Epyc Diagnostics Llc

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the survey on September 12, 2024, at approximately 11:05 a.m., a review of the laboratory's policy and procedure, College of American Pathologists (CAP) proficiency testing (PT) records, and an interview with the technical supervisor (TS), it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for Carbon Dioxide (CO2) analyte in 2024. The findings include: 1. Based on review of PT records for the second event of 2024 (Q2-2024), CAP reported an unsatisfactory score report as follows: C02 PT Q2-2024 Overall score: 60% Specimen Reported Expected CHM-06 23 23 - 34 CHM-07 *10 25 - 38 CHM-08 17 16 - 27 CHM-09 *13 14 - 24 CHM-10 27 27 - 43 2. The TS affirmed by interview on September 12, 2024, at approximately 11:05 a.m. that the laboratory obtained the PT scores mentioned in statement #1. 3. According to the laboratory's testing declaration submitted on the day of the survey, the laboratory performed approximately 960 Routine Chemistry test samples, including CO2 analyte, during the time the laboratory had unsatisfactory proficiency testing results. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 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 -- This STANDARD is not met as evidenced by: Based on the lack of documentation of the testing personnel competency assessment, review of patient records, and interview with the technical supervisor (TS) on September 12, 2024, as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to establish and follow written policies and procedures to assess the testing personnel competency for the year 2024. Findings include: 1. Based on the lack of the laboratory's policies and procedures and competency evaluations' records, the laboratory failed to have established and follow written policies and procedures for competency assessment of the testing personnel (TP) for Microbiology, Diagnostic Immunology, Chemistry, and Hematology specialties. 2. Based on the review of patient records, the laboratory failed to provide documentation of training and an initial and six-month competency assessment for the TP performing tests for moderate and high complexity. These involved sample processing, testing, and reporting results at the laboratory for the year 2024. 3. This deficient practice was affirmed by an interview with the TS on September 12, 2024, at approximately 11:57 a.m. 4. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory reported and performed approximately 1,600 test samples for Microbiology, Diagnostic Immunology, Chemistry, and Hematology specialties for which competencies of the testing personnel were not performed. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policies and procedures, proficiency testing records and interview with the technical supervisor on September 12, 2024; it was determined that the laboratory director is cited herein due to failure to ensure that several aspects of the postanalytic phases of the laboratory testing were monitored. 1. Less than 80 percent score in proficiency testing. See D2087 D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on the interview with the technical supervisor, lack of documentation of testing personnel competency, and review of the laboratory's competency policies and procedures on September 12, 2024, the laboratory director is herein cited for failure to ensure that policies and procedures were established for monitoring individuals who -- 2 of 3 -- conduct analytical and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens and perform test procedures promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. See D5209 -- 3 of 3 --

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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performance. (See D2096) 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Total Protein (Protein, Total), as follows: 2021 Q3 2022 Q2 Protein, Total 40% 40% Q2 = Second testing event Q3 = Third testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Protein, Total. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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: Based on a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, Protein, Total, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (see D2016 and D2096) -- 2 of 2 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing records and interview with the testing personnel (TP); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for multiple Chemistry analytes for the years 2019 and 2020. The finding included: 1. Based on review of PT records for 2019 and 2020, AAB reported the following unsatisfactory scores for the following analytes: Q3-2019 Iron = 40%, Q3-2019 Vitamin B12 = 50%, Q1-2020 Total Protein = 40%, Q2-2020 Glycohemoglobin = 0% and Q2-2020 Triiodothyronine = 60% 2. Based on the laboratory testing declaration submitted at the time of the survey on 02/11/2021 the laboratory analyzed and reported approximately 64,450 Routine and Special Chemistry tests for each year during the time the laboratory had unsatisfactory proficiency testing results. 3. The TP affirmed 02/11/2021 at approximately 2:00 p.m. that the laboratory received the above unsatisfactory proficiency testing scores D2122 HEMATOLOGY CFR(s): 493.851(b) 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 Association of Bioanalysts (AAB) proficiency 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 -- testing (PT) records and interview with the testing personnel (TP); it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent in Coagulation for the first event of 2019 (Q1-2019) and Urinalysis in the third event of 2019 (Q3-2019) which is unsatisfactory performance. The findings included: 1. On the date of the survey 2/11/2021 at approximately 11:00 a.m. based on review of the PT scores, the laboratory obtained for Coagulation Activated Partial Thromboplastin (APTT) Q1-2019 and overall score of 40% and Urine Sediment Q3-2019 and a score of 50% as follow: Q1-2019 APTT Overall score 40%: Sample Reported Expected Score 1 39.9 32.2 - 43.5 A 2 43.1 26 - 35.1 U 3 48.3 35.6 - 48.1 U 4 51.8 38.5 - 52.1 A 5 33.2 23.8 - 32.2 U A = Acceptable U = Unacceptable Q3-2019 Urine Sediment overall score 50%: Sample 11 reported Blood /Hemoglobin cast; expected result mixed cellular cast and sample 12 reported Triple phosphate crystal which was the expected reported result. 2. The TP affirmed on 02/11/2021 at approximately 12:15 pm the laboratory obtained the PT scores in 1. 3. According to the laboratory testing declaration submitted on the day of the survey (02/11/2021) for the years 2019-2020, the laboratory performed approximately 11,333 Hematology samples (quarterly) during the time the laboratory received an unsatisfactory PT performance score. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of reagent manufacturer's product insert, ten (10) random review of patients reports from 08/02/2019 to 01/30/2021, and interview with the laboratory testing personnel; it was determined that for the year 2020, the laboratory failed to follow manufacturer's instructions for the periodic calculation for International Normalized Ratio (INR). The findings included: 1. The laboratory performed Prothrombin and Activated Thromboplastin Time on the Coagulation Instrumentation Laboratory equipment. The manufacturer's products insert states to "periodically verify for each thromboplastin lot number in use, the correct normal patient Prothrombin time mean and the International Sensitivity Index (ISI) value being used for calculating the INR value" 2. On the day of the survey 02/11/2021 at approximately 1:00 pm testing personnel confirmed that laboratory failed to periodically verify the accuracy of the INR calculation as mandated in the manufacturers package insert instructions. 3. Based on the laboratory's annual testing declaration submitted on 02/11/2021, the laboratory analyzed and reported approximately 34,400 hematology test results . D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient -- 2 of 3 -- results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on observation, lack of documentation, random patient sampling, and interview with the general supervisor (GS) and testing personnel (TP); it was determined that the laboratory failed perform quality control on the Kirby-Bauer (KB) antimicrobial susceptibility testing method each day the test was performed. The findings included: 1. On the day of the survey, February 11, 2021, the laboratory lacked the documentation for KB antimicrobial susceptibility use of control organisms for each day the KB antimicrobial susceptibility test was performed. 2. The laboratory had not developed an Individualized Quality Control Program for KB susceptibility testing a procedure which may be used in the laboratory for the antimicrobial susceptibility testing method determination of QC frequency. 2. For two (2) out of ten (10) random patient sampling test results reviewed, covering period 8/16/2019 to 1/30/2021, the laboratory analyzed and reported patient test results for KB antimicrobial susceptibility during the time when the laboratory did not use control organisms for each day the KB antimicrobial susceptibility tests method was performed. 3. The GS and TP affirmed on 02/11/2021 at approximately 1:25 p.m. that the laboratory was not performing quality control organisms for each day the KB antimicrobial susceptibility test was performed. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of random patient testing records, quality control data, and interviews with the general supervisor and testing personnel; it was determined that the laboratory director failed to ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality control as they occur. See D5411 and D5507. -- 3 of 3 --

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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Hematology constituting unsuccessful PT performances. (See D2130) 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 -- 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Hematocrit (HCT), resulting in an "subsequent" (non-first) unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, HCT, as follows: 2018 Q2 2018 Q3 2019 Q1 HCT 60% 0% 0% Q1 = First Testing Event Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an subsequent unsuccessful performance for the analyte, HCT. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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: Based on a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, HCT, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performances. (See D2016 and D2130) -- 2 of 2 --

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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Hematology constituting unsuccessful PT performances. (See D2130) 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 -- 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analytes, Red Blood count (RBC) and Hematocrit (HCT), resulting in "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analytes, RBC and HCT, as follows: 2018 Q2 2018 Q3 RBC 60% 0% HCT 60% 0% Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analytes, RBC and HCT. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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: Based on a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analytes, RBC and HCT, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performances. (See D2016 and D2130) -- 2 of 2 --

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, quality control & patient testing records, and interview with the laboratory testing personnel, the laboratory failed to maintain an information or record system that includes the identity of the personnel who performed the test(s). The findings include: a. The laboratory's urinalysis test records shows the test was performed on March 21, 2018 for the patients, # 14016131 and 14016134. The testing person's identity was not documented. b. On August 20, 2018 at 2:55 pm laboratory testing personnel affirmed that the laboratory did not maintain any record to identify the testing person. c. The laboratory testing declaration form, signed by the laboratory Director on August 11, 2018, indicates that the laboratory performs about 785 urinalysis tests annually. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical 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 -- consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, quality control & patient testing records, and interview with the laboratory testing personnel, the laboratory Director failed to assure compliance with the applicable regulations. The findings include: See D5787 and D6042. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory policy & procedure, patients sample and quality control test records, and interview with the laboratory testing personnel, the laboratory Technical Consultant failed to establish an appropriate quality control program for the creatinine test. The findings include: a. In the laboratory's LIS, the acceptable range for creatinine control level 1 was 1.96 - 3.01 for lot# 06537B. The testing personnel did not know where that range was from. The manufacturer's range was 1.96 - 2.94. The laboratory's quality control policy states it uses assayed control from manufacturer. The manufacturer's assayed control has its mean and assigned acceptable range. The lab might establish its own mean and acceptable range, instead. The laboratory did not have any records that shows the used range was established at the laboratory. b. On August 20, 2018 at 12:50 pm, laboratory testing personnel affirmed that the used quality control range for creatinine was not correct. c. The laboratory testing declaration form, signed by the laboratory Director on August 11, 2018, indicates that the laboratory performs about 26,658 tests in routine chemistry, annually. -- 2 of 2 --