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Based on observation, document review, and interview, the Critical Assess Hospital (CAH) failed to perform surgical procedures in a safe manner. The cumulative effect of their systemic problems resulted in the CAH's inability to ensure patient safety during surgical procedures and an environment free from surgical hazards. Therefore, the CAH was unable to meet the Condition of Participation for Surgical Services at 42 CFR 485.639. These deficient practices resulted in an immediate jeopardy to patient safety.

Findings include:

C-321 Based on observations, document reviews and interviews the hospital failed to ensure that practitioners performed surgeries in accordance with the CAH's policies and procedures which resulted in harm to one patient (P3). The CAH failed to ensure a sterile environment was maintained for 1 of 2 surgical procedures (unidentified patient) when the surgeon left the (operating room) OR suite. The CAH failed to conduct surgical counts to ensure patients were free from retained foreign objects for 5 of 24 (P2, P3, P4, P5, P6) surgical cases reviewed. P3 was harmed when an additional surgery was required to remove a retained foreign object. This failure places all surgical patients at risk of retained foreign objects. The CAH failed to ensure electrosurgical/cautery instruments used to cut and cauterize tissue during surgical procedures were holstered or secured in accordance with manufacturers specifications for 1 of 3 (P1) surgical procedures observed. This practice places all surgical patients at risk of burns and surgeries at risk for fire. These deficient practices resulted in an immediate jeopardy to patient safety.

The immediate jeopardy began on 3/7/2014, when the CAH first became aware of a surgeon leaving the OR suite and entering a non-restricted area of the CAH then returning to the OR suite and refusing to remove the non-sterile gown and gloves, scrub, and don sterile gloves and a sterile gown before proceeding with the surgery. The administrator was notified of the immediate jeopardy on 6/30/2014 at 10:30 a.m. The immediate jeopardy was not removed by the exit date of the survey.

Based on observations, document reviews and interviews the hospital failed to ensure that practitioners performed surgeries in accordance with the CAH's policies and procedures which resulted in harm to one patient (P3). The CAH failed to ensure a sterile environment was maintained for 1 of 2 surgical procedures (unidentified patient) when the surgeon left the OR suite. The CAH failed to conduct surgical counts to ensure patients were free from retained foreign objects for 5 of 24 (P2, P3, P4, P5, P6) surgical cases reviewed. P3 required an additional surgery to remove a retained foreign object. This failure places all surgical patients at risk of retained foreign objects. The CAH failed to ensure electrosurgical/cautery instruments used to cut and cauterize tissue during surgical procedures were holstered or secured in accordance with manufacturers specifications for 1 of 3 (P1) surgical procedures observed. This practice places all surgical patients at risk of burns and surgeries at risk for fire. These deficient practices resulted in an immediate jeopardy to patient safety. The immediate jeopardy was not removed by the exit date.

Findings include:

The CAH's failure to ensure a sterile environment was maintained during surgery.Review of the CAH's Incident Reporting Information System (IRIS) form dated 3/7/14, at 4:30 p.m. revealed surgeon-D left the OR suite during an unknown procedure. Surgeon-D left the restricted surgical suite and semi-restricted surgical area to request supplies from a sterile supply room located in the not restricted hospital hallway. The surgery manager accompanied surgeon-D and indicated surgeon-D kept his gloved hands together at his upper abdomen not touching any items. The surgery manager carried the supplies for surgeon-D to the OR. Upon return to the OR suite, the operating room technician (ORT) requested surgeon-D remove his gloves and gown and replace them with sterile gloves and a sterile gown. Surgeon-D refused to put on new sterile gloves and gown and returned to the procedure.

On 6/3/14, at 12:16 p.m. interview with circulating registered nurse (RN)-I revealed during the 3/28/14, surgery when surgeon-D left the OR restricted and semi-restricted area, he entered the not restricted hallway and entered the supply room where the sterile supplies were stored. According to circulating RN-I, surgeon-D's gown worn during the surgery contained visible blood. Interview with the Interim Vice President of Nursing Services and Interim Quality Director on 6/4/14, at 9:29 a.m. revealed surgeons were not to leave the OR suite during surgery. However, when necessary for a surgeon to leave the OR suite, the surgeon should remove the old gloves and gown, scrub and don new sterile gloves and a sterile gown. Both indicated the procedure was best practice regarding prevention of infections.

