Bmg Family Physicians Group Foundation, Inc

Summary Statement of Deficiencies D0000 During a recertification survey performed on March 20, 2025, the laboratory was NOT IN COMPLIANCE with the following conditions: 493.1250 Condition: Analytic systems. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on direct observation, review of proficiency testing records, and staff interview, the laboratory failed to retain the 2023 Event Three Proficiency Testing (PT) records for Complete Blood Count with automated White Blood Cell differential (CBC w /Diff) (one of eight PT records from 2023, 2024, and 2025.) The findings include: 1. Laboratory observation on 03/20/25 at 9:15 a.m. revealed the Sysmex XS 1000i CBC w/Diff instrument used for patient testing. 2. A review of the laboratory's PT records revealed that the 2023 Event Three CBC w/Diff records were unavailable. 3. The laboratory liaison confirmed the survey findings during an interview on 03/20/25 at 11:30 a.m. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's College of American Pathologists (CAP) Proficiency Testing (PT) records, lack of documentation, and staff interviews, the laboratory failed to provide documentation of testing personnel retraining and reassessment of competency after failed urine microscopy and wet prep proficiency testing in 2024. The findings include: 1. A review of the laboratory's proficiency testing records revealed the following: The urine microscopy results for 2024 Event One revealed an unacceptable response for USP-01. The expected response was Red Blood Cell cast, and the response provided by the laboratory was Erythrocyte. The vaginal wet prep results for 2024 event One revealed an unacceptable response for CMMP-26. The expected response was Epithelial Cell Present, the laboratory responded with Clue Cells Present. The urine microscopy results for 2024 Event Two revealed unacceptable responses for USP-05 and USP-06. The expected response for USP-05 was Fiber Fecal Contamination, and the response provided by the laboratory was Mucus Strand. The expected response for USP-06 was Bacteria, and the response provided by the laboratory was Waxy Cast. 2. The laboratory failed to provide documentation that the documented

Summary Statement of Deficiencies D0000 During a recertification survey on 09/27/23, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1215 Condition: Hematology 42 CFR 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records and staff interview, the testing personnel who performed the microscopy portion of the PT events for 2022 did not sign the attestation statements (three of three events from 2022). The findings include: 1. Review of the laboratory's proficiency testing records revealed the attestation statements for 2022 events one, two and three were not signed by the persons who performed the microscopy portion of the PT events. 2. Interview with the laboratory liaison on 09/27/23 at 9:40 am confirmed that the testing personnel who performed the microscopy portion of the PT events for 2022 did not sign the attestation statements. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the laboratory's PT records and staff interview, the laboratory failed to ensure PT records contained the identity of the person who performed the microscopy portion of the PT events for 2022 events one, two, and three (three of three events from 2022). The findings include: 1. Review of the PT records for 2022 events one, two and three revealed the records did not contain the identity of the person who performed the microscopy portion of the PT events. 2. Interview with the laboratory liaison on 09/27/23 at 9:40 am confirmed the laboratory failed to ensure the PT records contained the identity of the person who performed the microscopy portion of the PT events from 2022 events one, two and three. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the laboratory's procedure manual, the Centers for Medicare and Medicaid Services Laboratory Personnel Report (Form CMS 209), testing personnel records, observation of the laboratory, review of environmental records, manufacturer instructions for use, review of quality control records, the Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), lack of documents, quality assurance records, and staff interviews, the laboratory failed to ensure ensure it followed its' own testing personnel policy (Refer to D5209), failed to ensure the laboratory procedure for CBC included procedures to follow when changing control lots and failed to include proceures to follow for patient results flagged by the CBC instrument (Refer to D5401), failed to ensure collection tubes were not used past their expiration date (Refer to D5417), failed to ensure quality control (QC) was monitored over time (Refer to D5441), failed to ensure QC ranges were verified (D5469), and failed to ensure its' quality assessment (QA) processes were adequate to detect, correct, and prevent problems with quality control (Refer to D5793). 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: -- 2 of 11 -- Based on review of the laboratory procedure manual, review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS- 209), testing personnel records and staff interview, the laboratory failed to follow their own procedure for training and six month competency assessment for testing person number six in 2020 (one of nine new testing personnel). The findings include: 1. Review of the laboratory's testing personnel competency assessment policy revealed that new testing personnel would be checked off on all aspects of lab duties during their training period. The policy also required a competency assessment at six months after hire. 2. Review of the Form CMS-209 from the previous survey conducted on 01 /16/20 with comparison to the Form CMS-209 for the current survey revealed testing person number six was new since the last survey. 3. Review of the laboratory's testing personnel records revealed testing personnel number six had a hire date of 04/27/20. There was no documentation of initial training or six month competency. 4. Interview with the lab liaison on 09/27/23 at 12 pm revealed the following: Testing person number six was previously employed at the facility and was previously trained. She came back in April 2020. She did not go back through initial training or have a six month competency assessment. This confirmed the survey findings. 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 observation of the laboratory, review of the laboratory procedure manual and interview with the laboratory liaison, the laboratory procedure for Complete Blood Count failed to include procedures for setting quality control (QC) limits in the Sysmex XS 1000i instrument and procedures to follow for results with instrument flags. The findings include: 1. Observation of the laboratory on 09/27/23 at 9:50 am revealed two Sysmex XS 1000i instruments in use for patient testing, one in the main laboratory (serial #74898) and one in the nursing laboratory (serial #74897). A percent limit guide was posted on the front of the instruments. 2. Review of the procedure titled "CBC performed on Sysmex XS-1000i" revealed the procedure did not include instructions for entering and setting CBC control limits in the Sysmex XS 1000i instruments or steps to follow for results that are flagged by the instrument. 3. Interview with the laboratory liaison on 09/27/23 at 5 pm revealed the following: The laboratory uses the manufacturer evidence based percent limits to set their quality control ranges. The percent limits are posted on the instrument. The approved procedure did not include procedures/instructions for entering and setting the control limits in the Sysmex XS 1000i CBC instrument. She stated the lab repeats results that are flagged, but procedures to follow were not included in the approved procedure. This confirmed the survey findings. 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 -- 3 of 11 -- 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 observation of the laboratory, review of the laboratory's environmental monitoring records, the manufacturer instructions for use, and interview with the laboratory liaison, the laboratory failed to define ranges for humidity and room temperature that was consistent with manufacturer requirements for operation of the Sysmex XS 1000i Complete Blood Count (CBC) instrument from 06/01/23 to the date of the survey on 09/27/23. The findings include: 1. Observation of the laboratory on 09 /27/23 at 9:50 am revealed two Sysmex XS 1000i instruments in use for patient testing for CBC, one in the main laboratory (serial # 74898) and one in the nursing laboratory area (serial #74897). 2. Review of the laboratory's environmental monitoring records revealed a humidity range of 20-85% and a room temperature range of 15-35 degrees Celsius. 3. Review of the Sysmex XS 1000i manufacturer instructions for use revealed an operating humidity range of 30-85% and an ambient temperature range of 15-30 degrees Celsius. 4. Interview with the laboratory liaison on 09/27/23 at 5 pm confirmed the laboratory did not define humidity and room temperature ranges that were consistent with the Sysmex XS 1000i manufacturer requirements. 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 observation of the nursing laboratory area and staff interview, the laboratory failed to label the saline used for collecting and transporting patient samples for wet prep on the date of the survey (09/27/23). The findings include: 1. Observation of the nursing laboratory area on 09/27/23 at 10:15 am revealed clear vials of liquid in a rack inside a drawer that were used for collection and transport of patient samples for wet prep. The vials were not labeled. 2. During an interview with the laboratory liaison on 09/27/23 at 10:15 am, the lab liaison communicated the following: The vials in the drawer were saline that were used for collecting and transporting wet prep samples to the lab. The liquid in the vials had been poured off from a master container, but were not labeled. This confirmed the survey findings. 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. -- 4 of 11 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory and staff interview, the laboratory failed to ensure tubes used for capillary collection of Complete Blood Count (CBC) were not used past their expiration date on the date of the survey (09/27/23). The findings include: 1. Observation of the laboratory on 09/27/23 at 9:50 am revealed tubes used for capillary collection of CBCs in the phlebotomy chair drawer that were expired (lot#1363407, expiration date of 06/30/23). The tubes were discarded on the date of the survey. 2. Interview with the lab liaison on 09/27/23 at 9:55 am confirmed the expired tubes in the drawer were there to be used if the laboratory collected a CBC by fingerstick. 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 observation of the laboratory, review of QC records, the CMS-116, and staff interview, the laboratory failed to print cumulative quality control for the two Sysmex XS 1000i instruments in use for patient CBC testing in 2021, 2022, and 2023, resulting in the laboratory not ensuring the QC ranges used were appropriate to detect errors and no retention of the QC ranges that were in use at the time of QC performance in 2021, 2022, and 2023. The findings include: 1. Observation of the laboratory on 09/27/23 at 9:50 am revealed two Sysmex XS 1000i CBC instruments in use for patient testing, one in the main laboratory (serial #74898) and one in the nursing lab (serial # 74897). 2. Review of the laboratory's QC records revealed no records of cumulative quality control records to monitor accuracy and precision over time from the past two years. 3. Cumulative reports printed after correction of QC limits for lots in the lab and nursing instrument revealed dates with QC that was outside the laboratory's acceptable range. (Refer to D5469) 4. Review of the CMS- 116 annual test volume estimates revealed approximately 4,963 patients are reported annually, resulting in approximately 9,926 patient reported during the period when the cumulative reports were not printed. 5. Interview with the office manager on 09/27/23 at 3:00 pm confirmed there were no cumulative printouts of the laboratory's CBC quality control for either instrument from 2021, 2022, or 2023. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When -- 5 of 11 -- 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. (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. (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of quality control (QC) records, the Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), and staff interview, the laboratory failed to verify the use of correct quality control ranges for a period from 02/28/23 to the date of the survey (09/27/23) for the laboratory instrument, and a period from 04/17/23 to the date of the survey (09/27/23), resulting in the potential for reporting of patient CBC results with unacceptable quality control. Approximately 2,480 patient CBCs were performed during the period when the incorrect QC limits were in use. The findings include: 1. Observation of the laboratory on 09/27/23 at 9:50 am revealed two Sysmex XS1000i instruments in use for patient CBC testing (serial #74898 in the main lab, serial #74897 in the nursing lab). Taped to both instruments was a document titled "XS Control limits." The limit range % posted on the instruments for use by the lab for setting QC ranges were as follows for selected parameters: Level 1 Level 2 Level 3 RBC 5.0 4.0 4.0 HGB 6.0 4.3 4.2 HCT 6.0 5.1 5.0 PLT 23 12 9.7 WBC 11.4 7.8 7.8 NE% 11.1 8.9 8.1 LY% 12.1 9.1 7.7 MO% 35 24 19.7 EO% 29.3 28.3 28.4 BA% 34.9 31.1 31.1 All other CBC parameters had specific/defined limit range percents as well. 2. Review of the laboratory's available quality control records/lots that were still maintained in the lab's instruments revealed the following: Serial #74898 (main lab instrument) Lot number 30380804, 30380805, 30380806, date from = 02/28/23 date to: 04/28/23. The limit range % was set at 100% for all analytes, resulting in the following QC ranges: Level one (30380804): RBC=0.0 - 5.22, HGB=0.0 - 12.2, HCT=0.0 - 39, PLT=0 - 106, WBC=0. 0 - 5.98, NE%=0.0 - 72.2, LY%=0.0 - 79, MO%=0.0 - 19.8, EO%=0.0 - 19.8, BA%=0. 0 -10.8. Level two (30380805): RBC=0.0 - 8.98, HGB=0.0 - 25.6, HCT=0.0 - 78.4, PLT=0 - 464, WBC=0.0 - 13.84, NE%=0.0 - 83.2, LY%=0.0 - 65.0, MO%=0.0 - 19.2, EO%=0.0 - 20.2, BA%=0.0 - 12.4. Level three (30380806): RBC=0.0 - 10.79, HGB=0.0 - 32.8, HCT=0.0 - 98.4, PLT=0 - 1114, WBC=0.0 - 13.84, NE%=0.0 - 83.2, LY%=0.0 - 65.0, MO%=0.0 - 19.2, EO%=0.0 - 20.2, BA%=0.0 - 12.4. Lot numbers 30940804, 30940805, 30940806, date from: 04/17/23, date to: 06/23/23. The limit range % was set at 100% for all analytes, resulting in the following QC ranges: Level one (30940804): RBC=0.0 - 5.12, HGB=0.0 - 12.4, HCT=0.0 - 39.8, PLT=0 - 106, WBC=0.0 - 5.92, NE%=0.0 - 75.8, LY%=0.0 - 76.4, MO%=0.0 - 17.8, EO%=0.0 - 18.4, BA%=0.0 - 11.6. Level two (30940805): RBC=0.0 - 8.76, HGB=0.0 - 24.0, HCT=0.0 - 73.6, PLT=0 - 454, WBC=0.0 - 13.74, NE%=0.0 - 83.0, LY%=0.0 - 66.6, MO%=0.0 - 18.0, EO%=0.0 - 19.8, BA%=0.0 - 12.6. Level three (30940806): RBC=0. 0 - 10.86, HGB=0.0 - 31.6, HCT=0.0 - 95.8, PLT=0 - 1096, WBC=0.0 - 32.04, NE% =0.0 - 89.8, LY%=0.0 - 56.2, MO%=0.0 - 18.2, EO%=0.0 - 21.6, BA%=0.0 - 14. Lot numbers 31940804, 31940805, 31940806, date from: 06/12/23, date to: 08/18/23. The limit range % was set at 100% for all analytes, resulting in the following QC ranges: Level one (31940804): RBC=0.0 - 5.06, HGB=0.0 - 11.6, HCT=0.0 - 37.0, PLT=0 - 104, WBC=0.0 - 5.98, NE%=0.0 - 76.6, LY%=0.0 - 74.6, MO%=0.0 - 19.6, EO%=0.0 -- 6 of 11 -- - 18.2, BA%=0.0 - 11.2. Level two (31940805): RBC=0.0 - 8.62, HGB=0.0 - 24.2, HCT=0.0 - 73.2, PLT=0 - 426, WBC=0.0 - 14.04, NE%=0.0 - 82.2, LY%=0.0 - 65.2, MO%=0.0 - 20.2, EO%=0.0 - 19.8, BA%=0.0 - 12.6. Level three (31940806): RBC=0. 0 - 10.6, HGB=0.0 - 32.2, HCT=0.0 - 96.0, PLT=0 - 1054, WBC=0.0 - 34.02, NE%=0. 0 - 88.0, LY%=0.0 - 56.2, MO%=0.0 - 20.6, EO%=0.0 - 21.4, BA%=0.0 - 13.8. Lot numbers 32050804, 32050805, 32050806, date from: 08/07/23, date to: 09/27/23 (survey date). The limit range % was set at 100% for all analytes, resulting in the following QC ranges: Level one (31940804): RBC=0.0 - 5.14, HGB=0.0 - 12.8, HCT=0.0 - 39.6, PLT=0 - 110, WBC=0.0 - 6.08, NE%=0.0 - 79.8, LY%=0.0 - 79.8, MO%=0.0 - 18.6, EO%=0.0 - 17.8, BA%=0.0 - 10.8 Level two (31940805): RBC=0.0 - 8.62, HGB=0.0 - 24.4, HCT=0.0 - 73.4, PLT=0 - 462, WBC=0.0 - 13.56, NE%=0.0 - 81.6, LY%=0.0 - 67.0, MO%=0.0 - 29.6, EO%=0.0 - 19.6, BA%=0.0 - 12.2. Level three (31940806): RBC=0.0 - 10.54, HGB=0.0 - 32.6, HCT=0.0 - 96.4, PLT=0 - 1100, WBC=0.0 - 31.64, NE%=0.0 - 88.4, LY%=0.0 - 57.2, MO%=0.0 - 19.0, EO%=0.0 - 21.6, BA%=0.0 - 13.8. Serial #74897 (nursing lab instrument) The same issue with incorrect QC limits (% limits set at 100%) was observed for the nursing unit instrument for the lots that were still maintained in the instrument. Lot numbers 30940804, 30940805, 30940806, date from: 04/17/23, date to: 06/23/23. The limit range % was set at 100% for all analytes, resulting in QC ranges that approximated the ones observed for the laboratory instrument. Lot numbers 31940804, 31940805, 31940806, date from: 06/12/23, date to: 08/18/23. The limit range % was set at 100% for all analytes, resulting in QC ranges that approximated the ones observed for the laboratory instrument. Lot numbers 32050804, 32050805, 32050806, date from: 08/07 /23, date to: 09/27/23 (survey date). The limit range % was set at 100% for all analytes, resulting in QC ranges that approximated the ones observed for the laboratory instrument (see above). The QC limit range % for both instruments was corrected before the survey was concluded for all existing lots in the instruments. 3. Review of the Form CMS 116 revealed an estimated annual patient CBC test volume of 4963, resulting in approximately 2,480 patients reported during the period when incorrect QC ranges were in use. 4. Interview with the laboratory liaison on 09/27/23 at 5 pm confirmed the laboratory failed to ensure the control ranges in use on the laboratory instrument from 02/28/23 to the date of the survey on 09/27/23 were verified before placing into use, and failed to ensure the control ranges in use on the nursing instrument from 07/17/23 to the date of the survey on 09/27/23 were verified before placing into use. Word Key: Quality Control (QC) %=percent RBC=Red Blood Cell HGB=Hemoglobin HCT=Hematocrit PLT=Platelet WBC=White Blood Cell NE%=Neutrophil % LY%=Lymphocyte % MO%=Monocyte % EO% =Eosinophil % BA%=Basophil % 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 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 observation of the laboratory, review of the laboratory procedure manual, laboratory records, and interview with the laboratory liaison, the laboratory failed to follow the procedure for instrument comparison in 2019. The findings include: 1) Observation of the laboratory on January 16, 2020 at 8:45 a.m. revealed two complete blood (CBC) instruments in use for patient testing (serial numbers 74897 and 74898). 