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Based on observation and interview, the provider failed to store chemicals separate from patient supply items in three of three randomly observed areas (housekeeping storage, the patient whirlpool room, and central storage) and separate from one of one handwashing sink in the emergency room. Findings include:

1. Random observations on 4/5/16 from 9:30 a.m. to 4:00 p.m. revealed:
*Liquid soap, bags of alcohol hand gel, and bathroom spray deodorizers were stored over paper towels and toilet paper in the housekeeping storage room.
-Interview with housekeeper C confirmed those findings and was unaware those cleaners and chemicals should not be stored over patient use supply items.
*Disinfectants were stored on top for the paper towel dispenser in the whirlpool room. Disinfectants were also stored intermingled with patient personal care items such as lotion, body spray, body wash, and talcum powder.
*Chemicals were stored intermingled and over hand lotion and hand sanitizer in the main supply room.
-Interview with radiologic technologist A revealed she was in charge of the main central supply room. She confirmed the inappropriate storage of chemicals, but she was not aware disinfectants, chemicals, and cleaners should not have been stored with patient care or patient use items.

Interview on 4/6/16 at 6:15 p.m. with the acute care coordinator and director of nursing (DON) revealed they were not aware chemicals were stored intermingled and/or over patient supply items.

2. Observation and interview with the DON on 4/6/16 at 4:00 p.m. revealed cleaners and disinfectants were stored on the top ledge of the handwashing sink in the ER. She confirmed the finding but was not aware of the concern for storing cleaners and chemicals above a handwashing sink.

No policy or guidelines were found by the provider regarding storage of patient care items with cleaners, disinfectants, or chemicals.

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A. Based on record review, observation, interview, and policy manual review, the provider failed to ensure the temperature and humidity for one of one operating room (OR) was monitored for five of five sampled patients' (14, 29, 30, 31, and 32) surgical medical records. Findings include:

1. Review of patients 14, 29, 30, 31, and 32's surgical medial records revealed no documentation of the temperature and humidity of the OR during their surgical procedures. Those surgical procedures took place on 6/4/15, 4/2/15, 10/11/15, 1/7/16, and 3/3/16, respectively.

Observation and interview on 4/6/16 at 4:00 p.m. with the acute care coordinator in the operating suite revealed:
*There was a thermometer and a humidity gauge in both the outer scrub sink area and also in the OR.
*The temperature and humidity was looked at on the surgical days only.
*The thermostat was always set to 68 degrees Fahrenheit, and the humidity never went below 30 percent.
*No documentation of the temperature and humidity was maintained.

Review of the signed Surgical Services policy and procedure manual revealed no policy on monitoring temperature and humidity in the OR.

B. Based on observation and interview, the provider failed to ensure:
*Two of two sets of unfinished wooden shelves in x-ray were cleanable.
*Two of two countertops in physical therapy had cleanable surfaces.
*The wall behind the scrub sink in the OR suite was a cleanable surface.
*Food items were not kept in the soiled utility room of the surgical suite.
*A temporary shelf in the OR was maintained in a cleanable manner.
Findings include:

1. Observation and interview on 4/5/16 at 10:30 a.m. with radiation technicians A and B revealed an unfinished wooden shelf above the desk in the x-ray examination (exam) room. Patient care items such as tape, positioning devices, and two clean towels were stored on that shelf. In addition there were three unfinished wooden shelves in the closet next to the x-ray exam room. Piles of clean linen were stored on those shelves. They confirmed those findings. They stated they had not considered those shelves were not cleanable and could absorb odors, stains, and were a potential source of cross-contamination.

2. Observation and interview on 4/6/16 at 3:55 p.m. with the physical therapy assistant (PTA) of the physical therapy (PT) suite revealed two countertops in the old cardiac rehabilitation (rehab) room were covered with contact paper. That contact paper was peeled, ripped, and left ridges where the old contact paper had been ripped off the counter and created an uncleanable surface. The PTA confirmed that finding. She stated PT had moved into the old cardiac rehab area just before Halloween last year. She stated she had not had a chance to request new countertops or to have those countertops refinished.

3. Observation and interview on 4/6/16 at 4:00 p.m. with the acute care coordinator of the operating suite revealed:
*The wall behind the scrub sink had an approximately six inch square area of peeling paint. That paint could easily be flaked off. That created an uncleanable surface.
*There was a one-quarter full box of candy on a shelf above the two compartment sink in the soiled utility room. The acute care coordinator agreed the candy should not have been in the soiled utility room.
*There was a board in the OR suite lying across two stainless steel basin stands. The board was covered in contact paper and had areas on the corners where the contact paper was peeling away. The acute care coordinator stated the board was used as an extra shelf to put surgical supplies on during surgery.

Based on document review and interview, the provider failed to ensure an immediate supply of emergency water was available for the hospital. An emergency water supply agreement dated 7/3/14 was in effect for the skilled nursing facility but did not include the hospital. Findings include:

1. Review of an email dated 7/3/14 from a commercial kitchen contractor revealed it would take all reasonable actions to provide emergency water to the Avera Oahe Manor (skilled nursing facility). Additional information could not be located nor supplied to ensure an emergency water supply was available for the hospital.

Interview on 4/6/16 at 6:00 p.m. with the administrator revealed he had been in contact with the local grocery store to provide emergency water. He stated he only had a verbal agreement and had nothing in writing for an emergency water supply for the hospital when requested.

Based on document review and interview, the provider failed to ensure a specialized and independent governing board meeting, records, and minutes were unique to the provider was developed and maintained for the facility. Findings include:

1. Review of the governing board minutes dated 4/16/15, 6/18/15, and 10/15/15 revealed on the following dates:
*4/16/15:
- ____ (former administrator for Avera Gettysburg) has submitted his resignation effective 5/26/15.
-Patient satisfaction surveys will be initially conducted.
-Marketing and PR (public relations) for employee recruitment.
-Architect on-site 4/24/15 for future project.
-Credentialing information for providers.
-Annual review and updated the medical staff by-laws.
*6/18/15:
-Medical staff recommendation.
-Results from the Avera Gettysburg Employee Engagement survey.
-Wellness program, Hospital, expansion of outpatient services.
*10/15/15:
-Department of Health Survey held 10/2015 (Oahe Manor nursing home).
-Boiler failure and replacement.
-Summary of occurrences.

Interview on 4/6/16 at 10:00 a.m. with the administrative assistant revealed neither she nor anyone else kept individual notes for the governing board. The meetings were held in Pierre. She stated she could not verify if the all encompassing board meeting for the Avera facilities around Pierre would include separate notations and entries for the Avera Gettysburg Hospital. She also was not aware there were no minutes for the December 2015 meeting included in the governing board minutes from the Pierre administration.

Interview on that same day at 1:00 p.m. with the administrative assistant revealed she had received an email from Pierre regarding the appointment of the new administrator. He had started approximately 6 months ago. That email read "The October 15, 2015 agenda for Gettysburg included an introduction and comments from ___ (new administrator), but there isn't anything formally appointing ___ (new administrator)."

At 5:50 p.m. on 4/6/16 no other documentation was delivered from the provider about the governing board or about the December 2015 meeting.

Interview on that same day at 6:00 p.m. with the administrator confirmed the governing board minutes were held in conjunction with Avera facilities located around and adjacent to Pierre. He confirmed there were no separate and distinct governing board meetings for the Gettysburg facilities in relation to the following:
*Appointment of the administrator/CEO (chief executive officer).
*Ensure all Medicare or Medicaid patients were under the care of a licensed practitioner.
*Admitted only by those practitioners with admitting privileges.
*Ensure a physician was on duty or on call at all times for the hospital emergency room.
*Review and update of the annual institutional plan and budget.
*Quality Assurance Performance Improvement plan was reviewed and evaluated to include contracted services.

No policy or description regarding the governing board could be presented by the hospital administration by the end of the survey.

Based on observation, interview, policy review, record review, and manufacturer's product label review, the provider failed to ensure:
*One of two enzymatic cleaners used on all sterilized instruments from the emergency room (ER) and operating room (OR) had not expired.
*An air removal test was conducted on the autoclave as part of the sterilization process.
*Sterilization records were kept to ensure the outside ophthalmologist's surgical instruments were sterilized in-house prior to use in the provider's OR.
*One of one plastic laundry tub was not used to transport clean and dirty hospital laundry.
*All toys in the waiting room were sanitized daily.
*Two of two Oxivir Tb Spray disinfectants in the utility room were not expired.
*One of one ice/water self-dispensing machine in the nourishment room of the patient wing was kept clean and sanitized.
Findings include:

1. Random observation and interview on 4/5/16 from 9:45 a.m. to 5:30 p.m. and on 4/6/16 from 8:00 a.m. to 6:30 p.m. revealed:
a. A one gallon container of enzymatic cleaner was stored on top of a counter by a two compartment sink. That cleaner had expired on 3/1/16. Interview with radiological technologists (rad tech) A and B confirmed that finding. They stated they were not aware enzymatic cleaner had an expiration date. Rad tech A also stated they used that cleaner in the ER and the hopper room.

b. Review of the sterilization and servicing records revealed an air removal test was never done for the dynamic air autoclave. Interview with rad techs A and B revealed they were not aware an air removal test was needed for the autoclave. Rad tech A stated they had started using the new autoclave on 10/28/11. She stated they had not been trained by their parent hospital on doing an air removal test.

Phone interview on that same day with a MidMark autoclave service representative revealed they gave no guidelines for in-house testing of their instruments to verify sterilization. They would tell facilities they must follow federal and state regulations. The service representative also verified the MidMark autoclave was a dynamic air-removal steam sterilizer.

Review of the "10/14" dated Sterilization Policy revealed an ATTEST biological Indicator test is done with the first load of each day. No instructions were given for conducting an air removal test.

Review of the "September 2014" dated Handling and Storage of hospital-processed Sterile supplies - Event Related Sterility revealed the references used for sterilization were AORN (Association of periOperative Registered Nurses).

Review of the 2014 AORN guidelines for Dynamic air-removal steam sterilizers on p. 596 revealed "A Bowie-Dick air-removal test should be performed each day that the sterilizer is used and should be performed before the first load of the day but after a warm-up cycle is run."

c. Continued interview with rad techs A and B revealed they were not aware outside physicians' instruments and surgical kits must be reprocessed/sterilized in-house prior to any operations. They stated they had never reprocessed/sterilized the outside ophthalmologists surgical instruments.

Interview on 4/6/16 at 6:15 p.m. with the acute care coordinator revealed she was the scrub nurse for the ophthalmologist when he did monthly procedures at the hospital. She stated she personally sterilized the outside physician's instruments prior to his operations the next day. The surveyor requested the sterilization records for the ophthalmologist's instruments. As of 5:00 p.m. on 4/06/16 those records had not been obtained by the provider.

Review of the "2/14" dated Ophthalmologist job duties revealed no guidelines for re-processing his sterilized instruments for in-house procedures.

Review of the "10/14" dated Sterilization Policy revealed Cataract instruments are brought sterile by the ophthalmologist and returned sterilized.

Review of the September 2014 dated Handling and Storage of hospital-processed Sterile supplies - Event Related Sterility revealed the references used for sterilization were AORN.

Review of the 2014 AORN guidelines for Care of Instruments, p. 542, revealed: "Loaner instruments should be decontaminated and sterilized in the borrowing facility according to the manufacturer's written instructions before use."

d. Interview on 4/5/16 at 2:00 p.m. with laundry aides E and F revealed:
*One plastic laundry wheeled tub was used to transport both dirty and clean laundry from the hospital to the laundry room.
*They would use a disinfectant to wipe out the dirty tub from the soiled laundry before using it for the clean laundry.
*Laundry aide E stated "I use about that much [holding her fingers up to show about 1/2 inch] of disinfectant and add it to the bucket in the sink. Then I fill the bucket with water and wipe down the soiled linen tub from the hospital."
*Laundry aide F confirmed laundry aide E's interview and added "I use about two tablespoons to about 1/2 gallon of water."
*Neither aide was aware of the contact time or the correct amount of disinfectant to mix with water.
*Review of the label directions for the disinfectant revealed the guidelines were to use two ounces of disinfectant per one gallon of water.

After being requested and up to the end of the survey, no policy could be located by the provider for disinfection of the one laundry tub for the hospital.

e. There was a large box of assorted toys, dolls, and building blocks in the waiting room. Interview with housekeeper D revealed they would use Diversey End Bac II solution on the toys in the waiting room. Review of the label directions for the Diversey product revealed if it was used for sanitation and would have any human contact it was required to have a potable (clean drinking water) rinse.

Interview on 4/6/16 at 10:00 a.m. with housekeepers C and D revealed they were not aware the toys must have a potable rinse after disinfection. They agreed there were small children who would put the toys or blocks in their mouths.

Upon request and up to the end of survey, no policy or procedure could be provided for the disinfection of toys in the waiting room.

f. Two cans of Oxivir Tb Spray disinfectant sat on the counter in the utility room of the patient wing. Those spray disinfectants had expired on November 2014 and May 2015.

Interview on 4/6/16 at 6:15 p.m. with the acute care coordinator revealed she was not aware those spray cans had expired. She stated she was not aware if they were ever used by anyone.

g. There was a self-dispensing ice and water machine in the nourishment room of the patient wing. It had a multi-colored layer of dried liquid debris on the underside of the dispensing chute. That layer of dried debris could be scraped and chipped off with a fingernail.

Interview on 4/6/16 at 6:15 p.m. with the acute care coordinator, director of nursing, and administrator revealed they were not aware the ice and water dispenser was dirty. They stated it should have been cleaned by dietary but were unaware if it was on a cleaning list.

Based on document review and interview, the provider failed to ensure the quality assurance (QA) committee:
*Reviewed all contracted services including V-Rad (twenty-four hour radiologist service), registered dietitian/licensed nutritionist (RD/LN),
and registered pharmacist (RPh).
*Reviewed all hospital departments and services were reviewed.
*Noted or addressed any patient grievances.
Findings include:

1. Review of the QA reporting sheets for contracted services in March 2015 revealed no documentation or review of the contracted services including V-Rad, the RD/LN, and the RPh. The contracted services QA reporting sheets for 2015, 2013, 2012, 2011, and 2010, and 2009 included the same four services that included DMS (Diagnostic Medical Systems), UHS (Universal Hospital Services), Midwest Radiation, and Mobile Mammography.

The QA for 2015 also included:
*Housekeeping for the skilled nursing facility (SNF)but not the CAH.
*Human Resources with the last report being in 2014.
*Physical Therapy that only included out-patient services.
*Patient grievances only for the SNF.

Swing bed services, OPO (organ procurement program), pastoral care, maintenance, and ophthalmologist services, included the services that were not included in the QA.

Interview on 4/6/16 at 10:55 a.m. with the certified dietary manger revealed she had not reviewed the quality or effectiveness of the RD/LN services.

Interview on that same day at 2:00 p.m. with the radiology technician revealed she was not aware of any QA for the V-Rad service for twenty-four hour x-rays.

Interview on that same day at 6:00 p.m. with the director of nursing (DON) revealed she:
*Was the QA coordinator.
*Reviewed the contracted services for the QA program.
*Did not have reviews or reports from all department managers or administration in regards to their reviews or audits of contracted services or the unique services for the CAH.
*Was unaware all the contracted services must be reviewed that involved patient care or patient services.
*Was unaware the QA reporting sheets must change annually if QA deemed the current identified concern had been resolved.
*Was unaware the QA of the contracted services must include the effectiveness of the service and the quality of care.

Interview and confirmation at the above same times with the administrator revealed he was aware of what the QA program should encompass. He also confirmed he was responsible for the outside RPh services but had not done a QA on that service.

Review of the July 2015 through June 2016 Avera Gettysburg Hospital Quality Plan revealed no plan to include an annual review of contracted services.