The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

Based on record review and interview the facility failed to ensure the governing body placed patient safety and quality of care as a high priority in care of surgical patients and professional accountability of medical staff and employees. Specifically, the governing body failed to ensure:

1) A consistent culture of safety;

2) It acted promptly to safety concerns that had the potential to adversely affect patients; and

3) Systematic processes to prevent adverse events from reoccurring. These failed practices constituted an immediate jeopardy of the governing body lack of oversight in surgical services and placed patients at risk for harm and/ or death.

The facility administration was notified of the immediate jeopardy on 2/23/17. The facility submitted an acceptable abatement plan on 2/27/17. Findings:

In summary, the Governing Body, which included the Board of Directors, the Chief Exectutive Officer, and all Directors failed to ensure a culture of safety amongst staff and patients. Multiple forms of communication and documentation were reviewed over a 1 year time frame.

What should have prompted the resolution to multiple complaints and incident reports created immediate jeopardy to patients receiving surgical services in the facility. Refer to Citations C 278 and 320.

Based on interview and record review the infection prevention committee failed to identify and investigate potential surgical site infections after the Medical Director had been made aware of non-medical refurbished surgical instruments having been used during lumbar surgeries. This failed practice: 1) placed all patients who had lumbar surgeries during the timeframe, the refurbished surgical instruments was used, at risk for a surgical site infection and 2) denied the infection prevention committee the knowledge of patients having surgical site infections, post surgery. Findings:

Infection Control Committee Medical Director (ICC MD)

During an interview on 2/23/17, the ICC MD was shown a refurbished surgical retractor, which had been welded with a black coating applied. The retractor appeared to have had extensions welded onto either side of the handle. The retractor also had a black paint like coating that was grossly chipped along the blade of the retractor. Closer observation of the modified retractor, with the ICC MD, revealed the black coating easily chipped off.

During the same interivew the ICC MD confirmed the the paint chipping off the refurbished retractor, used in a body cavity, i.e., lumbar surgery, could increase the potential risk of infection.

The ICC MD stated s/he became aware of a refurbished retractor being used by an Orthopedist on staff at the hospital in September of 2016 and that was reported to the Board of Directors (BOD) during the October 2016 meeting. The ICC MD was not clear how long the refurbished retractors had been used. The ICC MD was not aware of follow-up investigations of potential surgical site infections that were not readmitted . In addition, s/he stated s/he was not aware if the Infection Control Committee had been made aware of the retractor finding.

During an interview on 2/22/17 at 10:30 am the Operating Room (OR) Manager stated the retractor, as near as s/he could ascertain from staff, had been refurbished 2-3 years ago.

The OR Manager, the Director of Nurses, and the Quality/Risk Director had communicated through email with the contract instruments sales representative who stated IMS-Integrated Medical Systems had no record of receiving a retractor for ebonization or coating clear back to 2008.

Record review of the list of patients (provided by the hospital coders) who had lumbar surgeries from 1/2015 - 9/9/16, revealed 71 patients.

During multiple interviews on 2/22-23/17, sugical staff confirmed the refurbished retractor had been in use for at least 2 years and stated the retractors had been used on patients having lumbar surgery.

Infection Control Committee Minutes

Record review of the ICC minutes from 1/1/16 - 2/23/17 revealed no documented discussion of the refurbished retractor.

Review of the March 2, 2016 ICC minutes revealed, a hospital acquired infection listed with a note stating the patient, who had a lumbar procedure, was on 6 weeks of intravenous antibiotics for a hospital acquired surgical site infection.

Further review of the IP's more detailed surveillance documentation for the lumbar infection revealed nothing more than what would be found in the medical record. No surgical observations, no staff interviews and no sterile processing surveillance had been done. In addition, no surveillance had been requested to be done in the OR by the committee.

During an interview on 2/22/17 the Infection Preventionist stated s/he looked at culture results and readmissions to capture surgical site infections after patients were discharged from the hospital. In addition, The IP stated the committee was working on sending 30 and 90 day questionnaires to surgeons for postoperative information for their patients regarding infections. The expectation would be that the surgeons would report that information back to the ICC so they could monitor any surgical site infections. The ICC stated the surgons had not been reporting any infections seen on outpatient basis.

Review of the Professional Standards from the Association for Professional for Infection Control and Epidemiology, 4th edition, revealed:

"Extrinsic factors that influence surgical site infections [SSIs] . . . surgical scrub; skin antisepsis; surgical attire; sterile draping; duration; antimicrobial prophylaxis;. Ventilation; ... sterilization ...; Surveillance for SSIs should include post-discharge follow up, given that up to 84% of SSIs are detected after the patient leaves the hospital setting... instruments and equipment should be maintained and serviced in accordance with the de-vice manufacturer's written instructions for use (IFU). Preventive maintenance requirements or recommendations are what the device manufacturer has determined as necessary to keep instruments and equipment in optimal working order."

C320 - Surgical Services

Based on interview and record review the facility failed to ensure: 1) a policy for the introduction of new or re-furbished surgical instruments and equipment were brought into the OR (operation room); 2) staff compliance with sterile processes; and surveillance of OR practices.

In summary, the surgical services department was not able provide quality safe care to all patients from the community for the use of home-made surgical devices for cervical traction and re-furbished surgical instruments used multiple times during lumbar surgeries. In addition, through interviews with staff in the OR and the newly hired certified surgical technician professional standards for the safety of the patients was not followed because of the multiple concerns expressed by them to leadership had been insufficient to change the practices. Surveillance in the OR was minimal, in that no documentation was provided, except for the immediate use steam sterilization rate.

These failed practices placed all patients receiving lumbar surgery in the OR in Immediate Jeopardy (IJ) for infection and/or injury and/ or death from inappropriately processed sterile equipment and/or injury and/or death from misuse of medical devices.

The facility was notified of the Immiate Jeopardies on 2/23/17. The facility submitted an abatement plan that removed the immediate threat to patients' safety on 2/28/17.

Record review was from 2/22-23/17.

Record review revealed homemade equipment was used on patients during surgical surgeries. Specifically, 1 homemade cervical traction device and 2 refurbished metal retractors. One retractor had welded handle extensions and 2 retractors had been coated with a black paint like substance that chipped.

Cervical Traction

Record review revealed [Patient Name] had a surgical procedure performed, on 9/13/16, "C[cervical] 4-5, C5-6, and C6-7 anterior cervical discectomy, and fusion using acuity cervical plating and cortical cancellous allograft bone." The operative report revealed " ...Ten pounds of cervical traction was applied to head halter." The head halter was attached to the cervical traction device for the purpose of stabilizing the spine during the surgical procedure.

Review of the Director of Quality (DQR) summary email sent to the Director of Nurses and the OR Manager after the 10/5/16 at 2:48 pm meeting with the Orthopedist revealed: Situation . . . 2) personally designed (personal design manufactured at a local shop) pulley system? This part attaches to the bed. The ropes from the chin strap are threaded through the grooved wheel allowing a weight to hang free providing necessary cervical traction ....Our surgeon contends this part is more stable than current FDA approved models resulting in safer patient care ... our surgeon contends there is no infection control risk because this part does not touch the patient ... Our surgeon would like to use the above mentioned instrument in surgery based on the fact he feels this provides optimal patent safety thorough advanced safe work practice."

During an interview on 2/22/17 at 3:05 pm the OR Manager was asked about the cervical traction that was used on Patient #2 during on 9/13/16. The OR Manager stated s/he had not been aware of a homemade cervical traction device having been used prior discovery in late September of 2016. In addition, stated once s/he was aware of the device, notified the Director of Quality, and had OR Staff #1 remove the device from service.

During interview on 2/23/17 at 7:28 am, when asked if the facility was using equipment that had not come from a surgical instrument manufacturer, OR Staff #2 stated "Yes" there was a cervical traction used in the OR. H/he stated it was seen yesterday morning (2/22/17) with the other OR equipment. OR Staff #2 said someone had told him/her it was homemade by OR Staff #1 and that it had also been removed from the facility.

During an interview on 2/23/17 at 8:25 am, when asked about the cervical traction equipment that was used in the operating room, OR Staff #1 stated the "Traction is homemade by me and someone else" and "[Orthopedist #1] and [Surgeon #1] approved the traction." When asked if the homemade traction device had been discussed with the OR Manager, s/he could not recall.

Lumbar Trays

During an interview on 2/23/17 at 7:45 am OR Staff #2 stated there were 2 Lumbar surgical trays where the lumbar reactor would have been placed in for sterilization.

During an observation on 2/23/17 at 9:00 am the Contract Certified Sterile Technician (CST) was asked to examine the instruments in the 2 lumbar surgical trays. The CST was asked to pull any instruments in the trays that should not be present in the trays due to biofilm, rust, damage, or pitting.

The CST removed the following items from the sterile lumbar trays and stated they should not have been in the trays: two instruments with worn tape around the ends of the instruments; 2 damaged instruments that would require replacement; and an approximate 5" U-shaped piece of metal with large, wide and deep letter engravings on one side. The engraving did not appear professionally done.

During this same observation and interview, when asked the CST, OR Staff #2, and OR Manager stated the u-shaped metal, with engraving on one side, was not a FDA approved medical instrument or device, and it appeared to have been engraved nonprofessionally. All three persons stated it should not have been sterilized for use in the OR.

During this same observation and interview OR Staff #2 stated the u-shaped metal had been sterilized multiple times at the request of the OR Staff #1 who stated the Orthopedist required the u-shaped metal for collecting, then replacing bone fragments during a lumbar surgery.


Review of a "SBAR [Situation, Background, and Recommendation] SURGICAL EVENT", dated 8/23/16, for [Patient name] surgery of 8/16/16, revealed ". . . When opening the case, it was noted the wrappers covering the spinal instruments and spinal implants (2 trays) had holes which contaminated the instruments and implants. . . The trays were taken to SPD for reprocessing and placed in the autoclave [machine used for sterilization] at 0738 [7:38 am] . . . with a 3 hour biological [indicator placed in the tray during sterilization to detect if sterilization had been met] . . . the instruments/implants would not be released for use until the biological was read at 11:45 [3 hours later]."

Further review of the SBAR revealed; "At 0810 [8:10 am] [OR Staff #1] informed [Orthopedist #1]" ... the instruments had 20 minutes left and asked [him/her] if [s/he] wanted to move forward "(both fully aware the instruments/implants were not to be released from SPD until the biological was read). . .[Orthopedist #1] said he wanted to go forward ... at 0813 [8:13 am] the Patient was transferred to the surgical suite. At 0820[8:20 am] [the [Assistant Operating Room Manager] (AORM)] became aware of the Patient transfer and instructed [staff names] to immediately stop the induction process. . ."

In addition the SBAR Surgical Event revealed "Assessment . . . reiterated to the staff that [AORM] is in charge of running the board [schedule of surgical cases] and that no one gives the go ahead for moving a patient to the room but [him/her] . . . Staff told not to take this direction from [OR Staff #1]."

Record review of an email sent from the DQR to the HR Director, OR Manager, and the DON, dated 9/28/16, revealed OR Staff #1 was told "no non-medical grade instrumentation could be used in surgery." Refer to "Confidential Memo" to the BOD dated October 2016, where the cervical traction was again used in the OR on 10/11/16.

Further review of the DQR email sent after the 10/5/16 at 2:48 pm to the HR Director, OR Manager, and the DON, revealed:

"Situation: 1) Modified retractor - handles extended bilaterally: Our surgeon feels the modified retractor offers safe patient handling . . . there is no infection prevention risk because the handle does not touch the patient . . ."

