The adenosine triphosphate test is a rapid and reliable audit tool to assess manual cleaning adequacy of flexible endoscope channels

Ranekka Dean, MPA RN CICJune 17, 2015

APIC Greater NY Chapter 13 – Journal Club

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Summary Report for Documents Reviewed at the APIC Greater NY Chapter 13 Journal Club

Date: 6/17/2015 Reviewer: Ranekka Dean, MPA RN CIC Appraisal Score:

Article/Research Study Being Evaluated: The adenosine triphosphate test is a rapid and reliable audit tool to assess manual cleaning adequacy of flexible endoscope channels LEVEL OF EVIDENCE REPORT OF A SINGLE RESEARCH STUDY? □ Yes □ No (if no go to summary) SETTING: brief description here SAMPLE SIZE: brief summary here COMPOSITION: sample selection, brief 1-2 lines summary of article INTERVENTION(S) □ Yes □ No CONTROL □ Yes □ No RANDOM ASSIGNMENT □ Yes □ No YES to intervention, control and random assignment □ LEVEL I Randomized Controlled Trial (RCT) or Experimental Study YES to Intervention and either Control or Random Assignment □ LEVEL II Quasi-experimental (no manipulation of independent variable; may have Random

Assignment or Control YES to intervention only OR NO to intervention, Control and Random Assignment

□ LEVEL III Non-experimental (no manipulation of independent variable; includes descriptive, comparative, and correlational studies; uses secondary data □ LEVEL III Qualitative (exploratory 〔e.g., interviews, focus groups〕) starting point for studies where little research exists; small samples sizes; results used to design empirical studies.

QUALITY OF EVIDENCE: STUDY Does the researcher identify what is known and what is not known about the problem and how the study will address any gaps in knowledge?

□Yes □No

A HIGH

Consistent, generalized result Sufficient sample size Adequate control Definitive conclusions Consistent recommendations based on comprehensive literature review that includes thorough reference to scientific evidence

Was the purpose of the study clearly presented? □Yes □No Was the literature review current (most sources within last 5 years)? □Yes □No Was sample size sufficient based on study design and rationale? □Yes □No

If there was a control group: - Were the characteristics and/or demographics similar in both control

and intervention groups? - If multiple settings were used, were the settings similar? - Were all groups treated equally except for the intervention group(s)

□Yes □No □NA □Yes □No □NA □Yes □No □NA

B GOOD

Reasonably consistent result Sufficient sample size for the study design Some control Fairly definite conclusions Reasonably consistent recommendations based on fairly comprehensive literature review that includes some reference to scientific evidence

Are data collection methods described clearly? □Yes □No □NA

Was instrument validity discussed? □Yes □No □NA C Low Quality

Or Major Flaws

Little evidence with inconsistent results Insufficient sample size for the study design Conclusions cannot be drawn

Was the instrument reliable (e.g. Cronbach’s α ≥ 0.70)? □Yes □No □NA If survey/questionnaire was used, was response rate ≥ 25% □Yes □No □NA

If tables were presented, was the narrative consistent with the table content?

□Yes □No □NA Additional Comments:

Were the results presented clearly? □Yes □No □NA Were conclusions based on results? □Yes □No □NA Were study limitations identified and addressed? □Yes □No □NA

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SUMMARY

• This study investigated if the accepted benchmark for Adenosine Triphosphate (ATP) monitoring was achievable in a busy endoscopy clinic following manufacturer’s manual cleaning instructions

• This study also evaluated the manual cleaning benchmarks of protein and bioburden levels for flexible endoscope channels

RELEVANCE

•Most healthcare facilities use manual cleaning for reprocessing of endoscopes

•Manual cleaning is prone to human error

•Recent reports links outbreaks of multiresistant organisms to inadequate cleaning

•Need for rapid audit tool for ongoing quality monitoring of manual cleaning

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OBJECTIVE

• To verify if the ATP benchmark of <200 Relative Light Units

(RLUs) is achieved following the manufacturer’s manual cleaning process for flexible endoscopes

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SAMPLE•10 patient-used endoscopes•tested post-patient use prior to manual cleaning

•20 patient used endoscopes•tested after manual cleaning

•10 unused endoscopes•manually cleaned, received HLD

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METHODS

•All channels/lumens from patient-used endoscopes were sampled after manual cleaning and tested for residual ATPATP benchmark set at <200 RLUs

Protein benchmark set at <6.4ug/cm2

Bioburden <4-log10 cfu/cm2

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VARIABLES

•Dependent (DV)RLU (protein & bio burden) measurement

•Independent (IV)Reprocessing methods: manual cleaning (& HLD)

