral
9-18-2018 Reconstruction of breast with implant (Right)

The return to surgery log did not list the indication for the second surgery, nor did it indicate if an investigation was initiated.

The surgery department did not ensure that any surgical case, specifically implant cases, that required a return to surgery for complication or infection were identified and investigated.


During an interview with Staff # 15 on 12-6-2018 at 9:51 am revealed the following:

Staff #15 was asked the Surgery Committee meetings addressed any of the problems identified on the return to surgery log. Staff #15 said he was not aware of any discussion on the issue. Staff #15 was asked if occurrence reports were filed on any return to surgery that indicated a complication/infection from previous surgery. Staff #15 said he was not aware of any occurrences and had not investigated any that he could remember.


Review of Patient #8's medical records reveal the following:

6-14-2018 Left Breast Biopsy
8-9-2018 Bilateral Mastectomy with reconstruction placement of bilateral breast implants.
9-4-2018 Bilateral suprapectoral prosthetic placement of breast implants
9-18-2018 Removal of Right breast infra and supra pectoral breast implants/ replacement. Right breast incision was noted to have a dehiscence of approximately 3 cm with exposed silicone implant. Staff #16 noted the dehiscence was likely due to non-compliance and no evidence of surgical site infection.


Review of Patient #8's medical record from facility B revealed the following:

Patient #8 presented to the Emergency Room at facility B on 9-23-2018. Review of the "Emergency Room Visit Notes" revealed the following:


"Patient is a 47 year old female who presents with tenderness and redness to incision sites of bilateral breasts with leaking from right side ...Patient underwent bilateral mastectomy on 8/9/2018 with bilateral implants/reconstruction on the same day by Physician #16 with two implants in each breast area ... Patient said on 8/12/2018 the right side began to leak, on 8/13/2018 she was seen in the office and Physician #16 sutured the area that was leaking ....On 9/3/2018 the area was leaking and she was seen in the office and on 9/4/2018 she underwent removal of implants and insertion of new set of implants bilaterally ....On 9/14/2018 she stated the right side began leaking again she was seen in the office on 9/17/2018 and on 9/18/2018 Physician #16 removed the right side implants and inserted new implants on the right side only ....On 9/23/2018 the site began leaking again she was seen in the office on 9/24/2018 and Physician #16 sutured the area ...On 9/25/2018 the leaking worsened and on 9/27/2018 she had the sutures applied by a nurse in the office. Today she contacted another physician (#17) for a second opinion who advised her to go to the ER."


Review of the consult note revealed a phone call made to physician #17's office. There was a notation that office staff spoke with #17 and instructions were given to have patient #8 follow up in physician #17's office on Monday 10/1/2018 at 10 AM.

An additional emergency room visit was noted in the record on 9-3-2018 for complaints of small area of dehiscence in the incisional site. The ED record shows phone consult with physician #17. Physician #17 instructed ER to discharge patient and instruct patient #8 to continue antibiotics and keep appointment with him 10/1/2018 at 10 AM.


Review of the History and Physical from 10/1/2018 by physician #17 revealed the following:

"Review of Systems

Breasts: Reveals cellulitis throughout the inferior aspect of her breasts bilaterally. There is a 3.5 x 3 cm open wound with the implant exposed."

"Plan

Incision and Drainage of bilateral breasts with removal of both implants, bilateral breasts. She is aware that removing her implants she is gravida flat, hollow, deflated appearing breasts. She will need further reconstruction in order to improve this result. She understands these implants were infected and they need to come out."


Review of the operative note dated 10/2/2018 revealed the following:

"Pre-Operative Diagnosis:
Infected breast bilaterally, breast abscesses bilaterally, open wound of right breast with exposed breast implant."

"Post-Operative Diagnosis:
Infected breast bilaterally, breast abscesses bilaterally, open wound of right breast tissue with exposed right breast implant. In addition, she has a right breast ruptured implant (puncture wounds noted on periphery of implant), a ruptured left breast submuscular silicone implant."

Patient #8 was listed on the return to surgery log three times in 45 days. There was no investigation initiated in these returns.



FOLEY CATHETER PLACEMENT (OR1 Patient #1)

During a tracer observation on 12-5-2018 at 9:32 AM the following was observed:
Staff #24 was observed inserting a Foley catheter into Patient #1. Staff #24 was observed to open the labia. Staff #24 then used a 4x4 sponge soaked in betadine and starting cleansing the patient. Staff #24 was observed to place the betadine sponge at the urinary meatus and swipe down cleaning the patient. Staff #24 then using the same 4x4 sponge swiped up from bottom and went back up to the ureteral meatus. This process was done twice.

After completing foley insertion, Staff #24 repositioned the patient and began the surgical prep. Staff #24 was observed to prep using chloraprep. Staff #24 was observed to swipe around top of abdomen and touch blanket with the prep sponge. Staff #24 did this two times during the prep. Staff #24 did not stop and get new prep after contaminating the prep sponge.

Review of Lippincott guidelines for urinary Foley insertion (Female) dated November 2017 revealed the following:

" ...Separate the labia majora and labia minora as widely as possible with the thumb, middle, and index fingers of your non-dominant hand so that you have a full view of the urinary meatus. Keep the labia separated throughout the procedure so that they don't obscure the urinary meatus or contaminate the area when its cleaned.

...With you dominate hand, use an antiseptic swab or, using plastic forceps,, pick up a cotton ball soaked with sterile antiseptic, sterile water, or sterile saline to clean the labium minus furthest from you using a downward stroke; then discard the swab or cotton ball ..."




STERILE PROCESSING SUPPLY STORAGE ROOM (WRAPS, PEEL PACKS, STERILIZATION SUPPLIES)

Instrument protector sheets used during sterilization of surgical instruments were stored in a bin in the Sterile Processing supply room with a buildup of dust and debris. External shipping cardboard boxes were stored above the protector sheets and next to surgical instrument wraps used during sterilization of instruments.

PATHOLOGY ROOM IN SURGERY

A Pathology room in the Operating Room had Instruments stored on top of the counter in open bin. Instruments were not labeled clean/dirty. The countertop was in disarray.


STERILE PROCESSING AUTOCLAVE ROOM

Two autoclaves in the sterile processing room were covered with a brown/rust colored substance on all of the inside walls of the autoclave.

Review of Steris invoice dated 10-16 to 10-17-2017 showed cleaning of the autoclaves at the facility. The invoice noted the chambers had been professionally cleaned using a combination of mechanical and chemical actions to remove residues from inside of the chamber walls.

Staff #15 said the chamber of the autoclaves had not been cleaned since 10-17-2017. Staff #15 said the facility did not have a schedule for chamber cleaning of the autoclave.


OR #3

The walls had multiple missing chips and scrapes that exposed sheetrock in OR #3. The wheel casters in operating room #3 had chips missing in the protective coating and rust on the wheel casters and base of the operating table. There was a buildup of dust, dirt, and debris in a cabinet in operating room #3 that stored sterile supplies.


STERILE PROCESSING CLEAN AREA

Sterile Processing clean room had splash guards for equipment stored in wire baskets. Sterile instruments/supplies were observed stored in a wire basket shelve with no splash guard exposing items to contamination from splashing when floor was mopped/cleaned.


OR ATTIRE

The staff were observed in Operating room #1 during a surgical procedure not wearing shoe covers. Staff #15 said the Operating room staff wore dedicated operating shoes; however, several of the shoes observed were discolored and had brown stains indicating they were worn outside of the operating room.


Review of the facility policy titled Dress Code: Restricted areas with a final approval date of 5/10/2016 revealed the following:

"F...Shoe covers will be worn over shoes when employee is wearing shoes from outside hospital."

Q. Ensure all medications and chemicals were dated with a beyond use date after opening:

Sevoflurane anesthesia gas was found opened and undated in OR Room #3. Also the anesthesia gas was stored with an adapter lid on it exposing the operating room to leaks of anesthesia gas.

Observed an Americlear clearing solvent used in histology procedures in the pathology room of the surgery department. The jug was found to be open and not labeled with a Beyond use date labeled on the bottle.


Staff #3 and #15 confirmed the above findings.




Review of the facility policy titled, "Infection Prevention and Control Program Plan" with a final approval date of 5-8-2018 revealed the following:

"Surveillance
3. Regularly conducting tours of the physical attributes of the facilities to ensure that risks for transmission of disease or occupation hazards are maintained and a sanitary hospital environment is maintained."

