Dr Katherine A Kelley State Public Health Lab

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 record review and staff interview, the laboratory failed to perform annual competency assessments for the General Supervisors. Findings include: 1. Review on 7/10/2023 of the laboratory's competency records revealed lack of documentation of annual competencies for nine of nine General Supervisor's (GS) for the year 2021 and 2022. 2. Staff interview on 7/11/2023 at 1:30 PM with the Quality Assurance Manager (QAM) confirmed the laboratory did not have the competency of GS. The QAM further stated that he/she was unaware of the requirement of annual competency assessments for the GS. 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: A. Based on record review, client service manual (laboratory services), patient test 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 -- requisition, final patient report, and interview with Toxicology Testing Person #1 (TP#1), the laboratory failed to ensure specimen integrity was maintained (collection, storage and transport conditions) per their own written procedures for one of four patients. Findings include: 1. Interview on 07/11/2023 at 11:20 AM with Toxicology TP#1 confirmed the laboratory performed Opioid and Illicit Drug Metabolite Screening in urine using Liquid Chromatography and Quadrupole Time of Flight Mass-Spectrometry. 2. Review of the client service manual (laboratory services) titled, "Fentanyl Plus Drug Screen" (screening assay for the presumptive identification of opiates, opioids, prescription drugs, illicit drugs, and their metabolites in urine) under the section "Specimen Handling & Transport" stated, "Store specimens at 2-8C for up to 24 hours. If a delay is expected, store specimens at -20C or lower. Transport specimens using cold packs." 3. Review of the laboratory's "CLINICAL TEST REQUISITION" revealed the following for one of four patients: a. No documentation of "Specimen Storage (prior to Delivery)" on the test requisition. b. No documentation of "Specimen Transport/Delivery" on the test requisition. c. No documentation of "Date Collected" on the test requisition. 4. Review of the patient (1098670001) test reported on 08/26/2022 at 11:29 AM and interview on 07/11/2023 at 11:45 AM with Toxicology TP#1, confirmed the laboratory failed to ensure collection, storage, and transport conditions were maintained and documented to ensure specimen integrity. 5. The laboratory performed 222 Opioid and Illicit Drug Metabolite Screenings in 2022. B. Based on record review, laboratory standard operating procedure, client service manual (laboratory services), patient test requisition, final patient report, and interview with Lead Testing Person #1 (TP#1), the laboratory failed to ensure specimen integrity was maintained (collection, storage and transport conditions) per their own written procedures for three of three patients. Findings include: 1. Interview on 07/11/2023 at 11:05 AM with Lead TP#1 confirmed the laboratory performed Whole Blood Lead testing by Inductively Coupled Plasma-Mass Spectrometry (ICP- MS) on the Perkins Elmer NexION 2000 analyzer. 2. Review of the laboratory's standard operating procedure titled, "Determination of Lead in Whole Blood by Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)" under the section, "B. SPECIMEN HANDLING, HOLDING TIME AND STORAGE:" stated, "Specimens can be transported at ambient temperature. Specimens can be stored at 2-8C for up to 10 weeks or at -30 to -10C for up to one year ..." 3. Review of the client service manual (laboratory services) titled, "Lead Confirmation" under the section, "Specimen Handling & Transport" stated, "Store specimen at 2-8C. Transport at ambient temperature.". 4. Review of the laboratory's "CLINICAL TEST REQUISITION" revealed the following for three of three patients: a. Patient 114415501 test reported on 03/21/2023 - No documentation of "Specimen Storage (prior to Delivery)" on the test requisition. No documentation of "Specimen Transport/Delivery" on the test requisition. b. Patient 1153341001 test reported on 05/10/2023- No documentation of "Specimen Transport/Delivery" on the test requisition. No documentation of "Date Collected" on the test requisition. c. Patient 1159876001 test reported on 06/15/2023 - No documentation of "Specimen Transport/Delivery" on the test requisition. 5. Interview on 07/11/2023 at 11:35 AM with Lead TP#1, confirmed the laboratory failed to ensure collection, storage, and transport conditions were maintained and documented to ensure specimen integrity 6. The laboratory performed 13 Lead tests between January 2023 through June 2023. C. Based on laboratory standard operating procedure, observation, and interview with New Born Screening (NBS) Technical Supervisor #1 (TS #1), and the Assistant Supervisor of Specimen Receiving, the laboratory failed to ensure specimen integrity was maintained during transportation per their own written procedures for eight of eight patients. Findings include: 1. Interview with NBS TS #1 on 07/10/2023 at 01:00 PM confirmed the laboratory performed New Born Screening Bloodspot testing for the detection of 60 metabolic -- 2 of 4 -- and genetic disorders. 