Immediate Care Foley

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, and an interview with the General Supervisor (GS), the laboratory failed to implement a mechanism to verify the accuracy of the D-Dimer test, a non-regulated analyte. The surveyor noted unsatisfactory PT evaluations occurred in two of the three events in 2025. The findings include: 1. A review of the 2025 AAB-MLE PT records revealed failing D- Dimer scores of 40 percent for the following events: A) Chemistry M2 2025 Event B) Chemistry M3 2025 Event 2. The GS confirmed the above findings during the exit conference on 11-19-2025 at 4:30 PM. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 reviews of the Abbott Cell-Dyn Hematology maintenance records, the Abbott Cell-Dyn Emerald Operator's manual, and an interview with the General Supervisor (GS), the laboratory failed to perform and document the semi-annual maintenance, as per manufacturer's instructions. There was no documentation the laboratory performed the required semi-annual maintenance the past 15 months since Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- the analyzer installation on 08-16-2024. The findings include: 1. A review of the Hematology maintenance records revealed the Abbott Cell-Dyn Emerald analyzer had no documentation of the semi-annual maintenance from the date of installation, 08-16- 2024 through date of the current survey, 11-19-2025. 2. A review of the Cell-Dyn Emerald Operator's manual revealed on page 9-13, "Section 9: Service and Maintenance ...Semi-Annual Maintenance - Lubricating the Pistons...". 3. The GS confirmed the above findings during the exit conference on 11-19-2025 at 4:30 PM. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following: This STANDARD is not met as evidenced by: Based on reviews of the i-STAT maintenance logs, the ABBOTT i-STAT System Manual and an interview with the General Supervisor (GM), the laboratory failed to perform and document function checks required by the manufacturer every six months on the i-STAT analyzer from the previous survey on 05-24-2023 to the current survey on 11-19-2025. The findings include: 1. A review of the i-STAT maintenance logs revealed no documentation of the manufacturer's required function checks for the Thermal Probe every six months. 2. A review of the i-STAT System Manual on page 14-17 revealed the following: "...Thermal Probe Check: Check the thermal probes on the i-STAT 1 Analyzer as follows: ...4. Interpretation of the thermal probe check value: Acceptable: a value from -0.1 to +0.1, inclusive... Documentation of Results: ... use the form included in this section of the manual to record the results." 3. The laboratory was unable to provide documentation of the thermal probes checks during the survey. 4. During the exit conference on 11-19-2025 at 4:30 PM, the GM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of off-site proficiency testing (PT) desk review of scores in the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and verified with the laboratory's proficiency testing provider, AAB-Medical Laboratory Evaluation (AAB- MLE). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director . D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from AAB-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Creatine Kinase, isoenzyme (CK- MB), an analyte in the specialty of Chemistry. The laboratory failed two consecutive 2025 PT events, resulting in initial unsuccessful proficiency testing performance. Refer to D2096. . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from AAB-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Creatine Kinase, isoenzyme (CK- MB). The laboratory failed two consecutive 2025 PT events, resulting in initial unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Reports revealed the laboratory received failing scores for CK-MB in two consecutive AAB-MLE PT events, as follows: A) 2025 M1: CK-MB 20% B) 2025 M2: CK-MB 40% 2. A review of the laboratory's proficiency testing evaluation reports from the AAB-MLE website confirmed these findings. . 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: Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from AAB- Medical Laboratory Evaluation (AAB-MLE), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D6016. . D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from AAB-Medical Laboratory Evaluation (AAB-MLE), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for Creatine Kinase, isoenzyme (CK-MB) for two consecutive 2025 PT events. Refer to D2096. . -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on February 14, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing records (graded copies from the AAB-Medical Laboratory Evaluation (MLE) and the CASPER report 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 2 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- /14/2024, the laboratory failed to maintain satisfactory performance in four of seven testing events (2021-Event 3, 2022-Event 2 and 2023-Events 2 & 3) resulting in unsuccessful participation for Platelets analyte. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing records (graded copies from the AAB-MLE and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 2/14/2024, the laboratory failed to achieve satisfactory performance for Platelets in four of seven testing events in 2023. Findings include: 1. A review of the laboratory records from the the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for Platelets: Year 2021 - 3rd Event: 60% Year 2022 - 2nd Event: 60% Year 2023 - 2nd Event: 20% Year 2023 - 3rd Event: 60% 2. A review of the AAB-MLE proficiency testing records confirmed the laboratory received the above results. 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: Based on surveyor desk review of the laboratory proficiency testing records (graded copies from the AAB-MLE and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 2/14/2024, the laboratory director failed to provide overall management and direction of laboratory services as required under Subpart H. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing records (graded copies from the AAB-MLE and CASPER report 0153D/0155D from the Centers for -- 2 of 3 -- Medicare and Medicaid Services data system) on 2/14/2024, the laboratory director failed to ensure successful participation in an HHS approved proficiency program. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) Records, a review of the Form CMS- 209 Laboratory Personnel Report, and an interview with Testing Personnel #1, the laboratory failed to ensure Proficiency Testing samples were rotated among all personnel who performed patient testing. This was noted for three out of three PT events reviewed. The findings include: 1. A review of Medical Laboratory Evaluation records revealed Testing Personnel #1 performed all PT for events 2022 M2, 2022 M3, and 2023 M1. 2. A review of the CMS-209 Laboratory Personnel Report revealed five Testing Personnel who performed non-waived patient testing. 3. During an interview on 5/24/2023 at 11:30 PM, Testing Personnel #1 confirmed the above findings. 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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the CMS (Centers for Medicare and Medicaid) CASPER reports and (Medical Laboratory Evaluation) MLE Proficiency Testing (PT) reports, the surveyor determined the laboratory failed to successfully participate in PT for Platelets for two of three events, Event #3, 2021 and Event #2, 2022. These failures resulted in an initial unsuccessful PT participation. The findings include: Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on a review of the CMS (Centers for Medicare and Medicaid) CASPER reports and (Medical Laboratory Evaluation) MLE Proficiency Testing (PT) reports, the surveyor determined the laboratory failed to satifactorily perform in PT for Platelets for two of three events, Event #3, 2021 and Event #2, 2022. These failures resulted in an initial unsuccessful PT participation. The findings include: 1. A review of the CASPER report #155 revealed the laboratory scored the following for Platelets: a) 60 % for Event #3, 2021 b) 60 % for Event #2, 2022 2. The surveyor's review of the MLE PT reports confirmed the laboratory scored 60 % for Platelets for Event 2021 MLE 3 and Event 2022 MLE 2, resulting in an initial unsuccessful PT participation. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on reviews of the validation records for the non-waived "Chem 8+" cartridge (used for the determination of Sodium [Na], Potassium [K], Chloride [Cl], Carbon Dioxide [CO2], Blood Urea Nitrogen [BUN], Creatinine and ionized Calcium [iCa]) on the I-Stat analyzer, and an interview with Testing Personnel #1, the laboratory failed to ensure the manufacturer's performance specifications for precision were verified, and the Laboratory Director's review and approval of the validation was documented as indicated by signature and date after the test was deemed moderate- complexity by the FDA (Food and Drug Administration) in 2020. This affected one of one new non-waived tests implemented since the previous survey. The findings include: 1. A review of the poorly organized "I-Stat" binder revealed validation studies for the Chem 8+ cartridge were mixed in with other records. The surveyor noted the Chem 8+ procedure at the front of the binder with a note from the previous technical consultant, "validation completed 6/2020" [June 2020]. The Laboratory Director had initialed the page with the dates, "2/20/20" and "2022". 2 The surveyor located the data for Quality Control Level 1 runs from 5/15 thru 5/24/2020 (ten days). However, there was no documentation the data was analyzed and evaluated to confirm the precision of the analytes, as stated in the manufacturer's performance specifications. In a different section of the binder, the surveyor located a Calibration Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Verification performed on 6/11/2020 (which may have been used to establish Reportable Range and Accuracy). There was no indication the Laboratory Director had reviewed any of the above documentation after the validation testing was performed. 3. During an interview on 4/26/2022 at 5:30 PM, Testing Personnel #1 confirmed she had no other records for the Chem 8+ validation. . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of calibration verification (C/V) records for the non-waived "Chem 8+" cartridge (used for the determination of Sodium [Na], Potassium [K], Chloride [Cl], Carbon Dioxide [CO2], Blood Urea Nitrogen [BUN], Creatinine and ionized Calcium [iCa]) on the I-Stat analyzer, and an interview with Testing Personnel #1, the laboratory failed to perform one of two 2021 C/V's. The findings include: 1. A review of the records for the non-waived I-Stat Chem 8+ cartridge revealed the laboratory performed a three-level C/V on 6/19/2021. However, there was no indication the C/V due the second half of 2021 was performed. 2. During an interview on 4/26/2022 at 5: 30 PM, Testing Personnel #1 searched the December 2021 records, and confirmed she had no documentation for the second 2021 C/V. . 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the records for the non-waived "Chem 8+" cartridge (used for the determination of Sodium [Na], Potassium [K], Chloride [Cl], Carbon Dioxide [CO2], Blood Urea Nitrogen [BUN], Creatinine and ionized Calcium [iCa]) on the I- Stat analyzer, and an interview with Testing Personnel #1, the laboratory failed to ensure a valid IQCP (Individualized Quality Control Plan) which included the Laboratory Director's review and approval (as indicated by signature and date) was in effect after the test was deemed moderate-complexity by the FDA (Food and Drug Administration) in 2020. This affected one of one new non-waived tests implemented since the previous survey. The findings include: 1. A review of QC records for the non-waived I-Stat Chem 8+ cartridge revealed the laboratory had implemented an IQCP to reduce the frequency of QC testing to every 30 days and with each new lot number/shipment. The approval page for the I-Stat IQCP and page three of the IQCP procedure with spaces for the Laboratory Director's signature and date were both blank. The surveyor noted the Laboratory Director's initials (with no date) toward the bottom of page two of three of the I-Stat IQCP procedure, however it was unclear whether this indicated approval. 2. During an interview on 4/26/2022 at 5:00 PM, the surveyor and Testing Personnel #1 reviewed the above documents; Testing Personnel #1 then stated the laboratory did have the Laboratory Director's approval of the IQCP. However, the IQCP approval page Testing Personnel #1 provided was for the Triage Meter at another facility in Mobile; the laboratory was unable to provide documentation of the Laboratory Director's approval of the I-Stat Chem 8+ IQCP. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of CMS CASPER Reports (#153/#155) and a review of MLE (Medical Laboratory Evaluation) proficiency testing records, the surveyor determined the laboratory failed to successfully participate in proficiency testing for Platelets (Hematology) for Events #2 and #3 of 2019. The laboratory scored sixty percent (60 %) for the platelet count for these two consecutive testing events, resulting in an initial unsuccessful proficiency testing participation. The findings include: 1. A review of the CASPER Reports revealed the laboratory scored 60 % for the platelet Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- count for two consecutive testing events, Events #2 and #3 of 2019. 2. The surveyor's review of the MLE proficiency testing records confirmed the laboratory's scores as mentioned in paragraph 1. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of CMS CASPER Reports (#153/#155) and a review of MLE (Medical Laboratory Evaluation) proficiency testing records, the surveyor determined the laboratory failed to satisfactorily perform in proficiency testing for Platelets (Hematology) for Events #2 and #3 of 2019. The laboratory scored sixty percent (60 %) for the platelet count for these two consecutive testing events, resulting in an initial unsuccessful proficiency testing participation. The finding include: Refer to D2016. -- 2 of 2 --

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 a review of the MLE (Medical Laboratory Evaluation) proficiency testing records for Hematology and Chemistry, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure the Laboratory Director (or qualified delegee) signed the attestation statements for testing events; 2018 MLE M3 and 2019 MLE M2. This affected two of six testing events reviewed by the surveyor. The findings include: 1. A review of the MLE proficiency testing records revealed the Laboratory Director [or qualified delegee (technical consultant)] had not signed the attestation statements for Event 2018 MLE M3 and Event 2019 MLE M2. 2. In an interview on October 3, 2019 at 12:30 PM, the surveyor asked TP #1 to review the proficiency testing manuals for the attestation statements for Event M3 of 2018 and M2 of 2019. TP #1 reviewed the attestation statements (manuals), and confirmed the Laboratory Director (nor a qualified delegee) had signed. TP #1 stated there's usually a copy, since she has to sent the statements to another location for the director to sign. However, signed attestation statements (by the Laboratory Director) for the above mentioned events were not found during the survey review. 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 --