Campus Health Services Of Louisville

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing (PT) scores obtained from the national database and verified with the PT company. The laboratory was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 a proficiency testing (PT) desk review of the Certification and Survey 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 -- Provider Enhanced Reporting (CASPER)-0155 and American Association of Bioanalysts (AAB) Medical Laboratory Evaluation 2024 records (1st and 2nd events), the laboratory failed to successfully participate in a PT program. The laboratory failed to successfully participate in the specialty of Hematology for Hematocrit (HCT) for 2 of 2 testing events. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the CASPER-0155 Individual Laboratory Report and American Association of Bioanalysts (AAB) Medical Laboratory Evaluation 2024 records (1st and 2nd events), the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in 2 of 2 consecutive testing events in Hematology for Hematocrit (HCT). The findings include: 1. Review of the CASPER -0155 report revealed the following: Hematology 2024- 1st Event Laboratory received an unsatisfactory score of 20% for HCT. Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 60% for HCT 2. A PT desk review from AAB Medical Laboratory Evaluation 2024 PT records confirmed the above 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: Based on a proficiency testing (PT) desk review of the CASPER-0155 Individual Laboratory Report and American Association of Bioanalysts Medical Laboratory Evaluation 2024 records (1st and 2nd events), it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services to ensure successful PT participation of Hematocrit (HCT) testing during 2 of 2 testing events. Refer to D6016. 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; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on a proficiency testing (PT) desk review of the CASPER-0155 Individual Laboratory Report and American Association of Bioanalysts Medical Laboratory Evaluation 2024 records (1st and 2nd events), the laboratory director failed to ensure that the PT samples were tested as required under Subpart H during 2 of 2 testing events. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on staff interview and record review on February 1, 2019, the laboratory failed to monitor and document the Humidity in the laboratory where testing was performed. There was no documented evidence Humidity was recorded from January 5, 2017 through January 31, 2019. Findings include: 1. Review of the Manufacturer's Operations Manual for the Sysmex analyzer, revealed the operating range for Humidity for the analyzer should be between thirty percent (30%) and eighty-five percent (85%). 2. Review of the Maintenance Log, revealed no documented evidence the Humidity had been monitored and recorded from January 5, 2017 through January 31,2019. 3. Testing personnel acknowledged in an interview on February 1, 2019 at 10:36 AM, the Laboratory Director failed to have a system in place to ensure the laboratory Humidity was monitored and documented daily. 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. 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 -- This STANDARD is not met as evidenced by: Based on staff interview and record review on February 1, 2019, the Technical Consultant failed to perform and document annual competency using the six (6) mandated competency assessment requirements for testing personal. Competency assessment was performed using one (1) of six (6) methods of assessment for three (3) out of three (3) employees from January 5, 2017 through January 31, 2019. Findings include: 1. Record review on February 5, 2019, revealed there was no documented competency assessments between January 5, 2017 and January 31, 2019, for three (3) employees that included the following: direct observation of routine patient test performance, direct observation of performance of instrument maintenance function checks and calibration, monitoring the recording and reporting of test results, review of worksheets, review of quality control records, review of proficiency test results, review of maintenance records, assessment of testing external proficiency testing samples and problem solving skills. 2. Interview with staff on February 1, 2019 at 10: 36 AM, revealed the facility failed to have a system in place between January 5, 2017 and January 31, 2019 to ensure competency was performed using all six (6) mandated competency assessment requirements. -- 2 of 2 --