2. Review of the laboratory's standard operating procedure for one NBS test titled, "Analysis of C26:0-Lysophosphatidylcholine in Dried Blood Spots Using Tandem Mass Spectrometry (MS/MS) for the Detection of X-Linked Adrenoleukodystrophy (V-ALD)" under "4.0 Specimen" stated "4.2 Specimens should be stored at room temperature (15-22C.) until transport to the laboratory, which should occur within 24 hours of specimen collection. Samples are transported at room temperatures by mail, delivery service or courier service. Humidity or moisture are detrimental to the stability of the dried blood spots and must be avoided. High temperatures may result in degradation of certain analytes and must also be avoided." 3. Observation on 07/12/2023 at 09:00 AM of 8 NBS Blood-Spot specimen cards revealed the following for eight of eight patients: a. Patient 74289860 - No documentation the specimens were transported at room temperature (15-22C.). b. Patient 74289861 - No documentation the specimens were transported at room temperature. c. Patient 74289862 - No documentation the specimens were transported at room temperature. d. Patient 75293401 - No documentation the specimens were transported at room temperature. e. Patient 75293397 - No documentation the specimens were transported at room temperature. f. Patient 75293387 - No documentation the specimens were transported at room temperature. g. Patient 75293399 - No documentation the specimens were transported at room temperature. h. Patient 75293400- No documentation the specimens were transported at room temperature. 4. Interview on 07/12/2023 at 09:20 AM with the Assistant Supervisor of Specimen Receiving, confirmed the findings above. 6. The laboratory performed 13,106 NBS tests between January 2023 through June 2023. 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: A. Based on record review, laboratory standard operating procedure, and interview with Technical Supervisor #1 (TS#1), the laboratory failed to ensure the heat block temperature was monitored for 12 of 12 months. Findings include: 1. Interview with TS#1 on 07/12/2023 at 11:00 AM confirmed the laboratory used Real-Time PCR for the Detection of Shiga Toxins in Enterohemorrhagic Escherichia coli. 2. Record review conducted on 07/12/2023 from January 2022 through December 2022 revealed that the laboratory failed to document the VWR heat block temperature for 12 of 12 months. 3. Review of the laboratory standard operating procedure titled, "Real-Time PCR for the Detection of Shiga Toxins in Enterohemorrhagic Escherichia coli" under section, "8. PROCEDURE" stated: a. "8.1 DNA Extraction" b. "8.1.1 Preheat a heating block to 100 5C" c. "8.1.6 Place in heat block at 100 5C for 10 minutes" 4. Interview with TS#1 on 07/12/2023 at 11:30 AM confirmed the findings as indicated above. 5. The laboratory performed 199 Shiga Toxins in Enterohemorrhagic Escherichia coli patient tests in 2022. B. Based on record review, manufacturer's instruction, and interview with Technical Supervisor #1 (TS#1), the laboratory failed to ensure the BD Paper Discs were maintained according to the manufacturer's -- 3 of 4 -- requirement for five of six months. Findings include: 1. Interview with TS#1 on 07/12 /2023 at 12:00 PM confirmed the laboratory used BD Paper Disc for the detection of Streptococcus pneumoniae. 2. Review of the manufacturer's storage requirement on 07 /12/23 revealed a storage requirement between 8 to -20C. 3. Record review conducted on 07/12/2023 from January 2023 through June 2023 revealed temperatures were colder than -20C for five months of six months: a. February - 3 of 16 freezer temperatures were documented colder than -20C. b. March - 20 of 26 freezer temperatures were documented colder than -20C. c. April - 22 of 25 freezer temperatures were documented colder than -20C. d. May - 4 of 27 freezer temperatures were documented colder than -20C. e. June - 21 of 25 freezer temperatures were documented colder than -20C. 4. Interview with TS#1 on 07/12 /2023 at 12:30 PM confirmed the findings as indicated above. 5. The laboratory performed 141 Streptococcus pneumoniae patient tests between January 2023 and June 2023. C. Based on record review, manufacturer's instruction, and interview with Technical Supervisor #2 (TS#2), the laboratory failed to ensure the invitrogen Express qPCR SuperMixes and Two-Step qRT-PCR Kits were maintained according to the manufacturer's requirement for six of six months. Findings include: 1. Interview with TS#2 on 07/12/2023 at 12:15 PM confirmed the laboratory used the Invitrogen Express qPCR SuperMixes and Two-Step qRT-PCR Kits on the ABX 7500 instruments. 2. Review of the manufacturer's storage requirement on 07/12/23 under the section, "Kit Components and Storage" stated, "Storage: Store all components at -20C for long-term storage." 3. Record review conducted on 07/12/2023 from January 2023 through June 2023 revealed temperatures were colder than -20C for six months of six months: a. January - 20 of 20 freezer temperatures were documented colder than -20C. b. February - 17 of 17 freezer temperatures were documented colder than -20C. c. March - 22 of 22 freezer temperatures were documented colder than -20C. d. April - 18 of 18 freezer temperatures were documented colder than -20C. e. May - 22 of 22 freezer temperatures were documented colder than -20C. f. June - 22 of 22 freezer temperatures were documented colder than -20C. 4. Interview with TS#2 on 07 /12/2023 at 12:40 PM confirmed the findings as indicated above. -- 4 of 4 --

Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on record review and staff interview with the Newborn Screening (NBS) Laboratory Technical Supervisor (TS), the laboratory failed to retain copies of preliminary reports generated from the Horizon Laboratory Information System (LIS). Findings include: 1. Record review conducted on 07/20/2021 of a preliminary report copy for patient DPH Lab ID 1022372001 found that the report noted as a "DRAFT", was missing the provider name and address information, and included a "Date Reported" as 07/20/2021, 2:13 pm. 2. Interview with the NBS TS at 2:18 pm revealed that a preliminary report was sent to the patient's provider due to an abnormal 17- hydroxyprogesterone level of 129.3 ng/mL. The NBS TS stated the preliminary report was actually sent on 07/14/2021 and not 07/20/2021. The "Draft" copy of the report was printed 07/20/2021 at 2:13 pm. The NBS TS further revealed that the NBS Laboratory was unable to print copies of preliminary reports issued from the Horizon LIS. The NBS Laboratory was also not able to produce a copy of the original preliminary report sent on 07/14/2021. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This CONDITION is not met as evidenced by: Based on surveyor review of Newborn Screening (NBS) Laboratory records, staff interviews, and surveyor observation, the laboratory failed to include the "result override" process in their approved NBS procedure manual (refer to D5403); failed to determine if the Horizon laboratory information system (LIS) changes performed acceptability before implementing new test methods (refer to D5421 and D5423); failed to follow their Quality Assurance Manual (QAM) after issuing NBS corrected reports due to incorrect analytical results (refer to D5891), and failed to implement effective policies and procedures to prevent the ongoing problem of issuing NBS corrected result reports from the Horizon LIS (refer D5893). The cumulative effect of these systematic problems resulted in the laboratory's inability to ensure the accuracy and reliability of NBS results reported from the Horizon LIS. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to verify the accuracy of Hepatitis A Ribonucleic Acid(RNA) and Candida auris Polymerase Chain Reaction (PCR) at least twice annually. Findings include: 1. Record review on 7/19/2021 of the laboratory's 2020 proficiency testing (PT) records revealed: a. PT for Hepatitis A RNA was not performed in 2020. b. PT for Candida auris PCR was performed once in 2020. 2. Staff interview on 7/19/2021 at 11:30 am with the virology technical supervisor (VTS), confirmed the findings in 1a and 1b. The VTS also stated patient results were reported during that time. 3. The laboratory performs 28 Candida auris PCR and 15 Hepatitis A RNA tests annually. 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 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to test proficiency testing (PT) samples in the same manner as routine patient samples by personnel who routinely perform the testing in the sub-specialty of syphilis serology. Findings include: 1. Record review of the College of American Pathologists syphilis serology PT records for 2017 and 2018 on 7/16/19 revealed the following: a) 2017 - two PT events were tested by testing personnel (TP) #1 and one PT event by TP#2. b) 2018 - all three PT events were tested by TP#2. c) No PT events were tested by TP#3 in 2017 and 2018. 2. Staff interview with the Diagnostic Immunology Section Supervisor (DISS) on 7/16/19 at 11:00 AM confirmed the above findings. The DISS further stated all three TP did not participate in PT events each calendar year although patient samples were tested by three TP. 3. The laboratory performs 9,595 syphilis serology tests annually. 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: 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 -- Based on surveyor observation and staff interview, the laboratory failed to take adequate safety precautions to prevent potential biological contamination of floor covering during specimen receipt and data entry. Findings include: 1. Surveyor observation of the specimen processing area on 7/15/19 at 2:25 PM, revealed the processing was being performed in Room 1515 labeled 'Data Entry'. This room consisted of wall to wall carpeting with multiple workstations for data entry. 3 of 3 laboratory staff had specimen requisitions along with biological specimens at their workstations. Coverage of the carpeting with non-porous material was not present for proper decontamination and clean-up in event of a biological spill. 2. Staff interview with the Laboratory Administrative & Scientific Support Services Director (LASSD) on 7/15/19 at 2:25 PM confirmed the above findings. In addition, LASSD revealed the following: a. The laboratory specimen processing area had been relocated to Room 1515 due to a fire. b. Room 1515 is a temporary situation while repairs are being completed. c. The carpet was not removed because of the safety hazard due to carpet glue. d. If a spill occurs staff have been directed to pour bleach on the carpet and the carpet would be replaced. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for precision using operator variance. Findings include: 1. Record review on 7/15/19 of the laboratory's validation protocol for the Aptima HIV-1 Quant Assay, Verification Protocol section revealed, "A laboratory analyst who was adequately trained in the use of the Aptima HIV-1 Quant Assay on the Panther System by a Hologic Field Application Specialist performed the verification study." 2. Record review on 7/16/19 of the Aptima HIV-1 Quant Assay validation's raw data revealed only one testing personnel (TP) performed testing and participated in the validation. 3. Staff interview on 7/16/19 at 10:00 AM with the virology technical supervisor (TS) confirmed the above findings. The TS stated, "Two TP perform routing patient HIV Quant testing, but only one TP participated in the validation." 4. The laboratory performs 20 Aptima HIV-1 Quant Assays annually. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as -- 2 of 7 -- applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review and staff interview,the laboratory failed to establish performance specifications for the new Nexion 2000P ICP-MS instrument used for high complexity testing in the specialty of chemistry. Findings include: 1. Record review of the laboratory's CMS List of tests performed on-site & Annual test volume report on 7/17/19 revealed the Nexion 2000P ICP-MS instrument was a new instrument used to perform blood/urine metal testing for cadmium (Cd), lead (Pb) and mercury (Hg). 2. Record review of the laboratory's validation studies for the above on 7/17/19 revealed the performance specification studies for the Nexion 2000P ICP-MS instrument were not available or approved by the laboratory director for Cd, Pb, and Hg prior to the start of patient testing in February of 2019. 3. Staff interview with the department manager (DM) on 7/17/19 at 2:00 PM confirmed the laboratory failed to conduct the performance specifications listed above for the Nexion 2000P ICP-MS instrument. DM stated he/she was not aware that new instrumentation needed to be validated if it was the same platform. 4. The laboratory performs 72 blood/Urine metal testing annually. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on test record review and staff interview with the Quality Assurance Manager (QAM) and Laboratory Director (LD), the laboratory failed to ensure that test results were accurately and reliably sent to the final report destination. Findings include: 1. Record review conducted on 7/16/19 of the test report records from 04/01/19 to 06/30 /19 revealed that that the laboratory failed to perform routine checks to verify that test results were accurately transmitted to their final report destination after the laboratory released test results for reporting. 2. The record review conducted on 7/16/19 of Newborn Screening Laboratory (NBS) test reporting records revealed that the NBS released 862 test results on June 12, 2019 to be reported. The record review further revealed that the laboratory was unable to provide documentation demonstrating that the 862 NBS test results were accurately and reliably transmitted by fax or email to the health care providers authorized to receive the test results. 3. Record review conducted on 7/16/19 of test records for July 11, 2019 and June 28, 2019 also revealed that the laboratory was unable to provide documentation demonstrating that Connecticut Department of Public Health, Laboratory Branch (CTPHL) ensured test results released for reporting on 7/11/19 and 6/28/19 were accurately and reliably -- 3 of 7 -- transmitted by fax or email to their final report destination. 4.Interview with the QAM and the LD on 7/16/2019 at 11:17 AM confirmed the findings above. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: A. Based on record review and staff interview with the Newborn Screening Laboratory (NBS) Technical Supervisor (TS) and the Laboratory Director (LD), the laboratory failed to include the name and address of the laboratory where the amino acids, succinylacetone and acylcarnitines in dried blood spots by Tandem Mass Spectrometry (MS/MS) was performed. A. Findings include: 1. Record review conducted on 7/16/19 of June 2019 and July 2019 NBS test result records revealed the "CT NBS Contact Information report used to send abnormal the amino acids, succinylacetone and acylcarnitines MSMS results to the NBS Tracking Unit Nurse was missing the address where the tests were performed. 2. Interview with the NBS TS and LD on 7/16/19 at 3:30 PM confirmed the findings above. B. Based on record review and staff interview with the newborn screening technical supervisor (TS) and the laboratory director (LD), the laboratory failed to follow its procedure for reporting abnormal amino acids, succinylacetone and acylcarnitines in dried blood spots by Tandem Mass Spectrometry (MS/MS) on Connecticut Department of Public Health, Laboratory Branch (CTPHL) Newborn Screening (NBS) test reports. B. Findings include: 1. Record review conducted on 7/16/19 of the CTPHL Detection of Amino Acids, Succinylacetone and Acylcarnitines in Dried Blood Spots by Tandem Mass Spectrometry (MS/MS), Document ID NBS-02-5, Effective date 8/15/2016, Section 10.0, " ... results where 2 out of the 3 analyses generate an abnormal tool score then the final reported result is abnormal". 2. Record review conducted on 7/16/19 of randomly selected CTPHL NBS abnormal test reports issued between May 2019 and June 2019 Lab IDs 853754001 and 855983001 revealed a single result value reported for each abnormal acylcarnitines. The review further revealed that the calculation used to determine the single abnormal acylcarnitines result value was not documented in the CTPHL Detection of Amino Acids, Succinylacetone and Acylcarnitines in Dried Blood Spots by Tandem Mass Spectrometry (MS/MS) approved procedure. 3. Interview with the NBS TS and LD on 7/16/19 at 3:30 PM confirmed the findings above. 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. -- 4 of 7 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure the final interpretation reported on the final patient test report correlates with the interpretation in the procedure manual in the specialty of virology. Findings include: 1. Record review on 7/16/19 of the 'CMV IgM Detection in Serum Using the Captia EIA Kit' procedure revealed: a. Section 6.0 Reporting Results: 6.1 Analysis: "0.91 -1.09 Equivocal Sample should be retested" 6.1.2: "Samples that remain equivocal after repeat testing should be retested on a alternate method, e.g. immunofluorescence assay (IFA)." b. Section 8.0 Limitations: 8.4: "Samples that remain equivocal after repeat testing should be retested on a alternate method, e.g. immunofluorescence assay (IFA). If results remain equivocal upon further testing, an additional sample should be taken." 2. Record review on 7/16/19 of the 'Trinity Biotech Captia Cytomegalovirus IgM' package insert revealed: a. Analysis: "0.91 -1.09 Equivocal Samples should be retested. See number 2 below." "Samples that remain equivocal after repeat testing should be retested on an alternate method, immunofluorescence assay (IFA)." b. Limitations Of Use: "Samples that remain equivocal after repeat testing should be retested on an alternate method, immunofluorescence assay (IFA)." If results remain equivocal upon further testing, an additional sample should be taken." 3. Record review of a final test report on 7/16/19 revealed: "Cytomegalovirus IgM 1.069 ISR, Final Interpretation: Equivocal, Please submit another sample to confirm analysis." "0.91 - 1.09 Equivocal" 4. Staff interview with the virology technical supervisor (TS1) on 7/16/19 at 11:00 AM confirmed the above findings. The TS1 stated the laboratory does not have an alternate method to retest equivocal specimens. Currently equivocals are repeated using the same method. 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: Based on record review and staff interview, the laboratory's amended reports failed to indicate what corrections were made on their Newborn Screening (NBS) patient final test reports. Findings include: 1. Record review on 7/17/19 of the laboratory's corrected final patient report log from 6/1/19 through 6/30/19 revealed the following: a. 6 of 6 NBS amended reports reviewed failed to indicate what corrections were made on the final reports. b. 8 of 8 NBS reports revealed no corrections were made but indicated report was amended. 2. Staff interview with the quality assurance manager (QAM) on 7/17/19 at 1:30 PM confirmed the above findings. 3. The laboratory performs 362,000 NBS tests annually. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems -- 5 of 7 -- identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to monitor and assess the accuracy of the laboratory's corrected reports issued to ensure compliance with the laboratory's approved corrected test report policy and procedure. Findings include: 1. Record review conducted on 7/17/19 of the Connecticut Department of Public Health, Laboratory Branch (CTPHL) Module 1A Quality Assessment Program for Clinical Testing Manual (QAM) 4th edition, document ID QA-CLIA, effective June 20, 2017, revealed in section 7.4 Correction of Test Reports "The reason for a corrected report must be inserted as a comment when the report is changed in the LIMS." 2. Record review of corrected reports from 4/1/19 to 6/30/19 revealed that 178 of 531 corrected reports issued during this time period were missing comments. 3. Interview with the Quality Assurance Manager on 7/16/19 at 3:30 PM confirmed the findings above. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved