HospitalInspections.org

Based on observation, interview, documentation in 7 of 7 medical records reviewed of patients who sustained burns while in the OR (Patients 1 through 7), review of hospital policies and procedures, and review of other documentation, it was determined the hospital failed to ensure each patient's right to receive care in a safe setting. Patients 1 through 7 developed skin alterations and injuries from burns at or near their surgical sites as a result of incorrectly installed OR lights.

This failure represents a Condition-level deficiency that substantially limits the hospital's capacity to furnish safe and adequate care.

Findings included:

1. Refer to the findings identified under Tag A700, 42 CFR 482.41, the Condition of Participation for Physical Environment. That deficiency reflects the hospital's failures to ensure OR lights were inventoried, correctly installed with required filters, and PM conducted prior to the provision of surgical services for Patients 1 through 7 and approximately 2100 other patients.

Based on observation, interview, documentation in 7 of 7 medical records reviewed of patients who sustained burns while in the OR (Patients 1 through 7), review of hospital policies and procedures, and review of other documentation, it was determined the hospital failed to ensure timely investigations were conducted of serious adverse events, and corrective actions planned, implemented and tracked in accordance with hospital policies and procedures.

Findings included:

1. The hospital's policy and procedure titled "Adverse Event Reporting," dated last revised "November 2014" required the following: "...All adverse events are reported internally through the SH Quality Management Memo reporting process...The director of Quality & Risk Services or designee reports adverse events to the Patient Safety Committee and the Continuous Quality Improvement (CQI) Committee, assures completion of required Root Cause Analysis (RCA)...An RCA methodology will be used to determine root cause(s) and contributing factors, and to develop an action plan." Appendix A of the policy titled "Reportable Hospital Serious Adverse Events" included the following: "Any unanticipated, usually preventable consequence of patient care that results in patient death or serious injury...Patient death or serious physical injury associated with a burn incurred from any source while being cared for in a healthcare facility."

2. The hospital's policy and procedure titled "Quality Management Memo Reporting," dated last revised "June 2014" required the following: "...The Quality Management Memo (QMM) is used to report events that adversely affect or could adversely affect the quality of patient care, patient safety...Information contained in the QMM will be tracked and trended with timely reporting, investigation and follow up action...Quality & Risk Services is responsible for maintaining a confidential database of QMM reports and performing analysis for trends in order to perform further performance improvement in patient care, patient safety..."

3. Refer to the findings identified under Tag A700, 42 CFR 482.41, the Condition of Participation for Physical Environment. That deficiency reflects the hospital's failure to ensure timely investigation and corrective action in accordance with hospital policies and procedures for Patient's 1 through 7 who experienced burn injuries as a result of incorrectly installed OR lights.

Based on observation, interview, documentation in 7 of 7 medical records and reviewed of patients who sustained burns while in the OR (Patients 1 through 7), review of hospital policies and procedures, and review of other documentation, it was determined the hospital failed to ensure OR lights were inventoried, correctly installed with required filters, and PM conducted in accordance with manufacturer's instructions and hospital policies and procedures. Patients 1 through 7 developed skin alterations and injuries at or near their surgical sites as a result of burns from the OR lights.

These failures represent a Condition-level deficiency that substantially limits the hospital's capacity to furnish safe and adequate care.

Findings included:

1. The medical record of Patient 5 was reviewed. The record reflected the patient was admitted to the hospital 10/11/2013 at 1028. The "Operative Note" electronically signed by the physician and dated 10/15/2013 at 0719 reflected the patient had a right knee surgery on 10/11/2013. The "Procedure Description" reflected "The incision was closed with staples...I noticed that the patient had a large blister on the medial aspect of the leg." The patient was discharged from the hospital on the same day on 10/11/2013 at 2028. There was no documentation in the record related to a cause for the identified skin alteration.

2. The medical record of Patient 1 was reviewed. The record reflected the patient was admitted to the hospital 03/18/2014 at 0705 with an admitting diagnosis of "Left Lateral Malleolus ORIF." The "Operative Note" electronically signed by the physician and dated 03/28/2014 at 1143 reflected that the patient had a left ankle surgery on 03/18/2014. The "Procedure Description" reflected "With the surgery completed...The drapes were removed including the...dressing. When this was performed, unfortunately there was a 10cm X 8cm area on the anterior aspect of the ankle away from the incision where the epidural layer was removed...This was an unplanned complication..." and "...unintended abrasion to the anterior aspect of the ankle..." The "Complications" section reflected "When the...dressing was removed from the leg there was approximately a 10cm x 8cm area where the skin itself, the epidermal layer, was removed. This most likely had to do with the adhesion of the skin prep. "The record reflected the patient was discharged on the same day, 03/18/2014 at 1720. There was no documentation in the record related to a definitive cause for the "unintended abrasion" or the identified skin "complication."

3. The medical record of Patient 6 was reviewed. The record reflected the patient was admitted to the hospital on 06/12/2014 at 0905. The "Operative Note" electronically signed by the physician and dated 06/13/2014 at 1316 reflected the patient had an umbilical hernia repair on 06/12/2014. It contained no documented assessment of the surgical site at the end of the procedure. The patient was discharged from the hospital on the same day, 06/12/2014 at 1713.

A color copy of a photograph of Patient 6's wound was provided and reviewed. It revealed a blister-like skin wound with an untitled and unsigned document placed next to the wound. The document included the following information: "[Surgeon name]...Patient Name: [Patient 6]...Date of Service 06/20/2014...Appt Type Followup...Comments: Hernia... "

4. The medical record of Patient 3 was reviewed. The record reflected the patient was admitted to the hospital on 07/24/2014 at 1247. The "Operative Note" electronically signed by the physician and dated 08/25/2014 at 2142 reflected the patient had a left ankle surgery on 07/24/2014. It contained no documented assessment of the surgical site at the end of the procedure. The patient was discharged from the hospital on 07/25/2014 at 1200.

An outpatient record for Patient 3 contained a "Wound Care Order" signed and dated by the physician on 09/08/2014 at 1500. The order reflected "Evaluate and Treat Wounds...[left] ankle eschar debridement."
The outpatient record also contained a wound assessment dated 09/11/2014 which reflected "Left Lateral Calf...post op wound site infection..." There was no documentation in the record related to a definitive cause of the post operative ankle and calf injuries.

5. The medical record of Patient 4 was reviewed. The record reflected the patient was admitted to the hospital 08/04/2014 at 0551. The "Operative Note" electronically signed by the physician and dated 08/06/2014 at 1231 reflected the patient had an umbilical hernia surgery on 08/04/2014. It contained no documented assessment of the surgical site at the end of the procedure. The patient was discharged from the hospital on 08/04/2014 at 1340.

The record for an ED visit on 08/07/2014 for Patient 4 was also reviewed. The ED triage report recorded by the RN and dated 08/07/2014 at 2031 reflected the patient's chief complaint was "surgical wound check." The physician notes reflected "9 square cm abd burn...3X6X5 cm triangular third degree burn adjacent to umbilical operative site. Onset during surgery...1-2 percent [Burn Surface Area] burn...[Patient] had hernia repair a few days ago. Post op they were informed of a burn to the abdomen adjacent to the op site. Today with changing the Silvadene dressing, there was a green/yellow drainage, and concern of infection became present...deterioration of the dermis, [consistent with] 3rd degree burn...Burned area has no sensation to pressure, sharp edge. There is a thin layer of eschar."

6. The medical record of Patient 2 was reviewed. The record reflected the patient was admitted to the hospital 10/06/2014 at 1001 with an admitting diagnosis of "Rt Total Hip Arthroplasty." The Operative Note electronically signed by the physician and dated 10/08/2014 at 0738 reflected the patient had a right hip surgery on 10/06/2014. A document titled "Case Record Report" signed by a "Circulator" and dated as "Printed on 10/07/2014 at "03:13:01 PM" reflected "Nurses Notes: Skin tear near incision due to adhesive drape..." The record reflected the patient was discharged on 10/10/2014 at 1400. There was no other documentation in the record related to a definitive cause for the identified skin alteration.

7. The medical record of Patient 7 was reviewed. The record reflected the patient was admitted to the hospital on 11/25/2014 at 0652. The "Operative Note" electronically signed by the physician and dated 12/22/2014 at 1755 reflected the patient had a right leg/knee surgery on 11/25/2014. The "Procedure Description" section reflected "...As I was starting to close the subcutaneous tissue I noticed that there was a blanched area of skin at the proximal aspect of the wound. There was nothing in this area I could account for from the surgical field. I proceeded to close the surgical incision and asked the OR manager to come into the room and take a picture so we could better document this unforeseen complication. My clinical impression was that it appeared to be a burn, however, there were no objects on this part of the skin...I elected to treat this as if it was a second degree burn."

8. A document titled "Summary of OR Lighting Concerns" dated 12/01/2014 which indicated it was completed by the OR manager was reviewed. The summary reflected the following:

* "[A physician] reported a burn after seeing [Patient 6] in June during [the patient's] routine post op check. The surgery was an umbilical hernia repair and there was no injury reported on the DOS. I spoke at length with [a physician] and all OR staff. This was done on an individual, small scale, and all hands meetings. There was no causative factors to be found." There was no documentation to reflect when these activities occurred.

* "[A physician] reported a blistering of [Patient 4] immediate post umbilical hernia repair. I spoke at length with [two physicians], and the two of them even spoke together about this issue. Once again, all staff was made aware and causative agent could not be found." There was no documentation to reflect when these activities occurred.

* "[A physician] reported a blistering of [Patient 8] immediately post op mastectomy. This blistering looked different than the other 2 cases reported. [Three physicians] spoke and no causative agents could not be found..." There was no documentation to reflect when these activities occurred.

* "[Patient 4's spouse] contacted me about [Patient 4's] burns. I had not heard any follow up for [him/her] and I assumed [he/she] had some superficial burn that had healed. Upon realizing the gravity of the problem, I spoke again to the staff to brainstorm ideas. The OR techs decided that chloroprep might be a causative agent...After numerous phone calls and emails it was determined Chloroprep was not likely the causative agent..."
There was no documentation to reflect when these activities occurred.

* "On November 25th, [a physician] reported a [an unidentified patient] with a reported 'pressure' injury. After further investigation, it was determined to be caused from the overhead lights. The following day...we discovered the burn had turned into a rather large blister..." There was no documentation to reflect when the "further investigation" activities occurred.

* "In reviewing how hot the Skytron lights are, all staff agreed that the lights have been excessively hot. The staff and surgeons report not being able to tolerate the heat for more than a very short period of time...[Employee] tried to shine the lights on [his/her] neck but could not tolerate it for more than 4 minutes before the burning pain got too intense..." There was no documentation to reflect when these activities occurred.

* "Thursday, November 27th, I heard back from our local rep. He did not recommend using this lighting in any capacity until things were evaluated further. I made arrangements for [a biomedical type company] to evaluate the lighting Friday morning, November 28th, 2014. [Biomed staff] confirmed that the lighting was likely our causative agent as it was apparent that the heat diffusers and UV filters were not installed. It was just clear plastic and also that due to the intense heat, the deflector plates had begun to break down and small metallic fragments could be seen in and around the lighting. In one room, these fragments were found outside the lights on the outer surface."

* "In speaking with [a physician], [he/she] related the case of [Patient 2] who had an unfortunate post op healing. [He/she] was noted to have significant sores after [his/her] total hip surgery. This was not reported the DOS. This patient had been treated in our [wound clinic]..." There was no documentation to reflect when these activities occurred.

