Gamma Healthcare, Inc - Poplar Bluff

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation and interview, the laboratory failed to maintain a uni-directional workflow process to prevent contamination for COVID-19 PCR testing (Refer to D3005). D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on observation of the COVID-19 testing room and interview with the general supervisor (GS) #1, technical supervisor (TS) #2, and testing personnel (TP) #7, the laboratory fails to have a uni-directional workflow that includes separate areas for 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 -- specimen preparation, amplification, and product detection for COVID-19 using the Taq-Path PCR testing. Uni-directional workflow refers to the manner in which testing personnel and patient specimens move through the molecular testing process to prevent cross-contamination of patient specimens, and consists of separate areas for reagent preparation, pre-amplification, and post-amplification. Findings: 1. Observation of the COVID-19 testing room showed two hoods located next to each other for processing and setting up the patient extraction 96 well plate, one desk area for reaction tray and quality control (QC) setup next to one of the hoods, two King Fischer extractors located diagonally from the processing hoods, four Applied Biosystems 7500 Fast Real Time PCR analyzers located in the middle of the room, one refrigerator, which stores COVID-19 specimens, one freezer next to one centrifuge, and one freezer with the positive control next to the KingFischer extractors. 2. Interview on October 6, 2020 at 11:45 AM with GS #1 and TP #7 confirmed "on day shift, the tech walks across the room to get the samples out of the refrigerator and takes to the hood. The tech makes up the first 96 well plate patient extraction tray, walks across the room to put it on the KingFischer extractor, cleans the area with alcohol and begins to setup the second 96 well patient extraction tray. On evening shift, two techs are setting up a total of two each, 96 well patient extraction trays. They start the second tray after the first patient tray is on the extractor. After the extraction is completed on the KingFischer, the tech carries the tray back to the hood for reaction tray processing and then puts the tray on the 7500 Fast Track PCR analyzers." These analyzers are located in the middle of the room. The TP walk across the room and back to the setup areas several times to obtain reagents, specimens, quality control, and supplies. 3. Interview on October 6, 2020 at 12:00 PM with the TS #2 and GS #1 confirmed the laboratory failed to have a uni- directional workflow to include separate areas to prevent contamination of patient specimens, equipment, instruments, reagents, materials, and supplies. 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)

Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of Applied Biosystems 7500 Fast Real Time PCR (TaqPath) procedure, patient test reports, review of quality assurance (QA) policy, and interviews, the laboratory director (LD) failed to provide overall management and direction to the laboratory. The LD failed to ensure verification procedures for the TaqPath included performance specifications for interfering substances (Refer to D6086); failed to ensure testing personnel are performing TaqPath COVID-19 test methods as required for accurate and reliable results (Refer to D6087); and failed to ensure staff identify problems and potential problems in real time for COVID-19 PCR patient testing (Refer to D6094). D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of Applied Biosystems 7500 Fast Real Time PCR (TaqPath) of the laboratory's verification of performance specifications, patient test volumes and interview with the technical supervisor #2, the laboratory failed to establish 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 -- performance specifications to include interfering substances, for the TaqPath COVID- 19 test before reporting patient test results. Findings: 1. Review of the laboratory's validation reports for performance specifications of the TaqPath instrumentation revealed the laboratory failed to verify specificity for interfering substances for COVID-19 testing prior to performing patient testing on April 7, 2020. 2. Approximately 26,239 patients have been tested for COVID-19 since April 7, 2020. 3. Interview with the technical supervisor #2 on July 1, 2020 at 10:00 AM confirmed the laboratory failed to establish performance specifications for interfering substances before reporting patient test results. 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 Taq Path COVID-19 PCR procedure, five of five patient test reports for COVID-19, email correspondences with Thermo Fischer technical support, interviews with testing personnel (TP) #15, technical supervisor (TS) #2, Thermo Fischer technical support, and the laboratory owner, the laboratory director (LD) failed to ensure TP perform the test methods as required for accurate and reliable results. Findings: 1. Review of the COVID-19 Taq Path PCR procedure showed "Prepare the processing plates according to the following table.... Cover the plates with a temporary seal (such as MicroAmp (Trademark) Clear Adhesive Film), then store at room temperature for up to 1 hour while you set up the sample plate....Use separate areas for the preparation of patient samples and controls....Place the Elution Plate on ice for immediate use in real-time RT-PCR. False-positive results may arise from: - Cross contamination during specimen handling or preparation - Cross contamination between patient samples - Specimen mix-up - RNA contamination during product handling " 2. Interview on July 1, 2020 at 10:30 AM, TP #15 stated, "I make up the plates for the King Fischer extractor in the morning, cover with the film and keep them at room temperature until the specimens are ready to go on the extractor. I also make up the 96 well plate with the specimens, seal it, and store the plate in the refrigerator with the specimens for COVID until the King Fischer extractor is ready for processing....all specimens and controls are made up under the hood. I do not put the elution plate on ice." 3. Phone interview with Thermo Fischer Technical Application Scientist on July 2, 2020 at 8:30 AM, confirmed "Once the specimen testing process for COVID is started, there should be no stoppage until extraction. The premade King Fischer extraction plates are only good for up to one hour at room temperature. Controls and specimens need to be processed in a separate area to prevent contamination...the elution plate needs to be placed immediately on ice." 4. Review of five patient test reports for COVID-19 showed the laboratory reported out inconsistent results for: Patient A 6/10/20 patient test result "not detected" 6/24/20 patient test result "positive" 6/29/20 patient test result "not detected" Patient B 6/24/20 patient test result "positive" 6/29/20 patient test result "not detected" Patient C 6/27/20 patient test result "positive" 6/29/20 patient test result from laboratory B "negative" Patient D 6/27/20 patient test result "positive" 6/29/20 patient test result from a laboratory B "negative" Patient E 6/27/20 patient test result "positive" 6/29/20 patient test result from laboratory B "negative" 5. Review of email correspondences with Thermo Fischer senior field application scientist sent June 29, 2020 at 9:13 PM revealed, "That is a suspiciously high number of positive samples in -- 2 of 4 -- one plate.....My initial assessment is that there is significant contamination. I can't say for sure if this might have happened at the extraction or PCR steps but I would repeat the samples from this batch." Another email sent on June 30, 2020 at 8:31 AM revealed, ".......It is important to always use clean, new plasticware whenever working with these reagents and never return reagents to their stock containers. A new bottle of water should be opened and aliquoted into single use tubes of an appropriate volume based on the workflow and once opened and used, they should then be discarded. It is also acceptable to aliquot any, or all, of the extraction or PCR reagents into new tubes or bottles. Working from stock bottles, especially bottles which contain enough reagent to process up to 2000 samples, is always a potential source of contamination....." 6. Review of email correspondence with Thermo Fischer technical application scientist sent on June 30, 2020 at 11:01 AM revealed, "I have looked at the data file you sent. I also think that there is contamination by MS2 control...." 7. Interview with TS #2 and the laboratory owner on July 1, 2020 at 10:30 AM, confirmed the LD failed to ensure TP are performing the test methods as required for accurate and reliable results. 38475 D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assessment (QA) program, patient COVID- 19 testing records for June 2020, and interview with technical supervisor #2, the laboratory director failed to maintain the QA program and identify failures as they occur. The laboratory failed to establish criteria for accepting or rejecting 152 of 152 patient test batches during June 2020 based on positivity rate for COVID-19 patient testing. Findings: 1. The QA program states, "It is the duty of each employee to identify problems and potential problems, to correct these on the spot or report these to their supervisor if it is beyond their capacity to correct the problem. The manager of laboratory operations, director of technical services and the laboratory director have the overall responsibility for managing problems related to the quality of their laboratory work." 2. The QA program did not establish criteria for identifying problems or potential problems for positivity rates associated with COVID-19 PCR patient batchs (runs) to determine acceptability or rejection. 