Footcare Specialists Of Arizona

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of quality control (QC) documentation for review and interview with the laboratory director, the laboratory failed to retain documentation of the Quality Control (QC) that is performed for Dermatophyte Test Medium (DTM) testing. Findings include: 1. The laboratory performs DTM testing, with an approximate annual test volume of 300. 2. The laboratory's established policy titled, "Quality Control" states, "This is to be done for each batch of DTM's. We are to order positive and negative cultures from our DTM manufacturer and test each batch of DTM's for a positive and negative. The batch is not to be used for patient samples until we have accurate results. A log will be in place that will have the lot# of the batch being tested, date, personnel conducting the test, and control information". 3. No QC documentation was presented for review during the survey for testing that occurred from the date of the previous survey conducted on 7/26/16 through the date of the survey conducted on 09/10/18. 4. The laboratory director stated that QC was performed as indicated above, but the QC documentation could not be located at the time of the inspection. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of Proficiency Testing (PT) reports for 2017 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analyte, Dermatophyte Identification, under the sub-specialty of Mycology. Findings include: 1. The laboratory's PT performance was unsatisfactory for the 1st event of 2017 for the regulated analyte, Dermatophyte Identification, with a score of 60%. 2. The laboratory's PT performance was unsatisfactory for the 3rd event of 2017 for the regulated analyte, Dermatophyte Identification, with a score of 60%. D2044 MYCOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.827(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on the information furnished to the State Agency by the Proficiency Testing (PT) provider, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failure for the analyte, Dermatophyte Identification, for the 1st and 3rd testing event of 2017. See D2016 for findings. D2046 MYCOLOGY CFR(s): 493.827(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve an overall testing event score of satisfactory performance for the sub-specialty of Mycology for the 1st and 3rd event of 2017, resulting in unsuccessful PT performance. See D2016 for findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6016 - ensuring that the proficiency testing samples are tested as required under Subpart H. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined that the laboratory director failed to ensure that PT samples are tested in a manner that results in successful participation in a proficiency testing program for the regulated analyte, Dermatophyte Identification. See D6000 and D2016 for findings. -- 3 of 3 --