Core Analytics Laboratory, Inc

Summary Statement of Deficiencies D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, and interview with the laboratory technical supervisor on May 20, 2025, at 12:24 p.m., the laboratory failed to document complaints and problems reported to the laboratory. The findings include: 1. The laboratory stated that it received phone calls about complaints however, it did not have any documentation of any complaints and investigations. Therefore, the quality of the laboratory services cannot be assured and may have harmed patients. 2. The laboratory technical supervisor on May 20, 2025, at 12:24 p. m., affirmed that the Laboratory did not document complaints. 3. The laboratory's testing declaration form, signed by the laboratory director on 5/13/2025, stated that the laboratory performed approximately 5,743,531 tests, annually. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. 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 Surveyor review of laboratory's specimen processing, storage and preservation, and interview with the laboratory technical supervisor on May 20, 2025, at 1:58 p.m., the laboratory failed to follow its procedure to process and store the specimens for 1 sample out of 5 samples, reviewed. The findings include: 1. The laboratory received a blood sample (250520084) that was collected on 5/20/2025 at 4: 50 a.m. The laboratory's procedure instructed to centrifuge within 2 hours of collection to separate the serum. However, the laboratory did not centrifuge the blood sample even after 7 hours of collection. Therefore, the sample quality might have been compromised and the accuracy of the patients' test results rendered by the laboratory cannot be assured since it used compromised samples and may have harmed patient. 2. The laboratory technical supervisor on May 20, 2025, at 1:58 p.m., confirmed that the laboratory did not follow its procedure to centrifuge the blood samples. 3. The laboratory's testing declaration form, signed by the laboratory director on 5/8/2025, stated that the laboratory performed approximately 5,743,531 tests, annually. D5813 TEST REPORT CFR(s): 493.1291(g) (g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's patient testing records, final reports, and interview with the laboratory technical supervisor on May 20, 2025, at 3:19 p.m., the laboratory failed to report the panic value to the responsible physician for 1 sample out of 10 samples, reviewed. The findings include: 1. The laboratory obtained a panic value for the platelet test for sample # 2401241707. However, the laboratory did not treat the result as panic value and did not report. It cancelled the test instead after talking to the nurse. The consequence of not reporting the panic value immediately may have harmed patient. 2. The laboratory technical supervisor on May 20, 2025, at 3:19 p.m., affirmed that the laboratory did not treat the result as panic value and did not report. 3. The laboratory's testing declaration form, signed by the laboratory director on 5/8/2025, stated that the laboratory performed approximately 5,743,531 tests, annually. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, test records, final reports, and interview with the laboratory technical supervisor on May 20, 2025, at 3: 19 p.m., the laboratory director failed to ensure that the laboratory personnel are performing the test methods as required for accurate and reliable results. The laboratory director's failure to ensure quality laboratory services has a consequence of potential erroneous test result reporting and patient harm. The findings include: See D5205, D5311 and D5813. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) (e) The laboratory director must-- (e)(1) 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 Surveyor review of laboratory's policy & procedure, and interview with the laboratory technical supervisor on May 20, 2025, at 1:58 p.m., the laboratory director failed to ensure that the laboratory used testing systems that provide quality laboratory services for all aspects of test performance. The laboratory director's failure to ensure quality laboratory services has a consequence of potential erroneous test result reporting and patient harm. The findings include: See D5311, D5311 and D5813. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on July1, 2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) records (2024-1 and 2024-2), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the specialty of Toxicology for the analyte Lithium (Li) resulting in unsuccessful performance. Refer to D2118 . D2118 TOXICOLOGY CFR(s): 493.845(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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API evaluation reports, the laboratory failed to achieve satisfactory performance for two consecutive proficiency events in 2024 (first and second testing events of 2024) for analyte Lithium (Li). The finding include 1. The laboratory received the following scores: 60% on the 2024 Li first event 60% on the 2024 Li second event 2. A review of the 2024 proficiency testing scores from American Proficiency Institute 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 desk review of the CASPER 155 report API records for 2024-1 and 2024-2 events, the laboratory director failed to provide overall management and a direction of the laboratory services. 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: Based on a proficiency testing desk review of CASPER 155 report API records for 2024-1 and 2024-2 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2118 . -- 2 of 2 --

Summary Statement of Deficiencies D2088 ROUTINE CHEMISTRY CFR(s): 493.841(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 Proficiency Institute (API) proficiency testing records and interview with the technical supervisor (TS); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for LD /LDH and LDL cholesterol, The finding included: 1. Based on review of PT records for Q2-2020, API reported an unsatisfactory score of 0% for LD/LDH and 20% for LDL cholesterol. LD/LDH (U/L) Sample # Reported Intended range Performance 6 336 364-548 Unacceptable 7 258 278-419 Unacceptable 8 434 453-681 Unacceptable 9 205 217-322 Unacceptable 10 304 321-483 Unacceptable LDL cholesterol (mg/dL) Sample # Reported Intended range Performance 6 54 41-53 Unacceptable 7 43 32-42 Unacceptable 8 65 49-63 Unacceptable 9 34 27-35 Acceptable 10 48 37-47 Unacceptable 2. Based on the laboratory testing declaration submitted at the time of the survey on 08/03/2021 the laboratory analyzed and reported approximately 3,304,698 routine chemistry tests including LD/LDH and LDL Cholesterol during the time the laboratory had unsatisfactory proficiency testing results. 3. The TS affirmed 08/03/2021 at approximately 4:15 p.m. that the laboratory received the above unsatisfactory proficiency testing scores. D2098 ENDOCRINOLOGY CFR(s): 493.843(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. 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 -- This STANDARD is not met as evidenced by: Based on review of the American Proficience Institute (API) proficiency testing records, random patient sampling test results, and interview with the technical supervisor (TS) and laboratory testing personnel (TP); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Free T3, PSA, and Free Thyroxine. The findings included: 1. Analyte Event Performance Free T3 Q2-2019 60% PSA Q-2 2019 67% Free Thyroxine Q1-2020 40% 2. For four (4) out of four (4) random patient sampling test results reviewed covering period from 5/14/2019 to 08/10/2020, the laboratory analyzed and reported 37, 867 endocrinology quantitative tests including Free T3, PSA and Thyroxine during the period the laboratory received the unsatisfactory proficiency testing score. 3. The TS and TP confirmed on 08/03/2021at approximately 4:00 p.m. that the laboratory received the above unsatisfactory proficiency testing scores for Free T3, PSA, and Free Thyroxine. D2109 TOXICOLOGY CFR(s): 493.845(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 second quarter event in 2019 (Q2-2019) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results, and interview with the technical supervisor (TS); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in the Digoxin. The findings included: 1. The API reported for Q2-2019, an unsatisfactory proficiency testing score of 40% for Digoxin analyte. 2. For two (2) out of two (2) random patient sampling test results reviewed covering period from 3/15 /2019 to 5/14/2019, the laboratory analyzed and reported Digoxin analyte during the time the laboratory received an unsatisfactory proficiency testing score. 3. The TS affirmed on August 3, 2021 at approximately 1:30 p.m. that the laboratory received the above unsatisfactory proficiency test score. 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 observation and interview with the technical supervisor (TS) and testing personnel (TP); it was determined that the microbiology laboratory lacks a biosafety cabinet (BSC) for processing samples for microbiology pathogens and positive blood cultures. The laboratory failed to observe safety procedures to ensure protection from biohazardous materials. The findings included: 1. On the day of the survey 08/03 /2021 at approximately 1:30 p.m. the surveyor observed that the microbiology section lacked a BSC to work with infectious pathogens. 2. The TS and TP affirmed the lack of a BSC to process microbiology samples and work with isolated infectious -- 2 of 4 -- pathogens. 3. Based on the laboratory's annual testing volume declaration submitted on august 3, 2021, the laboratory processes and reports 330,293 microbiology tests. 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 observation on the lack of calibrated thermometers in all refrigerators and incubators to verify digital temperature readings and interviews with the technical supervisor (TS) and testing personnel (TP); it was determined that the laboratory failed to monitor the temperature of equipment essential for proper storage of reagents and specimens that adversely affect patient test results. The findings included: 1. On the day of the survey, August 3, 2021 based on observation and interview with the TS and TP the laboratory failed to have calibrated thermometers on refrigerators, freezers, and incubators that verify accurate digital thermometers readings which affect proficiency and patients' samples testing. 2. The TS and GS confirmed on 08/03 /2021, at approximately 11:30 a.m. that the laboratory has no calibrated thermometers in refrigerators, freezers, and incubators. 3. Based on the laboratory's submitted testing declaration volume, the laboratory tested and reported approximately 18,043 samples daily D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on the surveyors' observation, examination of laboratory reagents, and interview with the technical supervisor (TS) and testing personnel (TP), it was determined that the laboratory failed to not use reagents when they have exceeded their expiration date. The findings included: 1. On the day of inspection, August 3, 2021 at approximately 1:00 p.m.the surveyor found the Gram stain iodine reagent being used beyond its expiration date: Reagent Lot # Expiration Date Gram stain iodine 153601 04/30/2021 2. The TP affirmed on 08/03/2021 at approximately 1:15 p. m.using Gram stain iodine reagent beyond its expiration date. 3. Based on the laboratory's submitted testing declaration volume, the laboratory tests and reports approximately 328,213 Bacteriolo tests annually including gram stains. D5815 TEST REPORT CFR(s): 493.1291(h) -- 3 of 4 -- When the laboratory cannot report patient test results within its established time frames, the laboratory must determine, based on the urgency of the patient test(s) requested, the need to notify the appropriate individual(s) of the delayed testing. This STANDARD is not met as evidenced by: Based on review of laboratory's policies and procedures, patient test records review from March 15, 2019 to July 20, 2021, and interview with the technical supervisor (TS); it was determined that the laboratory failed to have a policy for turn-around time (TAT) for all tests performed in the laboratory. 1. The laboratory failed to provide TAT of testing for ten (10) out of ten (10) randomly chosen patients at the time of the survey (August 3, 2021). The laboratory did not provide a TAT policy which may adversely impact patient management. 2. The laboratory TS on August 3, 2021 at approximately 12:00 p.m. affirmed that the laboratory did not have a TAT policy to notify any delay on testing to the ordering physicians. 3. The laboratory's testing declaration form, signed by the laboratory director on 08/03/2021, stated that the laboratory performs 6,585,798 test annually. 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 review of the laboratory's records for policies and procedures, proficiency testing results, expiration date of reagents in use, lack of a biosafet cabinet, and interview with the technical supervisor and laboratory staff on August 3, 2021; it was determined that the laboratory director failed to ensure that several aspects of the preanalytical and analytical phases of laboratory testing were monitored. See D3011, D5413, D5415, D5417, D2098, D2109, and D2088 . -- 4 of 4 --

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(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 second quarter (Q2-2017) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results, and interview with the technical supervisor, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte. The findings included: a. Q2-2017, API reported 53% for Susceptibility testing. b. For seven (7) out of seven (7) random patient sampling test results reviewed covering period from 5/6/2017 to 3/15/2018, the laboratory analyzed and reported susceptibility tests for both gram positive and gram negative organisms during the time the laboratory received an unsatisfactory proficiency testing score for susceptibility tests. c. The technical consultant confirmed (1/7/2019, 1530), that the laboratory received the above unsatisfactory proficiency test score. 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 third quarter (Q3-2017), first quarter (Q1-2018) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results, and interview with the technical consultant, it was determined Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- that the laboratory failed 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. The findings included: a. API Reported the following unsatisfactory proficiency testing scores. Analyte: Score: Event/Year Calcium 20% Q3-2017 LDH 0% Q1-2018 b. For thirteen (13) out of thirteen (13) random patient sampling test results reviewed covering period from 3/5/2017 to 2/5/2018, the laboratory analyzed and reported Calcium analyte during the time the laboratory received an unsatisfactory proficiency testing score. c. The technical consultant confirmed (1/7/2019, 1530), that the laboratory received the above unsatisfactory proficiency test scores. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 second quarter (Q2-2018) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results, and interview with the technical consultant, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte. The findings included: a. Q2-2018, API reported 40% for Triiodothyronine (T3) analyte. b. For two (2) out of two (2) random patient sampling test results reviewed covering period from 10/15/2018 to 10/21/2018 the laboratory analyzed and reported T3 during the approximate time the laboratory received an unsatisfactory proficiency testing score. c. The technical consultant confirmed (1/7/2019, 1530), that the laboratory received the above unsatisfactory proficiency test score. D2109 TOXICOLOGY CFR(s): 493.845(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 third quarter (Q3-2018) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results, and interview with the technical consultant, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte. The findings included: a. Q3-2018, API reported the unsatisfactory proficiency testing score of 60% for Theophylline. b. For two (2) out of two(2) random patient sampling test results reviewed covering period from 2/3/2017 and 10/16/2018, the laboratory analyzed and reported Theophylline analyte during the time the laboratory received an unsatisfactory proficiency testing score. c. The technical consultant confirmed (1/7 /2019, 1530), that the laboratory received the above unsatisfactory proficiency test score. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) -- 2 of 5 -- At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results, and interview with the technical supervisor, it was determined that the laboratory failed to at least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. The findings included: a. API reported the following unsatisfactory proficiency testing scores. Routine Chemistry Analyte: Score: Event /Year: Ammonia 33% Q1-2017 UMicro Alb 0% Q2-2017 Troponin I 50% Q2-2017 LDL Chol 40% Q3-2017 UMicro Alb 0% Q1-2018 25-OH Vit D 0% Q1-2018 LDL Chol (measured) 40% Q1-2018 LDL Chol (calculated) 20% Q2-2018 Ferritin 67% Q1-2018 UIBC 0% Q2-2018 UIBC 20% Q3-2018 Toxicology Analyte: Score: Event /Year: Amikacin 60% Q1-2017 Amikacin 60% Q2-2017 Urinalysis Analyte: Score: Event/Year: Urine Bili 50% Q2-2017 Ketones 0% Q3-2018 Leuk Est 0% Q3-208 Nitrite 0% Q3-2018 Ammonia For one (1) out of one (1) random patient sampling test result reviewed for Ammonia test analyzed and reported 1/9/2018. Amikacin For two (2) out of two (2) random patient sampling test result reviewed for Amikacin test analyzed and reported 1/20/2017 and 1/15/2018. Urinalysis For five (5) out of five (5) random patient sampling test result reviewed for Urinalysis test analyzed and reported 5/6/2017 to 3/5/2018. b. Based on the laboratory's annual testing declaration submitted for 2017-2018, the laboratory analyzed and reported approximately 1,349,220 tests which included the above analytes that have received an unsatisfactory proficiency testing scores. c. The technical supervisor confirmed (1/7/2019, 1530), that the laboratory received the above unsatisfactory proficiency test scores. D5777 COMPARISON OF TEST RESULTS CFR(s): 493.1281(b)(c) (b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available: (b)(1) Patient age. (b)(2) Sex. (b)(3) Diagnosis or pertinent clinical data. (b)(4) Distribution of patient test results. (b)(5) Relationship with other test parameters. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of random patient sampling test results, and interview with the technical consultant, and the laboratory staff, it was determined that the laboratory failed to assess and evaluate patient test results for inconsistencies. The findings included: a. For three (3) out of five (5) random patient sampling test results reviewed covering period from 5/6/2017 503/15/2018, three (3) patient test results do not correlate with the urinalysis macroscopic against the microscopic results: Patient #1: Macro Results: Micro Results: Leuko Est. Neg 22/HPF Blood Neg 5/HPF Patient #2: Macro Results: Micro Results: Leuko Est. Neg 2/HPF Blood Neg 3/HPF Nitrite Neg Moderate Patient #3: Macro Results: Micro Results: Nitrite Neg Many b. The technical consultant, and the laboratory staff confirmed (1/28.2019, 11:30) that the laboratory has not established a system to identify and assess patient test results that appear inconsistent. D6019 LABORATORY DIRECTOR RESPONSIBILITIES -- 3 of 5 -- CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved