Family Medicine Center Alexandria

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Family Medicine Center Alexandria, CLIA # 19D0931056, on March 20, 2024. Family Medicine Center Alexandria was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1415 CONDITION: Laboratories performing moderate complexity testing; Clinical Consultant 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 review of CMS-209 (Laboratory Personnel Report), laboratory policy and procedures, and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for Clinical Consultant were complete. Findings: 1. Review of the laboratory's CMS-209 form provided to surveyor revealed the laboratory did not have a qualified Clinical Consultant listed on the form. 2. In interview on March 20, 2024 at 11:13 am, the Laboratory Director stated the laboratory is currently filling the position of Clinical Consultant. 3. Review of the laboratory's policy for Clinical Consultant revealed the laboratory did have a policy for duties and responsibilities for the role of Clinical Consultant; however, the policy did not specify a frequency for competency assessment performance. 4. In further interview on March 20, 2024 at 11:13 am, the Laboratory Director confirmed the laboratory did not have a frequency included in the Clinical Consultant policy. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) 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 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 observation by surveyor, review of manufacturer's package inserts, laboratory policy and procedures and interview with personnel, the laboratory failed to ensure specimen collection and preparation requirements were maintained as required by the manufacturer. Findings: 1. Observation by surveyor during the laboratory tour on March 20, 2024 at 10:40 am revealed the laboratory utilizes the following analyzers for patient testing: a) Vitros 350 Chemistry analyzer with the following tests: Glucose (Gluc), Blood Urea Nitrogen (BUN), Creatinine (Crea), Sodium (Na), Potassium (K+), Chloride (CL), Carbon Dioxide (CO2), Calcium (Ca), Phosphorus (Phos), Total Protein (TP), Albumin (Alb), Total Bilirubin (TBil), Aspartate aminotransferase (AST), Alanine transaminase (ALT), Alkaline phosphatase (ALP), Direct Bilirubin (DBil), Cholesterol (Chol), Triglyceride (Trig), High Density Lipoprotein (HDL), Uric Acid (UA), Magnesium (Mag) b) Beckman Coulter Access 2 with the following tests: Free Thyroxine (FT4), Thyroid Stimulating Hormone (TSH), Vitamin B12, Folate, Vitamin D 2. Further observation on March 20, 2024 at 10:25 am revealed the laboratory receives specimens from an alternate collection site. 3. In interview on March 20, 2024 at 10:46 am, the Laboratory Director stated the laboratory is currently collecting patient samples at another facility and transporting the uncentrifuged samples to the laboratory within two (2) or more hours. 4. Review of the Beckman Coulter Access 2 chemistry package inserts revealed the manufacturer requirements for the following analytes: a) Vitamin B12: Physically separate serum or plasma from contact with cells as soon as possible b) Thyroid Stimulating Hormone (TSH): Physically separate serum or plasma from contact with cells as soon as possible c) Folate: Physically separate serum or plasma from contact with cells as soon as possible d) Free Thyroxine (FT4): Physically separate serum or plasma from contact with cells as soon as possible e) Vitamin D: Physically separate serum or plasma from contact with cells as soon as possible 5. Review of the Vitros 350 chemistry package inserts revealed the manufacturer requirements for the following analytes: a) Glucose: Centrifuge specimen and remove the serum/plasma from the clot within 30 minutes after collecting specimen to avoid metabolism of glucose by the cells b) Potassium: Centrifuge specimens and remove the serum or plasma from the cellular material within 2 hours of collection c) Magnesium: Centrifuge specimens and remove the serum or plasma from the cellular material as soon as possible after collection 6. In interview on March 20, 2024 at 10:46 am, the Laboratory Director confirmed the laboratory did not send the patient samples with the current specimen handling and preparation as required by the manufacturer. 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on observation by surveyor, review of maintenance logs and interview with personnel, the laboratory failed to perform weekly maintenance procedures per manufacturer's requirements for two (2) of two (2) chemistry analyzers in 2023. Findings: 1. Observation by surveyor during the laboratory tour on March 20, 2024 at 10:40 am revealed the laboratory utilizes the following two (2) chemistry analyzers for patient testing: a) Beckman Coulter Access 2 b) Vitros 350 2. Review of the maintenance logs for the Beckman Coulter Access 2 chemistry analyzer revealed the laboratory performs the following weekly maintenance: a) Clean Instrument Exterior b) Inspect Liquid Waste Bottle c) Check Wast Filter Bottle d) Inspect/Clean Primary Probe e) Replace/Clean Aspirate Probes f) Run Daily Maintenance g) Run System Check 3. Review of maintenance logs for the Vitros 350 chemistry analyzer revealed