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Based on record review, policy review, and interview, the provider's governing board failed to ensure:
*A comprehensive surgical, sterilization, and anesthesia services infection control program under the direction of a fully trained infection control officer was established.
*A comprehensive surgical, sterilization, anesthesia services, swing bed, organ procurement, and discharge planning quality management program was established and monitored.
Findings include:

1. Review of the entire infection control program revealed a lack of proper supervision, implementation, and integration of the infection control program into surgical services, sterilization, and anesthesia services. Refer to C278, findings 1 and 2; C320, findings 1 through 4.

2. Review of the entire quality assurance program revealed lack of proper implementation and integration of quality assurance programs across all services. Refer to C320, findings 1 and 2; C330, findings 1-3.

Based on interview and policy review, the provider failed to ensure patient care policies and procedures were written for swing bed services and social services. Findings include:

1. Interview on 5/31/11 from 3:10 p.m. until 3:45 p.m. with the director of nursing revealed the provider had no swing bed policy and procedure manual. Further interview revealed whatever swing bed policies the provider had would have been in the nursing policy and procedure manual. She further stated there were no swing bed policies and procedures written to address care conferences, discharge planning, or social services. She then stated she had been trying to decide whether a swing bed policy and procedure manual was needed.

Review of the nursing policy and procedure manual revealed there was a discharge planning policy that had addressed all of the hospital patients. There had been no other policies and procedures addressing swing beds or addressing care conferences and social services for swing bed patients.

Interview on 6/2/11 at 11:05 a.m. with the social worker confirmed she was not aware of any policies and procedures for social services for the inpatients or the swing bed patients.

Based on observation, interview, and policy review, the provider failed to ensure:
*Pre-drawn intravenous medications and solutions in the operating room were labeled with the date, dosage, and the initials of the person who had drawn them up.
*Opened multiple (multi)-use vials of normal saline were labeled to establish an expiration date.
Findings include:

1. Observation in the procedure room during a colonoscopy on 6/1/11 from 9:30 a.m. through 10:00 a.m. revealed:
*On the certified nurse anesthetist's (CRNA) medication cart:
-One opened 20 milliliter (ml) bottle of 0.9% sodium chloride.
-Two unlabeled syringes filled with a milky-white substance.
-Four more syringes filled with clear liquids in the following amounts and with handwritten labels:
*Two and one half ml labeled atropine.
*Five ml labeled ephedrine.
*One and one half ml labeled 2% lidocaine.
*Five ml labeled succinylcholine.
*On a tray table by the scope machine were two unlabeled thirty-five ml syringes filled with a clear liquid.

Further observation revealed the bottle of 0.9% sodium chloride had not been dated when it had been opened. The six syringes with the milky-white and clear substances had not been labeled with the date they had been drawn up, the dosages of each medication in the syringes, or the initials of the person that had drawn up the medication. The syringes of clear liquid on the tray table by the scope machine had no labels or anything written on them identifying the liquid in them or the date they had been drawn up.

Interview with CRNA B at 9:50 a.m. that same day confirmed the above observations. He revealed he had drawn up the medications in the syringes on the anesthetist cart that morning before the procedure. He stated he had known what the dosages of those medications were. He agreed they should have been labeled with the dosage of the medication, the date they had been drawn up, and his initials. He also agreed the bottle of sodium chloride should have been dated when it was opened.

Interview with an unidentified operating room nurse at that time revealed the thirty-five ml syringes had been filled with sterile water and were used to clean the scopes. She also agreed those syringes should have been labeled with their contents, the date, and the initials of the person who had drawn them up.

Review of the provider's multi-dose vial policy reviewed in May 2011 revealed all multi-dose vials would be dated when the seals were broken.

Review of the provider's medication safety policy reviewed in May 2011 revealed the correct labeling of medications would be followed.

Review of the Revision Bulletin <797>, Pharmaceutical Compounding-Sterile Preparations, United States Pharmacopeia, revealed multiple-dose containers were formulated for removal of portions on multiple occasions, because they usually contained antimicrobial preservatives. The beyond-use dating after initially entering or opening (e.g. needle-punctures) multiple-dose containers was 28 days unless the manufacturer specified a longer period of time.

