Colorado Dept Of Public Health & Environment

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and Wisconsin State Laboratory of Hygiene (WSLH) records, the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Toxicology for the Lead analyte. Refer to D2118 and D2119. D2118 TOXICOLOGY CFR(s): 493.845(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and WSLH proficiency testing records (2024 and 2025), the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three consecutive testing events (2024, Event 2 and 2025, Event 1) in the subspecialty of Toxicology for the Lead analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: WSLH Chemistry 2024 - 2nd Event. The laboratory received an unsatisfactory score of 0% for Lead. WSLH Chemistry 2025 - 1st Event. The laboratory received an unsatisfactory score of 0 % for the Lead. 2. A review of WSLH 2024 and 2025 proficiency testing records confirmed the laboratory received the above results. D2119 TOXICOLOGY CFR(s): 493.845(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and WSLH proficiency testing records (2024 and 2025), the laboratory failed to achieve satisfactory performance (80% or greater) for the overall subspecialty of Toxicology in two of three consecutive testing events (2024, Event 2 and 2025, Event 1). Findings included: 1. Review of the CASPER 0155 report revealed the following results: WSLH Chemistry 2024 - 2nd Event. The laboratory received an overall Toxicology unsatisfactory score of 0%. WSLH Chemistry 2025- 1st Event. The laboratory received an overall Toxicology unsatisfactory score of 0%. 2. A review of WSLH 2024 and 2025 proficiency testing records confirmed the laboratory received the above results 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and WSLH proficiency testing records (2024 and 2025), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and WSLH proficiency testing records (2024 and 2025), the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2118 and D2119. -- 3 of 3 --

Summary Statement of Deficiencies D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observations, record reviews, and interviews, the laboratory failed to ensure the microbioloigy department policies and procedures were reviewed and revised as stated in its policies and procedures (D5401), failed to discard expired media before patient testing (D5417), failed to perform a positive and negative quality control test for Carbapenem-Resistant Enterobacterales test (D5455), failed to perform a positive and negative quality control test for indole (D5471), failed to perform and document quality control testing that demonstrated growth (positive) or inhibition (negative) reactions for Acetate Differential Slant media (D5477), failed to document the lot numbers and expiration dates of reagents, dates of test performance, and identity of testing personnel for bacterial culture specimens (D5787), and failed to follow established quality assessment procedures for the microbiology department (D5791). 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 review of competency documentation and interview with the microbiology Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Technical Supervisor (TS), the laboratory failed to perform competency assessment for 1 of 2 microbiology testing personnel (TP) in 2022. The laboratory performs approximately 1877 MALDI mass spectrometer microbiological identification tests annually. Findings: 1. A review of personnel competency documentation revealed that no competency assessments were performed for TP 1 for the use of the MALDI mass spectrometer for microbiological identification in 2022. 2. On 1-23-2023, at approximately 2:10 PM, the TS 3 confirmed that competency assessment for TP 1 had not been completed. 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 reviews of the laboratory procedure manuals, laboratory records, microbiology worksheets, and interviews with the Technical Supervisor (TS 3) and the Quality Assurance Coordinator, the laboratory failed to follow its written procedures for reviewing policies and procedures on an annual basis. The laboratory performed approximately 8,600 microbiology tests per year. Findings: 1. A review of the laboratory's procedure titled "Document Control" states "...Laboratory will review program documents on an annual basis." 2. A review of laboratory records titled "Overdue Micro Procedures and Micro Under Review Procedures" revealed that 29 of 39 microbiology SOPs failed to be reviewed and revised since the last survey conducted on 3-11-2021. 3. An interview on 1-25-2023, at around 10:00 AM, with the Quality Assurance Coordinator confirmed the laboratory failed to review and revise 29 microbiology SOPs since the last survey conducted on 3-11-2021. 4. A review of the laboratory's procedure titled "Data Review, Approval, and Reporting" states "... The data reviewer shall ensure that the data set references the unique identification of all reagents, media, and chemicals used. If data is missing or unacceptable, it shall be returned to the analyst for completion." 