Based on interview and record review, the facility failed to ensure they maintained an effective and ongoing quality assessment and performance improvement program. The facility failed to ensure they measured and analyzed adverse surgical events and implemented preventative actions in 9 of 24 sampled patients (Patient #'s 8, 9, 10, 12, 13, 14, 22, 23, and 24).

The facility failed to ensure an adverse event involving unsanitary practices being used to dry a surgical incision were addressed and corrective actions implemented.

The facility failed to ensure adverse events involving complications involving surgical removal and insertion of breast implants were addressed and preventative actions implemented. There were report of patients breast implants falling out and surgical incisions opening up. There were reports of surgical procedures being performed which were not listed on the practitioner's surgical privilege list.


The facility failed to ensure there was documentation that the quality program shared information about surgical returns with the infection control coordinator for tracking and trending for potential infections. The facility failed to ensure that any surgical case, specifically implant cases, that required a return to surgery for complication or infection were identified and investigated.


Refer to tag A0286 for additional information.

Based on interview and record review, the facility failed to ensure they measured and analyzed adverse surgical events and implemented preventative actions in 9 of 24 sampled patients (Patient #'s 8, 9, 10, 12, 13, 14, 22, 23, and 24).

The facility failed to ensure an adverse event involving unsanitary practices being used to dry a surgical incision were addressed and corrective actions implemented.

The facility failed to ensure adverse events involving complications involving surgical removal and insertion of breast implants were addressed and preventative actions implemented. There were report of patients breast implants falling out and surgical incisions opening up. There were reports of surgical procedures being performed which were not listed on the practitioner's surgical privilege list.


The facility failed to ensure there was documentation that the quality program shared information about surgical returns with the infection control coordinator for tracking and trending for potential infections. The facility failed to ensure that any surgical case, specifically implant cases, that required a return to surgery for complication or infection were identified and investigated.


This deficient practice had the likelihood to cause harm to all patients.



Findings include:




Review of facility occurrence reports revealed the following incidents logged:




Patient #13

Review of the clinical record of Patient #13 revealed patient was a 63 year old female who presented for a laparoscopic ventral hernia repair with mesh on 01/11/2018.

Review of the operative report dated 01/11/2018 revealed after the surgical procedure was performed, the incision was stitched up and Dermabond (surgical incision adhesive) was applied. According to the report Staff #16 was the surgeon and Staff #20 was the first assist.

Review of an occurrence report dated 01/11/2018 revealed the first assist (Staff #20) took the bair hugger hose off and used it to dry the wound off. Staff #15 documented on the form that the first assist needed education regarding not using warming device as unit for drying Dermabond or anything on patient's skin.

During an interview on 12/06/2018 after 9:30 a.m.,,the following was reported:

Staff #12 confirmed that there was no documentation written on the form asking for further investigation.


Staff #6 reported they did not do anything about the incident. They just put it in their quality for tracking and trending.




Patient #10

Review of an occurrence report dated 08/28/2018 for an incident that occurred on 08/27/2018 revealed Staff #16 (Surgeon) did not have implants in a case that was posted as a replacement. Patient #10 had come back for surgery twice.

There was documentation on the report that Patient #10 had surgery on 04/16/2018 for a bilateral mastectomy /SNASM. Patient #10 came back on 05/21/2018 for I & D (Incision and drainage) of the left breast with bilateral implant removal. Patient #10 came back on 08/27/2018 for bilateral breast implants replacement with reconstruction/mentor. Patient #10 did not have implants in before the last surgery.



During an interview on 12/06/2018 after 9:30 a.m.,the following was reported:

Staff #12 confirmed that there was no documentation written in asking for further investigation. Staff #12 reported that staff were reporting that Patient #10 was scheduled for implant reconstruction and she did not have any. They only did insertions (of breast implants).




Patient #14

Review of an occurrence report dated 09/04/2018 revealed that Patient #14 had 1 previous breast implant of 250 cc silicone placed in a prior surgery . "Today scheduled for removal of ruptured implant, right breast capsulectomy and replacement of right breast silicone implant. During surgery Staff #16 (Surgeon) removed the original implant, cultured site, asked circulator size of implants we have available. He was told that 800 cc was what we were directed by his office to order for the patient. He replied back he wanted 300 cc implants and asked why we don't have any ....He implanted the 800 cc implant then removed it, washed out the site and closed the patient up. His op note does not make mention of any implant being placed or removed."

There was documentation by Staff #15 on 09/04/2018 that the implant was wasted. There was documentation to "Please review privileges granted versus what procedure performed. Review op note. Probably listed as staged reconstruction."


During an interview on 12/06/2018 after 9:30 a.m. the following was stated;

Staff # 12 confirmed she received the report and she documented that it needed further investigation. The information had been sent to Staff #6 (Quality).

Staff #6 (Quality) reported that she had not seen the occurrence report and knew nothing about the incident. There had been no investigation on it as of today (12/06/2018).

Staff #15 confirmed he turned the incident in. Staff #15 reported they (surgery department) needed clarification on what immediate reconstruction versus patients being brought in for removals and replacements of breast implants. What was done during the surgery was not listed on the clinical privileges.



Patient #8



The occurrence report dated 09/18/2018 revealed that Patient #8's breast implants were visible through an approximately 3 centimeter open wound during surgery prep. According to the report Patient #8 had double implants removed and replaced. They were placed above and below the muscle. Patient #8 told staff that she did not need to remove her bra, unit in operating room because the implants would fall out.


During an interview on 12/05/2018 after 10:30 a.m.,the following was reported:

Staff #12 confirmed the report and revealed it was passed on to Quality on 09/18/2018 for further investigation and tracking and trending.



Patient #9

According to the occurrence report dated 09/24/2018 Patient #9 was brought in with a wound dehiscence (separation) on the right upper breast. The first surgery was on 08/30/2018 which was a right partial mastectomy and Patient #9 was back again on 09/24/2018.


During an interview on 12/05/2018 after 10:30 a.m.,,the following was reported:

Staff #12 confirmed the report and revealed it was passed on to Quality on 09/24/2018 for further investigation and tracking and trending.




Patient #12

According to the occurrence report Patient #12's original surgery was on 09/24/2018 for a reconstruction of the breast with bilateral implants. The infection control nurse was notified on 11/13/2018 at 12:30 p.m. in case of infection and for tracking ....The report made was that Patient #12's right implants fell out at home and the left one was bulging from the side.

Review of documentation on the report revealed it needed further investigation for tracking and trending.


During an interview on 12/05/2018 after 10:30 a.m., the following was reported:

Staff #12 confirmed that Patient #12's breast implants had fallen out during a shower at home. The report was sent to Quality for an investigation to be completed on 11/12/2018.

Staff #12 reported that the conclusion of the investigation was to track and trend.


During an interview on 12/5/2018 after 11:40 a.m., the following was reported about Patient #12:

Staff #10 and Staff #13 reported Patient #12's right breast implant had fallen out in the shower and the other side was eroded when she came to them on 11/12/2018.

Staff #10 reported that Staff #20- first assist was allowed to close wounds from the bottom to the top (meaning all tissue layers).

Staff #6 (Quality) reported that the process was for the Risk Manager to report the occurrences to her and the specific departments. Staff #6 (Quality) confirmed that she does the tracking and trending. That no improvement projections had been implemented to address the problems mentioned about the surgeries. Staff #6 confirmed there was no documentation of concerns with the surgeries in the quality meeting minutes.


Staff #1 (Administrator) reported they had been having monthly meetings about surgeries since June 2018. Staff #1 confirmed they had not implemented anything to prevent the surgical complications. Staff #1 reported that having a CNO would help them because they realized that their weakness was not having nursing oversight on their campus.


During an interview on 12/06/2018 after 9:30 a.m., following was reported:

Staff #15 confirmed staff had reported to him about Staff #20 closing incisions and that immediate supervision was needed. Staff #15 reported they (surgery department) needed clarification on what immediate reconstruction versus patients being brought in for removals and replacements of breast implants. What was done during the surgery was not listed on the clinical privileges for Staff #20.





Review of quality minutes from October 25, 2017 to November 20, 2018 made no documentation of the concerns mentioned in the occurrence reports.





39801

Review of the Return to Surgery log revealed the following:

Patient #12

11-12-2018 Bilateral breast reconstruction with Bilateral implants
11-28-2018 Bilateral Mastectomy Simple

Patient #22

7-26-2018 Mastectomy Simple Left
8-21-2018 Mastectomy Simple Left

Patient #23
9-10-2018 Bilateral Modified Radical Mastectomy
10-8-2018 Incision and Drainage of Left Breast

Patient #24
5-22-2018 Mastectomy Simple
6-14-2018 Incision and Drainage of Left Breast

Patient #8
8-9-2018 Bilateral Modified Radical Mastectomy
9-4-2018 Reconstruction Breast with implant Bilateral
9-18-2018 Reconstruction of breast with implant (Right)

The return to surgery log did not list the indication for the return to surgery, nor did it indicate if an investigation was initiated.

During an interview with Staff # 15 on 12-6-2018 at 9:51 am revealed the following:

Staff #15 was asked if the Surgery Committee meetings addressed any of the problems identified on the return to surgery log. Staff #15 said he was not aware of any discussion on the issue. Staff #15 was asked if occurrence reports were filed on any return to surgery that indicated a complication/infection from previous surgery. Staff #15 said he was not aware of any occurrences and had not investigated any that he could remember.


Review of Patient #8's medical records revealed the following:

6-14-2018 Left Breast Biopsy
8-9-2018 Bilateral Mastectomy with reconstruction placement of bilateral breast implants.
9-4-2018 Bilateral suprapectoral prosthetic placement of breast implants
9-18-2018 Removal of Right breast infra and supra pectoral breast implants/ replacement. Right breast incision was noted to have a dehiscence of approximately 3 cm with exposed silicone implant. Staff #16 noted the dehiscence was likely due to non-compliance and no evidence of surgical site infection.


Review of Patient #8's medical record from facility B revealed the following:

Patient #8 presented to the Emergency Room at facility B on 9-23-2018. Review of the "Emergency Room Visit Notes" revealed the following:


"Patient is a 47 year old female who presents with tenderness and redness to incision sites of bilateral breasts with leaking from right side ...Patient underwent bilateral mastectomy on 8/9/2018 with bilateral implants/reconstruction on the same day by Physician #16 with two implants in each breast area ... Patient said on 8/12/2018 the right side began to leak, on 8/13/2018 she was seen in the office and Physician #16 sutured the area that was leaking ....On 9/3/2018 the area was leaking and she was seen in the office and on 9/4/2018 she underwent removal of implants and insertion of new set of implants bilaterally ....On 9/14/2018 she stated the right side began leaking again she was seen in the office on 9/17/2018 and on 9/18/2018 Physician #16 removed the right side implants and inserted new implants on the right side only ....On 9/23/2018 the site began leaking again she was seen in the office on 9/24/2018 and Physician #16 sutured the area ...On 9/25/2018 the leaking worsened and on 9/27/2018 she had the sutures applied by a nurse in the office. Today she contacted another physician (#17) for a second opinion who advised her to go to the ER."



Review of the consult note revealed a phone call made to physician #17's office. There was a notation that office staff spoke with #17 and instructions were given to have patient #8 follow up in physician #17's office on Monday 10/1/2018 at 10 AM.

An additional emergency room visit was noted in the record on 9-3-2018 for complaints of small area of dehiscence in the incisional site. The ED record shows phone consult with physician #17. Physician #17 instructed ER to discharge patient and instruct patient #8 to continue antibiotics and keep appointment with him 10/1/2018 at 10 AM.


Review of the History and Physical from 10/1/2018 by physician #17 revealed the following:

"Review of Systems

Breasts: Reveals cellulitis throughout the inferior aspect of her breasts bilaterally. There is a 3.5 x 3 cm open wound with the implant exposed."

"Plan

Incision and Drainage of bilateral breasts with removal of both implants, bilateral breasts. She is aware that removing her implants she is gravida flat, hollow, deflated appearing breasts. She will need further reconstruction in order to improve this result. She understands these implants were infected and they need to come out."


Review of the operative note dated 10/2/2018 revealed the following:

"Pre-Operative Diagnosis:
Infected breast bilaterally, breast abscesses bilaterally, open wound of right breast with exposed breast implant."

"Post-Operative Diagnosis:
Infected breast bilaterally, breast abscesses bilaterally, open wound of right breast tissue with exposed right breast implant. In addition, she has a right breast ruptured implant (puncture wounds noted on periphery of implant), a ruptured left breast submuscular silicone implant."

Patient #8 was listed on the return to surgery log for Facility A three times in 45 days. There was no investigation initiated in these returns.


During an interview on 12-6-2018 at 9:51 AM the following was revealed:

Staff #15 was asked if he was aware of any complications/infections of surgical cases done by Physician #16. He said he was aware of some. One of the cases he was aware of involved a patient who told the pre-op nurse that her breast implant had fallen out at home in the shower. Staff #15 was asked if an investigation had been initiated into that case? Staff #15 said yes, he went to the operating room and took pictures of the wound and filed an incident report. Staff #15 was asked what the outcome was from the investigation. He said he did not know. Staff #15 said once the incident report is filed he does not usually hear a follow up. Staff #15 was asked if he had been made aware of staff concerns regarding Staff #20 working outside her scope of practice. Staff #15 said yes, and he had filed incident reports on that concern as well. Staff #15 said he had not heard anything on follow up from those incident reports either.



Review of the Surgery Committee Meeting Minutes dated July 31, 2018 revealed the following:

"Topic
Surgery Committee Routine Agenda Items

Findings/Conclusions
...4. Unplanned Return to Surgery - January we had 1, general surgery; February we had 1, CV case; March we had 2, 1 general surgery and 1 was spine; none in April; May we had 1, general surgery. Staff #6 stated she had a couple of issues for closed session.

Recommendations/Actions/Follow Up
...Informational"

The Surgery Committee meeting minutes did not address the return to surgery log or incident reports that had been completed and submitted on complications/infections in surgery.

Based on interview and record review, the facility failed to ensure that orders were authenticated promptly by the ordering practitioner. This deficient practice was found in 4 of 4 patients reviewed (Patiemt #'s 1, 2, 3, and 8).

This deficient practice had the likelihood to cause harm in all patients.



Findings Include:


PATIENT #1

Review of the medication orders revealed the following:

Heparin (Blood Thinner) was ordered on 12/5/2018. The ordering physician was Physician #16. The order was entered on 12/5/2018 at 0734 by Staff #26. The order was not signed by the physician. The supervising provider tab was blank.

An order to admit to Inpatient was ordered on 12/5/2018 at 1204. The ordering physician was Physician #16. The order was entered on 12/5/2018 at 12:03 by Staff #27. The order was not signed by the physician. The supervising provider tab was blank.

An order for NPO (Nothing by mouth) was ordered on 12/5/2018 at 07:19 AM. The ordering physician was Physician #28. The order was entered on 12/5/2018 at 7:19 AM by Staff #26. The order was not signed by the physician. The supervising provider tab was blank.


PATIENT #2

Promethazine-codeine (Anti-nausea/Allergic reactions/Insomnia) was ordered on 11/29/2018 at 4:12 PM. The order was entered on 11-29-2018 at 4:12 PM by Staff #29. The order was not signed by the physician. The supervising provider tab was blank.

Xanax (Benzodiazepine medication used to treat anxiety) was ordered on 11-29-2018 at 4:11 PM. The order was entered on 11-29-2018 at 4:12 PM by Staff #29. The order was not signed by the physician. The supervising provider tab and the ordering physician tab was blank.

An order to discharge the patient was entered on 12-5-2018 at 1:44PM. The order was entered by Staff #27 on 12-5-2018. The order was not signed by the physician. The ordering physician was listed as Staff #16. The supervising provider tab was blank.


PATIENT #3

Losartan (ARB used to treat hypertension) was ordered on 11-26-2018 at 8:45 AM. The order was entered on 11-26-2018 by Staff #30. The ordering physician tab and the supervising physician tab was blank.

Metformin (Used to treat Diabetes) was ordered on 11-26-2018 at 8:45 AM. The order was entered on 11-26-2018 by Staff #30. The ordering physician tab and the supervising physician tab was blank.

Dilaudid (Pain Medication) was ordered on 12-5-2018 at 3:12 PM The order was entered on 12-5-2018 by Staff #27. The ordering physician was listed as Staff #28. The supervising provider tab was blank.

Naloxone (medication used to block the action of opioid pain medications). The order was entered on 12-5-2018 by Staff #27. The ordering physician was listed as Staff #28. The supervising provider tab was blank.

An order to discharge the patient was entered on 12-5-2018 was entered on 12-5-2018 at 3:12 PM. The order was entered by Staff #27 on 12-5-2018. The order was not signed by the physician. The ordering physician was listed as Staff #16. The supervising provider tab was blank.


PATIENT #8

Carvedilol (Cardiac Medication) was ordered on 5-4-2018 at 11:35 AM. The order was entered on 5-4-2018 to discontinue medication. The order was entered by Staff # 31. The ordering physician tab was blank. The order was not signed by the physician. The supervising provider tab was blank.



During an interview on 12-5-2018 at 9:12 AM, Staff #26 said all orders were entered electronically. Staff #26 said the physician was responsible for entering the orders for patients.

Based on observation, interview, and record review, the facility failed to ensure the infection control officer developed a system that maintained a clean and sanitary environment for the provision of surgical services. The facility failed to ensure proper infection control practices were utilized in 10 of 10 areas. (Sterile Processing clean area, Clean Equipment room, Operating Room 1, Operating room 3, operating room 4, Crash cart, Difficult Intubation cart, Sterile processing instrument storage, Sterile processing supply storage (Wraps), Sterile processing autoclave room)



The facility failed to:

A. Ensure that Surgical Instrument sets that contained implants (Screws and plates) were not released from the Sterile Processing department prior to the biological test resulting. There was no way to determine conditions were met to kill a specified amount of microorganisms for a sterilization process prior to releasing the implants to the operating room for surgery.

B. Ensure that a single use item was not re-sterilized. The facility was not following manufacturer instructions on the single use item. The facility was re-sterilizing Medtronic Endo-scrub sheaths used during nasal/sinus surgeries.

C. Ensure the facility was free from expired implants. There were two Ligaclip appliers used in general surgeries that were expired. One Ligaclip expired 4/2018, 7 months ago and one expired 7/2018, 4 months ago. Two uterine stents used in gynelogical surgeries were expired. One expired in 9/2018, 2 months ago. One expired 11/18/2018, 3 weeks ago.

D. Ensure that emergency supplies on the crash cart/difficult airway cart were not expired. An AED (Automatic Emergency Defibrillator) pad was observed stored on the crash cart that had expired 11/30/2018, 5 days ago. Naso/Oral endotracheal tubes x 11 observed on the difficult airway cart were expired. The expiration dates ranged from 11-2017 to 3-2018, a year ago.
Two Laryngo-Tracheal Atomization Device on the difficult airway cart were expired. Both packages expired 10-2017, 2 months ago.

E. Ensure facility followed manufacturer recommendations for shelf life on sterilized instruments. Surgical instruments were stored in central supply instrument room past the date of guaranteed sterilization date by manufacturer (4 months past date of sterilization guarantee)

F. Ensure that any surgical case, specifically implant cases, that required a return to surgery for complication or infection were identified and investigated.

G. Ensure that indwelling Foley catheter placements were done with aseptic technique and in accordance with accepted standards of practice.

H. Ensure there were no cardboard boxes in the OR's. There were corrugated cardboard boxes in the clean equipment room that stored Kidney Balloons (Sterile Supply) with other sterile supplies. Also, there were external shipping cardboard boxes stored next to protective cover sheets used in sterilization of surgical instruments and instrument tray wraps used to sterilize surgical instrument trays.

I. Ensure the facility was free from dirt and dust. The clean equipment room had multiple bins that stored surgical supplies coated in dust, dirt, and debris.

J. Ensure anesthesia laryngoscope blades stored on crash cart and difficult intubation cart were sanitized and stored according to the manufacturer instructions. Laryngoscope blades were sterilized in surgical peel packs and left undated. There was no way to tell how long the blades had been stored in the packs.

K. Ensure all expired supplies were removed from the clean equipment room.

L. Ensure autoclaves were clean and sanitary. Two autoclaves in the sterile processing room were covered with a brown/rust colored substance on all of the inside walls of the autoclave.

M. Ensure all walls in the operating room were free from chips and scrapes. The walls had multiple missing chips and scrapes that exposed sheetrock in OR #3.

N. Ensure the OR was free from rust and chips on the operating room table and wheel casters. The wheel casters in operating room #3 had chips missing in the protective coating and rust on the wheel casters.

O. Ensure the Sterile Processing clean room had splash guards for equipment stored in wire baskets. Sterile instruments/supplies were stored in a wire basket shelf with no splash guard exposing items to contamination from splashing when floor was mopped/cleaned.

P. Ensure the surgical staff wore protective attire in the surgical procedure to prevent contamination of the procedure from outside sources. The staff were observed in Operating room #1 during a surgical procedure not wearing shoe covers.

Q. Ensure all medications and chemicals were dated with a beyond use date after opening.


Refer to tag A749 for additional information.



It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients having surgery in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death.

Based on observation, interview, and record review, the facility failed to ensure the infection control officer developed a system that maintained a clean and sanitary environment for the provision of surgical services. The facility failed to ensure proper infection control practices were utilized in11 of 11 areas (Sterile Processing Department, Clean Equipment room, Crash Cart, Difficult Airway Cart, Sterile Processing Instrument Storage Room, Operating Room 1, Operating room 3, Sterile processing supply storage, Pathology room in surgery, Sterile processing autoclave room, Sterile Processing Clean area).

It was determined that the deficient practice posed an Immediate Jeopardy to patient health and safety and placed all patients having surgery in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death.



During an observation tour on December 5, 2018 after 9:30 am the following was observed:


STERILE PROCESSING DEPARTMENT

Review of "The steam sterilization record" revealed the following:
The record listed Load #1 to contain several orthopedic implants to include screws and plates. The biological test was noted to be out of the incubator at 8:40 am on 12-5-2018. Staff #21 was asked what time the instrument sets with the implants was released to the room. Staff #21 said approximately 7:30 am on 12-5-2018 when the sets came out of autoclave but prior to the biological test resulting. The instrument set was released to operating room for Patient #7. Staff #21 was asked if the facility routinely released sterilized implants prior to the biological test resulting. Staff #21 said it depended on when the case was scheduled, but if the case was early they would release the set when they needed.

Review of Patient #7 medical record revealed the following:

Patient #7 entered the OR (Operating Room) at 7:23 AM. The surgical case started at 7:48 am, 1 hour prior to the biological test resulting. The surgical case completed at 9:41 am. Review of the implant log noted on the OR record indicate multiple plates and screws on Patient #7.

Surgical Instrument sets that contained implants (Screws and Plates) were released from the Sterile Processing department prior to the biological test resulting. There was no way to determine conditions were met to kill a specified amount of microorganisms for a sterilization process prior to releasing the implants to the operating room for surgery.


Review of the Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79 2012 Guidelines revealed the following:


10.6 Routine load release

10.6.1 Process monitoring devices
Every sterilization load containing implants should be monitored with a POD containing a BI (an El challenge test pack). A Class 5 Integrating CI should be included in this PCD. Implants should be quarantined until the results of the BI testing are available (CDC, 2008).

10.6.3 Release criteria for implants

As with all cycles, an experienced, knowledgeable person should review the sterilizer chart or printout at the end of the sterilization cycle, as well as the results of other indicators that have been used to monitor the sterilization process. The load should be quarantined until the results of the BI testing are available (CDC, 2008).

Releasing implants before the El results are known is unacceptable and should be the exception, not the rule. When documented medical exceptions dictate (e.g., the need for trauma-related orthopedic screw-plate sets), it could be necessary to release an implantable device before the El results are known. In this case, the release of the device before the El results are known should be documented; the El result obtained later should also be documented. (See Annex L for examples of an implant log and an exception form.) It is critical that this
documentation be fully traceable to the patient. Emergency situations should be defined in written guidance developed in consultation with infection prevention and control, the surgeon, and risk management. Steps should be taken to reduce the frequency of emergency release of implantable items. For example, ongoing periodic reviews of the exception forms and implant logs could reveal consistent patterns of events that are causing emergency release and that could be corrected.

Staff #3, 15, and 21 confirmed the above finding.



CLEAN EQUIPMENT ROOM

A peel pack containing a sheath and tubing was observed in a bin re-sterilized that had been labeled Sharpsite #1880152. The peel pack was stored in the same bin with sterile supplies labeled Endo Scrub 2 Item #1912000, to be used with K. Storz Sharpsite AC 4 mm #1880152. The sterile supplies in the original manufacturer package were noted to have lot numbers and expiration dates.

Staff #15 confirmed the finding. Staff #15 was asked to identify what the items in the peel pack were that had been sterilized. Staff #15 confirmed they were Endo Scrub 2 sheath that had not been used on a previous surgical case so they had been re-sterilized. Staff #15 was asked what the manufacturer IFU (Instructions for Use) for Endo Scrub 2 listed as parameters for re-sterilizing. The facility did not have any IFU on site.

