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Based on interviews, a review of 49 open and closed medical records, a review of the medical staff bylaws and selected policies and procedures from the hospital, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital as an institution.

Findings:

1. The governing body failed to ensure a Certified Nurse Midwife met the requirements of the medical staff for completion of appropriate proctoring to assist in a C-Section. Cross reference A049.

2. The governing body failed to ensure that contracted services for dialysis equipment had been monitored to ensure patient safety. Cross reference A083.

3. The governing body failed to ensure that infection control standards were met in terminal cleaning and disinfecting procedures in the surgical suites. Cross reference A951 #3 and #4.

4. The governing body failed to ensure that quality assurance and performance improvement follow up had been provided to monitor improvement in patient safety. Cross reference A291 and A313.

5. The governing body failed to ensure the implementation of the P&P for the counting of sharps and sponges during a surgical procedure, resulting in two patients requiring a second surgery to remove a retained sponge. Cross reference A951 #1 and #2.

6. The governing body failed to ensure the daily management of dietary services in order to provide patients, staff and visitors with safe, high quality food and to ensure the food service met the needs of the patients, staff, and visitors during a disaster. Cross reference A620.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the medical staff failed to ensure patient care was provided by a practitioner who had been granted privileges in accordance with the criteria established by the governing body when CNM A was independently functioning as a first assistant to the physician during C-Sections before completion of the hospital's proctoring process. This resulted in potential harm to a patient by an inexperienced practitioner.

Findings:

On 9/8/10, review of the California Board of Registered Nursing's explanation of Standardized Procedure requirements for CNM Practice dated 2/01, showed when CNMs performed medical functions, such as serving as the first assistant in a surgical procedure, a standardized procedure was required.

On 9/8/10, review of the hospital's Allied Health Professional Rules and Regulations, revised November, 2009, showed CNM privileges shall be proctored as follows: the CNM shall second assist for a minimum of five C-Sections. The CNM will then first assist for a minimum of five C-Sections. An evaluation form shall be completed by the on-site surgeon following each procedure and shall be sent to the Medical Staff Office. The Chairman of Obstetrics and Gynecology is responsible for assuring that all hospital and department policies are carried out accordingly.

Medical record review for Patient 43 was initiated on 9/8/10. The patient was admitted to the hospital on 7/13/10 and delivered an infant via C-Section. Review of the operative report for the C-Section showed the surgeon was assisted by CNM A.

The Manager of Medical Staff was interviewed on 9/8/10 at 1350 hours. The Manager stated CNMs were privileged to act as a first assistant to the surgeon during delivery of an infant by C-Section. The Manager was asked to provide evidence of proctoring for CNM A. Proctoring forms dated 6/9, 6/16, 6/24, 7/13, 8/2, 8/2, 8/5, and 8/6/10, were reviewed. The documentation showed CNM A was proctored by another CNM on 6/9/10 and acted as the second assistant during the surgery. Following that first surgery, the proctoring forms for CNM A were signed off by the physician on the case and showed the CNM acted in the role of first assistant. When asked, the Manager stated there were no additional proctoring forms submitted for CNM A. The Manager stated CNM A should have had an additional CNM or physician with her during the first five C-Sections, as she would be in the role of the second assistant. The Manager was requested to provide the operative reports for the proctoring dates for confirmation CNM A was acting solely as a first assistant.

During a follow up interview with the Manager of Medical Staff on 9/9/10 at 1010 hours, the Manager stated, upon interview, CNM A stated she acted as a second assistant to the surgeon for the C-Section of 6/9/10 only. The Manager stated the CNM stated she was informed by the physician group that she had done well and did not need to continue with the second assistant proctoring. When asked, the Manager stated for this to have happened, it would have needed the approval of the Department Chairman. The Manager stated this had not been done.

During an interview with CNM A on 9/13/10 at 1010 hours, the CNM was asked about the proctoring process for C-Sections. The CNM stated she acted as a second assistant at maybe two C-Sections. The CNM stated she was then told by the Medical Staff office that she was OK to be the first assistant. When asked if she received a written confirmation of this privileging, CNM A stated she did not remember.

During an interview with the Manager of the Medical Staff office on 9/13/10 at 1035 hours, the Manager stated she was unable to provide written notification sent to CNM A regarding her completion of proctoring to assist with C-Sections. The Manager stated her office realized a couple of months ago that their standardized protocol for CNMs, the Allied Health Professional Rules and Regulations, did not match their Privilege Delineation form for CNMs. The Manager stated this other form showed only five proctoring procedures were required in order to assist during a C-Section. When asked the standard enforced by the hospital, the Manager stated the Allied Health Professional Rules and Regulations was the standardized protocol for CNMs.

Based on record review, staff interview and policy review, the hospital failed to ensure the contracted service for dialysis care provided and updated the information regarding services furnished to the hospital, training and competencies for the biomedical engineering staff (staff who apply engineering principles and techniques to the medical field), and made available their policies and procedures. These deficiencies had the potential to result in unqualified personnel and faulty machine testing and maintenance.

Findings:

Review of the Hospital Based Clinical Ancillary Services Agreement dated 1/23/09, for the provision of dialysis services, showed the facility would be provided with documentation of the licenses, current competencies and other qualifications/certifications of all personnel providing ancillary services to the facility. The provider would also submit written documentation to the facility regarding all repairs, maintenance activities and results of electrical safety tests performed on the dialysis equipment by the dialysis company's biomedical department.

1. On 9/7/10 at 1530 hours, training information and competencies for the provider's biomedical staff was requested. The information was not available on site and had to be requested from the dialysis provider. Review of the competency forms provided showed the forms had been completed and verified by an instructor. The forms contained the month and day completed; however, there was no year on the form to show the year the competencies had been done.

2. Review of the dialysis provider policy manual showed a policy entitled, "Machine Maintenance Schedule," with an effective date of 9/04. The policy showed the provider would perform an inspection repair/replacement and calibration every three months on the dialysis machines. Review of the maintenance logs for the dialysis machines showed calibrations were only being done every six months.

A telephone interview was conducted on 9/7/10 at 1535 hours, with the dialysis provider's Chief Biomedical Technician. He stated the dialysis machines were serviced per the manufacturer's recommendations, with calibrations done every six months. Every three months the machines were checked and repaired or parts replaced as needed.

The policy in the contract service's manual provided to the facility did not reflect the verbal information given to the surveyor or the manufacturer's recommendations for machine service.

2a. Review of the contracted service's machine maintenance logs provided to the facility showed the testing and calibration for three machines, serial numbers: 4HOS-3620, 2HOS-1306 and 0148796. On 9/13/10 at 1050 hours, during a visit to the dialysis storage room with RN N, the serial numbers on the two machines in the room were checked. It was observed that one of the machines in the storage room had a serial number of 4HOS-3629. The service records for this machine were not in the provider's manual and RN N stated the facility would request the service records for that machine. On 9/13/10 at approximately 1300 hours, copies of the service records for machine 4HOS-3629 were given to the surveyor. Review of the records showed the machine received service on 6/10/09, 9/14/09, 12/11/09, 3/18/10 and 6/12/10.

Further review of the records for machine 4HOS-3629 showed that from 6/10/09 to 3/18/10, this machine was recorded as machine #3, and on 6/12/10 was recorded as machine #10. Dialysis machines track the total hours the machine is used each treatment, and the number of hours are accumulated over the life of the machine as service requirements are based on the hours. The usage hours for machine 4HOS-3629 were recorded as follows:
* 6/10/09 the total accumulated usage hours were 28566.
* 9/14/09 the total accumulated hours were 28952.
* 12/11/09 the total accumulated hours were 29536.
* 3/18/10 the total accumulated hours were 29521.
* 6/12/10 the total accumulated hours were 28154.

From 12/11/09 to 3/18/10 the records showed a decrease in the number of accumulated usage hours as the machine was used. On 6/12/10, the total number of usage hours again showed a decrease. There was an inconsistency regarding the total accumulated usage hours for this machine in the reports given to the facility.

2b. Review of the monthly microbiologic monitoring for the dialysis water and dialysate for the months of April, May and June 2010, was done with RN N and the Infection Control Preventionist. When asked why the last month of reports available were for June 2010, the Infection Control Preventionist stated the dialysis provider only sent the reports on a quarterly basis. The Infection Control Preventionist was asked how the facility would know if a culture done since June was outside of the limits. She stated if a test was outside the limits, the dialysis provider would come and remove that machine from service.

The microbiologic testing reports had a cover form that listed the culture site, the date the culture was done, and the results of the testing. The cover report listed dialysis machines #1, #2 and #3 with the serial numbers for each machine. It also showed the reverse osmosis machines attached to the dialysis machines as #1, #2, and #3 with their serial numbers. The cover report had a space at the bottom showing the reports had been checked by an employee of the service provider. The individual microbiologic reports for April and May corresponded to the machines and serial numbers listed on the cover sheet.

The cover sheet for the June report was the same as for April and May. However, upon review of the individual microbiologic reports it showed they were for machines #10, #11, and #12. Machines #11 and #12 and their serial numbers corresponded to the dialysis machines and reverse osmosis machines listed as #1 and #2 on the cover sheet. The serial number for machine #10 did not correspond with any of the dialysis machine serial numbers on the cover sheet. The reverse osmosis machine listed as machine #10 corresponded with the serial number for the machine previously listed as machine #3. The cover sheet showed the reports had been checked by the same employee as for April and May.

The hospital failed to ensure the accuracy of the reports submitted by the contracted company.

4. Review of the copy of the Hospital Based Clinical Ancillary Services Agreement made and entered into on 1/23/09, with the dialysis service provider, showed the agreement had been signed by the representative of the dialysis provider, but the area for the covered entity (the hospital) signature was blank.

Based on observation, interview and record review, the hospital failed to ensure patients received care in a safe environment as evidenced by:
*OR suites were not terminally cleaned in a manner that prevented recontamination of cleaned surfaces.
*Surgical instruments were not processed in an open position to ensure sterility.
*Dialysis machines were not maintained per manufacturers' recommendations.
*Patient care equipment was not date labeled to show how long it had been in use.
*Staff were not observed to wash hands before patient care.
*The pharmacy did not properly maintain the area in the pharmacy designated as clean for the sterile preparation and compounding of IV medications.
*PHF in the cafeteria was not monitored for safe temperatures and dietary staff were unable to completely state the cool down process for cooked food.
* Sufficient water for use in an emergency was not available as based on the number of patients, staff, and visitors estimated by the hospital.
* The Infection Control Preventionist for the hospital failed to maintain surveillance of infection control practices in the OR and dietary areas.