5. A review of the laboratory's microbiology worksheets revealed that the laboratory failed to record the unique identification of all reagents, media, and chemicals used. The laboratory failed to collect lot numbers, expiration dates, etc., and does not have a way to correlate patient test results with the specific supplies used for patient testing and quality control. 6. An interview on 1-23- 2023, at around 10:15 AM, with TS 3 confirmed the laboratory did not record the unique identification of all reagents, media, and chemicals used on their microbiology worksheets. 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 a direct observation and an interview with the microbiology Technical -- 2 of 6 -- Supervisor (TS 3), the laboratory failed to discard laboratory supplies when they had exceeded their expiration date. The laboratory performed approximately 5,058 microbiology cultures annually. Findings: 1. An observation of the microbiology bench on 1-23-2023, at around 9:30 AM, revealed one sleeve of 10 plates of expired microbiology media, MacConkey agar (lot #514595) expired 12-29-2022. 2. An interview on 1-23-2023, at around 9:35 AM., with the TS 3 confirmed the media was expired and unable to confirm if the media was used for patient testing. D5455 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(v)(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 molecular amplification procedure, include two control materials and, if reaction inhibition is a significant source of false negative results, a control material capable of detecting the inhibition. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review of the GeneXpert Cepheid Carbapenem-Resistant Enterobacterales (CRE) quality control test results, and an interview with the Technical Supervisor (TS 3), the laboratory failed to perform a positive and a negative quality control test for CRE prior to patient test results being reported. The laboratory performed approximately 10 CRE tests during November and December 2022. Findings: 1. A record review of the GeneXpert Cepheid Carbapenem-Resistant Enterobacterales (CRE) quality control test results revealed the laboratory failed to document positive and negative quality control test results during November and December 2022, prior to patient test results being reported. 2. An interview with the TS 3, on 1-24-2023, at approximately 1:30 PM, confirmed that the microbiology laboratory failed to perform and document quality control test results for the CRE test. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on an observation of the microbiology laboratory workbench, a record review of the microbiology laboratory quality control forms, and an interview with the Technical Supervisor (TS 3), the laboratory failed to perform a positive and a negative quality control test for Indole at least concurrent with patient testing. The laboratory performed approximately 2500 bacterial culture tests per year. Findings: 1. An observation of the microbiology workbench, on 1-24-2023, at 9:35 AM, revealed two opened boxes of BD BBL Indole droppers, lot numbers B01E206M and B05E111M, -- 3 of 6 -- with no open dates indicated on the boxes or in laboratory records and which both failed to have positive and negative control tests performed and documented prior to patient test results reported. 2. A record review of the laboratory database where microbiology quality control results were recorded failed to show that quality control testing was performed and documented for the two lots of Indole. 3. An interview with the TS 3, on 1-24-2023, at approximately 10:00 AM, confirmed that the microbiology laboratory failed to perform and document quality control test results for Indole. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review of quality control logs and an interview with the Technical Supervisor (TS 3), the laboratory failed to perform and document quality control tests that demonstrated growth (positive) or inhibition (negative) reactions for one lot of Hardy Acetate Differential Slant media prior to patient test results being reported. The laboratory performed approximately 1050 bacterial culture tests for Escherichia coli and Shigella per year. Findings: 1. An observation of the microbiology workbench, on 1-24-2023, at 9:35 AM, revealed one lot of Hardy Acetate Differential Slant media, lot number 505121, opened on 1-10-2023, which failed to have positive and negative control tests performed and documented prior to patient test results being reported. 2. A record review of the laboratory database where microbiology quality control results were recorded failed to show that quality control testing for the Acetate media was performed and documented. 3. An interview with the TS 3, on 1-24-2023, at approximately 10:00 AM, confirmed that the microbiology laboratory failed to perform and document quality control test results for the Acetate media. D5513 MYCOBACTERIOLOGY CFR(s): 493.1262(b)(c) (b) For antimycobacterial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimycobacterial agent(s) before, or concurrent with, initial use, using an appropriate control organism(s). (b)(1) The laboratory must establish limits for acceptable control results. (b)(2) Each week tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(3) The results for the control organism(s) must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a record review of quality control logs and an interview with the Technical Supervisor (TS 3), the laboratory failed to document the lot numbers, date opened, -- 4 of 6 -- and expiration dates for the Flurochrome acid-fast quality control reagents used for mycobacterial smears from the dates reviewed 10-25-2022 through 12-13-2022. Findings: 1. A record review of the Fluorochrome Stain Quality Control results log revealed the laboratory failed to record or document the lot numbers, expiration dates, and the open dates of the acid-fast stain from 10-25-2022 through 12-13-2022. 2. An interview with the TS 3, on 1-24-2023, at approximately 1:30 PM, confirmed that the microbiology laboratory failed to document the acid-fast quality control reagent lot numbers and dates. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on a record review and an interview with the microbiology Technical Supervisor (TS 3), the laboratory failed to document the lot numbers and expiration dates of reagents, dates of test performance, and identity of testing personnel for 6 out of 6 bacterial culture worksheets reviewed from December 2022 through January 2023. Findings: 1. A record review of the Shigella Culture/Confirmation and Tuberculosis Culture Worksheets, revealed the laboratory culture worksheets failed to document testing personnel, dates of each test performed, and lot numbers and dates of reagents used for bacterial identification by culture for patient bacteriology specimens. 2. An interview with the microbiology TS 3, on 1-24-2023, at approximately 1:30 PM, confirmed the laboratory failed to document each step of testing for bacteriology cultures on the worksheets. This is a repeat deficiency from the last survey March 11, 2021. 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 the review of laboratory procedure manuals, quality control (QC) records, observations, and interviews with the Technical Supervisor (TS 3), the laboratory failed to follow established policies that monitor, assess, identify, and correct problems in the microbiology department analytic system. The laboratory performed approximately 8,600 microbiology tests per year. Findings: 1. A review of the microbiology laboratory policies revealed the laboratory failed to follow its policies to monitor the analytic testing systems in microbiology. 2. A review of QC records revealed that the laboratory failed to conduct quality control for Indole, Acetate Differential Slant media, and the GeneXpert Cepheid Carbapenem-Resistant -- 5 of 6 -- Enterobacterales. (Cross refer D5455, D5471 and D5477) 3. An observation of expired MacConkey agar. (Cross refer D5417) 4. An observation of the failure to document the open and expiration dates of the acid-fast stain. (Cross refer D5513) 5. An interview on 1-25-2023, at around 10:15 AM, with TS 3, confirmed the laboratory failed to follow its procedures to monitor, identify and correct the analytic system issues in the microbiology department. -- 6 of 6 --

Summary Statement of Deficiencies 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 personnel competency records reviewed and staff interview, the laboratory failed to ensure technical supervisors (TS) and general supervisors (GS) competency assessment included specific position responsibilities listed in Subpart M. Findings include: 1. Personnel competency records for 2019 and 2020 failed to include documentation of evaluations of specific TS and GS responsibilities besides duties related to patient testing and/or report of patient test results for 12 of 12 TS and for 6 of 6 GS. 2. In an interview conducted on 03/08/2020 at approximately 2:30 P.M. the quality assurance manager confirmed that competency assessments for TS and GS failed to include specific position responsibilities. 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 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 -- 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 test requisition reviewed and staff interview, the laboratory failed to ensure the test requisition solicits the time of specimen collection. Findings include: 1. Laboratory test requisitions for microbiology, serology and molecular testing failed to have a space for recording the time of specimen collection. 7 out of 10 test requisitions reviewed failed to include the time of specimen collection. 2. In an interview conducted on 03/09/2020 at approximately 4:00 P.M. the accessioning department supervisor confirmed the laboratory did not always collect the time of specimen collection. 