During a phone interview with Staff #22 on 12-7-2018 it was confirmed that item #1912000 was a disposable single use item. The item could not be re-sterilized.

The facility was not following manufacturer instructions on the single use item (Endo scrub 2). The facility was re-sterilizing Medtronic Endo-scrub sheaths used during nasal/sinus surgeries.


The clean equipment room had multiple bins that stored surgical supplies coated in dust, dirt, and debris. A build up of dust, debris was observed in bins that were holding sterile supplies (Surgical dressing) in the clean equipment room.

There were two Ligaclip appliers used in general surgeries that were expired. One Ligaclip expired 4/2018, 7 months ago and one expired 7/2018, 4 months ago. Two uterine stents used in gynelogical surgeries were expired. One expired in 9/2018, 2 months ago. One expired 11/18/2018, 3 weeks ago.

There were corrugated cardboard boxes in the clean equipment room that stored Kidney Balloons (Sterile Supply) with other sterile supplies. Also, there were external shipping cardboard boxes stored next to protective cover sheets used in sterilization of surgical instruments and instrument tray wraps used to sterilize surgical instrument trays.

There were two boxes of expired surgical sutures. One expired 7-31-2018, 4 months ago and one expired 9-30-2018, 2 months ago.

A Photon Blade used in surgery to enhance illumination of blue dye in procedures was found expired 9-15-2018, 3 months ago.

Eight Endometrial suction catheters were found with expiration dates that ranged from 9-2017, over one year ago to 10-2018, 2 months ago.


Review of ANSI/AAMI ST79:2017 revealed the following:
"11.1 Sterile Storage
Sterile items should be stored under environmentally controlled condition that reduces the potential for contamination ...
Supplies should be removed from external and web-edged shipping container before transport to any restricted area ..."


CRASH CART/DIFFICULT AIRWAY CART

An AED (Automatic Emergency Defibrillator) pad was observed stored on the crash cart that had expired 11/30/2018, 5 days ago. Naso/Oral endotracheal tubes x 11 observed on the difficult airway cart were expired. The expiration dates ranged from 11-2017 to 3-2018, a year ago. Two Laryngo-Tracheal Atomization Device on the difficult airway cart were expired. Both packages expired 10-2017, 2 months ago.

KY Lubricating jelly found that expired 11/2018, 5 days ago. Safety Intravenous catheters with Expiration dates, 2-2018 9 months ago and 12-2018, 1 year ago. Blunt Plastic Cannula expired 1-2018, 11 months ago. Safety IV Catheters found expired 2018, 9 months ago.

Anesthesia laryngoscope blades stored on crash cart and difficult intubation cart were sanitized and stored according to the manufacturer instructions. Laryngoscope blades were sterilized in surgical peel packs and left undated. There was no way to tell how long the blades had been stored in the packs.

An oxygen flowmeter in the crash cart was not covered or labeled. There was no way to determine if it was clean or dirty.


STERILE PROCESSING INSTRUMENT ROOM

Surgical instruments were stored in central supply instrument room past the date of guaranteed sterilization date by manufacturer (4 months past date of sterilization guarantee)


Review of IFU for Halyard Sterilization wrap revealed the following:

"Additional real time testing also supports maintenance of package sterility for Halyard Quick check and Halyard one step for:

1 year following pre-vacuum steam and EO
1 year following sterrad"

Review of IFU for Cardinal Health Sterilization Pouches revealed the following:

"Real time test supports maintenance of package sterility for 6 months after steam sterilization and 24 months after EO sterilization"

Review of the facility policy titled, "Guidelines for Infection Control" with a final approval date of 3/13/2018 revealed the following:

"Shelf Life will be defined as event related in that sterilized items are considered sterile unless there is loss of integrity of sterile packaging." The policy did not follow the manufacturer recommendations.



OR DEPARTMENT RETURN TO SURGERY LOGS/OCCURRENCES


Review of the Return to Surgery log revealed the following:

Patient #12

11-12-2018 Bilateral breast reconstruction with Bilateral implants
11-28-2018 Bilateral Mastectomy Simple

Patient #22

7-26-2018 Mastectomy Simple Left
8-21-2018 Mastectomy Simple Left

Patient #23
9-10-2018 Bilateral Modified Radical Mastectomy
10-8-2018 Incision and Drainage of Left Breast

Patient #24
5-22-2018 Mastectomy Simple
6-14-2018 Incision and Drainage of Left Breast

Patient #8
8-9-2018 Bilateral Modified Radical Mastectomy
9-4-2018 Reconstruction Breast with implant Bilateral
9-18-2018 Reconstruction of breast with implant (Right)

The return to surgery log did not list the indication for the second surgery, nor did it indicate if an investigation was initiated.

The surgery department did not ensure that any surgical case, specifically implant cases, that required a return to surgery for complication or infection were identified and investigated.


During an interview with Staff # 15 on 12-6-2018 at 9:51 am revealed the following:

Staff #15 was asked the Surgery Committee meetings addressed any of the problems identified on the return to surgery log. Staff #15 said he was not aware of any discussion on the issue. Staff #15 was asked if occurrence reports were filed on any return to surgery that indicated a complication/infection from previous surgery. Staff #15 said he was not aware of any occurrences and had not investigated any that he could remember.


Review of Patient #8's medical records reveal the following:

6-14-2018 Left Breast Biopsy
8-9-2018 Bilateral Mastectomy with reconstruction placement of bilateral breast implants.
9-4-2018 Bilateral suprapectoral prosthetic placement of breast implants
9-18-2018 Removal of Right breast infra and supra pectoral breast implants/ replacement. Right breast incision was noted to have a dehiscence of approximately 3 cm with exposed silicone implant. Staff #16 noted the dehiscence was likely due to non-compliance and no evidence of surgical site infection.


Review of Patient #8's medical record from facility B revealed the following:

Patient #8 presented to the Emergency Room at facility B on 9-23-2018. Review of the "Emergency Room Visit Notes" revealed the following:


"Patient is a 47 year old female who presents with tenderness and redness to incision sites of bilateral breasts with leaking from right side ...Patient underwent bilateral mastectomy on 8/9/2018 with bilateral implants/reconstruction on the same day by Physician #16 with two implants in each breast area ... Patient said on 8/12/2018 the right side began to leak, on 8/13/2018 she was seen in the office and Physician #16 sutured the area that was leaking ....On 9/3/2018 the area was leaking and she was seen in the office and on 9/4/2018 she underwent removal of implants and insertion of new set of implants bilaterally ....On 9/14/2018 she stated the right side began leaking again she was seen in the office on 9/17/2018 and on 9/18/2018 Physician #16 removed the right side implants and inserted new implants on the right side only ....On 9/23/2018 the site began leaking again she was seen in the office on 9/24/2018 and Physician #16 sutured the area ...On 9/25/2018 the leaking worsened and on 9/27/2018 she had the sutures applied by a nurse in the office. Today she contacted another physician (#17) for a second opinion who advised her to go to the ER."


Review of the consult note revealed a phone call made to physician #17's office. There was a notation that office staff spoke with #17 and instructions were given to have patient #8 follow up in physician #17's office on Monday 10/1/2018 at 10 AM.

An additional emergency room visit was noted in the record on 9-3-2018 for complaints of small area of dehiscence in the incisional site. The ED record shows phone consult with physician #17. Physician #17 instructed ER to discharge patient and instruct patient #8 to continue antibiotics and keep appointment with him 10/1/2018 at 10 AM.


Review of the History and Physical from 10/1/2018 by physician #17 revealed the following:

"Review of Systems

Breasts: Reveals cellulitis throughout the inferior aspect of her breasts bilaterally. There is a 3.5 x 3 cm open wound with the implant exposed."

"Plan

Incision and Drainage of bilateral breasts with removal of both implants, bilateral breasts. She is aware that removing her implants she is gravida flat, hollow, deflated appearing breasts. She will need further reconstruction in order to improve this result. She understands these implants were infected and they need to come out."


Review of the operative note dated 10/2/2018 revealed the following:

"Pre-Operative Diagnosis:
Infected breast bilaterally, breast abscesses bilaterally, open wound of right breast with exposed breast implant."

"Post-Operative Diagnosis:
Infected breast bilaterally, breast abscesses bilaterally, open wound of right breast tissue with exposed right breast implant. In addition, she has a right breast ruptured implant (puncture wounds noted on periphery of implant), a ruptured left breast submuscular silicone implant."

Patient #8 was listed on the return to surgery log three times in 45 days. There was no investigation initiated in these returns.