These deficiencies resulted in the inability of the hospital to ensure the provision of care in a safe environment.

Findings:

Cross reference A083, A501, A620, A749 and A951.

Based on interview and review of documents, the hospital failed to follow up and track performance regarding identified QAPI issues of physician documentation of a complete history and physical and the use of fentanyl patches to ensure actions implemented to improve these areas were effective and maintained. This resulted in the potential for problems to continue, or to increase in areas identified as a priority for patient safety.

Findings:

1. The Executive Director for Performance Improvement & Patient Safety was interviewed on 9/8/10 at 1000 hours. The survey team's concerns with incomplete H&Ps was discussed. The Executive Director stated the hospital's QA program had addressed this issue and had made recommendations for improvement. The QAPI (quality assurance performance improvement) data dated June, 2008, for "incomplete history and physical examinations prior to surgery by selected required items" was reviewed with the Executive Director. The data showed 22 dictated history and physical examinations and five "short form" history and physical examinations were reviewed. The data revealed evidence that 40% of patients presenting for surgery to the hospital had incomplete history and physical examinations. Documentation of allergic reactions to medications was incomplete 20% of the time and treatment plans were absent or incomplete for 10-20% of the clinical records reviewed. Recommendations were made for the medical staff leadership and nursing to review the data and make recommendations as needed. When the Executive Director was asked if any follow up studies had been conducted to ensure recommended improvements had been maintained, he stated, no they had not.

Review of medical records showed three of 49 sampled patients did not have complete H&Ps in their records (Patients 19, 43 and 47). Cross reference A358.


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2. On 9/13/10 at 1002 hours, the DOP presented documents from the hospital's QAPI program. One document entitled, "Measurement of New and Modified Medication Management Processes," listed ten "process changes" for the year 2009, and six for the year 2010. The process changes were implemented due to weaknesses or deficiencies found, but follow up on these changes only occurred if another error was reported. There was no proactive monitoring to determine if these errors were still occurring but had not been reported.

A process change listed for Quarter 1, 2009, showed, "Due to confusion with the timing of hanging lipids of 1000 was initiated (Lipids is a broad group of naturally occurring molecules which includes fats, waxes, sterols, fat-soluble vitamins). Nurses will take down lipids daily at 2200. IV technicians will monitor lipid infusions during their morning IV reconciliation rounds." The first sentence of this process change pertaining to "1000" was confusing as written. On 9/13/10 at 1002 hours, the DOP stated there were no documented outcomes to ensure monitoring was done by the IV technician.

A process change listed for Quarter 2, 2010, showed a fentanyl patch was ordered upon admission. The patient had applied the fentanyl patch prior to admission. The first scheduled dose of fentanyl was held by the RN but the time was not adjusted. This resulted in the next scheduled time for removal and replacement of the patch to be inaccurate. A decision has been made to remove patches on admission and replace based on new orders." On 9/13/10 at 1002 hours, the DOP stated, since we made this change there were no further reports of this occurring. When asked the DOP stated there was no monitoring of medical records to determine if the issue with fentanyl patches had reoccurred and was not reported.

Based on interview and review of documents, the hospital's governing body failed to ensure the QAPI program collected data to track performance of identified issues regarding physicians' documentation of complete histories and physicals and the use of fentanyl patches, to ensure actions implemented were maintained. This resulted in the potential for problems to continue or to increase in areas identified as a priority for patient safety.

Findings:

Cross reference A291.

Based on interview, medical record and document review, the hospital failed to ensure the enforcement of the Allied Health Professional Rules and Regulations of the hospital for CNMs acting in the role of first assistant during a surgical procedure when CNM A was independently functioning as a first assistant to the physician during C-Sections before completion of the hospital's proctoring process. This resulted in potential harm to a patient by an inexperienced practitioner.

Findings:

Cross reference A049.

Based on interview and medical and document record review, the medical staff failed to ensure the requirement for a physician to document a complete history and physical examination in the medical record prior to a surgery or a procedure requiring anesthesia services for three of 49 sampled patients (Patients 19, 43 and 47) was enforced.

Findings:

The hospital's General Rules and Regulations dated 10/26/09, required a comprehensive complete admission history and physical examination and any required updates. A complete history and physical examination was to include the chief complaint and history of present illness, past medical and surgical history, family history, social history, allergy history, current medications, review of systems, and a complete and comprehensive physical examination.

1. Patient 19 was admitted to the hospital for surgical services on 7/7/10. A review of the history and physical examination for Patient 19 revealed no documentation of the review of systems. The physical examination failed to document status of the heart and lungs for Patient 19.

2. Patient 43 was admitted to the hospital for labor and delivery services on 7/13/10. At approximately 2115 hours on 7/13/10 Patient 43 was taken to the operating room for an elective cesarean section due to non-reassuring fetal heart pattern noted on fetal monitoring. The medical record contained no documentation of a preoperative history and physical examination for Patient 43, as is required by the medical staff bylaws of the hospital.

3. Patient 47 was admitted to the hospital for surgery on 9/7/10. A review of the history and physical examination revealed no assessment of a previous cancer operation, family history, social history, details of the history of lupus, or review of systems for Patient 47. The physical examination failed to assess the status of the abdominal findings in this patient with an ileostomy (the surgical opening from the ileum through the abdominal wall, permitting drainage of the contents of the small bowel). There was no description of the ileostomy or documentation of a rectal and pelvic exam.

4. The QAPI (quality assurance performance improvement) data dated June, 2008, for "incomplete history and physical examinations prior to surgery by selected required items" was reviewed with the Executive Director. The data showed 22 dictated history and physical examinations and five "short form" history and physical examinations were reviewed. The data revealed evidence that 40% of patients presenting for surgery to the hospital had incomplete history and physical examinations. Documentation of allergic reactions to medications was incomplete 20% of the time and treatment plans were absent or incomplete for 10-20% of the clinical records reviewed. Recommendations were made for the medical staff leadership and nursing to review the data and make recommendations as needed. When the Executive Director was asked if any follow up studies had been conducted to ensure recommended improvements had been maintained, he stated, no they had not.

Based on interview, medical record and document review, the hospital failed to ensure a CNM was practicing within the criteria developed by the medical staff in the Allied Health Professional Rules and Regulations of the hospital for CNMs acting in the role of first assistant during a surgical procedure. CNM A was found to be functioning independently as a first assistant to the physician during C-Sections prior to the completion of the hospital's proctoring process. This resulted in potential harm to a patient by an inexperienced practitioner.

Findings:

Cross reference A049.

Based on observation, medical record review and staff interview, the hospital's director of nursing services failed to be responsible for the development of a P&P to reflect the hospital's current patient care practices for one of 49 sampled patients (Patient 6) who required a lumbar drain. In addition, there was no P&P developed for the use of ICP (intracranial pressure) monitoring devices for intermittent drainage of brain/spinal fluid and specimen collection, ICP dressing changes and the maintenance of the ICP device. This resulted in the potential for staff not to know the procedures for care of these patients.

Findings:

1. On 9/7/10 at 0900 hours, during the initial tour of the ICU accompanied by the ICU Director and RN C, a lumbar drain system was observed attached to Patient 6. The patient was reported as being ruled out for meningitis (brain infection). The set-up had no sticker attached to determine the date and time it was initiated and by whom.

On 9/7/10 at 0915 hours, RN C was asked how frequently the set-up was changed. RN C stated most lumbar drain set-ups were not kept for long. The ICU Director was asked to provide the hospital's P&P on care and maintenance of the lumbar drain. After two days, the ICU Director acknowledged there was no current P&P available to show the hospital's current practice for the use of lumbar drains which would include: the date, time and site the monitoring system was inserted; drain maintenance based on aseptic techniques; and when to change the drainage bag.

2. Further tour of the ICU revealed an intracranial pressure monitor (ICP) cart that contained the necessary equipment for insertion of the monitor in the patient's skull to continuously monitor pressures which if increased, could potentially squeeze and injure the brain tissues. The intracranial monitor set-up had the option to drain the brain/spinal fluid (ventriculostomy drainage) to decrease the amount of pressure inside the head allowing blood flow and oxygenation to brain tissues, provide access to collect brain/spinal fluid laboratory specimens, and to administer medications directly to the brain in cases of brain infection, all in strict aseptic techniques.

On 9/7/10 at 0920 hours, the ICU Director was asked regarding the hospital's P&P on ventriculostomy and insertion of an intracranial pressure monitor. The ICU Director was able to access information on the hospital computer at the nurse's station. This information showed the intracranial insertion procedure, the ICP monitor's general maintenance and nursing interventions, as referred by the American Association of Neurosurgical Nurses (AANN) Reference Series for Clinical Practice, published in an unknown year. However, there was no hard copy of the AANN information and no hospital P&P was provided by the Director to include: who among the neurosurgeons could insert the device and who among the nursing staff (from ER, ICU or OR) were trained and qualified to care for such patients. The AANN instructions mentioned adequate sedation but was not specific with regard to the level of sedation and the use neuromuscular blocking agents and pain medication.

On 9/9/10 at 1000 hours, the ICU Director stated the staff needed a hard copy of the ICP P&P in case of power failure. The ICU Director acknowledged there was not a P&P available. The ICU Director asked RN R, the ICU supervisor, to provide a temporary P&P, however he admitted the P&P committee had not approved it.

Based on observation, staff interview and record review, the Intensive Care Unit (ICU) nurses failed to supervise an echocardiogram technician with regard to observance of infection control practices while performing a procedural test for one of 49 sampled patients (Patient 36). Patient 36 was in a droplet and contact isolation room, precautionary measures to prevent the spread of infection. Failure of the nurses to ensure other patient care staff followed isolation procedures had a potential for the spread of infection throughout the hospital.

Findings:

On 9/7/10, review of the hospital's P&P on Droplet Isolation Precautions showed droplet precautions were used for patients known or suspected to be infected with microorganisms transmitted by droplets (large-particle droplets that could be generated by the patient during coughing, sneezing, talking, or the performance of procedures). Some of the illnesses requiring droplet precautions included meningitis, pneumonia and sepsis. Wearing a mask in addition to standard precautions which involved wearing gloves, gown and handwashing, were required during procedures and when caring for the patient.

Further review of the P&P on Infection Control revealed the nursing authority for initiating isolation precautions and their responsibilities to ensure that the patient and patients' family were taught the reason and uses of isolation/precautions. This included the responsibility to inform other personnel about isolation precautions. In addition, The Infection Control Preventionist was responsible to make sure patients were isolated properly.

An initial tour of the ICU was conducted with the Unit Director and RN C (Clinical Nursing Supervisor) on 9/7/10 at 0930 hours. Echo Tech A was observed inside ICU Room 282 about to initiate an echocardiogram test (use of sound waves to determine heart size and heart valves). The signs posted at the entry door indicated that Patient 36 was on droplet and contact isolation. The sign showed PPE of a mask, gloves, and a gown were required during care of the patient. Handwashing was required before exiting Patient 36's room. The patient was reported as being ruled out for possible meningitis infection. Echo Tech A was observed wearing mask and gloves only. The observation of inadequate PPE of Echo Tech A was discussed with RN C and the Unit Director. When RN C asked Echo Tech A to wear an isolation gown, the Tech stated she felt hot wearing the gown so she decided to drape the gown on the patient instead. The three ICU nurses at the nurse station had not reminded Echo Tech A to put on the required PPE to comply with the isolation protocol.

Based on record review and staff interview, the hospital failed to ensure the ED nursing staff developed and kept a nursing care plan for one of 49 sampled patients (Patient 27) as stated in their P&P. Patient assessments were to be developed into a plan of care to guide nursing interventions and evaluation of the patients' responses to interventions. Failure to develop a care plan had the potential for Patient 27's needs not being met.

Findings:

On 9/8/10, review of the hospital's P&P on "Admission, Nursing Responsibilities" showed the purpose of the document was to provide guidelines for the nurses' role in admission of a patient to a nursing unit. On letter J the P&P showed appropriate care plans should be initiated.

On 9/8/10, record review of Patient 27 showed the patient was admitted to the ED on 4/13/10 at 1956 hours, and was discharged on 4/13/10 at 2344 hours. At 2006 hours, Patient 27 was triaged as level 3 on a 1-5 acuity level (1 with stable vital function and 5 with danger zone vital signs). A bed was assigned to Patient 27 in the hallway. The medical screening examination (MSE) was provided by a physician's assistant (PA) at 2155 hours. Further record review failed to show a care plan had been developed while the patient was in the hospital. A written plan to address post-hospital discharge needs was not located. The nurses' notes contained an assessment of the patient needs and the patient's response to interventions. These assessments were not reflected in a nursing care plan to be revised according to the patient's response to the interventions in a timely manner.

On 9/9/10 at 1400 hours, in an interview with the ED Nursing Director and ER Medical Director, it was stated that the reason the nursing care plan was not initiated was because the patient's short stay in the ED. Both acknowledged the need to revise hospital's current P&P to reflect the current ED practice.

Based on staff interview, medical record review and review of the hospital's P&P, the hospital failed to ensure accurate documentation of the sponge, sharps and instrument counts during an operative procedure for two of 49 sampled patients (Patients 29 & 43) who required a second surgery for removal of a retained sponge. The Intraoperative forms did not contain information to show the time of the sponge count or at which point in the procedure the count was completed.

Findings:

On 9/8/10, review of the P&P for Count of Sharps and Sponges revised 3/09, showed the sharps and sponges were counted in the OR by the scrub nurse/OR Tech and the circulating RN: prior to the procedure to establish baseline counts; before closure of any body cavity or part there of; before closure of any deep or large incision; at the time of change of the scrub or circulating nurse; and immediately before the completion of the surgical procedure, e.g. skin closure.

1. On 9/9/10, record review for Patient 29 revealed the patient underwent surgery in the hospital on 4/13/10. During the operative procedure the sponge count was found to be incorrect, however the missing sponge was unable to be located before the conclusion of the surgery. After subsequent confirmation by x ray, a second surgery was performed on the patient two days later for the removal of the sponge from the patient's abdomen.

The Operating Room (OR) record review of Patient 29 showed there were four sponge, sharps and instrument counts done on the day of surgery. However, the events were documented in the medical records without a time, making it difficult to determine the succession of the events which occurred during the surgery.

On 9/9/10 at 1545 hours, the documentation of the sponge counts on the Operative Report form for Patient 29, dated 4/13/10, were reviewed with RN S. The RN confirmed he had been present for the surgery on 4/13/10. RN S stated the times were documented on the counting board in the OR but he did not realize the computerized documentation did not translate the actual time on the medical records.


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2. The medical record for Patient 43 was reviewed on 9/8/10. The patient was initially admitted to the hospital on 7/13/10. The patient underwent a C-section on 7/13/10.

Further review of the medical record for Patient 43 showed the patient presented to the Ed of the hospital on 9/1/10. The ED physician documented the patient was seven weeks post C-section. Patient 43 underwent surgery on 9/2/10 for removal of a retained sponge from the C-section of 7/13/10.

On 9/8/10 at 1110 hours, the Manager for Maternal Child Health was interviewed. In attendance were the CNO and the L&D (Labor and Delivery) Clinical Supervisor. The non electronic Intraoperative Record form used in the L&D OR was reviewed. The form showed an area for documentation of boxes to check for yes or n/a for sharps, sponges and instruments. In addition were lines for the first, second and third counts, with a check off box to show the count was conducted and a line for the signatures of the scrub person and RN circulator. There was no area for documentation of the time, or at which point in the procedure the count was conducted.

The Intraoperative Record, dated 7/13/10, for Patient 43 was reviewed. The form was completed to show the initial use of sharps, sponges, and instruments and the subsequent first, second, and third counts completed with a correct count. The form did not indicate the time of the count or at which point in the procedure the count was completed.

Based on observation, interview and record review, P&Ps of the hospital had not been updated to reflect the implementation and the use of the EPIC computer system in entering and reviewing medication orders. In addition, the hospital failed to obtain competency assessments for pharmacists to regulate Coumadin (a blood thinning medication used to prevent serious blood clots from forming) by the hospital approved protocol. The lack of completion of a competency test could have improperly trained pharmacists adjusting doses of potent drugs resulting in potential harm to a patient.

Findings:

1. On 9/13/10 at 0923 hours, during an interview, the DOP stated there were approximately 15 registered pharmacists working in the hospital and all had passed competencies to regulate all five of the hospital's approved drug protocols (aminoglycosides, total parenteral nutrition, heparin, vancomycin, and Coumadin). On 9/13/10 at 0954 hours, RPh C stated that pharmacists must complete and pass annual competencies that covered all medications they regulated by protocol.

The P&P entitled, "Competency Assessment Tool (CAT)" was reviewed on 9/13/10. Under "Procedure" showed " Employees hired prior to April 1 of a fiscal year are required to have an annual CAT after the close of the fiscal year."

On 9/13/10 at 1052 hours, review of RPh D's personnel file revealed competencies completed for four of the five drug protocols. There was no competency assessment for Coumadin located in RPh D's file. The other competencies for total parenteral nutrition, aminoglycosides, and vancomycin showed the RPh was last assessed for competence in 2008, beyond the yearly requirement as was documented in the hospital's policy and procedure.

On 9/13/10 at 1052 hours, the DOP stated, "Competencies are to be done each year."

On 9/13/10 at 1129 hours, review of RPh E's personnel file also revealed that the competency assessment was missing for Coumadin.



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2. On 9/8/10 at 1350 hours, the following policies were reviewed:
* MED-005, "Automatic Substitution of Medication orders", revised 03/05.
* PTC-215, "Physician Orders", revised 03/07.
* MED-085 "Medication Orders", revised 06/09.
Information contained in these policies was not consistent with the current use of the EPIC computer system. This computerized system had been installed and in use since March 2010. An interview with the Director of Pharmacy indicated that these policies were being revised to reflect current practices.

Based on interview, observation and record review, the hospital failed to investigate on a daily basis, the reason individual patient's drugs in cassette drawers were returned to the pharmacy from the patient care units unused; failed to have chilled saline available for use during a potential hyperthermia emergency caused by anesthetic agents, and failed to have policies for education of patients regarding their medications at discharge. This resulted in the potential for medication errors to go unrecognized; the inability to swiftly cool a hyperthermic patient and patients to not know about the medications they were to take at home after hospitalization.

Findings:

1. On 9/7/10 at 1001 hours, patients' cassette drawers containing returned medications were observed in the central pharmacy. These cassettes were part of a system used in the hospital to send a 24 hour supply of medications for each patient to the patient's nursing unit. Every 24 hours the cassettes were exchanged for a new supply of medications. When interviewed, the Director of Pharmacy was unable to show a follow-up was done by the Pharmacist as to why the returned doses of drugs were not administered to the patient as ordered.


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2. A tour of the hospital was conducted on 9/8/10 at approximately 0930 hours. During the tour of the OR, the Malignant Hyperthermia (an acute anesthetic and surgical emergency that may result from the use of certain anesthetic gases and medications utilized to induce general anesthesia) supplies were inspected and reviewed with the Perioperative Manager. The Perioperative Manager stated the Malignant Hyperthermia Association of the United States (MHAUS) guidelines were utilized by the hospital in the event of this type of emergency. The Manager was asked to provide evidence of chilled saline, as was required by the MHAUS guidelines to cool the patient during the hyperthermia. Observation of the refrigerator in the OR area demonstrated no chilled saline for use in an emergency situation for Malignant Hyperthermia.


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3. On 9/13/10 at 0923 hours, the DOP stated pharmacists were not involved in providing information about discharge medications to patients being discharged. The DOP stated he was unsure if patients received handouts, although he stated the hospital's computer program had the capability to print them.

On 9/13/10 at 1002 hours, review of the P&P entitled, "Discharge of Inpatient," showed that a registered nurse will review time, route and dose of medications with patient and/or family." There were no handouts that accompanied the verbal information. There was no further information required by the nurse regarding the indication of the medication, the potential side-effects or cautions.

California Health and Safety Code Section 1262.5(e) states that, "A hospital must establish and implement a written policy to ensure that each patient receives, at the time of discharge, information regarding each medication dispensed."

Based on observation and interview, the hospital failed to ensure the pharmacy properly maintained the area in the pharmacy designated as clean, for the sterile preparation and compounding of IV medications, resulting in the potential for contamination during the preparation of these medications.

Findings:

On 9/7/10 at 0955 hours RPh B was observed entering the IV compounding room not wearing a gown and gloves. RPh B walked across a line on the floor marking the "clean" area and handed a vial to a pharmacy technician who was compounding IV solutions under the laminar flow hood (a preparation area to maintain a clean environment). Prior to this occurrence the Director of Pharmacy, on interview, had indicated staff members must be gowned and gloved to enter the "clean" area on the other side of the line on the floor of the IV room.

Based on observation and interview, the hospital failed to ensure drugs and irrigation solutions available for patient use in the central pharmacy , the OR and the ICU were not outdated or were date labeled to show the length of time the medications and solutions had been available for use. This resulted in the potential for the use of drugs with altered potency and contamination with bacteria.

Findings:

1. At 0930 hours on 9/7/10, outdated drugs were observed in the central inpatient pharmacy. One tube of halobetasol propionate cream 0.05%, Lot #05408019, showed an expiration date of March 2010. Two vials of Enlon, Lot #71368A, showed an expiration date of 7/10. Both of the outdated drugs were located in an area where drugs were available to be dispensed for patient use.


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2. A tour of the OR with the Perioperative Manager and the PACU Manager was conducted on 9/7/10 at 1000 hours. The solution warmer was inspected and two, three liter bags of normal saline and sorbital were observed inside. The PACU Manager stated all the solutions in the warmer were date labeled when placed in the warmer. She stated the solutions were used for irrigation purposes during diagnostic and surgical procedures. Further observation of the solution bags did not show a date label as to when they were placed in the warmer. The Perioperative Manager stated the solution bags should have been labeled as per hospital policy.


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3. On 9/7/10 at 1000 hours, during the initial tour of the ICU accompanied by the ICU Director and RN C, the intracranial pressure monitor (ICP) cart was found to have six vials of expired sodium chloride ready for patient use. Four vials were dated 2/10, while the other two vials were dated 3/09.

4. On 9/7/10 at 1015 hours, two opened plastic bottles of Maalox and magnesium sulfate were found in ICU medication room. The bottles had not been date labeled to show how long they had been opened. RN C acknowledged bulk containers of medications should be labeled on the first day they were opened.

5. Further inspection of the ICU showed a liter of normal saline irrigation solution stored in a patient's room was not labeled with the date it had been opened. RN C, when asked, stated the P&P required, in addition to the date opened, the bottle should also be identified with the patient's name.

Based on observations, staff interviews and document reviews, the hospital failed to have a Director of Food and Nutritional Services who ensured the daily management of dietary services in order to provide patients, staff and visitors with safe, high quality food and to ensure the food service met the needs of the patients, staff, and visitors during a disaster.

Findings:

1. According to the 2009 Food Code of the FDA (Food and Drug Administration), if time without temperature control is used as the public health control for a working supply of ready to eat PHF that is displayed or held for sale or service: (1) Written policies shall be prepared in advance, maintained in the food establishment, and made available to regulatory authority upon request...If time with temperature control is used as a public health control up to a maximum of 4 hours: (1) The food shall have an initial temperature of 41 degrees F or less when removed from cold holding temperature control. (2) The food shall be marked or otherwise identified to indicate the time that is 4 hours past the point in time when the food is removed from the temperature control. (3) The food shall be cooked and served, served at any temperature, or discarded within 4 hours from the point in time when the food is removed from temperature control, and (4) The food in unmarked containers or packages or marked to exceed a 4-hour limit shall be discarded.

During a tour of the kitchen on 9/7/10 at 1020 hours, the Deli Bar in the cafeteria was noted to have a pan of tuna salad and a pan of sliced turkey luncheon meat set in ice. The temperature of each was checked: the tuna registered 45.4 degrees Farenheit (F), the turkey registered 46.6 degrees F.

During a concurrent interview with the Cafeteria Lead, he stated he had taken both items from the cafeteria refrigerator approximately 20 minutes earlier. The Cafeteria Lead stated the cafeteria's Deli Bar hours were from 1100 - 1400 hours and then from 1700 - 1830 hours. He stated it was the hospital's practice to put any items, leftover from the Deli Bar at the end of lunch service, in the cafeteria refrigerator. The leftover items would then be used again for the dinner service. The Cafeteria Lead stated he took the temperatures of the food but did not record them.

Observation of the external temperature reading on the cafeteria refrigerator showed it registered 53.7 degrees F. The Cafeteria Lead stated it was his practice to monitor the temperature of the refrigerator using the externally displayed thermometer. He stated there was no thermometer on the inside with which to record the ambient temperature. The Cafeteria Lead further stated the temperature of the refrigerator was high (greater than 41 degrees) because it had been opened while setting up the cafeteria for lunch service. Review of the hospital's "Refrigeration Log" for 9/7/10, indicated that the temperature of the refrigerator that morning had been 38 degrees F.

On 9/7/10, review of the hospital's P&P titled "Kitchen Refrigeration Food Storage Units" reviewed 8/14/08, showed "each morning a designee will be assigned to read the interior temperature and document on the refrigeration log." The P&P further showed, "refrigerator temperatures should read 41 degrees or less."

The DFNS (Director of Food and Nutrition Services) confirmed the temperature of the cafeteria refrigerator was greater than 41 degrees F at the reading of 53.7 degrees F. The DFNS stated that it was probably elevated because it was opened recently to prepare for lunch service.

During a concurrent interview with Cafeteria Worker 1, she stated that the dietary staff had just made the tuna salad before it was placed on the Deli Bar.

On 9/7/10 at 1415 hours, four hours after the first temperatures were taken on the Deli Bar, the Cafeteria Lead verified the same tuna salad and turkey luncheon meat had just been placed back in the cafeteria refrigerator.

The temperatures were again checked. The tuna salad registered 42.7 degrees F and the turkey meat registered 45.7 degrees F. When asked what he planned to do with these items, he stated that they were to be used on the Deli Bar for the dinner service at 1730 hours.

At that time, observation of the cafeteria refrigerator thermometer showed a reading of 55 degrees F. These temperatures again were verified by the DFNS.

On 9/7/10 at 1605 hours, nearly six hours since the first temperatures were noted to be greater than 41 degrees, the temperatures of the tuna salad and turkey meat were taken. The tuna salad registered 47.9 degrees F and the turkey meat registered 49.0 degrees F. The cafeteria refrigerator temperature read 52 degrees F. The hospital had placed a thermometer inside the refrigerator earlier in the day which read 65 degrees F at this time.

On 9/7/10 at 1610 hours, when asked what was planned to be done with the food in the refrigerator, the DFNS stated the tuna salad and turkey meat would be discarded. The DFNS stated the hospital would discontinue using the cafeteria refrigerator until it could be repaired. The DFNS stated the dietary department did not have a system in place to monitor and record the temperature of the food on the Deli Bar. She verified food could potentially be placed on the Deli Bar for 4 hours during lunch service (including set up time) and leftovers from lunch be placed back on the Deli Bar for another 2 hours during the dinner service. When asked for the department's policy for holding of PHF on the Deli Bar, she stated they did not have a policy. The DFNS could not explain why there was no policy to guide the staff on how to properly hold and store PHF on the Deli Bar.

2. During a tour of the kitchen on 9/7/10 at 1000 hours, with the Food Service Supervisor (FSS), a pan of frozen previously cooked chicken breasts was found in the freezer dated as, cooked on 7/23/10, discard on 7/26/10. The FSS was unable to explain why it had not been discarded one and one half months after the discard date.

During an interview with the DFNS on 9/7/10 at 1005 hours, when asked how the staff monitored safe cooling of cooked PHF, the DFNS directed the surveyor to the Lead Cook.

During an interview with the Lead Cook on 9/7/10 at 1010 hours, he stated that previously cooked PHF to be cooled and held for later service was monitored using the "HACCP (Hazard Analysis Critical Control Point) - Flow of Food Temperature/Time Chart." He explained that PHF was cooked to it's appropriate safe temperature. He stated for example, turkey was cooked to 165 degrees F. The Lead Cook stated once the food reached that temperature, the food was removed from the heat and the temperature was checked two hours later. The Lead Cook stated at the 2 hour check the temperature of the food needed to be 70 degrees F or less. The Lead Cook stated two hours later the temperature of the food needed to be less than 41 degrees F.

Review of the" HACCP - Flow of Food Temperature/Time Chart" dated 9/6/10, with the Lead Cook showed a turkey had been cooked to an internal temperature of 165 degrees F. Two hours later the temperature was checked and recorded at 72 degrees F. The Lead Cook was asked what he did when the temperature of a cooked food did not reach 70 degrees F in two hours. The Lead Cook stated he either placed ice around the food or put it in the freezer to cool more rapidly.

During a concurrent interview with the DFNS, she confirmed this was the practice of the department. Both the Lead Cook and the DFNS were unable to verbalize that if the temperature did not cool from 140 degrees F to 70 degrees F within 2 hours, it must be reheated to 165 degrees F for 15 seconds and the cooling process must start over again, as per the 2009 Food Code of the FDA.

According to the 2009 Food Code of the Food and Drug Administration, cooked PHF shall be cooled within two hours from 135 degrees F to 70 degrees F, and within a total of six hours from 135 degrees F to 41 degrees F or less. Safe cooling required removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of PHF (time/temperature control for food safety) had been consistently identified as one of the leading contributing factors to food borne illness. During slow cooling, PHF (time/temperature control for food safety) was subject to the growth of a variety of pathogenic microorganisms. A longer time near ideal bacterial incubation temperatures, 70 - 125 degrees F, was to be avoided. If food was not cooled in accordance with the Code requirement, pathogens may grow to sufficient numbers to cause food borne illness.

3. During an observation of the hospital's disaster water supply with the Director of Plant Operations on 9/9/10 between 0900 and 0950 hours, it was noted that the hospital's total disaster water supply totaled 1189 gallons of water.

On 9/9/10, review of the P&P "Disaster Cage Dry Storage Inventory, 3-Day Supply," undated, showed the disaster plan was to feed 1062 people for 3 days. This number included the 218 bed capacity, 44 visitors and 800 hospital employees.

During a concurrent interview with the Director of Plant Operations, he stated he was unable to recall how the hospital determined the amount of water that needed to be stored for the disaster supply. He was also unable to provide documentation of how this number of gallons was determined to be adequate for disaster water supply.

