Fusion Diagnostics Laboratories, Llc

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Technical Supervisor (TS) the laboratory failed to perform the CA correctly for four out of four Testing Personnel (TP) from 2/22/18 to the date of the survey. The findings include: 1. The laboratory did not assess test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples on four out of four TP. 2. "competent to perform the skill" column on the CA was not checked for four out of four TP for CA's performed in the calendar years 2018 and 2019. 3. The Laboratory failed to perform a CA on one out of four TP in the calendar years 2018 and 2019. 4. The TS confirmed on 2/11/20 at 11:00 am that the CA was not performed correctly. 35471 D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to review and evaluate coded PT results obtained with the College of American Pathologists (CAP) in the calendar year Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 2019. The findings include: 1. The laboratory did not evaluate Code 20 (No appropriate target/response; cannot be graded) for: a. Urine Drug Testing (screening) - Benzodiazepine Group samples UDS-12 and 15 in event 2 b. General Chemistry /Therapeutic Drugs - Triiodothyronine and Free Triiodothyronine for sample CHM-13 in event C. 2. The laboratory did not evaluate Code 26 (educational challenge) for: a. Diagnostic Immunology - Rheumatoid Factor screening titer samples RF-03, 04, 05 and Antistreptolysin O samples ASO 03- 05 in Event A b. Tick Transmitted Diseases - Borrelia burgdorferi Test 1 and 3 for sample TTD-01 and sample TTD-01 in event A c. Serology - Anti-iTG IgG, Qualitative for Celiac CES-04, 05, 06 in event A d. Diagnostic Immunology - Antistreptolysin O samples ASO-06, 08 in event B e. Hematology Auto Differentials - FH13 Blood Cell ID sample BCP-02 in event A f. Hematology Auto Differentials - FH13 Blood Cell ID samples BCP16-B20 in event B and samples BCP 26 -30 in event C g. Diagnostic Immunology - Rheumatoid Factor screening titer for samples RF-06, 07, 10 in event B h. Bacteriology Agar Diffusion samples D01 - D05 in event A-2019 i. Bacteriology Disk Differential samples D15- D20 in event C-2019 3. The laboratory did not evaluate Code 27 (lack of participant or Referee consensus) for: a. Hematology Auto Differentials - FH13 Blood Cell ID Ungraded for samples BCP-02 in event A. b. Special Immunology - Anti-gliadin IgG qual for samples CES 04- 06 in event B c. Special Immunology - Anti- ribonucleoprotein qualitative sample S2-20, Anti-Sjgren's-syndrome-related antigen A sample S2-20 in event C 4. The laboratory did not evaluate Code 28 (response qualified with a greater or less than sign; unable to quantitative) for Blood Lead - sample BL-5 event A, BL-10 event B and BL-11 event C. 5. The laboratory did not evaluate Code 30 (Scientific Committee decision) for General Chemistry/Therapeutic Drugs Samples serum Phosphorus samples CHM 06, 07 and 09 for event B. 6. The TS confirmed on 2/11/20 at 1:30 pm that the laboratory failed to evaluate coded results for PT events. 35471 D5401 PROCEDURE MANUAL CFR(s): 493.1251(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: Based on surveyor review of the Procedure Manual (PM) and interview with the Technical Supervisor (TS), the laboratory failed to follow the procedure to verify new lot numbers of Quality Control (QC) used in Hematology tests on the Coulter LH 750 from October 2019 to the date of the survey. The finding includes: 1. The PM stated new lots of QC "will be verified by the laboratory prior to being placed into use" but: a. Lot 865600 expired 10/20/19 - new lot was verified 10/21/19 b. Lot 866700 expired 1/12/20 - new lot was verified on 1/13/20 2. The TS confirmed 2/12/20 at 1:30 pm that the laboratory did not follow the PM. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as -- 2 of 8 -- determined under 493.1253. This STANDARD is not met as evidenced by: a. Based on surveyor observation, review of the Manufacturer's Package Insert (MPI) and interview with the Technical Supervisor (TS), the laboratory failed to follow the manufacturer's instruction for storage of Analytical Profile Index (API) media on the date of survey. The finding includes: 1. The MPI stated to store API reagent from 2 to 8 degrees Celsius (C) but the laboratory stored an unopened box in the freezer. 2. The TS confirmed on 2/12/2020 at 1:10 pm that the laboratory did not follow the MPI. b. Based on surveyor review of the MPI, Microbiology Quality Control (QC) records and interview with the TS, the laboratory failed to follow the MPI for BD BBL Sensi- Disc Antimicrobial Susceptibility Test Discs for Urine Culture Sensitivity tests from 2 /22/18 to the date of the survey. The findings include: 1. The MPI for Zone Size Interpertation stated: a. Zone size for Staphylococcus aureus with Levofloxin had an assigned value of 25-30 but 29-37 was on the QC record in the laboratory. b. Zone size for Pseudomonas aeruginosa with Cefepime had an assigned value of 23-29 in the MPI but 24 -30 was on the QC record in the laboratory. 2. The TS confirmed on 2/12 /20 at 2:10 pm the laboratory did not follow the MPI. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor review of the Temperature Logs and interview with the Technical Supervisor, the laboratory failed to monitor and document the Freezer Temperature where sensitivity discs for Bacteriology tests were stored from 2/3/20 to the date of survey. The TS confirmed on 2/11/20 at 10:20 am that the laboratory did not document freezer temperature. 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 surveyor review of Manufactures Package Insert, observation of the Quality Control material, and interview with the Technical Supervisor (TS), the laboratory failed to put a new expiration date on Hematology, Chemistry, Immunology and -- 3 of 8 -- Endocrinology Control material on the date of the survey. The TS confirmed on 2/12 /20 at 1:10 pm the laboratory failed to put a new expiration date on the control material. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of reagents and interview with the Technical Supervisor (TS), the laboratory failed to discard expired reagents from 11/2/19 to the date of the survey. The findings include: 1. Expired reagents were found as below: a. Herpes Simplex 1- Specific Immunoglobulin G (HVS-1 Specific IgG) used on the Liasion Diasorin XL b. Lipase - used on the Beckman Coulter AU480 c. Creatine Kinase used on the Beckman Coulter AU480 2. The TS confirmed on 2/12/20 at 1:10 pm that the laboratory did not discard expired reagent. D5419 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(e) Components of reagent kits of different lot numbers must not be interchanged unless otherwise specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor observation of Reagent Kits (RK) and interview with the Technical Supervisor (TS), the laboratory failed to ensure all components of RK used on the Diasorin and DSX analyzers for Immunology Tests of different lot numbers were not interchanged from 2/22/18 to the date of the survey. The findings include: 1. Mixed RK were found as follows: a. Tissue transglutaminase (tTG) Immunoglobin A (IgA) Elisa kit 050432 contained 8 unpackaged and unsealed microcuvettes, (lot number unknown). HRF sample diluents 045902, 057435, 0554419 b. Gladian IgA contained two kits of unsealed microcuvettes in opened unsealed bag. Lot numbers not known. c. Anti-cyclic citrullinated peptide (CCP 3.3) Immunoglobulin G (IgG)/IgA Kit 053873 contained: i. HRP IgG/IgA Conjugate 503871, 053871, 2 vials 051687 ii. TMB Chromogen 055554 - 057050 iii. HRP Stop Solution 005526, 057429, 052910 iv. Negative QC 057531 - 040428 v. Low Positive 055716 - 05168 vi. Sample Diluents - 2 -TMP Stop Solution - Poured off lot number or expiration date not recorded d. Sjgren's-syndrome-related antigen B (SS-B) IgG lot 052098 contained i. HRP wash concentrate 049104, 3 - 053057, 051868 ii. HRP sample diluents 3 - 053058, 052537, 053267 iii. TMB Chromogen 2 - 052449, 049549 iv. HRP Stop Solution 050025, 052221 v. HRP IgG Conjugate 047994 2. Approximately 20 tests are run per week with RK. 3. The TS confirmed on 2/12/20 at 12:10 pm the laboratory interchanged components of the RK. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory -- 4 of 8 -- 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 surveyor observation of Incubator 3 and interview with the Technical Supervisor (TS), the laboratory failed to perform and document maintenance as specified by the manufacturer on Incubator 3 used in Bacteriology testing at the time of the survey. The finding includes: 1. Observation of Incubator 3 revealed a red warning "Alarm Replace Hepa Filter". 2. Testing Personnel on site at the time of the survey stated the laboratory does not replace the Hepa Filter. 3. The TS confirmed on 2 /12/20 at 2:05 pm that maintenance as specified by the manufacturer was not performed. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Technical Supervisor (TS), the laboratory failed to titer a positive control for Syphilis, Mononucleosis, Antistreptolysin O and Rheumatoid Factor tests from 2/22/18 to the date of survey. The finding includes: 1. There was no documented evidence a positive control was titered further than 1:2 when a patient result was titered beyond 1:2. 2. The TS confirmed on 2/12/20 at 10:00 am that a positive titered control was not titered every time a patient was tittered. 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: Based on the surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check each new lot number and shipment of media for its ability to support growth and select or inhibit organisms from 2/22/18 to the date of the survey. The findings include: 1. There was no documented evidence ability to support growth and select or inhibit organisms was checked on any lot number of the Agar listed below: a. BBL Trypticase Soy b. -- 5 of 8 -- Columbia CNA c. BBL Mac Conkey d. BBL Mueller Hinton II e. BBL Mueller Hinton f. BBL Heckton Enteric g. CDC Anaerobic Blood Agar 2. The TP #4 listed on CMS form 209 confirmed on 2/11/20 at 10:00 am the laboratory did not perform the above QC. D5781

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: a) Based on surveyor review of the Competency Assessment (CA) records and interview with the Laboartory Director (LD), the laboratory failed to perform CA correctly on four out of four testing personnel in 2016 and 2017. The findings include: 1. The laboratory did not document when testing personnel were observed, what records were reviewed and how assessment was done. 2. The LD confirmed on 2/21 /18 at 11:00 am that CA was not performed correctly. b) Based on surveyor review of CA and interview with the LD, the LD failed to ensure that qualified personnel performed CA in 2016 and 2017. The LD confirmed on 2/21/18 at 11:15 am that qualifed personnel did not perform CA. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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: a) Based on surveyor review of the Procedure Manual (PM) and interview with the Laboratory Director (LD), the laboratory failed to follow the Urine Culture (UC) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- procedure entitled "Rejection Criteria" from 5/7/15 to the date of survey. The finding includes: 1. The PM stated to reject the sample "when the collection time and method of collection have not been provided" but a review of five requisitions revealed five out of five had no collection method stated and the samples were not rejected. 2. The LD confirmed on 2/22/18 at 2:10 pm that the PM was not followed. b) Based on surveyor review of the PM and interview with the LD, the laboratory had an incorrect procedure for Quality Control (QC) of media from 5/7/15 to the date of survey. The finding includes: 1. The QC procedure in the PM stated "For each shipment or lot of media, the laboratory has documentation that the manufacturer's QC practices conform to the Clinical and Laboratory Standards Institute (CLSI) specifications" but CLSI guidelines were removed from the regulations. 2. The LD confirmed on 2/22/18 at 2:20 pm that the procedure in the PM was not the current QC procedure. 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 surveyor review of the Individualized Quality Control Plan (IQCP) for Disk Diffusion Antimicrobial Susceptibility Testing and interview with the Laboratory Director (LD), the laboratory failed to have an approved, signed and dated IQCP Quality Control Plan procedure by the Laboratory Director (LD) from 1/4/16 to the date of the survey. The findings include: 1. A review of the IQCP plan revealed that there was no evidence of review, approval or signature of the LD on the Risk Management portion of the IQCP. 2. The IQCP did not include a Qualtiy Control Plan. 3. The LD confirmed on 2/22/18 at 1:45 pm that all portions of the IQCP were not signed. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on surveyor review of the Coagulation Procedure Manual (PM) and interview with the Laboratory Director (LD), the laboratory failed to record a discontinuance date on Coagulation procedure ceased on 4/30/17. The LD confirmed on 2/21/18 @ 12:00 pm that a discontinuance date was not recorded. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: -- 2 of 6 -- Based on surveyor review of the Quality Control (QC) records, Manufacture package insert (MPI), QC material, and interview with the Testing Personnel (TP), the laboratory used expired QC material for Hepatitis C Virus tests performed on the Architect analyzer from 10/24/17 to the date of survey. The findings include: 1.The MPI stated that QC material expires sixty days after opening. 2. Bio-Rad Virotrol I control Lot # 119650 was opened 9/1/17 expired 10/24/17. 3. Approximately 560 patients were run and reported to the date of survey. 4. The TP # 1 listed on CMS form 209 confirmed on 2/22/18 at 1:30 pm that the laboratory used expired QC material. 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 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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Individualized Quality Control Plan (IQCP) for Disk Diffusion Antimicrobial Susceptibility Testing and interview with the Laboratory Director (LD), the laboratory failed to establish and document the number, type and frequency of testing control material before implementing the IQCP from 1/4/16 to the date of the survey. The LD confirmed on 2/22/18 at 2::00 pm that the laboratory did not have a Quality Control procedure in the IQCP 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: Based on surveyor review of Quality Control (QC) records and interview with the Laboratory Director (LD), the laboratory failed to check the physical characteristics of each batch of media used in Bacteriology testing from 5/7/15 to the date of the survey. The LD listed confirmed on 2/22/18 at 2:20 pm that the laboratory did not perform the above mentioned QC check. D5481 CONTROL PROCEDURES -- 3 of 6 -- CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's 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: Based on surveyor review of the laboratory's Individualized Quality Control Plan (IQCP) for Disk Diffusion Antimicrobial Susceptibility Testing and interview with the Laboratory Director (LD) the laboratory failed to have documentation of data used to support their Risk Assessment (RA) for Disk Diffusion Antimicrobial Susceptibility Testing before reporting patient results from 1/4/16 to the date of the survey. The LD confirmed at 2:30 pm on 2/22/18 the laboratory did not have documentation of controls used to support their RA. D5783