HospitalInspections.org

Based on document review, interview and observation, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities for the operation and management of the hospital. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:

CFR 482.25 Pharmaceutical Services

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Based on observation, policy review, and staff interview on 2/6/14, it was determined that the facility failed to ensure that pharmaceutical services are provided in a safe manner.

Findings include:

1. The facility failed to implement policies and procedures to ensure that drugs in single dose vials are not available for use on multiple patients. (Refer to Tag A-0491)

2. The facility failed to implement policies and procedures to ensure that drugs in multiple dose vials that are used in immediate patient treatment areas are not available for use on multiple patients. (Refer to Tag A-0491)

These findings were cause for an Immediate Jeopardy to be identified on 2/6/14. The Immediate Jeopardy was abated on the afternoon of 2/6/14 after receiving an acceptable plan of correction.

Repeat Deficiency

A. Based on observation, policy review, and staff interview, it was determined that the facility failed to implement policies and procedures to ensure that drugs in single dose vials are not available for use in multiple patients.

Findings include:

Reference: Facility policy titled "Multi-Dose/Single-Dose Injectable Vial Policy" (Effective Date: November 2013) states, "... Policy: ... Single dose injectable products/containers MUST be used only one time on one patient and discarded."

1. On 2/6/14 at 11 AM, in the presence of Staff #9, the following opened single dose vials of medications were found in a surgical cart located in the Surgical Clinic in E-level of the Ambulatory Care Center:

a. One opened Marcaine 0.25% 30 ml vial labeled "single-dose vial-preservative free".

b. One opened Bupivacaine 0.25% 30 ml vial labeled "single-dose".

c. Upon interview, Staff #30 stated that the surgical cart is used in the procedure room.

B. Based on observation, policy review, and staff interview, it was determined that the facility failed to implement policies and procedures to ensure that drugs in multiple dose vials that are used in immediate patient treatment areas are not available for use in multiple patients.

Findings include:

Reference: Facility policy titled "Multi-Dose/Single-Dose Injectable Vial Policy" (Effective Date: November 2013) states, "...Policy: ... Any multidose vial used in immediate patient care areas shall be discarded after single use."

1. On 2/6/14 at 11 AM, in the presence of Staff #9, one opened Kenalog-10 50 mg/5 ml multiple dose vial was found in a surgical cart located in the Surgical Clinic in E-level of the Ambulatory Care Center.

a. Upon interview, Staff #30 stated that the surgical cart is used in the procedure room.

2. On 2/6/14 at 11:30 AM, in the presence of Staff #4, one opened Glycopyrrolate 1 mg/5 ml multiple dose vial was found in the Anesthesia Pyxis machine in OR#12.

Not Corrected
A. Based on observation, staff interview, and review of facility documents, it was determined that facility policy, manufacturer's instructions and industry standards were not followed for the immediate-use sterilization of instruments used for surgical procedures in the Operating Room.

Findings include:

Reference #1: Manufacturer's instructions for Flash Pak sterilization container system by Riley Medical states "Valves located at the top and bottom of the container should be vented at least once a day, when the container is cool."

1. The Plan of Correction states a new Immediate Use Sterilization Log form was developed. The form requires documentation that the valve on the Riley Flash Pak is vented daily in the morning before use. Date of was completion 12/11/13.

2. Verification could not be provided to identify if valves are checked daily on each Flash Pak observed.

a. On 02/06/14 Staff # 2 stated FlashPaks are returned to the Central Services Dept for cleaning and venting by Central Services' technicians, but a record is not maintained.

3. The Flash Sterilization Log reviewed for January 2014 in OR substerile room 9 does not document venting of FlashPaks being used for the month of January 2014.

4. On 02/06/14 at 4:00 PM, Staff #3 confirmed Immediate Use Steam sterilization (IUSS) forms were revised to document venting of FlashPak, but were not yet implemented.

5. Staff competencies "Critical Elements for Flash Sterilization Competency" documents all OR staff completed competencies on 2/4/14. The Competency form states "#4. Confirms flash container washed before using; vents Riley Flash Pak; documents venting".

Not corrected

B. Based on observation, it was determined that the facility failed to ensure a
sanitary environment to avoid sources and transmission of infections and communicable diseases where methods for processing reusable medical devices conform with Association for the Advancement of Medical Instrumentation(AAMI) ST79:2010 Comprehensive guide to Steam Sterilization and sterility assurance in health care facilities (ST 79 replaces and supersedes ST46 by consolidating ST 46 with 4 other AAMI standards [ST33, ST37, ST42, and ST35] approved 7/10/2009).

Findings include:

Reference #1: AAMI ST 79:10.3.1 "Lot control numbers" states Ideally, every reprocessed medical device, especially an implant, should be fully traceable to the patient on whom it is used or in whom it is implanted; such traceability can be accomplished by recording the sterilizer load identifier on the patient chart or the patient name on the load record.

1. The Plan of Correction (POC) states "On 11/18/13 a new Implant Log form was implemented in SPD to track all implants using a lot control number. New Patient load cards ordered and effective 12/23/13 will be placed on all implant trays." Completion date given 12/30/13.

2. On 02/06/14 at 12:30 PM, Staff #3 stated new patient load cards were not received until yesterday (02/05/14). The new cards would be implemented by Monday (2/10/14) in the comments of the EPIC system to identify the item, lot number, date and patients name.

New Findings
C. Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to follow manufacturer's instructions and industry standards for the immediate-use sterilization of instruments used for surgical procedures in the Operating Room.

Findings include:

Reference: "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" AAMI ST79:2010- 7.2.2 states that the device labeling should identify specific methods of cleaning and sterilization that have been validated by the manufacturer. The manufacturer ' s written IFU (instructions for use) should be kept on file and periodically reviewed for any updates. If there are no specific written IFUs in the labeling, then the manufacturer should be contacted directly to provide a documented method.

1. On 02/06/14, manufacturer's instructions for sterilization for the Biomet phoenix tibial nail system instrument that was sterilized on the IUSS cycle on 1/22/14 were not available in the OR on request.2. At 12:30 PM, Staff #3 provided Biomet instructions for use which provide sterilization cycle parameters for wrapped cycles only, allowing a 30 minute dry time. Flash sterilization cycle parameters were not provided.3. At 4:00 PM, Staff #3 stated the Biomet company was contacted to verify sterilization parameters, and flash sterilization is not recommended and no parameters would be issued. 4. Facility policy "Steam Sterilization for Immediate Use-(SSIU-Flash Sterilization)" effective January 15, 2014, states "#5. Manufacturer's instructions for Flash sterilization will be kept on file and readily accessible to OR staff. This information should be updated at least every 2 years."


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Not Corrected
D. Based on observation, staff interviews, and review of facility documents, it was determined that the facility failed to ensure the implementation of facility policy, manufacturer's instructions and industry standards for instrument processing in the Ambulatory Care Center.

Findings include:

Reference #1: Manufacturer of 'GE Ultrasound Transducer' states, "Transducer cleaning: These generalized cleaning instructions are indicated for use with all GE transducers. Cleaning is defined as the removal of all visible soil or contaminants from the transducer. All transducers must be cleaned after every use - this is an essential step before disinfection or sterilization is attempted. 1. After every exam, ensure the acoustic coupling gel is completely wiped off the transducer. Transducers should not be left soaking in gel. 2. Remove any transducer cover, biopsy guides, or protective devices from the transducer ... 4. Use a moistened soft cloth or wipe to remove any remaining contaminants that remain on the transducer or cable. Do not re-use cloths or wipes. Soap, detergents or enzymatic cleaners should be used in accordance with the manufacturer's instructions. 5. If rinsing is required, use caution not to expose the system connector to moisture or liquids. 6. Use a lint-free soft and clean dry cloth or wipe to thoroughly dry the transducer and cable.
Note: If a manual disinfection process is utilized, ensure that all staff is properly trained and disinfectant instructions for use are followed precisely. DO: Utilized wall-mounted transducer holders with lens facing up. DO NOT: Do not drop transducers into holders or disinfectant containers with lens face down."

1. On 2/6/14, at 12:30 PM, Staff #28 stated that the manual disinfection process begins at the bed side, when he/she pre-cleans the transducer by removing the transducer cover and wiping the exterior with a disinfectant wipe. The transducer is then transported to the patient bathroom located directly next to the procedure room, where the transducer is rinsed with running water at the hand washing sink and wiped with a disposable hand towel. Staff #28 then places the transducer probe into the open CIDEX OPA disinfectant solution container with the lens facing down.

Reference #2: Facility policy #831-200 on 'Procedural Barriers For Cleaning and or High Level Disinfection Outside of the Sterile Processing Department' states, "... 3. Staff competencies for compliance with stated polices will be verified and documented initially and annually by SPD or as designated."

Reference #3: Manufacturer of 'CIDEX OPA Solution Test Strips' states, "CIDEX OPA Solution Test Strips monitor the minimum effect concentration(MEC) of CIDEX OPA Solution during its use life. DIRECTIONS FOR USE: WHEN TO TEST: Test solution before each usage to guard against dilution, which many lower the Ortho-phthaladehyde level of the solution below its MEC. Test solution before immersing instruments. HOW TO TEST: Completely submerge indicating pad of the strip into CIDEX OPA solution. Hold for one second and remove. REMOVE excess solution by standing the strip upright on a paper towel. READ results at 90 seconds after removal from solution. Pad will be completely purple to indicate effective solution. If ANY BLUE appears on the pad apart from the top line, solution is ineffective. If read past 90 seconds color will gradually change to indicate fail."

1. On 2/6/14 at 1:00 PM, Staff #28 stated that he/she routinely tests the MEC of CIDEX OPA Solution once a day in the morning and not before each patient use.

a. Based on review of the facility's most current 'CIDEX OPA SOLUTION LOG SHEET', the activated solution was tested once a day between 7 AM to 8:30AM on the following dates:1/24/14, 1/27/14, 1/28/14, 1/29/14, 1/30/14, 1/31/14, 2/3/14, 2/4/14, 2/5/14, and 2/6/14.

2. On 2/6/14 at 1:15 PM, Staff # 28 stated that the CIDEX OPA Solution Test strip result is read at 2 minutes after removal from the solution, not at 90 seconds as required by the manufacturer.

3. The facility's POC states that all areas of Ambulatory Care departments involved with reprocessing activities were identified and visits will be made to each area by 1/10/14. On 2/6/14, when Staff #28 and Staff #29's competencies were requested from Staff #3, Staff #3 stated that he/she was unaware of reprocessing activities occurring at the GYN ultrasound clinic located at level C of the Ambulatory Care Center, therefore both were not included in the competency evaluation.

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Not corrected
Based on review of quality assurance reports for the physical medicine and rehabilitation service (PM&R), and staff interviews it was determined that the facility failed to implement their plan of correction (PoC) for chart audits.

Findings include:

1. On 2/6/14 at 1:40 PM the quality assurance for PM&R was reviewed in the presence of Staff #21. The PoC indicates that 30 charts will be audited for three months or until 100% compliance is sustained, for the following criteria:

a. frequency of treatment as ordered

b. adjustment in care plan if frequency of treatment was adjusted

c. documentation of reason why a patient was not seen for treatment on a monthly basis

2. The facility did not complete 30 chart audits per month.

a. Review of the chart audits indicated an initial evaluation, and then a subsequent audit in January as follows:

i. Occupational Therapy: 9 charts, then 24 charts

ii. Physical Therapy: 11 charts, then 11 charts

iii. Speech Therapy: 5 charts, then 17 charts

b. The aggregated data is not broken down into the three identified criteria, thus making it difficult to determine the facility's compliance or non-compliance with each criteria identified.