To ensure the deficient practice does not recur, the laboratory indicated that quarterly audits will be performed and suggested that the audits results would be reviewed within the laboratory's QMPI Program. However, the laboratory did not establish the procedure by which these quarterly audits are to be conducted. In its submission, the laboratory indicates that a "tracer audit may [emphasis added] be used," but did not provided a protocol for a "tracer audit," the means by which a “tracer audit” would be documented, and whether the results of a "tracer audit" would be the information reviewed by the QMPI Program.
The laboratory failed to adequately address this deficiency and provide acceptable evidence of correction consisting of the required documentation and information set forth above and in our January 25, 2016 letter.
D5407
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
Although the laboratory's submitted protocol (provided at Ex. A, Tab 1 § 4.13) indicates that the laboratory director must sign all procedures prior to use, the response does not include an explanation as to why the cited procedures were not signed by the laboratory director prior to use as required by the laboratory's protocol available at the time of the onsite survey.
In Ex. L, Tab 26 the submission states: "The lab's overarching review of its systems and primary instruments has identified the patients affected or having the potential to be affected by this issue." The laboratory did not define the criteria used to make this determination or provide documentation as to how they came to this conclusion.
The laboratory failed to adequately address this deficiency and provide acceptable evidence of correction consisting of the required documentation and information set forth above and in our January 25, 2016 letter.
D5413
The laboratory's allegation of compliance is not credible and evidence of correction is not acceptable.
Finding #1
Although the laboratory's submitted protocol indicates that the allowable temperature should be posted on the unit (see Ex. A, Tab 29), the response does not address the incorrect labelling for acceptable temperatures on the freezer doors. Documentation contained in Ex. A. Tab 29, § 4.5 indicated that the laboratory supervisor or designee was responsible for monitoring and recording temperatures. However, we could not determine if the new procedure had been effectuated as no documentation was submitted to show that the freezer units had been labelled appropriately. In addition, the laboratory states that training had occurred subsequent to the survey, but it is not clear who should be trained as "laboratory supervisor or designee" was not defined. Training records provided in Ex. A, Tab 30 included only training documents for one general supervisor. Several freezers were identified as "not used in patient testing" (see Ex. N, Tab A); however, based on
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