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Based on staff interviews, policies and procedures, observations, and other pertinent documentation review, it was determined that the hospital failed to provide adequate oversight of environmental services, a contracted service, and to ensure the services provided are in compliance with the Medicare Conditions of Participation and standards of practice.


In early 2012, the operating room director expressed concerns about the consistency and thoroughness of terminal cleaning in the operating rooms. She notified the Environmental Service Director. There was an evaluation with the Senior Director of Operations, the environmental service contractor and the OR leadership. The environmental service contractor assured Suburban Hospital that the terminal cleaning was being performed according to standards. There is no indication that the hospital requested immediate terminal cleaning of the operating rooms, devised a plan to monitor the terminal cleaning process, requested to see documentation or logs indicating that the terminal cleaning had been performed nor was Infection Control, Quality, and Administrative Leadership involved.


In March, the issue regarding terminal cleaning of the operating rooms was again discussed with the environmental services contractor who assured the hospital that the terminal cleaning was being performed according to standards. When the hospital attempted to validate the cleaning by reviewing the cleaning logs, no logs could be produced for the period of January through April 2012. The hospital policy, Infection Control in the Operating Room, requires that operating rooms be terminally cleaned at least once/day each twenty-four hours. The COO stated she was notified about the problems at the end of April 2012 and the risk manager stated she was made aware of the problems when she received the complaint letter from the Office of Health Care Quality on May 7, 2012. The surveyors' review of the quality committee and infection control committee minutes revealed the minutes were void of any mention of the problems identified and actions taken by the hospital.


There is no documentation or indiction that any actions were taken by the Quality Assessment and Performance Improvement program to assess the contracted environmental services to identify quality and performance problems, implement appropriate corrective or improvement activities and to ensure the monitoring and sustainability of those corrective or improvement activities.

Based on staff interviews, review of policies, procedures, and other pertinent documentation, the hospital failed to provide sufficient safeguards to ensure that access to all information regarding patients is limited to those individuals designated by law, regulation, and policy; or duly authorized as having a need to know.


While reviewing the personnel file of a surgical technician, the surveyor found that an employee had received disciplinary action for bringing an acquaintance to work with him during the night shift in November 2010, who remained in the operating room all night. The visitor to the operating room was not authorized to be in the department where access to the patients' paper medical record and computer stored information was possible. The employee received a final written warning and re-education regarding the process for visitors in the department.


The hospital failed to protect the healthcare information for patient's scheduled for surgery with the unauthorized visitor in the operating room. This violation represented a break in HIPAA, corporate compliance and privacy laws.

Based on staff interviews, policies and procedures, observations, and other pertinent documentation review, it was determined that the hospital failed to implement and maintain an effective, hospital-wide quality assurance and performance improvement program and failed to provide adequate oversight of surgical and environmental services.


On March 7, 2012 the OR educator validated that the surgical technician had forged the bio-test result for autoclave 2B. The two surgical instrument trays processed by the technician were used during two patients surgical procedures.


Two out of 2 surgical instrument trays were improperly autoclaved and used during surgical procedures on Patient #4 and #5. Patient #4 is an 83 year old female who had D&C performed on 3/2/12 for vaginal bleeding at Suburban Hospital. The patient's other diagnoses included hypertension, type II diabetes, and arrhythmias. Patient #5 is a 28 year old female who had D&C for endometrial polyps and bleeding.


There were also questions regarding the consistency and thoroughness of terminal cleaning in the operating rooms. The hospital staff discussed these concerns on two occasions with the environmental service contractor who assured the hospital that the terminal cleaning was performed according to standards. The contractor was unable provide the cleaning logs from January through April 2012. Other than the cleaning logs, there was no indication the hospital was providing monitoring and oversight of the environmental service.


Based on interview with the staff of Risk Management/ Quality on June 1, 2012 the surveyor determined that the department was not aware of the problems in surgical services and environmental services until receipt of the letter containing the complaint on 5/7/12. The minutes from the quality committee meetings reviewed by the surveyor on June 1, 2012 did not reveal any discussion of on-going problems with terminal cleaning of operating rooms and environmental services nor problems with staff forging of autoclave results.


The following timeline is a chronology of the events regarding the falsification of the autoclave log:

October 11, 2011 - The OR staff nurse assumed process of autoclave log quality control audits from Sterile Processing Department.

March 7, 2012 - The OR Educator determined that there was falsification of the biologic quality control test. Although documented, it was determined that the test had not been performed. The investigation revealed that the violation was limited to one employee and confined to one incident on that day. The Interim OR Director was notified and in turn, contacted the OR Director.

March 8, 2012 - The OR Director verified the falsification of the log and conferred with Human Resources regarding disciplinary action.

March 9, 2012 - The employee responsible for the falsification of the log was terminated. The COO was notified of the employee termination.

April 24, 2012 - The COO notified the CEO of the autoclave incident and employee termination.

May 11, 2012 - The Board Chair was notified of the findings.

June 6, 2012 - The Board meeting minutes reflected notification of leadership.

June 11, 2012 - The issuing agency for the employee's certification was notified of the conduct of the terminated employee.


Further review of the records reviewed by the surveyor revealed that between July 2011 and April 2012 the total numbers of flash or immediate use sterilizations performed in the months between July 2011 and April 2012 ranged from 81 to 137 with the total number of surgical cases each month ranging between 731 to 873. Immediate use sterilizations should only be used on an emergency basis whereas these numbers indicate, 10-12% of the surgical cases performed, that it has become routine. This practice increases the possibility of breeches in the standards of operation during the sterilization process and indicates possible planning and resource problems.

The chronology of the events related to the terminal cleaning log is as follows:

January 16, 2012- The OR Nurse manager raises concerns regarding consistency of OR cleaning in an e-mail to the Director of the OR. The hospital environmental services are provided by contracted company.

January 17, 2012 - Walking rounds of the OR were conducted by the contracted EVS Supervisor, OR Director, and the Nurse Manager. The OR Nurse Manager e-mail the EVS Regional Director about the difference between the Association of Perioperative Registered Nurses (AORN) guidelines of terminal cleaning with machine/wet vacuum every night verses the EVS schedule (according to the EVS supervisor) of :
1. Mop daily
2. Machine daily
3. Deep machine side to side monthly

January 23, 2012 - A request was made by Suburban Senior Director of Operations to the EVS Regional Director for an investigation into the claims that the terminal cleaning being employed was not consistent with the AORN standards was performed in the ORs.

January 25, 2012 - The EVS Regional Director reports to the Senior Director of Operations that terminal cleaning is being performed in accordance with established standards.

February 17, 2012 - EVS company terminates the EVS Supervisor at Suburban Hospital and a new EVS Supervisor begins on 2/21/12.

March 8 & March 13, 2012 - Mock surveys were performed by the parent company of Suburban Hospital by the Senior Director of Accreditation and Certification and general OR cleanliness issues are identified and reported to the staff and executive leadership. Action plans are formulated and implemented by OR staff and leadership.

March 22, 2012 - Incomplete OR terminal cleaning logs and e-mail are identified by the OR Nurse Manager. This information is forwarded to the OR Director and the OR Educator, including a copy of the incomplete terminal clearing log found in the notebook located in the EVS closet in the Main OR.

March 26, 2012 -The Suburban Senior Director of Operations discussed log concerns with the EVS Regional Director and EVS Hospital Director in a regularly scheduled meeting.

April 24, 2012 - A meeting with the EVS Director, the new EVS Supervisor, the OR Director and Assistant Nurse Manager was held and a directive to the EVS company to perform terminal cleaning of all OR rooms was immediately issued. The OR Nurse Manager was terminated. The Chief Operating Officer (COO) and the Chief Executive Officer (CEO) were notified.

April 26, 2012 - A meeting was held between the new EVS Regional Director, EVS Supervisor and the OR Director.

April 30, 2012 - A mock survey was performed by the parent company of Suburban Hospital Senior Director of Accreditation and Certification and general OR cleanliness issues were again identified and reported to executive leadership.

May 1, 2012 - Intensive monitoring of terminal cleaning logs was initiated, with daily logs being emailed to executive leadership.

May 2, 2012 - OR cleaning expectations education provided to OR Specialty Coordinators.

May 7-10, 2012 - The parent company of Suburban Hospital Senior Director of Accreditation and Certification and the Perioperative Director provided oversight and monitoring in OR, meeting with OR staff and leadership as well as hospital executive leadership, and helping them draft action plans with accountability and monitoring.