During interviews on 2/23/17 from 7:30 - 9:00 am with OR Staff #s 1, 2, and 3, that had performed sterile processing of surgical instruments over the last 12 months or longer. All 3 OR Staff were asked the same questions regarding what to look for during contamination of instruments before sterilization and what constituted a compromised instrument (could not be sterilized). Each of the 3 OR staff responded to the questions with the knowledge of best practice standards for when not to sterilize an instrument: not to sterilize instruments that did not functional as designed, or had evidence of pitting, chipping, or rust.

When questioned about the modified painted retractors, all 3 OR Staff stated they had seen the retractors placed in the orthopedic lumbar tray for sterilization.

During the interview OR Staff #2 stated the retractor had been in use 2-3 years. OR Staff #3 stated they had been in use since h/her employment in 2/2016. OR Staff #s 1, 2, and 3 all stated the retractors could not be effectively sterilized and should have been removed from service.

The OR staff # 2 and 3 stated they had been told to sterilize the retractors by the OR Manager(s), Orthopedist #1, and OR Staff #1.

During an interview on 2/22/17 at 10:15 am the Director of Quality/Risk (DQR) who reviews and compiles incidents/incident log for the hospital was asked for the incident log from September 2015 - January 2017.

During review of the log, from 2/22-23/16, the Director of Quality/Risk was asked for investigations with conclusions of the following incidents:

12/14/16 (Occurrence date): #OCR315 Received 12/18/16 "IP [Infection Prevention] MD asked for a formal plan of corrections on flash rate. 2 week deadline. As of 1/18 plan not received." Documentation reviewed, the rate was reported incorrectly.

1/4/16 (Occurrence date): # 3 Received 2/15/16 "Noted no sterile processing had been done since 12/18/15. Instruments not labled [labeled] with load #. OR Staff #1 stated he was going to go back and recreate documentation. (Crossover with 9)" There was no clear resolution on the follow up with the OR Staff #1.

8/16/16 (Occurrence date): # 8 Received 8/16/16 "Tears in wrapper of surgical trays. Accidently used 3 hr. biological instead of 1 hr. Pt was put on table, anesth [anesthesia] was administered. Pt had to be moved to the recovery room. It would still be 2 hours until biological could be read."

9/6/16 (Occurrence date): # 3, Received 9/7/16 "Surgical retractors have been altered by local welder. Treated with a coating that is chipping and peeling. Not medical grade." (Multiple emails between leadership, CEO, OR Manager, and facility Insurance agent) No clear resolution based on finding in the documentation. The altered surgical retractors were found at the time of the survey in the equipment hall of the OR.

1/5/17 (Occurrence date): #OCR268 Received 1/5/17 "Received instruments from 2 different ortho [orthopedic] cases w/dried [with dried] blood. Standard procedure is to begin decontamination in OR." OR Staff #1 had been given oral reprimand.

1/10/17 (Occurrence date): #OCR277 Received 1/10/17 "These are some of the instruments I received from OR tech on 1/10/17 total knee. (Photos received) ...SEE OCR 268"

2/1/17 (Occurrence date): #OCR344 Received 2/1/17 "After anesthesia induction noticed that TPS drill was contaminated. Re-processed. Additional hour of anesthesia for pt. [patient]. Pictures only.

1/20/17 (Occurrence date): #OCR345 Received 2/1/17 "Minor tray noted to have small hole in wrap prior to case. Contaminated tray isolated and major tray opened. No delay in case"

1/24/17 (Occurrence date): #OCR346 Received 2/1/17 "Upon inspection, wrapped spine tray had small hole in wrap. Pan isolated and replacement spine tray opened. No delay in case."

Documentation provided regarding the investigations and resolutions were minimal and incomplete.

Further review of multiple emails sent between the DQR, OR Manager, DON and the Insurance agent regarding # 3 Occurrence date 9/6/16, revealed:

"9/28/16 at 2:22 am " ...I have decided to meet with [OR Staff #1] and [Orthopedist #1] and [General Surgeon] to investigate the modified surgical tool ...As Risk Manager, I cannot in good faith answer to the BOD [Board of Directors] about an issue of this magnitude without personally investigating ..."

" 9/28/16 at 8:15 am to OR Manager "Question: when you send an instrument off to IMS isn't there paperwork you submit? And wouldn't you keep a copy for your records? So, if [OR Staff #1] sent this to IMS s/he would have the paperwork, correct?"

"9/28/16 at 8:16 am from OR Manager "We both would have the paperwork, IMS and us. We could not find it so we checked with them, they didn't have it either."

"9/28/16 at 8:34 am from OR Manager "I did not call any shops in town. There was welding done on two of the retractors to modify, the real problem for me was the coating someone put on the retractor because it is flaking off and looks like it was not professionally done. [OR Staff #1] argued that it was coming off because the drill bumps into, which is true. Does not negate the fact that the dipping was not done medical grade by a certified company with a product approved for being placed inside a human body."

"9/28/16 at 9:09 am from OR Manager "What I would like to see happen as a result of your investigation: boundaries re-established for processing of instruments and interacting with reps. Drilling down that [OR Staff #1]has no authority to modify any instruments or bring any instruments or equipment in for trial."

"10/20/16 at 10:11 am from Staff at Hudson Insurance Group "This e mail is in response to your question regarding the ongoing use and remediation of an altered surgical instrument at South Peninsula ...As discussed previously by phone, use of an altered medical device can void any warranties offered by the manufacturer and further complicate defense of any claim based on injury associated with the altered device. This should be made clear to your CEO [Chief Executive Officer]. Furthermore, any injury caused by this altered instrument requires a report under the Safe Medical Device Act (SMDA). An altered device might increase scrutiny by the FDA. Finally, the insurance policy will certainly address further use of altered instruments by way of exclusion. This should be clearly understood going forward ..."

Review of a "CONFIDENTIAL MEMO", dated October 2016, written by the Director of Quality and Risk (DQR) to the "BOD [Board of Directors] & PCCQC Executive Committee" revealed "Occurrence(s) submitted by [OR Manager]. 2 Surgical retractors altered by local welder. 1 treated with an "unidentifiable black coating" that is chipping and peeling and handle extended and another shortened. Non-FDA [Food and Drug Administration] approved medical equipment. Great Harm Event, equipment does not meet standard of care and is a liability issue to patients, staff and facility . . . Additionally, currently we have become aware of a personally designed . . . pulley system: This part attaches to the bed. The ropes from the chin strap are threaded through the grooved wheel allowing a weight to hand free providing necessary cervical traction. This is a non-FDA approved medical device . . . Occurrence Report has been submitted. [CEO, OR Manager, DON and General Surgeon] and I held a meeting Monday 10/10/2016 to discuss and also contacted [Orthopedist #1] by phone to determine next steps. [Orthopedist #1] was allowed to use the pulley system but not the retractor in surgery on Tuesday 10/11/2016. This is an ongoing risk issue . . . there are differing opinions from our group on how this issue should be handled. Although I sincerely want our surgeons to be happy and satisfied at work, as Risk Manager, I feel SPH [South Peninsula Hospital] should only allow FDA approved medical devices, purchased through a certified medical supplier to be used in our facility."

During an interview on 2/23/17 the Human Resource (HR) Director stated the BOD recommendations for staff consequence had not been implemented. The HR Director was unable to state if the BOD was aware of the facility's inaction.

During an interview on 2/23/17 at 10:10 am the OR Director was asked if any new policies for the OR had been initiated or implemented with regards to non-medical grade instruments/equipment brought into the OR, and stated there had been no initiation of those policies.