3. Review of COVID-19 PCR testing records from June 2, 2020 through June 27, 2020 showed the following positivity (pos) rates: June 3, 2020 Batch ID Pos. Rate Patients tested HW 25.30% 83 patients tested LRT 25.84% 89 patients tested June 4 , 2020 Batch ID Pos. Rate Patients tested HW1A 21.79% 78 patients tested RP-LRT 22.54% 71 patients tested June 5, 2020 Batch ID Pos. Rate Patients tested LRT1A 21.21% 99 patients tested June 6, 2020 Batch ID Pos. Rate Patients tested RMP 25.33% 75 patients tested June 10, 2020 Batch ID Pos. Rate Patients tested HW 29.35% 92 patients tested June 19, 2020 Batch ID Pos. Rate Patients tested RMP1 62.82% 78 patients tested June 23, 2020 Batch ID Pos. Rate Patients tested RMP4 19.77% 86 patients tested June 26, 2020 Batch ID Pos. Rate Patients tested RMP1 23.33% 90 patients tested HW3A 21.33% 75 patients tested June 27, 2020 Batch ID Pos. Rate Patients tested RMP2 54.35% 92 patients tested 4. The laboratory did not detect or identify problems or potential problems regarding positivity rates as it occurred or before patient results were reported to clients. 5. Interview with technical supervisor #2 on July 1, 2020 at -- 3 of 4 -- 10:30 AM confirmed the laboratory director failed to ensure staff identify problems and potential problems in real time for COVID-19 PCR patient testing. Technical supervisor # 2 said the laboratory contacted manufacturer technical support on June 29, 2020 and confirmed the positivity rates were problematic and required investigation and

Summary Statement of Deficiencies D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on observation of the microbiology area and interview with the technical supervisor (TS) #2, the laboratory failed to be arranged to ensure adequate space for conducting all phases of the testing process. Findings: 1. Observation of the microbiology laboratory showed three Vitek 2 analyzers for microbiology testing located next to two Applied Biosystems 7500 Fast Real Time PCR analyzers and the King Fischer RNA Extractor for COVID-19 testing. The King Fischer RNA Extractor was situated next to the microbiology specimen media plating bench. 2. Observation of the room temperature in the microbiology laboratory showed a temperature of 76 degrees Fahrenheit. Observation of the microbiology laboratory showed one Vitek MS analyzer located in the middle of the room within two feet of the specimen processing area. The microbiology area was crowded with the potential of specimen contamination. 3. Observation of the microbiology laboratory showed only one hood for processing specimens for COVID-19 testing. The laboratory failed to have another ventilation hood to process microbiology specimens. 4. Interview with the TS #2 on June 22, 2020 at 11:30 AM confirmed the laboratory failed to be arranged to prevent contamination of patient specimens. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous 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 -- materials. This STANDARD is not met as evidenced by: Based on the lack of COVID-19 safety procedures, observation of one of four testing personnel (TP) for high complexity COVID-19 testing, and interview with the technical supervisor (TS) #2, the laboratory failed to ensure a safe environment from biological hazards associated with COVID-19. Findings: 1. The laboratory could not provide written procedures to show it established safety procedures for collecting, processing, and testing COVID-19 specimens. 2. Observation of COVID-19 testing showed TP #15 was pipetting COVID-19 specimens in the microbiology laboratory with a N95 mask that was not fitted properly and hanging off the face of TP #15. 3. Interview with TS #2 on June 22, 2020 at 11:30 AM confirmed the LD failed to establish policies and procedures for activities associated with COVID-19 testing. 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 laboratory policies and procedures, patient testing volume and email correspondence with technical supervisor (TS) #2, the laboratory failed to establish written policies for specimen submission, handling and referral for COVID- 19 (SARS-CoV-2 RT PCR) specimens Findings: 1. The laboratory did not establish written policies and procedures for each of the following: a) Patient preparation b) Specimen collection c) Specimen storage and preservation d) Conditions for specimen transportation e) Specimen acceptability and rejection f) Specimen referral 2. Patient testing volumes retrieved by TS #2 showed the laboratory processed 26,239 PCR specimens beginning April 7, 2020 through June 22, 2020. 3. Email correspondence on June 22, 2020 at 4:03 PM with TS #2 confirmed the laboratory did not have a formal policy to address specimen acceptability, submission, handling and rejection for COVID-19 testing. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of laboratory procedures and email correspondence with technical supervisor (TS) #2, the laboratory failed to ensure COVID-19 procedures were approved, signed and dated by the current laboratory director before use. Findings: 1. The laboratory could not provide documentation to show the laboratory director approved, signed, and dated COVID-19 procedures performed on the Architect -- 2 of 4 -- (SARS CoV IgG antibody) and Applied Biosystems 7500 Fast Real Time PCR instrumentation (SARS CoV-2-RT-PCR). 2. Email correspondence with TS #2 on June 22, 2020 at 4:30 PM confirmed the laboratory could not provide approved, dated and signed COVID-19 testing procedures by the current laboratory director. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: 35554 Based on review of observations, verification procedures and interviews, the laboratory director failed to ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards (refer to D6084); failed to ensure verification (validation) procedures were adequate for the instrument prior to patient testing (refer to D6086), and failed to ensure all personnel received appropriate training prior to testing COVID-19 specimens on the PCR instrumentation (refer to D6102). D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: 35554 Based on observation of the microbiology laboratory and interview with the technical supervisor (TS) #2, the laboratory director failed to provide a safe environment in which employees are protected from physical, chemical and biological hazards. Findings: 1. Observation of the microbiology plating area showed a countertop with media plates and urine specimens. No ventilation hood for plating microbiology specimens was available for testing personnel to prevent exposure to biohazardous specimens. 2. Interview with TS #2 on June 22, 2020 at 11:30 AM confirmed the laboratory director failed to provide proper ventilation and a shield barrier to ensure personnel is protected from biological hazards. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on the lack of cohesive verification procedures for COVID-19 testing for two of two Applied Biosystems 7500 Fast Real Time PCR instruments, review of -- 3 of 4 -- verification procedures for COVID-19 IgG antibody testing on the Architect instrument, patient testing volume and email correspondence with technical supervisor (TS) #2 confirmed, the laboratory director failed to ensure verification procedures were adequate before patient testing started. Findings: 1. The laboratory could not provide cohesive and approved verification procedures for the Applied Biosystems 7500 Fast Real Time PCR instruments prior to patient testing for COVID-19. In an email addressed to the laboratory director dated April 7, 2020 at 3:56 PM TS #2 stated "I've attached the raw data of our study for your review. I'll package it more neatly later if that is okay with you." We are ready to start testing as soon as you approve unless there is something else you think we need to do." In an email addressed to the laboratory director dated June 22, 2020 at 1:52 PM TS #2 stated," I don't have your signature that you approved our validation data for the 7500 DX. Could you respond to this email indicating approval." The laboratory director responded 8 minutes later at 2:00 PM by email. The laboratory director stated, 'this confirms review and discussion regarding use of the 7500 DX following validation." 2. Review of COVID-19 antibody verification procedures performed on the Architect instrument revealed no documentation to show approval by the laboratory director. 3. The laboratory tested 26,239 COVID-19 PCR patient specimens on the Applied Biosystems 7500 Fast Real Time PCR instruments from April 7, 2020. through June 22, 2020. The laboratory tested 278 COVID-19 IgG antibody patient specimens on the Architect instrument from May 17, 2020 through June 22, 2020. 4. Email correspondence with TS #2 on June 22, at 4:03 PM confirmed the laboratory director failed to ensure verification procedures were adequate before COVID-19 patient testing started on the PCR instrument D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on the lack of initial training documentation and interview with technical supervisor(TS) #2, the laboratory director failed to ensure four of four testing personnel(TP) received appropriate training prior to testing COVID-19 patient specimens on the Applied Biosystems 7500 Fast Real Time PCR instrumentation. Findings: 1. The laboratory could not provide documentation to show TP #2, 13, 14, 15 received initial training prior to testing COVID-19 specimens on the Applied Biosystems 7500 Fast Real Time PCR instrumentation. 2. Interview with TS # 2 on June 22, 2020 at 11:30 AM confirmed the laboratory director failed to ensure all personnel received appropriate training prior to testing COVID-19 specimens on the PCR instrumentation. -- 4 of 4 --

Summary Statement of Deficiencies 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 controls and reagents and interview with the general supervisor #1, the laboratory failed to label controls and calibrators with expiration dates. Findings: 1. Observation of one bottle of Biorad Liquichek 1(lot #68531) and one bottle of Liquichek 2 (lot #68532) showed an open date of 8/15/2019 with no expiration date. 2. Observation of one bottle of high density lipoprotein calibrator showed an open date of 8/9/2019 with an unreadable expiration date. 3. Interview with the general supervisor #1 on August 27, 2019 at 11:00 AM confirmed the laboratory failed to mark expiration dates on prepared controls and calibration material. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must 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 -- be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of maintenance documentation, observation of five of five VWR pipettes, one fume hood and interview with the general supervisor #1, the laboratory failed to define and perform a function check protocol to verify the accuracy of the fume hood and VWR pipettes for microbiology testing. Findings: 1. No documentation was found to show the laboratory defined or performed a function check protocol to verify the accuracy of the volumes of 5 of 5 VWR pipettes since 2017. 2. Observation of the fume hood showed the laboratory had not performed a function check since 2017. 3. Interview with the general supervisor #1 on August 27, 2019 at 11:00 AM confirmed, the laboratory failed to define a protocol and perform a function check to verify the accuracy of the fume hood and the volumes of 5 of 5 VWR pipettes. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) and patient logs and interview with the general supervisor #1, the laboratory failed to perform a positive and negative control each day of testing for moderately complex helicobacter pylori (H. pylori). Findings: 1. Review of QC logs for H. pylori kit testing revealed the laboratory failed to perform a positive and negative external control each day of testing. 2. Review of patient logs revealed three patients were resulted on July 18, 2019. No QC was performed on July 18, 2019. 3. Interview with the general supervisor #1 on August 27, 2019 at 11:00 AM confirmed, the laboratory did not test a positive and negative control each day of testing. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) logs, patient logs, and interview with the general supervisor #1, the laboratory failed to perform a negative and titered positive control for Rheumajet rheumatoid factor (RF) titered testing. Findings: 1 No QC was performed at least once a day for positive titered RF testing. 2. Review of patient logs -- 2 of 3 -- showed 59 patient results were reported out for titered RF from January 2019 to date August 27, 2019. 3. Interview with general supervisor #1 on August 27, 2019 at 11:00 AM confirmed the laboratory reported out titered RF results and failed to perform a negative and known titered control material each day of testing. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of 2018, 2019 instrument comparison documentation and interview with the general supervisor #1, the laboratory failed to perform instrument comparisons two times a year for two of two Beckman Coulter DXI 600 analyzers for the analytes: troponin, human chorionic gonadotropin (HCG), creatine kinase muscle /brain (CKMB), testosterone, and parathyroid hormone (PTH). Findings: 1. Review of the laboratory instrument comparison documentation showed the laboratory failed to perform and document comparison studies for two Beckman Coulter DXI 600 analyzers for troponin, HCG, CKMB, testosterone, and PTH testing for 2018 and to date August 27, 2019. 2. Interview with the general supervisor #1 on August 27, 2019 at 11:00 AM confirmed, the laboratory failed to perform instrument comparisons for the analytes: troponin, HCG, CKMB, testosterone, and PTH testing two times a year. -- 3 of 3 --