Women's Medical Center, The

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Newco Women's Medical Center, CLIA # 19D0982695, on May 26, 2022. Newco Women's Medical Center was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing; Technical Consultant 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 review of the laboratory's proficiency test records, monthly quality assurance checklist, and interview with personnel, the laboratory failed to ensure Testing Personnel and/or Laboratory Director signed the attestation statement for five (5) of five (5) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's "Monthly Quality Assurance Checklist: revealed the following monitor: "Proficiency Testing: All PT results reviewed. All failed PT was evaluated in accordance with the written PT procedure." 2. Review of the laboratory's American Proficiency Institute (API) and College of American Pathologists (CAP) records for the third event of 2020, 2021, and first event of 2022 revealed the Testing Personnel and /or Laboratory Director did not sign the attestation statement for the following events: 2020 API Immunology/Immunohematology 3rd Event: Laboratory Director did not sign and date; two (2) Testing Personnel did not indicate sample set each personnel tested 2021 API Chemistry Core 1st Event: Laboratory Director did not sign and date; two (2) Testing Personnel did not indicate sample set each personnel Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- tested 2021 CAP D8-B Group B Strep Detections: Laboratory Director did not sign 2021 API Hematology/Coagulation 2nd Event: Laboratory Director and Testing Personnel did not sign and date 2021 API Immunology/Immunohematology 3rd Event: Laboratory Director did not sign 2021 API Hematology/Coagulation 3rd Event: Laboratory Director did not sign and date 2021 API Chemistry Core 3rd Event: Laboratory Director did not sign and date 2022 CAP MVP-A (Molecular Vaginal Panel): Laboratory Director and Testing Personnel did not sign and date 2022 CAP HC6-A (C. trachomatis and N.gonorrhoeae by Nucleic Acid Amplification): Laboratory Director and Testing Personnel did not sign and date 3. In interview on May 26, 2022 at 3:00 pm the Testing Personnel confirmed the laboratory's personnel did not sign the attestation statements as required for the identified events. 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 review of the laboratory's proficiency test records, monthly quality assurance checklist, and interview with personnel, the laboratory failed to ensure the Laboratory Director reviewed the proficiency testing performance evaluation results for six (6) of seven (7) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's "Monthly Quality Assurance Checklist: revealed the following monitor: "Proficiency Testing: All PT results reviewed. All failed PT was evaluated in accordance with the written PT procedure." 2. Review of the laboratory's American Proficiency Institute (API) and College of American Pathologists (CAP) records for the 2020, 2021, and first event of 2022 revealed the laboratory did not have documentation of review of their results for the following events: 2020 CAP D8-C Group B Strep Detection: no signature and date by Laboratory Director 2020 API Chemistry Core 3rd Event: no signature and date by Laboratory Director 2020 CAP VS-A Vaginitis Screen: no signature and date by Laboratory Director 2021 CAP HS6- C Chlamydia/GC by NAA: no signature and date by Laboratory Director 2021 CAP MVP-B Molecular Vaginal Panel: no signature and date by Laboratory Director 2021 CAP D8-B Group D Strep Detection: no signature and date by Laboratory Director 3. In interview on May 26, 2022 at 3:00 pm the Testing Personnel confirmed the Laboratory Director did not sign and date the identified PT evaluation forms. 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 review of the laboratory's proficiency testing records, policies, and interview with personnel, the laboratory failed to establish and document complete proficiency testing assessment activities for one (1) of six (6) events reviewed. Findings: 1. Review of the American Proficiency Institute (API) testing records for the Fern test for 2020 and 2021 revealed the following unacceptable result: 2021 Hematology /Coagulation 2nd Event Fern Test: Score: 0% 2. Review of the laboratory's performance evaluation form for that event revealed the following: a) Corrective -- 2 of 17 -- action "Test was misplaced and as a result, we submitted no answers" 3. In interview on May 26, 2022 at 3:00 pm, the Testing Personnel confirmed the laboratory did not perform any further action following the misplacement of the Fern test samples. 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 observation by surveyor, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to establish a complete policy and procedure manual. Refer to D5401. 2. The laboratory failed to ensure policies and procedures were updated to current practices and signed by the current Laboratory Director. Refer to D5407. 