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Based on observation, interview, and record review, the governing body failed to effectively govern the conduct of the hospital's infection control program. Findings include:

1. Review of the entire infection control program revealed a lack of proper oversight, implementation, and integration. Refer to A747, findings 1-6; A748, finding 1; A749, finding 1; and A750, finding 1.

Based on record review and interview, the provider failed to ensure:
*Nursing care plans were prepared and implemented for all same day surgery patients.
*Nursing care plans were prepared and implemented at the time of admission for all inpatients.
Findings include:

1. Review of patients 26 and 27's entire medical records revealed:
*Both patients were same day surgery patients.
*Neither of the patients had a nursing care plan on record.

Interview on 2/16/11 at 10:20 a.m. with registered nurse (RN) F assigned to the recovery care center (inpatient area) revealed:
*Nursing care plans were only implemented for inpatients.
*The nursing care plan was not prepared or implemented for inpatients until after the patient had surgery and was admitted to the recovery care center.

Interview on 2/16/11 at 10:40 a.m. with RN H assigned to the pre-operative area revealed nursing care plans were not prepared or implemented in the pre-operative or operative areas.

Interview on 2/16/11 at 11:30 a.m. with RN G assigned to the step-down unit revealed nursing care plans were not prepared or implemented in the step-down unit.

Interview on 2/16/11 at 11:40 a.m. with assistant director of nursing B revealed:
*The provider did not have a nursing care plan policy and procedure.
*Nursing care plans were not prepared or implemented for same day surgery patients.
*Inpatients did not have a nursing care plan until they were admitted to the recovery care center.
*She agreed nursing care plans should have been prepared and implemented for all patients beginning at the time of admission.

Based on observation, interview, and record review, the provider failed to ensure:
*The manufacturer's written preventative maintenance plan was followed and appropriately documented for six of six sterilizers.
*Warmed irrigation fluids and intravenous fluids were not re-warmed.
Findings include:

1. Interview on 2/16/11 at 1:20 p.m. with instrument technician J revealed:
*No log was kept by the provider's instrument technicians on the preventative maintenance of the sterilizers used in the facility.
*The facility engineer was responsible for maintenance other than daily cleaning.
*She or one of the other instrument technicians would contact the facility engineer if they had problems with the sterilizers.

Interview, manufacturer's maintenance plan review, and provider's maintenance log review on 2/17/11 at 10:10 a.m. with facility engineer I revealed:
*All of the preventative maintenance for the provider's sterilizers was provided by facility engineer I and his staff members.
*No maintenance personnel had formal training in the maintenance and repair of the facility's sterilizers.
*No service contract existed for the maintenance or repair of the provider's sterilizers. He would contact a service agency only if he could not figure out the problem himself.
*He did not follow multiple required preventative maintenance areas outlined in the manufacturer's manual. That included the calibration of the equipment as he did not feel competent to perform those procedures.
*He did not keep preventative maintenance records that identified the completion of the daily, weekly, quarterly, annual, or as needed maintenance functions as outlined in the manufacturer's manual.

Interview on 2/17/11 at 10:40 a.m. with director of nursing A revealed:
*She was not aware the provider's sterilizers were not under a service contract.
*She agreed proper maintenance and preventative maintenance of the sterilizers was imperative to ensure patient safety.

2. Observation on 2/14/11 at 2:45 p.m. of the equipment/supply room across from operating room 2 revealed:
*Two warm-to-the-touch 3000 milliliter (ml) sealed plastic bags of sterile water were found on a shelf with several other 3000 ml bags of sterile water.
*The bags of sterile water were not marked with anything other than the manufacturer's labeling.

Observation on 2/14/11 at 2:50 p.m. of the hallway storage cabinets between operating rooms 1 and 2 revealed:
*The cabinet next to the warmer contained two warm-to-the-touch 1000 ml bags of lactated ringers.
*The bags of lactated ringers were not marked with anything other than the manufacturer's labeling.

Interview on 2/14/11 at 2:50 p.m. with registered nurse M revealed:
*She agreed the sterile water and lactated ringers mentioned above were warm-to-the-touch.
*She stated the fluids must have been taken out of the warmers.
*Fluids placed in the warmer were to be marked with the date they were placed in it. She agreed the fluids found warm-to-the-touch in storage were not marked at all.
*She agreed the unmarked solutions could have been warmed and re-warmed several times by mistake since the solutions were not labeled as per the provider's policy.

Interview and policy review on 2/15/11 at 4:15 p.m. with director of nursing A revealed:
*Per the provider's policy on warming fluids dated 7/23/07 fluids placed in a warmer were to have been dated with a permanent marker prior to warming them. That date then would serve as the identifier the fluid had been warmed.
*Fluids should never have been re-warmed.
*She agreed the unlabeled fluids found above should have been labeled per the provider's policy.
*She agreed the unmarked fluids could have been warmed and re-warmed several times by mistake since the solutions were not labeled as per the provider's policy.

Based on observation, interview, and record review, the provider failed to maintain appropriate levels of humidity in 6 of 13 operating rooms (5, 6, 7, 11, 12, and 14). Findings include:

1. Observations on 2/14/11 beginning at 2:45 p.m. of the operating rooms revealed none of the provider's operating rooms had humidistats.

Interview on 2/14/11 at 3:00 p.m. with registered nurse M revealed:
*Humidity was not documented or monitored by operating room personnel.
*The facility engineer controlled the humidity in the operating rooms.
*She was not aware of any facility policy related to operating room humidity.

Interview and record review on 2/15/11 at 8:00 a.m. with director of nursing (DON) A, assistant director of nursing (ADON) B, and facility engineer I revealed:
*No policy and procedure existed related to humidity levels in the operating room.
*They were not aware of the State of South Dakota administrative rule that required operating room humidity to be kept between 45-60 percent.
*Facility engineer I monitored humidity levels in the operating room via computerized sensors in the duct work once a day.
*The facility engineer had been having trouble keeping humidity levels above the 20 percent level for operating rooms 5, 6, 7, 11, 12, and 14 since the time they had been added on several years ago. The reason for that was related to the size of the pipe feeding humidity to those operating rooms was inadequate.
*The provider had not contacted any contractor to remedy the inadequate humidity for operating rooms 5, 6, 7, 11, 12, and 14.
*All agreed proper humidity levels were not being maintained for operating rooms 5, 6, 7, 11, 12, and 14.
*All agreed operating room staff did not have the ability to monitor humidity levels in the operating room.
*DON A and ADON B agreed Association of Operating Room Nurses (AORN) standards for operating humidity levels were not being met.

Based on observation, interview, and record review, the provider failed to ensure:
*Flash sterilization was not the primary method of sterilization for ophthalmic instruments.
*Open flash sterilized ophthalmic instruments were transported in a manner to prevent cross- contamination.
*Chemicals were monitored to ensure appropriate concentrations for disinfection of the operating room.
*Un-cleanable items were not reused in the operating room.
*Single-use items opened in the operating room were disposed of after each procedure.
*Ensure infection control policies and procedures had been properly reviewed and revised.
*The infection control program was fully monitored, reviewed, and integrated into the provider's day-to-day operations.
Findings include:

1. Observation on 2/15/11 of the surgical instrument sterilization process for patient 26 revealed:
*The instruments had been flash sterilized in an open pan.
*The setting for the sterilizer was 4 minutes sterilization with a 2 minute dry time.
*The flash sterilization occurred in the main sterilization area.
*The instruments were removed from the sterilizer and transported through the sterilization area down the surgery hallway through the operating room door and then onto the sterile field. Those uncovered instruments passed three unmasked hospital personnel on the way to the operating room as well as this surveyor.

Interview on 2/15/11 at 1:00 p.m. with instrument technician J revealed:
*Ophthalmic instrument were always flashed sterilized in the above manner.
*Only the ophthalmic cases were now open flash sterilized. All other instruments that were flash sterilized were done in closed containers.
*She agreed it was a long distance to carry uncovered instruments, and a potential for cross- contamination of the instruments existed.

Interview on 2/15/11 at 1:15 p.m. with director of nursing (DON) A revealed:
*She was aware of the current ophthalmic instrument sterilization process.
*She agreed it was a long distance to carry uncovered instruments and a potential for cross- contamination of the instruments existed.
*The provider owned one set of ophthalmic instruments, and the physician brought two sets the day she had cases at the facility.
*The average day of ophthalmic cases consisted of 9-12 cases.
*Ophthalmic cases occurred on Tuesdays only.
*She agreed open flash sterilization was the primary means of sterilization for ophthalmic instruments.
*The reason the provider had not done closed flash sterilizing ophthalmic instruments was due to the fact they would then have to run the instruments for ten minutes rather than four minutes. That was an issue due to the fact the physician did not want to slow down the turn around times of the operating rooms.
*The provider had been looking at getting more sets of ophthalmic instruments but had not yet formally ordered any.

Interview on 2/16/11 at 1:15 p.m. with infection control officer D revealed she did not monitor or review the sterilization process.

