Southwest Urology Inc

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and an interview with the Clinical Operations Manager (COM), the Technical Consultant (TC) failed to evaluate and document the competency of four out of 11 Testing Personnel (TP) in 2021 assuring their competency was maintained in order to perform moderately complex routine chemistry and hematology testing procedures and report the test results promptly, accurately, and proficiently. All testing conducted by TP#1, TP#2, TP#3 and TP#4 for two out of two test systems from 01/01/2021 to 10/07/2022 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's "Laboratory Competency Policy ", provided on the date of the inspection, found the following instructions for TP competency assessments: "3. A Six Month & Annual Laboratory Competency Assessment will be conducted yearly on each employee performing patient testing." 2. Review of the laboratory's Form CMS-209, approved, signed, and dated by the Laboratory Director on 10/17/2022, revealed 11 TP listed and credentialed to perform moderately complex chemistry and hematology testing procedures. 3. Review of the laboratory's 2021 competency assessment records did not find a competency assessment for TP#1, TP#2, TP#3 and TP#4 who conducted post-vasectomy presence or absence of sperm and urinalysis with microscopic testing. The Inspector requested the 2021 competency assessment for TP#1, TP#2, TP#3 and TP#4 from the COM. The COM confirmed, via an electronic email on 10/18/2022 at 2:48 PM, that the 2021 competency assessment for TP#1, TP#2, TP#3 and TP#4 was not completed as required and was unable to provide the requested documentation. 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 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: Based on record review and interviews with the Office Manager and former Laboratory Director (LD), the laboratory failed to ensure that the position of Laboratory Director was filled according to the qualification requirements of 493. 1405 of this subpart in order to provide overall management and direction in accordance with 493.1407 of this subpart. All patients tested at this laboratory from 1 /29/2020 to 10/26/2020 had the potential to be affected. Findings include: 1. Review of the CMS-116 and CMS-209 forms, on 10/21/2020, found that the Clinical Consultant (CC) and Technical Consultant (TC), designated by the former LD, had approved the CMS-116 and CMS-209 forms via signature and date of 10/19/2020. 2. Review of the CMS-209 form, on 10/21/2020, failed to find an individual listed as the Laboratory Director to provide overall management and direction in accordance with 493.1407 of this subpart. 3. An email interview with the Office Manager ,on 10/21 /2020 at 4:40 PM, revealed that the former LD had retired as of 1/29/2020, but was '... still available for consult,' and that the formerly designated CC and TC had approved the CMS-116 and CMS-209 forms via signature and date in the former LD's absence. 4. A telephone interview with the former LD, on 10/22/2020 at 1:01 PM, confirmed that he had retired on 1/29/2020, was not performing the responsibilities of the lab director after 1/29/2020, and had no knowledge of the testing of patient specimens after 1/29/2020; thus, the laboratory failed to ensure that the position of the LD was filled, after 1/29/2020, according to the qualification requirements of 493.1405 of this subpart in order to provide overall management and direction in accordance with 493. 1407 of this subpart. 5. An on-site review of laboratory policies, procedures and 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 -- documentation, on 10/26/2020 at 9:30 AM, confirmed that former LD had not preformed the responsibilities of the LD after 1/29/2020. -- 2 of 2 --