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 serology quality control records reviewed and staff interview, the laboratory failed to ensure statistical parameters for control materials were established over time through concurrent testing of control materials. Findings include: 1. Laboratory lacked documentation to demonstrate the establishment of its own statistically-based quality controls limits for syphilis and HIV ran on the Abbot Architect. 2. Reviewed of the Abbot Architect package insert for syphilis controls states "each laboratory should establish its own concentration target and ranges for new control lots". The Abbot Architect package insert for HIV controls states "using its own standard statistical quality control methods, each laboratory should establish its own S/CO range for each control". 3. In an interview conducted on 03/11/2020 at approximately 1:30 P.M. the serology technical supervisor confirmed the laboratory did not establish its own quality controls ranges for syphilis and HIV ran on the Abbot Architect. Instead they were using the ranges provided by the manufacturer. 4. The laboratory tested approximately 500 samples yearly for syphilis and HIV respectively. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the -- 2 of 4 -- manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the microbiology quality control documents for in-house media, and an interview with the microbiology technical supervisor 2, the laboratory failed to document all quality control steps for the microbiology media made by the laboratory during 2020. Findings: 1. A review of the microbiology quality control spreadsheet for media prepared by the laboratory, revealed the laboratory failed to document all observations and measurements for the microbiology media during 2020. 2. An interview with the microbiology technical supervisor 2, on March 9, 2020, at approximately 11:30 AM, confirmed the laboratory failed to document all control activities for the microbiology media made by the laboratory. 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 a record review and an interview with the microbiology program manager, the laboratory failed to have a system in place to document the comparison of molecular testing for Sars-Cov-2 performed on the ABI 7500 Dx Fast and the Quant Studio 5 reverse transcription polymerase chain reaction (RT-PCR) instrumentation at least twice a year since January 2021. Findings: 1. A record review of the laboratory's procedure manual, revealed the laboratory failed to have a system in place to evaluate 6 out of 6 ABI 7500 Dx Fast and 4 out of 4 QuantStudio 5 RT-PCR instrumentation and methodologies used to test patient samples for Sars-Cov-2 at least twice a year since January 2021. 2. An interview with the microbiology program manager, on March 9, 2020, at approximately 4:30 PM, confirmed the laboratory failed to have a system in place to evaluate the performance of different test systems for the Sars-Cov- 2 tests. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on a record review and an interview with the microbiology technical supervisor 3, the laboratory failed to document the dates, times, identity of testing personnel, and -- 3 of 4 -- each step of bacteriology culture isolation and identification from 20 out of 20 culture specimens received August through December 2020. Findings: 1. A record review of the Clinical Bioterrorism Worksheets from August through December 2020, revealed the worksheets failed to include each step of media inoculation and identification for patient bacteriology samples received for testing. 2. An interview with the microbiology technical supervisor 3, on March 9, 2020, at approximately 10:30 AM, confirmed the laboratory failed to document each step in bacteriology culture inoculation and isolation on the worksheets. -- 4 of 4 --

Summary Statement of Deficiencies 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 review of competency documentation, review of the quality assurance manual, and interview with the Scientific Director, the laboratory failed to follow written procedures for competency assessment in newborn screening (NBS) for seven of 10 employees in 2017 and 2018. Findings include: 1. Section 5.2 of the Quality Assurance manual states staff will be assessed annually for competency. 2. Review of personnel competency documentation revealed no competency was performed for Biotinidase in 2017, and for GSP, no assessment was performed from 6/30/17 and 9/30 /18 for the NBS technical supervisor. 3. Review of personnel competency documentation revealed no competency was performed for CF DNA in 2017, and for PKU and MS/MS, no assessment was performed from 7/31/17 and 10/31/18 for the general supervisor. 4. Review of personnel competency documentation revealed no competency was performed for Biotinidase and PKU in 2017, and for HPLC in 2018 for testing personnel 9. 5. Review of personnel competency documentation revealed no competency was performed for CF DNA in 2017, Biotinidase no assessment was performed from 6/22/17 and 10/31/18, and Hemaglobin IEF no assessment was performed from 8/14/17 and 11/16/18 for testing personnel 2. 6. Review of personnel competency documentation revealed no competency was performed for Biotinidase and GALT in 2017 for testing personnel 8. 7. Review of personnel competency documentation revealed no competency was performed from 3/17/17 and 9/19/18 for CF DNA and 2/23/17 and 5/11/18 for GSP for testing personnel 3. 8. Review of personnel competency documentation revealed no competency was performed for MS /MS in 2017, and for GALT, no assessment was performed from 7/11/17 and 10/2/18 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 -- for testing personnel 4. 9. In an interview conducted on 11/27/2018 at approximately 2:00 PM, the Scientific Director confirmed the competency assessments mention above were not performed according to established policy. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing documentation (PT) and staff interview, the laboratory failed to evaluate CDC Newborn Screening Quality Assurance Program (NSQAP) proficiency testing results in a timely manner for four of four quarters in 2017, and two of four quarters in 2018 in newborn screening. Findings include: 1. 2017 NSQAP Quarter 1 PT specimens were tested on 1/25/17, results were received on 2/15/17, discrepancy report was initiated on 4/17/17, signed as reviewed by the program manager on 6/7/17, and signed by the laboratory director on 6/9/17. 2. 2017 NSQAP Quarter 2 PT specimens were tested on 4/3/17, results were received in June 2017, discrepancy report was initiated on 12/11/17, signed as reviewed by the program manager on 1/26/18, and signed by the scientific director on 5/21/18. 3. 2017 NSQAP Quarter 3 PT specimens were tested on 7/10/17, results were received on 9/30 /17, discrepancy report was initiated in January 2018, signed as reviewed by the quality manager on 4/27/18, and signed by the laboratory director on 5/22/18. 4. 2017 NSQAP Quarter 3 PT specimens were tested on 10/2/17, results were received on 11 /30/17, discrepancy report was initiated in November 2017, signed as reviewed by the program manager on 4/5/18, and signed by the laboratory director on 5/22/18. 5. 2018 NSQAP Quarter 1 PT specimens were tested on 1/10/18, results were received on 3/16 /11, signed as reviewed by the testing supervisor on 8/7/18, and signed by the laboratory director on 9/12/18. 6. 2018 NSQAP Quarter 2 PT specimens were tested on 4/30/18, results were received in July 2018, discrepancy report was initiated on 10 /15/18, and signed by the laboratory director on 10/23/18. 7. In an interview conducted on 11/28/2018 at approximately 11:00 AM, the Scientific Director confirmed the laboratory failed to evaluate the NBS proficiency testing results mentioned above in a timely manner. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of manufacture's storage requirements for reagents used in the Molecular testing laboratory, as well as staff interview, the laboratory failed to define an appropriate range for reagent storage. Findings include: 1. Review of manufacture's -- 2 of 5 -- product insert for primers and probes used in molecular testing revealed the storage requirements to be less than or equal to -20C. 2. Review of temperatures logs for the following storage freezers revealed that reagents were only being stored at -15 or less but not achieving the required -20C. a. Instrument # MOLRFG02 - Refrigerator /Freezer Rm 137A b. Instrument # MOLRFG07- Fisher ISOTemp c. Instrument # MOLFRZ05 - Fisher ISO Temp 137A 3. In an interview conducted on 11/28/2018 at approximately 10:50 AM, the Molecular Testing Supervisor confirmed that this was an oversight by the laboratory and that Molecular primers and probes were not being stored at -20C or less. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A. Based on the lack of documentation and staff interview, the maintenance on the EVOLIS test system in Serology was not performed as required by the manufacturer. Findings include: 1. Review of maintenance logs for 2018 revealed that weekly maintenance was not documented for 12 of approximately 43 weeks. 2. Review of the Evolis instrument manual indicated that weekly maintenance activities are required. 3. In an interview conducted on 11/27/2018 at approximately 3:00 PM, the Serology Testing Supervisor confirmed that weekly maintenance was sometimes missed on this testing platform. B. Based on lack of documentation, review of quality assurance manual and staff interview, the laboratory failed to define an instrument maintenance protocol for 1 of 2 microscopes used in Serology. Findings include: 1. Observation of the Zeiss D2 microscope revealed no maintenance documentation was available for 2017 or 2018 and no preventive maintenance service documentation was available for 2017. 2. Section 9.2 of the quality assurance manual states "Each program will have procedures for preventative maintenance to be performed on each piece of equipment and each instrument in use in the program." 3. In an interview conducted on 11/27 /2018 at approximately 11:10 AM, the Serology Testing Supervisor confirmed that there were no maintenance records for this microscope, as well as no documentation for the bulb replacement. D5781