Microbial Diseases Laboratory (Mdl)

Summary Statement of Deficiencies D0000 A recertification survey was performed October 29, 2024, through October 30, 2024 by federal CMS surveyors. Standard level deficiencies were cited as follows: 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: I. Based on direct observation, review of reagent package insert, room temperature logs, laboratory Individual Quality Contol Plan, and staff interview, the laboratory failed to ensure room temperature ranges were within manufacturer's specifications for storage of 77 of 77 boxes of the Xpert Carba-R reagent cartridges used with the GeneXpert instruments in the MTB/RIF Assay section (Room A-366) and Foodborne and Waterborne Diseases section (Room A-262). Findings included: 1. A reagent package insert for the Xpert Carba-R cartridges stated, "Store the Xpert Carba-R Assay cartridges at 2-28 degrees Celsius." 2. An Individualized Quality Control Plan (IQCP) for Quality Control of GeneXpert Carba-R Assay, Version 091319, page 2 stated, "Store the Xpert Carba-R Assay cartridges at 2-28 degrees Celsius." 3. An Individualized Quality Control Plan (IQCP) for Xpert MTB/RIF Assay stated, "Store Xpert MTB/RIF Assay cartridges and reagents at 2-28 degrees Celsius. 4. Review of Room Temperature logs revealed the following room temperature ranges: a. Foodborne and Waterborne Diseases section, room A-262: Acceptable Temperature Range, 15 to 30 degrees Celsius. b. MTB/RIF Assay section, room A-366: Acceptable 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 -- Temperature Range, 15 degrees Celsius to 30 degrees Celsius. 5. An observation during a tour of laboratory rooms A-262 and A-366 on 10/30/2024 at 2:00 pm, revealed the following: a. Room A-262: 72 boxes of Xpert Carba-R reagent cartridges stored on shelves. b. Room A-266: 5 boxes of Xpert Carba-R reagent cartridges stored in cupboard under the counter. 6. An interview on 10/30/2024 at 10:50 am with the Laboratory Director confirmed that the laboratory failed to define specified temperature requirements for the storage of Xpert Carba-R reagent cartridges on the temperature logs for room A-262 and A-366. 46043 II. Based on direct observation, review of manufacturer's instructions, lack of environmental logs, and confirmed in staff interview, the laboratory failed to ensure the manufacturer's specified conditions for storage of media preparation reagents for ten of ten months in 2024. Findings included: 1. During a tour of the laboratory on 10/30/2024 at 09:50 am in Room B101, dry reagents used for bacterial media preparation were observed stored in cabinets along two walls of the area. 2. A random review revealed the following reagents stored in Room B101 and the manufacturer's storage temperature requirements stated on the reagent label: Becton Dickinson Rhamnose; required storage temperture 2C - 25C HIMedia Lysine Decarboxylase Broth; required storage temperture 10C - 30C HIMedia DNase Test Agar Base; required storage temperture 10C - 30C Becton Dickinson Difco Gelatin; required storage temperture 2C - 25C Becton Dickinson Difco Plate Count Agar; required storage temperture 2C - 25C Becton Dickinson Difco Potato Dextrose Agar; required storage temperture 2C - 25C 3. The laboratory was asked to provide documentation of room temperature monitoring for Room B101 for 2024. No documentation was provided. 4. In an interview on 10/30/2024 at 9:55 am, the Laboratory Director confirmed that the room temperature was not monitored. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation, review of manufacturer's instructions, and confirmed in staff interview, the laboratory failed to document the manufacturer's specified revised expiration date for nine of nine vials of reconstituted Bacterial Test Standard (BTS) reagent. Findings included: 1. During a tour of the laboratory on 10/30/2024 at 10:30 am, nine vials of reconstituted and aliquoted BTS reagent were observed. The vials were stored in a larger container labeled with "Lot number 6030223009, Expiration date 05/31/2025". 2. The manufacturer's instructions titled "US IVD Bacterial Test Standard" (Document Number 5030609 Revision K April 2023) stated. " ...3.3 Storage after dissolution and aliquoting ...Aliquoted US IVD BTS solution can be stored frozen for up to 5 months at -18C/0F or below ..." 3. In an interview on 10/30 /2024 at 10:50 am, Mycology Technical Supervisor stated that the BTS reagent was reconstituted on 10/14/2024. After review of the manufacturer's instructions, the Laboratory Director confirmed that the laboratory failed to document the revised expiration date of five months from the date of preparation. D5429 MAINTENANCE AND FUNCTION CHECKS -- 2 of 5 -- 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: I. Based on review of the standard operating procedure, the manufacture's operator manual, instrument maintenance records, test reports and staff interview, the laboratory failed to document daily maintenance procedures for the GeneXpert MTB /RIF Assay instrument (Serial Number: 8001139) from January 12, 2024, to October 28, 2024. Findings included: 1. A GeneXpert MTB/RIF Assay Standard Operating Procedure (6/16/2022), SOP Number: MDL-MMPDS-MPI SOP-004, Version 5.0 that stated, "Daily, weekly, and yearly preventative maintenance (PM) actions must be performed according to the manufacturer guidelines, to ensure optimal system functionality and to avoid GX failures." 