Prescott Healthcare Solutions, Llc Dba

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 lack of calibration verification documentation for the Beckman DXC 700 and TOSOH G8 analyzers and interview with the General Supervisor (GS-1), the laboratory failed to perform and document calibration verification procedures at least once every 6 months during 2023 and 2024. Findings include: 1. The laboratory began performing A1C testing utilizing the TOSOH G8 analyzer in February 2023. 2. The laboratory began performing chemistry testing on patients utilizing the Beckman DXC 700 analyzer in September 2023. 3. No documentation was presented for review to indicate the laboratory performed a calibration verification on the Beckman DXC 700 analyzer at least once every six months during 2024, including at least a minimal (or 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 -- 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. 4. No documentation was presented for review to indicate the laboratory performed a calibration verification on the TOSOH G8 analyzer at least once every six months during 2023 and 2024, 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. 5. The GS-1 interviewed on 1/27/25 at 10:20 AM confirmed the laboratory failed to perform calibration verification procedures on the chemistry analyzers indicated above during 2023 and 2024. 6. The laboratory's reported annual test volume in the specialty of Chemistry is 1,024,414. -- 2 of 2 --

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the number and severity of deficiencies cited for quality practices identified during the complaint investigation conducted on August 22, 2023, it was determined that the laboratory failed to monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. See D5203 and D5291 for findings. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of patient test requisitions and test reports from 2022 and 2023 and interview with the General Supervisor (GS), the laboratory failed to follow established policies and procedures to ensure positive identification of a patient's specimen from 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 -- the time of collection through completion of testing and reporting of results. Findings include: 1. The laboratory performs testing in the specialties of Hematology and Chemistry, with an approximate annual test volume of 436,667. 2. The laboratory's established policy 'Patient Identification' states, "Each patient will be correctly identified and entered in a computerized format into the Laboratory Information System (LIS). Each patient will receive a unique ID number (accession number) when he/she is processed, and this number will appear on all files, reports and correspondence regarding this patient sample." 3. During the sample accessioning process, the laboratory matches the labeled specimen with the corresponding test requisition and generates a printed label containing an assigned accession number. The printed label is then affixed to the sample prior to testing. The printed label is also affixed to the patient's test requisition. 4. 17 out of 17 patient test reports and corresponding test requisitions reviewed during the survey showed one unique ID number assigned to two separate patients. 5. 10 out of 10 patient test reports and corresponding test requisitions reviewed during the survey indicated the specimen was incorrectly identified during the accessioning process, resulting in mislabeled specimens and test results being reported on the incorrect patient. 6. The laboratory failed to follow established policies and procedures to ensure positive identification of a patient's specimen from the time of collection through completion of testing and reporting of results, as indicated above. 7. The GS interviewed on 08/22/23 at 10:56 AM confirmed the laboratory failed to follow established policies and procedures to ensure positive patient identification throughout the entire testing process. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of established Quality Assessment (QA) policies and procedures and interview with the general supervisor (GS), the laboratory's QA policies and procedures failed to include an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Findings include: 1. No QA documentation from 2022 and 2023 was provided for review during the complaint investigation conducted on 08/22/23 to indicate the laboratory has an ongoing mechanism to monitor, assess and, when indicated, correct problems identified with specimen and patient identification. See D5203 for specific findings. 2. The laboratory provided evidence of 3 separate email communications from the laboratory staff to the ordering provider (dated 01/12/23 at 1:08 PM, 06/28/23 at 9:58 AM and 06/28/23 at 10:20 AM) to notify the ordering provider of incorrect test results due to patient identification errors, however no documentation was presented for review to indicate how the laboratory monitored and assessed the issue to prevent the issue from recurring. 3. The GS interviewed on 08/22/23 at 12:00 PM confirmed the laboratory failed to provide QA documentation to indicate the laboratory has an ongoing mechanism to monitor, assess and correct problems identified with the general laboratory systems requirements specified at 493.1231 through 493.1236. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL -- 2 of 5 -- CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of patient test reports, review of the laboratory's established policies and procedures and interview with the General Supervisor (GS), the laboratory failed to follow established policies for specimen storage and preservation and failed to establish policies and procedures for specimen acceptability and rejection and specimen referral. Findings include: 1. The laboratory performs testing in the specialties of Hematology and Chemistry, with an approximate annual test volume of 436,667. The laboratory refers certain specimens to other CLIA-certified laboratories for testing if the laboratory is unable to perform the test requested. 2. The laboratory's established policy for 'Specimen Stability and Processing' states, "Chemistries: serum SST tiger top tube: Refrigerated 7 days." 3. Review of final test reports for two out of two specimens sent to a referral laboratory for testing indicated the laboratory exceeded the specimen stability requirement of 7 days (refrigerated) as follows: - patient ID# 53671, specimen for Prostrate Specific Ag (PSA) collected on 07/21/23 10:12, received by referral laboratory on 08/01/23 06:20:05, test result reported by referral laboratory on 08/01/23 06:04:15. - patient ID# 91088, specimen for Complete Metabolic Panel (CMP) colleted on 07/19/23 14:43, received by referral laboratory on 07/31/23 18:04:03, test result reported by referral laboratory on 07/31/23 18:03:00 4. The 'Specimen Stability and Processing' policy presented for review failed to include information regarding the specimen stability and processing requirements of frozen specimens prior to sending to a reference laboratory for testing. \ 5. The laboratory failed to establish policies and procedures for specimen acceptability and rejection, including specimens which have exceeded the stability requirement, specimens not stored properly and specimens that are mislabeled or unlabeled. 6. The laboratory failed to establish policies and procedures for specimen referral. 7. The GS interviewed on 08/22/23 at 10:52 AM acknowledged the laboratory's policies and procedures for specimen storage and preservation, specimen acceptability and rejection, and specimen referral were not followed or not established as indicated above. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on lack of quality assessment (QA) records and interview with the general supervisor (GS), the laboratory failed to establish QA policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. Findings -- 3 of 5 -- include: 1. No QA documentation was provided for review during the complaint investigation conducted on 08/22/23 to indicate the laboratory established policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the preanalytic systems, including identified issues related to specimen referral and specimen stability. 2. The GS interviewed on 08/22/23 at 12:00 PM confirmed the laboratory failed to provide documentation of established QA policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified with the preanalytic systems specified at 493.1241 through 493.1242. D5779

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of established Quality Assessment (QA) policies and procedures and interview with the testing personnel, the laboratory failed to follow QA policies and procedures to monitor, assess, and when indicated, correct problems identified in the general laboratory systems. Findings include: 1. The laboratory's established QA policy titled, Quality Assurance Program & General Operating Procedures, states, "The laboratory will produce quarterly Quality Assurance reports." 2. No QA documentation was provided for review during the survey conducted on 11/10/2022 to indicate the laboratory documented QA activities on a quarterly basis during 2020, 2021 and 2022 (through the date of the survey) to monitor, assess and, when indicated, correct problems identified in the general laboratory systems. 3. The testing personnel interviewed on 11/10/22 at 2:50pm confirmed the laboratory failed to provide documentation of quarterly QA reports to monitor, assess and correct problems identified with the general laboratory systems. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of patient test requisitions and interview with the testing personnel, three out of three test requisitions reviewed during the survey failed to include the date and time of specimen collection. Findings include: 1. The laboratory utilizes the Indiko Plus chemistry analyzer for the drug screen testing and the Shimadzu LC/MS 4080 analyzer for the drug confirmation testing; the Sysmex XN-350 hematology analyzer; and the Vitros 5600 chemistry analyzer for routine chemistry testing and testing performed in the sub-specialty of Endocrinology. The laboratory's approximate annual test volume is 436,667. 2. The test requisitions presented for review during the survey for specimen accession# 20220518153608, 20220512122858 and sample ID# 141097 failed to include the date and time of specimen collection. 3. The testing personnel interviewed at 11:45am on 11/10/2022 confirmed the date and time of specimen collection were not documented on the test requisitions referenced above. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of established Quality Assessment (QA) policies and procedures and interview with the testing personnel, the laboratory failed to follow QA policies and procedures to monitor, assess, and when indicated, correct problems identified in the preanalytic laboratory systems. Findings include: 1. The laboratory's established QA policy titled, Quality Assurance Program & General Operating Procedures, states, "The laboratory will produce quarterly Quality Assurance reports." 2. No QA documentation was provided for review during the survey conducted on 11/10/2022 to indicate the laboratory documented QA activities on a quarterly basis during 2020, 2021 and 2022 (through the date of the survey) to monitor, assess and, when indicated, correct problems identified in the preanalytic laboratory systems. 3. The testing personnel interviewed on 11/10/22 at 2:50pm confirmed the laboratory failed to provide documentation of quarterly QA reports to monitor, assess and correct problems identified with the preanalytic laboratory systems. D5779