FOLEY CATHETER PLACEMENT (OR1 Patient #1)

During a tracer observation on 12-5-2018 at 9:32 AM the following was observed:
Staff #24 was observed inserting a Foley catheter into Patient #1. Staff #24 was observed to open the labia. Staff #24 then used a 4x4 sponge soaked in betadine and starting cleansing the patient. Staff #24 was observed to place the betadine sponge at the urinary meatus and swipe down cleaning the patient. Staff #24 then using the same 4x4 sponge swiped up from bottom and went back up to the ureteral meatus. This process was done twice.

After completing foley insertion, Staff #24 repositioned the patient and began the surgical prep. Staff #24 was observed to prep using chloraprep. Staff #24 was observed to swipe around top of abdomen and touch blanket with the prep sponge. Staff #24 did this two times during the prep. Staff #24 did not stop and get new prep after contaminating the prep sponge.

Review of Lippincott guidelines for urinary Foley insertion (Female) dated November 2017 revealed the following:

" ...Separate the labia majora and labia minora as widely as possible with the thumb, middle, and index fingers of your non-dominant hand so that you have a full view of the urinary meatus. Keep the labia separated throughout the procedure so that they don't obscure the urinary meatus or contaminate the area when its cleaned.

...With you dominate hand, use an antiseptic swab or, using plastic forceps,, pick up a cotton ball soaked with sterile antiseptic, sterile water, or sterile saline to clean the labium minus furthest from you using a downward stroke; then discard the swab or cotton ball ..."




STERILE PROCESSING SUPPLY STORAGE ROOM (WRAPS, PEEL PACKS, STERILIZATION SUPPLIES)

Instrument protector sheets used during sterilization of surgical instruments were stored in a bin in the Sterile Processing supply room with a buildup of dust and debris. External shipping cardboard boxes were stored above the protector sheets and next to surgical instrument wraps used during sterilization of instruments.

PATHOLOGY ROOM IN SURGERY

A Pathology room in the Operating Room had Instruments stored on top of the counter in open bin. Instruments were not labeled clean/dirty. The countertop was in disarray. An Americlear clearing solvent used in histology procedures in the pathology room of the surgery department. The jug was found to be open and not labeled with a Beyond use date labeled on the bottle.


STERILE PROCESSING AUTOCLAVE ROOM

Two autoclaves in the sterile processing room were covered with a brown/rust colored substance on all of the inside walls of the autoclave.

Review of Steris invoice dated 10-16 to 10-17-2017 showed cleaning of the autoclaves at the facility. The invoice noted the chambers had been professionally cleaned using a combination of mechanical and chemical actions to remove residues from inside of the chamber walls.

Staff #15 said the chamber of the autoclaves had not been cleaned since 10-17-2017. Staff #15 said the facility did not have a schedule for chamber cleaning of the autoclave.


OR #3

The walls had multiple missing chips and scrapes that exposed sheetrock in OR #3. The wheel casters in operating room #3 had chips missing in the protective coating and rust on the wheel casters and base of the operating table. There was a buildup of dust, dirt, and debris in a cabinet in operating room #3 that stored sterile supplies.

Sevoflurane anesthesia gas was found opened and undated in OR Room #3. The anesthesia gas container was found to be open and not labeled with a Beyond use date labeled on the bottle.The anesthesia gas was stored with an adapter lid on it exposing the operating room to leaks of anesthesia.


STERILE PROCESSING CLEAN AREA

Sterile Processing clean room had splash guards for equipment stored in wire baskets. Sterile instruments/supplies were observed stored in a wire basket shelve with no splash guard exposing items to contamination from splashing when floor was mopped/cleaned.


OR ATTIRE

The staff were observed in Operating room #1 during a surgical procedure not wearing shoe covers. Staff #15 said the Operating room staff wore dedicated operating shoes; however, several of the shoes observed were discolored and had brown stains indicating they were worn outside of the operating room.


Review of the facility policy titled Dress Code: Restricted areas with a final approval date of 5/10/2016 revealed the following:

"...Shoe covers will be worn over shoes when employee is wearing shoes from outside hospital."



Staff #3 and #15 confirmed the above findings.




Review of the facility policy titled, "Infection Prevention and Control Program Plan" with a final approval date of 5-8-2018 revealed the following:

"Surveillance
3. Regularly conducting tours of the physical attributes of the facilities to ensure that risks for transmission of disease or occupation hazards are maintained and a sanitary hospital environment is maintained."


Staff #3 and #15 confirmed the above findings.




Review of the facility policy titled, "Infection Prevention and Control Program Plan" with a final approval date of 5-8-2018 revealed the following:

"Surveillance
3. Regularly conducting tours of the physical attributes of the facilities to ensure that risks for transmission of disease or occupation hazards are maintained and a sanitary hospital environment is maintained."


Review of the Surgery Committee Meeting Minutes dated July 31, 2018 revealed the following:

"Topic
Surgery Committee Routine Agenda Items

Findings/Conclusions
...4. Unplanned Return to Surgery - January we had 1, general surgery; February we had 1, CV case; March we had 2, 1 general surgery and 1 was spine; none in April; May we had 1, general surgery. Staff #6 stated she had a couple of issues for closed session.

Recommendations/Actions/Follow Up
...Informational"

Review of the facility document titled, "The Medical Center of Southeast Texas Port Arthur Campus Environment of Care Rounds results dated 10-26-2016 revealed the following:
"Infection control

Issue

OR1 the nasal airways on the Pedi cart are not individually wrapped.
Corrective Action Plan
Placed nasal airways in individual bags. Future purchases will be individually contained."

There were no issues noted on the infection control rounds that identified the unsanitary environment findings listed above. Staff #6 confirmed there were no additional Infection control rounding sheets.

Based on interview and record review, the facility failed to ensure surgical privileges were delineated according to competencies for the types of surgical procedures that were being performed in 1 of 2 surgery departments (off-site campus). The facility failed to:

A. ensure surgeons provided surgical services that they had privileges to perform. The surgeon performed surgical procedures which were not listed on his approved privileges form on 2 of 24 sampled patients (Patient #'s 12 and 14).

Patient #14 had a mastectomy 4 years ago and breast implants placed in 1 year ago from an outside surgeon. Staff #16 (facility's surgeon) removed a breast implant on 09/04/2018. Attempted to place a larger breast implant in Patient #14 and changed his mind. The implant was removed and Patient #14's incision was closed. The procedures performed was not listed on the surgeon's approved privilege list. A request was made by surgery staff to administrative staff to check the surgeon's privileges and this was not done.

Patient #12 was 4 months post-operative for a mastectomy with insertion of breast implants and removal 1 month later by another surgeon.

Patient #12 received breast implants during a surgery on 09/24/2018 by Staff #16 (facility' s surgeon).

Patient #12 returned on 11/12/2018 for surgery. Patient #12 had returned because one of her breast implants had fallen out in the shower and the other was bulging out through an opened incision. During the surgery on 11/12/2018, Patient #12 received removal of the old implants and new implants were placed in. The first assist was allowed to completely suture up one of the breast incision and this was not listed as a task she had privileges to perform.
The procedures performed was not listed on the surgeon's approved privilege list.


It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment and /or subsequent death.


B. ensure surgical assistants were not performing procedures which were not listed on their privileges. The surgical assistants were administering anesthetic injections and performing nerve blocks. This deficient practice was found in 4 of 21 sampled patients (Patient #'s 2, 3, 10 and 14).


C. ensure ultrasound techs working in the surgery area had training and competencies related to the surgery area. The ultrasound tech received a needle stick during a surgical procedure. The surgeon used the same contaminated needle during a surgical procedure on Patient #11. The facility failed to put a system in place to prevent this from occurring again.


Refer to tag A0945 for additional information.



39801




SITE MARKING

D. The facility failed to ensure that the physician marked a surgical site according to facility policy in 1 of 1 patients observed. (Patient #3)

During a tracer observation on December 5, 2018 after 2:00 PM the following was observed:

Patient #3 was a 53 year old male who was admitted for Right inguinal hernia repair. Physician #16 was listed as the surgeon on the case.

Observed Staff #25 at the beside talking with Patient #3 at 2:15 PM. Staff #25 put the medical record on the bed and started leaving pre-op area. Staff #25 was asked if Physician #16 had spoken with the patient. Staff #25 said I think so. Staff #25 went to check the pre-op board and relayed that the physician had seen the patient. Staff #25 was then asked if the physician had marked the surgical site, as this was a laterality procedure. Physician #16 walked up to the bed at that time and stated, "Yes, the patient has been marked." Physician #16 was asked how he marked site. Physician #16 closed the pre-op curtain and laid back covers to reveal a X on right lower groin area. Physician #16 was asked who marked the groin. Physician #16 confirmed he did.

