Shamra Medical Laboratory, Llc

Summary Statement of Deficiencies 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 surveyor review of the Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the laboratory failed to review and evaluate PT results obtained from the American Proficiency Institute (API) for the 2nd Chemistry event of 2025 . The finding includes: 1. The laboratory did not evaluate "Not Graded 9", from API in event 2, 2025 for the following: a) Bilirubin, Total (mg/dL) samples CH- 07, 09, and 10. 2. The TC confirmed on at 10:30 am on 11/19/25 that the laboratory failed to evaluate the above mentioned coded results. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the laboratory failed to verify the accuracy of Total Bilirubin (TBIL) results obtained from the American Proficiency Institute (API) for the Chemistry-Core 2nd event of 2025. The findings include: 1. The laboratory 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 -- received a score of 100%, but received a code "9" for Total Bilirubin samples CH-07, 09 and 10. 2. API reported the range for TBIL sample CH-07 as 1.8 - 2.9 mg/dL. 3. The laboratory reported TBIL Sample CH-07 as out of range with 1.2 mg/dL. 4. API reported the range for TBIL sample CH-09 as 1.3 - 2.2 mg/dL . 5. The laboratory reported TBIL Sample CH-09 as out of range with 1.1 mg/dL. 6. API reported the range for TBIL sample CH-10 as 2.4 - 3.7 mg/d . 7. The laboratory reported TBIL Sample CH-10 as out of range with 1.7 mg/dL. 8. The laboratory obtained a 40% for TBIL 2nd event of 2025 with API. 9. The TC confirmed on 11/19/25 at 10:20 am, the accuracy of the PT results were not verified. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: A) Based on surveyor review of the Procedure Manual (PM), Quality Control (QC) and interview with the Technical Consultant (TC), the laboratory failed to follow the procedure "Quality Control" for the Cobas Integra 400 plus analyzer used to perform Routine Chemistry testing from 6/1/25 to 11/19/25 . The findings include: 1. The PM stated "18. The laboratory director or Technical consultant will review and sign the QC logs each month." 2. There was no documented evidence that the above mentioned procedure was performed in June of 2025. 3. The TC confirmed on 11/19 /25 at 10:55 am the laboratory failed to follow the above mentioned procedure. B) Based on surveyor review of the PM, Quality Control Validation (QCV) and interview with the TC, the laboratory failed to follow the procedure "Control Validation" for the cobas integra 400, plus analyzer used to perform Routine Chemistry, CLA-1 Luminometer used to perform specific IgE testing in from 12/17 /21 to 11/19/2025. The findings include: 1. The PM stated as follows: a) "2. Check the values of the new QC against the manufacturer's expected ranges" b) "5. Document the date put into use on the package insert" 2. There was no documented evidence that the above mentioned procedures were performed. 3. The TC confirmed on 11/19/25 at 10:50, am the laboratory failed to follow the above mentioned procedures. C) Based on surveyor review of the Procedure Manual (PM), and interview with the Technical consultant (TC), the laboratory failed to have a procedure for verifying the accuracy of unregulated testing at least two times each year from June 2022 to 11/19/2025. The findings include: 1. The laboratory performs unregulated specific IgE on the CLA-1 Luminometer analyzer. 2. There was no procedure for verifying the accuracy of specific IgE testing at least two times each year. 3. The TC confirmed on 11/19/25 at 11:55 am, the laboratory failed to have available the above mentioned procedure. 48354 D) Based on surveyor review of the PM, QCV procedures and interview with the TC, the laboratory failed to follow the procedure "Control Validation" for the Abbott Cell Dyn analyzer for Hematology testing from 10/17/24 to 11/20/2025. The findings include: 1. The QCV procedure stated the following: a) "document the date put into use on the package insert." b) "initial or sign document who performed the control validation." 2. There were no dates the verified quality control materials were put into use for lot #'s 5230, 5146, 5062, 4344, and 4288. 3. There were no signatures on the QCV records for lot 5062. 4. The TC confirmed on 11/20/25 at 1:45 am, the laboratory failed to follow the QCV procedure. -- 2 of 4 -- D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: A) Based on surveyor observation of reagents, review of the Procedure Manual (PM) and interview with the Technical Consultant (TC), the laboratory failed to discard expired reagents used for Chemistry testing from 11/30/22 to 11/20/25. The findings include: 1. Surveyor observation of the reagents revealed the following to be expired: a) One unopened vial of Precinorm Uplus 1, lot # 45946201 expired on 11/30/22. b) One uponed vial of Precinorm Uplus 2, lot # 45946201 expired on 11/30/22. 2. The TC confirmed on 11/20/25 at 1:20 pm, the laboratory failed to discard expired reagents. B) Based on surveyor observation of Quality Control (QC) material in use, review of the Control Kits Manufacturers Package Insert (MPI) and interview with the Technical Consultant (TC), the laboratory used unstable QC material and failed to put correct expiration dates for routine Chemistry and Endocrinology tests from 2/1/24 to 4/3/25. The findings include: 1. The expiration date of the Precicontrol (PC) QC material shortens once reconstituted. 