Lakeside Orthopedic Inst Llc

Summary Statement of Deficiencies D0000 An initial survey was performed on September 26, 2024. The facility was found to be NOT in compliance with the following CLIA conditions for specialties/subspecialties surveyed for 42 CFR: 493.1240 - Toxicology 493.1403 - Moderate Complexity Laboratory Director 493.1409 - Technical Consultant - Moderate Complexity 493. 1421 - Laboratory Testing Personnel D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of manufacturer's package inserts for testing performed on the Indiko Plus analyzer and interview with the testing personnel (TP-1), the laboratory (A) failed to retain the manufacturer's package inserts for at least 2 years for each lot of Quality Control (QC) and test reagent material used on the analyzer; (B) failed to retain record of QC lot numbers and expiration dates used on the analyzer from 11/01 /2022 through 9/26/2024; and (C) failed to retain calibration records from 11/01/2022 through 1/04/2023. Findings include: 1. The laboratory began patient testing on 11/01 /2022 and reports 30,591 urine drug screen tests performed annually utilizing the Indiko Plus analyzer. A1. No evidence was presented for review to indicate the laboratory retained the manufacturer's assay information sheets for each lot of QC and test reagent material used on the Indiko Plus analyzer from 11/01/2022 through 9/26 /2024. B1. No evidence was presented for review to indicate the laboratory retained record of the lot numbers and expiration dates of QC material used on the Indiko Plus analyzer from 11/01/2022 through 9/26/2024. C1. No evidence was presented for review to indicate the laboratory retained record of calibration records for the Indiko Plus analyzer from 11/01/2022 through 1/04/2023. 2. TP-1 interviewed on 9/26/2024 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 18 -- at 3:00 PM confirmed the laboratory failed to retain the manufacturer's assay information sheets for at least 2 years for each lot of QC and test reagent material used on the Indiko Plus analyzer, failed to retain record of the lot numbers and expiration dates of QC material used on the analyzer for at least two years, and failed to retain instrument calibration records from November 1, 2022 through January 4, 2023, as indicated above. 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 the number and severity of deficiencies cited herein for services provided in the subspecialty of Toxicology, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256 and 493.1281 through 493.1299. See D5203, D5205, D5209, D5217, D5291, D5305, D5311, D5313, D5391, D5401, D5415, D5417, D5421, D5425, D5441, D5469, D5779, D5791, D5801, and D5891 for findings. 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 lack of policies for review and interview with the facility personnel, the laboratory failed to establish written policies and procedures to 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. Findings include: 1. The laboratory began patient testing on 11/01/2022 and reports 30,591 urine drug screen tests performed annually utilizing the Indiko Plus analyzer. 2. The laboratory failed to provide evidence of an established written policy and procedure to 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. 3. The facility personnel interviewed on 9/26/2024 at 2:00 PM confirmed the laboratory failed to provide evidence of written policies and procedures to ensure positive identification and optimum integrity of a patient's specimen throughout the entire testing process, for testing performed on the Indiko Plus analyzer. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations -- 2 of 18 -- of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on lack of established policies and procedures for review on 9/26/2024 and interview with the facility personnel, the laboratory failed to have a system in place to document all complaints and problems reported to the laboratory. Findings include: 1. No evidence was presented for review during the survey conducted on 9/26/2024 to indicate the laboratory has a system in place to investigate and document all complaints and problems reported to the laboratory. 2. The facility personnel interviewed on 9/26/2024 at 2:05 PM confirmed the laboratory failed to have a system in place to address complaints and problems reported to the laboratory. 3. The laboratory's annual test volume in the specialty of Chemistry is 30,591. 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 lack of employee competency policies and procedures for review and interview with the facility personnel, the laboratory failed to establish policies and procedures to assess the competency of the Clinical Consultant (CC) and the Technical Consultant (TC). Findings include: 1. The CMS-209, Laboratory Personnel form submitted for review during the survey conducted on September 26, 2024 listed one Technical Consultant (TC-1) who provides technical oversight for testing performed in the specialty of chemistry, and one Clinical Consultant (CC-1) who provides consultation regarding the appropriateness of the testing ordered and interpretation of test results in the specialty of chemistry. 2. No documentation was presented for review to indicate the laboratory established policies and procedures to assess the competency of the Technical Consultant and Clinical Consultant. 3. The facility interviewed on 9/26/2024 at 2:10 PM confirmed the laboratory failed to establish policies and procedures to assess the competency of the TC and CC indicated above. 4. The laboratory began testing patient specimens in November 2022 in the specialty of chemistry and reports 30,591 tests annually. 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: Based on lack of accuracy verification documentation for review and interview with the facility personnel, the laboratory failed to verify the accuracy of urine drug screen testing performed under the subspecialty of Toxicology at least twice annually during 2023. Findings include: 1. The laboratory began patient testing on 11/01/2022 in the subspecialty of Toxicology, with an annual test volume of 30,591. 2. No documentation was presented for review to indicate the laboratory verified the -- 3 of 18 -- accuracy of urine drug screen testing testing at least twice annually during 2023. 3. The facility personnel interviewed on 9/26/2024 at 2:20 PM confirmed the laboratory failed to verify the accuracy of urine drug screen testing testing at least twice annually during 2023. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of established quality assessment (QA) policies and procedures and interview with the facility personnel, the laboratory failed to establish policies and procedures to monitor, assess and correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Findings include: 1. No QA documentation was provided for review during the survey conducted on 9/26 /2024 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the general laboratory system requirements specified at 493.1231 through 493.1236. 2. No documentation was presented for review to indicate the laboratory established policies and procedures related to the verification of accuracy process for testing performed in the specialty of Chemistry. 3. No documentation was presented for review to indicate the laboratory established policies and procedures related to training and evaluating the competency of Testing Personnel for testing performed in the specialty of Chemistry. 4. The facility personnel interviewed on 9/26/2024 at 3:40 PM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified in the general laboratory systems requirements. 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 3 out of 3 test requisitions and interview with the facility -- 4 of 18 -- personnel, the laboratory's test requisition failed to include the test(s) to be performed and the date and time of specimen collection. Findings include: 1. The laboratory began patient testing on 11/01/2022 under the sub-specialty of Toxicology, with a reported annual test volume of 30,591. 2. The laboratory performs a urine drug screen test on the Indiko Plus Analyzer which includes the following analytes: Creatinine, pH, Specific Gravity, Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Hydrocodone, Methadone, Opiate, and Oxycodone. 3. Three out of three test requisitions presented for review (Accession #010001055, 010004676 and 010006814) failed to include the date and time of specimen collection. 4. Three out of three test requisitions presented for review (Accession #010001055, 010004676 and 010006814) failed to include the test(s) to be performed, specific to the analytes tested. The test requisitions reviewed listed the test to be performed as "UDS/11-panel drug screen", with no indication of the specific analytes included in a 11-panel drug screen, whether in laboratory policy or listed on the test requisition. 5. The facility personnel interviewed on 9/26/2024 at 2:40 PM confirmed that the test requisitions reviewed during the survey and all the test requisitions for testing performed from 11 /01/2022 through 9/26/2024 failed to include the information listed above. 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 lack of written policies and procedures for review and interview with the facility personnel, the laboratory failed to establish policies and procedures for patient preparation, specimen collection, specimen labeling, specimen storage and preservation, conditions for specimen transportation, specimen processing, specimen acceptability and rejection, and specimen referral. Findings include: 1. The laboratory began urine drug screen testing on the Indiko Plus analyzer on November 1, 2022. The laboratory's reported annual test volume in the specialty of Chemistry is 30,591. 2. No documentation was presented for review during the survey conducted on September 26, 2024 to indicate the laboratory established policies and procedures for patient preparation, specimen collection, specimen labeling, specimen storage and preservation, conditions for specimen transportation, specimen processing, specimen acceptability and rejection, and specimen referral. 3. The facility personnel interviewed on 9/26/2024 at 2:05 PM confirmed the laboratory failed to provide evidence of the above referenced policies and procedures at the time of the survey. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on review of 3 out of 3 test requisitions and test reports reviewed during the -- 5 of 18 -- survey and interview with the facility personnel, the laboratory failed to document the date and time it receives a specimen for all specimens tested by the laboratory from November 1, 2022 through September 26, 2024. Findings include: 1. The laboratory performs urine drug screen testing in the specialty of Chemistry with a reported annual test volume of 30,591. The laboratory began patient testing on November 1, 2022. 2. No evidence was presented for review to indicate the laboratory documented the date and time it receives a specimen for 3 out of 3 records reviewed during the survey (Accession# 010004676, 010001055 and 010006814). 3. The laboratory failed to document the date and time it receives a specimen for all specimens tested by the laboratory between November 1, 2022 through the date of the survey, September 26, 2024. 4. The facility personnel interviewed on 9/26/2024 at 2:40 PM confirmed the laboratory failed to document the date and time it receives a specimen. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on lack of quality assessment (QA) policies and procedures and interview with the facility personnel, the laboratory failed to establish QA policies and procedures to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. Findings include: 1. No QA documentation was provided for review during the survey conducted on 9/26/2024 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the preanalytic systems specified at 493. 1241 through 493.1242. 2. The facility personnel interviewed on 9/26/2024 at 3:40 PM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified with the preanalytic systems. 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 lack of a written procedure manual for review and interview with the facility personnel, the laboratory failed to have a written procedure manual for urine drug screen testing performed under the sub-specialty of toxicology. Findings include: 1. The laboratory began patient testing on November 1, 2022 on the Indiko Plus analyzer, with a reported annual test volume of 30,591. 2. No evidence of an approved procedure manual for urine drug screen testing was presented for review during the survey conducted on 9/26/2024. 3. The facility personnel interviewed on 9/26/2024 at 1:57 PM confirmed that the laboratory failed to have an approved, written procedure manual for urine drug screen testing at the time of the survey. -- 6 of 18 -- 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 of Quality Control (QC) and Calibration material located in the laboratory and interview with the testing personnel (TP-1), the laboratory failed to label two of two vials of QC and Calibration material used on the Indiko Plus analyzer with the preparation and expiration dates. Findings include: 1. Observation of QC vials located in the laboratory for the Indiko Plus analyzer showed one bottle of drug screen control, DOAT 5 control lot #DAT 26035A, opened and in use with no preparation (open date) and expiration date. 2. Observation of calibration materials located in the laboratory for the Indiko Plus analyzer showed one bottle of DRI Hydrocodone Calibrator lot #74969724, opened and in use with no preparation (open date) and expiration date 3. Interview with the TP-1 on 9/26/2024 at 3:25 PM confirmed the laboratory failed to label the DOAT 5 control and DRI Hydrocodone calibrator with a preparation and expiration date. 4. The laboratory reports 30,591 patient results annually under the specialty of Chemistry. 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 direct observation of quality control (QC) and calibration material and interview with the testing personnel (TP-1), the laboratory used QC and calibration materials past the expiration date. Findings include: 1. During the survey conducted on 9/26/2024, direct inspection of the control and calibration materials in use at the time of the survey for the Indiko Plus analyzer revealed the laboratory used the control and calibration materials past the expiration date as evidenced below: Manufacturer's open vial stability requirement of 30 days after opening: - DOAT 2 control, lot# DAT 24032A, mfg. exp. date listed on vial - 3/31/24, open date listed on vial was 6/18/24, control was in use for 179 days past the expiration date - DOAT 3 control, lot# DAT 24033A, mfg. exp. date listed on vial - 3/31/24, open date listed on vial was 6/18/24, control was in use for 179 days past the expiration date - DOAT 4 control, lot# DAT 26084B, mfg. exp. date listed on vial - 8/31/26, open date listed on vial was 5/08/24, control was in use for 112 days past the expiration date - DOAT 5 control, lot# DAT 26035A, mfg. exp. listed on vial - 3/31/26, no open date listed on vial Manufacturer's open vial stability requirement of 60 days after opening: - DRI Hydrocodone Low control, lot#74939683, mfg. exp. date listed on vial - 11/2024, open date listed on vial was 6/27/24, control was in use for 33 days past the expiration date - DRI Hydrocodone calibrator, lot# 74969724, mfg. exp. date listed on vial - 01 /2025, no open date listed on vial Manufacturer's expiration date printed on vial is the -- 7 of 18 -- expiration date: - DRI pH Detect 3.6 control, lot# 74801007, mfg. exp. date listed on vial - 3/31/24, open date listed on vial was 5/06/24, control was in use for 179 days past the expiration date - DRI pH Detect 7.8 control, lot# 74860437, mfg. exp. date listed on vial - 5/31/24, open date listed on vial was 4/11/24, control was in use for 118 days past the expiration date - DRI pH Detect 10.0 control, lot# 74801008, mfg. exp. date listed on vial - 3/31/24, open date listed on vial was 4/04/24, control was in use for 179 days past the expiration date - DRI pH Detect 11.5 control, lot# 74801006, mfg. exp. date listed on vial - 4/30/24, open date listed on vial was 3/25/24, control was in use for 149 days past the expiration date 2. The total number of patients tested from 3/31/24 through 9/26/24 using the expired control or calibration materials could not be determined at the time of the survey. 