2. A manufactures GeneXpert Dx System, Operator Manual, Software Version 5.3, that described the daily maintenance as "Cleaning the work area daily using good laboratory practices to avoid contamination of specimens or reagents", "Check that all module doors are closed daily to avoid contamination of the modules", and "Discard used cartridges from the GeneXpert Dx system modules and on the surrounding work surfaces." 3. A review of specimen test reports and maintenance records for the GeneXpert instrument, serial number 801139, revealed no daily maintenance procedures were documented for 8 out of 8 days (11 total specimens tested). Test Report Dates and Sample IDs: a. 01/12/24 Sample ID: M24N000047 b. 02/26/24 Sample ID: M24N000226 c. 03/15/24 Sample ID: M24N000300 Sample ID: M24N000305 d. 06/11/24 Sample ID: M24N000505_MTBR-01 Sample ID: M24N000505_MTBR-02 Sample ID: M24N000506_MTBR-03 e. 07/15/24 Sample ID: M24N000562 f. 09/09/24 Sample ID: M24N000681 g. 09/13/24 Sample ID: M24N000703_20240913 h. 10/28/24 Sample ID: M24N000799_10282024 4. An interview with the Technical Supervisor of the MTB/RIF Assay section on 10/29/2024 at 12:45 pm confirmed that daily maintenance procedures were not completed for the GeneXpert instrument for the 8 identified test days with 11 total specimens tested from January 12, 2024, to October 28, 2024. 46043 II. Based on direct observation, review of manufacturer's instructions, laboratory policy, Magna Pure 24 records (03/06/2024 - 09/11/2024) and confirmed in staff interview, the laboratory failed to ensure daily and weekly maintenance requirements were performed and documented according to manufacturer's instructions for six of six months. Findings included: 1. During a tour of the laboratory on 10/30/2024 at 09:30 am, one Magna Pure 24 automated clinical nucleic acid extraction system (Serial Number 2067) was observed. 2. The manufacturer's instructions for the Magna Pure 24 System (OS-010974-01) stated, " ...Overview of Cleaning ...Outside of the instrument Weekly; Inside of the Instrument Weekly; Reagent Rack, Sample Rack, Sample tube adapters Weekly; Processing station Adapters Weekly ...Liquid Waste inserts Daily; Tip waste container Daily; Reagent Tip Park Daily; Output adapters, Post elution adapter, Downholder frame Weekly ..." 3. The procedure titled; "Magna Pure 24 Instrument Maintenance Procedures" (Document Number MDL-MMPDS-PRS-SOP-003) stated the following: " ...5. Post- run (Daily) Maintenance 5.2 Dispose all liquid waste ...5.2.1 Clean the liquid waste insert ...5.2.2 Clean the tip waste ...5.2.3 Clean the reagent tip park ...6. Weekly Maintenance ...6.1.1 If in use, clean the reagent rack, sample racks, and sample tube adapters ...6.1.2 Clean the processing station adapter ...6.1.3 Clean the output adapter ...6.1.4 Clean the outside and inside of the instrument ..." Included with the laboratory -- 3 of 5 -- procedure was the "Magna Pure 24 System Maintenance Log". 4. Review of the laboratory record titled, "Magna Pure 24 User Log" from 03/06/2024 through 09/11 /2024 revealed the laboratory failed to document performance of the specific requirements for daily and weekly maintenance. 5. In an interview on 10/30/2024 at 1: 10 pm, the Laboratory Director was asked to provide Magna Pure 24 weekly and monthly documentation as specified in the manufacturer's instructions and in the laboratory procedure. No documentation was provided. This confirmed the findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on direct observation, review of the Individual Quality Control Plan (IQCP) specimen test worksheets, quality control records and staff interview, the laboratory failed to follow their IQCP quality control procedures during the months of patient specimen testing for two of three Cepheid GeneXpert Carba-R Assay instruments from March 5, 2024, to July 2, 2024. Findings included: 1. An IQCP for Quality Control of GeneXpert Carba-R Assay, Version 091319, Page 14 stated "External QC must be performed monthly." 2. An observation during a tour of the Foodborne and Waterborne Diseases section on 10/30/2024 at 9:30 am revealed 3 individual Cepheid GeneXpert test systems in use: Cepheid GeneXpert (Serial Number 110019063), Cepheid GeneXpert System 2 (Serial Number 819594), and Cepheid GeneXpert System 4 (Serial Number 815607). 3. A review of patient specimen test worksheets and external quality control records revealed external quality control procedures were not completed for 6 of 6 specimen test runs (27 total specimens) on the GeneXpert Instruments, ID 815607 and Instrument ID 819594. Test Dates and Sample ID's: a. 03 /05/24 Sample IDs: M24R000220, M24R000234, M24R000269, M24R000271, M24R000274 b. 03/12/24 Sample IDs: M24R000255, M24R000293, M24R000298, M24R000255 c. 03/19/24 Sample IDs: M24R000300, M24R000302, M24R000303, M24R000304, M24R000305, M24R000310 d. 03/26/24 Sample IDs: M24R000319, M24R000330, M24R000331, M24R000333, M24R000335 e. 03/27/24 Sample ID: M24R000205 f. 07/02/24 Sample IDs: M24R000733, M24R000737, M24R000741, M24R000746, M24R000751, M24R000756 4. An interview with the Laboratory Director on 10/30/24 at 3:15 PM confirmed there were no external QC procedures completed for 6 of 6 patient specimen test runs using instrument ID 815607 and instrument ID 819594. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its -- 4 of 5 -- ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory policy, media quality control (QC) records, and confirmed in staff interview, the laboratory failed to perform quality control checks on each batch of media to include its ability to support growth for six of six lot numbers of Blood microbiological media slants. Finding included: 1. The laboratory policy titled, "Receipt and Quality Control Testing of Media and Reagents" (Document number MDL-BDS-QA-010) stated, " ...1.6.8 Test the medium or reagent for performance and sterility ... 2. Review of the laboratory's media quality control record for Blood Slants (03/26/2024 through 10/16/2024) revealed the laboratory failed to perform quality control check to ensure the media's ability to support growth (performance) for the following six lot numbers: Lot numbers 777599, 777585, 777571, 777564, 777557, and 777550 The record documented sterility checks only for each lot number. 3. In an interview on 10/30/2024 at 1:50 pm, the Laboratory Director confirmed the findings. 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 direct observation, review of correlation verification worksheets, and staff interview, the laboratory failed to evaluate and define, twice per year, the relationship between test results among the three individual Cepheid GeneXpert instruments used for the same analyte testing for eight of eight months (12/08/2023 to 07/02/2024). Findings included: 1. An observation during a tour of the Foodborne and Waterborne Diseases laboratory, room A-262, identified three individual GeneXpert instruments used for qualitative testing of gene sequences, blaKPC, blaNDM, blaVIM, blaOXA- 48 and blaIMP. The three instruments are as follows: a. Cepheid GeneXpert Serial number: 110019063 b. Cepheid GeneXpert System 2, Serial Number: 819594 c. Cepheid GeneXpert System 4, Serial Number: 815607 2. A review of the laboratory's GeneXpert CARBA-R Correlation Verification Worksheet revealed the laboratory failed to evaluate and compare all three individual Cepheid GeneXpert instruments. Instead, the laboratory compared two instrument results, serial number 110019063 and serial number 815607/819594 (two instruments combined). 3. An interview on 10 /30/2024 at 1:30 pm with the Laboratory Director confirmed the laboratory failed to evaluate and define, twice per year, the relationship between test results among the three Cepheid GeneXpert instruments in use. -- 5 of 5 --

Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 1. Based on laboratory personnel interviews and quality control record review on December 12, 2022 at 11:30 am, for media checks, the laboratory failed to maintain documentation to indicate that the batch of TSI reagents used to culture patient specimens, before or concurrent with the initial use, had been checked for sterility, ability to support growth, and that the physical characteristics of the reagent had not been compromised. Findings included: a. In the Salmonella serotyping section, it was the practice of the laboratory to test patient specimens using TSI reagents. b. For 2 (specimen accession numbers M22X002432 and M22X002603) of 2 randomly selected patient specimens in which the laboratory reported final Salmonella serotyping test results on November 30, 2022 and December 5, 2022, respectively, the laboratory maintained no documentation to indicate that the batch of TSI reagents used to test these patient specimens had been checked for sterility, ability to support growth, and that the physical characteristics of the media had not been compromised. c. Based on laboratory documents, the laboratory performed and reported approximately 2891 patient Salmonella serotyping test results annually. 2. Based on laboratory personnel interviews and quality control record review on December 12, 2022 at 11:30 am, for ONPG reagent checks, the laboratory failed to maintain documentation to indicate that the batch of ONPG reagents used to test patient 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 -- specimens, before or concurrent with the initial use, had been checked for sterility. Findings included: a. In the Salmonella serotyping section, it was the practice of the laboratory to test patient specimens using ONPG reagents. b. For ONPG reagents made/received on December 6, 2022, the laboratory maintained no documentation to indicate that sterility had been checked before or concurrent with the initial use. c. Based on laboratory documents, the laboratory performed and reported approximately 2891 patient Salmonella serotyping test results annually. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: 1. Based on laboratory personnel interviews and quality control record review on December 12, 2022 at 11:30 am, the laboratory failed to maintain an information or record system that included the date of all TSI reagents quality control testing, including the identity of the personnel who performed the tests. Findings included: a. In the Salmonella serotyping section, it was the practice of the laboratory to test patient specimens using TSI reagents. b. For TSI reagents, laboratory records failed to indicate the date and the personnel who performed TSI reagent quality control checks for TSI reagents made/received on November 17, 2022. c. Based on laboratory documents, the laboratory performed and reported approximately 2891 patient Salmonella serotyping test results annually. 2. Based on laboratory personnel interviews and patient test worksheets record review on December 12, 2022 at 11:30 am, the laboratory failed to maintain an information or record system that included the dates of all specimen testing. Findings included: a. In the Salmonella serotyping section, it was the practice of the laboratory to document all patient specimens testing records using established worksheets. b. For specimen accession number M22X002432, in which the laboratory reported final Salmonella serotyping test results on November 30, 2022, the laboratory's record system failed to indicate the date(s) on which tests were performed/read. c. For specimen accession number M22X002603, in which the laboratory reported final Salmonella serotyping test results on December 5, 2022, the laboratory's record system failed to indicate which tests were performed/read on which of the multiple dates recorded. d. Based on laboratory documents, the laboratory performed and reported approximately 2891 patient Salmonella serotyping test results annually. 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. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on laboratory personnel interviews and quality control record review on December 12, 2022 at 11:30 am, the laboratory failed to follow 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. Findings included: a. According to the laboratory's protocol titled "Quality Assessment Manual (SOP Number MDL-MQAM-001)," quality assessment reviews of quality control records were to occur at least monthly. b. In the Salmonella serotyping section, the laboratory maintained no document to indicate that quality assessment reviews had occurred for: i.) TSI reagents made/received on July 20, 2022, July 29, 2022, August 10, 2022, August 19, 2022, September 2, 2022, September 14, 2022, September 28, 2022, October 6, 2022, October 13, 2022, October 24, 2022, November 2, 2022, November 17, 2022, and December 1, 2022. ii.) ONPG reagents made/received on December 6, 2022. c. The "Supervisor Review" section of the form for TSI and ONPG reagents for the dates listed was blank. d. Based on laboratory documents, the laboratory performed and reported approximately 2891 patient Salmonella serotyping test results annually. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies 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: Based on laboratory personnel interviews and Foodborne & Waterborne Diseases Section policies and procedures record review on December 2, 2020, the laboratory failed to establish written policies and procedures for specimen labeling. Findings included: a. In the Foodborne & Waterborne Diseases Section, the laboratory routinely accepted patient specimens for bacteriology testing. b. According to laboratory personnel, at a minimum, the patient's name and unique identifier is required on a patient specimen label for the specimen to be acceptable. The Foodborne & Waterborne Diseases Section was unable to provide a written policy and procedure that detailed this information. c. According to laboratory records, the laboratory performs and reports approximately 12,400 patient 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 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 -- 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 D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's Proficiency testing records on April 24, 2018, the laboratory failed to perform the internal proficiency testing blind samples the in the same manner as it tests patient specimens. Findings Include: a. The laboratory performed internal PT for laboratory developed testing for molecular testing of Brucella, Botulism, and Parasitology pathogens (Ehistocytes, Giardia, Cryptospridium), due to lack of PT program availability in 2017. b. The laboratory created five blind specimens for each of the samples, and all three testing personnel tested the same five samples. For Brucella internal PT event 1, 2017: Testing Person 3. performed samples on 3/24/2017- A1, A2, A3, A4, A5 Testing Person 2. performed samples on 3/27/2017- A1, A2, A3, A4, A5 Testing Person 1. Performed samples on 3 /23/2017- A1, A2, A3, A4, A5 All results were reviewed for evaluation on 03/27 /2017. For Brucella internal PT event 2, 2017: Testing Person 3. performed samples on 12/01/2017- B1, B2, B3, B4, B5 Testing Person 2. performed samples on 11/14 /2017- B1, B2, B3, B4, B5 Testing Person 1. Performed samples on 11/29/2017- B1, B2, B3, B4, B5 All results were received for evaluation on 12/06/2017. For Botulinum Enterotoxin Event 2, 2017: the three testing personnel were provided instructions to run three tubes to identify Clostridium Botulinum by culture, by gram 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 -- stain, and by CMGS: Testing Person 3. performed samples on 12/01/2017- tube 1, tube 2, tube 3, Testing Person 2. performed samples on 11/13/2017- tube 1, tube 2, tube 3, Testing Person 1. Performed samples on 11/13/2017- tube 1, tube 2, tube 3, All results were received for evaluation on 01/04/2018 For Parasitology Stool pathogens, Event 1 of 2017: Testing Person 3. performed samples on 12/01/2017- tube 1, tube 2, tube 3, Testing Person 2. performed samples on 11/13/2017- tube 1, tube 2, tube 3, Testing Person 1. Performed samples on 11/13/2017- tube 1, tube 2, tube 3, All results were received for evaluation on 01/04/2018 c. The laboratory department Technical Supervisor affirmed this testing process by interview on, April 24, 2018 at approximately 1:47 pm, and is not the process used to test patients samples. d. The laboratory reports testing approximately 19,438 patient samples annually. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of control logs and interviews with the laboratory director and department staff on April 23 rd and 24th, 2018, the laboratory failed to test staining materials each day of use for intended reactivity. Findings include: a. For immunohistochemical and florescent stains the laboratory reportedly do not perform quality control testing on day of use. b. For mycology specimens, the laboratory did not perform or document quality controls to test the procedure with known positive and negative organisms. c. For biochemical testing and antimicrobial testing the laboratory did not perform or document quality control testing with know positive and negative organisms. d. These deficient practices were affirmed by interview on April 24th, 2018 at approximately 0900 am, by the laboratory Director and the laboratory staff. e. The laboratory reports performing approximately 19, 438 patient samples annually. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel competency records, the laboratory director failed to specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the -- 2 of 4 -- preanalytic, analytic, and postanalytic phases of testing, and resulting of patient specimens. Findings include: a. The personnel training and competency records do not identify the duties and responsibilities of the consultants, supervisors and testing personnel in the laboratory. b. The laboratory proficiency reports are signed off by the laboratory supervisor no designation of authority provided. c. Testing personnels semi- annual and annual competency records are signed by the general supervisors, no designation of authority provided. d. This lack of documentation of authority was affirmed by interview with the laboratory director on April 24th, 2018 at approximately 3:00 pm. D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: Based on review of the laboratory quality control records and policy's on April 23 and, 2018, the technical supervisor failed to establish a quality control program appropriate for the testing performed. Findings include: a. The laboratory performs Mycobacterium testing. The laboratory did not perform daily QC with positive and negative organisms each time of use for immunoflorescent stains. b. The laboratory did not perform or document quality control testing for lactophenol blue staining on each day of use for mycology testing. c. The laboratory did not perform or document quality control testing in bacteriology for antimicrobial reagents each day of testing. d. This lack of documentation of quality control for acceptable levels of analytic performance throughout the testing processes were affirmed by interview of laboratory staff, records review and interview with the laboratory director on April 23 and 24th of 2018 at approximately 3:00 pm. e. The laboratory reports performing approximately 19,438 patient specimens annually. D6128 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 annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of the laboratory testing personnel training and competency records on April 23rd, 2018, the technical supervisors failed to evaluate and document the performance of individuals responsible for high complexity testing at least annually after the first year, and when test methodology or instrumentation changes, prior to reporting patient test results, reevaluate the testing personnel to include the use of the new test methodology or instrumentation. Findings Include: a. The laboratory has multiple testing departments and staff are periodically reassigned from one to another -- 3 of 4 -- department. During those times of reassignment the Technical Supervisors did not perform reevaluation on the testing personnel for 6 month competency or for a general annual competency. Out of 39 testing personnel- 4 were missing an annual competency for 2016 and 4 were missing annual or initial competency for-2017. b. The laboratory director affirmed this deficient practice by interview on April 24th, 2018. c. The laboratory reports performing approximately 19,438 specimens annually. -- 4 of 4 --