Based on observation, interview, record review, and policy review, the provider failed to ensure:
*Proper hygiene and sanitization methods were followed in one of one procedure rooms.
*Single-use items opened in the procedure room were disposed of after each procedure.
*Infection control policies and procedures were developed for the sterilization and disinfection areas.
*Proper testing for the one vacuum steam sterilizer.
*Training of the infection control provider was appropriately documented and readily available.
*Training and competency of sterilization staff was appropriately carried out and documented.
*Infection control was fully integrated into the surgical services, anesthesia, and sterilization/disinfection area.
Findings include:

1. Observation, interview, policy review, and record review on 6/1/11 and 6/2/11 revealed proper infection control principals and practices were not being followed. Refer to C320, findings 1 and 2.

Based on interview and policy review, the provider failed to have written policy and procedures for dietary practices for all patients. Findings include:

1. Interview on 6/2/11 at 10:15 a.m. with the dietary manager (DM) revealed the following dietary policies for the hospital:
*Afternoon lunch for residents and swing bed policy last reviewed July 2009.
*Standing operating procedures regarding hospital guest trays policy last reviewed July 2009.
*Hospital and nursing home tray service policy last reviewed September 2009.

She stated the hospital dietary department was also a part of the nursing home. She confirmed there were policies and procedures for the nursing home. The policies for the hospital should have included:
*Availability of a diet manual and therapeutic diet menus to meet patients' nutritional needs.
*Frequency of meals served.
*System for diet ordering and patient tray delivery.
*Accommodation of non-routine occurrences such as enteral nutrition (tube feeding), total parenteral nutrition, peripheral parenteral nutrition, change in diet orders, early/late trays, nutritional supplements, etc.
*Integration of the food and dietetic service into the CAH-wide QA and Infection Control programs.
*Guidelines for acceptable hygiene practices of food service personnel.
*Guidelines for kitchen sanitation.
*Safety practices for food handling.
*Emergency food supplies.
*Orientation, work assignments, supervision of work, and personnel performance.
*Menu planning, purchasing of foods and supplies, and retention of essential records such as cost, menus, personnel, training records, quality assurance (QA) reports, etc.
*Dietary service QA program.

Further interview revealed the provider's diet manual was a 2004 edition. The diet manual had not been approved by the registered dietitian nor the medical staff.

Interview on 6/2/11 at 1:30 p.m. with the director of nursing confirmed there was not a current diet manual at the nurses station.

Based on interview and policy review, the provider failed to ensure policies were reviewed annually for two of seven departments reviewed (dietary services and rehabilitation services). Findings include:

1. Interview on 6/2/11 at 10:15 a.m. with the dietary manager revealed there were three policies related to hospital patients. Those policies had last been reviewed in 2009. She confirmed there was not a policy and procedure manual for dietary services specific for hospital patients. There was a policy and procedure manual for the nursing home.

2. Interview on 6/2/11 at 11:05 a.m. with the rehabilitation department director revealed he was not sure when the rehabilitation department's policy and procedure manual had last been reviewed. He was unable to locate any documentation the manual had been reviewed within the last year.

Based on interview, record review, and policy review, the provider fail to:
*Ensure proper hygiene and sanitization methods were followed in one of one procedure room.
*Single-use items opened in the procedure room were disposed of after each procedure.
*Infection control policies and procedures were developed for the sterilization and disinfection areas.
*Proper testing for the one vacuum steam sterilizer.
*Training of the infection control provider was appropriately documented and readily available.
*Training and competency of sterilization staff was appropriately carried out and documented.
*Infection control was fully integrated into the surgical services, anesthesia, and sterilization/disinfection area.
*Have sterilization/disinfection policies and procedures specific to the surgical care area.
*Ensure proper life saving equipment was tested and readily available.
*Have a quality assurance program specific to surgical services, sterilization, and anesthesia.
*Have current job descriptions for operating room and sterilization staff.
*Have all of the regulation required surgical policies and procedures.
Findings include:

1. Observation on 6/1/11 beginning at 8:30 a.m. of patient 15's colonoscopy procedure revealed after the procedure was finished:
*The physician used his contaminated gloves to attempt to untie his gown. During that time he contaminated his shirt, neck, hair, and back of the gown with the gloves. After being unable to get the gown untied the physician had an un-gloved staff member untie his gown. That staff member did not witness the cross-contamination and did not perform hand hygiene afterwards. The staff member was then observed working with several clean supplies and equipment.
*The gastrointestinal scope used during the procedure was hung on a multiple shelf stainless steel cart for preliminary cleaning. That scope touched every shelf of the cart. Each shelf contained multiple patient supplies and linen used from case-to-case.
*The anesthesia cart had an opened endotracheal tube on top of it that sat on two stained surgical towels. That anesthesia cart was removed from the procedure room after the procedure was completed. That cart was not cleaned, and the endotracheal tube and towels from that case were left on it and placed in the main anesthesia storage area.