During an interview with the DFNS on 9/9/10 at 0950 hours, she stated the plan for disaster water supply was based on five to six cups or 40 to 48 ounces of water per person per day. She confirmed this would require a total water supply of 1195 gallons for a 3 day supply of disaster water for 1062 people.

According to the American Red Cross, one gallon per person per day for 3 days was recommended to be stored for healthy individuals for disaster supplies.

The hospital's disaster water supply provided for only 0.37 gallons (or 47 ounces) of water per person per day. This is only about 37% of what was recommended for healthy individuals by the American Red Cross.

4. During a tour of the kitchen on 9/7/10 at 1000 hours, with the DFNS, the following outdated products were observed: four two pound containers of yogurt with a use by date of 8/26/10, frozen potato product with a use by date of 9/6/10, a pan of previously cooked chicken breasts with a use by date of 7/26/10, a pan of tomato sauce with a use by date of 9/2/10, a case of individually packed custard cups (48 count) with a use by date of 8/15/10, 3 individual 4 ounce cups of custard with a use by date of 9/6/10. Also observed were an open bag of frozen french fried potatoes and an individual frozen meal removed from the original container with no open or use by dates indicated on either item.

During a concurrent interview with the DFNS, she stated that it was the hospital's policy to date all opened items with the date they are opened and with a use by date. She was unable to explain why there were 2 items that did not contain either an open or use by date.

She further stated that it is the department's policy to discard items immediately after the use by date. She stated that the department has an AM Food Service Worker (FSW) and a PM FSW who are responsible for daily monitoring of the expiration and use by dates of all items in the department. She further stated that it is the responsibility of the FSS to monitor compliance by these FSWs. She could not explain how products with use by dates as old as 43 days past their expiration or use by dates were still being stored in the department.

A review of the hospital policy titled "Storage - Food and Supplies," last reviewed by the hospital 8/14/10, revealed that it was the departmental policy to protect the quality of the food supply during storage as well as to provide timely and safe production of the patient and non-patient meals. It further showed that all perishable items are stored in either a refrigerator or a freezer and are properly covered, dated and labeled.

5. During a tour of the kitchen on 9/7/10 at 1000 hours, with the DFNS, ice was observed accumulating on the plastic flaps that covered the entry to the walk-in freezer and the floor of the freezer. The floor of the freezer was slippery upon entry which made it difficult to enter safely.

During a concurrent interview with the DFNS, she stated a new freezer door had been ordered. She confirmed the ice accumulation was a slip/fall hazard for the department employees. She was unable to explain why the ice accumulation was not removed to prevent this hazard.

During an interview with the Director of Plant Operations on 9/9/10 at 1430 hours, he stated the ice in the walk-in freezer had been accumulating for one week. He was unable to explain why the ice was not removed to prevent the slip and fall hazard to the dietary employees.

Based on observation, interview, and record review, the hospital failed to customize their on-line diet manual to be hospital specific in order to ensure therapeutic diet orders, and modifications, were approved by the hospital's staff of physicians, and were in conformance with physician diet orders. This did not ensure staff had the necessary guidance to meet patients' nutritional needs.

Findings:

During an interview with the DFNS on 9/7/10 at 1400 hours, she stated the hospital's diet manual was the "American Dietetic Association's Nutrition Care Manual." She further stated the hospital was in the process of customizing the online diet manual to be specific for the hospital, but it was not yet complete.

During an observation of the trayline on 9/8/10 at 1210 hours, an order was observed for a standard renal diet: 60 grams protein, 2 grams sodium, 2 grams potassium, 1.5 grams phosphorus and with a 1500 milliliters fluid restriction. The order further directed to omit the 2 gram potassium and send a high potassium diet. The tray for this patient was observed to contain a tuna salad sandwich on wheat bread, apple sauce, a green lettuce only salad, two eight ounce glasses of water and a four ounce glass of cranberry juice. There were no foods high in potassium noted on the tray.

During a concurrent interview with the DFNS, she stated that patient had received two servings of strawberries at breakfast to help meet the order for high potassium. She stated that strawberries were considered a medium potassium containing food, not high. When asked how the hospital determined the amount of potassium to send on a high potassium diet, she stated the diet manual did not specify the amount of potassium to send. She further confirmed the lunch tray that was served did not contain any high potassium foods and that it contained only low potassium foods as would be sent on a potassium restricted diet. She verifed the online diet manual did not provide adequate guidance to the dietary department or the medical staff in order to be able to determine the amount of potassium to be included on a high potassium diet.

The hospital's policy for the diet manual was requested but according to the DFNS, there was no policy.

Based on observation and staff interview, the hospital failed to ensure supplies were stored safely in the dialysis supply room resulting in the potential for a toxic chemical spill. The hospital failed to ensure the medication refrigerator in the ICU, the counters and sinks in the ED, the PACU and the laboratory were clean and maintained to ensure safety for patients and staff. The hospital failed to ensure equipment in the OR was maintained in a manner that allowed for maximal cleaning and safety for patients. In addition, the hospital failed to ensure the emergency cart in Radiology was checked daily per P&P for all necessary equipment. This resulted in the potential for the spread of infection and for equipment not to be available and fully functional for emergency care of Radiology patients.

Findings:

1. On 9/7/10 at 1500 hours, an observation of the dialysis supply storage room with RN N, showed bleach and vinegar in one gallon containers were being stored together on the bottom shelf. During an interview with Contract Dialysis Employee A, the employee stated he was unaware these two products should not be stored near each other, and was not aware of what would happen should the containers accidentally rupture and the two products mix together.

According to the website, Chemistry.About, an entry for Monday 2/2/09, showed when bleach and vinegar were mixed together, a toxic chlorine gas was released.

On 9/13/10 at 0900 hours, a follow-up observation of the storage room was done with RN N. A review of the dialysis provider's P&P manual, showed there was no policy and procedure regarding the correct storage for the bleach and vinegar containers.

2. On 9/8/10 at 1030 hours, during observation of the operating room (OR) with the OR
Supervisor, holes were observed in the covering of the arm rest used during surgical procedures which exposed the porous material underneath.

3. During a tour of the ED on 9/8/10 at 0900 hours, the following was observed:
* Countertops had large missing areas of the laminate covering. In addition, small holes had been drilled through the covering where equipment had been mounted exposing the porous wood underneath.
* The tops of trash containers and IV pole stands were dirty.
* The varnish on the wood trim had worn off exposing the porous wood underneath.
* The sink at the nursing station had water damage. The wood under the laminate covering of the backsplash around the sink countertop was swollen from water damage, causing the laminate covering to split apart at the seams where it was glued together, exposing the damp wood underneath.

4. On 9/8/10 at 1040 hours, during observation of the PACU, a black substance was observed along the top of the sink where it touched the wall.

5. On 9/8/10 at 1030 hours, during an observation of the laboratory area, the sink outside the door of the blood bank was noted to have water damage. Along the front edge of the sink, extending out from under the bottom edge of the laminate covering, a brown material was observed which looked like wood particles and was damp to the touch.


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6. On 9/7/10 at 0930 hours, during the initial tour of the ICU accompanied by RN C and the ICU Director, the refrigerator in the medication room was found to have a brown discoloration in the bottom of the refrigerator that appeared to be rust. RN C verified the situation and showed the refrigerator to the ICU Director. It was planned to replace the refrigerator.

On 9/9/10 at 1000 hours, the ICU Director showed the surveyor that the ICU medication refrigerator did not need to be replaced after the housekeeper cleaned the refrigerator's interior.

7. On 9/7/10 at 0900 hours, an inspection of the Department of Radiology, Imaging Services, was conducted. The crash cart daily checklists for two crash carts (adult and pediatric) were observed not to be completed.

The pediatric crash cart's Daily Check List log showed no documentation of signatures for 9/6/10 and 9/7/10, to show a clinical staff member had checked the cart for completeness.

An adult crash cart's Daily Check List log showed no documentation of signatures on 9/1/10, 9/2/10, 9/3/10, 9/6/10 and 9/7/10, to show a clinical staff member had checked the cart for completeness.

An interview with the Manager of Imaging Services was conducted on 9/7/10 at 0915 hours. The Manager stated the policy of the hospital was for crash carts to be checked on a daily basis unless the department was closed. The Manager stated if the department was closed a clinical staff member would document on the log that the department was closed.

There was no documentation on either crash cart daily logs that the department was closed at any time.

8. On 9/8/10 at 0900 hours, during observation of the ED with RN N and the ED Manager, the following items were found:
* Countertops had large missing areas of the laminate covering. In addition, small holes had been drilled through the covering where equipment had been mounted exposing the porous wood underneath.
* The varnish on the wood trim had worn off exposing the porous wood underneath.
* The sink at the nursing station had water damage. The wood under the laminate covering of the backsplash around the sink countertop was swollen from water damage, causing the laminate covering to split apart at the seams where it was glued together, exposing the damp wood underneath.

9. On 9/8/10 at 1040 hours, during observation of the PACU, a black substance was observed along the top of the sink where it touched the wall.

10. On 9/8/10 at 1030 hours, during an observation of the laboratory area, the sink outside the door of the blood bank was noted to have water damage. Along the front edge of the sink, extending out from under the bottom edge of the laminate covering, a brown material was observed which looked like wood particles and was damp to the touch.

Based on observation, interview and record review, the Infection Control Preventionist failed to develop a system for surveillance of staff practices in all areas of the hospital as evidenced by:

* Failure to develop and implement a P&P with specific guidelines to guide staff in the terminal cleaning process in the OR and for the use and maintenance of lumbar drains in the ICU.

* Failure to ensure processing of surgical instruments in the open position to ensure sterility.

* Failure to ensure cleanliness in the ED.

* Failure to ensure staff disinfected shared patient equipment in between use and to label patient care items to show how long the items had been in use.

* Failure to ensure staff washed their hands prior to contact with patients.

* Failure to ensure surveillance in two high risk areas, the OR and the dietary department.

* Failure to ensure food service guidance, policies and procedures, and staff monitoring systems were in place with infection control quality assurance to ensure safe food handling standards were planned and implemented.

These findings had the potential to create an unsafe environment for patient care and for infectious diseases and foodborne illness to spread throughout the hospital.

Findings:

1. The P&P titled: Cleaning of Perioperative Areas was reviewed on 9/9/10. The P&P did not include specific techniques/procedures for the terminal cleaning and disinfection of the OR suites.

Review of the 2010 Perioperative Standards and Recommended Practices, showed terminal cleaning defined as follows: Cleaning that is performed at the completion of a surgical practice settings' daily surgical schedules. Terminal cleaning was performed in surgical procedure rooms and scrub/utility areas and included, but was not limited to: surgical lights and external tracks; fixed and ceiling-mounted equipment; all furniture, including wheels and casters; all equipment; handles of cabinets and push plates; ventilation faceplates; horizontal surfaces e.g., tops of counters, sterilizers, and fixed shelving; the entire floor; and kick buckets and scrub sinks.

On 9/9/10 at 0815 hours staff failed to follow these standards of practice when performing terminal cleaning in the OR.

The Infection Control Preventionist was interviewed on 9/9/10 at 1400 hours. The Preventionist was asked her role in the surveillance and monitoring of the cleaning process in the OR suites. The Preventionist stated she did not perform monitoring or observation of terminal cleaning in the ORs. When asked if she observed terminal cleaning for isolation rooms in the hospital, she stated, "She did not." Cross reference A951 #3.

2. A tour of the operating rooms and the sterile processing department was conducted on 9/8/10 at approximately 0930 hours. The area containing processed and double wrapped surgical instruments was inspected. An observation was made of one hemostat clamp and one pair of surgical scissors that had been processed with the blades in a closed position. When interviewed, the Sterile Processing Supervisor confirmed that to process instruments in a closed position was in violation of the hospital's P&P for the processing of these instruments.

The Executive Director of Performance Improvement and Patient safety and the Infection Control Preventionist were interviewed on 9/13/10 at 1430 hours. When asked about infection control oversight for OR terminal cleaning and the processing of surgical instruments, both hospital representatives stated the infection control department did not carry out direct oversight of these areas.


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3. During the course of the survey the following unsafe dietary practices were identified:

* Dietary staff failed to monitor the temperature of potentially hazardous foods on the cafeteria's Deli Bar with either time or temperature controls for food safety.

*The dietary staff responsible for the rapid cooling of previously cooked potentially hazardous foods was not knowledgeable on the proper procedures to implement if the foods did not cool to the safe temperature range within the proper timeframe.

These failures to provide a safe and sanitary environment had the potential to result in food borne illness, and further compromise the patients medical status. Cross Reference A620

During an interview with the Infection Control Preventionist on 9/9/10 at 1400 hours, she stated she did not monitor in the dietary department for the proper maintenance of the temperatures of potentially hazardous food. The Infection Control Preventionist stated she left that up to dietary. The Infection Control Preventionist stated she monitored compliance of the dietary staff with the use of hairnets, hand hygiene, use of gloves, and the keeping of cooked and raw foods separate. The Infection Control Preventionist further stated she conducted inservices for the dietary staff on hand hygiene. When asked, the Infection Control Preventionist stated she did not keep a record of the monitoring done in the dietary department. She stated there was no mechanism in place for her to have identified the food service sanitation concerns found in the dietary department.

There was no system in place to identify food sanitation and infection control concerns as evidenced by the deficient practices that were identified during the course of the survey.


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4. On 9/7/10 at 0900 hours, during the initial tour of the ICU accompanied by the ICU Director and RN C, the following observations were made.

a. A lumbar drain system was observed attached to Patient 6. The patient was reported as being ruled out for meningitis (brain infection). The set-up had no sticker attached to determine the date and time it was initiated and by whom.

On 9/7/10 at 0915 hours, RN C was asked how frequently the set-up was changed. RN C stated most lumbar drain set-ups were not kept for long. The ICU Director was asked to provide the hospital's P&P on care and maintenance of the lumbar drain. After two days, the ICU Director acknowledged there was no current P&P available to show the hospital's current practice for the use of lumbar drains which would include: the date, time and site the monitoring system was inserted; drain maintenance based on aseptic techniques; and when to change the drainage bag.

b. An intracranial pressure monitor (ICP) cart was observed. This cart contained the necessary equipment for insertion of the ICP monitor into a patient's skull for continuous monitoring of pressures, which if increased, could potentially squeeze and injure the brain tissues. The intracranial monitor set-up had the option to drain the brain/spinal fluid (ventriculostomy drainage) to decrease the amount of pressure inside the head allowing blood flow and oxygenation to brain tissues, provide access to collect brain/spinal fluid laboratory specimens, and to administer medications directly to the brain in cases of brain infection, all in strict aseptic techniques.

On 9/7/10 at 0920 hours, the ICU Director was asked regarding the hospital's P&P on ventriculostomy and insertion of an intracranial pressure monitor. The ICU Director was able to access information on the hospital computer at the nurse's station. This information showed the intracranial insertion procedure, the ICP monitor's general maintenance and nursing interventions, as referred by the American Association of Neurosurgical Nurses (AANN) Reference Series for Clinical Practice published in an unknown year. However, there was no hard copy of the AANN information and no hospital P&P was provided by the Director to include who among the neurosurgeons could insert the device, and who among nursing staff (from ER, ICU or OR) were trained and qualified to care for such patients. The AANN instructions mentioned adequate sedation but were not specific with regard to neuromuscular blockers and pain medications.

After two days, on 9/9/10 at 1000 hours, the ICU Director stated the staff needed a hard copy of the ICP P&P in case of power failure. It was acknowledged there was no available one. The ICU Director asked RN R, the ICU supervisor, to present a temporary P&P and admitted the P&P committee had not approved it.

c. Observation of an ICU room revealed a liter of normal saline for used for irrigation was not labeled with the date it had been opened. RN C, when asked, stated that P&P required in addition to the date opened, the bottle should also be identified with the patient's name. A disposable irrigation tray used to flush the nasogastric tube (for feeding or emptying stomach contents) composed of a syringe and an irrigation bottle were not labeled as to the date and to whom it belonged.

d. Observation of Patient 5 showed the closed tracheal suction system used for multiple, deep tracheal suctioning had no date sticker to indicate when it was changed. The closed suction system, which was incorporated into the ventilator circuit via a standard T-piece elbow, allowed for continuous mechanical ventilation while the patient was suctioned under sterile procedure. When the RTA was asked regarding the date the suction system was last changed, he responded by placing a sticker date on the tubing without verifying when it was changed last.

e. Further inspection of the ICU revealed a urinal in a shared bathroom with no label as to whom it belonged.



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5. On 9/8/10, review of the facility policy for Isolation, Contact Precautions reviewed and revised on 2/09, showed after glove removal and handwashing, staff were to ensure hands did not touch potentially contaminated environmental surfaces or items in the patient's room. If the use of common equipment or items was unavoidable, then adequately clean and disinfect them before use for another patient.

a. On 9/7/10 at 0950 hours, during a tour of the medical floor with RNs N and O, PCA A was observed coming out of an isolation room pushing an electronic blood pressure machine. PCA A was not wearing gloves. The PCA pushed the blood pressure machine over to an isolation cart, put on gloves and started to remove a sanitizing wipe from the container on top of the cart. As there were no wipes in the container PCA A removed her gloves, pushed the blood pressure machine over next to the wall, went to the next isolation cart and removed a wipe from the container on that cart. The PCA put on new gloves and wiped down the machine. PCA A did not wash her hands prior to putting on the gloves, between gloves changes or after removing the gloves. PCA A then pushed the blood pressure machine into another isolation room.

b. On 9/7/10 at 1110 hours, RN L was observed to enter an isolation room to administer medications to the patient. After entering the room the RN put on an isolation gown and gloves. The RN then exited the room and wheeled a mobile computer cart from the hallway into the room over near the patient's bed. After giving the patient's medications, RN L removed her gown, gloves and cleaned her hands. The RN then wheeled the computer out of the isolation room. The computer was observed not to be disinfected after it was removed from the room.

6. On 9/8/10 at 1030 hours, during observation of the OR with the OR Supervisor, holes were observed in the covering of the arm rest used during surgical procedures, exposing the porous material underneath. When a comment was made regarding the holes, the OR RN Supervisor stated the arm rest was covered with a pillow case during use.

7. On 9/7/10 at 1450 hours, a dialysis treatment was observed in a room on the medical floor. During an interview, RN P was asked about the extra packaged dialyzer observed on the machine. He stated that he kept an extra dialyzer in case there was a problem and the dialyzer needed to be changed. RN P pointed to a small white plastic container on top of the machine that contained extra supplies and an opened box of treatment gloves on top of the machine. This was all being stored on the dialysis machine where the potential for contamination by the patient's blood was high. This machine with the stored supplies potentially would be used on multiple patients in the hospital.

On 9/7/10 at 1545 hours, a dialysis machine sitting in the hallway in the ICU was observed with RN N and the Dialysis Charge Nurse. Items observed stored on the machine included: One bottle of liquid potassium chloride; One bottle of liquid calcium chloride; Rolls of tape; 1 bottle of blood leak test strips; and an opened box of treatment gloves. In addition, the bracket holding the filter for the reverse osmosis system on the back of the machine was rusted and a rubber glove had been placed over a connection on the reverse osmosis system on the back of the machine. The glove was full of fluid. A rubber tourniquet was tied around the IV pole.

When asked, the Dialysis Charge Nurse stated the glove was placed over the connection to prevent water from leaking on the floor since it was an old machine. She also stated the biomedical department had been notified and they were aware of the leak. When asked about infection control issue with keeping supplies on the machines which were moved from patient to patient, the nurse did not respond. The nurse began removing the supplies from the machine but left the opened box of gloves on top of the machine. When asked about the tourniquet tied around the IV pole being disinfected between patients, the nurse also removed the tourniquet.

During a follow up observation of two dialysis machines in the dialysis storage room on 9/14/10, opened boxes of treatment gloves were observed stored on top of the machines.

8. On 9/8/10 at 0900 hours, during observation of the ED with RN N and the ED Manager, the following items were found:
* Room 10- the computer keyboard had no plastic covering over the keys for cleaning. Blood was observed on the wall behind the sharps container and on the second shelf where medical supplies were kept.
* Bed 6- the floor was dirty.
* Bed 4- blood was observed on the wall behind the sharps container.


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9. Review of the hospital's P&P entitled "Handwashing (Hand Hygiene)" instructed staff to "Decontaminate hands before having direct contact with patients."

a. On 9/8/10 beginning at 0845 hours, RN J was observed preparing and administering medications to Patient 18. RN J entered Patient 18's room and did not sanitize her hands prior to administering the patient's medications. After she had completed the passing of the medications to Patient 18, she sanitized her hands upon leaving the patient's room.

b. On 9/8/10 beginning at 0852 hours, RN J was observed preparing and administering medications to Patient 20. RN J entered Patient 20's room and did not sanitize her hands prior to administering the patient's medications. After she had completed the passing of the medications to Patient 20, she sanitized her hands upon leaving the patient's room.

c. On 9/8/10 beginning at 0900 hours, RN J was observed preparing and administering medications to Patient 21. RN J entered Patient 21's room and did not sanitize her hands prior to administering the patient's medications. After she had completed passing the medications to Patient 21, she sanitized her hands upon leaving the patient's room.

Based on observation, interview, medical record review, and review of hospital documents, the hospital failed to ensure surgical services were provided in accordance with acceptable standards of practice to ensure patient safety.

Findings:

1. The hospital failed to ensure the P&P for the counting of sharps and sponges during a surgical procedure was implemented for two of 49 sampled patients, resulting in the patients requiring a second surgery for the removal of a retained sponge. Cross reference A951 #1 and #2.

2. The hospital failed to ensure appropriate terminal cleaning (mopping floors and scrubbing all surfaces from top to bottom) of the OR suites. Cross reference A951 #3.

3. The hospital failed to ensure a CNM completed the proctoring process prior to acting as a first assistant to the physician in a surgical procedure. Cross reference A945.

4. The hospital failed to ensure chilled saline was immediately available in the OR suites for the treatment of malignant hyperthermia. Cross reference A951 #5.

5. The hospital failed to ensure sterile instruments were processed with clamps and scissors in the open position to ensure cleanliness and sterility of the hemostat and scissor blades. Cross reference A951 #4.

6. The hospital failed to ensure a complete and comprehensive H&P was documented for all patients previous to a surgical procedure. Cross reference A952.

7. The hospital failed to ensure the Infection Control Officer provided surveillance of terminal cleaning and instrument sterilization activities in surgical services. Cross reference A951 #3 and #4.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the medical staff failed to ensure patient care was provided by a practitioner who had been granted surgical privileges in accordance with the criteria established by the governing body. CNM A was independently functioning as a first assistant to the physician during C-Sections before completion of the hospital's proctoring process. This resulted in potential harm to a patient by an inexperienced practitioner.

Findings:

Cross reference A049.

Based on observation, interview and medical record review, the hospital failed to ensure P&Ps governing surgical care were developed, implemented and enforced to ensure high standards of surgical care were achieved and maintained. The hospital failed to ensure the implementation of the P&P for the counting of instruments and sponges during a surgical procedure for two of 49 sampled patients (Patients 29 and 43) which resulted in the patients undergoing a second surgery for the removal of retained sponges. Patient 43 developed an abscess (infection) and bowel perforations requiring surgery and an eight day hospitalization for treatment.

In addition, the hospital failed to develop a P&P to guide staff in the proper process of terminal cleaning in the OR suites, failed to ensure surgical instruments were processed in an open position to ensure sterility, and failed to store chilled saline for the treatment of malignant hyperthermia (a severe reaction to particular drugs that are often used during surgery and other invasive procedures).

Findings:

On 9/8/10, review of the P&P for Count of Sharps and Sponges, revised 3/09, showed the sharps and sponges were counted in the OR by the scrub nurse/OR Tech and the circulating RN prior to the procedure to establish baseline counts; before closure of any body cavity or part there of, e.g. bladder, uterus; before closure of any deep or large incision; at the time of permanent or change of shift relief of the scrub or circulating nurse; immediately before the completion of the surgical procedure, e.g. skin closure. Additional counts might be indicated according to circumstances. The names and times of all relief personnel should be listed on the operative record. The surgeon was to be immediately informed whenever the count was incorrect. If a search failed to reveal a missing item, an x-ray of the patient was taken before the patient left the OR.

1. The medical record for Patient 43 was reviewed on 9/8/10. The patient was initially admitted to hospital on 7/13/10. The patient underwent a C-section on 7/13/10 at 2156 hours. Documentation on the physician's operative note showed there were no complications. The patient was discharged home with her infant on 7/16/10.

Further review of the medical record for Patient 43 showed the patient presented to the ED of the hospital on 9/1/10. The ED physician documented the patient was seven weeks post C-section The patient was assessed to have a hard painful area in the left lower abdomen and a 1 cm opening in the previous incision with purulent drainage.

Review of the CT study of the abdomen and pelvis done for Patient 43 on 9/2/10, showed a finding of an object in the left mid abdomen. A 5 x 8 cm mass was noted suspicious for a retained surgical sponge, possibly with bowel injury or abscess.

Patient 43 underwent surgery on 9/2/10 for removal of a foreign object. Review of the physician's operative report showed dense adhesions (scar tissue) were found in the pelvis and lower abdomen with a hole in the mid jejunum (small bowel) and the sigmoid (descending) colon. The surgeons performed a small bowel resection and sigmoid colectomy (removal of two pieces of bowel).

On 9/8/10 at 1110 hours, the Manager for Maternal Child Health was interviewed. In attendance were the CNO and the L&D (Labor and Delivery) Clinical Supervisor. The Manager for Maternal Child Health stated interviews were conducted with OR Tech A and RN M on 9/4/10. The Manager stated these staff members were present for Patient 43's C-section on 7/13/10. The Manager stated, in questioning OR Tech A, the tech stated she usually did only three sponge counts during a C-section. The tech stated she would count sponges on the pretable initially and then would count again during the procedure before the uterus was replaced in the abdomen. The the third count was conducted prior to the closure of the fascia (a general layer lining the walls of the abdominal cavity and surrounding the abdominal organs). The Manager stated RN M stated she did not usually work with OR Tech A and thought it strange not to do a fourth count before the final skin closure. RN M stated however the counts had been correct.
The non electronic Intraoperative Record form used in the L&D OR was reviewed with the Manager for Maternal Child Health. The form showed an area for documentation of the precount with boxes to check for yes or n/a for sharps, sponges and instruments. In addition were lines designated as the first, second and third counts. There was a check off box to show the count was conducted with a line for the signatures of the scrub person and RN circulator. There was no area for documentation of the time, or at which point in the procedure the count was conducted. When asked, the Manager stated the form did not show a count documented as the "fourth count." The Manager stated staff were trained to do four counts during a C-section.
The Intraoperative Record dated 7/13/10, for Patient 43 was reviewed. The form was completed to show the initial use of sharps, sponges and instruments and the subsequent first, second, and third counts completed with a correct count.

The hospital's official transcripts of the interviews with OR Tech A and RN M, conducted on 9/4/10, were reviewed on 9/13/10. OR Tech A stated she usually did only three counts. The tech stated, in the main OR four counts were done, but in the L&D OR suite "we only do three and that was how I was trained." Following a discussion with the Manager of Maternal Child regarding the hospital's P&P Counts of Sharps and Sponges, which required the four counts, OR Tech A stated she sometimes did four counts. The tech stated she would do a fourth count if the count was not correct before the closing of the skin. RN M stated she remembered that three sponge counts were done. The RN stated the patient had more bleeding than usual so more sponges had been added to the field, but the sponge counts had been correct. RN M stated, as the incision was being closed she thought to herself there should be another count. RN M stated however, she felt it was the OR tech's area of expertise, and she did not feel comfortable saying anything. When asked to confirm the number of sponge counts during Patient 43's C-section on 7/13/10, RN M stated a fourth count was not done. Both staff members were asked, if the count was correct, why do you think this occurred? Both OR Tech A and RN M stated they were not sure, as it did not make sense. RN M stated that perhaps the count was not correct before the closure of the fascia. Both OR Tech A and RN M agreed that a fourth count before the closure of the skin would have revealed a missing sponge.


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2. Medical record review for Patient 29 was on 9/9/10. The patient underwent an elective surgical procedure for colostomy closure (to close the colon's artificial opening) on 4/13/10. Per the anesthesia record dated 4/13/10, the operation started at 1230 hours and lasted until 1645 hours. Per review of the operative report by the surgeon, dated 4/15/10, the final needle count was correct but the final sponge count was incorrect. X-rays of the kidneys, ureter and bladder (KUB) were taken twice, of the upper and lower abdomen, in order to cover the entire abdomen. No laparotomy sponge was found. Patient 29 was awakened and sent to the PACU for recovery and then to the ICU.

On 4/16/10, while Patient 29 was in the ICU, an abdominal series x-ray was ordered due to abdominal pain. Per the radiologist report, the presence of a laparotomy sponge was seen projecting over the left side of the abdomen at the level of the fourth lumbar (L4) vertebral body. The surgeon explained the situation to Patient 29 who agreed to go back to surgery for the removal of the foreign body which was a "definite potential for abscess development and sepsis." On 4/16/10 at 1809 hours, the retained laparotomy sponge in Patient 29's abdomen was removed under general anesthesia. The patient was re-exposed to the risks of general anesthesia and the risks of bleeding and possible injury to adjacent abdominal structures.

Further review of Patient 29's OR documentation on 4/13/10, showed there were only a total of 4 counts done for the sponges, sharps and instruments used - first, closing, relief personnel and the final count. There was no additional count made when the incorrect count was discovered by the second shift. In addition, out of four circulator nurses and two OR scrub techs, only one relief count was documented.

On 9/9/10 at 1530 hours, the total of four sponge counts was reviewed with RN S. RN S stated there should be additional counts performed and documented whenever there was a change of personnel assisting in the operation. It was added that aside from verbal report and keeping the OR count board current, the personnel should verify what sponge, sharps, or instruments were on the table versus what was written on the OR count board.

On 9/13/10 at 0900 hours, the Director of Performance Improvement and Patient Safety was interviewed. The lack of documentation to show additional sponge counts were conducted following the incorrect final sponge count was discussed. In addition, there was no documentation additional counts were conducted during the change of shift or the change of personnel assisting during the operation.


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3. The P&P titled: Cleaning of Perioperative Areas was reviewed on 9/9/10. The P&P did not include specific techniques/procedures for the terminal cleaning and disinfection of the OR suites.

Review of the 2010 AORN (Association of periOperative Registered Nurses) Perioperative Standards and Recommended Practices, showed terminal cleaning defined as follows: Cleaning that is performed at the completion of a surgical practice settings' daily surgical schedules. Terminal cleaning was performed in surgical procedure rooms and scrub/utility areas and included, but was not limited to: surgical lights and external tracks; fixed and ceiling-mounted equipment; all furniture, including wheels and casters; all equipment; handles of cabinets and push plates; ventilation faceplates; horizontal surfaces e.g., tops of counters, sterilizers, and fixed shelving; the entire floor; and kick buckets and scrub sinks.

An observation of the terminal cleaning process of an OR suite was conducted on 9/9/10 at 0815 hours. In attendance were the CNO, the OR Supervisor, and the Housekeeping Manager. PCA B and PCA C performed the cleaning procedure.

The PCAs wore surgical attire (scrubs, hats and booties) and gloves but did not wear eye protection.

PCA B and C were asked to describe their technique for the cleaning and disinfection of surfaces and equipment. The PCAs both stated they cleaned from "top to bottom."

PCA B obtained disinfectant solution in a half gallon plastic bucket. Within the bucket were several wash clothes. The PCA's were observed to perform a portion of the cleaning and disinfecting and then exchange the cloth. The dirty cloth was placed in a plastic bag sitting on the operating room floor. PCA B and PCA C shared the same plastic bucket to obtain clean cloths.

The cleaning cloths were placed on a handle and used to scrub and disinfect the ceiling and walls. PCA C was observed to wipe portions of the ceiling, bring the cloth down the wall, touch the floor, and then use the same cloth to wipe the wall in an upward vertical sweep, contaminating areas already disinfected. During the cleaning process of the walls and ceiling, PCA C was observed to touch the floor a total of two times prior to exchanging the cloth. PCA C recontaminated areas already cleaned a total of six times during the cleaning of the ceiling and the walls. PCA C exchanged her cloth a total of four times during cleaning of the ceiling and walls. When asked, PCA C stated she exchanged the cloth when portions of the ceiling and walls were completed. PCA B and PCA C did not change gloves when exchanging the dirty cloths for clean cloths.

PCA B and PCA C removed equipment from the operating room suite into the hallway. The PCAs touched carts and equipment in the hallway and then reentered the operating room without changing gloves. Each piece of equipment brought into the hallway remained in the hallway until the ceiling, walls, and non-movable pieces of equipment in the operating room were cleaned/disinfected. PCA B and PCA C did not change gloves while going in and out of the operating room. The PCAs did not perform handwashing or apply hand sanitizer upon removal of gloves.

The anesthesia cart left in the operating room was not wiped down or disinfected. The anesthesia tubing and cables running from the machine were picked up off the floor surface by the PCAs and wiped down/disinfected; however, during handling, they were allowed to touch the floor. The operating room light was not disinfected and the air conditioner grills were not vacuumed.
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During the cleaning of the OR table, PCA B was observed to place the table pads and other portions of the table on the floor. During the cleaning process, the PCA was observed to touch the floor with her cleaning cloth on one sweep resulting in recontamination the table surface.

When asked the required wet/dry time for the disinfectant solution they were using PCA C stated, "after a few minutes."

The equipment brought out of the OR was cleaned in the hallway. PCA B and PCA C were observed to wipe equipment down from the top and then proceed down. While cleaning an instrument table the PCA touched the floor with a cloth and then brought the cloth back up touching/ recontaminating the surface of the instrument table. The wheels and casters of the equipment were wiped down and then this same cloth was reapplied to clean surfaces. A Mayo table was observed to be cleaned/disinfected with a cloth that had touched the floor during the cleaning process. The PCAs did not change gloves between pieces of equipment or upon exchange of the cloth. The PCAs did not wipe down computer equipment left in the OR room.

Hospital policy and manufacturers's recommendation require the floor to have a wet time of 10 minutes. A staff member was brought in to wet vac (wet vacuum) the floor approximately two minutes after the floor was soaked with the disinfectant. The wet vac machine was not wiped down prior to entering the operating room suite and the operator of the wet vac machine did not change gloves prior to beginning the procedure. The operator of the wet vac machine touched equipment in the room that had been disinfected.

The OR Supervisor was interviewed on 9/9/10 at 0955 hours. The Supervisor stated the method for cleaning was to clean from top to bottom (clean to dirty). When asked about the wet vac procedure to clean the floor, the Supervisor stated the wet vac was to be done when the surface of the floor had been soaked with disinfectant for a total of ten minutes. The Supervisor verified the PCA performed the wet vac procedure immediately after it was washed. When asked, the Supervisor stated the cleaning of the OR suites was under the supervision of the Housekeeping Manager.

The Housekeeping Manager was interviewed on 9/9/10 at 1000 hours. The Manager was asked the procedure for changing of gloves and the cleaning and disinfection during terminal cleaning. She stated both PCA's did not change their gloves as often as they should. The Manager stated the PCA were to clean from top to bottom. The Manager stated her observation of PCA B and C showed they also moved from bottom to top recontaminating surfaces already disinfected. When asked about training for the staff, the Manager stated all PCAs in the operating room had competency evaluations and annual training regarding terminal cleaning.

Personnel file review was conducted with Human Resource Employee A on 9/9/10 at 1145 hours. The personnel files for PCA B and PCA C did not show documentation of training or competencies assessed for the terminal cleaning procedure in the OR. Review of the personnel file for the Housekeeping Manager did not show documentation of training and competency for the terminal cleaning methodology. Documentation of a training seminar dated 12/14/09, provided by a disinfectant vendor titled: General Cleaning and Disinfecting, failed to list terminal cleaning as content of the training.

The Infection Control Preventionist was interviewed on 9/9/10 at 1400 hours. The Preventionist was asked her role in the surveillance and monitoring of the cleaning process in the OR suites. The Preventionist stated she did not perform monitoring or observation of terminal cleaning in the ORs.

4. A tour of the operating rooms and the sterile processing department was conducted on 9/8/10 at approximately 0930 hours. The area containing processed and double wrapped surgical instruments was inspected. An observation was made of one hemostat clamp and one pair of surgical scissors that had been processed with the blades in a closed position. When interviewed, the Sterile Processing Supervisor confirmed that to process instruments in a closed position was in violation of the hospital's P&P for the processing of these instruments.

The Executive Director of Performance Improvement and Patient Safety and the Infection Control Preventionist were interviewed on 9/13/10 at 1430 hours. When asked about infection control oversight for OR terminal cleaning and the processing of surgical instruments, both hospital representatives stated the Infection Control department did not carry out direct oversight of these areas.

5. A tour of the hospital was conducted on 9/8/10 at approximately 0930 hours. During the tour of the OR, the Malignant Hyperthermia (an acute anesthetic and surgical emergency that may result from the use of certain anesthetic gases and medications utilized to induce general anesthesia) supplies were inspected and reviewed with the Perioperative Manager. The Perioperative Manager stated the Malignant Hyperthermia Association of the United States (MHAUS) guidelines were utilized by the hospital in the event of an emergency. The Manager was asked to provide evidence of chilled saline, as was required by the MHAUS guidelines to cool the patient during the hyperthermia crisis. Observation of the refrigerator in the OR area demonstrated no chilled saline for use in an emergency situation for Malignant Hyperthermia.

Based on interviews, a review of the medical staff bylaws and rules and regulations, and a review of 49 open and closed medical records, the hospital failed to ensure the provision of a complete history and physical examination prior to surgery or a procedure requiring anesthesia services for three of 49 sampled patients (Patients 19, 43 and 47). This had the potential for important information about the patient not to be readily available to the operating team.

Findings:

The hospital's General Rules and Regulations dated 10/26/09, required a comprehensive complete admission history and physical examination and any required updates. A complete history and physical examination was to include the chief complaint and history of present illness, past medical and surgical history, family history, social history , allergy history, current medications, review of systems, and a complete and comprehensive physical examination.

1. Patient 19 was admitted to the hospital for surgical services on 7/7/10. A review of the history and physical examination for Patient 19 revealed no documentation of the review of systems. The physical examination failed to document status of the heart and lungs for Patient 19.

2. Patient 43 was admitted to the hospital for labor and delivery services on 7/13/10. At approximately 2115 hours on 7/13/10 Patient 43 was taken to the operating room for an elective cesarean section due to non-reassuring fetal heart pattern noted on fetal monitoring. The medical record contained no documentation of a preoperative history and physical examination for Patient 43, as is required by the medical staff bylaws of the hospital.

3. Patient 47 was admitted to the hospital for surgery on 9/7/10. A review of the history and physical examination revealed no assessment of the previous cancer operation, family history, social history, details of the history of lupus, or review of systems for Patient 47. The physical examination failed to assess the status of the abdominal findings in this patient with an ileostomy (the surgical opening from the ileum through the abdominal wall, permitting drainage of the contents of the small bowel). There was no description of the ileostomy or documentation of a rectal and pelvic exam.

Based on observation, document review, and staff interview, the respiratory therapy department failed to revise written P&Ps to reflect the current standard of practice. The hospital failed to ensure implementation of infection control P&Ps for closed tracheal suction systems by respiratory therapy personnel. This had the potential for the patients acquiring pulmonary infections in the hospital.

Findings:

On 9/7/10 at 0930 hours, during the initial tour of the ICU accompanied by the ICU Director and RN C, observation of Patient 5 showed the closed tracheal suction system used for multiple, deep tracheal suctioning had no date sticker to indicate when it was last changed. When RT A was asked regarding the date the suction system was last changed, he responded by placing a sticker date on the tubing without verifying when it was changed last.

On 9/9/10, the hospital's P&P on Changing of Patient Care Equipment, revised on 5/2002 and reviewed by the Respiratory Department on 6/2005, stated that the mechanical ventilator circuits would be changed when visibly soiled or malfunctioning. Deep tracheal suctioning was a sterile procedure to be performed to mobilize secretions from the patient's airway. This was achieved by the attachment of a closed tracheal suction system incorporated into the ventilator circuit via a standard T-piece elbow. The system allowed for multiple use tracheal catheters to suction excess secretions with uninterrupted/continuous mechanical ventilator support reducing the potential for infection. The suction catheters designed for continuous use would be changed also when visibly soiled or malfunctioning and this would be documented in the patient's chart.

On the document's segment 3.13, it showed a 24-hour sticker should be placed over the suction valve on the in-line suction catheter. Moreover, a note should be added to change the catheter every 24 hours or more frequently as necessary.

However, in an interview with RT B on 9/9/10 at 0930 hours, he stated continuous suction systems should be changed every 24 hours. The ventilator circuit was to be changed every 3 days or as necessary when visibly soiled or malfunctioning.