Access Behavioral Care

Summary Statement of Deficiencies D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: . Based on observation and interview with the Technical Consultant, the laboratory failed to have an EasyRA Surfactant Kit to perform its qualitative urine toxicology testing. Findings include: 1. The surveyor observed the laboratory's EasyRA qualitative urine toxicology test system and reagents on 7/8/24 at 10:28 am and noticed a lack of EasyRA Surfactant which is added to reagent-grade water to be used as the diluent. 2. An interview on 7/8/24 at 11:10 am with the Technical Consultant confirmed the laboratory did not have the EasyRA Surfactant in stock. 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 record review and interview with the Technical Consultant, the laboratory failed to have test requests for 10 (Patients 1-10) of 10 patient testing records reviewed. Findings include: 1. A review of 10 patient test records revealed the following patients received qualitative urine toxicology testing from the laboratory: a. Patient 1 had testing performed on 6/22/24. b. Patient 2 had testing performed on 4/19 /24. c. Patient 3 had testing performed on 1/18/24. d. Patient 4 had testing performed on 11/11/23. e. Patient 5 had testing performed on 9/30/23. f. Patient 6 had 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 2 -- performed on 8/25/23. g. Patient 7 had testing performed on 7/21/23. h. Patient 8 had testing performed on 4/14/23. i. Patient 9 had testing performed on 12/22/22. j. Patient 10 had testing performed on 10/25/22. 2. An interview on 7/8/24 at 11:40 am with the Technical Consultant revealed the laboratory did not have test requests for the patients receiving testing listed above. 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 observation and interview with Technical Consultant (TC), the laboratory failed to ensure Methadone Reagent was not used beyond the expiration date for one reagent observed. Findings include: 1. The surveyor observed one reagent wedge of Methodone reagent on instrument reagent carousel with an expiration date of 06/04 /2024. 2. An interview was conducted with the TC on 07/08/2024 at 10:40 am and confirmed that the reagent was expired. The TC indicated the last instrument run date for Methadone was 06/5/2024. 3. A review of patient testing data revealed a total of 21 patients had been tested since the Methadone reagent had expired. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review and interview with the Laboratory Director, the laboratory failed to have test request from an authorized person for urine qualitative toxicology testing for 10 (Patients 38170, 26590, 38300, 22470, 37970, 28520, 38170, 37950, 39600, and 37400) of 10 patient test reports reviewed. Findings include: 1. A review of patient test records revealed the following patients had qualitative urine toxicology testing performed and a lack of a test request: a. Patient 38170, performed on 04/09 /2022 b. Patient 26590, performed on 02/25/2022 c. Patient 38300, performed on 12 /19/2021 d. Patient 22470, performed on 09/18/2021 e. Patient 37970, performed on 07/26/2021 f. Patient 28520, performed on 06/05/2021 g. Patient 38170, performed on 04/17/2021 h. Patient 37950, performed on 02/21/2021 i. Patient 39600, performed on 12/19/2020 j. Patient 37400, performed on 10/05/2020 2. An interview on 5/19/22 at 12:03 pm with the Laboratory Director revealed the laboratory did not utilize test requests for its qualitative urine toxicology testing and test requests were not available. **This is a repeated deficiency from the 12/7/20 initial survey** 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 D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Based on observation and interview with Testing Personnel #1 (TP1), the laboratory failed to ensure specimen aliquot tubes were labeled with positive identification for 1 of 1 patient testing event observed. Findings include: 1. An observation by the surveyor on 9/30/20 at 10:22 am revealed TP1 aliquoted a urine specimen from the specimen cup to a smaller aliquot tube to be loaded on the analyzer without labeling the tube with patient information prior to analysis. 2. A review of the laboratory's established "Internal Quality Control" procedure revealed a section titled "Specimens" stating, "Use only the specimen described in the individual test instructions. Be sure that the specimen has been properly collected, stored, and labeled with patient's first and last name as well as the date of collection." 3. An interview on 9/30/20 at 10:22 am with TP1 confirmed the laboratory did not label specimen aliquot tubes with patient identification. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to verify the accuracy of its toxicology testing at least twice annually for 1 (July 2019 to July 2020) of 1 year reviewed. Findings include: 1. An interview on 9/30/20 at 9:27 am with the TC revealed the laboratory started patient testing on 7 /27/19. 2. A review of the laboratory's test menu revealed it is currently testing the following analytes: a. Amphetamines b. Cocaine c. Methadone d. Opiates e. Oxycodone f. Benzodiazapine 3. A review of the laboratory's proficiency testing documentation revealed a lack of data for 2019. 4. A review of the laboratory's established "Proficiency Testing" procedure revealed a section titled "Split Samples" stating, "If proficiency testing is not provided for an analyte, then split samples will be run twice per year. Two samples will be run and each samples difference must be within 25%. A score of less than 80% will be considered failing and