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Based on observation, interview, and record review, the facility failed to ensure the bilateral wrist restraint orders were renewed according to the facility's policy for Patients 28 and 29. The failed practice had the potential to result in the unnecessary use of restraints.

Findings:

On January 10, 2011, a tour of the ICU was conducted. Patients 28 and 29 were observed on bilateral soft wrist restraints.

1. On January 10, 2011, Patient 28's record was reviewed. The patient was admitted in the ICU on December 29, 2010, with orders for bilateral soft wrist restraints.

The "Physician Order Non-Violent /Non-Behavioral Restraint" dated December 29, 2010, at 4:45 p.m., indicated Patient 28 was cognitively impaired, will not ask for assistance, and disconnects and/or removes therapeutic devices (ventilator).

The record indicated, "...My signature below indicates that I have performed a face-to-face (re)assessment of the patient and the patient required restraint..." The section, "Physician/Prescriber Signature or Authentication" was blank.

Further review of the record revealed the patient continued to be placed on the bilateral restraints on December 30, 31, 2010, and January 1, 2011. On all three days, the physician's order did not contain the physician's signature. There was no documented evidence the physician conducted an assessment and evaluation for the use of the restraints in Patient 28's record.

The record indicated Patient 28 was extubated (removal of the breathing tube) on January 2, 2011, and the bilateral wrist restraints were discontinued.

The "Physician Orders" dated January 3, 2011, at 5 a.m., indicated, "Please re-intubate (place the breathing tube back into the throat) the pt (patient)."

The "Physician Order Non/Violent/Non-Behavioral Restraint" dated January 3, 2011, at 5 a.m., the section, "Physician/Prescriber Signature or Authentication" was blank. There was no documented evidence the physician conducted an assessment and evaluation for the use of the bilateral wrist restraints in the patient's record.

The record indicated the patient continued to have bilateral wrist restraints from January 3 through January 9, 2011. The restraint orders were not signed by the physician. There was no evidence in the patient's record the physician conducted an assessment or evaluation for the use of the restraints from January 3 through January 9, 2011.

On January 10, 2011, at 1:50 p.m., Patient 28's record was reviewed with the CNO. The CNO was unable to find evidence the attending physician conducted initial assessment and evaluation for the continued use of the bilateral wrist restraints. The CNO stated, "This physician has had issues in signing."

The facility policy titled, "Restraint and Seclusion" effective August 2009, was reviewed. The policy indicated, "This organization's approach to restraint is one that protects the patient's health and safety, and preserves his or her dignity, rights, and well-being...Through the establishment of guidelines the organization will limit the use of restraint to those situations with appropriate and adequate justification..."

The policy further indicated:

"...Restraint is initiated upon order of a physician or other licensed independent practitioner..."

"...If restraint continues to be clinically justified, continued use of restraint beyond the first 24-hours must be authorized by the physician or other licensed independent practitioner. Restraint orders must be renewed on a daily basis not to exceed 24 hours. A face-to-face physical examination by the physician at least every 24 hours determines the clinical justification for the continued use of restraints..."

2. On January 10, 2011, Patient 29's record was reviewed. The patient was admitted in the ICU on January 8, 2011, with orders for bilateral soft wrist restraints.

The "Physician Order Non-Violent /Non-Behavioral Restraint" dated January 9, 2011, at 1:30 a.m., was reviewed. The order sheet did not indicate the following:
- Indication for restraint;
- Restraint devices;
- Time limit; and
- Criteria for Release.

On January 10, 2011, at 2:45 p.m., the CNO was interviewed and stated the physician's order for restraints should be completed.

The facility policy titled, "Restraint and Seclusion" effective August 2009, was reviewed. The policy indicated, "...Contents of a seclusion or restraint order will include: The type of restraint, device employed, the maximum length of time restraint may be utilized, the specific behaviors that present a danger to the patient which require the use of restraint..."

Based on observation, interview, and record review, the facility failed to ensure the development and implementation of a hospital-wide, data-driven quality assessment and performance improvement program when the program failed to do the following:

1. The program did not use data collected regarding infection control restraints, and physician performance to monitor the effectiveness and safety of services and quality of care. The failed practice had the potential to result in incorrect restraint use or violation of patients' rights, the risk of an unsanitary environment and the spread of infection, and the risk of substandard physician performance (refer to A274).

2. The program did not analyze an adverse event by performing a root cause analysis, creating the risk of unrecognized poor practices and the risk of substandard care for all patients using the facility (refer to A311).

3. The program did not analyze physician peri-operative documentation and quality of care data, creating the risk of substandard medical care for all patients treated by facility physicians (refer to A340).

The cumulative effective of these systemic problems resulted in the inability of the facility to ensure a quality assurance program were performed proactively, which resulted in an unsafe environment for all patients using the facility and creating the risk of substandard medical care by facility physicians to occur unrecognized.