May 11, 2012 - The Chief Operating Officer (COO) met with Chief Executive Officer (CEO) and Board Chair to discuss a variety of issues including OR terminal cleaning concerns.

May 16, 2012 - An internal investigation identified that no reliable OR terminal cleaning logs were available for the period of January through April 2012. This information was communicated to the COO and CEO.

May 18, 2012 - EVS Supervisor was terminated and the EVS Director terminated shortly after.

June 4, 2012 - An action plan by the Infection Control Department, including observing the cleaning of Five OR room per week, was initiated.

June 6, 2012 - Terminal cleaning issues were documented in minutes to governing body, reported by the COO to the Suburban Board.

There is no documentation that any type of occurrence reports or management variance reports were generated by surgical service staff, which could have triggered the investigation process for the issues. Further there was no evidence that the hospital conducted a root cause analysis or notified the two patients, their primary care physicians or surgeons that they may have been exposed to infection due to improper autoclave sterilization. The hospital staff did not follow its quality plan in regards to adverse event identification and reporting and notification of unanticipated outcome of care, therefore, there was no feedback provided to Infection Control, Quality/Performance Improvement and hospital leadership.


The hospital failed to grasp the seriousness of the on-going problems and the potential risk for infection. There is no documentation that surgical services provided immediate remedial actions to address the on-going problems or report these problems to infection control, quality or hospital administration. The timeline reveals the hospital's failure to recognize and respond to a substantial risk to patient safety. While the investigation was proceeding the OR rooms should have been immediately terminally cleaned and oversight and monitoring through the Infection Control program initiated.

Based on staff interviews, policies and procedures, observations, and other pertinent documentation, it was determined that the governing body of the hospital did not ensure that the surgical services, environmental and infection control had an ongoing and effective program for quality improvement.


On March 7, 2012, the operating room educator was reviewing the surgical department records for autoclave and noted that there was no machine generated documentation strip for the second bio-test for autoclave 2B. When the daily sterilizer test form was reviewed, it was noted that documentation by the surgical technician for the second test was completed. The operating room educator ran a subsequent test on the autoclave and the machine documented that this was the second run in that time period. Appropriate autoclave testing is crucial to ensure that pathogens are destroyed during the sterilization process. The failure of the hospital to test the autoclave resulted in unnecessary patient exposure to potentially life-threatening infection.



It was noted that there were two instrument trays placed in the invalid run and that these two trays were used during the surgical procedures for two patients, patients #4 and 5. As of the date of the survey, the hospital has not notified the patients, their primary care physicians or surgeons that they may have been exposed to infection due to improper autoclave sterilization. Two out of 2 surgical instrument trays were improperly autoclaved and used during surgical procedures on Patient #4 and #5. Patient #4 is an 83 year old female who had D&C performed on 3/2/12 for vaginal bleeding at Suburban Hospital. The patient's other diagnoses included hypertension, type II diabetes, and arrhythmias. Patient #5 is a 28 year old female who had D&C for endometrial polyps and bleeding. The patients, their primary care physicians, or surgeons were not notified by the hospital of the improper autoclave sterilization and their potential exposure to infection.


The operating room staff had been trained to perform sterilization and until recently were routinely sterilizing trays using flash or immediate use sterilization, instead of central sterile processing. Immediate use flash sterilization should only be used in an emergency. The hospital immediate use sterilization rate is 10-12% of the surgical cases performed for the months of July 2011 through April 2012.


In addition, in early 2012, the operating room director expressed concerns about the consistency and thoroughness of terminal cleaning in the operating rooms. She notified the Environmental Service Director. There was an evaluation with the Senior Director of Operations, the environmental service contractor and the OR leadership. The environmental service contractor assured Suburban Hospital that the terminal cleaning was being performed according to standards. There is no indication that the hospital requested immediate terminal cleaning of the operating rooms, devised a plan to monitor the terminal cleaning process, request to see the terminal cleaning logs nor involved Infection Control, Quality, and Administrative Leadership. In March, the issue regarding terminal cleaning of the operating rooms was again discussed with the environmental service contractor who assured the hospital that the terminal cleaning was being performed according to standards. When the hospital attempted to validate the cleaning by reviewing the cleaning logs, no logs could be produced for the period of January through April 2012. The hospital policy, Infection Control in the Operating Room, requires that operating rooms be terminally cleaned at least once/day each twenty-four hours. The COO stated she was notified about the problems at the end of April 2012 and the risk manager stated she was made aware of the problems when she received the complaint letter from the Office of Health Care Quality on May 7, 2012. The surveyors review of the quality committee and infection control committee minutes revealed the minutes were void of any mention of the problems identified and actions taken by the hospital.