Observation of the site did not reveal any initials or other evidence to indicate who marked the site. Review of the medical record did not reveal any further documentation on site marking.

Review of the facility policy titled, "Universal Protocol" with a final approval date of 10/26/2017 revealed the following:

"Site Marking: The purpose of site marking is to clearly identify, without ambiguity or doubt, the intended site of the procedure. Site marking is done by the proceduralist using his/her initials. The method of marking and the type of mark will be clearly defined in writing and consistent throughout the organization ...

...Site Marking Requirements & Exemptions:
Procedures exempt from site marking are:
Midline, single organ procedures as well as endoscopies without intended laterality;

...When to mark the site:
The procedure site will be initially marked before the patient is moved to the location where the procedure will be performed and takes place with the patient involved, awake and aware if possible.
In the surgical setting, this marking is to be accomplished before the patient leaves the surgical holding area.

Responsibility for Marking the Site:
1. The procedure site is marked by the physician or other provider who is privileged or permitted to perform the intended procedure (proceduralist).
2. The proceduralist will mark the site with his/her initials at or near the procedure site or incision site, with or without a line representing the proposed incision (if no line is used, the initials mark the site).





TEMPERATURE AND HUMIDITY

E. The facility failed to ensure the temperature in the Operating room (OR) was within acceptable standards to inhibit microbial growth, reduce the risk of infection, promote patient comfort and assure the physical safety of all patients. The temperature was out of range of 69 of 91 days reviewed. There was no documentation on the log to indicate corrective action taken and the temperature on follow up after corrective action was done.

SEPTEMBER 2018

Review of the Temperature Logs for September 2018 revealed the following:

Specialty Room 2 - The temperature was documented out of range 8 of 30 days.
Specialty Room 3 - The temperature was documented out of range 9 of 30 days.
Sterile Supply - The temperature was documented out of range 14 of 30 days.
Tissue Room - The temperature was documented out of range 3 of 30 days.

OCTOBER 2018

Review of the Temperature Logs for October 2018 revealed the following:

OR 1 - The temperature was documented out of range 4 of 31 days.
OR 2 - The temperature was documented out of range 2 of 31 days.
OR 3 - The temperature was documented out of range 2 of 31 days.
OR 4 - The temperature was documented out of range 3 of 31 days.
OR 5 - The temperature was documented out of range 5 of 31 days.
Specialty Room 2 - The temperature was documented out of range 30 of 31 days.
Specialty Room 3 - The temperature was documented out of range 29 of 31 days.
Sterile Supply Room - The temperature was documented out of range 11 of 31 days.
Tissue Room - The temperature was documented out of range 16 of 31 days.


NOVEMBER 2018

Review of the Temperature Logs for November 2018 revealed the following:

OR 3 - The temperature was documented out of range 1 of 30 days.
Specialty Room 2 - The temperature was documented out of range 7 of 30 days.
Specialty Room 3 - The temperature was documented out of range 21 of 30 days.
Sterile Supply - The temperature was documented out of range 25 of 30 days.
Tissue Room - The temperature was documented out of range 24 of 30 days.

Review of the AORN Perioperative Standards and Recommended Practices,

"Temperature should be maintained between 68 degrees F to 73 degrees F (20 degrees to 23 C) within the operating room suite and general work areas in sterile processing.

Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas.

Low humidity increases the risk of electro static charges, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed.

Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation, and air conditioning) system.

Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation, and air conditioning) system."

Based on interview and record review, the facility failed to ensure surgical privileges were delineated according to competencies for the types of surgical procedures that were being performed in 1 of 2 surgery departments (off-site campus). The facility failed to:

A. ensure surgeons provided surgical services that they had privileges to perform. The surgeon performed surgical procedures which were not listed on his approved privileges form on 2 of 24 sampled patients (Patient #'s 12 and 14).

Patient #14 had a mastectomy 4 years ago and breast implants placed in 1 year ago from an outside surgeon. Staff #16 (facility' s surgeon) removed a breast implant on 09/04/2018. Attempted to place a larger breast implant in Patient #14 and changed his mind. The implant was removed and Patient #14's incision was closed. The procedures performed was not listed on the surgeon's approved privilege list. A request was made by surgery staff to administrative staff to check the surgeon's privileges and this was not done.

Patient #12 was 4 months post-operative for a mastectomy with insertion of breast implants and removal 1 month after that from another surgeon.

Patient #12 received breast implants during a surgery on 09/24/2018 by Staff #16 (facility's surgeon).

Patient #12 returned on 11/12/2018 for surgery. Patient #12 had returned because one of her breast implants had fallen out in the shower and the other was bulging out through an opened incision. During the surgery on 11/12/2018, Patient #12 received removal of the old implants and new implants were placed in. The first assist was allowed to completely suture up one of the breast incision and this was not listed as a task she had privileges to perform.
The procedures performed was not listed on the surgeon's approved privilege list.

It was determined that this deficient practice posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment and /or subsequent death.


B. ensure surgical assistants were not performing procedures which were not listed on their privileges. The surgical assistants were administering anesthetic injections and performing nerve blocks. This deficient practice was found in 4 of 21 sampled patients (Patient #'s 2, 3, 10 and 14).


C. ensure ultrasound techs working in the surgery area had training and competencies related to the surgery area. The ultrasound tech received a needle stick during a surgical procedure. The surgeon used the same contaminated needle during a surgical procedure on Patient #11. The facility failed to put a system in place to prevent this from occurring again.




Findings include:





SURGEON/FIRST ASSIST


Patient #14


Review of clinical record of Patient #14 revealed she was a 69 year old female who had diagnoses which included breast cancer.

Review of an office clinic note dated 08/07/2018 revealed the following:

"Patent presents with a history of breast cancer with mastectomy greater than 4 years with outside surgeon.
Bilateral reconstruction with silicone implants 1 year ago by outside surgeon.
Patient presents after MRI showing a small area of concern on the right breast.
We will plan for removal of ruptured implant and right capsulectomy with replacement of silicone implant right breast."

A capsulectomy is the surgical removal of scar tissue, or capsule that has become thickened and hardened around a breast implant.



Review of Staff #16's (surgeon) implant order form dated 08/10/2018 revealed an order for two 800 cc breast implants.


Review of an operative note dated 09/04/2018 (day of surgery), revealed Patient #14 had a right breast capsulectomy and right complex wound closure.


Review of an occurrence report dated 09/04/2018 revealed that Patient #14 had 1 previous breast implant placed on prior surgery of 250 cc silicone. Today scheduled for removal of ruptured implant, right breast capsulectomy and replacement of right breast silicone implant. During surgery Staff #16 (Surgeon) removed the original implant, cultured site, asked circulator size of implants we have available. He was told that 800 cc was what we were directed by his office to order for the patient. He replied back he wanted 300 cc implants and asked why we don't have any ....He implanted the 800 cc implant them removed it, washed out the site and closed the patient up. His op note does not make mention of any implant being placed or removed.

There was documentation by Staff #15 on 09/04/2018 that the implant was wasted. There was documentation to "Please review privileges granted versus what procedure performed. Review op note. Probably listed as staged reconstruction."

Review of an operative note dated 09/04/2018 (day of surgery) on Patient #14 revealed no documentation of the attempt to place the 800 cc breast implant and removing it.

There was no replacement of the breast implant performed on 09/04/2018 as scheduled..



During an interview on 12/06/2018 after 9:30 a.m. the following was stated;

Staff # 12 confirmed she received the report and she documented that it needed further investigation. The information had been sent to Staff #6 (Quality).

Staff #6 (Quality) reported that she had not seen the occurrence report and knew nothing about the incident. There had been no investigation on it as of today (12/06/2018).

Staff #15 confirmed he turned the incident in. Staff #15 reported they (surgery department) needed clarification on what immediate reconstruction versus patients being brought in for removals and replacements of breast implants. What was done during the surgery was not listed on the clinical privileges.





Patient #12


Review of the clinical record of Patient #12 revealed she was a 63 year old female who had diagnoses which included asthma, hypertension and breast cancer.

An office clinic note dated 08/28/2018 revealed Patient #12's chief complaint was "4 mo. post mastectomy with implants/implant removal after 1 mo". Patient #12 presented for check of tissue flaps for possible reconstruction surgery ...The plan was for a capsulectomy with placement of silicone implants bilateral with reconstruction.