Interview on 6/1/11 at 10:20 a.m. with the operating room manager revealed:
*She agreed the physician and staff member cross-contaminated themselves and other surfaces and items in the procedure area.
*The gastrointestinal scope was always hung for preliminary cleaning touching the shelves containing clean supplies and linen as witnessed above.
*She agreed cross-contamination of the supplies and linen on the above cart had occurred.

Interview on 6/1/11 at 10:55 a.m. with nurse anesthetist B revealed:
*He agreed endotracheal tubes were single-use items and once opened during a case were considered contaminated and should have been disposed of.
*He had not cleaned the anesthesia cart or removed the towels on top of the cart prior to removing the cart from the procedure room.

2. Interview on 6/1/11 at 10:35 a.m. with registered nurse A regarding cleaning and disinfecting gastrointestinal scopes revealed:
*He was in charge of disinfecting gastrointestinal scopes.
*The provider had recently started using a new Steris machine for the decontamination of the gastrointestinal scopes.
*He had received training on the Steris by the factory representative but was not aware of any records that were kept documenting that training. No competency checklist was completed at the time of that training.
*He was not aware of any policies or procedures that guided gastrointestinal scope disinfection.
*The infection control officer had never reviewed or observed any of the disinfection processes.

Interview and record review on 6/2/11 at 9:00 a.m. with registered nurse A regarding the provider's sterilization process revealed:
*He was in charge of sterilization for the provider.
*He had received some on-the-job training related to sterilization from the operating room manager prior to starting to sterilize the instruments. He was unsure if any documentation of that training existed. No competency checklist had been completed at the time of that training.
*He was not aware of any policies and procedures that guided the sterilization process or training in sterilization.
*He was not aware what a Bowie-Dick test was for and had never run one before.
*The infection control officer had never reviewed or observed any of the sterilization processes.

Interview, policy review, and manufacturer's manual review on 6/2/11 at 10:40 a.m. with the administrator, director of nursing, and operating room manager revealed:
*They confirmed no policies and procedures existed for the sterilization and disinfection areas of surgical services.
*They currently did not have a set of standards of practice for sterilization and disinfection that they followed.
*The provider did not have a specific set of infection control standards of practice that were followed.
*The infection control provider was out for the duration of the survey. In the absence of the infection control provider the administrator was unable to produce any of the training records of the infection control provider.
*The current infection control officer had been in the position for a period of roughly six months and had no prior experience as a infection control officer.
*The infection control officer did not observe the practices or make rounds of surgical services, sterilization, or anesthesia services.
*They stated the infection control officer had little knowledge of the practices of the surgical, sterilization, and anesthesia service areas as she was a laboratory technician.
*They were not aware according to the manufacturer's manual that a Bowie-Dick challenge test should had been performed on the sterilizer.
*Training for sterilization and disinfection was not documented nor was a list of competencies developed. Training was just passed on from nurse-to-nurse with no formal process. No annual training was provided after initial on-the-job training.
*They agreed the Bowie-Dick challenge test should have been performed as per the sterilizers manufacturer's instructions and current nursing standards.
*No formal process was in place to monitor surgical site infections other than physicians verbally reporting infection back to the provider.
*They all agreed infection control for surgical services, sterilization, and anesthesia was lacking appropriate integration and monitoring.

Review of the Association of periOperative Registered Nurses, Perioperative Standards and Recommended Practices, 2010 Edition, Denver, CO, pages 457-477, revealed:
*The provider should have policies and procedures for the sterilization and disinfection process. Those policies should be reviewed periodically and be readily available in the practice setting.
*Training of sterilization and disinfection staff should include review of the provider's policies and procedures.
*Initial and annual training of sterilization staff should occur.
*The Bowie-Dick challenge test should had been run daily to ensure the efficacy of air removal and steam penetration.

3. Observation on 6/1/11 at 8:30 a.m. of the defibrillator and emergency cart outside of patient 15's procedure room revealed:
*The defibrillator was off, and there was no evidence of it having been tested prior to the start of the current procedure.
*No tracheostomy tray was available for use.

Interview on 6/1/11 at 8:40 a.m. with nurse anesthetist B revealed:
*He never tested the defibrillator. He was unable to tell this surveyor how or who for sure tested the defibrillator.
*He agreed he would be responsible for defibrillating the patient if the patient arrested, and he should ensure his equipment was tested and functioning appropriately.
*He was unsure as to the whereabouts of the tracheostomy set. He thought it was in the emergency cart.

Interview on 6/1/11 at 10:00 a.m. with the operating room manager revealed:
*The defibrillator was tested once a week and was never tested immediately prior to the start of the procedure day.
*The testing log of the defibrillator was kept in the intensive care area; not with the defibrillator so staff could verify its testing.
*She was unsure as to the whereabouts of the tracheostomy set. She thought it was in the emergency cart. The operating room manager stated during that time she would have to look for it.

Interview on 6/1/11 at 10:20 a.m. with the operating room manager revealed:
*She had found the tracheostomy set, and it was being stored in the emergency room in a cupboard.
*She agreed all emergency equipment should have been readily available and tested prior to operations or procedures being performed in the surgical area.
*She agreed surgical staff should have been knowledgeable about emergency equipment testing and its whereabouts prior to operations or procedures being performed in the surgical area.
*The provider had no policy or procedure related to emergency equipment in the surgical area being tested and readily available.

4. Interview on 6/1/11 with the director of nursing and the operating room manager revealed:
*The only quality assurance initiatives initiated by the provider for surgical, sterilization, and anesthesia areas over the past three years were to ensure surgical and procedure consent forms were properly signed, dated, and timed. That quality measure had been met for multiple months.
*No formal quality assurance process was utilized by the provider to identify possible concerns within surgical services, sterilization, or anesthesia services.

5. Interview, policy review, and job description review on 6/1/11 at 3:35 p.m. with the administrator, director of nursing, and the operating room manager revealed:
*No policies or job descriptions outlined the responsibilities/duties of sterilization staff or operating room staff.
*The provider did not have policies and procedures on:
-Identification of infected and non-infected cases.
-Patient care requirements.
-Safety practices.
-Do not resuscitate status of patients.
-Sterilization and disinfection procedures.

Based on interview, record review, and policy review, the provider failed to ensure swing bed, discharge planning processes, surgical services, sterilization, anesthesia services, and organ procurement were incorporated into the provider's quality management (QM) program to determine how well those areas were working. Findings include:

1. Interview on 5/31/11 from 3:10 p.m. until 3:45 p.m. with the director of nursing (DON) revealed the QM program had not included anything specific to the swing bed or discharge planning processes.

Review of the QM committee meeting minutes from 2010 and 2011 confirmed there had been no QA studies completed for the swing bed or the discharge planning areas.

Review of the Discharge Planning Process policy and procedure reviewed in May 2011 revealed "Q.M. discharge planning and physician discharge summary will be performed on a regular basis to ensure that the discharge planning process is working satisfactorily."

Review of the Quality Management Plan effective 1/6/09 revealed one of its purposes was to improve the quality of patient care. It further revealed:
*The chairperson would receive reports of review and evaluation of all patient care areas, hospital and medical staff committees, and any other activities related to the quality of care within the hospital.
*All departments and services with the organization had ongoing responsibility to undertake quality improvement processes and activities.
*The premise was to focus on the processes of care and service and to emphasize continuous improvement.

Interview on 6/2/11 from 10:20 a.m. until 11:04 a.m. with the QM coordinator revealed each department director was responsible for his/her own QM activities. He further revealed he had relied on each department to keep track of their own data and for the communication of their activities to the QM committee members. He also stated each department would keep their own data that tracked the effectiveness of their QM activities. Continued interview revealed the DON had been responsible for the QM activities of the swing bed and discharge planning areas.



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2. Interview on 6/1/11 with the director of nursing and the operating room manager revealed surgical services, sterilization, and anesthesia services were not integrated into the facility wide QM process. Refer to C320, finding 3.




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3. Interview on 6/2/11 at 10:30 a.m. with the DON revealed:
*The organ/tissue bank performed audits on the provider's death records.
*The information obtained from the audits was not submitted to the provider's quality assurance program.