Clinlab, Inc

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 2019 and 2020 syphilis serology proficiency testing (PT) results reported to the CLIA database by the PT provider, the laboratory failed to successfully participate in PT. See D-tag 2074, unsatisfactory performance in two out of three consecutive syphilis serology PT challenges. D2074 SYPHILIS SEROLOGY CFR(s): 493.835(e) Failure to achieve an overall testing event score of satisfactory performance for two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of 2019 and 2020 syphilis serology proficiency testing (PT) results, the laboratory failed to achieve an event score of satisfactory performance for syphilis serology in two out of three testing events. Findings: 1. The laboratory obtained an unsatisfactory score of sixty percent for syphilis serology in the second testing event of 2019. 2. The laboratory obtained an unsatisfactory score of sixty percent for syphilis serology in the first testing event of 2020. -- 2 of 2 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on review of established written safety procedures, manufacturer's quality control (QC) package inserts, observation of specimen and QC materials handling and interview with the technical supervisor, testing personnel # 7 failed to observe procedures to ensure protection from biochemical and biohazardous materials. Findings: 1. The laboratory's universal precautions policy states," Gloves will be worn when in contact with blood, mucous membranes, non-intact skin or potentially infectious materials is likely." Section B, "Personal Protective Equipment" states " employees are required to wear gloves when employees have potential for direct skin contact with blood, hazardous chemicals and other infectious materials." 2. The manufacturer's QC package insert for MAS liquid drugs of abuse controls showed the QC material mays cause" allergic skin reaction." The package insert for the MAS Chemtrak control materials showed the QC material is a "biological risk." 3. Observation of specimen and QC materials handling on February 4, 2019 at 09:50 AM revealed testing personnel # 7 did not wear gloves when handling/pipetting MAS QC materials or when handling patient purple top tubes containing blood. 4. On February 4, 2019 at 09:55 AM, testing personnel #7 said she does not wear gloves when handling QC materials. Interview with the technical supervisor on February 4, 2019 at 11:00 AM confirmed safety procedures were not observed when handling biochemical or biohazard materials. 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 No Tags No deficiency details available. 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 --