the laboratory performs the following weekly maintenance: a) Clean tray platform and transport arm b) Clean cup retainer c) Clean diluent bottles d) Clean tip locater assembly e) Clean control unit screen f) Clean keypad cover g) Inspect, clean, and/or replace air filter h) Back up QC/Config/Calibration Data 4. Further review of the 2023 maintenance logs for the Beckman Coulter Access 2 and the Vitros 350 chemistry analyzers revealed the weekly procedures were not performed for the following weeks: a) Beckman Coulter Access 2: maintenance not performed for week of October 31, 2023 through November 6, 2023 b) Vitros 350: maintenance not performed for week of November 30, 2023 through December 6, 2023 5. In interview on March 20, 2024 at 3:10 pm, the Laboratory Director confirmed the identified weekly maintenance was not performed as required by the manufacturer. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of laboratory policy and records along with interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to ensure specimen collection and preparation requirements were maintained as required by the manufacturer. Refer to D5311. 2. The laboratory failed to perform weekly maintenance procedures per manufacturer's requirements for two (2) of two (2) chemistry analyzers in 2023. Refer to D5429. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate -- 3 of 5 -- consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on review of CMS-209 (Laboratory Personnel Report), laboratory policy and procedures and interview with personnel, the Laboratory Director failed to ensure the laboratory employed a Clinical Consultant to consult with and render opinions to the laboratory's clients. Refer to D6057. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of laboratory policy and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Findings: 1. The laboratory failed to ensure written policies and procedures to assess competency for Clinical Consultant were complete. Refer to D5209. D6056 CLINICAL CONSULTANT CFR(s): 493.1415 The laboratory must have a clinical consultant who meets the qualification requirements of 493.1417 of this part and provides clinical consultation in accordance with 493.1419 of this part. This CONDITION is not met as evidenced by: Based on review of personnel records and interview with personnel, the laboratory failed to ensure the position of Clinical Consultant was employed based on requirements for moderate complexity testing. Refer to D6057. D6057 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1417 The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1405(b)(1), (2), or (3)(i); or (b) Be a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine and possess a license to practice medicine, osteopathy or -- 4 of 5 -- podiatry in the State in which the laboratory is located. This STANDARD is not met as evidenced by: Based on review of the Laboratory Personnel Report (CMS 209) and personnel records as well as interview with personnel, the laboratory failed to ensure the laboratory employed a qualified Clinical Consultant as required. Findings: 1. Review of the Laboratory Personnel Report (CMS 209) and personnel records revealed the laboratory does not have personnel serving in the position of Clinical Consultant. 2. In interview on March 20, 2024 at 11:13 am, the Laboratory Director stated the previous Clinical Consultant left the position in December 2023. The Laboratory Director confirmed the laboratory does not have personnel serving as Clinical Consultant. -- 5 of 5 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on January 14, 2020 at Family Medicine Center, CLIA ID # 19D0931056. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 record review and interview with personnel, the laboratory failed to ensure the Laboratory Director signed the attestation statement for one (1) of six (6) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's American Proficiency Institute (API) proficiency records for 2018 and 2019 revealed the Laboratory Director did not sign the attestation statement for the following event: a) 2019 Hematology/Coagulation 1st Event 2. In interview on January 14, 2020 at 3: 20 pm, Personnel 2 stated that she must have overlooked the attestation statement when having the Laboratory Director review proficiency event. Personnel 2 confirmed the Laboratory Director did not sign the attestation statement for the above event. D2094 ROUTINE CHEMISTRY 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, 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 -- 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 record review and interview with personnel, the laboratory failed to document remedial action for unacceptable Chemistry scores. Findings: 1. Review of the laboratory's 2018 and 2019 Proficiency Testing (PT) results revealed the laboratory received the following unacceptable results: a) 2018 Chemistry - Core - 1st Event: CH-01 ALT/SGPT 80% 2. Further review of PT records revealed the laboratory did not have any documentation of

Summary Statement of Deficiencies D0000 A PT Desk Review SURVEY was performed on October 5, 2018. Family Medicine Center- 19D0931056 was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of proficiency testing results from the CMS-153, CMS-155D and American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing as evidence by: 1. The laboratory failed to attain a score of at 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 -- least 80% for all Hematology analytes. Please refer to D2121. 2. The laboratory failed to attain an overall satisfactory score of at least 80% for Hematology in Event 2 of 2018. Refer to D2122. 3. The laboratory failed to achieve satisfactory performance for White Blood Cell Differential in two of three consecutive events resulting in initial unsuccessful participation. See D2130 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the CMS 155D Report and American Proficiency Institute (API), the laboratory failed to attain a score of at least 80% for all Hematology analytes. Findings: 1. Review of API Proficiency Testing Records revealed that the laboratory failed to achieve a score of at least 80% for analytes in the specialty of Hematology for the following events: a) For the 2nd Event in 2018 the laboratory received a score of 0% for Red Blood Cell (RBC), Hematocrit (HCT), Hemaglobin (HGB), White Blood Cell (WBC), Platelets (PLT) and White Blood Cell Differential (WBC Diff). b) For the 1st Event in 2018 the laboratory received a score of 33% for White Blood Cell Differential (WBC Diff D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing results, the laboratory failed to attain a satisfactory score of at least 80% for Hematology in Event 2 of 2018. Findings are: 1. Review of CASPER Reports 0155D and 0153D along with API Proficiency Testing Records revealed the laboratory received an overall score of 0 % for Hematology in the second event of 2018. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing results from the CMS-155D and American Proficiency Institute (API), the laboratory failed to achieve a score of at least 80% for White Blood Cell Differential in two of three consecutive events. Findings: 1. Review of proficiency testing records and the CMS 155D Report revealed the following proficiency testing scores for White Blood Cell Differential (WBC Diff) resulting in initial unsuccessful performance: a. 2018 Event 2: Score of 0% b. 2018 Event 1: Score of 33% -- 2 of 3 -- 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 record review and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: The laboratory director failed to ensure that proficiency testing samples are satisfactory as required. Findings: 1. The laboratory failed to attain a score of at least 80% for all Hematology analytes. Please refer to D2121. 2. The laboratory failed to attain an overall satisfactory score of at least 80% for Hematology in Event 2 of 2018. Refer to D2122. 3. The laboratory failed to achieve satisfactory performance for White Blood Cell Differential in two of three consecutive events resulting in initial unsuccessful participation. See D2130 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on February 14, 2018 at Family Medicine Center-CLIA ID # 19D0931056. Family Medicine Center laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation and record review, the laboratory failed to report Urine Drug Screen (UDS) test results as preliminary results and failed to confirm all UDS test results as required by the manufacturer. Findings: 1. Observation by the surveyor on February 14, 2018 revealed the laboratory utilized the AmediCheck Instant Test Cup test system for Urine Drug Screen (UDS) testing and reporting of Amphetamine (Amph), Barbiturates (Barb), Benzodiazepines (Benzo), Cocaine (COC), MDMA, Methadone (Meth), Methamphetamine (Methamph), Opiates (OPI), Opiate300 (OPI300), Oxycodone (Oxy), Phencyclidine (PCP), Cannabinoids (THC) and Tricyclic Antidepressants (Tricyclic) in patient urine samples. 2. Review of the AmediCheck Instant Test Cup package insert revealed under the "Indications For Use: This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary results are used." 3. Review of the Task 1 and 3 Form submitted to 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 6 -- surveyor on February 14, 2018 revealed the laboratory performs the following annual volumes for UDS testing: 146 - Amph, 146 - Barb, 146 - Benzo, 146 - COC, 146 - MDMA, 146 - Meth, 146 - Methamph, 146 - OPI, 146 - OPI300, 146 - Oxy, 146 - PCP, 146 - THC and 146 - Tricyclic. 4. Interview with the Laboratory Director on February 14, 2018 confirmed that patient urine drug screen test results did not include the disclaimer. The Laboratory Director confirmed the UDS test results are not reported as preliminary results and that they do not confirm all UDS results. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to maintain copies of the proficiency testing program attestation statements signed by the analyst and the laboratory director for a minimum of two years for two (2) of twelve (8) Proficiency Test (PT) events reviewed. Findings: 1. Review of American Proficiency Institute (API) PT records from January 1, 2016 through February 14, 2018 revealed the laboratory failed to maintain copies of attestation statements signed by the analyst and the laboratory director for the following two (2) events: a) 2017 Chemistry 2nd Event - the laboratory director failed to sign the attestation. d) 2017 Microbiology 3rd Event - testing personnel failed to sign the attestation. 2. Interview with personnel 2 on February 14, 2018 confirmed the laboratory did not maintain copies of the proficiency testing program attestation statements signed by the analyst and the laboratory director, for the two (2) PT events in 2017 for Hematology. 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 observation, record review and interview with laboratory personnel the laboratory failed to calibrate laboratory centrifuges at least every 6 months as required by the manufacturer. Findings: 1. Observation by surveyor on February 14, 2018 revealed the laboratory utilized a PSS Select PSS602 Centrifuge for the spinning of patient Chemistry and Endocrinology samples for testing. 2. Review of the PSS Select PSS602 Centrifuge Operators Manual revealed that it is "recommended that your -- 2 of 6 -- centrifuge's rpm be calibrated at least every 6 months." 3. Interview with personnel 2 on February 14, 2018 revealed she was unaware of the manufacturer's requirement to calibrate the centrifuge every 6 months. Personnel 2 did confirm the centrifuge has not been calibrated every 6 months. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, and interview with laboratory personnel, the laboratory failed to ensure that Access Vitamin B12 Calibrators are not used beyond their expiration dates. Findings: 1. Observation by the surveyors during the tour of the laboratory on February 14, 2018 revealed the following expired items in place for patient testing: Access Vitamin B12 Calibrators - lot number 613098, with an expiration date of 2018- 0131. 2. Interview with personnel 2 on February 14, 2017 confirmed by observation the items cited were expired and in place for patient testing. 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 observation, record review and interview with personnel, the laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the Beckman Coulter Access 2 Chemistry Analyzer. Findings: 1. Observation by surveyor on February 14, 2018 revealed the laboratory maintained a Beckman Coulter Access 2 Chemistry Analyzer utilized for the following patient testing: Free Thyroxine (FT4), Thyroid Stimulating Hormone (TSH), Vitamin B12 (B12), Folate, and Vitamin D (VitD). 2. Review of the Laboratory's Policy and Procedure Manual revealed a "Performance Verification Procedure" that was effective November 30, 2012. The Method Validation policy revealed written policies and procedure for: A) Accuracy: is established by comparing results to a definitive or reference method, or may be verified by comparing results to an established comparative method. Use of reference materials (e.g. commercial control material) or other material with known concentrations or activities is suggested is establishing or verifying accuracy. B) Precision: is established by repeat measurement of samples at varying concentrations or activities within-run and between-run over a period of time. C) Reportable Range: the analytic measurement range (AMR) is the range of analyte values that a method can directly measure on the specimen without any dilution or concentration. D) Reference Range: Normal values -- 3 of 6 -- are initially established or verified for each specimen source when appropriate. Literature references or manufacturer package insert may be appropriate, but should be verified based on patient population. Further review of the "Performance Verification Procedure failed to include: a) For Accuracy, Reportable Range and Reference Range: how many samples are needed, who is to perform, and what the acceptability criteria is. b) For Precision: how many samples are needed, who is to perform ( to meet operator variance requirement), and what the acceptability criteria is. 3. Review of the Performance Verification Study for the Beckman Coulter Access 2 Chemistry Analyzer revealed: a) Raw data from April 4, 2017 through April 5, 2017 that was signed off by the Beckman Coulter Senior Application Specialist. NOTE: There was no documentation that laboratory personnel participated. b) Simple Precision was calculated, evaluated and signed of by the Laboratory Director NOTE: There was no documentation for within-run, between-run or operator variance. c) Method Comparison: Evaluation of the data was signed of by the Laboratory Director on April 8, 2018. NOTE: The raw data used was from the Beckman Representative d) Tab for Linearity just had a Summary stating the Linearity passed for FT4, TSH, Folate, B12 and VitD. There was no data. The summary was not signed of e) There was no Reference Range Study information. The laboratory failed to maintain all the data to support accuracy, precision, reportable and reference ranges. The data supplied failed to include documentation of laboratory personnel that participated in the performance verification studies. 4. Review of the Task 1 and 3 Form submitted to the surveyors on February 14, 2018 revealed the laboratory performs the following annual volumes: 171 - FT4, 1439 - TSH, 281 - Folate, 289 - B12 and 289 - VitD. 5. Interview with personnel 1 on February 14, 2018 confirmed the laboratory failed to follow laboratory policy for method validation, and confirmed the laboratory failed to maintain documentation to support that laboratory personnel performed the method validation. 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: I. Based on observation, record review and interview with personnel, the laboratory failed to document the weekly maintenance on the Beckman Coulter Access 2 Chemistry Analyzer as required by the manufacturer, for forty two (42) of forty two (42) weeks reviewed. Findings: 1. Observation by surveyor on February 14, 2018 revealed the laboratory maintained a Beckman Coulter Access 2 Chemistry Analyzer utilized for the following patient testing: Free Thyroxine (FT4), Thyroid Stimulating Hormone (TSH), Vitamin B12 (B12), Folate, and Vitamin D (VitD). 2. Review of the Beckman Coulter Access 2 Chemistry Analyzer Log revealed the laboratory is to perform a Weekly System Check that includes: Washed RLU/%CV Substrate RLU/% CV Unwashed RLU/%CV Wash Efficiency Substrate Ratio Substrate: Washed Ratio Techs initials Further review of the Beckman Coulter Access 2 Chemistry Analyzer Log from April 10, 2017 through January 25, 2018 revealed the laboratory failed to document the performance of the Weekly System Check for forty two (42) weeks or 100% of the time. 3. Interview with the Laboratory Director on February 14, 2018 revealed he was unaware the laboratory failed to document the Weekly System Check. Personnel 2 on February 14, 2018 confirmed the laboratory failed to document -- 4 of 6 -- the Weekly System Check. II. Based on observation, record review and interview with personnel, the laboratory failed to document the weekly maintenance on the Vitros 350 Chemistry Analyzer as required by the manufacturer, for seven (7) of forty two (42) weeks reviewed. Findings: 1. Observation by surveyor on February 14, 2018 revealed the laboratory maintained a Vitros 350 Chemistry Analyzer utilized for the following patient testing: Albumin (ALB), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), Total Bilirubin (TBil), Direct Bilirubin (DBil), Calcium (CA), Chloride (CL), Carbon Dioxide (CO2), Cholesterol (Chol), High Density Lipoprotein Cholesterol (HDL), Creatinine (Creat), Glucose (Glu), Potassium (K), Sodium (NA), Phosphorous (Phos), Total Protein (TP), Triglyceride (Trig), Blood Urea Nitrogen (BUN), and Uric Acid (Uric). 2. Review of the Vitros 350 Chemistry Analyzer Log revealed the laboratory is to perform a Weekly System Check that includes: Clean tray platform and transport arm Clean cup retainer Clean diluent bottles Clean tip locator assembly Clean control unit screen Clean keypad cover Inspect, clean, and/or replace air filter Back up QC/ Conf/ Calibration Data Further review of the Beckman Coulter Access 2 Chemistry Analyzer Log from April 10, 2017 through January 25, 2018 revealed the laboratory failed to document the performance of the weekly maintenance for the following seven (7) weeks: January 30, 2017 - February 3, 2017 February 6, 2017 - February 10, 2017 February 13, 2017 - February 17, 2017 February 20, 2017 - February 24, 2017 February 28, 2017 - March 3, 2017 May 30, 2017 - June 2, 2017 August 28, 2017 - September 1, 2017 3. Interview with the Laboratory Director on February 14, 2018 revealed he was unaware the laboratory failed to document the Weekly System Check. Personnel 2 on February 14, 2018 confirmed the laboratory failed to document the Weekly maintenance. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on observations, record review and interview with laboratory personnel, the Laboratory Director failed to ensure that verification procedures are performed to determine accuracy, precision, reportable and reference ranges for the Beckman Coulter Access 2 Chemistry Analyzer. Refer to D5421. Interview with personnel 1 on February 14, 2018 confirmed the laboratory failed to follow laboratory policy for method validation, and confirmed the laboratory failed to maintain documentation to support that laboratory personnel performed the method validation. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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 -- 5 of 6 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed testing as required for accurate and reliable results. Findings: 1. The laboratory failed to calibrate laboratory centrifuges at least every 6 months as required by the manufacturerRefer to D5411. 2. The laboratory failed to ensure that Access Vitamin B12 Calibrators are not used beyond their expiration dates. Refer to D5417. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, instrument maintenance records and interview with laboratory personnel, the Laboratory Director failed to ensure that the laboratory performed the required maintenance to ensure acceptable levels of analytical performance. Findings: 1. The laboratory failed to document the weekly maintenance on the Beckman Coulter Access 2 Chemistry Analyzer as required by the manufacturer, for forty two (42) of forty two (42) weeks reviewed. Refer to D5429 I. 2. The laboratory failed to document the weekly maintenance on the Vitros 350 Chemistry Analyzer as required by the manufacturer, for seven (7) of forty two (42) weeks reviewed. Refer to D5429 II. -- 6 of 6 --