Tennessee Department Of Health

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on direct observation, review of laboratory freezer temperature records, laboratory's policies and procedures, test volumes, and interview with the Technical Supervisor (TS)-16, according to the Centers for Medicare and Medicaid Services (CMS) Form 209, the laboratory failed to follow its own policy for the storage of Syphillis Serology specimens after testing for 2 of 2 freezers. Findings Included: 1) During a tour of the laboratory on 9/16/2025 at 11:08 AM, the following two freezers were observed with the storage of Syphillis Serology specimens inside: a. Freezer - Thermo Scientific #1 (Thermo Serial Number: M77487, Serial Number: 11464320501240322) b. Freezer - Thermo Scientific #2 (Thermo Serial Number: S29944, Serial Number: 1146922201240919) 2) Review of the laboratory's freezer temperature record charts from July through September 2025 revealed the following acceptable temperature ranges set for the two freezers: a. Freezer - Thermo Scientific #1 (-85 degrees Celsius to -65 degrees Celsius) b. Freezer - Thermo Scientific #2 (-85 degrees Celsius to -65 degrees Celsius) 3) Review of the laboratory's policy titled 'TN Department of Health Division of Laboratory Services Procedure for Fujirebio Serodia-TPPA' stated the following: "B. Specimen Handling, Transport & Storage: 3. Following testing, all non-reactive specimens are stored at 1 to 8 degrees Ceslius for seven (7) days. Specimens with initially detected reactive results are aliquoted and stored at less than or equal to -70 degrees Celsius." 4. Review of the laboratory's test volumes revealed an annual test volume of 2,081 for the Serodia TP-PA. 5. In an interview on 9/16/2025 at 11:10 AM in the Serology section of the laboratory, TS-16 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- confirmed the accepted temperature ranges set for the freezers did not follow the laboratory's policy for storing syphilis serology serum samples. II. Based on direct observation, review of laboratory freezer temperature records, laboratory's policies and procedures, test volumes, and interview with the Technical Supervisor (TS)-16, according to the Centers for Medicare and Medicaid Services (CMS) Form 209, the laboratory failed to follow its own policy for freezer storage temperatures of norovirus extracts for 9 of 55 days (random review from July 1 to September 17, 2025). Findings Included: 1. During a tour of the laboratory on 9/17/2025 at 1:49 PM, one ThermoScientific TSX freezer (Serial Number: 1146521701240521) was observed, with an acceptable temperature range set to -90 degrees Celsius to -70 degrees Celsius, and seven boxes of Norovirus extracts stored within. 2. Review of the laboratory's freezer temperature records revealed the following dates where temperature were recorded warmer than -80 degrees Celsius: 7/22, 7/23, 7/25, 7/29, 8 /7, 8/19, 8/27, 9/10, 9/12 3. Review of the laboratory's policy titled 'TN Department of Health Norovirus' stated the following under 'specimen criteria': "Samples tested for norovirus GI and GII will have an extract stored at -80 degrees Celsius, a stool aliquot spun and stored at -80 degrees Celsius and an original stool sample stored for 6 months at 4 degrees Celsius ..." 4. Review of the laboratory's test volume revealed an annual test volume of 246 Norovirus PCR tests performed 5. In an interview on 9/16 /2025 at 11:10 AM in the Virology section of the laboratory, TS-16 confirmed the accepted temperature ranges set for the freezers did not follow the laboratory's policy for storing Norovirus extracts and stool aliquots. 47272 III. Based on written laboratory procedure, observation, and staff interview, the laboratory failed to follow its own procedure for specimen storage for one of one box of dried blood spot filter cards. Findings included: 1. On 09/17/25 at 09:45 am, Technical Supervisor #15 (TS#15) verified the laboratory performed newborn screening to measure amnio acids, succinylacetone, free carnitine, acylcarnitines, nucleosides, and lysophospholipids testing from dried blood spots using the Revvity NeoBase 2 kit. 2. Review of the laboratory's procedure titled, "NBS NeoBase 2 Procedure Manual" section, "III. SPECIMEN REQUIREMENTS" stated, "A 1/8-inch disc is punched from a dried blood spot (DBS) collected properly on Whatman paper grade #903 or equivalent. DBS filter cards are stored in large plastic boxes containing desiccants in the specimen refrigerator at 2-8C." 3. Observation on 09/17/25 at 10:10 am of one plastic storage box for DBS specimens revealed no evidence of a desiccant. a. Examples of patient DBS filter cards Patient# - 20252481101 Patient# - 20252481102 Patient# - 20252481103 Patient# - 20252481104 Patient# - 20252481105 4. Interview on 09/17/25 at 10:15 am with TS #15, confirmed the findings above 5. Laboratory performs 121,396 tests annually using the NeoBase 2 kit. Word Key NBS - Newborn Screening IV. Based on written laboratory procedure, record review and staff interview, the laboratory failed to follow its own procedure for calibration verification for one of one year. Findings included: 1. On 09/17/25 at 02:10 pm, Technical Supervisor #15 (TS #15) verified the laboratory performed X-Linked Adrenoleukodystrophy (X-ALD) Screening by LC/MS/MS (Liquid Chromatography- Tandem Mass Spectrometry). 2. Review of the written laboratory procedure titled, "X- Linked Adrenoleukodystrophy Screening by LC/MS/MS" section, "D. Calibration Verification:" stated the following: a. "Frequency: After lot change, after major maintenance, or twice a year." b. "Purposed: To verify the reportable range." c. "To meet requirements, run CBC controls for X-ALDs like patient specimens on each system and compare values to CDC stated values. Values must be within 2 s.d." 3. Review of 2024 records revealed no evidence the laboratory performed calibration verification. 4. Interview on 09/17/25 at 02:40 pm with TS #15, confirmed the findings above. 5. Laboratory performs 11,653 screening tests annually. Word Key s. d. - standard deviation V. Based on laboratory written procedure, record review, and -- 2 of 10 -- laboratory staff interview, the laboratory failed to follow its own laboratory procedure for Blind Study/Tech Checks for six of six months for five of five testing persons. Findings included: 1. On 09/17/25 at 03:20 pm, Technical Supervisor #15 (TS #15) verified the laboratory performed G6PD (Glucose-6-phosphate dehydrogenase) testing from dried blood spots specimens. 2. A review of the laboratory's written procedure titled, "Glucose-6-phosphate Dehydrogenase (G6PD) Procedure Manual" section, "F. Blind Study/Tech Checks" stated, "A blind study is performed monthly to assess the method, reagents, and to verify the technique and proficiency of each tech." 3. Record review of "Tech Check" from March 2025 through August 2025 revealed no evidence of monthly Blind Study/Tech Checks for six of six months for the five of five Testing Persons (TP): a. TP# 6 b. TP# 38 c. TP# 58 d. TP# 63 e. TP# 70 4. Interview on 09/17/25 at 03:40 pm with TS #15, confirmed the findings above. 5. The laboratory performs 3,787 G6PD tests annually. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (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 general supervisor interview and bacteriology media quality control record review on September 18, 2025 at 09:15 am, the laboratory failed to have a written STEC CHROMagar media quality control procedure that had been approved, signed, and dated by the laboratory director before use. Findings included: a. In the bacteriology section, the laboratory performed patient bacteriology testing using STEC CHROMagar media. To ensure the quality of each lot of STEC CHROMagar media used, the laboratory performed media quality control procedures pursuant to 42 CFR 493.1256(e)(4). b. The laboratory maintained no documentation to indicate that the written STEC CHROMagar media quality control procedure had been approved, signed, and dated by the laboratory director before use. c. On September 18, 2025 at 09:15 am, the general supervisor confirmed these findings and indicated that the laboratory used STEC CHROMagar media to culture approximately 300 patient bacteriology specimens annually. 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, manufacturer's instructions, laboratory temperature records, test volumes, and interview with the Technical Supervisor (TS)-16, according to the Centers for Medicare and Medicaid Services (CMS) Form 209, the laboratory -- 3 of 10 -- failed to define freezer temperature ranges consistent with the manufacturer's instructions for 4 of 4 boxes of Centers for Disease Control and Prevention (CDC) reagents. Findings Included: 1. During a tour of the laboratory on 9/17/2025 at 1:49 PM, one Kenmore Upright freezer (Serial Number: WBB5025067) was observed in the Virology section Area E (Mid) - 3rd Floor, with an acceptable temperature range set to -25 degrees Celsius to -18 degrees Celsius, and the following stored within: a. Two boxes of CDC Influenza A/B Sars-Cov-2 Multiplex Positive Controls, Panel Lot: 230914, Manufacturer storage instructions -20 degrees Celsius and/or colder. b. Two boxes of CDC Human Influenza Virus RT-PCR Diagnostic Panels Influenza A Subtyping, Panel Lot: 220808, Manufacturer storage instructions -20 degrees Celsius and/or colder. 2. Review of the laboratory's freezer temperature records from July 1 to September 17, 2025, indicated an acceptable temperature range between -25 degrees Celsius and -18 degrees Celsius. 3. Review of the laboratory's test volume revealed an annual test volume of 1,679 Influenza CDC Multiplex tests performed. 4. In an interview on 9/17/2025 at 1:50 PM in the Virology section of the laboratory, TS-16 confirmed the temperature ranges of the freezer were not defined in accordance with the manufacturer's storage instructions. 47272 II. Based on manufacturer's instructions, environmental records, and laboratory staff interview, the laboratory failed to monitor room temperatures as required by the manufacturer for two of two months. Findings included: 1. On 09/16/25 at 10:35 am, Technical Supervisor #15 (TS #15) verified the laboratory performed Newborn Screening (Neonatal immunoreactive trypsinogen, Neonatal Biotinidase, Neonatal Galactose-1-phosphate uridyltransferase enzyme, Neonatal Galactose, Neonatal 17a-OH-Progesterone, and Neonatal Human Thyroid Stimulating Hormone) testing on the Revvity GSPs (Genetic Screening Processors). 2. Review of the Revvity GSP manufacturer's specifications section, "Environmental conditions" stated, "Temperature 18-27C". 3. Review of the laboratory's environmental records for July 2025 and August 2025 revealed no evidence of room temperature monitoring for two of two months. 4. Interview on 09/16/25 at 10:55 am with TS #15, confirmed the findings above. 5. The laboratory performs the following tests annually: Neonatal immunoreactive trypsinogen - 121,396 Neonatal Biotinidase - 121,396 Neonatal Galactose-1- phosphate uridyltransferase enzyme - 121,396 Neonatal Galactose - 121,396 Neonatal 17a-OH-Progesterone - 121,396 Neonatal Human Thyroid Stimulating Hormone - 121,396 III. Based on direct observation, manufacturer's instructions, environmental records, and laboratory staff interview, the laboratory failed to monitor room temperatures as required by the manufacturer for two of two months Findings included: 1. On 09/17/25 at 11:20 am, Technical Supervisor #15 (TS #15) verified the laboratory performed a qualitative screen for the presence of hemoglobins F, A, S, D, C, and E in eluates of neonatal dried blood spots. 2. A review of the "Bio-Rad Variant nbs Sickle Cell Program" manufacturer's instructions for "PREPARATION AND STORAGE OF REAGENTS" revealed the following for the "Elution Buffers and Wash Solution": a. "The Elution Buffers and Wash Solution will be stable until the expiration date when stored unopened at 15-30C. After opening the bottles, these reagents are stable for 30 days when stored at 15-30C.". 3. Direct observation on 09/17 /25 at 11:25 am revealed the following: a. Elution Buffer 1 Lot#64649186 b .Elution Buffer 2 Lot#64649188 c. Wash Solution Lot#64631972 4. Review of the laboratory's environmental records for July 2025 and August 2025 revealed no evidence of room temperature monitoring for two of two months. 5. Interview on 09/17/25 at 11:30 am with TS #15, confirmed the findings above. 6. The laboratory performs 121,396 Variant nbs Sickle Cell tests annually. Word Key nbs - newborn screening IV. Based on manufacturer's instructions, environmental records, and laboratory staff interview, the laboratory failed to monitor room temperatures as required by the manufacturer for two of two months. Findings included: 1. On 09/17/25 at 03:00 pm, Technical -- 4 of 10 -- Supervisor #15 (TS #15) verified the laboratory used PerkinElmer Panthera-Punchers dried blood spot punching devices for newborn screening testing four (serial numbers 2081017, 20810181, 20810179, and 20810331). 2. Review of the PerkinElmer Panthera-Puncher manufacturer's "Environmental conditions" stated, "Operating temperature: 15-30C". 3. Review of the laboratory's environmental records for July 2025 and August 2025 revealed no evidence of room temperature monitoring for two of two months. 4. Interview on 09/17/25 at 03:25 pm with TS #15, confirmed the findings above. 5. The laboratory performs 1,218,857 newborn screening tests annually. V. Based on manufacturer's instructions, environmental records, and laboratory staff interview, the laboratory failed to ensure the laboratory's humidity was maintained according to the manufacturer's requirements for 10 of 30 days Findings included: 1. On 09/17/25 at 03:00 pm, Technical Supervisor #15 (TS #15) verified the laboratory used PerkinElmer Panthera-Punchers dried blood spot punching devices for newborn screening testing four (serial numbers 2081017, 20810181, 20810179, and 20810331). 2. Review of the PerkinElmer Panthera- Puncher manufacturer's "Environmental conditions" stated, "Relative humidity: 20- 80%". 3. Review of the laboratory's environmental records for March 2025 revealed documented humidity readings below the manufacturer's requirements for 10 of 30 days. a. Serial number 20810178 03/01/25 documented humidity reading 16% 03/02 /25 documented humidity reading 12.7% 03/03/25 documented humidity reading 10% 03/06/25 documented humidity reading 16% 03/07/25 documented humidity reading 19% 03/09/25 documented humidity reading 15% 03/10/25 documented humidity reading 15% 03/17/25 documented humidity reading 18% 03/21/25 documented humidity reading 16% 03/22/25 documented humidity reading 18% b. Serial number 20810181 03/02/25 documented humidity reading 15% 03/06/25 documented humidity reading 16% 03/07/25 documented humidity reading 17% 03/09/25 documented humidity reading 15% 03/21/25 documented humidity reading 17% c. Serial number 20810179 03/01/25 documented humidity reading 17% 03/03/25 documented humidity reading 11% 03/05/25 documented humidity reading 16% 03/06 /25 documented humidity reading 14% 03/10/25 documented humidity reading 15% d. Serial number 20810331 03/02/25 documented humidity reading 15% 03/03/25 documented humidity reading 15% 03/09/25 documented humidity reading 18% 03/10 /25 documented humidity reading 18% 4. Interview on 09/17/25 at 03:30 pm with TS #15, confirmed the findings above. 5. The laboratory performs 1,218,857 newborn screening tests annually. VI. Based on direct observation, manufacturer's instructions, environmental records, and laboratory staff interview, the laboratory failed to ensure freezer temperatures met the manufacturer's requirement for seven of 31 days. Findings included: 1. On 09/16/25 at 01:00 pm, Technical Supervisor #15 (TS #15) verified the laboratory performed GALT (Neonatal Galactose-1-phosphate uridyltransferase enzyme) and Neonatal Galactose testing on the Revvity GSPs (Genetic Screening Processors). 2. Direct observation on 09/16/25 at 01:10 pm of Kenmore Freezer #5 (serial number BA44414570) revealed the following: a. Revvity GSP Neonatal total Galatose kit (Lot#760764) with a manufacturer's storage requirement of -16C to -30C. b. Revvity GSP Neonatal GALT kit (Lot#760893) with a manufacturer's storage requirement of -16C to -30C. 3. A review of the Kenmore Freezer #5 July 2025 records revealed freezer temperatures warmer than manufacturer requirements for seven of 31 days as follows: a. 07/10/25 documented freezer temperature -15.5C b. 07/13/25 documented freezer temperature - 15.5C c. 07/18/25 documented freezer temperature - 15.0C d. 07/19/25 documented freezer temperature - 14.8C e. 07/24/25 documented freezer temperature - 15.7C f. 07/27/25 documented freezer temperature - 15.9C g. 07/29/25 documented freezer temperature - 15.8C 4. Interview on 09/16/25 at 01:15 pm with TS #15, confirmed the findings above. 5. The laboratory performs the following tests annually: Neonatal Galactose-1-phosphate -- 5 of 10 -- uridyltransferase enzyme - 121,396 Neonatal Galactose - 121,396 VII. Based on direct observation, manufacturer's instructions, environmental records, and laboratory staff interview, the laboratory failed to ensure freezer temperatures met the manufacturer's requirement for 4 of 31 days. Findings included: 1. On 09/16/25 at 01:20 pm, Technical Supervisor #15 (TS #15) verified the laboratory performed Biotinidase testing on the Revvity GSPs (Genetic Screening Processors). 2. Direct observation on 09/16/25 at 01:30 pm of Hotpoint Freezer #18 (serial number CTX18CAZARWW) revealed the Revvity GSP Neonatal Biotinidase kit (Lot#760895) with a manufacturer's storage requirement of -16C to -30C. 3. A review of the Hotpoint Freezer #18 July 2025 records revealed freezer temperatures warmer than manufacturer requirements for four of 31 days as follows: a. 07/08/25 documented freezer temperature -15.4C b. 07/11/25 documented freezer temperature - 15.7C c. 07 /18/25 documented freezer temperature - 15.3C d. 07/27/25 documented freezer temperature - 13.6C 4. Interview on 09/16/25 at 03:30 pm with TS #15, confirmed the findings above. 5. The laboratory performs 121,396 Neonatal Biotinidase tests annually. VIII. Based on laboratory written procedure, direct observation, environmental records, and laboratory staff interview, the laboratory failed to ensure freezer temperatures met laboratory requirements for 16 of 16 days. Findings included: 1. On 09/17/25 at 03:20 pm, Technical Supervisor #15 (TS #15) verified the laboratory performed G6PD (Glucose-6-phosphate dehydrogenase) testing from dried blood spots specimens. 2. A review of the laboratory's written procedure titled, "Glucose-6-phosphate Dehydrogenase (G6PD) Procedure Manual" section, "VII. Quality Control" stated, " .... 8. Label a foil pouch with the level of control, the lot number, reconstitution date and expiration date. Expiration date is 6 months from the reconstitution date. Freeze at -20C in the foil pouch with desiccant and a humidity indicator card ....". 3. Direct observation on 09/17/25 at 03:25 pm of Hotpoint Freezer #18 (serial number CTX18CAZARWW) revealed the following G6D control material: a. Normal - Lot#01-96-25 b. Intermediate - Lot# 01-97-25 c. Deficient - Lot# 01-95-25 4. A review of the Hotpoint Freezer #18 (serial number CTX18CAZARWW) records from 09/02/25 through 09/17/25 revealed freezer temperatures warmer than the laboratory's written procedure for 16 of 16 days as follows: a. 07/02/25 documented freezer temperature -15.2C b. 07/03/25 documented freezer temperature -16.3C c. 07/04/25 documented freezer temperature -16.2C d. 07 /05/25 documented freezer temperature -15.0C e. 07/06/25 documented freezer temperature -17.6C f. 07/07/25 documented freezer temperature -18.0C g. 07/08/25 documented freezer temperature -18.0C h. 07/09/25 documented freezer temperature -14.6C i. 07/10/25 documented freezer temperature -17.1C j. 07/11/25 documented freezer temperature -18.0C k. 07/12/25 documented freezer temperature -15.2C l. 07 /13/25 documented freezer temperature -17.6C m. 07/14/25 documented freezer temperature -15.4C n. 07/15/25 documented freezer temperature -17.4C o. 07/16/25 documented freezer temperature -16.6C p. 07/17/25 documented freezer temperature -13.2C 4. Interview on 09/17/25 at 03:35 pm with TS #15, confirmed the findings above. 5. The laboratory performs 3,787 G6PD tests annually. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental -- 6 of 10 -- conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on quality control package insert, electronic quality control records, and laboratory staff interview, the laboratory failed to ensure control procedures that would detect immediate errors and test system failures for one of three levels of quality control for 18 of 18 days. Findings included: 1. On 09/16/25 at 10:35 am, Technical Supervisor #15 (TS #15) verified the laboratory performed Neonatal immunoreactive trypsinogen (IRT) testing on three Revvity GSPs (Genetic Screening Processors) as follows: a. Instrument "Sonny" - serial number 2020157 b. Instrument "Cher" - serial number 20210158 c.Instrument "Prince" - serial number 20210180 2. On 09/17/25 at 09:20 am, General Supervisor #10 (GS #10) confirmed the following: a. Three levels of QC (quality control) material (Kit Control 1, Kit Control 2, and Kit Control 3) were performed each day of IRT patient testing. b. New lots of QC materials included 30 runs of QC to calculate the mean, 1 SD (standard deviation), 2 SD, 3 SD, and CV% (Coefficient of Variation Percent) to ensure the calculated QC ranges fell within the manufacturer's stated ranges. c. The laboratory used Kit Control 1, Kit Control 2, and Kit Control 3 manufacturer's QC ranges for limits of acceptability for patient testing. 3. Review of the laboratory's electronic QC records from 06/12/25 to 06/30/25 revealed the following: a. Lot# 760138 was put into use 06 /12/25. b. No evidence of QC ranges for one of three levels of QC (Kit Control 3) for 18 of 18 days. 4. On 09/17/25 at 10:15 am, TS #15 confirmed the findings above. 5. The laboratory performs 121,396 IRT tests annually. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on general supervisor and testing personnel interviews and mycobacteriology quantiferon test record review on September 17, 2025 at 11:10 am, the laboratory failed to establish the statistical parameters for unassayed positive and negative quantiferon quality control materials over time through concurrent testing of quantiferon quality control materials having previously determined statistical parameters. Findings included: a. In the mycobacteriology section, it was the practice of the laboratory to perform and report patient quantiferon tests using Qiagen's QuantiFERON -TB Gold Plus test kits. To monitor patient quantiferon testing each day of testing, the laboratory pooled previously tested positive patient quantiferon specimens to use as the positive quantiferon quality control material, and pooled previously tested negative patient quantiferon specimens to use as the negative -- 7 of 10 -- quantiferon quality control material. b. On September 17, 2025 at 11:10 am, the general supervisor confirmed that the laboratory maintained no documentation to indicate that the statistical parameters for the pooled positive and negative quantiferon quality control materials, for which both quality control materials are considered unassayed quality control materials, had been established over time by the laboratory through concurrent testing of quantiferon quality control materials having previously determined statistical parameters. c. On September 17, 2025, the laboratory was using Qiagen's QuantiFERON-TB Gold Plus test kit lot number 57809306, expiration date 06/06/2027, to test patient quantiferon specimens. The general supervisor stated that the laboratory performed and reported approximately 100 patient quantiferon tests each week. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on general supervisor interview and parasitology trichrome straining quality control record reivew on September 17, 2025 at 10:20 am, the laboratory failed to maintain documentation to indicate that, each day of use, trichrome stains were reviewed for intended reactivity to ensure predictable staining characteristic. Findings included: a. In the parasitology section of the laboratory, it was the practice of the laboratory to stain patient parasitology specimens using a trichrome stain. b. As confirmed by the general supervisor on September 17, 2025 at 10:20 am, although the laboratory maintained documentation to indicate that quality control materials were routinely tested, the laboratory maintained no documentation to indicate that the trichrome stains were reviewed for intended reactivity to ensure predictable staining characteristics. c. According to laboratory records, the laboratory performed and reported 83 patient parasitology specimen test results annually. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 1. Based on general supervisor and testing personnel interviews and mycobacteriology quantiferon test record review on September 17, 2025 at 11:10 am, the laboratory failed to document all quantiferon quality control procedures. Findings included: a. In the mycobacteriology section, it was the practice of the laboratory to perform and report patient quantiferon tests using Qiagen's QuantiFERON -TB Gold Plus test kits. To monitor patient quantiferon testing each day of testing, the laboratory pooled previously tested positive patient quantiferon specimens to use as the positive quantiferon quality control material, and pooled previously tested negative patient quantiferon specimens to use as the negative quantiferon quality control material. b. On September 17, 2025 at 11:10 am, the general supervisor confirmed that the -- 8 of 10 -- laboratory maintained no documentation to indicate which patient specimens were used for any pooled positive and negative quantiferon quality control materials used to monitor patient quantiferon testing. c. On September 17, 2025, the laboratory was using Qiagen's QuantiFERON-TB Gold Plus test kit lot number 57809306, expiration date 06/06/2027, to test patient quantiferon specimens. The general supervisor stated that the laboratory performed and reported approximately 100 patient quantiferon tests each week. 2. Based on general supervisor interview and bacteriology media quality control record review on September 17, 2025 at 01:30 pm, the laboratory failed to ensure that it had a record system that documented the results of all media quality control procedures performed had met the laboratory's criteria for acceptability before reporting patient bacteriology culture test results. Findings included: a. In the bacteriology section, for patient testing, it was the practice of the laboratory to use blood agar plates (BAP) for the growth of bacteria from patient specimens. Pursuant to 42 CFR 493.1256(e)(4), laboratory records indicated that each lot of BAP culture media the laboratory received had met the laboratory's criteria for acceptability. b. On September 17, 2025 at 01:30 pm, the general supervisor confirmed that, although each lot of BAP culture media had met the laboratory's quality control criteria for acceptability, the laboratory records did not indicate which lot of BAP culture media was used to culture bacteria from a patient specimen. c. For example, BAP lot numbers 289732 and 294940 were available for patient testing as of August 25, 2025. During the period of time these BAP lots were available for use, laboratory records did not indicate which specific BAP lot was used to culture bacteria from any specific patient specimen. d. According to the general supervisor, the laboratory received, cultured, and reported approximately 70 patient bacteriology specimens weekly using BAPs. D5783

Summary Statement of Deficiencies D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on surveyor record review of Manufacturer Package Insert /Standard Operating Procedure (SOP) and interview with General Supervisor, the laboratory failed to have a supplement that lists specific laboratory testing requirements not included in the manufacturer package insert. . The findings include: 1. The review of the SOP for Virology, Influenza A/B (ABI 7500) and Immunoserology, Aptima Combo 2 Assay for Chlamydia trachomatis and Neisseria gonorrhoeae (Panther System) found the laboratory was using the manufacturer package insert as their SOP. The manufacturer package insert is used by all laboratories who purchase the test kit. 2. The laboratory failed to have a supplement for the Tennessee Department of Health, Division of Laboratory Services (TDH) listing specific procedures or requirements for testing personnel to perform not included in manufacturer package insert. 3. The Aptima Comb 2 Assay states on page 16 that " Each laboratory should implement appropriate control procedures to satisfy the requirements of CLIA regulations". 4. The laboratory made a change to the specimen collection device in June 20, 2019, that was documented in the laboratory test submission manual. 5. The laboratory Influenza A /B Typing Kit, PI provides guidance for laboratories to refer specimens to CDC. 6. Interview with the General Supervisor on 11/7/2019 in the Virology and Immunoserology section at 3:00 PM confirmed the laboratory did not have a TDH supplement. D5407 PROCEDURE MANUAL 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 -- CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the procedure manual, laboratory test records and interview with laboratory staff, the procedure manual for the Enterics section of the laboratory was not current for procedures performed in the Enterics section. Findings: 1. Review of the Campylobacter I.D. procedure in the Enterics SOP manual revealed the following: a. The Enterics SOP manual contained a title page which included a SOP under tab 8 for Campylobacter I.D. b. The Campylobacter I.D. procedure under tab 8 included a procedure for multiplex TaqMan PCR assay to differentiate between Campylobacter jejuni and Campylobacter coli. The procedure was not noted as discontinued for patient testing. c. Review of patient test records for 2019 revealed the laboratory identified Campylobacter by MALDI-TOF and biochemical reactions, but no records of multiplex TaqMan PCR assay were found. d. During interview the morning of November 7, 2019, Technical Supervisor 1 (TS #1) and Technical Supervisor 2 (TS #2) stated the laboratory discontinued performing the multiplex TaqMan PCR assay to differentiate Campylobacter species in 2017. When asked the specific date the PCR was discontinued, neither Technical Supervisor could provide a date. TS #1 stated the laboratory continued to perform quality control testing for the multiplex TaqMan PCR assay. The Laboratory Test and Equipment List form provided to the survey team indicated an annual test volume of 4 for the multiplex TaqMan PCR assay. e. The Enterics SOP manual was reviewed and signed by TS #1 on June 27, 2019 and by TS #2 on June 24, 2019. The Laboratory Director approved the Enterics SOP by signature on August 7, 2019. 2. Review of the Bioplex for Salmonella procedure in the Enterics SOP manual revealed the following: a. The Enterics SOP manual contained a title page which included a SOP under tab 15 for Bioplex for Salmonella. b. The Bioplex for Salmonella procedure was not noted as discontinued for patient testing. c. The Laboratory Test and Equipment List form provided to the survey team indicated for Salmonella serotyping testing "As of 8/1/2019, using Bionumeric exclusively". d. During interview the morning of November 7, 2019, TS #1 stated Salmonella serotyping is currently performed by MALDI-TOF and the Bioplex assay is no longer in use. e. The Enterics SOP manual was reviewed and signed by TS #1 on June 27, 2019 and by TS #2 on June 24, 2019. The Laboratory Director approved the Enterics SOP by signature on August 7, 2019. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on surveyor record review and interview with general supervisor, the laboratory failed to perform comparison studies for the same instrument in 2018 and once in 2019. The findings include: 1. The laboratory survey revealed the laboratory failed to -- 2 of 4 -- perform comparison studies for Hologic Panther (Immunoserology) and ABI 7500 (Virology) twice in 2018 and once in 2019. 2. The laboratory provided a copy of comparison testing completed September 9, 2019 for ABI 7500 and October 2, 2019 for Panther system. 3. The laboratory worksheet for "Instrument Comparison Studies" states "comparison studies must be performed twice per year". 4. The laboratory failed to include the comparison studies worksheet in the laboratory SOP or the Quality Assessment manual. 5. Interview with the general supervisor on 11/7/2019 in the Virology and Immunoserology section at 3:00 PM confirmed the comparison studies were not performed twice per year in 2018 and once in 2019. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assurance Manual, review of proficiency testing records and interview with laboratory staff, the laboratory failed to follow their Quality Assurance policy for external assessments. Findings: 1. Routine Testing Methods a. Review of the laboratory's quality assurance manual, TDH Division of Laboratory Services Quality Assurance Manual, revealed a policy for performing External Quality Assessments/Proficiency Testing on page 27 under "8.3 Quality Assessments". Under "1. Processing the Specimens" (c), the policy states "Use your laboratory's routine testing methods." The TDH Division of Laboratory Services The Quality Assurance Manual was reviewed and signed by the laboratory director on June 21, 2019. b. Review of the Enterics SOP for Campylobacter Identification and Workup states stool cultures, positive EIA broths, and isolates are cultured for isolation and purity. Suspicious colonies have an oxidase test performed and oxidase positive organisms are identified by MALDI-TOF assay. If MALDI-TOF assay does not provide an acceptable identification, the procedure indicates additional biochemical workup of the isolate. c. Review of the laboratory's College of American Pathologists (CAP) proficiency testing records for Campylobacter Survey (CAMP) for 2018 and 2019 indicate the laboratory performed identification of Campylobacter by Biofire assay in addition to MALDI-TOF assay. d. During interview on the afternoon of November 7, 2019, the surveyor asked TS #1 if the laboratory performed Biofire assay on patient samples ordered for isolation/identification of Campylobacter. TS #1 stated the laboratory performs the Biofire assay on proficiency testing samples but not on patient samples unless the patient order is for an enteric pathogens screen. 2. Proficiency Testing Records a. Review of the laboratory's quality assurance manual, TDH Division of Laboratory Services Quality Assurance Manual, revealed a policy for performing External Quality Assessments/Proficiency Testing on page 27 under "8.3 Quality Assessments". On page 28 under "2. Reporting the Test Results" (b), the policy states "File a copy of this report and all records used in performing PT tests in your section." b. On November 6, 2019, the surveyor requested TS #1 to provide records needed for review to include all proficiency testing records for 2018 and 2019. c. Review of proficiency testing records on the morning of November 7, 2019, revealed the proficiency testing files did not include documentation of biochemical workup and all molecular analysis performed by the laboratory to support the results sent to the proficiency testing organizations. For example, CAP -- 3 of 4 -- Campylobacter Survey PT files included records of Biofire analysis but no records of performance of oxidase or MALDI-TOF and Wisconsin State Laboratory of Hygiene proficiency testing records for Shiga Toxin included Biofire assay printouts which identify Shiga Toxin 1/2, but no records of the laboratory testing used to differentiate Shiga Toxin 1 from Shiga Toxin 2. d. TS #1 attempted to print out the needed PT testing records on the afternoon of November 7, 2019, however the surveyor did not have sufficient time to review. As a result, the surveyor was unable to determine if the Enterics section of the laboratory was in compliance with proficiency testing requirements. 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 identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assurance manual, TDH Division of Laboratory Services Quality Assurance Manual, and interview with Information Technology (IT) personnel the laboratory failed to establish a written policy and procedure to monitor and evaluate the accuracy of the laboratory's test reports supplied to clients. The findings include: 1. The laboratory's quality assurance manual did not include a procedure to verify that test reports received by the client are transmitted with accurate information. 2. On 11/6/19 at 2PM, the IT personnel stated the laboratory had not performed any evaluations of test reports after being sent to clients. D6085 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3) The laboratory director must ensure that the test methodologies selected have the capability of providing the quality of results required for patient care. This STANDARD is not met as evidenced by: Based on review of validation records, laboratory records and interview with laboratory staff, the laboratory director failed to review and approve test performance specifications for a laboratory developed test prior to patient testing. Findings: 1. Review of the Enteric Laboratory Validation records for Validation for the Detection of the Stx2f Variant by PCR revealed the performance specifications study was reviewed and signed by TS #1 and TS #2 on August 20, 2018. 2. Review of the Laboratory Test and Equipment List form provided to the survey team revealed the annual test volume for Detection of the Stx2f Variant by PCR testing was 300. 3. During interview on the afternoon of November 7, 2019, TS #2 acknowledged the laboratory director failed to review and approve the validation study for the Detection of the Stx2f Variant by PCR prior to patient testing. 4. Review of the Enteric Laboratory Validation records for Validation for the Detection of the Stx2f Variant by PCR revealed the performance specifications study was reviewed and signed by Laboratory Director on November 7, 2019, during the onsite recertification survey. -- 4 of 4 --