2. The MPI stated Parathyroid hormone (PTH) had a 3 day stability once reconsituted. a) PC Thyro 1 lot # 80574299, had a reconstituted date of 10/26/25. b) PC Thyro 2 lot #80574399, had a reconstituted date of 10/26/25. 3. The MPI stated Tumor Marker (TM) had a 2 week stability once reconsituted. a) PC TM 1 lot # 77723690, had a reconstituted date of 10/26/25. b) PC TM 2 lot # 77723790, had a reconstituted date of 10/26/25 4. The MPI stated Multi Marker (MM) had a 72 hour stability once reconsituted. a) PC MM 1 lot # 77744299, had a reconstituted date of 11/11/25. b) PC MM 2 lot # 77744499, had a reconstituted date of 11/11/25 5. Approximately 26 patients were run and reported with unstable quality control material. 6. The TC confirmed on 11/20/25 at 11:45 am, the laboratory used unstable quality control material. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Technical Consultant (TC), the laboratory failed to establish a procedure for periodically verifying the accuracy of calculated data by the Lab Information System (LIS) from 4/1/24 to 11/20/25. The finding includes. 1. The laboratory did not have a procedure for verifying Estimated Glomular Filtration Rate (eGFR) calculations by the LIS. 2. The TC confirmed on 11/20/25 at 2:00 pm, the laboratory did not verify the accuracy of calculated data by the LIS. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) -- 3 of 4 -- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on the lack of Performance Specification (PS) records and interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to ensure that PS was performed on CLA-1 Luminometer for specific IgE from June 2022 to 11/19/25. The findings include: 1) There was no documented evidence the laboratory verified the CLA-1 Luminometer prior to patient testing. 2) The TC confirmed on 11/19/2025 at 1: 00 pm, there were no PS records for the CLA-1 Luminometer. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on surveyor review of Testing Personnel (TP) files and interview with Technical Consultant (TC), the Laboratory Director (LD) failed to ensure that all TP had appropriate training documentation from 9/24/25 to 11/20/25. The findings include: 1. The intial training records for TP #3 as listed on the CMS 209 form had no signatures of approval by the director or trainer. 2. There were no dates of completion on the training records for TP #3. 3. The records did not state who trained TP #3. 4. The TC confirmed on 11/20/25 at 1:40 pm, the LD failed to ensure all TP had the appropriate training records. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on July 16, 2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and proficiency testing provider reports, the laboratory failed to achieve 80% or more in two consecutive events for Routine Chemistry for the analytes Alanine Aminotransferase (ALT), 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 -- Aspartate Transaminase (AST), Creatine Kinase (CK), Creatinine (CRE), Lactate Dehydrogenase (LDH), with the American Proficiency Institute (API). Refer to D2097 D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) (g) Failure to achieve an overall testing event score of satisfactory performance 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 review of the CASPER 155 report and graded results from American Proficiency Institute (API). The laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive events in the subspecialty Routine Chemistry for the analytes Alanine Aminotransferase (ALT), Aspartate Transaminase (AST), Creatine Kinase (CK), Creatinine (CRE), Lactate Dehydrogenase (LDH), resulting in initial unsuccessful performance. The findings include: 1) A review of the CASPER 155 report revealed the following. a) The laboratory scored 60% for ALT in event 1- 2025. b) The laboratory scored 60% for ALT in event 2-2025. c) The laboratory scored 0% for AST in event 1-2025. d) The laboratory scored 60% for AST in event 2- 2025. e) The laboratory scored 40% for CK in event 1-2025. f) The laboratory scored 60% for CK in event 2-2025. g) The laboratory scored 0% for CRE in event 1-2025. h) The laboratory scored 60% for CRE in event 2-2025. i) The laboratory scored 0% for LDH in event 1-2025. j) The laboratory scored 60% for LDH in event 2-2025. 2. A review of API graded results confirmed the laboratory failed two consecutive Proficiency Testing (PT) events. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CASPER 155 report and graded results from American Proficiency Institute (API). The Laboratory Director (LD) failed to provide overall management and direction to laboratory personnel to ensure that the Proficiency Testing (PT) surveys are performed satisfactorily and in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations. The findings include: 1. The LD failed to ensure PT surveys are performed satisfactorily and in compliance with CLIA regulations. Cross refer D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 a review of the CASPER 155 report and graded results from American Proficiency Institute (API), the Laboratory Director (LD) failed to ensure successful participation in a Department of Health and Human Services (DHHS) approved Proficiency Testing (PT) program for two consecutive PT events for the analytes Alanine Aminotransferase (ALT), Aspartate Transaminase (AST), Creatine Kinase (CK), Creatinine (CRE), Lactate Dehydrogenase (LDH), resulting in initial unsuccessful performance. Refer to D2097. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% or more for Chemistry tests performed with the American Proficiency Institute (API). The finding includes: 1) The laboratory scored 40% for Total Calcium, 20% for Total Cholesterol and 60% for Urea Nitrogen in event 1-2022 with the API. 2) The laboratory scored 20% for Total Calcium, 20% for Total Cholesterol and 40% for Urea Nitrogen in event 2-2022 with the API D2087 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(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve at least 80% for the Total Calcium, Total Cholesterol, and Urea Nitrogen tests. The finding includes: 1) The laboratory scored 40% for Total Calcium, 20% for Total Cholesterol and 60% for Urea Nitrogen in event 1-2022 with the American Proficiency Institute (API). 2) The laboratory scored 20% for Total Calcium, 20% for Total Cholesterol and 40% for Urea Nitrogen in event 2-2022 with the API D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to review and evaluate PT results obtained from the American Proficiency Institute (API) for Immunology, Chemistry and endocrinology events performed in 2020 and 2021. The findings include: 1. The laboratory did not evaluate "Not Graded" response from API for the following: a. SARS-CoV-2 IgM Sample SAB-2, 2nd event 2020 b. Adrenocorticotropic Hormone (ACTH) sample IAS-06 2nd event 2021 c. Folate sample IA-07, 2nd Event 2021 d. Folate sample IA-01, 3rd event 2021 2. The TP #2 listed on CMS form 209 confirmed on 12/16/21 at 10:00 am that the laboratory failed to evaluate the above mentioned coded results. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- the Testing Personnel (TP), the laboratory failed to verify the accuracy of chemistry, endocrinology, and Immunology test results obtained from the American Proficiency Institute (API) from January 2020 to the date of survey. The findings include: 1. The laboratory received a score of 100 but results were not graded. 2. There was no documented evidence the laboratory verified: a. SARS-CoV-2 IgM 2nd event 2020 b. Adrenocorticotropic Hormone (ACTH) 2nd event 2021 c. Folate sample 2nd and 3rd Event 2021 3. The TP #2 listed on CMS form 209 confirmed on 12/16/21 at 10:00 am accuracy of the PT results were not verified 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 surveyor review of Laboratory records and interview with the Testing Personnel, the laboratory failed to meet the analytic system requirements to provide quality testing at the from 6/19/21 to the date of survey survey. 1. The laboratory failed to review and evaluate Proficecy Test results. Cross refer D5211. 2. The laboratory failed to verify the accuracy of chemistry, endocrinology, and Immunology tests. Cross refer D5215. 3. The laboratory failed to follow the Operators Manual for "Pre-Calibration Procedures". Cross refer to D5411. 4. The laboratory retained expired Quality Control (QC) and Reganet Packs. Cross refer to D5417. 5. The laboratory failed to perform and document Calibration procedures at least once every six months. Cross refer D5437 6. The laboratory failed to perform and document QC on each day of patient testing. Cross refer D5445 7. The laboratory failed to take

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Quality Assurance Records (QAR) and interview with the Testing Personnel (TP), the laboratory failed to have a written procedure for Quality Assurance (QA) From 2/1/18 to the date of survey. The TP # 1 listed on CMS form 209 confirmed on 6/12/19 at 11:00 am that the laboratory did not have a written procedure for QA. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of Reagent Package Insert (RPI) and interview with the Testing Personnel (TP), the laboratory failed to follow RPI instructions for Folate tests performed on the Roche Cobas e411 analyzer for maintaining specimen integrity from 2/1/18 to the date of survey. The findings include: 1. The RPI for Folate stated "Serum: Stable 2 days at 2-8 degrees Celsius, 4 weeks at -20 degrees Celsius" but the 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 -- laboratory did not ensure that Folate specimens were frozen when assayed after 2 days. 2. On 5/20/19 one patient was run and reported four days after collection date. 3. On 6/4/19 three patients were run and reported five days after collection. 4. The TP #1 listed on CMS form 209 confirmed on 6/12/19 at 1:00 pm that RPI instructions were not followed. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: a) Based on surveyor review of Manufactures Package Insert, observation of the Quality Control (QC) material, and interview with the Testing Personnel (TP), the laboratory failed to put new expiration dates on PreciControl Varia on the Roche Cobas 400 from February 2018 to the date of survey. The findings include. 1. The MPI for PreciControl Varia stated that QC material for routine chemistry tests expires 72 hours after reconstitution if stored at 2 to 8 degrees Celsius. 2. The TP stated the controls are kept for 21 days stored at 2 to 8 degrees Celsius. 3. The TP was not aware that QC material expired 72 hours after reconstitution. 4. Approximately 150 patients run and reported for routine chemistry. 5. The TP #1 on CMS form 209 confirmed on 6/12/19 /19 at 11:00 am the laboratory failed to put new expiration dates on the control material. b) Based on surveyor review of Manufactures Package Insert, observation of the Quality Control (QC) material, and interview with the Testing Personnel (TP), the laboratory failed to put new expiration dates on PreciControl Tumor Marker Controls on the Roche Cobas e411 from February 2018 to the date of survey. The findings include. 1. The MPI for PreciControl Tumor Marker controls stated that QC material for Ferritine and Prostate-Specific antigen (PSA) tests expires 14 days after reconstitution if stored at 2 to 8 degrees Celsius. 2. The TP stated the controls are kept for 21 days stored at 2 to 8 degrees Celsius. 3. The TP was not aware that QC material expired 14 days after reconstitution. 4. Approximately 100 patients run and reported. 5. The TP #1 on CMS form 209 confirmed on 6/12/19 /19 at 11:00 am the laboratory failed to put new expiration dates on the control material. 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 -- 2 of 3 -- 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 (CV) records and interview with the Testing Personnel (TP), the laboratory failed to perform and document CV procedures at least once every six months for Routine Chemistry and Endocrinology tests performed on the Roche Cobas 400 and e411 analyzer from February 2018 to the date of the surveyor. The TP #1 listed on CMS for 209 confirmed on 6/12/19 at 12:00 pm CV was not performed every six months. -- 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 surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform CA correctly on two out of two TP from January 1, 2016 to the date of survey. The findings include: 1. The laboratory did not document when testing personnel were observed, what records were reviewed and how assessment was done. 2. TP #2 did not have a CA in the calendar year 2016. 3. Assessment of problem solving skills was not documented on CA for TP. 4. The Technical Consultant (TC) and Technical Supervisor (TS) did not have a CA for their responsibilities. 5. The TP #2 on CMS form 209 has an Associates Degree and performed the CA on and TC. 6. The TP #2 on CMS form 209 confirmed on 2/1/18 at 1:00 pm that the CA procedure was not performed correctly. 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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to review and evaluate coded Chemistry PT results obtained from the American Proficiency Institute (API) for the 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 -- calendar year 2017. The findings include: 1. There was no review or evaluation documented when the laboratory received "Not Graded" results in: a. Chemistry Core 1-2017 - Low Density Lipoprotein (LDL), Triglycerides and Free Thyroxine sample CH-01. b. Chemistry Miscellaneous 2-2017 - Folate sample 1A-06. 2. There was no review or evaluation documented when the laboratory received "Unacceptable" results in: a. Chemistry Core 1-2017 - Aspartate Aminotransferase (AST), Total Bilirubin, Cholesterol, Creatinine, Glucose, LDL and Blood Urea Nitrogen (BUN) - sample CH- 04. b. Chemistry Core 1-2017 - Calcium Total samples CH-03 and CH-05. c. Chemistry Core 1-2017 - Carbon Dioxide (CO2) samples CH-01 and CH-05. d. Chemistry Core 1-2017 Magnesium sample CH-05. e. Chemistry Core 1-2017 - Unsaturated Iron Binding Capacity (UIBC) sample CH-01. f. Chemistry Core 3-2017 - Thyroid Stimulating Hormone (TSH) sample CH-11. 3. The TP #2 listed on the CMS form 209 confirmed on 2/1/18 at 1:10 pm that the laboratory did not review all PT results. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to follow the procedure for new Quality Control (QC) verification for tests performed on the Cobas Intergra 400 plus and Cobas e411 analyzer from January 2016 to the date of survey. The findings include: 1. The PM stated to "run new QC material as patients to validate the new QC values" but there was no documented evidence of QC being run as patients in 2016 and 2017. 2. The PM stated to run new QC a minimum of three to five times before putting in use but there was no documented evidence that QC was verified. 3. The TP #2 on CMS form 209 confirmed on 2/1/18 at 2:10 pm that the PM was not followed. 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 sureveyor review of Performance Specifications (PS) records and interview with the Testing Personnel (TP), the laboratory failed to verify accuracy on Chemistry and Endocrinolgoy tests performed on the Cobas Integra 400 plus and Cobas e411 -- 2 of 3 -- analyzer before reporting patient test results from January 1, 2016 to the date of survey. The TP #2 on the CMS form 209 confirmed on 2/1/18 at 1:50 pm that PS were not done. D5781