Crestview Clinical Laboratory, Llc

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of test result reports requested and interview with the laboratory director (LD) and laboratory personnel (LP); it was determined that the laboratory failed to retrieve quality control (QC) failed- retesting results and instruments printouts for patients testing. The findings included: 1. The laboratory maintained digital electronic records only. 2. At the time of the survey on August 6, 2024, at approximately 1:30 p.m. the LP failed to retrieve QC failed - retesting and instrument printouts records for three (3) out of fourteen (14) randomly selected patients records requested for review. 3. The LP affirmed that QC failed - retesting and instrument printouts records for September 9, 2022 (two patients testing records) and January 27, 2023 (one patient testing records) were not retrievable at the time of the survey. 4. Based on the laboratory's testing declaration submitted at the time of the survey, the laboratory analyzed and reported approximately 1,200 tests annually for which the laboratory was unable to retrieve QC failed - retesting documentation and instrument printouts records from the Quant Studio analyzer. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures and interview with the laboratory director (LD) it was determined that the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor and assess records identified in the general laboratory systems. The findings included: 1. Based on the lack of a quality assurance plan and interview with the LD on the day of survey on August 6, 2024, at approximately 1:30 p.m., no documentation could be retrieved to show that the laboratory had established and performed quality assessment and assurance. 2. The LD affirmed by interview that the laboratory did not have any documentation of written policies and procedures reflecting the current practice for an ongoing mechanism to monitor and assess records identified in the general laboratory systems. 3. According to the testing declaration signed and dated by the LD submitted on August 6, 2024, the laboratory performed 1,200 tests annually. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on surveyors' review of the laboratory's policies and procedures, test requisitions, and interview with the laboratory director, and laboratory personnel; it was determined that the laboratory failed to monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as speciefied in 493.1249. for each specialty and subspecialty of testing performed. See D 5311 and D5391. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of randomly selected patients' sampling test orders and interviews with the laboratory director (LD) and laboratory personnel (LP) on August 6, 2024 at approximately 3:00 p.m., it was determined that the laboratory failed to have written or electronic requests for patient testing from an authorized person. The findings included: 1. On the day of the survey August 6, 2024, the laboratory failed to provide a complete list of authorized submitters. 2. In 2021 the laboratory accepted 3,561 tests requests from Community Wellness of America from a non-authorized person (non- MD). 3. From 3,561 accepted test requests from Community Wellness of America from a non-authorized person, the laboratory rejected 232 patients' specimens for reasons other than being submitted from a non-authorized person. 4. The laboratory -- 2 of 6 -- tested and reported 3,321 SARS-CoV-2 test results from Community Wellness of America from a non-authorized test requestor. 5. The LD and LP confirmed that the laboratory had processed and reported test results from a non-authorized submitter. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) 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 the surveyors' review of the preanalytical policy and procedures and interview with the laboratory director (LD) and laboratory personnel (LP) on 08/06 /2024 at approximately 2:00 pm, the laboratory failed to follow written policy and procedure for specimen acceptability and rejection criteria. The findings included: 1. The laboratory performed SARS-CoV-2 (Covid19) and the Multiplex (Covid19, Influenza A&B, and RSV) detection tests on patient specimens by Real Time Polymerase Chain Reaction (Rt-PCR) using the QuantStudio analyzer. 2. The LD and LP confirmed that the laboratory failed to follow written policies and procedures for patient Covid19 and Multiplex Rt-PCR tests for acceptance and rejection policy in regard to requisition validity. 3. According to the LD and LP, the laboratory begun testing for Covid19 on September 20, 2021, and Multiplex testing was performed in 2023 until April 30, 2024, without establishing and following policies for specimen acceptability and rejection as stated in 2. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on the surveyors' review of the laboratory's policies & procedures, patients' test records, and interview with the laboratory director (LD) and laboratory personnel (LP); the laboratory failed to establish and follow written policies and procedure to assess quality of its preanalytical systems. The findings include: 1. The laboratory did not have a system in place to identify problems in the preanalytical system such as test request and sample rejection. When the laboratory discovers an error or identifies a potential problem, actions must be taken to correct the situation. This correction process involves identification, immediate resolution of the problem, and development of policies that will prevent its reoccurrence. 2. The LD and LP on the day of the survey at approximately 2:30 p.m., affirmed that the laboratory did not establish and follow preanalytic systems quality assessment policies and procedures. 3. The laboratory's testing declaration form, signed by the laboratory director on 8/6 /2024 stated that the laboratory performed approximately 1,200 tests annually. -- 3 of 6 -- D5781

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performances for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting non-initial unsuccessful PT performance. (See D2096) 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performances for the same analyte or test in two out of three consecutive PT events for Iron, Total, as follows: 2019 2019 2020 Q2 Q3 Q1 Program AAB AAB API Iron, Total 20% 0% 60% Q1 = First testing event Q2 = Second testing event Q3 = Third testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in a subsequent unsuccessful performance for the analyte, Iron, Total. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte Iron, Total, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in non-initial unsuccessful PT performance. (See D2016 and D2096) -- 2 of 2 --

Summary Statement of Deficiencies D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: On review of the deficiency cited it was noted that a transcription error occurred. This statement should be cited under D2109. Based on review of the CMS proficiency testing (PT) records report 96D (CLIA Application and Survey Summary) for 2018 and 2019 testing results and interview with the laboratory technical supervisor, it was determined that the laboratory failed to participate in the PT first event 2018 (Q1- 2018) for Toxicology resulting in a score of zero. The findings included: a. The laboratory received a score of 0% for Q1-2018 in the subspecialty Toxicology. b. The technical supervisor (TS) affirmed 03/04/2020 at 15:00 that the proficiency testing records from AAB as well as patients reports from the year 2018 were not available for review due at the time of the survey (03/04/2020). c. The number of samples tested for lead during Q1-2018 time period is unknown. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- 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 review of the laboratory's Proficiency Testing policy SOP #CVDL.AN.215 the laboratory must document the handling, preparation, processing, examination, and each step in the testing, reporting, testing failures, and

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performance. (See D2096) 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Iron, Total, resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, Iron Total, as follows: 2019 Q2 2019 Q3 Iron, Total 20% 0% Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analytes, Iron, Total. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, Iron, Total, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2096) -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --