Advanced Comprehensive Laboratory Llc

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% or more for Hematology tests performed with the American Proficiency Institute (API). The finding includes: 1) The laboratory scored 60% for Erythrocyte Count (EC) Hematocrit (HCT), and Platelet Count (PLT) for 1st event - 2023 with API. 2) The laboratory scored 0% for EC, HCT, and PLT for 3rd event - 2022 with API. D2123 HEMATOLOGY CFR(s): 493.851(c) 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 -- 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 an office review of the CASPER reports 153, 155 and the performance summary form American Proficiency Institute (API). 2022 hematology event 3. The laboratory failed to participate in the third API aforementioned Proficiency Testing (PT) event of 2022 for Hematology tests. 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 surveyor review of Proficiency Testing (PT) and interview with the Testing Personnel (TP), the laboratory failed to achieve a score of 80% or more in two out of three events for for Hematology tests performed with the American Proficiency Institute (API). The findings include: 1) The laboratory scored 60% for Erythrocyte Count (EC) Hematocrit (HCT), and Platelet Count (PLT) for 1st event - 2023 with API. 2) The laboratory scored 0% for EC, HCT, and PLT for 3rd event - 2022 with API. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor review of the Proficiency Testing (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to maintain Attestation Statements (AS) for Urine Toxicology (UT), Oral Fluid Drug Testing (OFD), Urine Drug Adulterant/Integrity (DAI), Forensic Urine Drug Testing Confirmation (UDC) and Urine Drug Testing Screening (UDS) PT events in 2017 and 1-2018 with the College of American Pathologists (CAP). The findings include: 1. The AS was not found at the time of the survey for OFD - D 2017. 2. The Laboratory Director did not sign the AS for: a. UT - C 2017 b. UDC - D 2017 c. DAI - A 2018 d. UDS - A 2018 3. Testing Personnel did not sign the AS for UT - C 2017. 4. The TS confirmed on 5/15 /18 at 10:45 am that all PT records were not maintained. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing 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 -- performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the laboratory failed to evaluate coded results for Forensic Urine Drug Testing Confirmation (UDC), Oral Fluid Drug Testing (OFD), Urine Drug Adulterant/Integrity (DAI) and Urine Drug Screening (UDS) obtained with the College of American Pathologists (CAP) in the 2017 and 1-2018. The findings include: 1. The laboratory did not evaluate Code 26 (Educational challenge) as follows: a. 2017 - OFD- Diazepam Qualitative sample OFD -16 and Qualitative sample OFD - 19, Methylenedioxyamphetamine, Nordiazepam and Temazepam Qualitative samples OFD-16-20 b. 2018 - DAI - A Interpretation samples DAI 01-03 and OFD - A Oxycodone, Cocaine and Alprazolam Qualitative and Quantitative samples OFD 01-05, Delta 9 - THC - COOH, Buprenorphine and Norbuprenorphine Qualitative samples OFD 01-05 c. 2018 - UDS Amphetamine/Methamphetamine sample UDS - 05 2. The laboratory did not evaluate Code 30 ( Scientific Committee Decision) for UDS - Ethanol samples UDS 01 - 05. 3. The TC confirmed on 5/15/18 at 10:45 am that the laboratory failed to evaluate coded results. 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 surveyor review of the Proficiency Testing (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to evaluate results when the laboratory received an unacceptable score in PT for Forensic Urine Drug Testing Confirmation (UDC), Urine Toxicology(UT) and Oral Fluid (OFD) Forensic Drug Testing performed with the College of American Pathologists (CAP) in 2017 and 1- 2018. The finding includes: 1. There was no review or evaluation documented when the laboratory received an unacceptable result for Urine and Oral Fluid Toxicology Results as follows: a. UT - C 2017 sample UT-14 b. UDC - D 2017 Phencyclidine samples UDC - 32 and 36 c. OFD - D 2017 Benzoylecgonine sample OFD-16 d. CAP off cycle survey UDC Codeine UDC-56, Methamphetamine UDC-58, Delta-9-THC- COOH UDC-60, Phencyclidine UDC-52 e. Urine Drug Screening - UDS 2018 - Delta- 9-THC-COOH sample UDS-01 2. The TS confirmed on 5/15/18 at 10:00 am that the laboratory did not perform and document an evaluation of unacceptable PT performance. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Patient Data (PD) and -- 2 of 5 -- interview with the Technical Supervisor (TS), the laboratory failed to follow the established procedure for Chromatography review in May 2018. The finding includes: 1. The PM stated under Procedure section 4: if the Ion Ratio (IR) is outside the acceptable limit, the peak cannot be confirmed as the analyte and must be repeated. 2. Observation of the PD on the instrument revealed the IR failed but there was no documented evidence of a repeat. 3. The TS confirmed on 5/15/18 at 2: 05 pm that the PM was not followed. D5467 CONTROL PROCEDURES CFR(s): 493.1256(d)(9)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual, Calibrators, Controls and interview with the Technical Supervisor (TS), the laboratory failed to use different lot numbers of calibrators to make the calibrator and controls from October 2017 to the date of the survey. The TS confirmed on 5/15/18 at 2:10 pm the laboratory did not use different lot numbers of calibrators. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on the surveyor review of the Procedure Manual and interview with the Technical Supervisor (TS), the laboratory failed to establish written procedures to monitor and assess Quality Control for Toxicology tests performed on the AB Sciex from October 2017 to the date of the survey. The findings include: 1. The laboratory did not establish a procedure to validate the expiration date for prepared reagents, calibrators, standards and controls. 2. Expiration dates were arbitrarily given as follows: a. Controls and calibrators - one year b. Working calibrator - two weeks c. QC frozen and then thawed - 2 weeks after thawing d. Mobile Phase - 1 week e. Injection needle wash - 1 month 3. The TS confirmed on 5/15/18 at 12:00 pm the laboratory did not validate expiration dates. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report and interview with the Technical Supervisor, the laboratory failed to identify the source of the Cutoff Ranges used for Urine Drug Confirmation tests from October 2017 to the date of survey. The TS confirmed on 5/15/18 at 2:20 pm that the source of the Cutoff ranges was not known. 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 surveyor review of the Toxicology Performance Specification (PS) records and interview with the Technical Supervisor (TS), the laboratory director failed to ensure that accuracy was performed on qualitative tests performed on the AU 680 analyzer was adequate in January 2018. The findings include: 1. The laboratory had no positive agreement for qualitative method comparison for, Cocaine, Phencyclidine , Propoxyphene, Methenamine, and Ethanol. 2. The laboratory used two quantitative test methods when performing qualitative method comparison. 3. The TS Confirmed on 5/15/18 at 11:00 am that accuracy was not perfomred. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that 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 surveyor review of the Performance Specification (PS) records and interview with the Technical Supervisor (TS) the Laboratory Director (LD) failed to ensure PS were adequate to perform Toxicology testing on the AB Sciex from July 20, 2017 to the date of survey. The findings include: 1. A review of the Linearity, Accuracy, Carryover records for Buprenorphine revealed that Accuracy was unacceptable for the target value of two but two was used for the "lowest standard that met the ion's ratio's acceptance criteria (LOD)". 2. The linearity study for Buprenorphine revealed it to be linear from 5 -1000 but the LOD was two. 2. The Parallel Study performed for Fentanyl did not have any results or documentation of acceptance. 3. The Parallel Study for Buprenorphine was performed with one spiked sample. 4. There was no documentation to substantiate studies for interfering substance were performed. 5. There was no documented evidence to show the validation of the Hydrolysis Control was performed. 6. There was no documented evidence to show the results of the carryover study. 7. The method comparison reviewed at the time of the survey was performed using the Beckman Au 680 a -- 4 of 5 -- qualitative method not quantitative. 8. The TS confirmed on 5/15/18 at 1:40 pm that the LD did not ensure the PS were adequate. -- 5 of 5 --