When requested, the CAH was not able to provide a specific policy for changing the gloves and gown after leaving and before returning to an OR suite.

The CAH failed to ensure surgical counts were completed for every surgical procedure to ensure patients were free from retained foreign objects.

Review of the CAH's OR Nurse Note form included an area for counts of sponges, needles, sharps, instruments, and miscellaneous items. The checklist for counts was to be completed pre-operatively and following the procedure prior to closure of the surgical site. Documentation was required for any action taken for discrepancies in the counts.Review of P3's surgical record indicated on 9/17/13, P3 had surgery for an anterior left hip replacement. Review of the OR Nurse Note for P3 dated 9/17/13, revealed no counts had been completed for the trial femoral ball/head or temporary ball used to determine the correct size of the permanent femur head implant during P3's anterior left hip replacement surgery. On 3/10/14, (six months later) P3 was seen at the local clinic for complaints of left lower abdominal pain and a CT scan was done. The CT scan revealed a spherical retained foreign object near P3's left hip prosthesis that measured 2.5 x 3 cm. On 3/12/14, P3 was seen by surgeon-K (not P3's primary surgeon) and a MRI was done that showed a foreign object over the anterior aspect of P3's left hip. The object appeared to be the plastic trial femoral head from P3's left hip replacement surgery six months earlier. A telephone note dated 3/12/14, by surgeon-K established P3 had episodes of recurrent pain described as a sharp on some days and on other days P3 experienced no pain. P3 was scheduled to visit surgeon-F who completed the hip replacement surgery on 3/17/14. On 3/28/14, P3 underwent outpatient surgery for the retrieval of a foreign body of the left proximal thigh.
Review of P2's surgical OR Nurses Notes dated 12/17/13, indicated P2 had an outpatient surgery for a left shoulder scope with rotator cuff repair and decompression. The OR Nurses Note lacked documentation indicating surgical counts were taken before the surgery began and prior to the closure of the surgical site, or at the end of the procedure.

Review of P4's OR Nurse Note dated 3/18/14, indicated P4 had a left knee arthroplasty or knee replacement surgery on that date. The OR Nurses Note indicated surgical counts were taken pre-operatively for sponges, needles, sharps, and instruments however, the documentation indicated surgical counts were not completed prior to the closure of the surgical site, or at the end of the procedure.Review of P5's OR Nurse Note dated 5/28/14, indicated P5 underwent a right anterior femoral head replacement surgery that day. The OR Nurse Note indicated counts were completed for the sponges, needles, sharps, and cautery however, the counts did not include the trial femoral head ball count which was the object retained following P3's surgery.Review of P6's OR Nurse Note dated 6/5/14, revealed P6 had a left total knee replacement surgery that day. The trial implant parts for the knee replacement surgeries included the patella, femoral, and tibial temporary parts that were tested for size prior to the actual implant. The nurse notes did not include the counts for the trial implant parts used during P6's total knee replacement surgery.
On 6/5/14, at 10:59 a.m. the Interim Vice President of Nursing Services and the Interim Quality Director confirmed the counts were incomplete for P2, P3, and P4, surgeries and should have been completed.

On 6/18/14, at 1:25 p.m. surgeon-F was interviewed and following P3's retained foreign object, he ensures only one trial head/ball is used at a time and the trial head/ball is returned to the ORT prior to requesting another size trial head/ball or opening the actual replacement joint. Surgeon-F now participates in the actual counts to ensure compliance with the counts. On 6/18/14, at 3:21 p.m. the RN surgery manager was interviewed and stated on 5/12/14 a monitoring system was initiated to ensure compliance with surgical counts. The monitoring system included weekly record reviews for one joint replacement surgery each week. As of 6/5/14, four joint replacement surgery records had been reviewed. The surgery manager confirmed trial counts had not been completed for two of the four surgeries, one that occurred on 5/28/14, for P5's right hip replacement surgery done by surgeon-G and one on 6/5/14, for P6's left knee replacement surgery done by surgeon-H.
Review of the CAH's policy and procedure titled Responsibilities of OR Personnel with a review date of August 2011, stated, the RN circulating nurse would perform duties that were necessary for the safety of the surgical patient and included notifying the surgeon of the surgical counts. The responsibilities of the OR scrub technician included keeping track of needles, sponges, and instruments used throughout the procedure and assisting with counts according to hospital policy.
Review of the CAH's policy and procedure titled Sponge, Instrument, and Sharps Counts with a revision date of May 2014, stated, counts were to be completed on all procedures where a possibility existed to retain a foreign object. Sponges, sharps, and miscellaneous item counts would be completed prior to the procedure, before closure or end of the procedure, and when a permanent relief of a scrub person and/or the circulating RN.Cautery devices were not consistently placed in designated holsters in accordance with manufacturer's specifications during surgical procedures.

On 6/3/2014, from 9:16 a.m. until 10:40 a.m. observation was made of an umbilical hernia repair for P1. P1 was intubated for the procedure under general anesthesia. Surgeon-D was observed to secure a plastic cautery holster to the sterile drapes on the right side of surgeon-D. Surgeon-D was observed to use a pencil/blade cautery to open the surgical site. Surgeon-D did not holster the cautery between uses during the surgery, instead the cautery was placed below P1's umbilical incision on the sterile drape over P1's groin each time the cautery was not in use. P1 was not injured by the cautery. On 6/6/14, at 11:35 a.m. the ORT-A confirmed the cautery holster was not used during P1's surgery and was placed directly on the drape over P1's groin when not in use. ORT-A indicated the holsters for the cautery devices were not consistently used during surgical procedures that required a cautery.On 6/9/14, at 9:55 a.m. ORT-B indicated protective coverings and holsters were inconsistently used for surgeries that required cautery. ORT-B revealed laparoscopic surgeries performed with a cautery did not have a holster and no special procedures were used to ensure the cautery was kept away from the patients and surgical drapes during the procedure.On 6/9/14, at 10:07 a.m. RN-C revealed often staff made a large pocket out of cloth towels to holster the cautery devices during orthopedic surgeries. The pocket was usually attached to the patient's chest during surgery.
On 6/6/14, at 10:40 a.m. surgeon-D stated he had consistently used the holster for the cautery during P1's surgery. Surgeon-D indicated during laparoscopic procedures the cautery was too large to use a protective device for the cautery.On 6/6/14, at 11:48 a.m. the Interim Vice President of Nursing Services was interviewed and revealed management was not aware cautery devices were not being placed in the appropriate holsters or protective devices during surgeries. The Vice President of Nursing Services stated all cautery devices were to be holstered when not in use during surgical procedures.On 6/18/14, at 1:35 p.m. surgeon-F confirmed frequently a large cloth pocket was used to place the cautery devices during orthopedic surgeries. The cloth pocket was larger than those supplied and was able to hold more than one cautery device and suction for the surgery.

On 6/18/14, at 3:31 p.m. the surgical manager revealed the CAH used four types of cautery devices. The Valleylab electrode pencil/blade cautery, the triple option cautery which was similar to the pencil cautery with additional cautery options, and the Stryker laparoscopic and arthroscopic cautery.

Review of the manufacturers recommendations provided by the CAH titled Valleylab Force Triad Energy Platform, Chapter 2 and not dated, indicated, do not place active instruments near or in contact with flammable materials such as gauze or surgical drapes. Electrosurgical instruments (cautery) that are activated or hot from use can cause a fire. When not in use place electrosurgical instruments in a safety holster or safely away from patients, the surgical team, and flammable materials.Review of the CAH's policy and procedure titled Surgical Safety Checklist with a revision date of March 2012, stated, "Policy: The operating room surgical team will collaboratively participate and confirm that the surgical safety checklist for all patients is complete and documented. There are three specific stages of the checklist to be completed: I. Fire Risk Assessment (Pre-Operatively). Procedure: Each portion of the Surgical Safety Checklist is to be audible and collaborative between team members. A discrepancy... during this process must stop the case from proceeding until resolved. Pre-operatively: The fire risk assessment must be completed prior to the patient coming into the room so the necessary actions can be completed." The assessment included evaluating the oxygen source and ignition source and included protection of the ignition source.Review of the CAH's policy and procedure titled Fire Safety in the Perioperative Setting with an effective date of January 2014, stated when an electrosurgical device (cautery) was used during surgery, the device must be stored in a safety holster when not in use. Also, surgical drapes and linens were to be kept away from the activated electrosurgical device.

Based on document review and interview, the Critical Access Hospital (CAH) failed to ensure periodic evaluation of their services and ensure a system to report quality assurance issues related to deficient practice identified by the CAH. The cumulative effect of these systemic problems resulted in the CAH's inability to maintain effective quality assurance processes in order to ensure provision of quality health care. Therefore, the CAH was unable to meet the Condition of Participation of Periodic Evaluation & QA Review at CFR 485.641 . These deficient practices had the potential to impact all patients receiving services from the CAH.

Findings include:

See C331- Based on document review and interview, the critical access hospital failed to conduct an annual evaluation of the its total program at least once a year. This has the potential to affect all CAH patients.

See C334-Based on document review and staff interview, the CAH failed to review their health care policies as part of the annual program evaluation. This has the potential to affect all CAH patients.

See C342-Based on document review and interview, the critical access hospital failed to take appropriate action to address concerns identified in the quantity assurance plan related to surgical counts and retained foreign object. This has the potential to affect all CAH surgical patients.

Based on document review and interview, the critical access hospital (CAH) failed to conduct an annual evaluation of the total program at least once a year. This had the potential to affect all CAH patients.

Findings include:

During a review of the CAH's quality assurance program no evidence of an evaluation of the total program was provided. Review of the CAH's Board of Director meeting minutes from March 2013 through June 2, 2014, revealed no documentation of an annual evaluation of the CAH's total program.
On 6/5/14, at 11:07 a.m. interview with the vice president of nursing services confirmed the CAH had not conducted an annual evaluation of it total program since 2008. Although certain portions of the evaluation were completed, the CAH's electronic system was unable to obtain certain statistical information. On 6/19/14, at 8:15 a.m. the vice president of nursing services verified the CAH had not developed a group of individuals to complete the performance improvement annual evaluations.

Based on document review and interview, the Critical Access Hospital (CAH) failed to include the review of their health care policies as part of an annual program evaluation. This had the potential to affect all current and future CAH patients.

Findings include:

The CAH's quality assurance program was reviewed. There was no evidence all the CAH's health care policies were reviewed at least once a year. Review of the CAH's policies and procedures for surgical services were reviewed. The documents established the review and/or revision dates on the majority of the policies and procedures ranged from February 2011 to May 2013.

On 6/5/14, at 11:07 a.m. interview with the interim vice president of nursing services confirmed the CAH had not conducted an annual evaluation of it's total program since 2008. Although certain policies were reviewed by the individual managers in each department, their was no system to ensure every CAH policy was evaluated annually. The interim vice president of nursing services revealed only those policies that required revisions or review were brought to the Board of Director meetings for review.On 6/19/14, at 8:15 a.m. the vice president of nursing services verified the CAH had not developed a group of individuals to complete the performance improvement annual evaluations of the CAH's programs.

Based on document review and interview, the critical access hospital (CAH) failed to take appropriate remedial action to address the on-going failure of the surgical staff to complete surgical trial counts during orthopedic joint replacement surgeries. This failure had the potential to affect approximately 30 patients a month who on average undergo orthopedic surgery at the CAH.

Findings include: On 6/2/14, at 11:42 a.m. the surgical manager was interviewed and revealed the CAH had an incident of a retained foreign object for one surgery that was performed the previous year. A femoral trial head/ball which is a temporary ball used to determine the correct size of the femur head was left in a patient who underwent surgery for a left hip replacement. The surgical manager said there had been a revision in the process for surgical counts to include counting the trial head/balls for anterior hip replacement surgeries and the pins and trial parts or temporary joints used for the knee replacement surgeries. Prior to that time, those items had not been part of the surgical counts.Review of P3's surgical record indicated on 9/17/13, P3 had surgery for an anterior left hip replacement. Review of the OR Nurse Note for P3 dated 9/17/13, revealed no counts had been completed for the trial femoral ball/head or temporary ball used to determine the correct size of the permanent femur head implant during P3's anterior left hip replacement surgery. On 3/10/14, (six months later) P3 was seen at the local clinic for complaints of left lower abdominal pain and a CT scan was done. The CT scan revealed a spherical retained foreign object near P3's left hip prosthesis that measured 2.5 x 3 cm. On 3/12/14, P3 was seen by surgeon-K (not P3's primary surgeon) and a MRI was done that showed a foreign object over the anterior aspect of P3's left hip. The object appeared to be the plastic trial femoral head from P3's left hip replacement surgery six months earlier. A telephone note dated 3/12/14, by surgeon-K established P3 had episodes of recurrent pain described as a sharp on some days and on other days P3 experienced no pain. P3 was scheduled to visit surgeon-F who completed the hip replacement surgery on 3/17/14. On 3/28/14, P3 underwent outpatient surgery for the retrieval of a foreign body of the left proximal thigh.
On 6/4/14, at 9:02 a.m. the interim quality director and interim vice president of nursing services were interviewed and indicated a root cause analysis had been conducted following the discovery of the retained foreign object in P3. On 6/2/14, the root cause analysis was presented to the Board of Directors however the action plan and results of the actions taken to remedy the incident had not been presented to the Board of Directors. The action plan that was developed by quality assurance safety committee and included the following:

1. Sponge, instrument, and sharps count policy was revised to include a new procedure of counting trials or temporary joint replacement pieces used to ensure the correct size of the permanent implants, when the trials were removed from their trays. The OR staff incorporated a "hard stop" before opening any actual implants. During the "hard stop" all trials would be accounted for before proceeding with the actual implant.

2. All operating room (OR) staff were to be educated on changes to the policy/procedure held on 5/21/14.

3. Compliance observations would be conducted for 6 months with a goal of 90% compliance. The compliance observations began on 5/12/14.

4. The RN surgical manager would complete a log of the compliance observations.

5. A request was made for a new manufacturers representative to work with the CAH OR staff.

6. The new representative would work closely with the OR staff to organize and update all instruments and trial pans. The CAH established one complete set of pans fully organized and photographically documented.On 6/3/14, at 12:16 p.m. circulating registered nurse (RN)-I revealed she had not received the 5/21/14, education provided by the CAH and had not read minutes about the meeting.On 6/6/14, at 2:16 p.m. during an interview with the RN surgical manager it was discovered that although the log was being maintained for the compliance observations to ensure surgical trial parts were counted, 2 of the 4 joint replacement surgeries, 1 on 5/28/14, and 1 on 6/5/14, did not include counts of the trial parts or temporary replacement joints.Review of P5's OR Nurse Note dated 5/28/14, indicated P5 underwent a right anterior femoral head replacement surgery that day. The OR Nurse Note indicated counts were completed for the sponges, needles, sharps, and cautery however, it did not include a count of the trial head/ball. Circulating RN-I who said she had not received the staff training on counting trial parts was one of the circulating RN's for the surgery. In addition, the ORT present during the surgery had not received the education.Review of P6's OR Nurse Note dated 6/5/14, revealed P6 had a left total knee replacement surgery that day. The nurse notes did not include the count for the trial parts used prior to the joint replacement. Review of the attendance for the OR staff education held on 5/21/14, revealed 1 ORT and 1 certified surgical technician (CST) did not attend the OR educational meeting.On 6/10/14, at 9:30 a.m. the interim quality director was shown the compliance log maintained by the RN surgical manager. The interim quality director was not aware the OR was not compliant with the surgical trial counts and stated the expectation was 100% compliance.

On 6/18/14, at 3:21 p.m. the RN surgery manager revealed he was not aware of a plan to report the compliance findings to the quality director. The RN surgery manager said he was told to monitor one orthopedic surgery every week. When out of compliance the surgery manager indicated the OR staff involved were immediately trained to ensure future compliance.