Alere Toxicology Services, Inc

Summary Statement of Deficiencies D0000 A Certification survey was performed at Alere Toxicology Services, INC, CLIA ID # 19D0457328, on August 28, 2023. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard deficiencies were cited. 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 by surveyors, review of the laboratory's policies, and interview with personnel, the laboratory failed to ensure reagents did not exceed their expiration date. Findings: 1. Observation by surveyors during the laboratory tour on August 28, 2023 at 9:55 am revealed the following expired items: Lab Chem Carbonate Buffer pH 9.2, Lot M174-17, Quantity: ten (10) bottles "Received 7/20/22, Expire 7/20/23" 2. Further observation by surveyors revealed the identified carbonate buffer was labeled with a sticker that included an extended expiration date of "7/20/24." 3. Review of the laboratory's "Clinical Standard Operating Procedures: Lab Policies-US Toxicology Laboratories" under the "Reagent Receipt and Storage" section revealed "When reagents are removed from storage to be put into use, they will be examined for problems, and the expiration date will be checked. If the expiration date has passed, the reagent expiration may not be extended." 4. In interview on August 28, 2023 at 4:08 pm, the laboratory's Site Director confirmed the laboratory's policy is to not extend the expiration dates of clinical reagents. The Site Director and Technical Supervisor confirmed the identified reagents were expired. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) 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 -- The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation by surveyors, review of policies, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel were performing test methods as required. Refer to D5417. D6112 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451 The technical supervisor is responsible for the technical and scientific oversight of the laboratory. The technical supervisor is not required to be on site at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide supervision as specified in (a) of this section. This STANDARD is not met as evidenced by: Based on observation by surveyors, review of policies, and interview with personnel, the Technical Supervisors failed to provide technical and scientific oversight for the laboratory. Refer to D5417. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on January 24, 2022 at Alere Toxicology Services, CLIA ID # 19D0457328. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, patient test requisitions, test menu, and interview with personnel, the laboratory failed to ensure the test requisitions included the sex of the patient. Findings: 1. Review of the laboratory's "Client Services Manual- US Toxicology Laboratories" policy revealed the sex of the patient was not included. 2. Review of the following two (2) patient test requisitions revealed the sex of the patients was not included: Patient 83559 Patient 82173 3. In interview on January 24, 2022 at 1:44 pm, Technical Consultant 2 confirmed the laboratory's requisitions did 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 -- not include the sex of the patient. 4. Review of the laboratory's test menu revealed the laboratory performs 400 toxicology tests annually. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of policies, patient test requisitions, test menu, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5305. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of policies, patient test requisitions, test menu, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5305. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification survey was conducted at Alere-CLIA ID # 19D0457328 on July 17, 2019. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Refer to D6046 and D6053. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Consultants failed to ensure procedures to assess personnel competency were complete. Findings: 1. Review of personnel records revealed the laboratory utilized a "Certifying Technician" form for competency assessments. The forms included the minimum required six (6) procedures for assessing competency of testing personnel. 2. Review of the competency assessment forms for 2018 and 2019 revealed the Technical Consultants did not perform the competency assessments for the following Testing Personnel: Personnel 8 Personnel 9 Personnel 10 Personnel 11 Personnel 12 Personnel 13 Personnel 14 Personnel 15 Personnel 16 Personnel 17 Personnel 18 Personnel 19 Personnel 20 Personnel 21 Personnel 22 Personnel 23 Personnel 24 3. In interview on July 17, 2019 at 11:15 am, the RP non-negative Production Manager stated the Technical Consultants did not perform the competency assessments for Testing Personnel. The RP non-negative Production Manager further stated Testing Personnel observe each other perform the tasks. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Consultants failed to document the performance of individuals at least semi-annually during the first year for one (1) of five (5) testing personnel reviewed. Findings: 1. Review of personnel records for Personnel 23 revealed a competency form, "Certifying Technician" signed June 19, 2018 by the observer, Testing Personnel 19. 2. Further review of the identified competency form for Personnel 23 revealed no documentation of the assessment. 3. In interview on July 17, 2019 at 11:15 am, the RP non-negative Production Manager confirmed the semi-annual competency assessment for Personnel 23 was not completed. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were maintained for assessing personnel competency. Refer to D6120. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Supervisor failed to perform competency assessments for testing personnel. Findings: 1. Review of personnel records revealed the laboratory utilized a "Certifying Technician" form for competency assessments. The forms included the minimum required six (6) procedures for assessing competency of testing personnel. 2. Review of the laboratory's personnel records revealed the Technical Supervisors did not perform competency assessments for 2018 and 2019 for the following high complexity testing personnel: Personnel 2 Personnel 5 Personnel 6 Personnel 7 3. In interview on July 17, 2019, the RP non-negative Production Manager stated Testing Personnel observe each other perform the tasks for competency. The RP non-negative Production Manager confirmed the Technical Supervisors did not perform competency assessments for the identified personnel. -- 3 of 3 --