Utah Public Health Laboratory

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 a review of personnel competency records, the laboratory's Quality Assurance policy, and interviews with the Technical Supervisor (TS) and Laboratory Director (LD), the laboratory failed to establish policies and procedures to assess the competency of General Supervisors (GS) and Clinical Consultants (CC) and failed to conduct required competency assessments for 1 of 6 General Supervisors for 2023, and for 4 of 4 Clinical Consultants for 2023 and 2024. Findings: 1. On 05/06/2025, review of competency records revealed the following: a. No documented competency assessment for GS#2 for calendar year 2023. b. No documented competency assessments for CC#1, CC#2, CC#3, or CC#4 for calendar years 2023 and 2024. 2. On 05/06/2025, review of the laboratory ' s 2024 Quality Assurance Comprehensive Policy, Section 2.4, Employee Training and Competency Assessment, indicated: a. "Every employee will be evaluated for competency by the TS or GS two times per year during the first year the employee is testing patient samples (semi-annual and one-year competency), and annually thereafter." b. "The LD will evaluate the competency of each TS annually by reviewing QA activities and documentation." The policy does not address competency assessment procedures for individuals serving as General Supervisors or Clinical Consultants. 3. On 05/06/2025, at approximately 2:50 pm, interviews with TS#4 and the LD (listed on the form CMS 209) confirmed the following: a. Competency assessments were not performed for GS#2 in 2023. b. Competency assessments were not performed for CC#1 through CC#4 in both 2023 and 2024. c. The laboratory ' s current Quality Assurance policy does not include procedures for assessing the competency of individuals serving as GS or CC. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- D5305 TEST REQUEST CFR(s): 493.1241(c) (c) The laboratory must ensure the test requisition solicits the following information: (c)(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. (c)(2) The patient's name or unique patient identifier. (c)(3) The sex and age or date of birth of the patient. (c)(4) The test(s) to be performed. (c)(5) The source of the specimen, when appropriate. (c)(6) The date and, if appropriate, time of specimen collection. (c)(7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (c)(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 a review of final patient test reports for HSV-1, HSV-2, and VZV multiplex PCR testing; the RealStar Alpha Herpes PCR laboratory policy; and an interview with the Technical Supervisor (TS), the laboratory failed to include required interpretive comments in patient reports for 256 of 256 HSV-1, HSV-2, and VZV multiplex PCR tests performed since 01/22/2025. Findings Included: 1. During a random review of final patient test reports on 05/08/2025, at approximately 12:00 pm from January, February, and May 2025, it was identified that reports for HSV-1, HSV-2, and VZV multiplex PCR testing lacked interpretive comments. 2. A review of the laboratory ' s RealStar Alpha Herpes PCR policy on 05/08/2025, at approximately 1:00 pm., Section E: Reportable Comments, revealed that the following interpretive statements are required for inclusion in test reports: For inconclusive results: a. "An inconclusive result may occur if a specimen is improperly collected, transported, stored, or handled. An inconclusive result may also occur if amplification inhibitors are present in the specimen; if inadequate numbers of organisms are present in the specimen; or if the infecting organism has genomic mutations, insertions, deletions, or rearrangements in the target region. Please resubmit." For all results: a. "A false negative result may occur if a specimen is improperly collected, transported, stored, or handled. A false negative result may occur if amplification inhibitors are present in the specimen; if inadequate numbers of organisms are present in the specimen; or if the infecting organism has genomic mutations, insertions, deletions, or rearrangements in the target region." b. "Utah Public Health Lab, which is authorized under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing, determined the performance characteristics of this test. It has not been approved by the U.S. Food and Drug Administration. The results of this test are not intended to be used as the sole means for clinical diagnosis or patient management." c. "This assay has only been evaluated for the diagnosis of HSV in cutaneous, genital, and rectal specimens. Diagnosis of HSV in other sites or tissues should not be based solely on assay results but should be considered in the context of patient symptoms and clinical presentation." 3. During an interview with TS#4 (listed on the form CMS 209), on 05 /08/2025, at approximately 2:50 pm, it was confirmed that the laboratory did not include the above required reporting comments in the HSV-1, HSV-2, and VZV multiplex PCR patient reports. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL -- 2 of 7 -- CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory records, manufacturer instructions, the laboratory's online test menu for clients and interview with laboratory staff, the laboratory failed to have a system in place to ensure specimen integrity was maintained (transport conditions) for 2 of 2 specimens for virology testing. Findings included: 1. Review of patient test requisitions and test reports found the following specimens were received, tested and test results reported for Influenza virus PCR that failed to meet the manufacturer's transport temperature requirements, the laboratory's temperature requirements per their procedure and the temperature requirements specified in their online client services manual. a. NP (nasopharyngeal swab in VTM), accession #4005339, collected on 02/16/2025 and received on 02/19/2025. The temperature on receipt in laboratory was 12.2C. The test result was reported on 03/05/2025. b. NP (nasopharyngeal swab in VTM), accession #4006339, collected on 02/18/2025 and received on 02/25/2025. The temperature on receipt in laboratory was 13.1C. The test result was reported on 03/05/2025. c. Review of the Xpert Xpress CoV-2/Flu/RSV 302-8057, Rev. A, September 2023 instructions for use found the following: "12 Specimen Collection, Transport, and Storage Proper specimen collection, storage, and transport are critical to the performance of this test. Inadequate specimen collection, improper specimen handling and/or transport may yield a false result. Nasopharyngeal and anterior nasal swab specimens can be stored at room temperature (15-30 C) for up to 48 hours in VTM/UTM or eNAT until testing is performed on the GeneXpert Instrument Systems. Alternatively, nasopharyngeal and anterior nasal swab specimens can be stored refrigerated (2-8 C) up to seven days in viral transport medium ..." d. Review of the laboratory's procedure VIRO-1143 COVID Xpert Xpress COV-2 Flu RSV Assay, Version 1.4, approved 01/14/2025 found the following: "Specimen ... Storage ... "Nasopharyngeal and anterior nasal swab specimens can be stored at room temperature (15-30C) for up to 48 hours in VTM/UTM or eNAT ... "Nasopharyngeal and anterior nasal swab specimens in VTM/UTM can be stored at (2-8C) for up to 7 days until testing." e. Review of the laboratory's online test menu found the following: "Virology Influenza virus PCR Surveillance ....Processing ... Keep at 2-8C for up to 72 hours ...Transport ...Transport at 2-8C or if frozen, transport frozen (do not thaw)" 3. During interview on 05/07/2025 at approximately 12:20 pm., the Technical Supervisor for Virology (TS#7 listed on the form CMS 209) confirmed the two viral specimens received and tested were outside of the transport temperature. The laboratory failed to ensure specimens submitted for virology testing maintained transport temperatures specified by the manufacturer and required in their own policy. Word Key: VTM - Viral Transport Media UTM - Universal Transport Media eNAT - enhanced Nucleic Acid Transport PCR - polymerase chain reaction C - degree Celsius D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) (a) The laboratory must establish and follow written policies and procedures for an -- 3 of 7 -- 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 observation, record review and staff interview, the laboratory's quality assessment policy failed to determine the laboratory used a frost free freezer to store patient specimens in the sample receiving area and failed to monitor the temperature of the frost free freezer for 3 of 3 years. Findings Included: 1. During a tour of the sample receiving area on 05/07/2025 at approximately 11:00 am, a freezer (Summit Commercial accucold, Model #AFS49ML, Serial #21100010) was observed. The Lead for Infectious Disease Sample Receiving stated the freezer stored frozen serums, specimens for SARS-CoV-2 sequencing, Influenza PCR and Influenza sequencing until the specimens were taken to the laboratory sections. The freezer had a laminated note taped to the door that stated the alarm will sound every 12 hours when the freezer enters a defrost cycle. 2. The freezer had a TempTrak sensor (#029141220) installed on 04/04/2022 to record the temperature measurements. The temperature range was set at -15C to -25C. 3. Review of the TempTrak temperature measurements for 4/30 /2025 thru 05/07/2025 revealed the temperature was out of range for the following date /times: 05/02/2025 at 3:45 am -13.3C 05/02/2025 at 3:30 am -13.7C 4. TempTrak temperature measurements were requested for October and November of 2024 but were not provided by the laboratory. During interview on 05/07/2025 at approximately 3:00 pm, the Technical Supervisor of Immunology (TS #5 listed on the form CMS 209) stated the TempTrak sensor on the sample receiving area freezer did not record temperature measurements from the time the sensor was installed on 04/04 /2022 until 04/30/2025. 5. Review of the instruction manual for the freezer found on page 10 the following: "6) How to Set Defrost Frequency ..." 6. Review of the laboratory's Quality Assurance policy, UPHL-QA-1 quality Assurance 2024 Comprehensive, Version 4.0 approved 09/05/2024 found the following on page 11: "3. PRE-ANALYTIC SYSTEMS a. Specimen Identification and Integrity" This section of the policy did not address monitoring temperatures in the sample receiving area. Word Key: C = degree Celsius PCR = Polymerase Chain Reaction D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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: I. Based on direct observation, interview with staff, review of temperature logs and review of the instrument operator's manual, the laboratory failed to ensure room temperature was within manufacturer's specifications for the Bruker MALDI Biotyper sample preparation area. Findings included: 1. One MALDI Bruker Biotyper Sirius CA analyzer was observed in enterics area during a tour of the Bacteriology laboratory (Room #339) at approximately 10:15 am on 05/07/2025. 2. During -- 4 of 7 -- interview on 05/07/2025 at approximately 10:15 am, the Technical Supervisor of Bacteriology (TS #6 listed on form CMS 209) stated the sample preparation area for the MALDI plates took place on the enteric bench near the analyzer. 3. The operator manual for the Bruker MALDI Biotyper sirius CA analyzer stated the following: "2.4 Environmental Requirements - Sample Preparation ...Test organism samples intended to be analyzed in the MALDI Biotyper Sirius CA System must be prepared under the following conditions. +20C/+68F to +25C/+77F ...For best results, preparation of all solutions, Standard Solvent, and the entire sample preparation process including drying steps must be performed under controlled room temperature." 4. Review of the TempTrak room temperature logs for the enteric area indicated an acceptable room temperature of 16C - 26C. 5. Further review of the TempTrak room temperature logs for the enteric area found the room temperature out of range for 7 of 7 days reviewed. 04/05/ 2025 19.9C 04/12/2025 19.4C 04/13/2025 19.7C 04/26/2025 19.6C 04/27 /2025 19.4C 04/29/2025 19.8C 04/30/2025 19.8C II. Based on direct observation, record review and review of temperature logs, the laboratory failed to ensure temperatures in the laboratory met manufacturers' temperature requirements. 1. During the tour of the enterics area of Bacteriology laboratory (Room #339) on 05/07 /2025 at approximately 3:30 pm, the following was observed stored: a. On the counter, one open box of Remel RapID Inoculation Fluid, Lot #106479, Expiration 04 /02/2026, store at 20C - 25C. b. In a cabinet, one open box of Remel BactiDrop Oxidase reagent, Lot number 220098, Expiration 07/09/2026, store at 20C - 25C. 2. Review of the manufacturers' instructions for use found the following: a. Remel RapID Inoculation Fluid "Storage ...RapID Inoculation Fluid should be stored in the original container at room temperature (20-25C) until used." b. Remel BactiDrop Oxidase "Storage ...Store product in original container at 20-25C until used. Do not freeze or overheat. Protect from light." 3. Review of the TempTrak room temperature logs for the enteric area of the Bacteriology laboratory (Room #339) indicated an acceptable room temperature of 16C - 26C. 4. Further review of the TempTrak room temperature logs for the enteric area found the room temperature out of the manufacturers' temperature range for 7 of 7 days reviewed. 04/05/ 2025 19.9C 04/12 /2025 19.4C 04/13/2025 19.7C 04/26/2025 19.6C 04/27/2025 19.4C 04/29/2025 19.8 C 04/30/2025 19.8C III. Based on direct observation and review of temperature logs, the laboratory failed to ensure temperatures in the laboratory met manufacturer's temperature requirements for storage of antimicrobial susceptibility testing plates. 1. During the tour of the laboratory on 05/08/2025 at approximately 1 pm the following was observed: a. Stored in a hallway outside of Room #353D were approximately 15 boxes of Sensititre GN7F AST (antimicrobial susceptibility testing) plates, Lot #B5141, Expiration 03/31/2027, store at 15C - 25C. 2. The closest TempTrak sensor in was in the Virology area of the laboratory (Room #343), located several benches away from the hallway outside of Room #353D. 3. Review of the TempTrak room temperature logs for the Virology area indicated an acceptable room temperature of 16C - 26C. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(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. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. -- 5 of 7 -- This STANDARD is not met as evidenced by: Based on review of laboratory records, manufacturer's specifications, and interview with Technical Supervisor #3, the laboratory failed to have documentation of function checks for one Beckman coulter centrifuge located in the mycobacteriology Biosafety level (BSL-3) laboratory for one of one year reviewed. Findings Included: 1. In an interview with Technical Supervisor #3 on 05/08/205 at 02:31 pm stated that it was the laboratory's policy to have the centrifuged checked (by tachometer) by an outside company annually. 2. In review of the manufacturer's instructions for the Beckman Coulter Model J6-MI serial # CJE09803 states, "The following dynamic temperature calibration procedure will verify the accuracy of the temperature sensing and refrigeration systems. Perform this procedure when temperature control within +/- 1 degree C is required." 3.In review of the manufacturer's instructions for the Beckman Coulter Model J6-MI serial # CJE09803 states, " The speed control actual rotor speed will be with 20 RPM of set speed." 4. In review of the laboratory record #19250 Lab - inspection Workflow non-refrigeration (4) it did not have any documentation of 2024 temperature and rotational speed checks. The laboratory could not provide documentation of the Beckman Coulter CJE09803 centrifuge rotations (Tachometer) or temperature checks perform by the outside company in 2024. 5. In an interview with Technical Supervisor #3 (listed on the form CMS 209) on 05/08/2025 at 2:32 pm confirmed the laboratory did not have documentation for calibration of the centrifuge for thermometer or rotational speed used in the mycobacteriology BSL3 laboratory. 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. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory's quality assessment policy failed to determine the laboratory did not monitor or review TempTrack temperature measurements to ensure the room temperature was in range for clinical testing for 2 of 2 months. Findings Included: 1. Review of TempTrak temperature measurements for the room temperature of the virology and enteric laboratory areas for 2 of 2 months (4 /2025 and 5/2025) found the lower and upper limits were set at 16C and 26C, respectively. The limits do not meet the manufacturer's requirements for reagents stored in these areas nor the testing performed in these areas. See D5413. 2. On 05/08 /2025 at approximately 1:30 pm, the Technical Supervisor of Bacteriology (TS#6 listed on the form CMS 209) stated she did not review TempTrak temperature measurements. 3. On 05/08/2025 at approximately 2:05 pm, the Technical Supervisor of Bacteriology (TS#2 listed on form CMS 209) stated she did not review the TempTrak temperature measurements. 4. On 05/08/2025 at approximately 1:50 pm, the Technical Supervisor of Immunology (TS #4 listed on form CMS 209) stated the alarm on TempTrak sensor#198-156-092 for Refrigerator #1 was inactive on 1/28 /2025. The temperature measurements from 11:30 am - 2 pm ranged from -0.8C to 1.9 C. The temperature range for the refrigerator was set to 2C to 8C. 5. Review of the laboratory's Quality Assurance policy, UPHL-QA-1 quality Assurance 2024 Comprehensive, Version 4.0 approved 09/05/2024 found the following on page 15: -- 6 of 7 -- "4.8 Test Systems, equipment, instruments Temperature, humidity, and water quality will be monitored where necessary, for storage of reagents, testing requirements, etc. according to SOPs." -- 7 of 7 --

Summary Statement of Deficiencies D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on review of personnel records and interview with the laboratory director, the laboratory failed to have documentation of academic credentials to qualify one of 46 testing personnel (refer to D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of personnel documentation and interview with the laboratory director (LD), the laboratory failed to have the required documentation to qualify one of 46 testing personnel (TP). Findings: 1. The laboratory failed to have academic credentials to qualify TP #46. 2. Interview with the LD on February 25, 2021 at 2:00 PM confirmed, the laboratory failed to have the required documentation to qualify the individual serving as TP #46. -- 2 of 2 --

Summary Statement of Deficiencies 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 the correct range for reagent storage. Findings include: 1. Review of the manufacture's product insert for primers and probes used in molecular testing revealed the storage requirements to be less than or equal to -20C. 2. Based on a review of the TempTrak logs the laboratory did not maintain reagents at the correct temperature for 90 of the last 90 days. Review of temperatures logs for the storage freezer in room 331D revealed that the following reagents were being stored at a range of -14 to -27. a. CDC Trioplex Primers and Probes b. CDC Influenza Primers and Probes c. Quanta Master Mix 3. In an interview conducted on 12/12/2018 at 9:30 AM, the Diagnostic Immunology technical supervisor confirmed that molecular primers and probes were not being stored at -20C or less. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check 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 -- protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on the lack of documentation and staff interview, there were no records of daily maintenance or day of use maintenance being performed in rooms 331D, 331C and 331B. Findings include: 1. Review of maintenance logs for 2018 revealed that daily maintenance was not documented from January through December of 2018 for the following: a. Eppendorf Thermometer b. Cleaning of lab surfaces c. pH Meter AR 81203613 d. Workstation #1 AC632LFUVC41907 e. Workstation #2 AC632LFUVC41906 f. Cleaning of centrifuges 1 (5417) and centrifuge 3(5424) g. QIACubes #1, #2 and #3 h. Eppendorf Thermomixers #1 and #3 i. ABI #1 275010887 j. ABI #2 275010869 k. ABI #3 275011115 2. Review of the maintenance logs also revealed that no monthly maintenance was recorded for March 2018 for all three rooms. 3. In an interview conducted on 12/12/2018 at 8:35 AM, the Diagnostic Immunology technical supervisor confirmed that daily maintenance was not recorded. Additionally, the technical supervisor stated that March 2018 monthly maintenance was not documented. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of the final test reports in Serology/Virology the laboratory failed to include a reference interval or normal value, which must be made available to the individuals responsible for using the test results. Findings include: 1. Review of final test reports for the following tests revealed that no normal values were available on the final test reports for the following tests. a. Rapid Plasma Reagin Ab b. Syphilis TPPA c. Influenza d. Chlamydia trachomastis e. Neisseria gonorrhea 2. In an interview conducted on 12/11/18 at 10:50 AM, both Serology/Virology technical supervisors confirmed that these reports do not include the normal values. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on review of the amended test reports the laboratory failed to document the prompt notification to the authorized person ordering the test. Findings include: 1. Review of the amended test reports for Serology /Virology in 2018 revealed that there was no documentation of when or how the authorized person was notified, nor was there documentation of who performed the notification. Call logs could not be found for lab number 1253158 and 1251385. 2. In an interview conducted on 12/11/2018 at 10:55 AM, both technical supervisors confirmed that the only instruction in the Comprehensive Quality Management Plan was to create a