New Hampshire Public Health Lab

Summary Statement of Deficiencies D0000 Federal surveyors from the Centers for Medicare & Medicaid Services (CMS) Survey Branch conducted an announced CLIA recertification survey at the NH Public Health Laboratories from April 29, 2025, to May 1, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA regulations and was found to be in compliance with condition- level CLIA requirements. The following standard-level deficiencies were found during the CLIA recertification survey that concluded on May 1, 2025, at 1:30 pm. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records, lack of twice-annual verification of accuracy for MIA testing, and an interview with arbovirus supervisor, the laboratory failed to verify the accuracy of arbovirus MIA (Microsphere Immunoassay) testing at least twice a year in 2023 and 2024 (two of two years). Findings Included: 1. On the day of the survey, April 30, at 1:00 pm, a review of arbovirus PT testing records revealed, the laboratory verified the accuracy of arbovirus MIA testing once annually in 2023 and 2024. 2. The laboratory could not provide records of performing twice-annual verification for MIA testing for two out of two years (2023 and 2024). 3. By interview on April 30, 2025 at 1:35 pm, the arbovirus supervisor,confirmed PT for MIA testing was only performed once a year for the active testing season from May to December of each year. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) 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 -- (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: I. Based on review of laboratory procedures, manufacturer's instructions, the laboratory's online test menu, test requisitions and test reports, the laboratory failed to have a system in place to ensure specimen integrity was maintained (transport conditions) per their own specifications for 3 of 3 specimens for serology testing. 1. Review of the laboratory's procedure manual found the following: a. Procedure for Syphilis Rapid Plasma (RPR) Qualitative and Quantitative Card Test, Document ID: VI-NM-SOP-024, Revision: 5, Effective 1/30/2024 "6. SAMPLE HANDLING ... "The serum should be stored at 2-8C if testing is to be delayed more than 4 hours. Serum, removed from the clot, may be refrigerated at 2-8C for up to 5 days, or frozen at -20C or below." 2. Review of the manufacturer's instructions for use for the BD Macro-Vue RPR Card Tests found the following: a. "Specimen Collection and Preparation ...Serum, removed from the clot, may be refrigerated at 2-8C, for up to 5 days, or frozen at -20C or below ..." 3. Review of the laboratory's online test menu for clients found the following: a. "Rapid Plasma Reagin (RPR, for Syphilis) Qualitative ...Specimen: 1mL serum ...Instructions: Refrigerate specimens at 2-8C and transport within 5 days." 4. Review of patient test requisitions and test reports found the following: a. Specimen for RPR Qualitative testing- Accession number 2502140005, collected on 02/13/2025, received by the laboratory 02/14/2025. The temperature of the specimen when delivered to the laboratory was 19.7C with a note indicating "No Cold Pks". The laboratory reported a test result on 02/18/2025. b. Specimen for RPR Qualitative testing- Accession number 2503200005, collected on 03/19/2025, received by the laboratory 03/20/2025. The temperature of the specimen when delivered to the laboratory was 21.1C with a note indicating "No Cold Pack". The laboratory reported a test result on 03/24/2025. c. Specimen for RPR Qualitative testing- Accession number 2504100010, collected on 04/09/2025, received by the laboratory 04/10/2025. The temperature of the specimen when delivered to the laboratory was 24.4C with a note indicating "No CP". The laboratory reported a test result on 04/15/2025. II. Based on review of laboratory procedures, manufacturer instructions, the laboratory's online test menu, test requisitions and test reports, the laboratory failed to have a system in place to ensure specimen integrity was maintained (transport conditions) per their own specifications for 2 of 2 specimens for immunology testing. 1. Review of the laboratory's procedure manual found the following: a. Procedure for Focus Diagnostics HerpeSelect 1 and 2 Immunoblot, Document ID: VI-NM-SOP-018, Revision: 5, Effective 10/29/2024 "Preservation and storage of samples: "Separated serum/plasma should remain at 22C for no longer than 8 hours. If the assay will not be completed within 8 hours, refrigerate the sample at 2-8C. If the assay will not be completed within 48 hours, or for shipment of samples, freeze at -20C or colder." 2. Review of the manufacturer's instructions for use for the Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG test found the following: "Specimen Collection and Handling ... Separated serum/plasma should remain at 22C for no longer than 8 hours. If the assay will not be completed within 8 hours, refrigerate the sample at 2- 8C. If the assay will not be completed within 48 hours, or for shipment of samples, freeze at -20C or colder." 3. Review of the laboratory's online test menu for clients found the following: "Herpes Simplex Virus (HSV) Antibody IgG (Type 1 and 2) ... -- 2 of 5 -- Specimen: 1-2 mL serum ...Instructions: Refrigerate at 2-8C and transport within 2 days of collection." 4. Review of patient test requisitions and test reports found the following: a. Specimen for Herpes IgG Immunoblot test, Accession number 2405160036 collected on 05/15/2024, received by the laboratory on 05/16/2024. The temperature of the specimen when delivered to the laboratory was 23.4C. The laboratory reported a test result on 05/24/2024. b. Specimen for Herpes IgG Immunoblot, Accession number 2408290391 collected on 08/28/2024, received by the laboratory on 08/29/2024. The temperature of the specimen when delivered to the laboratory was 23.2C. The laboratory reported a test result on 09/05/2024. The laboratory failed to ensure specimens submitted for testing maintained transport temperatures specified in their own procedures, required by the manufacturer and listed in their online test menu. Word Key: BD - Becton Dickinson C - degrees Celsius IgG - immunoglobulin G D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on staff interview and record review of Bacteriology Proficiency Testing (PT) 2021 records, the laboratory failed to review and evaluate an unacceptable score for College of American Pathologists (CAP) PT sample D-12 in the D-B 2021 Bacteriology Survey Event. Findings include: 1. Record review conducted on 12/02 /2022 of CAP Bacteriology PT records revealed an unacceptable morphology score for sample D-12. The review showed that the laboratory submitted an unacceptable result of "Diplococci" for sample D-12 and the CAP PT Program's intended response was "Cocci". 2. Record review conducted on 12/02/2022 of the laboratory's completed "Proficiency Test Review FORM" (Document ID QU-FORM-770) for Bacteriology Survey D-B 2021 revealed," "Review and sign, no further action" checked under the Comment/Course of Action section of the form. 3. Record review conducted on 12/02 /2022 of the laboratory's Proficiency Testing SOP (Document ID: QU-SOP-770) revealed the following under Section 5.8 Proficiency Test Report "Results Investigation needs to be performed by the unit supervisor and/or Program Manager when unacceptable results are obtained in a PT or part of a PT." 4. Staff interview with the Technical Supervisor (TS#6) and the Quality Manager (QAM) conducted on 12/02/2022 at 11:30 AM confirmed that no investigation was conducted by the laboratory for the unacceptable PT result score. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) 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 -- 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 the surveyor's review of the laboratory's approved Syphilis Rapid Plasma Reagin (RPR) Qualitative and Quantitative Card Test (Document ID VI-NM-SOP- 024) procedure manual, laboratory room temperature charts, and interview with the Technical Supervisor 1 (TS#1), the laboratory failed to follow the manufacturer's room temperature requirements for the Macro-Vue (Trademark) RPR Card Test. Findings include: 1. Record review conducted on 12/01/2022 of the BD Macro-Vue (Trademark) RPR Card Tests manufacturer's package insert revealed the following, "allow the antigen to warm to room temperature (23 to 29 C) before use". 2. Record review conducted on 12/01/2022 of the laboratory's approved Syphilis Rapid Plasma Reagin (RPR) Qualitative and Quantitative Card Test (Document ID VI-NM-SOP- 024) procedure, effective 12/18/2019, included the following in the Limitation of the Procedure section, a. "Temperatures less than 25 C of sera, reagents, and testing area, decrease reactivity. Temperatures greater than 29 C increase reactivity." 3. Record review conducted on 12/01/2022 of the room temperature charts for Room 325 where the RPR Testing is conducted revealed an acceptable temperate range of 18C- 30C for the years 2021 and 2022. The review further revealed that only 14 days were within the acceptable RPR testing range of 23 to 29 C in 2021 and only 13 days in 2022. 4. Staff interview on 12/01/2022 at 2:50 PM confirmed the findings above. 5. The laboratory performed 1,044 RPR tests in 2022. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on staff interview and record review, the MALDI-TOF Mycobacteria Identification (ID CM-T-SOP-018) Standard Operating Procedure (SOP) was not signed and approved by the current laboratory director (LD) before use. Findings include: 1. Record review conducted on 12/02/2022 of the MALDI-TOF Mycobacteria Identification SOP (Document ID: MC-T-SOP-18), Revision 1, found that the procedure was not signed and approved by the current LD prior to use. 2. Record review conducted on 12/02/2022 of the Mycobacteria Brucker MALDI-TOF Validation Report revealed an LD approval date of 06/04/2022. 3. Record review conducted on 12/02/2022 of Mycobacteria MALDI-TOF patient test records for the period of June 2022 to November 2022 revealed reported MALDI-TOF test results. 4. Staff interview with the Technical Supervisor (TS#6) and the Quality Manager (QAM) on 12/02/2022 at 2:37 PM confirmed that the MALDI-TOF Mycobacteria Identification SOP (Document ID: MC-T-SOP-18) was put into use and not signed by the LD. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) -- 2 of 4 -- 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 and staff interview, the laboratory failed to define an acceptable temperature range for the Clinical Micro Fisher IsoTemp -20 Freezer in use during 2021 and 2022. Findings include: 1. Record review conducted on 12/02 /2022 of 2021 and 2022 temperature charts for the Clinical Microbiology Fisher IsoTemp -20 C Freezer, serial number 1168488901180323, revealed no acceptable temperature range. 2. Staff interview with the Technical Supervisor (TS#6) at 10:51 AM confirmed that the acceptable range was missing. The TS#6 further revealed that the Fisher IsoTemp -20 C Freezer was used during 2021 and 2022 for patient testing. B. Based on record review and staff interview, the laboratory failed to monitor and document the acceptable range of the MDX Clean Room 328 VWR Upright -20 C Freezer and the IsoTemp Glass Door Refrigerator for 2022. Findings include: 1. Record review conducted on 12/02/2022 of the MDX Clean Lab Room 328, VWR Upright Freezer -20C (serial # T01K-486158-TK) and IsoTemp Glass Door Refrigerator (serial # 0168579601110726) revealed: a. 19 missing temperature recordings in 2022 for the IsoTemp Glass Door Refrigerator (serial # 0168579601110726). b. 23 missing temperature recordings in 2022 for the WR Upright Freezer -20C (serial # T01K-486158-TK). 2. Staff interview with the Technical Supervisor (TS#3) on 12/02/2022 at 10:00 AM confirmed that the temperature recordings were missing. TS#3 further revealed that the VWR Upright Freezer -20C (serial # T01K-486158-TK) and IsoTemp Glass Door Refrigerator (serial # 0168579601110726) were used to store reagents, primers, and probes for molecular clinical testing. 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: Based on a review of records, manufacturer's instructions, and staff interview, the laboratory failed to follow the manufacturer's instructions for BioFire FilmArray Pouch Loading Station Decontamination procedures for the year 2022. Findings include: 1. Record review conducted on 12/02/2022, revealed no evidence the BioFire FilmArray Pouch Loading Station Decontamination procedure had been performed. 2. Staff interview with the General Supervisor (GS #8) on 12/02/2022 at 01:35 PM confirmed that the BioFire FilmArray Pouch Loading Station Decontamination procedure was not documented as being performed. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) -- 3 of 4 -- (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 record review and staff interview, the laboratory failed to evaluate and define the relationship between test results using different analyzers in 2022. Findings include: 1. Record review conducted on 12/02/2022, revealed the laboratory failed to evaluate Volatile Organic Compounds test results between the Agilent 5977 and Agilent 5973 instruments in the year 2022. 2. Staff interview with General Supervisor (GS #4) on 12/02/2022 at 10:30 AM confirmed the findings above. -- 4 of 4 --

Summary Statement of Deficiencies 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, the laboratory failed to successfully participate in proficiency testing for the subspecialty of Virology. Refer to D2064 and 2057. D2057 VIROLOGY CFR(s): 493.831(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories 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 -- failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the laboratory's graded proficiency testing (PT) results from the College of American Pathologists (CAP) and interview with the PT program provider, the laboratory failed to achieve successful performance for subspecialty of Virology, in two out of three testing events. Findings include: 1. Record review conducted on 06 /29/2021 of CAP 2020 and 2021 PT results for the Infectious Disease Respiratory (IDR) Panel revealed the laboratory received a score of 0% for the 3rd event in 2020 (IDR-C) and a score of 0% for the 1st event in 2021 (IDR-A). 2. Interview with the CAP PT provider on 06/26/2021 at 1:45 pm confirmed the laboratory failed to participate in the 2020 3rd and the 2021 1st events. The interview further revealed that the laboratory failed to notify the CAP PT Program regarding their inability to participate in both PT events. D2064 VIROLOGY CFR(s): 493.831(e) 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 review of the laboratory's graded proficiency testing (PT) results from the College of American Pathologists (CAP) and interview with the PT program provider, the laboratory failed to achieve successful performance for subspecialty of Virology, in two out of three testing events. Findings include: 1. Record review conducted on 06 /29/2021 of CAP 2020 and 2021 PT results for the Infectious Disease Respiratory (IDR) Panel revealed the laboratory received a score of 0% for the 3rd event in 2020 (IDR-C) and a score of 0% for the 1st event in 2021 (IDR-A). 2. Interview with the CAP PT provider on 06/26/2021 at 1:45 pm confirmed the laboratory failed to participate in the 2020 3rd and the 2021 1st events. The interview further revealed that the laboratory failed to notify the CAP PT Program regarding their inability to participate in both PT events. -- 2 of 2 --

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 D2009 TESTING OF PROFICIENCY SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory director (LD) failed to attest that proficiency testing (PT) samples were integrated into the patient workload using the laboratory's routine methods. Findings include: 1. Record review conducted on 11/28/18 of 2017 and 2018 College of American Pathologist (CAP) Immunology, Syphilis Serology, and Virology PT documentation revealed that the LD failed to sign the 2017 and 2018 CAP PT attestation statements. The record review further revealed that the Technical Supervisor (TS1) signed the 2017 and 2018 (CAP) Immunology, Syphilis Serology, and Virology PT attestation statements instead of the LD. 2. Record review conducted on 11/29/18 of 2017 and 2018 College of American Pathologist (CAP) Bacteriology, Mycology, Parasitology, and Mycobacteriology PT documentation revealed that the LD failed to sign the 2017 and 2018 CAP PT attestation statements. The record review further revealed that the Technical Supervisor (TS2) signed the 2017 and 2018 (CAP) Bacteriology, Mycology, Parasitology, and Mycobacteriology PT attestation statements instead of the LD. 3. Staff interviews conducted on with the TS1 on 11/28/18 at 11:45 AM and with the TS2 on 11/29/18 10:30 AM confirmed the above findings. 4. Staff interview with the Quality Assurance Manager on 11/29/18 at 1:30 PM confirmed the above findings and further revealed that the LD failed to delegate in writing the responsibility of signing the attestation statements to TS meeting the qualifications of 493.1447. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) 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 -- The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to review and evaluate an unacceptable VDRL, CSF Proficiency Test titer score the laboratory received for the College of American Pathologists (CAP), G-A 2018 Syphilis Serology proficiency testing (PT) event. Findings include: 1. Record review conducted on 11/26/2018 of the CAP G-A Syphilis Serology evaluation report revealed that the laboratory reported an unacceptable titer result of 1:2 for sample G- 01. The CAP G-A Syphilis Serology evaluation report included an acceptable titer range of 1:4 to 1:32 for sample G-01. 2. Record review conducted on 11/28/18 of 2017 and 2018 PT records revealed no documented review or evaluation of the unacceptable VDRL, CSF 1:2 titer result reported for sample G-01 in the CAP Syphilis Serology G-A 2018 event. 3. Interview with the technical supervisor (TS) on 11/28/18 at 10:45 AM confirmed the above findings. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on staff interview and record review, the Urine Multi-element by Inductively Coupled Plasma- Mass Spectrometry (ICP-MS) and Cobas Ampliprep Cobas Taqman HCV RNA v2.0 Procedures were not signed and approved by the current laboratory director (LD) before use. Findings include: 1. Record review conducted on 11/28 /2018 of the Urine Multi-element by ICP-MS, Document ID: QU-Template-SOPCH- B-SOP-401, Revision 6, effective 11/16/2018, and Cobas Ampliprep Cobas Taqman HVC RNA v2.0, Document ID: VI-MO-SOP-011, Revision 1, effective 04/05/2018, revealed that the procedures were not signed and approved by the current LD prior to use. 2. Interview with the Quality Assurance Manager (QAM) on 11/28/18 at 3:30 PM confirmed these findings. 3. Interview with the QAM on 11/28/18 at 3:30 PM further revealed that Qualtrax document control system folder assignments were modified after July 2017 and the LD folder assignment was removed. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review of 2017 and 2018 new employee competency assessment -- 2 of 3 -- records and interviews with the Virology, Chemistry, and Bacteriology Technical Supervisors (TS), the laboratory failed to evaluate and document the competency of 6 out 9 new testing personnel (TP) semi-annually during their first year performing high complexity testing. Findings include: 1. Record review conducted on 11/26/18, 11/28 /18, and 11/29/18 of employee competency documentation of new TPs hired in the specialties of Bacteriology, Virology, and Chemistry between 10/01/16 through 11/21 /18 revealed that 6 out of the 9 new TP were not evaluated semi-annually during their first year performing high complexity testing. 2. Interviews conducted with the Chemistry TS and Bacteriology TS on 11/29/18 10:45 AM and the Virology TS on 11 /28/18 10:00 AM confirmed the above findings. -- 3 of 3 --