Crescent City Surgical Centre Diagnostics, Llc

Summary Statement of Deficiencies D0000 An offsite PT Desk Review was performed on August 1, 2023 at Crescent City Surgical Centre, 19D2016117, was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1403 CONDITION: Laboratory Director, Moderate Complexity 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 laboratory's College of American Pathologist proficiency testing records, CASPER 153D & 155D report the laboratory failed to successfully participate in two of three consecutive proficency testing events in 2022-2023. 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 -- Findings: 1. The laboratory failed to achieve satisfactory score of human chorionic gonadotropin (hCG) in two of three consecutive events, resulting in initial unsuccessful performance. Refer to D2107. 2. The laboratory failed to achieve satisfactory overall score in Endocrinology for two of three consecutive events, resulting in initial unsuccessful performance. Refer to D2108 D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 153D & 155D Report and College of American Pathologists (CAP) proficiency testing results, the laboratory failed to achieve satisfactory score of human chorionic gonadotropin (hCG) in two of three consecutive events, resulting in initial unsuccessful performance. Findings: 1. Review of CASPER 153D & 155D report and proficiency testing results from (CAP) revealed the laboratory received scores of less than 80% for the following events for human chorionic gonadotropin (hCG): a. Event 1 of 2023 received a score of 0% b. Event 3 of 2022 received a score of 100% c. Event 2 of 2022 received a score of 0% D2108 ENDOCRINOLOGY CFR(s): 493.843(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 a review of the CASPER 153D & 155D Report and College of American Pathologists (CAP) proficiency testing results, the laboratory failed to achieve satisfactory overall score in Endocrinology for two of three consecutive events, resulting in initial unsuccessful performance. Findings: 1. Review of CASPER 153D & 155D report and proficiency testing results from (CAP) revealed the laboratory received an overall score of less than 80% for the following events for Endocrinology: a. Event 1 of 2023 received a score of 75% b. Event 3 of 2022 received a score of 100% c. Event 2 of 2022 received a score of 75% 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 CASPER 0155D Report and College of American Pathologists (CAP), the laboratory failed to attain a score of at least 80% for Partial Prothromboplastin Time (PTT) in 2023. Findings: 1. Review of the CMS 155D and -- 2 of 3 -- CAP proficiency testing records revealed the laboratory achieved a score of 40% for PTT in the second event in 2023 for the specialty of Hematology. 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 laboratory's proficiency testing records, CASPER 155D report, and interview with personnel, the Laboratory Director failed to provide overall management and direction. 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: Based on record review and interview with personnel, the Laboratory Director failed to ensure proficiency samples are tested as required. Findings: 1. The laboratory failed to achieve satisfactory score of human chorionic gonadotropin (hCG) in two of three consecutive events, resulting in initial unsuccessful performance. Refer to D2107. 2. The laboratory failed to achieve satisfactory overall score in Endocrinology for two of three consecutive events, resulting in initial unsuccessful performance. Refer to D2108 3. The laboratory failed to attain a score of at least 80% for Partial Prothromboplastin Time (PTT) in 2023. Refer to D2121 -- 3 of 3 --

Summary Statement of Deficiencies 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: A Follow-up survey was performed at Crescent City Surgical Centre, CLIA # 19D2016117 on April 4, 2023 through April 5, 2023. Based on observation by surveyors, review of the laboratory's temperature logs, and interview with laboratory personnel, the laboratory failed to ensure supplies were stored per the manufacturer's requirements for forty-one (41) of sixty-seven (67) days reviewed. Findings: 1. On April 4, 2023 at 9:45 a.m. during the laboratory tour, surveyor observed one (1) box of gram stain quality control slides Lot #004732 with storage requirements of 20-35 degrees Celsius in the storage room. 2. Review of the laboratory's temperature logs revealed the laboratory defined the storage room's acceptable temperature limits as 15- 25 degrees Celsius. 3. Further review of the laboratory's temperature logs revealed the laboratory documented temperatures below the manufacturer's requirements of 20-25 degrees Celsius on the following days: January 2, 2023 - 18.1 degrees Celsius January 3, 2023 - 18.2 degrees Celsius January 4, 2023 - 19.9 degrees Celsius January 10, 2023 - 18.1 degrees Celsius January 11, 2023 - 18.7 degrees Celsius January 12, 2023 - 18.6 degrees Celsius January 16, 2023 - 18.3 degrees Celsius January 17, 2023 - 18.7 degrees Celsius January 18, 2023 - 17.9 degrees Celsius January 19, 2023 - 18.7 degrees Celsius January 30, 2023 - 17.8 degrees Celsius January 31, 2023 - 18.9 degrees Celsius February 1, 2023 - 18.1 degrees Celsius February 3, 2023 - 18.6 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 -- degrees Celsius February 6, 2023 - 19.2 degrees Celsius February 7, 2023 - 17.6 degrees Celsius February 9, 2023 - 19.3 degrees Celsius February 14, 2023 - 17.7 degrees Celsius February 15, 2023 - 17.7 degrees Celsius February 16, 2023 - 17.9 degrees Celsius February 20, 2023 - 17.7 degrees Celsius February 21, 2023 - 17.9 degrees Celsius February 22, 2023 - 18.1 degrees Celsius February 24, 2023 - 18.3 degrees Celsius February 27, 2023 - 17.7 degrees Celsius February 28, 2023 - 17.8 degrees Celsius March 1, 2023 - 18.1 degrees Celsius March 2, 2023 - 19.3 degrees Celsius March 3, 2023 - 18.6 degrees Celsius March 6, 2023 - 18.4 degrees Celsius March 7, 2023 - 17.0 degrees Celsius March 8, 2023 - 16.9 degrees Celsius March 9, 2023 - 17.8 degrees Celsius March 10, 2023 - 17.0 degrees Celsius March 13, 2023 - 17.3 degrees Celsius March 20, 2023 - 19.5 degrees Celsius March 21, 2023 - 18.6 degrees Celsius March 24, 2023 - 19.8 degrees Celsius March 27, 2023 - 18.6 degrees Celsius March 28, 2023 - 19.2 degrees Celsius March 31, 2023 - 19.2 degrees Celsius 4. In interview on April 4, 2023 at 10:22 a.m., the Technical Consultant stated the item was not in use and was purchased for possible future testing. She confirmed the item was not stored at the manufacturer's required temperature. -- 2 of 2 --

Summary Statement of Deficiencies D5809 TEST REPORT CFR(s): 493.1291(e) The laboratory must, upon request, make available to clients a list of test methods employed by the laboratory and, as applicable, the performance specifications established or verified as specified in 493.1253. In addition, information that may affect the interpretation of test results, for example test interferences, must be provided upon request. Pertinent updates on testing information must be provided to clients whenever changes occur that affect the test results or interpretation of test results. This STANDARD is not met as evidenced by: A Revisit survey was performed at Crescent City Surgical Centre, CLIA ID # 19D2016117, on September 23, 2020 through September 25, 2020. Based on direct observation, review of Emergency Use Authorization (EUA) instructions test menu, and interview with personnel, the laboratory failed to include "Fact Sheets" to providers or patients for EUA COVID tests. Findings: 1. Observation by surveyor during laboratory tour and review of laboratory's test menu revealed the laboratory performs the following COVID test methods: a) Abbott ID Now b) DTPM COVID method on Quant Studio 5 analyzer c) Elecsys Anti-SARS-CoV-2 on Roche Cobas e801 analyzer 2. Review of the EUA instructions for the indicated tests revealed "Authorized laboratories using your product will include with test result reports, all authorized Fact Sheets." 3. In interview on September 25, 2020 at 9:24 am, Technical Consultant 1 stated she gives fact sheets to patients collected at the laboratory for the Abbott ID Now tests. Technical Consultant 1 stated she was unaware there were "Fact Sheets" for the other two test methods. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) 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 -- The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: A Revisit survey was performed at Crescent City Surgical Centre, CLIA ID # 19D2016117, on September 23, 2020 through September 25, 2020. Based on record review and interview with personnel, the Laboratory Director failed to ensure the laboratory performed performance specification studies for the Coronachek antibody test. Findings: 1. In interview on September 24, 2020 at approximately 9:22 am Technical Consultant 1 stated the laboratory previously used the Coronachek kits for antibody testing. Technical Consultant 1 stated the kits were waived. 2. Review of the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) COVID test list revealed the "Coronachek COVID-19 IgM/IgG Rapid Test Cassettes" were not listed as having an EUA authorization. 2. Review of the manufacturer's package insert revealed the manufacturer as Hangzhou Biotest Biotech Co., Ltd. 4. In interview on September 24, 2020 at 11:44 am, Technical Consultant 1 stated the Coronachek antibody test had an EUA. Technical Consultant 1 further stated the laboratory did not perform validation studies. 5. Review of the records provided by Technical Consultant 1 revealed an abstract article and EUA from a different manufacturer, "COVID-19 IgG/IgM Rapid Test Cassette by Healgen Scientific, LLC" issued May 29, 2020, not the indicated Coronachek kit. 6. Review of the laboratory's "Coronachek COVID-19 IgG/Ig M Test Cassette QC Log" and patient logs revealed the laboratory reported the following patients: Patient 0010889240 Patient 0010889241 Patient 0000001711 Patient 0010889242 Patient 0000001279 7. Further review of the laboratory's Coronachek patient logs revealed the laboratory reported a total of 176 patient results in April 2020 and eighteen (18) patient results in May 2020. D6098 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(8) The laboratory director must ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: A Revisit survey was performed at Crescent City Surgical Centre, CLIA ID # 19D2016117, on September 23, 2020 through September 25, 2020. Based on record review and interview with personnel, the Laboratory Director failed to ensure "Fact Sheets" were provided to patients and providers for EUA COVID tests. Refer to D5809. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting -- 2 of 3 -- and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: A Revisit survey was performed at Crescent City Surgical Centre, CLIA ID # 19D2016117, on September 23, 2020 through September 25, 2020. Based on record review and interview with personnel, the Laboratory Director failed to delegate, in writing, the responsibilities of Technical Supervisor and General Supervisor. Findings: 1. Review of the laboratory's CMS 209 (Laboratory Personnel Report) revealed Technical Consultant 1 serves as Technical Supervisor and General Supervisor. 2. Review of personnel records for Technical Consultant 1 revealed the laboratory did not have documentation of the Laboratory Director delegating the tasks of Technical Supervisor and General Supervisor to her. 3. In interview on September 24, 2020 at 9:22 am, Technical Consultant 1 confirmed the laboratory did not have documentation of the Laboratory Director delegating responsibilities of Technical Supervisor and General Supervisor to her. D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: A Revisit survey was performed at Crescent City Surgical Centre, CLIA ID # 19D2016117, on September 23, 2020 through September 25, 2020. Based on record review and interview with personnel, the Technical Supervisor failed to ensure that a quality control program was established to assure the quality of testing for COVID testing. Refer to D5401. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A PT Desk Review was performed on August 17, 2020. Crescent City Surgical Center, CLIA ID 19D2016117, 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 (PT) results from the CASPER 155D report, the laboratory failed to successfully participate in proficiency testing for Chemistry. Findings: 1. The laboratory failed to attain a score of at least 80% for Albumin and 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 -- Blood Urea Nitrogen (BUN) for two (2) events in 2020. Refer to D2087. 2. The laboratory failed to participate in two (2) events for 2020 resulting in unsatisfactory performance and a score of zero for Albumin. Refer to D2089. 3. The laboratory failed to achieve a score of at least 80% for Albumin in two consecutive events, resulting in an initial unsuccessful performance. Refer to D2096 I. 4. The laboratory failed to achieve a score of at least 80% for Blood Urea Nitrogen (BUN) in two consecutive events, resulting in an initial unsuccessful performance. Refer to D2096 II. D2087 ROUTINE CHEMISTRY 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 review of the proficiency testing results from the CASPER Report 155D, the laboratory failed to attain a score of at least 80% for Albumin and Blood Urea Nitrogen (BUN) for two (2) events in 2020. Findings: 1. Review of CASPER Report 155D proficiency test results revealed the laboratory did not achieve a score of at least 80% for the specialty of Chemistry for the following two (2) events and analytes: 2020 1st Event Albumin score received 0% 2020 2nd Event Albumin score received 0% 2020 1st Event BUN score received 60% 2020 2nd Event BUN score received 20% . D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the proficiency testing results from the CASPER Report 155D, the laboratory failed to participate in two (2) events for 2020 resulting in unsatisfactory performance and a score of zero for Albumin. Findings: 1. Review of CASPER Report 155D proficiency test results for Albumin revealed the laboratory did not participate and achieved a score of zero for the following two (2) test events in 2020: a) 2020 1st Event Albumin score received 0% b) 2020 2nd Event Albumin score received 0% D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two -- 2 of 3 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: I. Based on review of proficiency testing results from the CASPER 155D report, the laboratory failed to achieve a score of at least 80% for Albumin in two consecutive events, resulting in an initial unsuccessful performance. Findings: 1. Review of CASPER Report 155D proficiency test results for Albumin revealed the laboratory received the following scores resulting in an initial unsuccessful performance: a) 2020 1st Event Albumin score received 0% b) 2020 2nd Event Albumin score received 0% II. Based on review of proficiency testing results from the CASPER 155D report, the laboratory failed to achieve a score of at least 80% for Blood Urea Nitrogen (BUN) in two consecutive events, resulting in an initial unsuccessful performance. Findings: 1. Review of CASPER Report 155D proficiency test results for BUN revealed the laboratory received the following scores resulting in an initial unsuccessful performance: a) 2020 1st Event BUN score received 60% b) 2020 2nd Event BUN score received 20% 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, 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: Based on record review, the Laboratory Director failed to ensure that proficiency testing results are satisfactory as required. Findings: 1. The laboratory failed to attain a score of at least 80% for Albumin and Blood Urea Nitrogen (BUN) for two (2) events in 2020. Refer to D2087. 2. The laboratory failed to participate in two (2) events for 2020 resulting in unsatisfactory performance and a score of zero for Albumin. Refer to D2089. 3. The laboratory failed to achieve a score of at least 80% for Albumin in two consecutive events, resulting in an initial unsuccessful performance. Refer to D2096 I. 4. The laboratory failed to achieve a score of at least 80% for Blood Urea Nitrogen (BUN) in two consecutive events, resulting in an initial unsuccessful performance. Refer to D2096 II. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification Survey was performed at Crescent City Surgical Centre , CLIA ID # 19D2016117 on January 14, 2020 through January 15, 2020. Crescent City Surgical Centre 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to assess competency for two (2) of three (3) Technical Consultants per their policy. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed three (3) Technical Consultants. 2. Review of the laboratory's "Competency" policy revealed "Documented competency assessment is required for the personnel listed as Technical Consultant/Clinical Consultant on the 209 Form. This competency will be performed annually." 3. Review of personnel records revealed the laboratory did not perform competency assessments in 2019 for the duties of Technical Consultant for Technical Consultant 2 and Technical Consultant 3. 4. In interview on January 14, 2020, Technical 1 confirmed the Laboratory Director did not perform competency assessments for the identified Technical Consultants. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(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 12 -- 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 record review and interview with personnel, the laboratory failed to document the review of the performance evaluation for proficiency testing. Findings: 1. Review of the laboratory's "Proficiency Test" policy under "Survey Result Evaluation" section revealed "The Technical Consultant/Laboratory Manager is to perform the survey result evaluation review upon receipt of the result evaluation which includes any

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on February 27, 2018 at Crescent City Surgical Centre-CLIA ID # 19D2016117. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. 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 record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were maintained for assessing personnel competency, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Refer to D6051. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Consultant failed to ensure all testing personnel were assessed through testing previously analyzed specimens, internal blind samples, or external proficiency samples. Findings: 1. Review of the laboratory's CMS-209 (Laboratory Personnel Report ) form revealed the following testing personnel: Personnel 3 Personnel 4 Personnel 5 Personnel 6 Personnel 7 Personnel 8 Personnel 9 Personnel 10 Personnel 11 2. Review of the laboratory's "Personnel Competency" policy revealed "Competency evaluations should be accomplished by fulfilling the following requirements for each test that personnel are approved to perform: Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing." 3. Review of the laboratory's 2017 and 2018 American Proficiency Institute (API) Proficiency Testing (PT) and personnel competency assessment records revealed the following personnel did not perform previously analyzed specimens, internal blind samples, or external proficiency samples testing: Personnel 4 Personnel 5 Personnel 6 Personnel 7 Personnel 8 Personnel 9 Personnel 10 Personnel 11 4. In interview on February 27, 2018 at 2:30 pm, Personnel 3 stated she performs all testing of PT samples. Personnel 3 confirmed the identified testing personnel were not assessed through testing previously analyzed specimens, internal blind samples, or external proficiency samples. -- 2 of 2 --