Laurens County Health Department

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on June 10, 2021. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in four (4) of five (5) consecutive events (3rd event of 2019, 2nd & 3rd 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 -- events of 2020, and 1st event 2021), resulting in the second unsuccessful occurrence for bacteriology #0005. Findings include: Refer to D2021 D2021 BACTERIOLOGY CFR(s): 493.823(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Association of Bioanalyst (AAB) proficiency testing (PT) report, the laboratory failed to participate in four of five consecutive PT events (event #3 2019, events # 1, 2, 3 2020, event #1 2021) which resulted in the 2nd unsuccessful occurrence for Bacteriology. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed the subspecialty of Bacteriology # 0005 on events #3 of 2019, # 2,3 of 2020, and #1 of 2021 with scores of 0% on all events. 2. Desk review of the laboratory's proficiency testing reports from AAB confirmed the laboratory failed Bacteriology on the aforementioned events and revealed the 0% scores were for failure to participate. This resulted in the second unsuccessful performance. 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 laboratory director failed to maintain compliance with successful (American Association of Bioanalyst (AAB)) bacteriology proficiency testing (PT) for four of five consecutive events and failed to ensure the laboratory participated in PT on 2021 event 1, resulting in the second unsuccessful PT occurrence for Bacteriology. 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 -- 2 of 3 -- 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: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2019, 2020 and 2021 proficiency testing (PT) evaluation reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance for four of five consecutive proficiency testing events for Bacteriology #0005 resulting in the second unsuccessful PT occurrence for bacteriology. Findings include: 1. Review of the CMS 155 revealed the following unsatisfactory bacteriology scores: 2019 event three 0%, 2020 event two 0%, event three 0%, and 2021 event one 0%. 2. Review of the 2019 event three; 2020 events two, and three; and 2020 event one American Association of Bioanalyst (AAB) evaluation report revealed no data submitted. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on February 26, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 the American Associates of Bioanalysts (AAB) Proficiency Testing (PT) documents, the laboratory failed to receive successful scores for Potassium Hydroxide Prep (KOH), and Wet Prep for the 2019, and 2020. The laboratory has 4 out of 5 unsuccessful scores of 0% for WET PREP for events 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 4 -- and three in 2019 and events two and three of 2020. The laboratory had 4 out of 5 unsuccessful scores of 0% for KOH for event three of 2019 and events one,two,and three of 2020. REFERENCE: D2039, D2048 1. Review of the AAB PT documents for 2019, Wet Prep, the laboratory scored 0% for event two and three, and in 2020 the laboratory scored 0% for events two and three. 2. Review of the AAB PT documents for 2019, KOH, the laboratory scored 0% for event three. The laboratory scored 0% for events one, two, and three in year 2020. 3. The Assistant Nursing Director, confirmed by an email , dated 3/5/2021, samples were not tested or submitted, but were reviewed by all nursing staff. There was no documentation supporting the results of the nursing staff review and no documentation of the correct identification of the samples. The Assistant Nursing Director confirmed by email that results were not submitted for grading due to the pandemic. The Assistant Nursing Director also confirmed, that the laboratory continued seeing patients and patient testing continued onsite during the pandemic. D2039 MYCOLOGY CFR(s): 493.827(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of American Associates of Bioanalysts (AAB) Proficiency Testing (PT) documents, in the Microscopy speciality, the laboratory failed to participate in the third event of 2019, as well as the first, second, and third events of 2020 for Potassium Hyroxide (KOH). Findings: 1. Review of the AAB, PT documents for KOH skin prep, the laboratory failed to submit samples for scoring for the third event of 2019, as well as the first, second, and third event of 2020. 2. The Assistant Nursing Director, confirmed by an email dated 3/5/2021, PT samples were not tested or submitted but were reviewed by all nursing staff. There was no documentation supporting the results of the nursing staff review and no documentation of the correct indentification of the samples. The Assistant Nursing Director confirmed by email that results were not submitted for grading due to the pandemic. The Assistant Nursing Director confirmed by email that patients were seen and patient testing continued onsite during the pandemic. D2047 PARASITOLOGY CFR(s): 493.829(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the American Associated of Bioanalysts (AAB) Proficiency -- 2 of 4 -- Testing (PT) documents, the laboratory failed to attain an overall testing event score of at least 80 percent for Microscopy (Wet Prep) for the second event in 2019. Findings: 1. Review of the AAB PT documents for 2019 ( Wet Prep), the laboratory recieved a score of 0% for the second event. 2. Inteview with the Assistant Nursing Director, by an email dated 3/3/2021, at 10:58 pm, confirmed the laboratory did not receive a score of at least 80% for Wet Prep, AAB PT, second event, for year 2019. D2048 PARASITOLOGY CFR(s): 493.829(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the American Associates of Bioanalysts (AAB) Proficiency Testing (PT) documents for Microscopy, the laboratory failed to participate in the third event of 2019, as well as the second and third events of 2020 for Wet Prep. Findings: 1. Review of the AAB, PT documents for Wet Prep, the laboratory failed to submit samples for scoring for the third event of 2019, as well as the second and third event of 2020. 2. The Assistant Nursing Director, confirmed by an email dated 3/5 /2021, that the sampes were not tested or submitted, but were reviewed by all nursing staff. There was no documentation supporting the results of the nursing staff review and no documentation of the correct indentification of the samples. The Assistant Nursing Director confirmed that PT samples were not submitted for grading due to the Pandemic. The Assistant Nursing Director also confirmed pateints were seen and testing performed onsite during the pandemic. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on review of the American Associates of Bioanalysts (AAB) Proficiency Testing (PT) documents, the Technical Consultant(TC) failed to monitor and review the PT testing and scores for the test menu performed at the facilities. The laboratory received unsuccessful scores for Potassium Hydroxide Prep (KOH), and Wet Prep for the 2019, and 2020 testing year. The laboratory has 4 out of 5 unsuccessful scores of 0% for WET PREP for events two and three in 2019 and events two and three of 2020. The laboratory had 4 out of 5 unsuccessful scores of 0% for KOH for event three of 2019 and events one,two,and three of 2020. 1. Review of the AAB PT documents for 2019, Wet Prep, the laboratory scored 0% for event two and three, and -- 3 of 4 -- in 2020 the laboratory scored 0% for events two and three. 2. Review of the AAB PT documents for 2019, KOH, the laboratory scored 0% for event three. The laboratory scored 0% for events one, two, and three in year 2020. 3. The Assistant Nursing Director, confirmed by an email , dated 3/5/2021, samples were not tested or submitted, but were reviewed by all nursing staff. There was no documentation supporting the results of the nursing staff review and no documentation of the correct identification of the samples. The Assistant Nursing Director confirmed by email that results were not submitted for grading due to the pandemic. The Assistant Nursing Director also confirmed, that the laboratory continued seeing patients and patient testing continued during the pandemic. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 25, 2021. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Event 3 of 2019 & Event 2 of 2020), resulting 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 -- in the first unsuccessful occurrence for #0555 Bacteriology in the specialty of Microbiology. Findings include: Refer to D2028 D2028 BACTERIOLOGY CFR(s): 493.823(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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Event 3 of 2019 & 2 of 2020), resulting in the first unsuccessful occurrence for analyte #0555 Bacteriology in the specialty of Microbiology. 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #0005 Bacteriology, on Event 3 of 2019 and Event 2 of 2020 with a score of 0% for both events. 2. The criteria for acceptable performance for the specialty of Microbiology is 80%. 3. Desk review of the laboratory's proficiency testing reports from the American Association of Bioanalysts (AAB) confirmed the laboratory failed analyte #0005 Bacteriology for Event 3 of 2019 and Event 2 of 2020 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two out of three consecutive events (Event 3 of 2019 & Event 2 of 2020), resulting in the first unsuccessful occurrence for analyte #0555 Bacteriology in the specialty of Microbiology. The findings include: 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two out of three consecutive events (Event 3 of 2019 & Event 2 of 2020), resulting in the first unsuccessful occurrence for analyte #0555 Bacteriology in the specialty of Microbiology. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #0005 Bacteriology, on Event 3 of 2019 and Event 2 of 2020 with a score of 0% for both events. 2. The criteria for acceptable performance for the specialty of Routine Chemistry is 80%. 3. Desk review of the laboratory's proficiency testing reports from the American Association of Bioanalysts (AAB) confirmed the laboratory failed analyte #0555 Bacteriology for Event 3 of 2019 & Event 2 of 2020resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on December 5, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on the review of the American Association of Bioanalysts (AAB) Profeciency Testing(PT) documents and staff interview, the laboratory failed to document