Review of the Centers for Disease Control, Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 manual, page 58 through 59, pertaining to flash sterilization revealed:
*The time required for flash sterilization depended on the type of sterilizer and the type of items sterilized. The wrapped method of sterilization was the preferred method for sterilization.
*Performed correctly flash sterilization was an effective process for the sterilization of critical medical devices.
*Flash sterilization was a modification of conventional steam sterilization in which the items were placed in an open tray or placed in a specially designed, covered, rigid container to allow for rapid penetration of steam.
*"Historically, it is not recommended as a routine sterilization method because of the lack of timely biological indicators to monitor performance, absence of protective packaging following sterilization, possibility for contamination of processed items during transportation to the operating rooms, and the sterilization cycle parameters (i.e., time, temperature, pressure) are minimal."
*To address some of those concerns healthcare facilities had: "Placed equipment for flash sterilization in close proximity to the operating room to facilitate aseptic delivery to the point of use, extended the exposure time to ensure lethality comparable to sterilized wrapped items, used biological indicators that provide results in 1 hour for flash-sterilized items, and used protective packaging that permits steam penetration."
*"When sterile items are open to air, they will eventually become contaminated, the longer a sterile item is exposed to air, the greater the number of microorganisms that will settle on it."
*Flash sterilization was acceptable for processing cleaned patient-care items that could not be packaged, sterilized, and stored before use.
*Flash sterilization should not have been used for reasons of convenience as an alternative to purchasing additional instrument sets or to save time.

Review of the Association of periOperative Registered Nurses, Perioperative Standards and Recommended Practices, 2009 Edition, Denver, CO, page 651, revealed:
*"Flash sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method. Flash sterilization should not be used as a substitute for sufficient instrument inventory."
*Flash sterilization should have been performed only if all of the following conditions were met:
-The device manufacturer's written instructions on cycle type, exposure times, temperature setting, and dry times (if recommended) were available.
-Measures were taken to prevent contamination during transfer to the sterile field.
-Flash sterilized items were to be used immediately and not stored for later use.

2. Observations on 2/14/11 at 3:45 p.m. through 5:00 p.m. of all of the operating rooms revealed the provider used refillable spray bottles of a quaternary disinfectant to clean the operating rooms.

Interview on 2/14/11 at 4:30 p.m. with registered nurse M revealed:
*The provider used the quaternary product to disinfectant the floors and other surfaces of the operating rooms.
*The disinfectant came from a dispenser in the operating room janitor's closet.
*She was not aware if the concentration of the disinfectant was tested.

Interview on 2/16/11 at 9:00 a.m. with DON A revealed:
*Mixed quaternary products were not tested by the provider to ensure proper disinfection of the operating rooms had occurred.
*No test strips were available to test the provider's current supplies.
*She agreed the provider could not ensure this surveyor that adequate disinfection of the operating rooms had occurred without testing the levels of the disinfectant they were using.

Interview on 2/16/11 at 1:15 p.m. with infection control officer D revealed she:
*Did not monitor the types of chemicals used by the provider.
*Did not review or monitor operating room cleaning practices.
*Was not aware she should have been monitoring the above.

3. Observations on 2/14/11 from 3:45 p.m. through 5:00 p.m. of all of the operating rooms revealed each operating room had one-three opened endotracheal tubes opened on top of the anesthesia carts.

Observation on 2/14/11 at 3:45 p.m. of the provider's anesthesia storage area revealed thirteen endotracheal tubes were opened and placed back in the storage area.

Interview on 2/14/11 at 3:40 p.m. with registered nurse M and chief anesthetist L revealed:
*It was standard practice to leave opened endotracheal tubes in the operating rooms from case-to-case and day-to-day. That procedure was followed so they could check the balloon on the tube.
*They were unsure if the opened endotracheal tubes found in the anesthesia room came from the provider's operating rooms. They agreed that was a possibility.
*They both agreed the endotracheal tubes could be easily cross-contaminated after they had been opened.

Interview on 2/14/11 at 5:00 p.m. with DON A revealed she agreed:
*Opened endotracheal tubes should have not been left in the operating room from case-to-case and day-to-day.
*Opened endotracheal tubes should have never been returned to the main supply area.

4. Observations on 2/15/11 from 2:20 p.m. through 3:25 p.m. of patient 27's surgical procedure revealed:
*The patient's ulnar nerve areas were protected with uncovered eggcrate foam padding.
*The back of the patient's head was protected with a foam pad still in the manufacturer's shrink wrap.
*After the case had been completed those items were being saved and not disposed of.

Interview on 2/15/11 at 3:25 p.m. with surgery technician K revealed:
*The foam padding used during procedures was reused from case-to-case and day-to-day until it became visibly soiled.
*He agreed the padding was an un-cleanable surface that had direct contact with a patient.

Interview on 2/15/11 at 3:35 p.m. with DON A revealed she agreed the items above were single-use items and should not have been reused.

Review of the provider's policy operating room environmental sanitation revised 7/19/02 revealed un-cleanable items that came in direct contact with the patient should have been immediately disposed of after the surgical procedure.

5. Review of the provider's entire infection control manual revealed the policies and procedures had not been reviewed or revised since 2002.

Interview and policy review on 2/16/11 at 1:15 p.m. with DON A, assistant DON B, and infection control officer D revealed:
*They all agreed the provider's infection control policies and procedures had not been reviewed and revised since 2002.
*They all agreed they would not be able to determine if the provider's policies and procedures reflected current standards of practice since they had not been reviewed or revised since 2002.
*According to the provider's policy on policy and procedure review dated 5/4/10 all of the provider's policies and procedures should have been reviewed on at least an annual basis.

6. Interview on 2/16/11 at 1:15 p.m. with DON A, assistant DON B, operating room manager C, and infection control officer D revealed:
*Infection control officer D was not a certified infection control provider. Her education in infection control consisted of basic nursing education and annual inservices.
*Infection control officer D also served as the provider's quality assurance person and split her time between the areas.
*No formal hospital infection control committee existed. Infection control groups were put together on an as needed basis.
*The infection control officer had not been appointed in writing. Refer to A748, finding 1.
*Facility infection control rounds were not made by infection control officer D.
*Documented random monitoring of staff infection control practices were not completed by the infection control officer or other personnel.
*Chemicals were not approved for use or monitored by infection control officer D. Refer to finding 2.
*The infection control officer mainly worked on surveillance type of activities and had little hands on involvement with the infection control program.
*The provider's infection control policies and procedures had not been reviewed and revised since 2002. Refer to finding 5.
*The infection control officer did not do reviews of the provider's sterilization process. Refer to finding 1.
*Employee illnesses were not monitored or logged. Refer to A749, finding 1; and A750, finding 1.
*Specific policies and procedures related to the employee health area did not exist.
*The infection control officer did not oversee employee health infection control issues or procedures.

Based on interview, record review, and policy review, the provider failed to ensure the infection control officer had been designated in writing giving that person authority to oversee the infection control program. Findings include:

1. Interview on 2/16/11 at 1:15 p.m. with DON A, assistant DON B, operating room manager C, and infection control officer D revealed:
*Infection control officer D had been in charge of the infection control area for several years.
*Infection control officer D had never been designated in writing as the provider's infection control officer.
*They were not aware the infection control officer was to be designated in writing.

Based on observation, interview, record review, and policy review, the provider failed to ensure the appropriate implementation and evaluation of the hospital wide infection control program. Findings include:

1. Review of the entire infection control program revealed a lack of proper oversight, implementation, and integration. Refer to A747, findings 1-6; A748, finding 1; and A750, finding 1.

Based on interview and record review, the provider failed to ensure a log was created and maintained related to reported and identified employee infections and communicable diseases. Findings include:

1. Interview on 2/16/11 at 1:15 p.m. with DON A, assistant DON B, operating room manager C, and infection control officer D revealed:
*The infection control officer did not oversee the employee health program.
*Employee health was overseen by registered nurse (RN) E. RN E was a full-time nurse in the pre-operative area and did employee health as time allotted.
*They were not aware of any log that was kept by RN E related to employee infections and communicable diseases.
*Specific policies and procedures related to the employee health area did not exist.

Interview on 2/17/11 at 8:20 a.m. with RN E revealed:
*She had not created or maintained a log related to employee infections or communicable diseases.
*She was unsure if infection control officer D kept a log.

Based on record review and interview, the provider failed to ensure a complete operating room registry was maintained for 13 of 13 operating rooms. Findings include:

1. Review of the provider's operating room registry revealed:
*The registry consisted of copies of the day-to-day surgery schedule.
*The registry did not contain the patient's identification number, inclusive or total time of the operation, names of surgery assistants, names of nursing personnel, and pre/post-operative diagnosis.

Interview on 2/15/11 at 2:00 p.m. with director of nursing (DON) A and medical records director N revealed:
*They confirmed the operating room registry consisted of copies of the day-to-day surgery schedule.
*They agreed the provider's registry did not contain the patient's identification number, inclusive or total time of the operation, names of surgery assistants, names of nursing personnel, and pre/post-operative diagnosis.
*They agreed copies of the day-to-day surgery schedule did not meet the regulatory requirements for the operating room registry.
*They were unsure how long the operating room registry had been maintained in the above manner.

Interview on 2/15/11 at 4:15 p.m. with DON A revealed:
*The operating room registry had not included the above required information since 2002.
*No policy and procedure existed related to the requirements of the operating room registry.