* "It was determined that in June of 2013 surgeons and staff began having concerns about the efficacy of the lighting in OR #s 2, 3, and 4. It appeared that there was a discolored film on the outside surface. Staff contacted the Rep and [he/she] came in and evaluated. [He/she] determined we were using a harsh cleaning product and it had begun to breakdown the plastic. [He/she] recommended replacement of at least 3 diffusers (shields). After changing out these initial 3 (I am unsure who did the initial 3), the staff decided to replace ALL diffusers...there was a decision made that we could do the install ourselves and just the parts were ordered in. When the parts arrived, [a surgical tech] in the OR receiving department decided [he/she] could install these lights [him/herself]. It is clear at this point that any filters that may have been attached to the old diffusers were NOT placed back on." There was no documentation to reflect the dates of these concerns and when changes to the lights were made.

* "Per [Biomed staff], without the diffusers and the UV filter, the patients and anyone under the light would have been exposed to high temperature as well as excessive UV rays. [He/she] also noted that the reflector plates were in poor condition from being exposed to the elevated temperatures." There was no documentation to reflect the dates in which these activities occurred.

* "For approximately the past year, staff and surgeons have noted the OR lights getting excessively hot. Also difficulty maintaining room temperatures due to the heat from the lights. Staff and surgeons report that they have been unable to tolerate their hands being under the intense lights due to the heat. Staff have also reported that they had moved the lights to avoid any contact with their backs, arms, etc (sic) due to the elevated temperatures." There was no documentation to reflect the dates in which these reports were received.

9. An interview was conducted on 02/27/2015 at 1000 with the Director of Quality and Risk. During the interview he/she presented an undated and unsigned document titled "Patients with injuries likely from surgical lights." The director indicated that the document contained the names of seven patients who had experienced burns as a result of incorrectly installed OR lights in OR #s 2, 3 and 4. The director stated that the "Date of Service" for each patient was the date of the patient's surgical procedure; the "Date identified" was the date the hospital became aware of the patient's injury, and the "OR" was the operating room in which the patient's procedure was performed.

Review of the document reflected the following:

* For Patient 5, the date of service was 10/11/2013 and the date identified was 12/23/2014, and the OR was #3.

* For Patient 1, the date of service was 03/18/2014, and the date identified was 12/23/2014 and the OR was #4.

* For Patient 6, the date of service was 06/12/2014 and the date identified was 07/03/2014, and the OR was #2.

* For Patient 3, the date of service was 07/24/2014 and the date identified was 12/08/2014, and the OR was #4.

* For Patient 4, the date of service was 08/04/2014 and the date identified was 10/23/2014, and the OR was #2.

* For Patient 2, the date of service was 10/06/2014 and the date identified was 11/28/2014, and the OR was #4.

* For Patient 7, the date of service was 11/25/2014 and the date identified was "11/26/15 (sic)", and the OR was #4.

10. A tour of OR #s 2, 3 and 4 was conducted on 02/25/2015 at 1645 with the Interim Surgical Services Manager and the Director of Quality and Risk. Observation of the OR lights at the time of the tour and interview with hospital staff confirmed that the lights were LED.

A tour of the OR in the FBC was conducted on 02/27/2015 at 1110. Observation of the OR lights at the time of the tour and interview with hospital staff confirmed that the lights were halogen.

11. The hospital's policy and procedure titled "Medical Equipment Management Plan," dated as revised "January 2010" was reviewed. The "Policy Statement" section reflected "Silverton Hospital Network manages medical equipment risk with proper maintenance, training, and administrative controls." The "Definitions" section reflected the following:
"Medical Equipment: Any electrical appliance that is located in a patient care area or that is used on a patient.
"Preventative Maintenance: Tasks performed that include extending the useful life of the asset or recommend component replacement by the manufacturer.
Performance Assurance: Tasks performed to verify proper operation and calibration of the device.
Safety Testing: Tasks performed to verify that the device cannot harm the patient, user or others; usually consists of electrical safety."
The "Procedure" section reflected "The criterion in this plan applies to all medical equipment regardless of ownership."
The policy further reflected "Medical equipment maintenance and repair is managed by the Engineering Department with assistance from outside vendors...Prior to initial use, all medical equipment will undergo a safety and performance check assurance test...All medical equipment repairs, maintenance, and safety tests are documented...All maintenance procedures on medical equipment are documented...Equipment performance assurance or preventative maintenance occurs on medical equipment every six (6) months...An inventory of all medical equipment is maintained...New equipment purchases are regularly added to existing inventory."

