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Based on observation, interview and record review the facility failed to ensure: 1) expired medical supplies were removed from the service area's; 2) expired medications were discarded; 3) multi-dose vials were labeled per facility policy; and 4) a policy for the use and storage of contrast had been implemented. Findings:

Random observations on 6/10/15 revealed multiple expired supplies throughout the facility:

ED - lab tubes: multiple lab tubes with expiration dates of 1/15; 11/14; 12/14; 1/15; 4/15;

ED - blood culture swab collection and transport system kit, 1 expired 9/14;

ED dental room - Avagard expired 1/13;

ED Exam room 2 - Avagard expired 4/28/15;

ED trauma room - medicated lotion soap expired 5/14

Procedure room - Avagard expired 4/15 and Hibiclens expired 5/14;

Procedure room - blood culture swab collection and transport system kit expired 7/14;

Procedure room - Fix-Rite 2 pump spray bottled expired 11/14;

Alcove by room 109 - Avagard expired 9/12 and 2 medicated lotion soap had expired on 9/1/14 and 10/1/14;

Alcove by room 102 - 2 medicated lotion soap bottles expired 10/1/14;

Ante room #C105 - Hibiclens expired 10/11

OR - Avagard expired 9/12;

Tub room - Providone iodine expired 4/11;

Therapies - Avagard expired 4/28/15;


Random observations on 6/10/15 revealed multiple expired medications throughout the facility:

Code cart room 100 - 3 NS ampules expired 5/15

ED - Lidocaine 2% expired 6/1/15;

ED - Epinephrine 1:100,000 expired 6/1/15;

Medication room - 3, 1 liter IV bags of 20 mEq KCL/D5 0.45%;

Anesthesia cart - 1,250 ml bottle Terrell Isoflurine expired 9/14; and 1, 100 ml bottle Terrell Isoflurine expired 7/14;

Radiology - 2 bottles of "Redicat2" in the fridge expired on 9/13 and 10/14.


Observations on 6/10/15 revealed multiple opened multi-dose vials (MDV) with no open/discard date or had expired:

ED - 1 Lidocaine 1% MDV no open or discard date;

ED - 1 Lidocaine 2% MDV no open or discard date;

ED - 1 Lidocaine 1% MDV expiration date written on sticker after opening was 5/24/15;

During an interview on 6/11/15 at 9:30 am the Pharmacist confirmed the facility policy on MDV and SDV. In addition, stated Pharmacy staff check for medication outdates monthly and nursing is also responsible for out date removals.

Record review from 6/10-12/15 of the facility policy "Medication Storage" dated 10/14, revealed "Bulk, Vial..., Medications..., shall be dated when opened; single dose vials and ampoules shall be discarded after use..., multi-dose vials will expire 28 days after opening date..."

Radiology

Observations in the CT room with RS #1 on 6/10/15 at 1:10 pm revealed multiple vials of single dose, preservative free Omnipaque 300mgI/ml contrast. Further observations revealed 5 bottles of Omnipaque in the warmer and 2 vials in the cupboard above the warmer. The vials in the warmer were dated as follows:

2 vials had "exp: 7/1/15"

2 vials had "6/8/15"

1 vial had "4/13/15".


During an interview at this time with RS #1 stated the contrast in the warmer was used for IV procedures and the contrast in the cupboard was used as oral contrast. He further stated the date on the vials in the warmer "should be the expiration date" because the contrast can only be in the warmer 30 days. This would mean that the vial dated 4/13/15 should have been removed on 5/13/15.

In addition, RS #1 stated the oral contrast in the cupboard could be used for multiple patients after opening.

The cupboard revealed: 1 opened vial of single dose Omnipaque with 75 of 100 ml contrast remaining in the vial dated "open: 5/26/15."

Review of the instructions on the vial of Omnipaque revealed, "No preservative. Each bottle for 1 procedure only. Discard unused portion."

During an interview on 6/10/15 at 2:00 pm the Radiology Manager stated date on the vials of contrast was the date it was placed in the warmer and should be removed after 30 days and placed in the cupboard for use as oral contrast. The manager and staff stated a different process for the storage of contrast.

The facility did not have a policy on storage of contrast and did not follow single dose vial instructions for use.

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Based on observation, interview, and record review the facility failed to ensure: 1) high level disinfectants were used according to manufacturer's guidelines in the Radiology Department; 2) a policy for high level disinfection had been implemented; 3) the patient care equipment in the radiology department were clean and ready for use; and 4) ensure the Infection Prevention & Control Program (IPC) provided facility wide surveillance. Failure to maintain surveillance of all facility department's infection control processes placed patients at risk for transmission of infections. Findings:

High Level Disinfectant

Observation in the ultrasound treatment room on 6/10/15 at 1:35 pm with Radiology Staff #1 revealed one opened, undated, gallon container of Cidex OPA, a high level disinfectant.

In addition, a smaller container, used for soaking the vaginal ultra sound probe, had no dates on the container and was full of Cidex OPA.

During an interview, Radiology Staff (RS) #1 stated it was the radiology staffs' responsibility to monitor the high level disinfection using the Cidex OPA for the vaginal probes. However, RS#1 was not able to answer questions about the process for the monitoring of the high level disinfectant.

During an interview on 6/10/15 at 1:55 pm the Radiology Manager was also not able to communicate the process for monitoring of high level disinfectant and was not sure why the log for testing the efficacy of the Cidex OPA had no documentation for the year 2015.


Record review of the "Ultrasound transducer infection control log" revealed, "Change Cidex OPA solution every 14 days." The last date on the log of Cidex OPA "test strip results" was 4/23/14.

Record review of the Radiology patient log provided by the facility revealed the last vaginal ultrasound was completed was on 6/9/15.

The facility did not have a policy, process, or log that met the guidelines for high level disinfection with Cidex OPA.

Soiled Patient Equipment

CT room

Observations in the CT room on 6/10/15 at 9:30 am revealed multiple spots of a dried shiny substance on the CT table and multiple dried white substances on the CT wedge pillow.

Further observations in the CT room with RS#1 on 6/10/15 at 1:10 pm revealed the same dried shiny substance on the CT table and dried white substances on the wedge pillow.

Radiology Staff #1 confirmed the dried shiny substance on the CT table was IV contrast. Additionally, stated the CT table was to be cleaned immediately after use and that it did not appear clean and ready for use.

Further observation revealed, RS #1 cleaned the CT table then placed a pillow case on the dirty foam wedge and acknowledged the table was now ready for the next patient.



Ultra Sound room

During an interview on 6/10/15 at 1:30 pm RS#1 stated the disinfectant process of the ultrasound equipment was the responsibility of radiology staff.

Observations on 6/10/15 at 2:40 pm in the ultrasound room revealed 2 of 4 ultrasound probes attached to the ultrasound machine had dried blue transducer gel on them.

Observations on 6/11/15 at 7:45 am revealed 2 of the ultrasound probes attached to the ultrasound machine had dried blue transducer gel on them.

Record review of the Radiology patient log, provided by the facility revealed the last of 3 ultrasounds had been scheduled on 6/10/15 at 5:30 pm.

During an observation and interview on 6/11/15 at 10:00 am the Administrator and the Assistant Administrator/CNO confirmed the ultrasound probes were dirty and had dried blue transducer gel on them.


Infection Control Committee

During an interview on 6/12/15 at 9:00 am the Assistant Administrator/CNO and the Medical Director of the Infection Prevention and Control committee confirmed the infection control committee had not received any reports from the radiology department on the use of the high level disinfectant. In addition, they confirmed surveillance for infection prevention and control had not encompassed all departments.

Record review of the "Infection Control Compliance Rounds" form, no date, revealed no surveillance of high level disinfectant use, sterilization practices, or environmental rounds in the radiology department or operating room.

Further review of the Infection Control Committee meeting minutes, had no documentation of high level disinfectant use in the operating room or radiology department.

Record review of the "Infection Control/Employee Health Program Plan - 2015" revealed, "is designed to prevent or minimize the incidence...of acquiring and transmitting infection...the purpose of the Infection Control Plan is to establish a hospital-wide, inter-disciplinary program using established guidelines and methods to identify, control and prevent...necessary for all individuals caring for patients in both the inpatient and outpatient settings..."


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Based on observation, interview and record review the facility failed to ensure: 1) monitoring of the operating rooms for temperature and humidity and 2) have a policy and practice that addressed the hang time and reprocessing of endoscopes. This failed practice had the potential for increased risk to both patients and staff for fire and infections. Findings:

Temperature and humidity monitoring

Observation on 6/10/15 at 8:35 am revealed no humidity or temperature monitor in the operating room.

During an interview on 6/10/15 at 8:35 am OR staff #1 stated the humidity was monitored by maintenance.

During an interview on 6/12/15 at 9:15 am Maintenance Staff #1 stated maintenance did not monitor humidity in the operating room.

Record review of the Infection Control committee minutes dated 2/11/15, revealed "still waiting on humidity...monitors..."

During an interview on 6/12/15 at 9:00 am Assistant Administrator/CNO and the Medical Director of the Infection Prevention and Control committee confirmed the facility did not have humidity monitors in the operating, endoscopy, sterilization, or instrument processing rooms.

No documentation of temperature or humidity was being logged.


Endoscope reprocessing

During an interview on 6/10/15 at 8:30 am OR Staff #1 stated endoscopes may hang for several weeks after high level disinfection, and are considered to be clean and not re-processed before use. Additionally she stated she was not aware of a policy that addressed an interval of when endoscopes should be re-processed.

Record review of the "Infection Control Compliance Rounds" form revealed no surveillance of high level disinfectant use, sterilization practices, or environmental rounds in the radiology department or operating room.

Record review of the "Infection Control/Employee Health Program Plan - 2015" revealed, "is designed to prevent or minimize the incidence...of acquiring and transmitting infection...the purpose of the Infection Control Plan is to establish a hospital-wide, inter-disciplinary program using established guidelines and methods to identify, control and prevent...necessary for all individuals caring for patients in both the inpatient and outpatient settings..."

Review of the Perioperative Standards and Recommended Practices 2012, revealed "Relative humidity should be maintained between 30% - 60% within the perioperative suite, including operating rooms, recovery area,... endoscopy rooms, instrument processing area, and sterilizing areas..."

In addition, the same reference stated "Flexible endoscopes should be reprocessed before use if unused for more than five days..."

Review of the Center for Clinical Standards and Quality /Survey & Certification Group letter Ref: S&C: 13-25, dated April 19, 2013, "Center for Medicare & Medicaid (CMS) is issuing a categorical LSC waiver permitting new and existing ventilation systems supplying hospital and critical access hospital (CAH) anesthetizing locations to operate with a RH [relative humidity] of =20 percent, instead of =35 percent. We are also recommending that RH (relative humidity) not exceed 60 percent in these locations."


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