Tox Testing Inc

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 record review and interview, the laboratory failed to successfully participate in the virology proficiency testing program. Refer to D2064. D2064 VIROLOGY CFR(s): 493.831(e) 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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor, the laboratory failed to successfully participate in the virology proficiency testing program for two (2023 event 3 and 2024 event 2) of three consecutive proficiency testing events. Findings include: 1. A review of the laboratory's American Proficiency Institute (API) revealed the following scores for the virology specialty: a. 2023 event 3 had a score of 73%. b. 2024 event 2 had a score of 0%. 2. A phone interview on 8/12/24 at 9:00 am with the General Supervisor confirmed the score for 2023 event 3 and nonparticipation in 2024 event 2. -- 2 of 2 --

Summary Statement of Deficiencies 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 the General Supervisor (GS), the laboratory failed to establish and implement policies and procedures to assess the competency of personnel serving the roles of Clinical Consultant (CC), Technical Consultant (TC), Technical Supervisor (TS), General Supervisor (GS), and Testing Personnnel (TP) job responsibilities for 18 (May 2021 to October 2022) of 18 months reviewed. Findings include: 1. A review of the laboratory's personnel records revealed a lack of documentation for the competency assessments for the CC, TC, TS, GS, and TP job responsibilities. 2. A review of the laboratory's policy and procedure for assessing competency revealed a lack of job responsibilities for the CC, TC, TS, GS, and TP. 3. An interview on 10/25/22 at 9:53 am, the GS confirmed the laboratory had not established or implemented a policy or procedure for assessing competency for job responsibilities for the roles listed above. 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 D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation and interview with Testing Personnel #2 (TP2), the laboratory failed to label reagents and solutions with the strength or concentration, preparation dates, and expiration dates for three containers observed during the laboratory tour. Findings include: 1. During a tour of the laboratory on 5/20/21 at 8:52 am, the surveyor observed three reagent bottles that lacked strength or concentration of the solutions, preparation dates, and expiration dates labeled with the following: a. "Water + 4 mL FA" connected to the 4000 Qtrap toxicology analyzer. b. "LC/MS Needle Wash" connected to the 4000 Qtrap toxicology analyzer. c. "Needle Wash" found on the counter in the laboratory. 2. The surveyor requested the laboratory's reagent labeling policy on 5/27/21 at 12:51 pm and it was not made available 3. An interview on 5/20/21 at 8:51 am with TP2 revealed the reagent bottles listed above are all reagents that are prepared by the laboratory. "FA" stands for formic acid and the "Needle Wash" contains methanol, water, and isopropanol. TP2 confirmed the lack of strength or concentration of the solutions, preparation dates, and expiration dates listed on the reagent bottles listed above. 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 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 the CMS database and review of the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the specialty of hematology. Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for 2 (3rd 2019 and 1st 2020) of 2 consecutive testing events. Refer to D2123 and D2131. D2123 HEMATOLOGY 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 -- CFR(s): 493.851(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 CMS database and review of the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to participate in 2 (3rd 2019 and 1st 2020) of 2 testing events for the specialty of hematology, which is unsatisfactory performance resulting in a testing event score of 0%. Findings include: Unsatisfactory performance for 2 of 2 overall testing events for the failure to participate in the speciality of hematology constitutes unsuccessful performance. Hematology PT Events Score 3rd event 2019 0% 1st event 2020 0% D2131 HEMATOLOGY CFR(s): 493.851(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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to participate and achieve satisfactory performance for 2 (3rd 2019 and 1st 2020) of 2 testing events for the following overall hematology specialty and for each individual analyte: Cell Identification (ID) or white blood cell diff (WBC Diff), red blood cell count (RBC), hematocrit (HCT), hemoglobin (HGB), white blood cell count (WBC), and platelets. Findings include: For the hematology specialty and for each analyte listed above the following scores: Hematology PT Event Score 3rd event 2019 0% 1st event 2020 0% -- 2 of 2 --

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 review of the CMS database and review of the American Proficiency Institute (API) final graded proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the specialty of routine chemistry. Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for 2 (3rd 2019 and 1st 2020) of 2 consecutive testing events. Refer to D2089 and D2097. 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 -- 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 CMS database and review of the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to participate in 2 (3rd 2019 and 1st 2020) of 2 testing events for the specialty of routine chemistry, which is unsatisfactory performance resulting in a testing event score of 0%. Findings include: Routine Chemistry PT Event Score 3rd event 2019 0% 1st event 2020 0% D2097 ROUTINE CHEMISTRY CFR(s): 493.841(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 review of the CMS database and the American Proficiency Institute (API) final proficiency testing reports, the laboratory failed to achieve satisfactory performance for 2 (3rd 2019 and 1st 2020) of 2 testing events for the following overall routine chemistry analytes: Alanine transaminase (ALT), Albumin, Alkaline phosphatase (ALK Phos), Aspartate transaminase (AST), Total Bilirubin (T. bili), Calcium Total (CA Total), Chloride (CL), Cholesterol Total , Cholesterol High Density Lipoprotein (HDL), Creatinine, Glucose, Iron Total, Magnesium (MG), Potassium (K), Sodium (NA) , Total Protein (T. Protein), Triglycerides (Trigl), Urea Nitrogen (BUN), and Uric Acid. Findings include: For each analyte listed above the following scores: Routine Chemistry Analytes PT event Score 3rd event 2019 0% 1st event 2019 0% -- 2 of 2 --

Summary Statement of Deficiencies D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: . Based on physician standing order review, record review, and interview with the technical supervisor (TS) and general supervisor (GS), the laboratory failed to order tests correctly for five (#9, #11 - #14) of five patients reviewed. Findings include: Patient #9 1. Review of the physician standing order and the test requisition for patient #9 revealed the following drug results for the "10 Panel (DRUG SCREENS WITH REFLEX TO CONFIRMATION)" were not run: a. Marijuana metabolite (THC). 2. Review of the confirmation test report for patient #9 revealed the following: a. No results for Barbiturates and Marijuana. b. Results for Cyclobenzaprine and Gabapentin. Patient #11 and #12 1. Review of the physician standing order and the test requisition for patient #11 and #12 revealed the following drug results for the "10 Panel (DRUG SCREENS WITH REFLEX TO CONFIRMATION)" were not ordered that were run: a. Run not ordered - Heroin Meta 6AM and Alcohol. 2. Review of the confirmation test report for patient #11 and #12 revealed the following: a. No results for Barbiturates and Marijuana. b. Results for MDMA, MDEA, MDA, 6- Monoacetylmorphine, Cyclobenzaprine, and Gabapentin. Patient #13 1. Review of the confirmation test report for patient #13 revealed the following: a. No results for Barbiturates and Marijuana. b. Results for Cyclobenzaprine and Gabapentin. Patient #14 1. Review of the physician standing order and the test requisition for patient #14 revealed the following drug results for the "10 Panel (DRUG SCREENS WITH REFLEX TO CONFIRMATION)" were not ordered that were run: a. Run not ordered - Heroin Meta 6AM, Alcohol, and Ecstasy. 2. Review of the confirmation test report 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 -- for patient #14 revealed the following: a. No results for Barbiturates and Marijuana. b. Results for MDMA, MDEA, MDA, 6-Monoacetylmorphine, Cyclobenzaprine, and Gabapentin. 3. During interview on March 7, 2019 at approximately 4:00 PM, the TS and GS acknowledged there were discrepancies between the test requisition and test report. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on lack of records and interview with the technical supervisor (TS) and general supervisor (GS), the laboratory failed to document for six (#3 - #8) of eight patient charts audited the daily background count for the Horiba ABX Micros 60 hematology instrument as defined by the manufacturer. Findings include: 1. Record review of the daily background counts revealed there was no documentation to show the instrument had been started up at the beginning of the work day for six patient results audited as follows: a. September 26, 2017 b. December 7, 2017 c. February 4, 2018 d. May 25, 2018 e. July 30, 2018 f. November 2, 2018 2. On March 7, 2019 at approximately 3:30 PM when queried, the GS was unable to provide the documentation requested. 3. During the interview on March 7, 2019 at approximately 3:30 PM, the TS and GS confirmed an acceptable background count was not documented before patient testing. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on procedure review, lack of quality control records, and interview with the technical supervisor (TS) and general supervisor (GS), the laboratory failed to perform quality control as required for the hematology complete blood cell count (CBC) for seven (#2 - #8) of eight patient results audited. Findings include: 1. Procedure review for the "Quality Control" stated "2 of 3 controls must be within 2 SD" of the mean to be acceptable. 2. Record review for the daily hematology controls revealed the laboratory did not have any documentation to show the controls had been run each day of patient testing prior to reporting patient results as follows: a. June 21, 2017 b. September 26, 2017 c. December 7, 2017 e. February 4, 2018 f. May 25, 2018 g. July 30, 2018 h. November 2, 2018 3. During the interview on March 7, 2019 at -- 2 of 3 -- approximately 3:30 PM, the TS and GS confirmed there was no documentation to show quality control material was tested prior to reporting out patient test results. 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