3. Interview with the TP-1 on 9/26/2024 at 3:30 PM confirmed that the expired control and calibration materials indicated above were expired and in use at the time of the survey. 4. The laboratory performs urine drug screen testing on the Indiko Plus analyzer with a reported annual test volume of 30,591. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on lack of performance specification documentation for the Indiko Plus analyzer and interview with facility personnel, the laboratory failed to verify the accuracy and precision prior to reporting patient test results, failed to verify the reportable range and failed to verify the manufacturer's reference intervals for the Indiko Plus analyzer prior to reporting patient test results. Findings include: 1. The laboratory began using the Indiko Plus analyzer (serial# 864000092297) to perform urine drug screen testing on patient specimens on November 1, 2022. 2. The performance characteristic documentation reveiwed for accuracy and precision studies for the analyzer referenced above indicated the studies were performed on 11/29/2022 though 11/30/2022. Patient test results were performed and reported by the laboratory on 11/01/2022 (accession# 010001005). 3. The laboratory failed to demonstrate that it can obtain the reportable range comparable to that established by the manufacturer for the Indiko Plus analyzer prior to reporting patient test results. 4. The laboratory failed to verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population for the Indiko Plus analyzer prior to reporting patient test results. 5. The facility personnel interviewed on 9/26/24 at 1:15 PM confirmed the laboratory failed to perform the accuracy and precision studies prior to reporting patient test results, and failed to verify the reportable range and reference intervals for the Indiko Plus analyzer prior to reporting patient test results. 6. The laboratory's reported annual test volume under the specialty of Chemistry is 30,591. D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) -- 8 of 18 -- The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on lack of written documentation for Quality Control (QC) and calibration procedures for review during the survey performed on 9/26/2024 and interview with the testing personnel (TP-1), the laboratory failed to determine control and calibration procedures for the Indiko Plus analyzer. Findings include: 1. The laboratory began urine drug screen testing on the Indiko Plus analyzer on 11/01/2022 in the subspecialty of Toxicology with a reported annual test volume of 30,591. 2. No evidence was presented for review to indicate the laboratory determined QC and calibration procedures for testing performed on the Indiko Plus analyzer from 11/01 /2022 through 9/26/2024. 3. The TP-1 interviewed on 9/26/2024 at 2:45 PM confirmed the laboratory failed to provide evidence of written QC and calibration procedures for urine drug screen testing performed on the Indiko Plus analyzer. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of control procedure documentation, review of Quality Control (QC) records and interview with the testing personnel (TP-1), the laboratory failed to establish control procedures that monitor the accuracy and precision of the complete analytic process for the Indiko Plus analyzer, and the laboratory failed to establish control procedures that monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions. Findings include: 1. The laboratory began patient testing on 11/01/2022 in the subspecialty of Toxicology, with an approximate annual test volume of 30,591. 2. No evidence was presented for review during the survey conducted on 9/26/2024 to indicate the laboratory established control procedures for the Indiko Plus analyzer, including the number, type and frequency of testing control materials. See D5425 for findings 3. No documentation was presented for review during the survey to indicate the laboratory monitored QC results over time (from 11 /01/2022 through 9/26/2024) to identify shifts and trends in QC data and to ensure the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions. 4. The TP-1 interviewed on 9/26 /2024 at 3:10 PM confirmed the laboratory failed to have documentation of approved -- 9 of 18 -- QC procedures for the Indiko Plus analyzer and failed to produce documentation showing that QC results were monitored over time to ensure the accuracy and precision of test performance. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records from 11/01/2022 through 9/26/2024, lack of QC lot correlation documentation and interview with the testing personnel (TP- 1), the laboratory failed to verify the criteria for acceptability of quality control materials. Findings include: 1. The laboratory began patient testing on 11/01/2022 on the Indiko Plus analyzer, with a reported annual test volume of 30,591. 2. No documentation was presented for review to indicate the laboratory verified the criteria for acceptability of each lot of control material used on the analyzer indicated above from 11/01/2022 through the date of the survey on 9/26/2024. 3. The number of QC lots used on the analyzer from 11/01/2022 through the date of the survey could not be determined at the time of the survey. 4. TP-1 interviewed on 9/26/2024 at 3:10 PM stated "I have no idea how many lots of QC have been used on the analyzer" and confirmed the laboratory failed to verify the criteria for acceptability of quality control materials for each lot of QC used on the Indiko Plus analyzer from 11/01/2022 through 9/26/2024. D5779