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ANALYSIS

•2-tailed T-test •To detect differences in means (pre-post manual cleaning)

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MAJOR FINDINGS•96% (115/120) channels from the scopes met the ATP benchmark of <200 RLUs

•5 (25%) channels exceeded ATP benchmark (elevator guide-wire channels)

•10% of unused elevator guide wire channels had ATP levels >200 RLUs

•All 120 manually cleaned channels (suction biopsy, air-water, auxiliary) had compliant levels of protein and bio burden

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DISCUSSION/CONCLUSIONS

•Adequate manual cleaning was achieved in 96% of lumens tested •Elevator guide-wire channel is the most difficult to clean (high RLU post cleaning) & high levels of organic and bio burden levels after patient use•Bedside wipe and channel flushing very effective for lower levels•ATP tests not capable of reliably detecting low levels of microorganisms (best used after manual cleaning as an audit tool)•Observational audits indicated good compliance with manufacturer’s recommendations

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Evaluation

Strengths

•Exploratory•Analysis methods appropriate for stated objectives•Results supported discussion•Acknowledged limitations

Weaknesses/Limitations

•Inability to confirm that the bedside flush was done all endoscope channels tested•Inability to confirm flush volume per elevator guide wire channel•Not all scopes processed underwent ATP testing•Non-experimental (acknowledged) – findings by chance?•Relatively small sample size•Limited generalizability

EVALUATION

• Level III – non-experimental (no manipulation of IV, includes comparative data) study

• Grade – B, reasonably consistent results and recommendations, gateway for further studies

• Things to consider:– Acceptable level of cleaning compliance – Frequency of monitoring cleaning process

• Other suggestions?

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Summary Report for Documents Reviewed at the APIC Greater NY Chapter 13 Journal Club

Date: 6/17/15 Reviewer: Ranekka Dean, MPA RN CIC Appraisal Score: B

Article/Research Study Being Evaluated: type in article title/journal reference LEVEL OF EVIDENCE REPORT OF A SINGLE RESEARCH STUDY? X□ Yes □ No (if no go to summary) SETTING: Endoscopy clinic SAMPLE SIZE: 120 channels; 20 colonscopes & 20 duodeonsocopes COMPOSITION: sample selection, brief 1-2 lines summary of article INTERVENTION(S) □ Yes X□ No CONTROL □ Yes X□ No RANDOM ASSIGNMENT □ Yes X□ No YES to intervention, control and random assignment □ LEVEL I Randomized Controlled Trial (RCT) or Experimental Study YES to Intervention and either Control or Random Assignment □ LEVEL II Quasi-experimental (no manipulation of independent variable; may have Random

Assignment or Control YES to intervention only OR NO to intervention, Control and Random Assignment

□ LEVEL III Non-experimental (no manipulation of independent variable; includes descriptive, comparative, and correlational studies; uses secondary data □ LEVEL III Qualitative (exploratory 〔e.g., interviews, focus groups〕) starting point for studies where little research exists; small samples sizes; results used to design empirical studies.

QUALITY OF EVIDENCE: STUDY Does the researcher identify what is known and what is not known about the problem and how the study will address any gaps in knowledge?

□Yes □No

A HIGH

Consistent, generalized result Sufficient sample size Adequate control Definitive conclusions Consistent recommendations based on comprehensive literature review that includes thorough reference to scientific evidence

Was the purpose of the study clearly presented? □Yes □No Was the literature review current (most sources within last 5 years)? □Yes □No Was sample size sufficient based on study design and rationale? □Yes □No

If there was a control group: - Were the characteristics and/or demographics similar in both control

and intervention groups? - If multiple settings were used, were the settings similar? - Were all groups treated equally except for the intervention group(s)

□Yes □No □NA □Yes □No □NA □Yes □No □NA

B GOOD

Reasonably consistent result Sufficient sample size for the study design Some control Fairly definite conclusions Reasonably consistent recommendations based on fairly comprehensive literature review that includes some reference to scientific evidence

Are data collection methods described clearly? □Yes □No □NA

Was instrument validity discussed? □Yes □No □NA C Low Quality

Or Major Flaws

Little evidence with inconsistent results Insufficient sample size for the study design Conclusions cannot be drawn

Was the instrument reliable (e.g. Cronbach’s α ≥ 0.70)? □Yes □No □NA If survey/questionnaire was used, was response rate ≥ 25% □Yes □No □NA

If tables were presented, was the narrative consistent with the table content?

□Yes □No □NA Additional Comments:

Were the results presented clearly? □Yes □No □NA Were conclusions based on results? □Yes □No □NA Were study limitations identified and addressed? □Yes □No □NA

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