2) Review of the laboratory procedure manual revealed that comparisons between the instruments would be performed three times a year. 3) Review of laboratory records revealed comparisons between the two CBC instruments were not performed three times in 2019. 4) Interview with the laboratory liaison on January 16, 2020 at 2:00 p. m. confirmed the laboratory failed to follow the procedure for instrument comparison in 2019. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing attestation statements and interview with the operations manager, the laboratory failed to ensure attestation statements were signed by testing personnel and laboratory director in 2016, 2017, and 2018. The findings include: 1. Review of the laboratory's proficiency testing attestation statements revealed no signature of testing personnel for 2016 events one, two and three; 2017 events one, two and three; 2018 event one; no signature of the laboratory director for 2016 events one, two, and three, and 2017 events one and two. 2. Interview with the operations manager on June 5, 2018 at 2:30 pm confirmed the laboratory recorded the names of personnel responsible for the proficiency events but failed to obtain signatures of testing personnel and laboratory director on the proficiency testing attestation statements in 2016, 2017, and 2018. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of available laboratory records documenting quality assessment activities, review of the laboratory's quality assessment policy and interview with the operations manager the laboratory failed to retain quality assessment records for the complete blood count (CBC) laboratory for at least two years in 2016, 2017, and 2018. The findings include: 1. Review of available quality assessment records for the CBC laboratory revealed that no records were present for the last 2 years documenting laboratory director review of quality control for the CBC laboratory. 2. Review of the laboratory's policy titled "Quality Assurance Review" revealed the following statement "reviews are performed at least quarterly." Records for these reviews could not be located for 2016 quarters three and four, 2017 quarters one and two, and 2018 quarter one. 3. Interview with the operations manager on June 5, 2018 at 5:00 pm revealed the following: Quality control is printed off at regular intervals and is review by the laboratory director for acceptability, shifts and trends; however, those records cannot be located. The operations manager confirmed the laboratory failed to retain records documenting laboratory director review of quality control and quality assessment review documents for at least two years in 2016, 2017, and 2018. 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 observation of the laboratory, review of the Sysmex complete blood count (CBC) quality control package insert, and interview with the operations manager, the laboratory failed to ensure controls were labeled with open date and corrected expiration date in 2018. 1. Observation of the laboratory on June 5, 2018 at 12:15 pm revealed Sysmex CBC controls in the refrigerator in use for quality control testing that were not labeled with open date or corrected expiration date. 2. Review of the Sysmex CBC quality control package insert revealed that opened vials are stable for 14 days. 3. Interview with the operations manager on June 5, 2018 at 12:30 pm confirmed the laboratory failed to label controls with open date and corrected expiration date in 2018. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The laboratory director failed to ensure the quality control program was maintained -- 2 of 4 -- (refer to D6020) and failed to ensure the quality assessment program was maintained (refer to D6021) resulting in immediate jeopardy. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Sysmex XS-1000i operator's quick users guide, the document titled "Sysmex Evidence-Based Control Limits", the available complete blood count (CBC) instrument quality control (QC) records, the lack of laboratory director review of records, and interview with the operations manager, the laboratory director failed to ensure the quality control program was maintained in 2016, 2017, and 2018 resulting in immediate jeopardy. The findings include: 1. Observation of the laboratory on June 5, 2018 at 12:15 pm revealed the Sysmex XS-1000i CBC instrument in use for patient testing. 2. Review of the Sysmex quick users guide revealed the following for "new lot registration": For empty QC files the appropriate control level must be selected, the lot number manually entered and the 'limit range %" for each parameter entered. The information input must be verified. When reusing QC files, the old QC data is deleted, the lot number entered, and the limit range % must be verified for each parameter. 3. Review of the Sysmex quick users guide obtained from Siemens technical assistance center on June 7, 2018 at 5:13 pm revealed the following for establishing target values: "analyze each new control level once and compare to the assay sheet." "Analyze New Lot control at least 10 times before Auto Setting Targets." "Minimum of 5 days, 2 points per day." After auto setting the target "Verify that the values returned as your analyzer's target values fall within range for each parameter on the Assay Sheet." 4. Review of the Sysmex document titled "Sysmex Evidence-Based Control Limits" obtained from Siemens technical assistance center on June 7, 2018 at 5:13 pm revealed the following limit range % values for the red blood cell (RBC), hemoglobin (HGB), hematocrit (HCT), platelet (PLT) and white blood cell (WBC) analytes for the Sysmex XS 1000i instrument: Level 1 Level 2 Level 3 RBC 5.0 4.0 4.0 HGB 6.0 4.3 4.2 HCT 6.0 5.1 5.0 PLT 23.0 12.0 9.7 WBC 11.4 7.8 7.8 5. Review of the laboratory's available quality control records and instrument quality control settings for the Sysmex XS- 1000i revealed the following: Lot #s 62990804, 62990805, 62990806 Extremely wide QC limits. No documents available documenting verification of target and limit range % values. Review of the laboratory's report documenting peer comparison printed at the time of the survey revealed approximate in use dates from 11.21.2016 to 01.13.2017. Lot #s 80160804, 80160805, 80160806 Instrument QC setting for limit range % = 100% for RBC, HGB, HCT, PLT, WBC. No documents available documenting verification of target and limit range % value. Review of the laboratory's cumulative QC data reprinted from the instrument at the time of survey revealed in use dates from approximately 02.12.2018 to 04.06.2018. Lot # 80720804, expiration date 06.03.2018 Instrument QC setting for limit range % = 100% for RBC, HGB, HCT, PLT, WBC. No documents available documenting verification of target and limit range % values. Review of the laboratory's cumulative QC data reprinted from -- 3 of 4 -- the instrument at the time of survey revealed in use dates from approximately 04.09.2018 to 06.01.2018. 6. No records were available for the past two years to include: laboratory director review of quality control; documentation of verification of QC target compared to manufacturer's package insert; documentation of verification of QC limit range % compared to manufacturer's stated limit range % values; clear dates the QC lots were placed in use for patient testing. 7. Interview with the operations manager on June 5, 2018 at 9:00 pm revealed the following: The laboratory uses evidence based limits as recommended by the manufacturer, but was unsure what the correct limit range % value was suppose to be for each parameter. No document could be located that provided the manufacturer's correct limit range % value. The QC files used for maintaining the above lot numbers had incorrect limit range % values assigned. The laboratory director reviews the quality control cumulative data and statistics on a regular basis and the QC range in use is included on this report.The laboratory reports approximately 30 patient CBCs per day and a total of approximately 3400 patients could be affected by the period these lot numbers were in use. The operations manager confirmed the laboratory director failed to ensure the quality control program was maintained in 2016, 2017, and 2018. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review the policy titled "Quality Assurance Reviews," the document used for recording quality assessment reviews, and interview with the operations manager, the laboratory director failed to ensure the quality assessment program was maintained in 2016, 2017, and 2018 resulting in immediate jeopardy. The findings include: 1. Review of the policy titled "Quality Assurance Review" revealed the following statement: "These reviews are done at least quarterly." 2. Review of the documents used for recording quality assessment revealed the following: No quality assessment documents were available for the third and fourth quarter of 2016, the first and second quarter of 2017, and the first quarter in 2018. The quality assessments dated Aug 2017 and Dec 2017 were not signed by the laboratory director. 3. Interview with the operations manager on June 5, 2018 at 6:30 pm confirmed no quality assessment documents were available for third and fourth quarter of 2016, the first and second quarter of 2017, and the first quarter in 2018; there was no lab director signature on the reviews dated Aug 2017 and Dec 2017 and the laboratory director failed to ensure the quality assessment program was maintained in 2016, 2017, and 2018. -- 4 of 4 --