Based on interview and record review, the facility's quality assurance program did not review:
1. the data collected by supervisors regarding the use of restraints, creating the risk of incorrect restraint use for patients requiring restraints,
2. data regarding infection control, creating the increased risk of the spread of infection for all patients, and
3. data regarding physician performance, which was to have been forwarded to quality assurance for analysis, creating the risk of undetected substandard physician performance.

Findings:

1. In an interview in with the CNO on January 11, 2011, at 1:30 p.m., she stated that the night supervisors were to collect detailed information on restraint usage, and that information was to be forwarded to the quality department. However, she stated that she had recently realized that the data was not being compiled and forwarded to the quality department.

During a review of the Quality Council minutes for 2010, no evidence of review of detailed information regarding the appropriateness of restraints used or the adequacy of documentation was seen.

During a review of the facility policy, "Performance Improvement Plan" (rev 5), the duties of the Quality Council included, "Ensures that appropriate actions are implemented and effectiveness is monitored," and as described in the "Measuring and Monitoring Performance" section, that was to include collecting and analyzing data on, "Restraint and seclusion."

2. In an interview with the DQM on January 13, 2011, at 10:25 a.m., she stated that the infection control department did not report to quality assurance, but instead reported to the Medical Executive Committee. There was no direct mechanism for the quality assurance program to receive data collected regarding infection control.

During a review of the facility policy, "Performance Improvement Plan" (rev 5), the duties of the Quality Council included, "Ensures that appropriate actions are implemented and effectiveness is monitored," and as described in the "Measuring and Monitoring Performance" section, that was to include collecting and analyzing data on, "Infection Prevention and Control."

3. During an interview on January 11, 2011, at 1:30 p.m., with the Director of Medical Staff, she stated that the chief of the department made a request in 2009 for analysis of Surgeon 1's performance data, that the request had been noted by the medical staff office, but had not been sent to quality assurance for analysis. She stated that the data should have been sent for review, but were not sent in error.

When asked for other examples of physicians whose performance had been analyzed, she stated that no such analyses had been performed (refer also to A340).

Based on interview and record review, the facility failed to complete an investigation of a wrong site surgery performed on October 29, 2010, (Patient 27) creating a risk to patient safety for all other patients receiving surgery at the facility due to possible unidentified poor practices.

Findings:

The facility policy, "Conducting a Root Cause Analysis (RCA Policy)" (rev 1), was reviewed on January 13, 2011, and read in part, "The expectation is that an RCA be conducted on any reviewable event as defined by JC (the Joint Commission), as well as those events that are established as reportable per state regulations," and "Any potential or actual event must have a thorough and credible RCA completed within 14 days from the date of the event."

The facility reported that a wrong site surgery was performed on Patient 27 on October 29, 2010. During an interview on January 13, 2011, at 11:35 a.m., with RN 2 (recovery room nurse who cared for Patient 27), she stated that the title of the wrong surgery was the one announced to her by the operating room staff when they brought Patient 27 to the recovery room. She stated that Patient 27's mother discovered in the recovery room that the correct surgery had not been performed. She stated that she did not participate in any facility review process (RCA) to determine how the wrong site surgery occurred.

During an interview with the DQM on January 13, 2011, at 10:25 a.m., she concurred that a root cause analysis had not been done on the wrong site surgery incident, and that factors such as the Surgeon 1 not seeing the patient prior to surgery and the fact that the previous case done in the same room had the procedure that was performed in error on Patient 27 were not investigated as possibly contributing to the occurrence of the wrong site surgery. She also stated that they had not noted discrepancies in the medical record of Patient 27, such as the title of the wrong surgery on the anesthesiologist's intraoperative record (refer to A 951).

Based on interview and record review, physician quality of care was not subjected to review and analysis, creating the risk of substandard medical care by facility physicians.

Findings:

1. In an interview with the Director of Medical Staff on January 12, 2011, at 2 p.m., she stated that there was no mechanism in place to monitor the quality of the physician documentation pre- and post-operatively. She stated that this had been the task of the OR Manager, but had not been done.

During a review on January 11, 2011, of the medical record of Patient 27, the following issues were noted.

A. Patient 27's parent signed a consent form for resection of a tongue mass. However, at 10:15 a.m. on October 29, 2010, Surgeon 1 performed a tongue tie release, a procedure for which no consent had been obtained.

B. An order for Unasyn, an antibiotic that contains ampicillin, a drug closely related to penicillin, was seen in the pre-operative orders for October 29, 2010, and signed by Surgeon 1. An entry on the same order sheet indicated that Patient 27 was allergic to penicillin. A penicillin allergy was recorded on many other forms in Patient 27's record, such as the "Anesthesia Pre-operative Orders" and the "Post Anesthesia Care Orders."

During an interview with RN 1 on January 11, 2011, at 1:45 p.m., she stated that Patient 27's mother raised concerns pre-operatively about the plan to give Unasyn to her child. RN 1 spoke with Surgeon 1, who cancelled the pre-operative medication.

The handwritten operative note written by Surgeon 1 after surgery indicated he was ordering Patient 27 to take amoxicillin, another close relative of penicillin. The operative note dictated after the same surgery by Surgeon 1, indicated his plan to give Patient 27 amoxicillin as an outpatient.

During a review of the PDR (Physicians Desk Reference) 2010, history of allergic reaction to any of the penicillins is a contraindication to (strong reason against) giving amoxicillin or Unasyn.

C. Patient 27's "Pre-Operative History and Physical," dictated October 27, 2010, and signed by Surgeon 1, indicated that Patient 27's history was, "not significant for any medical problems," and that he had no allergies. Elsewhere, in the medical record it was recorded that Patient 27 had an extensive medical history, including asthma, two hospitalizations for respiratory illnesses, multiple surgeries, and an allergy to penicillin.

D. During a review of the medical record of Patient 27, the Surgical Pre-Operative Assessment form was signed by Surgeon 1, but the spaces on the preprinted form to indicate that the physician had reviewed the history and performed a physical exam were left blank.

During an interview with Surgeon 1 on January 12, 2011, at 11 a.m., he stated that "usually" he did not examine any patients on the day of surgery.

2. During an interview on January 12, 2011, at 1:30 p.m., with the Director of Medical Staff, she stated that the chief of the department made a request in 2009 for analysis of Surgeon1's performance data, that the request had been noted by the medical staff office, but had not been sent to quality assurance for analysis. She stated that the data should have been sent for review, but were not sent in error.

When asked for other examples of physicians whose performance had been analyzed, she stated that some physicians had been identified for review, but no such analyses had been performed.

The Director of Medical Staff also stated that the facility practice was to perform ongoing provider performance evaluations each nine months, but there was no current process for obtaining performance evaluations of anesthesiologists. She stated that the data that had been extracted from the computer for anesthesiologists was invalid and was not used.

Based on interview and record review, the facility failed to ensure that there was a policy about which tissues required macro and microscopic pathologic examination, creating the risk of unrecognized medical conditions and substandard patient care.

Findings:

During an interview with the DQM on January 13, 2011, at 10:30 a.m., she stated that she interviewed the nurses present during a wrong site surgery. The intended surgery on October 29, 2010, for Patient 27 was the removal of a tumor from the tongue of the pediatric patient, but no specimen was sent to pathology. The DQM stated that she interviewed the operating room nurses about why the lack of a specimen was not questioned, and the nurses stated that some specimens, such as small pathology specimens, were not submitted to the laboratory for analysis.

The facility policy, "Specimen Analysis" (rev 2), was reviewed on January 13, 2011, and the policy did not specify which tissue was to be subjected to analysis, or if there were tissues exempt from analysis.

During an interview with the CNO on January 13, 2011, at 1:15 p.m., she stated that the facility policy did not specify which tissues needed to be submitted for analysis.

Based on observation and interview, the facility failed:
1. To monitor the temperature and humidity in the Procedure Room, creating the risk of an unsanitary and uncomfortable operative environment, and
2. Monitor the temperature and humidity in the sterile processing area, creating an increased risk of infection for patients receiving surgery at the facility.

Findings:

1. During a tour of the procedure room on January 10, 2011, at 1:30 p.m., with the Director of the GI Lab, he concurred that there was no mechanism for monitoring temperature and humidity in that area, and that such monitoring was not being done.

During an interview on January 12, 2011, at 2:15 p.m. with the DirFac, she stated that the temperature and humidity were not being monitored in the procedure room, and that they would need to start monitoring those qualities.

2. During a tour of the sterile processing area on January 11, 2011, at 11:10 a.m., the temperature of the air was noted to be warm, and the recorded temperature for the morning was 78.3 degrees F.

During a concurrent interview with Sterile Processing Supervisor 1, she stated that she called plant operations when the temperature was out of the target range, and recorded subsequent temperatures on a whiteboard, but usually did not make permanent documentation of the temperatures except the first temperature of the day.

The December 2010 facility log of morning temperatures for the sterile processing area was reviewed on January 11, 2011, and contained the goal temperature range, 68 degrees F to 74 degrees F, along with the direction to call engineering if the temperature was outside of that range. The log indicated that the temperature had been above the goal range on 8 of 10 days. Two afternoon temperatures were also noted, including a high of 79.9 degrees F at 2:15 p.m. on January 5, 2011. On four days with elevated temperatures, there was a note indicating that the plant operations department had been called regarding the elevated temperatures, but on the other four days with elevated temperatures, there was no such notation.

During an interview with the DirFac on January 12, 2011, at 2:15 p.m., she stated that she was aware of the problem with controlling the temperature in the sterile processing area. She stated that adjustments were made to the heating circuit when they received notification, but that there was no documentation of the temperature being lower after the adjustments were made. She stated that they had employed a firm to assist with correcting the heating system, but that no specific plan to correct the sterile processing area heating had been made.

According to AORN Standards, the clean sterile storage area's temperature should be maintained equal or less than 75 degrees F.

Based on observation, interview and record review, the facility was allowing procedures to be performed in a room that had no emergency power , creating the risk of a poor surgical outcome in the event of a power outage.

Findings:

During a tour of the Procedure Room on January 10, 2011, at 1:30 p.m., with the Director of the GI Lab, he concurred that there were no red plugs to supply emergency power to the room. He concurred that a variety of technical procedures were done in the Procedure Room, and during a power outage, they would have to take the patient to the operating room to complete the procedure, or discontinue the procedure.

During an interview on January 12, 2011, at 2:15 p.m., with the DirFac, she stated that the Procedure Room did not have emergency power, that this had not been noted previously, and that the room should have emergency power available.

Based on interview and record review, the facility failed to ensure the completeness of the infection control program by not ensuring:

1. there was a policy in place for the use and cleaning of dehumidifiers in the operating rooms,

2. the disinfectant used to clean the operating rooms was allowed to have the required contact time, creating the increased risk of the spread of infection.

Findings:

1. During a tour of OR 1 on January 11, 2011, at 9:55 a.m., a machine approximately 18 inches high with a tan plastic cover was seen in the room. During a concurrent interview with the CNO, she stated that it was a dehumidifier, and that they were emptied in the evening during the terminal cleaning. The reservoir for the dehumidifier was opened and was more than half full.

During an interview with the DON on January 12, 2011, at 3 p.m., she stated that there was no policy in place regarding the use or cleaning of dehumidifiers in the operating rooms. She stated that the dehumidifiers had been in use since August 2010.

During a review of the Center for Disease Control Guidelines for Environmental Control in Health Care Facilities, June 6, 2003, regarding Air Handling Systems in Health Care Facilities, the guidelines included, "Monitor ventilation systems in accordance with engineers and manufacturers' recommendations to ensure preventive engineering, optimal performance for removal of particulates and elimination of excess moisture." And, "Coordinate HVAC (heating, ventilation and air conditioning) function with infection control staff ..."

2. During an interview with Cleaning Staff 1 on January 11, 2011, at 10 a.m., he stated that he was using Virex to clean the operating room in between surgeries.

Cleaning Staff 1 was observed. He applied the Virex to the horizontal surfaces in the operating room and it dried in 2 ? minutes. The solution was not reapplied to many areas.

During a review of the label for Virex II 256, the required contact time for surface disinfection was 10 minutes.

Based on observation, interview and record review, the facility failed to ensure acceptable standards of practice were implemented in the provision of surgical services by failing to ensure:

1. The time-out procedure was not correctly implemented, resulting in a wrong site surgery for Patient 27 and was not completed at all for 10 Laser eye surgery patients on October 22, 2010. This failed practice had the potential to result in surgical misadventure for other patients having surgery in the facility (refer to A951).

2. The facility failed to obtain informed consents for Laser eye surgery prior to the procedure, which could result in the potential for performance of the wrong surgery, (refer to A951).

3. Ensure an updated medical history and physical was completed prior to surgery for 10 of 41 of sampled patients (Patients' 27, 32, 33, 34, 35, 36, 37, 38, 39 and 41). This failed practice resulted in the wrong surgical procedure performed and creating the risk of undiscovered medical conditions and poor surgical outcome for the patients, (refer to A952).

4. The Procedure room did not have emergency power available, creating the risk of a poor surgical outcome in the event of an emergency (refer to A702).

5. The temperature was not being maintained within standards in the sterile processing area and the temperature and humidity were not being monitored in the procedure room, creating the increased risk of infection for patients undergoing surgeries (refer to A701).

The cumulative effect of these systemic problems resulted in unsafe surgical practices and unsafe environment for all patients receiving surgery in the facility.

3. On November 17, 2010, at 9:15 a.m., a visit was made to the facility for the purpose of investigating a complaint regarding laser eye surgeries being performed in the endoscopy room on October 22, 2010.

A review of a scheduling form dated October 22, 2010, for laser eye surgeries was conducted. The scheduling form indicated that 10 patients (Patients' 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10) had laser eye surgery that day.

On November 17, 2010, at 12:45 p.m., a review of the ten laser eye surgery medical records was conducted. All ten of the medical records did not have completed "time outs."

During an interview with OR Tech 1,November 17, 2010 at 1 p.m., he stated, he assisted with the laser eye surgeries in the endoscopy room on October 22, 2010. The OR tech indicated during the laser eye procedures the RN just brings the patients in the procedure room. He stated the RNs are responsible for ensuring the consents were signed in the preprocedure area. The OR tech stated that "time outs" are done in the procedure room with the physician, but he was unable to explain the reason ten patient records did not have completed "time outs" that should have been signed and dated.

A review of the facility's universal protocol for preventing wrong site, wrong procedure, wrong person surgery. The purpose was to establish a standard procedure for identifying the correct patient, procedure and anatomical side/site prior to all operative and invasive procedures. The protocol indicated the "time out" process shall be conducted in the location where the procedure will be done.

On January 12, 2011, at 1:40 p.m., an interview was conducted with RN 5. She stated she was asked by the OR director to assist in the laser procedure pre op area. She stated, "I was just winging it. I had to come back a few days later to complete the paper work."

On January 12, 2011, at 2:40 p.m., an interview was conducted with RN 1. She stated the OR director asked her to assist in the laser pre operative area on October 22, 2010. The RN indicated that she was unsure if a nurse was to be in the procedure room and did not know if a "time out" was done.

4. A review of Patient 2's record revealed her surgery start time was 1620 (4:20 p.m.), stop time was 1625 (4:25 p.m.) and the consent for the surgical procedure was signed at 1705 (5:05 p.m.), 40 minutes after the surgical procedure was completed.

During an interview with OR Tech 1, he stated, he assisted with the laser eye surgeries in the endoscopy room on October 22, 2010. He stated the RNs are responsible for ensuring the consents were signed in the preprocedure area. The OR Tech stated that "time outs" are done in the procedure room with the physician, but he was unable to explain the reason the unsigned consent for surgery was not detected.

The protocol the facility uses for "time out" process indicated that it shall be conducted in the location where the procedure will be done and shall involve the entire operative team and all relevant documentation including the consent form shall be verified by the team. If there were any discrepancies, the preprocedural team shall call the physician for clarification prior to the start of procedure.








25338

Based on interview and record review, the facility's surgical services failed to provide and maintain the highest standards of patient care by failing to ensure:

1. The facility preoperatively verified the site of surgery during the "time-out" process and pre-operative patient examination were conducted, according to the facility policy, to ensure the right surgery was performed for 1 of 44 sampled patients (Patient 27). The failed practice resulted in Patient 27's wrong surgical procedure;

2. Time-out (a system used by the surgery team members to verify the right patient, site, and type of surgery or procedure) was performed to ensure appropriate care was provided in the surgical room for 11 of 44 sampled patients (Patients' 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 36), which resulted in the potential for procedural errors during the surgery, and

3. Consent in writing for right eye surgery was signed and dated prior to a procedure for Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10.

Findings:

1. On December 2, 2010, at 10:10 a.m., an initial investigation was conducted for an entity reported incident. A concurrent interview with the CNO and DQR indicated Patient 27 received the wrong surgery on October 29, 2010. Patient 27 received a tongue-tie release (cut performed under the tongue) instead of tongue lesion resection.

On January 10, 2011, Patient 27's record was reviewed. Patient 27, a six-year old male was brought in by his parents for an outpatient surgery.

The "Pre-Operative History and Physical" dated October 27, 2010, performed by Surgeon 1, was reviewed and indicated, "Chief Complaint: Tongue lesion...lesion almost 1 x 1 cm over the center of the tongue...Plan for resection of the tongue lesion with reconstruction..." There was no indication of a tongue-tie release was considered.

The "Consent to Surgery" dated October 29, 2010, at 10 a.m., indicated, "Resection of tongue lesion."

The "Surgical Pre-Operative Assessment" dated October 29, 2010, was signed by Surgeon 1. The record did not indicate whether there were any changes or any updates to the original H&P.

The "Pre Op Surgical Check List" dated October 29, 2010, filled out by the surgical licensed nurses, indicated, "Resection of tongue lesion (removal of a growth on the tongue)."

The "Pre-Anesthesia Evaluation" dated October 29, 2010, at 10 a.m., signed by Anesthesiologist 1 was reviewed and indicated, "Pre-op dx: tongue tie lesion release tongue tie resection tongue lesion (the words tie, release tongue tie were lined out and initialed)..."

The "Anesthesia Record" dated October 29, 2010, with anesthesia start time of 10:05 a.m., indicated, "Surgical Procedure: release of tongue tie..."

The "Operative Report" dated October 29, 2010, at 10:26 a.m., indicated, "Preoperative and Postoperative Diagnoses...Ankyloglossia/tongue tie and speech disorder..." The record further indicated, "...The patient with a history of tongue tie/ankyloglossia (connection of the tip of the tongue to the bottom of the mouth). The release of tongue was indicated...Alternatives, benefits and risks...were already explained to the mother. She understood and agreed to proceed...The tongue was extruded and step by step with using cautery, the entire tongue was released..."

The "Universal Protocol Checklist Team Time-out" dated October 29, 2010, initiated at 10 a.m., indicated the "Scheduled Procedure" was "Removal of Tongue Mass, possibly fibroma..." The record indicated a "time-out" was performed at 10:19 a.m., which ensured each team member verbally verified the following:
-Correct patient identity;
-Correct side and site; and
-Agreement on the procedure to be done.

The "Intraoperative Nursing Record" dated October 29, 2010, with surgery start time at 10:20 a.m., indicated, "Preop Diagnosis: Tongue mass, most probably fibroma...Procedure: Release of Tongue Tie..."

The "PACU Record" dated October 29, 2010, with time in at 10:28 a.m., was reviewed and indicated, "Procedure: Release of tongue tie."

The record further indicated the following:
a. At 10:28 a.m. - "A 6 year old male admitted...via gurney from OR accompanied by (Anesthesiologist 1) and (RN 1)..."
b. At 10:32 a.m. - "Parent at bedside - mother asking about surgery. Advised she could see in his mouth under the tongue. She said no it is on the top of the tongue...Parents upset and mother keeps stating he was supposed to have tongue lesion removed and not anything was discussed about tongue tie..."

On January 11, 2011, RN 1 was interviewed. She stated she was the circulator nurse during the surgery for Patient 27. She stated she verified pre-op the procedure to be tongue mass resection. She stated she had conversations with Surgeon 1 about Patient 27 regarding medications that needed to be started with the patient. RN 1 stated the procedure was verified and confirmed with informed consent signed by the parent, which indicated tongue mass resection. RN 1 stated, "At no time tongue tie release was discussed with Surgeon 1 prior to the procedure." RN 1 stated the patient was brought in to the OR. She stated, when Surgeon 1 came in to the OR, "time-out" was initiated and confirmed the procedure as tongue mass resection. She stated, "Surgeon 1 said, Okay, okay." The surgeon proceeded to the mouth and performed the surgery. She stated Patient 1 was then brought to the PACU and report was given to the RN 2.

On January 11, 2011, RN 3 was interviewed and stated she was the second circulator in the case for Patient 27. She stated she heard Anesthesiologist 1 verified the procedure with the mother as tongue mass resection in the pre-op area. Patient 27 was brought to the OR for the procedure shortly after that. RN 3 recalled RN 1 going in and out of the other OR to verify with Surgeon 1 the IV orders for Patient 27. She recalled the surgeon indicated to RN 1 that IV was not needed because the procedure was a short procedure. RN 3 stated "time-out" was performed to verify the procedure was a tongue mass resection. She stated the team members verified the type of procedure according to what was written on the white board. She stated the information, which included the type of procedure, was written on an erasable board according to what was indicated in the informed consent. RN 3 stated Surgeon 1 did his procedures in a quick pace. She stated, "(Surgeon 1) stops now (during the time-out to verify) after this happened." She stated the members that definitely verified the "time-out" were the surgeon, anesthesiologist, and the primary circulator.

On January 11, 2011, at 12:55 p.m., the COA was interviewed. He verified Anesthesiologist 1 was unavailable for interview (on vacation). He stated he spoke with Anesthesiologist 1 regarding the case and particularly the "Pre-Anesthesia Evaluation" which was had information that was lined out. He stated Anesthesiologist 1 stated she had written, "tongue tie...release tongue tie" prior to speaking with the parent in the preop area. As soon as she verified the procedure with the mother and the informed consent as "tongue lesion...resection tongue lesion," she put a line through and wrote the right preop diagnosis and proposed operation. He stated the "Anesthesia Record" was brought in the OR where the anesthesiologist documented the activity in the OR.

The "Anesthesia Record" for Patient 27 dated October 29, 2010, with a start time of 10:05 a.m., was reviewed with the COA. He stated he was unaware that the record indicated, "release tongue tie." He was unable to explain why the record was left as "release of tongue tie" when the pre-anesthesia evaluation was corrected and indicated resection of the tongue lesion instead of tongue-tie release.

On January 12, 2011, at 10:45 a.m., a phone interview was conducted with Surgeon 1. He stated he recalled RN 1 coming in (while he was in another case) and verified some IV antibiotic orders for Patient 27. He gave orders to cancel the antibiotics for Patient 27 thinking antibiotics were not usually ordered for a tongue-tie release procedure and may be the reason why the nurse was verifying the antibiotic orders. He stated, "Nothing is better than honesty...do not recall any time-out..." He stated there could have been two possible reasons why this happened. He stated, "Either time-out was not done or it was done, but I could not recall what procedure was said." Surgeon 1 stated if the team members knew what was scheduled for Patient 27 (tongue lesion resection), nobody questioned, "Where is the specimen?" Surgeon 1 stated Patient 27 had a scar tissue under the tongue and the tongue-tie release was indicated "anyway." When the surgeon was asked whether he examined the patients in the pre-op area prior to the surgery, he stated, "Usually, I don't examine anybody. I sometimes visit...in this case, there was no time to do pre-op visit...From now on, I need to see the patient prior to surgery..." Surgeon 1 stated he had not seen the lesion before the surgery.