This lack of awareness on the part of hospital leadership directly affected patient outcomes because the two improperly autoclaved surgical instrument trays were used during surgery for two different patients. In addition, the environmental service contractor maintained its own quality assurance in the form of cleaning logs for the OR. A poor pattern of performance of surgical (sterilization process) and environmental services directly affected quality of care and infection control as identified by the OR Nurse Manager. Despite findings that the OR staff lacked competency in regard to the sterilization process and EVS company terminal cleaning process did not meet the Association of Perioperative Registered Nursing (AORN) guidelines and the parent company mock survey, also identified issues with general OR cleanliness, indicated that the EVS service and surgical services did not have an effective quality assurance program, hospital leadership neglected to provide the oversight necessary to monitor its activities and improve performance. The lack of awareness on the part of hospital leadership directly affected patient outcomes as the OR Nurse Manager continued to report problems within the surgical department regarding practices that did not meet standards and the potential risk for infection.


The EVS and surgical department did not share identified problems with the hospital's quality assurance program and infection control. Despite the hospital having appropriate policies/procedures and systems regarding reporting in place, the occurrence reporting system was not used to inform the quality program of problems with staff forging autoclave bio-test result and failure of contracted environmental service to perform terminal cleaning of the operating rooms. The hospital failed to monitor the services and despite questions of poor performance the hospital failed to provide the oversight necessary to monitor surgical and environmental service activities and improve performance.

Based on staff interviews, policies and procedures, observations, and review of pertinent documentation the hospital failed to provide or act on the ongoing concerns voiced by the Director of the OR regarding problems with the terminal cleaning service provided by environmental services nor did the hospital provide follow-up regarding two surgical instruments trays that were improperly processed and used during two surgical procedures. The hospital failed to follow-up with the two patients, their primary care physician or the surgeons regarding the patients' potential exposure risk.


On March 7, 2012, the operating room educator was reviewing the surgical department records for autoclave and noted that there was no machine generated documentation strip for the second bio-test for autoclave 2B. When the daily sterilizer test form was reviewed, it was noted that documentation by the surgical technician for the second test was completed. The operating room educator ran a subsequent test on the autoclave and the machine documented that this was the second run in that time period. Appropriate autoclave testing is crucial to ensure that pathogens are destroyed during the sterilization process. The failure of the hospital to test the autoclave resulted in unnecessary patient exposure to potentially life-threatening infection.


The operating room staff had been trained to perform sterilization and until recently were routinely sterilizing trays including flash or immediate use sterilization, instead of central sterile processing. Immediate use sterilization should only be used in an emergency. The records indicate that immediate use sterilizations occurred during 10-12% of the surgical cases on a monthly basis. Between July 2011 and April 2012 the number of flash sterilizations during surgical procedures ranged from 81 to 137 with the total number of surgical cases for these months ranging between 731 to 873. Immediate use sterilizations by OR staff should be minimized and should only be used in emergency basis, however, these numbers indicate that flash sterilization has become routine. Based on the review of the records, for more than 10% of all surgical procedures performed flash sterilization was used. This introduces variability into the quality of the sterilization process and indicates a lack of resources and planning for the surgical procedures being performed.


Additionally, 2 out of 2 surgical instrument trays were improperly autoclaved and used during surgical procedures on Patient #4 and #5. Patient #4 is an 83 year old female who had D&C performed on 3/2/12 for vaginal bleeding. The patient's other diagnoses included hypertension, type II diabetes, and arrhythmias. Patient #5 is a 28 year old female who had D&C for endometrial polyps and bleeding. The patient's other diagnoses included asthma, bipolar, and depression. The patients, their primary care physicians, or surgeons were not notified by the hospital of the improper autoclave sterilization and their potential exposure to infection.