3. The laboratory failed to ensure test kits did not exceed expiration dates. Refer to D5417. 4. The laboratory failed to perform performance verification studies for the ASI Rubella test. Refer to D5421 I. 5. The laboratory failed to perform complete performance verification studies for bacteriology testing on one (1) of the two (2) BD Max instruments. Refer to D5421 II. 6. The laboratory failed to ensure complete performance specifications studies were performed for the BD Affirm instrument. Refer to D5421 III. 7. The laboratory failed to ensure reference range studies were performed for the Sysmex XN 330 instrument utilized for Complete Blood Count (CBC) testing. Refer tod D5421 IV. 8. The laboratory failed to have a complete IQCP for the BD Max Vaginal Panel test. Refer to D5445 I. 9. The laboratory failed to have a complete IQCP for the BD Max CT/GC/TV test. Refer to D5445 II. 10. The laboratory failed to establish their own means and ranges for Quality Control (QC) material utilized for Chemistry testing as required by the manufacturer. Refer to D5469. 11. The laboratory failed to perform method comparison testing for Bacteriology testing at least twice a year. Refer to D5775 I. 12. The laboratory failed to perform instrument comparison testing for Bacteriology testing on two (2) BD Max instruments at least twice a year. Refer to D5775 II. 13. The laboratory failed to take

Summary Statement of Deficiencies D0000 A Certification Survey was performed on February 21, 2020 at Newco Women's Medical Center, CLIA ID # 19D0982695. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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: I. Based on record review and interview with personnel, the laboratory failed to establish complete competency assessment policies for physicians performing laboratory testing. Findings: 1. In interview on February 21, 2020, Testing Personnel 1 stated the physicians in the office perform wet preps and fern tests. 2. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed eight (8) physicians listed as testing personnel. 3. Review of the laboratory's personnel records for the eight (8) physicians revealed the laboratory did not include the following six (6) procedures as a minimal requirement for assessing the competency of the physicians performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 4. In interview on February 21, 2020, Testing Personnel 1 confirmed 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 9 -- laboratory did not have documentation of competency assessments for the physicians performing wet prep and fern tests. II. Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to address competency for one (1) of two (2) Technical Consultants were complete. Findings: 1. Review of the laboratory's CMS-209 (Laboratory Personnel Report) revealed the Laboratory Director serves as the Technical Consultant. 2. Review of the laboratory's quality control and proficiency test records revealed Testing Personnel 1 also serves as the Technical Consultant. 3. Review of the laboratory's policies and procedures revealed the laboratory did not include competency assessment criteria or frequency of performance for personal serving as Technical Consultant. 4. In interview on February 21, 2020 at 10:05 am, Testing Personnel 1 confirmed the Laboratory Director did not perform an assessment for her duties as Technical Consultant. Testing Personnel 1 stated she was unaware of the duties of a Technical Consultant. 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: ***Repeat deficiency from survey conducted March 20, 2018.*** Based on record review and interview with personnel, the laboratory failed to perform an assessment for unacceptable proficiency test (PT) results. Findings: 1. Review of the laboratory's "Proficiency Testing Procedure" revealed "Any result that is deemed unacceptable or unsuccessful must be investigated using the 'Unsuccessful/Unacceptable PT Checklist.' This form provides guidance in conducting an investigation of an unacceptable or unsuccessful PT result." 2. Review of the laboratory's 2019 American Proficiency Institute (API) results PT results revealed the laboratory received the following unacceptable results: 2nd Event Hematology/Coagulation: White Blood Cell Differential 80%: Granulocytes 80%, Lymphocytes 60% a) Sample HEM-08 for Granulocytes and Lymphocytes: "Unacceptable" b) Sample HEM-09 for Lymphocytes: "Unacceptable" 3. Further review of the laboratory's 2019 PT records revealed the laboratory did not perform an assessment for the identified unacceptable PT results. 4. In interview on February 21, 2020 at 11:30 am, Testing Personnel 1 and Testing Personnel 2 stated they were unsure of what was done about the identified PT results. Testing Personnel 1 and Testing Personnel 2 further stated the previous employee handled the PT results before Testing Personnel 1 was hired in November 2019. 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 record review and interview with personnel, the laboratory failed to follow their established quality control (QC) procedure for LIM broth. Findings: 1. Review of the laboratory's "Additional QC Procedures For Meridian Illumigene Group B -- 2 of 9 -- Strep Assay, LIM Broth" procedure revealed the laboratory is to perform the following procedures for each new lot and/shipment of broth and document: a) "QC for Sterility" b) "QC for Ability to Produce Growth" c) "Visual Inspection" 2. Further review of the identified procedure revealed the results for the QC procedures would be recorded on the "LIM Broth QC Log." 3. Review of the laboratory's documents for Group B streptococcus testing revealed the laboratory did not have documentation of QC for new lots and/or shipments for LIM broth. 4. In interview on February 17, 2020 at 12:03 pm, Testing Personnel 1 and Testing Personnel 2 stated they were unaware of the LIM Broth QC log book and QC procedure. Testing Personnel 1 confirmed the laboratory did not perform QC on new lot and/or shipment of LIM broth. 5. Review of the laboratory's test menu revealed the laboratory performs 1,675 Group B streptococcus tests annually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review and interview with personnel, the laboratory failed to monitor the temperature where supplies are stored. Findings: 1. Observation by surveyor during laboratory tour on February 21, 2020 revealed the laboratory stored the following supplies on a shelf in the bathroom without monitoring the temperature: a) Acid Reagent, Lot # 901654, Quantity: one (1) bottle b) Base Reagent, Lot # 867014, Quantity: one (1) bottle c) Wash 1,Lot #877362, Quantity: two (2) bottles 2. Review of the manufacturer storage requirements for the identified items revealed the following: a) Acid Reagent, storage temperature 2-25 degrees Celsius b) Base Reagent, storage temperature 2-25 degrees Celsius c) Wash 1, storage temperature 2-25 degrees Celsius 3. In interview on February 21, 2020 at 9:19 am, Testing Personnel 1 stated the temperature of the bathroom, where supplies are stored, is not monitored. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: -- 3 of 9 -- Based on record review and interview with personnel, the laboratory failed to perform temperature checks in 2019 on the thermal cyclers utilized for molecular testing. Findings: 1. Review of the laboratory's maintenance records revealed "Thermal Cycler Temperature Validation Record" forms for the laboratory's Eppendorf Mastercycler, Serial Number 5333Z0959146 and 5333ZN358788. The temperature validations were performed March 15, 2018. 2. Further review of the laboratory's maintenance records revealed the temperature validatios were not performed in 2019. 3. In interview on February 21, 2020 at 3:27 pm, Testing Personnel 1 stated she did not find documentation of the temperature validations being performed in 2019. Testing Personnel 1 stated it can no longer be done in-house because the supplies are not offered. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to perform calibration procedures on the Cell-Dyn 1800 utilized for Complete Blood Count (CBC) testing every six (6) months. Findings: 1. Observation by surveyor during the laboratory tour on February 21, 2020 revealed the laboratory utilized a Cell-Dyn 1800 instrument for CBC testing. 2. Review of the "Cell-Dyn 1800 System Operator's Manual" under "Calibration Procedures" revealed the following: "Criteria must be established for calibration verification. Criteria to include: a) when there is a reformulation of a vendor's reagent or when switching to a different reagent vendor b) when indicated by quality control data c) following major maintenance or service d) when directed by Abbott communications e) at least every 6 months" 3. Review of the laboratory's records revealed the laboratory did not have documentation of calibration verification performance in 2018 or 2019. 4. In interview on February 21, 2020, Testing Personnel 1 stated calibrations have not been performed since she has been at the laboratory (hire date November 2019). Testing Personnel 1 confirmed the laboratory did not have documentation of calibration verifications at least every six (6) months for 2018 or 2019. -- 4 of 9 -- D5783

Summary Statement of Deficiencies D0000 A PT Desk Review SURVEY was performed on October 5, 2018. Newco Women's Medical Clinic- 19D0982695 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 achieve satisfactory 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 -- performance for White Blood Cell Differential in two of three consecutive events resulting in initial unsuccessful participation. See D2130 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 670% b. 2018 Event 1: Score of 73% 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 achieve satisfactory performance for White Blood Cell Differential in two of three consecutive events resulting in initial unsuccessful participation. See D2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on March 20, 2018 at Newco Women's Medical Center-CLIA ID # 19D0982695. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. 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 record review and interview with personnel, the laboratory failed to perform an assessment for unacceptable proficiency test (PT) results. Findings: 1. Review of the laboratory's 2017 American Proficiency Institute (API) PT results revealed the laboratory received the following unacceptable results: 1st Event Chemistry Core: Sample CH-03 for HCG- 80% 3rd Event Hematology/Coagulation: Sample HEM-13 for Lymphocytes-80% 2. Review of the laboratory's PT records revealed the laboratory did not perform an assessment for the identified unacceptable PT results. 3. In interview on March 20, 2018 at 1:55 pm, Personnel 2 stated an assessment was not performed for unacceptable PT results. Personnel 2 further stated she thought since the overall scores were above 80% nothing further needed to be done. 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish complete policies and procedures. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not establish complete policies for the following: a) Performance specification: detailed procedures for performing accuracy and precision (day-to-day, run-to-run, and within-run variation, as well as operator variance) studies, acceptability criteria for studies, and actions to take when data from the studies fail to meet acceptability criteria 2. In interview on March 20, 2018 at 4:00 pm, Personnel 2 confirmed the laboratory did not have a policy for performance specification studies. 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: I. Based on observation, record review, and interview with personnel, the laboratory failed to have complete verification studies for Syphilis testing. Findings: 1. Observation by surveyor during laboratory tour on March 20, 2018 revealed the laboratory utilizes the Siemens Centaur XP instrument for Syphilis testing. 2. In interview on March 20, 2018 at 1:30 pm, Personnel 2 stated the Syphilis test was added to the Centaur in May 2017. 3. Review of the laboratory's policy and procedure manual revealed the laboratory did not have written policies and procedures for performance specifications that included: written detailed instructions on how testing personnel would verify the accuracy, precision (day-to day, run-to-run, within-run, and operator variance),and reportable and reference ranges as well as acceptability criteria for the verification of the performance specifications. 4. Review of the laboratory's performance verification study documents revealed the following information was not included: *Precision to include day-to-day, run-to-run, within- run, and operator variance *Acceptability criteria and Laboratory Director approval /signature of performance verification studies 5. In interview on March 20, 2018 at 4: 00 pm, Personnel 2 confirmed the laboratory did not have complete precision studies performed. Personnel 2 stated the laboratory performed a patient comparative study with CPL reference laboratory on May 25, 2017. 6. Review of the laboratory's Task 1 and 3 forms revealed the laboratory performs 3,078 Syphilis tests annually. II. Based on observation, record review, and interview with personnel, the laboratory failed to have complete verification studies for HIV testing. Findings: 1. Observation by surveyor during laboratory tour on March 20, 2018 revealed the laboratory utilizes the Siemens Centaur XP instrument for HIV testing. 2. In interview on March 20, 2018 at 1:30 pm, Personnel 2 stated the assay for HIV changed in May 2017. 3. Review of the laboratory's policy and procedure manual revealed the laboratory did not have written policies and procedures for performance specifications that included: written detailed instructions on how testing personnel would verify the accuracy, precision (day-to day, run-to-run, within-run, and operator variance),and reportable and reference -- 2 of 5 -- ranges as well as acceptability criteria for the verification of the performance specifications. 4. Review of the laboratory's performance verification study documents revealed the following information was not included: *Precision to include day-to-day, run-to-run, within-run, and operator variance *Acceptability criteria and Laboratory Director approval/signature of performance verification studies 5. In interview on March 20, 2018 at 4:00 pm, Personnel 2 confirmed the laboratory did not have complete precision studies performed. Personnel 2 stated the laboratory performed a patient comparative study with CPL reference laboratory on May 25, 2017. 6. Review of the laboratory's Task 1 and 3 forms revealed the laboratory performs 3,614 HIV tests annually. 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 observation, record review, and interview with laboratory personnel, the Laboratory Director failed to ensure that complete verification procedures were performed. Refer to D5421 I and D5421 II. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved