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The Governing Body failed to assure that the hospital was compliant with all Conditions of Participation in the areas of QAPI and Infection Control as it relates to gastrointestional (GI) scope re-processing.

See findings under Tag 263, 273,747,749 and 941.

The Quality Assurance Program did not ensure corrective actions related to GI scope disinfection were monitored and evaluated to ensure patient safety.

See findings under Tag 273 and 941.

Based on document review, observation and medical record review, the Quality Assurance Program failed to ensure corrective actions specific to GI scope reprocessing were implemented and monitored to ensure patient safety.

Findings Include:

Review of the Infection Prevention Department meeting minutes dated 8/17/12 indicated scope disinfection policies were updated to reflect a continuous process from start to finish, and Central Supply was performing manual cleaning/high level disinfection on off hours with the GI unit staff completing the process, utilizing the Medivators on their return to work. There is no evidence of any follow-up activity by the Infection Control Committee related to GI scope reprocessing.

Review of an e-mail received on 8/21/12 at 3:52pm from the Pentax (manufacturer) representative indicated immediately after (at least within one hour) of the completion of a procedure, that the endoscope and its components should be thoroughly and carefully cleaned.

Review of an e-mail received 9/27/12 from Pentax revealed Pentax conducted a phone conference with the facility on 8/23/12 to clarify the proper interpretation of the reprocessing instructions for Pentax 90 i-Series endoscopes. The information exchanged specifically highlighted the need to perform the following activities:
1. Pre-cleaning of an endoscope immediately after the conclusion of a patient procedure.
2. Initiation within one hour after completion of pre-cleaning of all subsequent steps of the endoscope reprocessing procedure.
3. Completion in uninterrupted fashion of all subsequent steps of the endoscope reprocessing procedure after pre-cleaning.

Review of an e-mail received on 8/24/12 at 9:44am from Staff #6 revealed the facility has immediately instituted, effective 8/23/12, a continuous process for cleaning and processing GI scopes. The scopes will be cleaned at the end of the case followed by immediate reprocessing. The policy was updated to reflect this process and all active GI staff received verbal education from the manager that the policy is in effect as of 8/23/12. GI staff will be required to review the updated policy and sign off by 8/31/12.

Review of the GI Division Meeting Minutes from 8/11/12 to 11/6/12 revealed no evidence the committee discussed the issues identified with scope reprocessing in the GI lab.

Observation on 1/14/13 at 7:45am (Monday) revealed a cart labeled "dirty scopes" that had 4 plastic bins housing 6 used scopes.

Medical record review of GI cases from 12/15/12 to 1/14/13 revealed 10 instances when GI scopes were not immediately reprocessed. Additonally, a mechanism for monitoring the reprocessing of GI scopes was not in place.

See findings under Tag #749.

Based on findings from document review, observation and interview lapses in generally accepted infection control practices were identified in the cleaning of GI scopes and the tracking of reprocessing. The Immediate Jeopardy identified in this situation was removed before the survey was completed.

See findings under Tag 273, 749 and 941.

Based on interview, document review, observation, and medical record review, the Infection Control Officer failed to monitor compliance with infection control policies and procedures and failed to implement infection control measures as they relate to GI scope reprocessing.

Findings Include:

Review of an e-mail received 9/27/12 from Pentax revealed Pentax conducted a phone conference with the facility on 8/23/12 to clarify the proper interpretation of the reprocessing instructions for Pentax 90 i-Series endoscopes. The information exchanged specifically highlighted the need to perform the following activities:
1. Pre-cleaning of an endoscope immediately after the conclusion of a patient procedure.
2. Initiation within one hour after completion of pre-cleaning of all subsequent steps of the endoscope reprocessing procedure.
3. Completion in uninterrupted fashion of all subsequent steps of the endoscope reprocessing procedure after pre-cleaning.

Review of Policy "Disinfecting of Scopes and Ancillary Equipment" last revised 8/24/12 indicated immediately after use, scopes are to be washed and suctioned in the procedure room. Scopes are brought to the cleaning room where they are leak tested, scrubbed with brushes and scope buddy used to flush the scope per manufacturer's guidelines. The scopes are reprocessed with an automatic disinfecting machine according to manufacturer's guidelines. Clean scopes are hung in scope cupboard with a tag indicating it is clean. After hours scopes will be transported to the GI lab for immediate and continuous processing.

Review of the Infection Prevention Department meeting minutes dated 8/17/12 indicate scope disinfection policies were updated to reflect a continuous process from start to finish, and Central Supply was performing manual cleaning/high level disinfection during off hours with the GI unit staff completing the process, utilizing the Medivators on their return to work. There is no evidence of any follow-up activity by the Infection Control Committee related to GI scope reprocessing.

Observation on 1/14/13 at 7:45am (Monday) revealed a cart labeled "dirty scopes" that had 4 plastic bins housing 6 used scopes. Medical record review of GI cases from 12/15/12 to 1/14/13 revealed 10 instances when GI scopes were not immediately reprocessed. Additonally, the GI lab did not have a mechanism in place to track the reprocessing of GI scopes.

Interview on 1/14/13 at 8:45am with Staff #8, the GI equipment attendant stated that some of the scopes had been used over the weekend. They were sent to the Sterile Processing Department (SPD) where the scopes were cleaned and soaked in Cidex OPA solution for disinfection but not reprocessed in the Medivator because the SPD staff had not been thoroughly trained. Staff #1 confirmed that some of the scopes were used yesterday.

Interview on 1/14/13 at 1:25pm with Staff #1 revealed there is no log to track when each scope is reprocessed after each use or if the scope has not been used within 72 hours. Strips of reprocessed scopes listing the reprocessing date, scope number, operator, reprocessing cycle, if the scope passed/failed and if the reprocessing cycle was completed are printed each month and placed in a clear plastic bag. Staff #1 stated staff knows if a scope hasn't been used within 72 hours because they are tagged with the date and time of reprocessing when stored in the scope closet. If a scope is not used within 72 hours it will be reprocessed.

Observation of the GI scope closets on 1/14/13 at 1:40pm revealed each scope has a tag but it did not list the date or time of reprocessing.

Review of medical records and Medivator reprocessing strips from 12/15/12 to 1/14/13 revealed the following:
- Patient #1: The procedure was performed on 1/12/13 at 8:20am using scope #A110895. On 1/14/13 at 7:50am this scope was observed unprocessed on the "dirty scope" cart. No evidence was found to indicate this scope had been reprocessed.
- Patient #3: On 1/14/13 at 7:50am scope #A110419 was observed unprocessed on the "dirty scope" cart. On 1/18/13 Staff #4 indicated that the date, time or patient that this scope was used on could not be determined. The last record of disinfection of this scope was on 1/11/13 at 11:45am in central processing utilizing manual cleaning and Cidex solution.
- Patient #5: The procedure was performed on 1/12/13 at 6:45am using scope #A110429 but was not reprocessed until 1/14/13 at 9:08am. No evidence was found to indicate it was manually cleansed and disinfected with Cidex post procedure.
- Patient #6: The procedure was performed on 1/13/13 at 11:00am using scope #A110431. No evidence was found to indicate this scope was reprocessed.
- Patient #14: The procedure was performed on 1/9/13 at 12:00pm using scope #A110268 but was not reprocessed until 1/10/13 at 6:24pm.
- Patient #15: The procedure was performed on 1/9/13 at 10:30am using scope #A110429 but was not reprocessed until 1/10/13 at 9:07am.
- Patient #18: The procedure was performed on 1/8/13 at 8:58am using scope #A110429 but was not reprocessed until 1/10/13 at 9:44am.
- Patient #21: The procedure was performed on 1/8/13 at 7:50am using scope #A110894 but was not reprocessed until 1/9/13 at 12:22pm.
- Patient #23: The procedure was performed on 12/15/12 using scope #A110441 but was not reprocessed until 12/17/12 at 7:23am.
- Patient #23: The procedure was performed on 12/15/12 using scope #A1100914 but was not reprocessed until 12/18/12 at 8:33am.

Review of the Cidex OPA logs from the SPD from 1/8/13 to 1/11/13 revealed documentation indicating the date, time, patient name, and type of item to be disinfected using Cidex solution. No logs for 1/12/13 or 1/13/13 were included. No evidence was found to indicate the scopes used for Patient #s 1, 3, 5, 6, 14, 15, 18, and 21 were manually reprocessed in SPD with Cidex.

Interview on 1/14/13 at 2:36pm with Staff #7, SPD supervisor, revealed no SPD Cidex logs were found for 1/12/13 or 1/13/13.

Based on document review the Surgical Services Committee failed to ensure corrective actions specific to GI scope reprocessing were implemented and monitored to ensure patient safety.

Findings Include:

Review of an e-mail received 9/27/12 from Pentax revealed Pentax conducted a phone conference with the facility on 8/23/12 to clarify the proper interpretation of the reprocessing instructions for Pentax 90 i-Series endoscopes. The information exchanged specifically highlighted the need to perform the following activities:
1. Pre-cleaning of an endoscope immediately after the conclusion of a patient procedure
2. Initiation within one hour after completion of pre-cleaning of all subsequent steps of the endoscope reprocessing procedure
3. Completion in uninterrupted fashion of all subsequent steps of the endoscope re-processing procedure after pre-cleaning

Review of the GI Division Meeting Minutes from 8/11/12 to 11/6/12 revealed no evidence the committee discussed the issues identified with scope reprocessing in the GI lab.

See findings under Tag 749.

Based on document review, observation and medical record review, Surgical Services staff failed to implement and enforce their written policies related to GI scope reprocessing and monitoring. Additionally, the policies lack specific information to ensure appropriate implementation of the procedures by staff.

Findings Include:

Review of the Pentax Instructions for Cleaning - Disinfection - Sterilization revealed scopes should be reprocessed immediately after (at least within one hour) the completion of a procedure, the endoscope and its components should be thoroughly and carefully cleaned.

Review of Policy "Disinfecting of Scopes and Ancillary Equipment" last revised 8/24/12 indicated immediately after use scopes are to be washed and suctioned in the procedure room. Scopes are brought to the cleaning room where they are leak tested, scrubbed with brushes and scope buddy used to flush the scope per manufacturer's guidelines. The scopes are reprocessed with an automatic disinfecting machine according to manufacturer's guidelines. Clean scopes are hung in scope cupboard with a tag indicating it is clean. After hours scopes will be transported to the GI lab for immediate and continuous processing. The policy does not indicate a timeframe in which scopes need to be transported to the cleaning room to initiate the cleaning process or a timeframe in which the scopes are to be disinfected using automatic disinfecting machine. The policy does not indicate what information should be listed on the tag identifying that the scope has been disinfected.

Review of an e-mail dated 8/24/12 from Staff #1 to various staff members revealed when equipment is used off hours the nursing supervisor must be notified at the end of the procedure. The equipment must be returned promptly to the GI unit to be processed. Starting 8/27/12 the SPD staff will clean all scopes after hours. This e-mail contradicts the policy which states after hours scopes will be transported to the GI lab for immediate and continuous processing.

Review of policy "Scope Monitoring" prepared 1/2012 revealed each scope will be tracked as follows:
- The serial number will be entered in each patient chart on the GI procedure form.
- The printout from the sterilizer/disinfector has the scope number and user initials/number.
- These printouts will be kept and stored.
The policy does not indicate how this information will be utilized to ensure each GI scope is reprocessed after use.

Observation on 1/14/13 at 7:45am (Monday) revealed a cart labeled "dirty scopes" that had 4 plastic bins housing 6 used scopes.

Medical record review of GI cases from 12/15/12 to 1/14/13 revealed 10 instances when GI scopes were not immediately reprocessed. Additonally, the GI lab did not have a mechanism in place to track the reprocessing of GI scopes.

See findings under Tag #749.

Based on policy review, interview and medical record review, Surgical Services does not ensure a comprehensive patient history and physical is completed prior to scheduled endoscopic procedures for 9 of 22 patients. (Patient #s 5, 7, 10, 11, 15, 16, 19, 20 and 21)

Findings Include:

Review of policy "Admission of the Patient into the Ambulatory Surgery Unit for IV Sedation, MAC, Regional or General Anesthesia Surgical Procedures" last revised 1/2012 revealed the medical record will include: pre-admission testing, History/Physical and/or medical clearance, preoperative orders, and consent.

Review of policy "History and Physical for Procedures Utilizing Moderate Sedation" last reviewed 7/2012 revealed patients presenting for procedures requiring moderate sedation require a shortened version of an H&P. This needs to include: a medical history, allergy history, and health history. This information may be collected by the admitting nurse and reviewed by the physician prior to the completion of the procedure.

Interview on 1/14/13 at 9:50am with Staff #1 and Staff #4 revealed medical histories (H&P) are expected to be faxed over from the physician's office prior to the procedure. The physician reviews the H&P prior to the procedure.

Review of medical records revealed Patient #s 5, 7, 10, 11, 15, 16, 19, 20 and 21 no evidence to indicate an H&P was completed prior to the scheduled procedure.

This finding was verified with Staff #1 and #4 on 1/14/13 at 9:50am.