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 review of Proficiency Testing (PT) reports for 2019 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analyte, Alanine Aminotransferase (ALT), under the specialty of Chemistry. Findings include: 1. The laboratory's PT performance was unsatisfactory for the 2nd event of 2019 for the regulated analyte, ALT, with a score of 20%. 2. The laboratory's PT performance was unsatisfactory for the 3rd event of 2019 for the regulated analyte, ALT, with a score of 60%. D2094 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on the information furnished to the State Agency by the Proficiency Testing (PT) provider, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failure for the analyte, ALT, for the 2nd and 3rd testing events of 2019. See D2016 for findings. 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the regulated analyte, ALT, for the 2nd and 3rd event of 2019 resulting in unsuccessful PT performance. See D2016 for 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: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6016 - ensuring that the proficiency testing samples are tested as required under Subpart H. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined that the laboratory director failed to ensure that the PT samples are tested in a manner that results in successful participation in a proficiency testing program for the regulated analyte, ALT. See D2016 for findings. -- 3 of 3 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on lack of employee competency policies and procedures for review and interview with the facility personnel, the laboratory failed to establish policies and procedures to assess employee competency. Findings include: 1. The laboratory began testing patient specimens in July 2017 in the sub-specialties of Routine Chemistry and Toxicology. 2. No documentation was presented for review to indicate the laboratory established policies and procedures to assess the competency of individuals who perform testing on patient specimens and to assess the competency of the Technical Consultant. 3. The facility personnel confirmed that the laboratory did not have policies established to assess the competency of testing personnel and the technical consultant. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (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 4 -- This STANDARD is not met as evidenced by: Based on direct inspection of patient specimens, review of the laboratory's policy and procedure manual and interview with the facility personnel, the laboratory failed to follow established policies for specimen identification and collection. Findings include: 1. The laboratory performs urine drug screen testing in the sub-specialties of Routine Chemistry and Toxicology, with an approximate annual test volume of 31,462. 2. The laboratory's established policy specific to Patient Identification states, "Patient information will include: ...Date and Time of Specimen Collection Clinically". 3. Direct inspection by the surveyor of the laboratory's collected specimens on August 8, 2018 revealed that the laboratory failed to consistently include the date and time of specimen collection on the collection cup. 4. The facility personnel confirmed that the laboratory personnel were not following laboratory policy by including the date and time of specimen collection on each specimen tested by the laboratory. 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 lack of documentation for review and interview with the facility personnel, the laboratory failed to document the humidity of the laboratory where patient testing is performed. Findings include: 1. The laboratory began patient testing in July 2017 under the sub-specialties of Routine Chemistry and Toxicology, with an approximate annual test volume of 31,462. 2. The laboratory performs patient testing on the Indiko Plus Chemistry analyzer which has a humidity requirement of 40% - 80%, as stated in the manufacturer's operating manual. 3. No documentation was presented for review during the survey to indicate the laboratory documented the humidity of the laboratory where patient testing was performed. 4. The facility personnel confirmed that the laboratory was monitoring the humidity of the room where patient testing is performed, but failed to document the humidity measurements. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the facility personnel, the laboratory failed to have a system in place to ensure the accuracy of test results that are electronically interfaced into the laboratory's information system (LIS). Findings include: 1. The laboratory performs approximately 31,462 patient tests annually under the sub-specialty of Routine Chemistry and Toxicology. 2. The laboratory performs testing on the Indiko Plus analyzer, and the test results are electronically interfaced from the analyzer to the LIS, Paracelsus. 3. No documentation was presented for review during the survey to indicate the laboratory has a system in place to ensure the accuracy of patient test results that are interfaced from the Indiko Plus analyzer to the LIS (Paracelsus). 4. The facility personnel confirmed that the laboratory did not have a system in place to verify the accuracy of the patient test results that are sent from the analyzer to the LIS. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the facility personnel, the laboratory failed to include on the test report the name of the laboratory where the testing was performed. Findings include: 1. The laboratory performs patient testing in the specialty of Chemistry, with an approximate annual test volume of 31,462. 2. Two out of two test reports reviewed during the survey, patient #100002545 and 10000309, were missing the laboratory name where the testing was performed. 3. The facility personnel confirmed that the laboratory name where the testing was performed was not included on the test reports referenced above. 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 lack of performance evaluation documentation and interview with the facility personnel, the technical consultant failed to evaluate and document the performance of one testing personnel, at least semiannually during the first year the individual tested patient specimens. Findings include: 1. No semiannual competency evaluation documentation was presented for review for one testing personnel who -- 3 of 4 -- began patient testing in July 2017. 2. The facility personnel confirmed that the laboratory did not have documentation of a semiannual competency evaluation for the testing personnel indicated above. -- 4 of 4 --