12. The hospital's policy and procedure titled "Medical Equipment Management Plan," dated as revised "July 2014" was reviewed. The policy reflected the similar information identified in the policy and procedure titled "Medical Equipment Management Plan," dated as revised "January 2010" reflected above with the exception of the following: "...Equipment functional testing or preventative maintenance occurs on medical equipment on an appropriate schedule based upon manufacturer's recommendations and/or industry prescribed best practice (including risk assessment and current hospital experience)."

13. The hospital's policy and procedure titled "Maintenance Request," dated as approved "12/30/09" was reviewed. The "Policy Statement" section reflected "All Maintenance Requests will be sent via Outlook and will be prioritized and tracked...Include a description of the equipment, location and a description of the problem...The Engineer assigned to the Maintenance Request will evaluate and inspect the equipment or building area and respond back to the sender as well as the department group...If the equipment requires parts or outside maintenance, Engineering will reply to the Maintenance Request via Outlook regarding the repair completion date or pending date."

14. The manufacturer instructions provided for the halogen lights that were in place in OR #s 2, 3, and 4 during the time in which Patients 1 through 7 experienced burn injuries, titled "Skytron Maintenance Manual" dated "Rev 12/05" was reviewed.

The "Daily Maintenance" section reflected "Periodically the filter/diffuser assemblies should be removed and dusted with a clean cloth or washed and air dried as a complete assembly...Do not operate the lights without the filter/diffuser assemblies in place..." The "Preventative Maintenance Procedures" section reflected "The following procedures should be done semi-annually or sooner as needed...Lighthead top cover should be removed and any accumulation of dust or lint removed...Check the focus drive mechanism for proper operation and lubrication. Lubricate the drive gears with the lithium grease and all pivot points with a lightweight oil as necessary...The filter/diffuser assemblies should be removed and dusted with a clean cloth or washed and air dried as a complete assembly. Use plexiglass cleaners, DO NOT use alcohol based cleaners on the acrylic diffusers...All attaching hardware (screws, nuts, etc.) should be physically checked for tightness. Any missing hardware MUST be replaced..." The "Focus Adjustment" section reflected "As part of normal Preventative Maintenance, the lighthead focus adjustment should be checked." If an adjustment is necessary, use the following procedures...Remove filter/diffuser assemblies. Check all bulbs...Install filter/diffuser assemblies and top cover when adjustments are complete."

Additional manufacturer's instructions for the halogen lights provided titled "Stellar Diffuser/Filter Replacement - Instructions For Use" dated 06/06/2013 reflected the following: "The purpose of this document is to demonstrate the proper techniques and procedures used to install diffusers...and diffuser filters..." The instructions reflected the following: "Remove Diffuser...Carefully separate the filter from the diffuser and remove....Obtain new filter...Align the new filter on the inside of the new diffuser...Install New Diffuser".

15. The manufacturer's instructions for the halogen lights in the FBC OR titled "Chromophare D650plus, D530plus, D650, D500 Service Manual (E)" dated "05/2009" reflected "The Chromophare lights should be serviced once a year...The Maintenance constist (sic) the steps as listed in the range of maintenance page 71." Page 71 of the manual was a checklist of 31 tasks and items to be checked including but not limited to the following: "Check maximum intensity of illumination...Tension of the support arm springs...Check the means of illumination...Check the contacts of the bulb supports...Check the power feed cables of the bulb supports...Check the reflectors of the halogen bulbs...Check the glass filter shields..."

16. The undated manufacturer instructions provided for the LED lights in OR #1 titled "Chromophare Surgical Lights, Single and Combination Lights Operating Manual," Manual No. 57404 was reviewed. The "Maintenance Schedule" section reflected "The following sections describe the maintenance work required...Annually...General maintenance in accordance with maintenance scope." The "Maintenance" section included instructions for the following: "Functional tests before each usage...Changing the LED Modules...Changing the fuses..."

17. An interview was conducted on 02/26/2015 at 1320 with the Surgical Supply Tech. The tech acknowledged that he/she replaced the "lenses" on the halogen lights in OR #s 2, 3 and 4. The tech stated he/she never received any information about how to install the OR light "lenses" and therefore he/she did not know that a filter was also supposed to be installed. He/she stated "They [the diffusers] looked like one piece. One piece comes out, and another piece goes in." He/she stated "Anything we do equipment wise, we do ourselves." He/she further stated "It was so preventable" and "Whoever ordered the lens covers should've let me know that engineering was going to install them."

18. An interview was conducted with the Facilities Manager and the Director of Support Services on 02/26/2015 at 1120. The Facilities Manager acknowledged that the diffusers on the halogen lights in OR #s 2, 3, and 4 were changed by surgical staff sometime in 2013. The Manager acknowledged he/she had no documentation that PM had ever been performed on the halogen lights. The Facilities Manager acknowledged that after learning that the surgical staff replaced the diffusers, the engineering department never checked the diffusers to ensure they were installed correctly. He/she stated the surgical staff told the engineering department that "the diffusers had been changed and they didn't need our services."

19. An interview was conducted with the Facilities Manager and the Director of Support Services on 02/27/2015 at 1415. The Facilities Manager indicated that in November 2014, all of the halogen lights in OR #s 2, 3 and 4 were replaced with LED lights. The Facilities Manager stated the LED lights that were replaced were "loaners," and therefore had not been added to the hospital's inventory of medical equipment or the hospital's PM system. He/she acknowledged having no documentation that PMs had been performed on the LED lights since they were installed and acknowledged not knowing how often PMs were recommended or required for the LED lights.

The Facilities Manager stated that OR #1 had LED lights which were installed approximately four years ago. The Facilities Manager acknowledged having no documentation that the LED lights were incorporated into the hospital's PM system and stated "The OR staff was maintaining that stuff."

The Director of Support Services acknowledged having no documentation that PM had been conducted in accordance with manufacturer instructions since the OR #1 lights were installed. He/she further acknowledged that the lights required annual PM and stated "We can't verify what was actually done on the lights."

The director also stated that the OR in the FBC currently had halogen lights. He/she acknowledged that PM was recommended once a year by the manufacturer, but he/she had no documentation that PM had been conducted since prior to 2012. He/she further stated that FBC lights were not scheduled for PM until 10/30/2015.

20. During an interview on 02/26/2015 at 0915 with the Director of Quality and Risk, undated and unsigned documentation was reviewed. It reflected that the diffusers for the OR lights were replaced in September 2013 and required filters were not replaced at that time. The report reflected those unfiltered lights were in use in three of five ORs until November 2014. It further reflected that the "September 2013 unscheduled maintenance" was performed by surgery staff.

21. An interview was conducted on 02/26/2015 at 1400 with the Director of Quality and Risk. The director acknowledged that the surgical tech should have gone through the engineering department in accordance with the "Maintenance Request" policy above, rather than installing the diffusers him/herself." The director acknowledged that the hospital had not developed a system to track whether or not appropriate and qualified staff were conducting maintenance activities on patient equipment in accordance with the hospital's policies.

22. During an interview conducted on 02/27/2015 at 1545, the Director of Quality and Risk confirmed that the hospital had no documentation of an investigation or analysis addressing any of the patient injuries reported prior to the "Summary of OR Lighting Concerns" dated 12/01/2014 identified under finding 8 of this tag, which was approximately 14 months after Patient 5 experienced a skin alteration identified at the time of the surgical procedure on 10/11/2013. The director stated "In hindsight, I wish we wouldn't have relied so much on one individual to do the investigation."

The director acknowledged that according to the OR manager's 12/01/2014 summary, staff had been complaining about the OR lights being excessively hot for more than a year before the hospital identified the problem and replaced the lights. He/she further acknowledged that more than 2100 patients had surgical procedures in OR #s 2, 3, and 4 during the time in which the halogen lights were in place without the required filters, and it was unknown at the time of the survey how many of those patients, in addition to Patients 1 through 7, may have experienced burn injuries.