Review of an operative report dated 09/24/2018 (day of surgery) revealed the following:

"PreOperative Diagnosis

History of breast cancer and treatment outside facility and surgeon presents for immediate reconstruction following completion mastectomy."

According to the report Patient #12 had the following surgical procedures performed on 09/24/2018:
Right Capsulectomy
Left capsulectomy
Right insertion of breast prosthesis 600 cc silicone implant
Left insertion of breast prosthesis 600 cc silicone implant
Right tissue defect with rearrangement..
Left tissue defect with rearrangement..
Right Complex wound closure ...
Left Complex would closure ...


Review of an office note dated 11/06/2018 revealed the following on Patient #12:

"Presents status post bilateral implant placement
Post op superficial necrosis and dehiscense
Plan exposed to the air
Patient is a former smoker
History of delayed wound healing
Plan for removal and replacement of implants with capsulectomy and reconstruction 350 and 400 cc silicone implants and 400 cc saline implants on hand"


Review of an operative report dated 11/12/2018 (day of surgery) revealed the following:

"PreOperative Diagnosis

"Status post bilateral skin nipple areolar sparing mastectomy with immediate reconstruction with need for silicone implant change."

PostOperative Diagnosis
Status post bilateral skin nipple areolar sparing mastectomy with immediate reconstruction with need for silicone implant change out secondary to superficial necrosis nonhealing type secondary to tobacco use and delayed wound healing."


According to the operative report Patient #12 had the following surgical procedures performed on 11/12/2018:

"RIGHT Repair complex trunk ...
LEFT Repair complex trunk ...
Right adjacent tissue rearrangement defect..
Adjacent tissue rearrangement defect..
Left removal of intact mammory implant..
Right periprosthetic capsulectomy
Periprosthectic capsulectomy
Right immediate insertion of breast prosthesis following reconstruction..
After immediate insertion of breast prosthesis following reconstruction ...
..repair complex trunk x 2 on the right x2 on the left ...."

Review of Surgical Procedures -Operating room notes dated 11/12/2018 revealed the following documentation:

"LEFT BREAST WOUND CLOSURE BY Staff #20 (First assist) RIGHT BREAST WOUND CLOSURE BY Staff #16 (Surgeon) AND Staff #20 (First assist)."



During an interview on 12/5/2018 after 11:40 a.m., the following was reported about Patient #12:

Staff #10 and Staff #13 reported Patient #12's right breast implant had fallen out in the shower and the other side was eroded when she came to them on 11/12/2018.

Staff #10 reported that Staff #20- first assist was allowed to close wounds from the bottom to the top (meaning all tissue layers).



During an interview on 12/06/2018 after 9:30 a.m., following was reported:

Staff #10 confirmed the documentation in the record about the wound closure on Patient #12. Staff #10 reported witnessing Staff #20-first assist, performing the complete closure on the left breast incision.

Staff #15 confirmed staff had reported to him about Staff #20 closing incisions and that immediate supervision was needed. Staff #15 reported they (surgery department) needed clarification on what immediate reconstruction versus patients being brought in for removals and replacements of breast implants. What was done during the surgery was not listed on the clinical privileges.





Review of "NON-PHYSICIAN SURGICAL ASSISTANT Specific Policies and Delineation of Services" form signed off by Staff #16 -Surgeon and Staff #20 - first assist on 05/31/2018 revealed the following:

Individual surgical assistant may provide only those services specifically authorized for him."Incisions and excisions are PROHIBITED!"
May not provide professional services to a patient whose problem or condition is outside the scope of privileges granted to the supervising physician."


Review of the privileges revealed Staff #20 (First assist) could suture skin and suture subcutaneous tissue.

There was no documentation of Staff #20 (First assist) being able to perform a complete incision closure.






Review of the "GENERAL SURGERY Qualifications for Clinical Privileges" form for Staff #16 (Surgeon) dated 03/27/2018 revealed he had been given privileges for the following;

"Excision of breast lesion, breast biopsy
Complete mastectomy
Partial mastectomy ...
..Bilateral Mastectomy with Immediate Reconstruction using Silicone Implants Supra Pectoral.."


Review of a facility's plan dated 12/10/2018 revealed the facility's definition of Immediate reconstruction was

"Immediate insertion of breast prosthesis following mastopexy, mastectomy or in reconstruction to improve the psychological well-being of our patients."



Both surgeries performed did not meet the facility's definition for immediate reconstruction.








FIRST ASSIST




Review of the clinical record revealed the following:


Patient #2

Review of an operative report dated 12/05/2018 revealed Patient #2 had a laparoscopic lysis of adhesions.

According to the operating room medication administration documentation Staff #20 (First assist) administered injections of the anesthetic agent Sensorcaine subcutaneous.

Patient #3

Review of an operative report dated 12/05/2018 revealed Patient #3 had a right inguinal herniorrhaphy with mesh placement and right iloinguinal nerve block.

According to the operating room medication administration documentation Staff #20 (First assist) administered injections of the anesthetic agents Sensorcaine and Lidocaine subcutaneous. According to documentation on the form Staff #20 (First assist) performed a local and femoral block (an analgesic technique that blocks sensation).


Patient #10

Review of a Perioperative record dated 08/27/2018 revealed Patient #10 had a "Mastectomy Modified Radical BILATERAL BREAST IMPLANT REPLACEMENT WITH RECONSTRUCTION."

According to the operating room medication administration documentation Staff #20 (First assist) administered injections of the anesthetic agents Sensorcaine subcutaneous.

According to a progress note dated 11/08/2018 revealed Patient #10 had a left breast implant placement with capsulectomy and reconstruction.

According to the operating room medication administration documentation Staff #20 (First assist) administered injections of the anesthetic agents Sensorcaine and Lidocaine subcutaneous.


Patient #14


Review of an operative note dated 09/04/2018 revealed Patient #14 had a right breast capsulectomy and right complex wound closure.


According to the operating room medication administration documentation Staff #20 (First assist) administered injections of the anesthetic agents Sensorcaine and Lidocaine subcutaneous.





Review of "NON-PHYSICIAN SURGICAL ASSISTANT Specific Policies and Delineation of Services" signed off by Staff #16 -Surgeon and Staff #20 - first assist on 05/31/2018 revealed no documentation that Staff #20 (First assist) could administer injectable anesthetic medications and perform nerve blocks.





ULTRASOUND TECH WORKING IN OR


Review of the clinical record on Patient #11 revealed she was a 55 year old female who presented to the on 08/01/2018 for a radiofrequency ablation of the right greater upper saphenous vein (varicose vein treatment).

Review of occurrence reports revealed that on 08/01/2018 that Staff #14 (ultrasound technician) received a needle stick during the surgical procedure on Patient #11. According to the report Staff #16 (Surgeon) stuck Staff #14 (ultrasound tech) and with the same needle stuck Patient #11.

Review of the report revealed Staff #16 (surgeon) reported he did not know he stuck Staff #14. Staff #14 ultrasound tech reported she was afraid to alarm Patient #11.

The resolution was to test Patient #11 and Staff #14 (ultrasound tech). Staff #14 was talked to and told to speak up.

During an interview on 12/05/2018 after 9:30 a.m., Staff #12 confirmed the date the incident occurred and their resolution.

During an interview on 12/05/2018 after 2:00 p.m., Staff #14 (ultrasound tech) reported during the procedure she had her hand on the wand on the ultrasound scanning down the vein. Staff #16 (surgeon) had the needle going in and out of the vein.. Staff #14 reported she hollered when he stuck her and pulled her hand out. It startled Patient #11. Patient #11 asked her what's wrong and she said everything is okay. Staff #16 (surgeon) asked her if she was okay and she replied "I will be fine". Staff #14 reported she did not realize the physician had used the same needle and she thought he knew he had stuck her. Staff #14 reported she had assisted with the procedures in the physician's office, but she did not know any thing about the surgery area. The only thing she had been trained in is what to put on in the surgery area. They had talked to her about speaking up,but there had not been any training on prevention of needles stick after the incident.


During an interview on 12/05/2018 after 2:20 p.m., Staff #6 (Quality) confirmed they knew about the incident and were tracking it.

During an interview on 12/06/2018 after 9:00 a.m., Staff #15 reported that he had not talked to surgery staff about needle stick prevention after the incident. He left the issue up to the ultrasound tech's supervisor.

During an interview on 12/06/2018 after 9:40 a.m., Staff #18 and 19 (administrative staff over radiology) confirmed Staff #14 did not have training in relation to working in the surgery area. They had just developed a competency for her..