On January 12, 2011, at 9:05 a.m., RN 4 (PACU nurse) was interviewed regarding the flow of patients from surgery through PACU. She stated the PACU received a schedule of surgeries for the day. The PACU RN will be informed at least 10 minutes in advance before the patient was transferred to the PACU from the OR. The OR RN and anesthesiologist brought the patient in the PACU and gave report to the receiving PACU RN. The PACU RN verified the report with the Operative Report and record of the patient. RN 4 stated she worked the day when the incident occurred. She stated she overheard the OR RN (RN 1) gave RN 2 (PACU nurse who received Patient 27) report. She stated the report given by RN 1 to RN 2 was that Patient 27 had a tongue-tie release.

On January 13, 2011, at 11:15 a.m., a phone interview was conducted with RN 2 (PACU nurse who received Patient 27). She stated the PACU nurses were given at least 10 minutes notice prior to receiving a patient from the OR. She stated, included in the notice, special endorsements were given when receiving a pediatric patient. Information given did not include the procedure(s) performed on the patient. She stated report was given when the patient was brought in the PACU. She stated on the day Patient 27 had his surgery, she recalled the patient being brought in by RN 1 and Anesthesiologist 1 to the PACU. She stated the report given to her (could not recall if both the RN and anesthesiologist gave report) was that Patient 27 underwent a tongue-tie release. She was also given report that the patient's mother wanted to be at the patient's bedside in the PACU. RN 2 stated when the mother asked about the patient's surgery, she told the mother she could go ahead and check under the tongue, knowing the surgery performed was a tongue-tie release, which was what was given in report. RN 2 stated that was when the mother questioned why she was being directed to look under the tongue when the surgery was on the top of the tongue. RN 2 stated that was when RN 1 went and got Surgeon 1 to talk to the family. She stated she documented "Release of tongue tie" in the "PACU Record" because that was what was given to her in the verbal report, which was verified through the post-op report.

On January 19, 2011, at 11:50 a.m., a phone interview was conducted with Patient 27's mother. She stated the wrong surgery was performed to her son. She stated her son had appointments and was seen by Surgeon 1 on August 9 and October 13, 2010. On August 9, 2010 (first appointment with Surgeon 1) was to have the tongue lesion checked. The October 13, 2010 visit was for the pre-operative preparations. She stated on the day of surgery, Anesthesiologist 1 came in the pre-op area and discussed the process with her, including verifying the type of surgery. She stated Surgeon 1 did not see her son in the pre-op area at any time. Her son was brought in the OR and after 10 to 15 minutes, she was called to the PACU area. In the PACU area, she asked the nurse how the surgery was. The nurse responded, "The skin was clipped off," which was confirmed by the anesthesiologist who was at the bedside. She stated her son woke up and she asked her son to open his mouth and stick his tongue out. She stated she still saw the tongue lesion on the tongue and questioned it. Surgeon 1 was called to verify the surgery, which verified that a tongue-tie release was performed. She stated she asked the surgeon why the tongue lesion was not removed. She stated the surgeon stated, "What lesion...That's so small we didn't even notice it (talking about the lesion)..." She stated the surgeon decided to bring her son back in the OR to do the right surgery.

On January 13, 2011, at 10:20 a.m., the CNO and DQR were interviewed regarding the wrong surgery performed on Patient 27. The CNO stated the facility identified the "time-out" did not appropriately occur. She stated the RN should have stopped the Surgeon and performed the "time-out" to verify all the information.

The facility policy titled, "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery" effective June 4, 2005, was reviewed. The policy indicated, "To establish a standard procedure for identifying the correct patient, procedure and anatomical side/site prior to all operative and invasive procedures..."

The policy further indicated:

a. "Pre-Procedural...The surgeon/physician, LIP or his/her designee performing the procedure is ultimately responsible for the verification process and shall verify the surgical site...";

b. "...Prior to performing the procedure, the surgical/procedural team will take a moment ("time out"). Time-out must be immediately performed before starting the procedure. The time-out process shall be conducted in the location where the procedure will be done and shall involve the entire operative team. The team shall verbally verify the following...Agreement on the procedure to be done..."; and

c. "Verification...The physician or Licensed Independent Practitioner (LIP) shall discuss the operative/invasive procedure with the patient before the anesthesia/moderate sedation. The patient shall verbalize agreement of the correct procedure and surgical site, and the discussion and patient verbalization shall be documented in the medical record..."

The policy further indicated, "...Prior to performing the procedure, the surgical/procedural team will take a moment ("time out"). Time-out must be immediately performed before starting the procedure. The time-out process shall be conducted in the location where the procedure will be done and shall involve the entire operative team. The team shall verbally verify the following...Agreement on the procedure to be done...All components of the above process shall be completed and documented on the verification checklist..."

2. On January 12, 2011, Patient 36's record was reviewed. The patient had tonsillectomy (removal of the tonsils) and adenoidectomy (removal of the adenoid) on October 29, 2010. The record did not contain documented evidence a "time-out" was performed.

On January 12, 2011, at 3 p.m., the CNO reviewed the record and was interviewed. The CNO stated she was not able to find evidence time-out was performed prior to the start of the surgery.

The facility policy titled, "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery" effective June 4, 2005, was reviewed. The policy indicated, "To establish a standard procedure for identifying the correct patient, procedure and anatomical side/site prior to all operative and invasive procedures..."

The policy further indicated, "...Prior to performing the procedure, the surgical/procedural team will take a moment ("time out"). Time-out must be immediately performed before starting the procedure. The time-out process shall be conducted in the location where the procedure will be done and shall involve the entire operative team. The team shall verbally verify the following...Agreement on the procedure to be done...All components of the above process shall be completed and documented on the verification checklist..."

During a review of the medical record of Patients 33, 34, 35, 36, and 38, the Surgical Pre-Operative Assessment form was signed by Surgeon 1, but the spaces on the preprinted form that indicated the physician had reviewed the history and performed a physical exam were left blank.

On January 12, 2011, Patients 32 and 37's records were reviewed. Surgeon 1 performed surgery on the patients on October 27, 2010. The Surgical Pre-Operative Assessment form was not signed by Surgeon 1, and the spaces on the preprinted form that indicated the physician had reviewed the history and performed a physical exam were left blank.

During an interview with the CNO on January 12, 2011, at 2:45 p.m., she concurred that the Surgical Pre-Operative Assessments were not completed.

During an interview with Surgeon 1 on January 12, 2011, at 10:45 a.m., he stated that "usually" he did not examine the patients on the day of surgery.

In an interview with the Director of Medical Staff on January 12, 2011, at 2 p.m., she stated that there was no mechanism in place to monitor the quality of the physician documentation pre- and post-operatively. She stated that this had been the task of the OR Manager, but had not been done.

The Medical Staff Rules and Regulations, approved September 16, 2010, page 6 read in part, "If a complete H & P (History and Physical) has been performed and documented (by the attending physician or other practitioner who has been granted privileges to perform such examination) within 30-days prior to inpatient admission, an update documenting any changes in the patient ' s condition is completed within 24 hours after inpatient admission but prior to surgery or a procedure requiring anesthesia."




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Based on interview and record review, the facility failed to ensure an updated medical history and physical examination was completed prior to surgery for 10 of 44 sampled patients (Patients' 27, 32, 33, 34, 35, 36, 37, 38, 39 and 41). This failed practice resulted in the wrong surgical procedure, performed on Patient 27 by Surgeon 1. The failed practice potentially created the risk of undiscovered medical conditions and poor surgical outcome for the patients.

Findings:

1. Patient 27's "Pre-Operative History and Physical," dictated October 27, 2010, and signed by Surgeon 1, indicated that Patient 27's history was, "not significant for any medical problems," and that he had no allergies. In Patient 27's "Medical History," it was recorded that the patient had an extensive medical history, including asthma, two hospitalizations for respiratory illnesses, and multiple surgeries, and an allergy to penicillin. This information was omitted from Patient 27's Pre-Operative History and Physical.

The "Pre-Operative History and Physical" of Patient 39 was reviewed on January 12, 2011. Patient 39 was scheduled for tonsillectomy and adenoidectomy under general anesthesia. The document included the chief complaint, history of the present illness, allergies, and an examination of the head and neck. There was no relevant past, social or family history noted, and no review of systems or examination of the heart or lungs.

During an interview with the CNO on January 12, 2011, at 2:45 p.m., she concurred that the documentation of history and physical examinations in Patient 27 and Patient 39's medical records were incomplete.

During a review of the Medical Staff Rules and Regulations approved September 16, 2010, page 5 read in part, "History and Physical must include" 1. chief complaint, 2. details of the present illness, 3. relevant past, social and family history, 4. allergies, 5. review of systems, 6. relevant physical examination to include inventory of body systems and vital signs."

2. During a review of the medical record of Patients 27, 39 and 41, the Surgical Pre-Operative Assessment form was signed by Surgeon 1, but the spaces on the preprinted form to indicate that the physician had reviewed the history and performed a physical exam were left blank.