Lab Usa, Inc

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview the laboratory did not enroll in an approved proficiency testing (PT) program for the subspecialty of Bacteriology. This deficiency was also cited at the last CLIA inspection performed on 3/31/2022. Findings include: 1. Record review on 5/15/2024 of the laboratory's CASPER Report 0096D 'CLIA Application and Survey Summary Report' revealed the laboratory did not have PT scores for the regulated analyte 005 Bacteriology for 2024 Event 1. 2. Record review on 5/15/2024 of the laboratory's CASPER Report 0157D Excused Nonparticipation Report revealed the laboratory was excused for 2023 event 3, Bacteriology. 3. Record review on 5/21/2024 of the laboratory's current and discontinued test list dated 5/21 /2024 (received by email on 5/21/2024 at 11:01 AM) revealed throat cultures were discontinued on 5/2024. The laboratory was unable to give an exact date that throat culture testing was stopped. 4. During staff interview with testing personnel #2 (TP2) on 5/15/2024 at 4:45 PM, TP2 stated, "We are no longer performing throat culture testing. We are only performing QC to use up supplies." D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 21 -- For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on record review and staff interview with technical supervisor #4 (TS4) and the Laboratory Director (LD) the laboratory failed to verify at least twice annually the accuracy of Influenza A and Influenza B Findings include: 1. Record review on 5/15 /2024 of the laboratory's 2022, 2023 and 2024 to date American Proficiency Institute (API) proficiency testing (PT) records revealed, the laboratory was not enrolled in PT for the non-regulated analytes Influenza A and Influenza B. 2. Staff interview with TS4 and the LD on 5/15/2024 at 4:30 PM confirmed the laboratory was not enrolled in PT in 2022, 2023 and 2024 for the non-regulated analytes Influenza A and Influenza B and the laboratory failed to verified their accuracy at least twice annually in another way. 3. The laboratory performs 2,079 test annually in the specialty of Microbiology. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to ensure proficiency testing (PT) was rotated amongst 2 testing personnel (TP) in the subspecialty of Toxicology. Finding include: 1. Record review on 5/15/2024 of the laboratory's 2022, 2023, and 2024 to date American Proficiency Institute (API) Toxicology PT records revealed, one of two liquid chromatography mass spectrophotometry (LCMS) Toxicology TP (ToxTP2) did not run PT samples in 2022, 2023 and 2024 to date. 2. Record review on 5/15/2024 of the laboratory's competency records for ToxTP2, revealed, ToxTP2 did not have documented LCMS competency records and did not run a PT sample in 2022, 2023 and 2024 to date. 3. Staff interview on 5/15/2024 at 11: 00 AM with ToxTP2 confirmed ToxTp2 did not participate in PT in 2022, 2023 and 2024 to date. 4. The laboratory performs 162,011 tests annually in the specialty of Chemistry. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during -- 2 of 21 -- the PT event. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) proficiency testing (PT) record review and interview with Technical Supervisor #4 (TS4), the laboratory failed to maintain a copy of all proficiency testing records in the specialty of Microbiology. Findings include: 1. Record Review on 5/15/2024 of the laboratory's CASPER Report 0096D 'CLIA Application and Survey Summary Report' revealed the laboratory had PT scores for the regulated analyte 005 Bacteriology for 2022 Events 2 and 3 and 2023 Events 1, 2, and 3. 2. Record review on 5/15/2024 of the laboratory's CASPER Report 0157D Excused Nonparticipation Report revealed the laboratory was excused for 2023 event 3. 3. Record review on 5/15/2024 of the laboratory's 2022, 2023 and 2024 to date API PT records revealed, the laboratory did not have PT records for the subspecialty Bacteriology. 4. Staff interview with TS4 on 5/15/2024 at 10:30 AM confirmed the above findings. 5. The laboratory performs 2,079 tests annually in the specialty of Microbiology. D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review of the laboratory's 2023 American Proficiency Institute (API) proficiency testing (PT) records and interview with Technical Supervisor #2 (TS2), the laboratory failed to submit the Routine Chemistry results for 2023 Event 2. Findings include: 1. Record review on 5/15/2024 of the laboratory's CASPER Report 0096D 'CLIA Application and Survey Summary Report' revealed the laboratory received an overall testing score of 0 percent for Routine Chemistry for 2023 Event 2. 2. Record review on 5/15/2024 of the laboratory's Core Chemistry 2023 Event 2 survey packet with the results that were run by the laboratory revealed: a. The laboratory did not submit results for Core Chemistry 2023 Event 2. b. The laboratory did not employ

