Psychological Addiction Services Llc

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor review of quality control (QC) logs and patient records and interview with the laboratory director, the laboratory used expired quality control material for seventy-two of seventy-two testing days between February 29, 2024, and June 10, 2024. Findings include: 1. Review of QC records showed a study from another facility, not the manufacturer, to extend the expiration date of the Biochemical Diagnostics QC used for patient testing. Further review showed the laboratory changed the expiration date from February 28, 2024, to August 31, 2024, based on the study. 2. Review of QC logs showed the expiration date for Lots CC01461, CC01460, CC01485 and CC01484 had an expiration date of February 28, 2024, on the February log and an expiration date of August 31, 2024, on the logs from March through June. 3. Review of patient records showed 4053 patient tests were performed from February 29, 2024, through June 10, 2024. 4. Interview with the laboratory director on June 10, 2024, at 10:45 AM confirmed the laboratory used expired quality control material from February 29, 2024, through June 10, 2024. 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 --

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: Based on surveyor review of laboratory procedures and interview with the laboratory director, the laboratory's procedure for proficiency testing (PT) did not specify the samples may be used to assess competency and did not specify discussing results with additional staff at another laboratory after the submission deadline to prevent referral of proficiency testing. Finding include: 1. Review of the "Quality Assessment Policy" under Proficiency testing showed the following statements: a. "In addition, results may not be discussed with staff at another laboratory until results have been submitted to the PT agency". b. "Residual PT specimens may be used to assess the competency of testing personnel". 2. Interview with the laboratory director on December 16, 2020 at 10:45 AM confirmed the procedure was not specific in referencing the submission deadline to prevent referral of proficiency testing. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have 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 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the laboratory director, the laboratory did not maintain documentation of their calibrator lots on the "PAS Calibrator Lot Log" to ensure expired supplies are not used for patient testing from April 2019 through December 2020. Findings include: 1. Review of the "PAS Calibrator Lot Log" showed the laboratory did not document: a. Specialty Drug Calibrator one through four after Start date of September 15, 2019 with an expiration date of October 24, 2020. b. Drugs of Abuse (DAU) Calibrator Level two after Start date of April 26, 2019 with an expiration date of July 5, 2019. c. Drugs of Abuse (DAU) Calibrator Level five after Start date of April 26, 2019 with an expiration date of July 24, 2019. d. Methadone metabolite (EDDP) Calibrator two after Start date of January 8, 2020 with an expiration date of March 31, 2020. 2. Interview with the laboratory director on December 16, 2020, at 10:45 AM confirmed the laboratory did not maintain documentation of the calibrator lots from April 2019 through December 2020. This is a repeat deficiency from December 5, 2018. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of manufacturer's instructions, patient result reports, and interview with the technical consultant, the laboratory did not follow manufacturer's instructions for confirming positive toxicology test results. Findings include: 1. Review of Siemens Syva Emit II Plus Opiate Assay package insert states: "The Emit II Plus Opiate Assay provides only a preliminary test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result." 2. Review of patient reports show results of "Positive" with no confirmatory testing performed. 3. Interview with the technical consultant on December 5, 2018 at 2:30 PM confirms that toxicology results are reported as positive and confirmatory testing is not always performed as required by the manufacturer. 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. 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 surveyor review of Siemens V-Twin Operator Manual, laboratory policies, maintenance logs, and interviews with lab testing personnel, the laboratory has not monitored and documented room temperature and humidity as required. Findings include: 1. Review of Siemens V-Twin Operator Manual states that room temperature must be between 15-32 degrees Celsius, and humidity between 0-80%. 2. Review of laboratory "Quality Assurance Policy" states that room temperature and humidity must be monitored to assure acceptable levels according to manufacturer requirements. 3. Review of laboratory maintenance logs show no documentation of room temperature or humidity. 4. Interview on December 5, 2018 at 3:30 PM with two of two testing personnel confirms the laboratory does not monitor or document room temperature and humidity as required to ensure manufacturer requirements are met. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with lab testing personnel, the laboratory does not have a mechanism to document reagent, calibrator, and control lot number in-use dates to ensure expired supplies are not used for patient testing. Findings include: 1. Review of "Laboratory Reagent/Calibrator/Control Lot Numbers" log shows no record of dates when controls and calibrators are put into use. 2. Further review of "Laboratory Reagent/Calibrator/Control Lot Numbers" log show no reagents for the Siemens V-Twin chemistry analyzer are documented on the log. 3. Interview with both lab testing personnel on December 5, 2018 at 3:30 PM confirms that reagents, calibrators and controls for the Siemens V-Twin chemistry analyzer are not documented when they are put into use, therefore there is no mechanism to ensure expired reagents are not used for patient testing. 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 quality control (QC) records of toxicology testing and interview with the technical consultant, the laboratory utilized calibration material of the same concentration and lot number used to calibrate the Siemens V-Twin chemistry analyzer as quality control material. Findings include: 1. Review of quality control records show the following calibrators were used on April 5, 2018 as control -- 2 of 6 -- materials: *Calibrator Level 0 used for QC for Cocaine, Methadone, and Opiates analytes. *Calibrator Level 1 used for QC for Amphetamines analyte. *Calibrator Level 2 used for QC for Benzodiazepine, Opiates, and Tetrahydrocannabinol (THC) analytes. *Calibrator Level 3 used for QC for Amphetamines, Cocaine, and Methadone analytes. *Calibrator Level 4 used for QC for Benzodiazepine and THC analytes. *Calibrators 2-Ethylidene-1, 5-Dimethyl-3, 3-Diphenylpyrrolidine (EDDP) Low 225 and EDDP High 375 used for QC for EDDP analyte. *Calibrators 6-Acetyl Morphine (6 AM) Level 1 and 6 AM Level 3 used for QC for 6 AM analyte. 2. Interview with the technical consultant on December 5, 2018 at 3:00 PM confirms the laboratory used calibration material of the same concentration and lot number used to calibrate the Siemens V-Twin chemistry analyzer as quality control material. 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 surveyor review of performance verification and proficiency testing records, and interview with the technical consultant, the laboratory director has not provided overall management and direction in accordance with 493.1407 of this subpart. Findings include: 1. Performance verification records were not approved before the start of patient testing. See D6013. 2. Proficiency testing reports were not reviewed to evaluate the laboratory's performance and identify problems. See D6018. 3. The laboratory did not have a qualified individual to provide technical oversight services to the laboratory for six months after patient testing began. See D6028. 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 performance verification records and interview with the technical consultant, the laboratory director failed to ensure the verification procedures were adequate for the Siemens V-Twin chemistry analyzer prior to implementation for patient testing on March 29, 2018. Findings include: 1. Review of performance verification records for the Siemens V-Twin analyzer show no evidence the lab director approved, signed, or dated the verification of performance specifications for the test system prior to implementation for patient testing on March 29, 2018. 2. Interview with the technical consultant on December 5, 2018 at 11:00 -- 3 of 6 -- AM confirms the lab director did not evaluate and approve the accuracy, precision, reportable ranges, and reference intervals as part of the performance verification for the Siemens V-Twin analyzer. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require