Valor Health

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 a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the American Association of Bioanalysts (AAB) and the American Proficiency Institute (API) and a telephone interview with the Laboratory Manager on 10/09/2024 at 13:56, the laboratory failed to successfully participate in proficiency testing for Immunohematology Compatibility Testing 2 (two) out of 3 (three) events for 2023 and 2024. Refer to D2181. D2181 COMPATIBILITY 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 -- CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), the laboratory's graded results from the American Association of Bioanalysts (AAB) and the American Proficiency Institute (API) and a phone interview with the laboratory manager on 10/09/2024 at 13:56, the laboratory failed to achieve an overall testing event score of satisfactory performance for (2) two out of (3) three testing events for Immunohematology Compatibility testing for 2023 and 2024. The findings include: 1. A PT desk review of Report 155D and graded PT results from AAB and API identified that the laboratory failed to achieve satisfactory scores for immunohematology compatibility testing. PT Analyte Year Event Score AAB Compatibility 2023 3 60% API Compatibility 2024 2 80% 2. A telephone interview with the laboratory manager on 10/09/2024 at 13:56 confirmed the above findings. 3. The laboratory reports performing 35 compatibility tests per year. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation from the American Association of Bioanalysts (AAB), the College of American Pathologists (CAP), the American Proficiency Institute (API), and an interview with the technical supervisor (TS) on 7/9/2024, the laboratory failed to have testing personnel and the laboratory director attest to the integration of PT samples with routine testing of patient samples in 2023 and 2024. The findings include: 1. A review of PT records from AAB for 2023 identified that the laboratory failed to have the laboratory director attest that the PT samples were integrated with patient samples for chemistry event one, urine drug screen event one and non-chemistry event one. 2. A review of PT records from API for 2024 identified that the laboratory failed to have the testing personnel and laboratory director attest that the PT samples were integrated with patient samples for chemistry events one and two and immunology/immunohematology event one. 3. A review of PT records from CAP for 2024 identified that the laboratory failed to have the testing personnel and laboratory director attest that the PT samples were integrated with patient samples for automated body fluid event one and laboratory director attest for alcohols event one. 4. An interview with the TS on 7/9/2024 at 11:37 am confirmed the above findings. 5. The laboratory reports performing 87,275 tests annually. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- 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 a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory policies, competency assessment records and an interview with the technical supervisor (TS) on 7/9/2024, the laboratory failed to follow written policies and procedures to assess testing personnel in 2023 and 2024. The findings include: 1. A review of the CMS 209 form identified nine testing personnel. 2. The laboratory policy "Laboratory Competency Assessment" states that there will be an initial training, six month competency then annual competency each year after. 3. A review of competency assessment records identified the laboratory failed to have six month competency assessments for one of three testing personnel in 2023 and three of four testing personnel in 2024. 4. A review of competency assessment records identified the laboratory failed to have annual competency for three of four testing personnel in 2023. 5. An interview with the TS on 7/9/2024 at 11:37 am confirmed the above findings. 6. The laboratory reports performing 87,275 tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Cepheid GeneXpert maintenance logs and an interview with the technical supervisor (TS) on 7/9/2024, the laboratory failed to perform maintenance as required by the manufacturer in 2023 and 2024. The findings include: 1. A review of Cepheid GeneXpert maintenance logs identified that the laboratory failed to perform quarterly maintenance of disinfection of the cartridge bay interior and the plunger rod for four of four quarters since 7/2/2023 as required by the manufacturer. 2. A review of Cepheid GeneXpert maintenance logs identified that the laboratory failed to perform monthly maintenance of archiving tests, purging tests and cleaning the fan filter in November 2023, December 2023, January 2024 and February 2024 as required by the manufacturer. 3. An interview with the TS on 7/9/2024 at 12: 05 pm confirmed that the above findings. 4. The laboratory reports performing 505 tests annually on the Cepheid. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. -- 2 of 3 -- (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a record review of immunohematology quality control (QC), patient test reports and an interview with the technical supervisor (TS) on 7/10/2024, the laboratory failed to document control material results for immunohematology testing in 2023. The findings include: 1. A review of immunohematology QC for 2022, 2023 and 2024 identified that the laboratory failed to document QC on 9/10/2023 and 10/24 /2023 for ABO grouping, Rh typing, and unexpected antibody detection. 