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Lab USA, Inc. laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Due to repeat deficiencies cited herein, the following Condition level deficiencies were deemed to be not met: CFR 493.801 Condition:Enrollment and testing of samples (Proficiency Testing) CFR 493.1443 Condition: Laboratory Director . D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on record review and interview with Technical Supervisor 3 (TS3) on 3/31/22 as well as an American Proficiency Institute (API) representative by telephone on 4/1 /22, the laboratory failed to enroll in an approved proficiency testing (PT) program for each Chemistry specialty and subspecialty as evidenced by the following: a) A review of API PT records on 3/31/22 for calendar years 2020 and 2021 revealed no scores for routine chemistry analytes for the first and second testing events of 2021. b) Technical Supervisor 3 confirmed in an interview on 3/31/22 at 10:00 A.M. that the PT service was not able to provide samples for chemistry for the first testing event of 2021. However the API proficiency testing representative stated that the ideal cutoff date was 11/1/2021. She further stated that the lab did not enroll until 2/11/22 at which 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 -- time the chemistry core module was sold out. c) The laboratory performs 288,576 chemistry tests annually. This deficiency was cited at the last CLIA inspection performed on 11/13/19. . D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) review and interview with Technical Supervisor 3 (TS3) on 11/13/19, the laboratory did not document and maintain a copy of all PT records as evidenced by the following: A review of American Proficiency Institute (API) and College of American Pathologists (CAP) PT records for calendar years 2020 and 2021 (6 testing events). The review revealed that signed attestation statements and/or coding forms provided by the PT program were not available for the following events: 1. API Hematology - first testing event 2021. 2. CAP Urine Toxicology 2021 testing events UT-B, and UT-C. 3. Sars - COV2 - both testing events (A and B)for 2021. Technical Supervisor 3 confirmed in an interview on 3/31 /22 at 10:30 AM that not all attestation statements as well as coding form documentation was being retained. This deficiency was cited at the last CLIA inspection performed on 11/13/19. . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on proficiency testing (PT) review and interview with Technical Supervisor 3 (TS3) on 3/31/22, the laboratory failed to review and evaluate all unacceptable PT results obtained on proficiency testing performed as specified in subpart H of this part as evidenced by the following: a) A review of the American Proficiency Institute (API) PT records for calendar years 2020 and 2021 (6 testing events). The review revealed that the laboratory failed to review and evaluate and investigate the following unacceptable testing event scores: 1. API testing event 3 for Vitamin D - score of 50% obtained. 2. API testing event 3 for Hemoglobin AIC - score of 50% obtained. Technical Supervisor 3 interviewed on 3/31/22 at 10:34 AM confirmed that the laboratory failed to review and evaluate the unacceptable PT analytes listed above. . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE -- 2 of 5 -- CFR(s): 493.1236(c)(1) 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 record review and interview, the laboratory failed to verify the accuracy of any test or procedure it performs that is not included in subpart I of this part at least semiannually as evidenced by the following: a) The laboratory performs toxicology (drugs of abuse) by liquid chromatography/mass spectroscopy (LC/MS). The lab is enrolled in College of American Pathologists (CAP) proficiency testing for the qualitative testing performed. However, the laboratory had no system in place to verify the accuracy of quantitative drug testing performed at least semi-annually. b) According to Technical Supervisor 3 interviewed on 3/31/22 at 9:15 a.m. the laboratory had no system in place to verify the accuracy of quantitative drug testing semiannually. c) The laboratory performs approximately 21,774 quantitative toxicology tests annually. . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to to perform validation studies to ensure that it can obtain performance specifications comparable to those established by the manufacturer for re-introduced test system as evidenced by the following: Endocrinology testing: a) In February of 2021 the laboratory restarted performing the following Endocrinology tests after a years hiatus of not performing them: 1. Thyroid Stimulating Hormone (TSH) 2. Total T4 3. Total T3 4. Free T4 5. Free T3 b) In an interview on 3/31/22 at 10:30 AM Technical Supervisor #2 stated that no validation of the test method had been performed prior to utilizing it for patient testing and reporting after a years hiatus of not performing them. c) The laboratory performs approximately 5,359 Endocrinology tests annually. . D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on observation, the laboratory failed to maintain documentation to verify function checks on all laboratory equipment as evidenced by the following: Biosafety hood -Virology * On the day of the survey at 10:55 AM in the presence of the laboratory director, and technical supervisor 3 it was observed that the biosafety hood had no certification documentation displayed to confirm that the airflow was adequate. The laboratory could provide no documentation at the time of the survey to confirm that the biosafety hood was operating correctly. . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform calibration verification as appropriate as evidenced by the following: a) A review of quality control records for calendar years 2020, 2021, and 2022 was performed. The review revealed that calibration verifications of at least 3 points were not performed once every six months for twenty four (24) of twenty four (24) chemistry analytes performed. A review of calibration verification documentation revealed that the laboratory had performed them on 4/5/21 and then on 1/24/22. There were no calibration verifications performed during the second half of 2021. b) Technical supervisor 3 interviewed on 3/31/22 at 11:30 AM confirmed that calibration verifications of at least 3 points had not been performed at least once every six months for routine chemistry analytes. c) The laboratory performs approximately 110,253 routine chemistry tests annually. This deficiency was cited at the last CLIA inspection performed on 11/13/19. . D6076 LABORATORY DIRECTOR CFR(s): 493.1441 -- 4 of 5 -- The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the fact that four of the deficiencies cited during this CLIA recertification survey had been cited at the previous CLIA survey (refer to D2000, D2015, D5211, and D5439), the Laboratory Director failed to provide overall management and direction in accordance with 493.1407 of this subpart and did not ensure that deficiencies cited were corrected and remained corrected through the implementation of appropriate monitoring mechanisms. a) The Laboratory Director failed to ensure that the laboratory was enrolled in an approved proficiency testing (PT) program for each Chemistry specialty and subspecialty. Refer to D2000. b) The Laboratory Director failed to ensure that the laboratory maintained documentation of all proficiency testing records. Refer to D2015. c) The Laboratory Director failed to ensure that all unacceptable PT results obtained on proficiency testing performed were reviewed and evaluated. Refer to D5211. d) The Laboratory Director failed to ensure that the laboratory performed calibration verifications on Routine Chemistry methods at least once every six months. Refer to D5439. -- 5 of 5 --

Summary Statement of Deficiencies D0000 Based on evidence of unsuccessful proficiency testing performance for the Creatinine analyte, the following Condition level deficiency was deemed to be not met: Condition 42 CFR 493.803 - Proficiency Testing - Successful Participation. . 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 review for calendar years 2019 and 2020 (three testing events), the laboratory failed to successfully participate (achieve a score of 80 percent or more) in the American Proficiency Institute (API) proficiency testing program for the Creatinine analyte. Refer to D2093 and 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 -- D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review of calendar years 2019 and 2020 proficiency testing results (three testing events), the laboratory failed to return proficiency testing results to the proficiency testing program within the time frame specified by the program as evidenced by the following: * Creatinine analyte. The laboratory achieved a score of 0 percent for the second testing event of 2020 (failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program). The failure to report proficiency testing results for the time period specified above was confirmed through a telephone interview with one technical supervisor on 7 /23/2020. . 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 an off site desk review of the laboratory's 2019 and 2020 American Proficiency Institute (API) proficiency testing (PT) records the laboratory failed to achieve satisfactory performance for the Creatinine analyte for two out of three testing events resulting in unsuccessful performance for the analyte as evidenced by the following: 1. Desk review of the laboratory's 2019 and 2020 API PT records revealed the laboratory achieved a score for Creatinine of less than eighty percent for the following Routine Chemistry testing events: 2020 first testing event - Creatinine score of sixty (60) percent; and, 2020 second testing event - Creatinine score of zero (0) percent (failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program - refer to D2093). 2. Review of API reports for the two testing periods above confirmed that the PT scores were correct. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Lab USA, Inc. laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on record review and interview with Technical Supervisor 3 (TS3) on 11/13 /19, the laboratory failed to enroll in an approved proficiency testing (PT) program for each Chemistry specialty and subspecialty as evidenced by the following: The surveyors reviewed the American Proficiency Institute (API) PT records on 11/13/19 for calendar years 2018 and 2019. The review revealed that the laboratory enrolled late for the API PT program in 2019 and failed to participate in 2019 Chemistry - Core Chemistry - 1st Event. TS3 confirmed in an interview on 11/13/19 at 10:00 A.M. that the Technical Surpervisor 2 failed to order the PT kits for Chemistry - Core Chemistry - 1st Event for 2019 in a timely manner and therefore PT was not performed. The laboratory performs 375,624 chemistry tests annually. . D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) 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 -- (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on proficiency testing (PT) review and interview with Technical Supervisor 3 (TS3) on 11/13/19, the laboratory did not document and maintain a copy of all PT records as evidenced by the following: The surveyors reviewed American Proficiency Institute (API) and College of American Pathologists (CAP) PT records for calendar years 2018 and 2019 (30 testing events). The review revealed that signed attestation statements provided by the PT program were not available for the following events: 11 out of 30 attestation statements were not signed by the analyst: 1. API Chemistry Core 2018 Events 1, 2, and 3. 2. API Hematology, Coagulation, Urinalysis 2018 Events 1, 2, and 3. 3. API Microbiology, Dermatophyte, Mycology, Mycobacteriology 2018 Events 1, 2, and 3. 4. API Immunology, Immunohematology 2018 Event 2. 5. API Chemistry Miscellaneous 2018 Event 2. 17 out of 30 attestation statements were not signed by the laboratory director: 1. API Chemistry Core 2018 Events 1, 2, and 3. 2. API Hematology, Coagulation, Urinalysis 2018 Events 1, 2, and 3. 3. API Microbiology, Dermatophyte, Mycology, Mycobacteriology 2018 Events 1, 2, and 3. 4. API Immunology, Immunohematology 2018 Events 1, 2, and 3. 5. API Chemistry Miscellaneous 2018 Events 1 and 2. 6. CAP Urine Toxicology 2018 Events UT-A, UT-B, and UT-C. TS3 confirmed in an interview on 11/13/19 at 10:34 AM that not all attestation statements were signed by the analyst and laboratory director. . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on proficiency testing (PT) review and interview with Technical Supervisor 3 (TS3) on 11/13/19, the laboratory director failed to effectively review and evaluate PT results obtained on proficiency testing performed as specified in subpart H of this part as evidenced by the following: The surveyors reviewed American Proficiency Institute (API) PT records for calendar years 2018 and 2019 (30 testing events). The review revealed that the laboratory director failed to review and evaluate 14 out of 30 final reports for the following testing events: 1. API Chemistry Core 2018 Events 1, 2, and 3. 2. API Hematology, Coagulation, Urinalysis 2018 Events 1, 2, and 3. 3. API Microbiology, Dermatophyte, Mycology, Mycobacteriology 2018 Events 1, 2, and 3. 4. API Immunology, Immunohematology 2018 Events 1, 2, and 3. 5. API Chemistry -- 2 of 4 -- Miscellaneous 2018 Events 1 and 2. TS3 interviewed on 11/13/19 at 10:34 AM confirmed that the laboratory director failed to review and evaluate the API PT results for 2018. . D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Supervisor 3 (TS3) on 11/13 /19, the laboratory failed to twice annually ensure the accuracy of the Ethyl Glucuronide (EtG) diagnostic test as evidenced by the following: The surveyor asked TS3 on 11/13/19 for documentation of twice annual accuracy checks for the EtG diagnostic test for 2018 and 2019. TS3 provided only documentation for one accuracy check performed in 2018 and no documentation for accuracy checks performed in 2019. The laboratory last performed an accuracy check for EtG on 4/30/18. TS3 confirmed in an interview on 11/13/19 at 11:05 A.M. that the laboratory failed to perform twice annual accuracy checks for EtG in 2018 and 2019. The laboratory performs 7,182 EtG tests annually. . D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the deficiencies cited herein, the laboratory failed to meet the the applicable analytic systems requirements in 493.1251 through 493.1283 as evidenced by the following: The laboratory failed to perform calibration verifications of at least 3 points once every six months in 2018 and 2019 for Fentanyl and Alcohol. This is a repeat deficiency. Refer to D5439. . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test -- 3 of 4 -- system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to perform and document calibration verifications as appropriate as evidenced by the following: Surveyors reviewed quality control records on 11/13/19 for calendar years 2018 and 2019. The review revealed that calibration verifications of at least 3 points were not performed once every six months for two (2) of thirty eight (38) chemistry analytes requiring calibration verifications tested on the Beckman AU680 analyzer. The only documented calibration verification for Fentanyl was performed on 11/7/19 and for Alcohol was performed on 11/4/19. Technical Supervisor 3 confirmed though interview on 11/13/19 at 11:30 AM that calibration verifications of at least 3 points had not been performed at least once every six months in 2018 and 2019 for Fentanyl and Alcohol. The laboratory performs 10,512 Fentanyl and 13,718 Alcohol tests annually. This is a repeat deficiency. . D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on record review and interview, the Technical Consultant (TC) failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tested patient specimens as evidenced by the following: Surveyors reviewed personnel training and competency records for calendar 2017, 2018, and 2019 on 11/13/19. The review revealed that a semiannual competency evaluation was not documented for one (1) newly hired testing person (TP) performing moderate complexity testing. The TC confirmed in an interview on 11/13/19 at 10 AM that semiannual competency evaluations for the new TP were not documented. -- 4 of 4 --