In early 2012, the operating room director expressed concerns about the consistency and thoroughness of terminal cleaning in the operating room and the failure to appropriately. The chronology of the events surrounding this concern is outlined under the deficiency cited at A267. The chronology demonstrates that the infection preventionist was not notified of this problem, consulted nor was he/she involved in resolving it in a timely manner.


Review of minutes from Quality and Infection Control revealed problems with forging the autoclave strip, use of improperly autoclaved surgical instruments and possible failure to perform terminal cleaning of the operating rooms although known, was not discussed or reported up through the committees. The concerns posed a potential significant risk for harm to patients. There is no indication that the hospital requested immediate terminal cleaning of the operating rooms, devised a plan to monitor the terminal cleaning process, nor did they request to see the terminal cleaning logs. Based on review of the hospital policy, "Infection Control in the Operating Room", it was determined that the hospital requires that operating rooms be terminally cleaned at least once/day each twenty-four hours. An effective infection control program is critical to ensure patients are protected from serious hospital acquired infections. There was no coordination and oversight by the Infection Control Program in concert with surgical services to ensure monitoring of these essential infection control measures.

Based on the deficiency cited at standard A951 it was determined that the condition of surgical services was not met as evidenced by:
1. The failure to thoroughly investigate allegations that the contractural environmental services company had terminally cleaned operating rooms as required in accordance with hospital policies and procedures and the standards of practice;
2. The failure of hospital staff to investigate and notify patients or their physicians of a potential exposure to infection as a result of improperly sterilized surgical equipment;
3. The failure of staff to wear appropriate attire in the OR; and
4. The failure of the surgical leadership to notify the hospital leadership and the appropriate committees and departments such as QA and Infection Control of these breeches in procedures as noted at A0083, A0267 and A0749.

Based on staff interviews, policies and procedures, observations, and other pertinent documentation, the hospital failed to properly sterilize surgical instruments, provide terminal cleaning of the operating rooms, and wear appropriate operating room attire.


On March 7, 2012, the OR educator validated that the surgical technician had forged the bio-test result for autoclave 2B. The two surgical instrument trays processed by the technician were used during two patients' surgical procedures. Two out of 2 surgical instrument trays were improperly autoclaved and used during surgical procedures on Patient #4 and #5. Patient #4 is an 83 year old female who had D&C performed on 3/2/12 for vaginal bleeding at Suburban Hospital. The patient's other diagnoses included hypertension, type II diabetes, and arrhythmias. Patient #5 is a 28 year old female who had D & C for endometrial polyps and bleeding. The patient's other diagnoses included asthma, bipolar disorder and and depression. The patients, their primary care physicians, or surgeons were not notified by the hospital of the improper autoclave sterilization and their potential exposure to infection.


In addition, there were questions regarding the consistency and thoroughness of terminal cleaning in the operating rooms. The hospital discussed these concerns on two occasions with the environmental service contractor who assured the hospital that the terminal cleaning was performed according to standards. The contractor was unable provide the cleaning logs from January through April 2012. Other than the cleaning logs, there was no indication that surgical services was providing monitoring and oversight of the terminal cleaning provided by environmental service.



In early 2012, the operating room director expressed concerns about the consistency and thoroughness of terminal cleaning in the operating room. She notified the Environmental Service Director. There was an evaluation with the Senior Director of Operations, environmental services contractor and OR leadership. The environmental service contractor assured Suburban Hospital that the terminal cleaning was being performed according to standards. There is no indication that the hospital requested immediate terminal cleaning of the operating rooms, devised a plan to monitor the terminal cleaning process, nor did they request to see the terminal cleaning logs. In March, the issue regarding terminal cleaning of the operating rooms was again discussed with the environmental service contractor who assured the hospital that the terminal cleaning was being performed according to standards. When the hospital attempted to validate the cleaning by reviewing the cleaning logs, it was found that no logs could be produced for the period of January through April 2012. The hospital policy, Infection Control in the Operating Room, requires that operating rooms be terminally cleaned at least once/day each twenty-four hours. The COO stated she was notified about the problems at the end of April 2012 and the risk manager stated she was made aware of the problems when she received the complaint letter from the Office of Health Care Quality on May 7, 2012. The surveyors review of the quality committee and infection control committee minutes revealed the minutes were void of any mention of the problems identified and actions taken by the hospital. OR leadership failure to report problems through the proper chain of command nor did they complete an event report.


In addition while observing the environmental staff clean OR #15 after a procedure, the surveyor asked about the warming jacket that a nurse was wearing. The jacket is the personal property of the employee and laundered by the employee. These jackets are worn in and out of the hospital and into the operating rooms. The scrubs worn by the hospital staff are provided and laundered by the hospital to avoid a source and transmission of infection. The employee's personal warming jacket is a potential source of infection and should not be worn in the OR.

Based on staff interviews, policies and procedures, observations, medical record review and other pertinent documentation the hospital failed to properly execute informed consent for surgery for patient #3.


In 1 of 10 medical records reviewed (patient #3), the hospital failed to ensure a properly executed informed consent for surgery. Patient #3 is a 40 year old female admitted to the hospital on 4/23/12. The patient's diagnoses included abdominal wall laxity, hypertrophic skin of the abdomen, localized hypertrophy of the abdomen and flanks, and post-partum cardiomyopathy with congestive heart failure an ejection fraction of 20%. Her surgeries included placement of an automatic internal defibrillator, abdominoplasty and placement of her lap band port in a new position.


On 4/23/12, patient #3 had a defibrillator placed, an abdominoplasty, and laparoscopic movement of lap band port due to substantial weight loss. The peri-operative progress note under pre-op diagnoses list the following: Abdominal wall laxity, hypertrophic skin of abdomen, cardiomyopathy, post-partum with Congestive Heart Failure, and possible lap band port/pain. Under planned procedure: (1) Abdominoplasty. There was a box checked for no changes to the History and Physical. The form was signed by the surgeon dated 4/23/12 and timed 7:10 am. The patient had 2 consent forms, one for Abdominoplasty with liposuction, which was signed by the patient on 4/23/12 at 6:55 am, by the surgeon at 7:10 am and anesthesia at 7:20 am. The second consent for placement of Implantable Cardioverter Defibrillator, which was signed by the patient on 4/23/12 at 6:55 am, was signed and dated by the surgeon but no time, and signed by anesthesia at 7:15 am. Both surgeries were to be performed. On the first consent the surgeon wrote an addendum to add the lap band port.


The immediate post-operative note for post diagnosis was written the same, under procedure abdominoplasty, insertion of AICD, transfer of lap band port to LLQ (lower left quadrant). The form lists the surgeon, no complications, blood loss as minimum, besides specimens - old lap band port removed and the form was signed, dated 4/23/12 and timed 12:10 pm by the surgeon.


The hospital investigation revealed that during the time-out procedure, it was noted that the surgical consent listed the AICD and the abdominoplasty, but the movement of the lap banding port was not listed on either consent. The patient had already signed the consent and was under anesthesia. The OR Director was made aware and discussed the situation with the surgeon. The hospital's investigation revealed that the surgeon discussed adding the additional procedure to the consent with the patient's significant other and then documented the second procedure to the consent form prior to initiating the surgery. The hospital views the infraction as a failure on the surgeon's part to comply with the informed consent documentation rather than failure to obtain informed consent from the patient.



The hospital's procedure on informed consent under #10 stated that the form must be executed by the patient and witnessed prior to the time the patient is given any medication, which would sedate or otherwise impair the patient senses or in any way detract from his/her ability to understand the form. Although the surgeon stated he had obtained informed consent, he failed to ensure the consent was appropriately executed and documented. The surgeon may have discussed the lap band port removal and new lap band placement with the patient but when it was noted that this procedure was not listed on the consent form, a new consent should have been obtained. The hospital has stated that the surgeon discussed adding the additional procedure to the consent with the patient's significant other than documented the procedure on the original consent form as an addendum prior to initiating the surgery. There is no signature from the significant other on the consent form. In addition, this change in procedure should have been clearly documented in the patient's medical record. No such note can be found. The only documentation available regarding the consent issue is the consent form which has written "Addendum: Replace lap band port."


There are other concerns regarding the informed consent procedure, under #4 it stated, a single consent form will be sufficient for a series of planned treatments or procedures, including treatments that span multiple hospitalizations, unless there has been a material change in the patient's condition, which affects the risks and benefits of the treatment, as determined by the physician.