New Oakland Family Centers

Summary Statement of Deficiencies D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on observations, review of records, and interviews, the laboratory failed to follow its competency assessment policies to ensure testing personnel competency (refer to D5209), failed to verify the accuracy of 41 of its 123 analytes at least twice annually (refer to D5217), failed to evaluate proficiency testing and perform and document

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 a test request for its quantitative toxicology testing for 14 (Patients UR21-1935, UR21-2879, UR21-2586, UR21-3359, UR21-3686, UR22-101, UR22- 880, UR22-1011, UR22-2896, UR22-4483, UR22-6016, UR22-6400, UR22-6954, and UR22-8821) of 14 patient test records reviewed. Findings include: 1. A review of 14 patient records revealed a lack of test request for the following patients receiving quantitative toxicology testing for Olanzapine without a test request: a. Patient UR21- 1935 received testing on 08/20/2021. b. Patient UR21-2879 received testing on 10/07 /2021. c. Patient UR21-2586 received testing on 09/21/2021. d.Patient UR21-3359 received testing on 11/04/2021. e. Patient UR21-3686 received testing on 12/07/2021. f. Patient UR22-101 received testing on 01/06/2022. g. Patient UR22-880 received testing on 02/24/2022. h. Patient UR22-1011 received testing on 03/03/2022. i. Patient UR22-2896 received testing on 05/11/2022. j. Patient UR22-4483 received testing on 06/20/2022. k. Patient UR22-6016 received testing on 08/05/2022. l. Patient UR22- 6400 received testing on 08/17/2022. m. Patient UR22-6954 received testing on 09/04 /2022. n. Patient UR22-8821 received testing on 10/25/2022. 2. An interview on 2/27 /23 at 4:30 pm with the Laboratory Director revealed an approved standing order policy had not been approved and implemented to include Olanzapine testing. The test requests provided by the ordering providers for patients listed above did not include testing for Olanzapine. 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 --