2. A review of patient test reports identified ABO grouping, Rh typing, and unexpected antibody detection was performed on one patient on 9/10/2023 and one patient on 10/24/2023. 3. An interview with the TS on 7/10/2024 at 10:59 am confirmed the above findings. 4. The laboratory reports performing 316 immunohematology tests annually. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of laboratory policies, temperature logs and an interview with the technical supervisor (TS) on 7/10/2024, the laboratory failed to perform alarm checks of the immunohematology refrigerator with the frequency prescribed in their policy in 2023 and 2024. The findings include: 1. A review of the policy " Blood Banking Temperature and Alarm Monitoring System" identified that the laboratory would perform quarterly alarm checks on the blood bank refrigerator and freezer. 2. A review of laboratory temperature logs identified that the laboratory failed to perform quarterly alarm checks on the blood bank refrigerator in October 2023 and January 2024. 3. An interview with the TS on 7/10/2024 at 10:14 am confirmed the above finding. 4. The laboratory reports performing 316 immunohematology tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 review of proficiency testing (PT) records from the College of American Pathologists (CAP) and an interview with the laboratory manager on 8/10/2022, the laboratory failed to prove the testing accuracy of Gamma Glutamyl Trans (GGT) for 2022 . The findings include: 1. A review of PT results from CAP for the analyte GGT identified that the laboratory failed two consecutive PT events for GGT with scores of 0% for 2022 event A and a 20% for 2022 event B. 2. An interview with the laboratory manager on 8/10/2022 at 9:50 am confirmed that the laboratory failed to prove testing accuracy for GGT in 2022. 3. The laboratory reports performing 15 GGT tests annually. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a record review of proficiency testing (PT) documents from the College of American Pathologists (CAP) and an interview with the laboratory manager on 8/10 /2022, the laboratory failed to review unsatisfactory PT results and take

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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the College of American Pathologists (CAP) the laboratory failed to successfully participate in PT for the specialty of Routine Chemistry for two (2) of three (3) consecutive testing events. The findings include: 1. A PT desk review revealed the laboratory had unsatisfactory scores for the 3rd event of 2020 and the 1st event of 2021 for the specialty of Routine Chemistry. D2096 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 2 -- 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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the College of American Pathologists (CAP), the laboratory failed to achieve an overall testing event score of satisfactory performance for two (2) consecutive testing events for the specialty of Routine Chemistry for the analyte BUN. The findings include: 1. A PT desk review of report 155D and graded results from CAP revealed the laboratory failed to achieve satisfactory results for the specialty of Routine Chemistry for the analyte BUN. Analyte Year Event Score BUN 2020 3 20 BUN 2021 1 40 -- 2 of 2 --

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 record review of competency assessment documentation, the CMS-209 personnel form, and an interview with the interim laboratory manger on 04/19/2021, the laboratory failed to document competency assessments for testing personnel listed on the CMS-209. The findings include: 1. A record review of competency assessment documentation revealed that the laboratory failed to document competency assessments for 6 of 7 testing personnel listed on the CMS-209 personnel form in accordance with 42 C.F.R. 493.1451(b)(8). 2. A record review of 6-month competency assessment documentation revealed that the laboratory failed to document 6-month competency assessments for 6 of 6 new testing personnel since the last survey on 11/05/2018. 3. An interview with the interim laboratory manager on 04 /19/2021 at 10:00 AM confirmed that competency assessments had not been performed on the testing personnel listed on the CMS-209 personnel form. 4. The laboratory reports performing 148,818 patient tests annually. 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 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 -- 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 of calibration documentation and an interview with the interim laboratory manager on 04/19/2021, the laboratory failed to provide documentation, at the time of survey, for calibration verification being performed at least every 6 months on the Sysmex XN 550 analyzer. The findings include: 1. A record review of calibration and calibration verification documentation for the Sysmex XN 550 revealed that the laboratory failed to provide documentation, at the time of survey, of calibration verification at least every 6 months for the Sysmex XN 550 analyzer since 03/25/2020. 2. An interview with the interim laboratory manager on 04/19/2021 at 1:30 PM confirmed that the laboratory was unable to provide calibration verification documentation for the Sysmex XN 550 analyzer at the time of survey. 3. The laboratory reports performing 38,962 patient tests annually on the Sysmex XN 550 analyzer. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on record review of testing personnel training documentation, the CMS-209 form, and an interview with the interim laboratory manager on 04/19/2021, the laboratory failed to provide documentation of initial training for new testing personnel, since the previous survey on 11/05/2018, prior to analyzing patient specimens. The findings include: 1. A record review of testing personnel documentation and the CMS-209 personnel form revealed that the laboratory failed to document initial training for 6 of 6 new testing personnel since the previous survey on 11/05/2018. 2. An interview with the interim laboratory manager on 04/19/2021 at 10: 00 AM confirmed that the laboratory failed to document initial training for 6 of 6 initial training. 3. The laboratory reports performing 148,818 patient tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) record review and an interview with the laboratory manager, the laboratory director failed to sign the attestation statements from the College of American Pathologists (CAP) for the specialties of Hematology, Chemistry, Immunology, Immunohematology, and Microbiology since January 18, 2017. Findings: 1. A CAP PT record review from 2017 and 2018, revealed the laboratory director failed to sign the attestation statements for the specialties of Hematology, Chemistry, Immunology, and Microbiology since the last survey. 2. An interview on November 5, 2018, at 1:50 PM, with the laboratory manager confirmed the laboratory director failed to sign the attestation statements from CAP and failed to delegate the responsibility of signing the attestation forms to the technical supervisor who is also the laboratory manager. . 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 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 -- 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 a record review and an interview with the laboratory manager, the laboratory failed to perform and document calibration verification procedures at least once every 6 months or as required for D-dimers performed on the Stago Satellite coagulation analyzer since February 2017. Findings: 1. A record review of calibration verification reports for D-dimer performed on the Stago Satellite analyzer revealed the laboratory failed to perform and document calibration verifications at least once every 6 months since February 2017. 2. An interview on November 5, 2018, at 1:30 PM, with the laboratory manager, confirmed the laboratory failed to perform and document calibration verifications. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review of quality control documents in bacteriology and an interview with the laboratory manager, the laboratory failed to check each lot or shipment of Chocolate agar, used in culture workups, for sterility, ability to support growth or inhibit specific organisms, or produce a biochemical response before use since the last survey on January 18, 2017. Findings: 1. A review of quality control records for the Chocolate agar revealed the laboratory failed to document each shipment or lot of media for sterility, growth and inhibition of specific organisms, and biochemical response either before or concurrent with initial use of media. 2. An interview on November 5, 2018, at 1:05 PM, with the laboratory manager, confirmed the laboratory failed to document each lot of agar before or concurrent with initial use of media and failed to write an Individualized Quality Control Plan for the media. D5809 TEST REPORT CFR(s): 493.1291(e) -- 2 of 4 -- The laboratory must, upon request, make available to clients a list of test methods employed by the laboratory and, as applicable, the performance specifications established or verified as specified in 493.1253. In addition, information that may affect the interpretation of test results, for example test interferences, must be provided upon request. Pertinent updates on testing information must be provided to clients whenever changes occur that affect the test results or interpretation of test results. This STANDARD is not met as evidenced by: Based on a record review of final patient reports and an interview with the laboratory manager, the laboratory failed to specify the method of test performance used for the testing of Prostate Specific Antigen (PSA) on patient test reports since the last survey on January 18, 2017. Findings: 1. A review of patient test reports containing PSA results revealed the testing methodology was not indicated on the patient reports. 2. An interview on November 5, 2018, at 1:15 PM, with the laboratory manager, confirmed the laboratory failed to state the PSA testing methodology on the final reports. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for -- 3 of 4 -- proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on a personnel records review and an interview with the laboratory manager, the laboratory failed to verify the education equivalency for one high-complexity testing person in the laboratory with a foreign degree since the last survey on January 18, 2017. Findings: 1. A review of education diplomas revealed 1 out of 6 testing personnel failed to have their foreign degree evaluated for equivalency since the last survey. 2. An interview on November 5, 2018, at 1:45 PM, with the laboratory manager, confirmed the laboratory failed to evaluate the 1 testing personnel's degree for equivalency. -- 4 of 4 --