Innovative Laboratories

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to sign and retain the attestation statements documenting that PT samples were tested in the same manner as patient specimens in four of four testing events. Findings: 1. Records from four PT events (2020 2nd, 2021 1st, 2021 2nd, and 2022 1st) were reviewed. 2. The signed attestation statements documenting that PT samples were tested in the same manner as patient specimens were missing from all four PT events. 3. During the survey on 08/10/2022 at 12:45 PM, the TC confirmed that PT records were missing the attestation statements signed by the testing person and the laboratory director or designee. 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 3 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the technical consultant (TC), the laboratory failed to ensure that quality control materials were not used past their expiration date for urine drug screen testing. Findings: 1. Bottles of the following calibrators and controls were found opened in the refrigerator during the on-site survey conducted on 08/10/2022: a. Siemens Syva Emit Calibrator/Control Level 1, catalog number 9A528UL-P3, expiration date 06/02/2022 b. Siemens Syva Emit Calibrator/Control Level 3, catalog number 9A568UL-P3, expiration date 03/02/2022 c. Bio-Rad S1E low opiate, liquichek urine toxicology control, lot number 71930, expiration date 07/31/2022 2. The instrument printouts did not contain the lot number and expiration dates for the controls or calibrators used for each batch of testing and there was no reagent log or inventory list that documented the lot numbers, expiration dates, and dates in use for the reagents, calibrators and quality control materials. 3. During the survey on 08/10/2022 at 11:00 AM, the TC confirmed that the laboratory does not keep a record of lot numbers and expiration dates and does not track which lot number is in use at any given time to ensure that reagents, calibrators, and quality control materials are not used past their expiration dates. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of records and interview with the technical consultant (TC), the laboratory failed to ensure that all quality assurance (QA) records were reviewed and that monthly reviews were performed in a timely manner to ensure that potential problems could be identified and

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on laboratory procedure manual and record review and interview with the technical consultant (TC), the laboratory did not ensure that the procedure for running quality control (QC) on the toxicology analyzer accurately reflected the current practice in the laboratory. Findings: 1. The procedure, "General QC Policy," "Quality Control Guidelines" states that "General chemistry testing requires two levels every 24 hours." During an interview at 10:25 AM, the TC stated that QC is only run on the days that the laboratory tests patients; and 2. The procedure, "General QC Policy," "Routine QC Procedures," "Control Frequency" states that "It is also recommended to run controls post batch run when non-daily testing is the routine test interval; this will prevent the need for a run to run if the next batch day QC is out and the correction requires reagent, calibration, or analyzer

Summary Statement of Deficiencies 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 laboratory test request forms and interview with the technical consultant (TC), the laboratory did not have all identifiers and information needed on the test request form when requesting and performing in house patient toxicology testing Findings: 1. The name and address of the laboratory "Providence Pain Management Center" was not on the test request form. 2. The time specimens were collected were not written on the laboratory test request by the collection person. 3. Two laboratory test request forms from collection date 5/24/18 and 5/30/18 did not have the collectors signature in the collectors box on the form. 4. The test request form did not have the definition of the "High Risk: Quantitative and Qualitative", "Mod Risk: Quantitative and Qualitative", Low Risk: Quantitative and Qualitative", "CUP POC Only", and LCMS Only" in the "lab order" section of the test request form. 5. The TC stated that the physicians will select a box for the "High Risk: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Quantitative and Qualitative", "Mod Risk: Quantitative and Qualitative", Low Risk: Quantitative and Qualitative", "CUP POC Only", and LCMS Only" in the "lab order" section that correlates to the patient history. 6. The laboratory did not provide on the test request form when not to send for additional confirmation testing when a patient in house toxicology test is "positive". 7. The TC stated that sometimes the physicians may decide not to send a positive in house test for confirmation due to the patient history. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the written procedure manual and interview with the technical consultant, the laboratory did not have a client service manual when urine toxicology specimens needed referral for confirmation testing. Findings: 1. The laboratory did not have a client service manual available to describe ordering, collection and submission of specimens for urine drug testing. 2. The laboratory provided qualitative testing based on clinical need. The laboratory did not have a client service manual that describes the tests making up each panel including methodology that is selected by the physician when send out for quantitative testing is performed. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)