Jorge Mazzini Md

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) (c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the Casper Report 155 Individual Laboratory Profile, proficiency testing records for 2024 and interview of facility personnel, the laboratory failed to participate in one of three proficiency testing events for the specialty of Hematology. The findings include: 1. Review of the Casper Report 155 Individual Laboratory Profile found the laboratory received a score of 0% in the 2024 third testing event for Hematology. 2 A review of the American Proficiency Institute (API) proficiency testing records found no documentation of

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the HemoCue Hb 201 Microcuvettes, surveyor observation of microcuvettes currently in use in the laboratory, and staff interview, it was revealed the laboratory failed to have documentation of monitoring the revised expiration date of the microcuvettes once the package was opened. The findings include: 1. A review of the manufacturer's instructions for the HemoCue Hb 201 Microcuvettes (151712140726) under the section titled "Storage and Handling" revealed: "Once the seal is broken the microcuvettes are stable for three months." 2. Surveyor observation of the microcuvettes currently in use revealed the laboratory failed to have documentation of when the microcuvettes were opened or when the microcuvettes would expire based the the manufacturer's instructions. 3. An interview with the technical consultant on 01 /18/2023 at 1100 hours in the exam room - after his review of the records- confirmed the findings. 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 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 -- 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 review of the laboratory's submitted Form CMS 209, review of the laboratory's American Proficiency Institute's proficiency testing records from 2022, and staff interview, it was revealed the laboratory failed to ensure 1 of 3 testing personnel participated in proficiency testing. The findings include: 1. A review of the laboratory's submitted Form CMS 209 revealed the laboratory identified 3 testing personnel. 2. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2022 revealed 1 of 3 testing personnel did not participate in proficiency testing. They were (as listed on Form CMS 209): Testing personnel number 3 3. The laboratory was asked to provide documentation on testing personnel number 3 participating in proficiency testing. No documentation was provided. 4. An interview with the technical consultant on 01/18/2023 at 940 hours in the exam room - after his review of the records- confirmed the findings. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute's proficiency testing records from 2022, and staff interview, it was revealed the laboratory failed to testing proficiency testing samples the same number of time it tested patient samples. The findings include: 1. A review of the laboratory' American Proficiency Institute's proficiency testing records from 2022 (Events 1, 2, and 3) revealed the laboratory tested each proficiency sample twice. The dates and times of each were as follows: a) Event 1 Sample Date/Time HSY-1 3/24 11:20 3/24 11:33 HSY-2 3/24 11:23 3/24 11: 35 HSY-3 3/24 11:24 3/24 11:37 HSY-4 3/24 11:27 3/24 11:40 HSY-5 3/24 11:30 3 /24 11:42 b) Event 2 HSY-6 7/21 10:27 7/21 10:38 HSY-7 7/21 10:30 7/21 10:40 HSY-8 7/21 10:32 7/21 10:42 HSY-9 7/21 10:32 7/21 10:45 HSY-10 7/21 10:36 7/21 10:47 c) Event 3 HSY-11 11/28 18:22 11/28 18:32 HSY-12 11/28 18:24 11/28 18:33 HSY-13 11/28 18:26 11/28 18:35 HSY-14 11/28 18:28 11/28 18:37 HSY-15 11/28 18: 30 11/28 18:38 2. An interview with the technical consultant on 01/18/2023 at 0935 hours in the exam room revealed the laboratory did not routinely test patient samples in duplicate. This confirmed the findings. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such -- 2 of 3 -- timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's test menu, review of the laboratory's patient test logs from July 2022 to December 2022, and staff interview, it was revealed the laboratory failed to have documentation of reporting 129 of 129 positive Covid Antigen results to the State/local authorities as required. The findings include: 1. A review of the laboratory's test menu revealed the facility started performing Covid Antigen testing utilizing the Lumira DX SARS-CoV-2 Ag test in February 2022. 2. A review of the laboratory's patient test logs from July 2022 to December 2022 revealed the laboratory had a total of 129 positive Lumira DX SARS-CoV-2 Ag results. The numbers, by month, were: July 2022 28 positive August 2022 44 positive September 2022 18 positive October 2022 10 positive November 2022 8 positive December 2022 21 positive 3. The laboratory was asked to provide documentation of positive results being reported to the State/local authorities and of a policy stating how and when positive results were to be reported. No documentation was provided. 4. An interview with testing personnel number 1 (as listed on Form CMS 209) on 01/18/2022 at 1115 hours in the exam room revealed she did not have documentation of positive results being reported as required. This confirmed the findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the Medonic M-series hematology analyzer, review of the laboratory's maintenance records from January 2022 to December 2022, and staff interview, it was revealed the laboratory failed to have documentation of performing 8 of 26 biweekly maintenances and 1 of 4 Three Month maintenances. The findings include: 1. A review of the manufacturer's instructions for the Medonic M-series hematology analyzer revealed the following maintenance was required: a) Every two weeks Clean Aspiration Probe Aspirate Sol. No.2 in PD Aspirate Diluent in PD Perform Clean Orifice x 3 Clot Prevention Run Background b) 3 Month Cleaning Hypochlorite 2% Enzymatic Cleaner Detergent Cleaner 2. A review of the laboratory's Medonic M-series maintenance records from January 2022 to December 2022 revealed the laboratory was missing documentation of the following maintenances: a) Every two weeks Missing: 3/3 4/21 6/24 8/14 9/8 10 /14 12/1 12/19 b) 3 Month Cleaning Missing: November 2022 3. The laboratory was asked to provide documentation of the missing maintenance. No documentation was provided. 4. An interview with the technical consultant on 01/18/2023 at 1030 hours in the exam room - after his review of the records- confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the HemoCue Hb 201 Microcuvettes, surveyor observation of microcuvettes currently in use in the laboratory, and staff interview, it was revealed the laboratory failed to have documentation of monitoring the revised expiration date of the microcuvettes once the package was opened. The findings include: 1. A review of the manufacturer's instructions for the HemoCue Hb 201 Microcuvettes (151712140726) under the section titled "Storage and Handling" revealed: "Once the seal is broken the microcuvettes are stable for three months." 2. Surveyor observation of the microcuvettes currently in use revealed the laboratory failed to have documentation of when the microcuvettes were opened or when the microcuvettes would expire based the the manufacturer's instructions. 3. An interview with the technical consultant on 01 /18/2023 at 1100 hours in the exam room - after his review of the records- confirmed the findings. 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 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 -- 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 review of the laboratory's submitted Form CMS 209, review of the laboratory's American Proficiency Institute's proficiency testing records from 2022, and staff interview, it was revealed the laboratory failed to ensure 1 of 3 testing personnel participated in proficiency testing. The findings include: 1. A review of the laboratory's submitted Form CMS 209 revealed the laboratory identified 3 testing personnel. 2. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2022 revealed 1 of 3 testing personnel did not participate in proficiency testing. They were (as listed on Form CMS 209): Testing personnel number 3 3. The laboratory was asked to provide documentation on testing personnel number 3 participating in proficiency testing. No documentation was provided. 4. An interview with the technical consultant on 01/18/2023 at 940 hours in the exam room - after his review of the records- confirmed the findings. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute's proficiency testing records from 2022, and staff interview, it was revealed the laboratory failed to testing proficiency testing samples the same number of time it tested patient samples. The findings include: 1. A review of the laboratory' American Proficiency Institute's proficiency testing records from 2022 (Events 1, 2, and 3) revealed the laboratory tested each proficiency sample twice. The dates and times of each were as follows: a) Event 1 Sample Date/Time HSY-1 3/24 11:20 3/24 11:33 HSY-2 3/24 11:23 3/24 11: 35 HSY-3 3/24 11:24 3/24 11:37 HSY-4 3/24 11:27 3/24 11:40 HSY-5 3/24 11:30 3 /24 11:42 b) Event 2 HSY-6 7/21 10:27 7/21 10:38 HSY-7 7/21 10:30 7/21 10:40 HSY-8 7/21 10:32 7/21 10:42 HSY-9 7/21 10:32 7/21 10:45 HSY-10 7/21 10:36 7/21 10:47 c) Event 3 HSY-11 11/28 18:22 11/28 18:32 HSY-12 11/28 18:24 11/28 18:33 HSY-13 11/28 18:26 11/28 18:35 HSY-14 11/28 18:28 11/28 18:37 HSY-15 11/28 18: 30 11/28 18:38 2. An interview with the technical consultant on 01/18/2023 at 0935 hours in the exam room revealed the laboratory did not routinely test patient samples in duplicate. This confirmed the findings. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such -- 2 of 3 -- timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's test menu, review of the laboratory's patient test logs from July 2022 to December 2022, and staff interview, it was revealed the laboratory failed to have documentation of reporting 129 of 129 positive Covid Antigen results to the State/local authorities as required. The findings include: 1. A review of the laboratory's test menu revealed the facility started performing Covid Antigen testing utilizing the Lumira DX SARS-CoV-2 Ag test in February 2022. 2. A review of the laboratory's patient test logs from July 2022 to December 2022 revealed the laboratory had a total of 129 positive Lumira DX SARS-CoV-2 Ag results. The numbers, by month, were: July 2022 28 positive August 2022 44 positive September 2022 18 positive October 2022 10 positive November 2022 8 positive December 2022 21 positive 3. The laboratory was asked to provide documentation of positive results being reported to the State/local authorities and of a policy stating how and when positive results were to be reported. No documentation was provided. 4. An interview with testing personnel number 1 (as listed on Form CMS 209) on 01/18/2022 at 1115 hours in the exam room revealed she did not have documentation of positive results being reported as required. This confirmed the findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the Medonic M-series hematology analyzer, review of the laboratory's maintenance records from January 2022 to December 2022, and staff interview, it was revealed the laboratory failed to have documentation of performing 8 of 26 biweekly maintenances and 1 of 4 Three Month maintenances. The findings include: 1. A review of the manufacturer's instructions for the Medonic M-series hematology analyzer revealed the following maintenance was required: a) Every two weeks Clean Aspiration Probe Aspirate Sol. No.2 in PD Aspirate Diluent in PD Perform Clean Orifice x 3 Clot Prevention Run Background b) 3 Month Cleaning Hypochlorite 2% Enzymatic Cleaner Detergent Cleaner 2. A review of the laboratory's Medonic M-series maintenance records from January 2022 to December 2022 revealed the laboratory was missing documentation of the following maintenances: a) Every two weeks Missing: 3/3 4/21 6/24 8/14 9/8 10 /14 12/1 12/19 b) 3 Month Cleaning Missing: November 2022 3. The laboratory was asked to provide documentation of the missing maintenance. No documentation was provided. 4. An interview with the technical consultant on 01/18/2023 at 1030 hours in the exam room - after his review of the records- confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the conditions of participation found in the CLIA regulations at 42 CFR 493 and recertification is recommended. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of the laboratory's proficiency testing records, and staff interview, it was revealed the laboratory failed to test proficiency samples in the same manner it tested patient samples. The findings were: 1. A review of the laboratory's Proficiency Testing policy approved by the laboratory director on May 20, 2003 stated: "PT specimens are to be treated the same as patient samples. The lab should document all steps taken in PT performance." 2. A review of the laboratory's Critical Values policy approved by the laboratory director on February 13, 2013 stated WBC: 2000 - 20,000 HGB: 7.5 - 18 HCT: 25 - 55 Platelets: 50,000 - 800,000 3. When the primary testing person was asked in interview on September 8, 2021 at 09:30 hours if the laboratory's routine practice was to repeat patient critical values for confirmation, she stated, "Yes." Review of instrument printouts from the Medonic M series hematology analyzer from May 2021 to September 2021 confirmed that the laboratory routinely repeated critical values for the hematology analytes WBC, HGB, HCT, and Platelets. 4. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2019 (events 1, 2, and 3), 2020 (events 1, 2, and 3), and 2021 (events 1 and 2) revealed the laboratory failed to test proficiency samples the same number of times it tested patient samples: 03-28-2019 HSY-01 HGB: 5.9 Not repeated 07-24-2019 HSY-08 HGB: 6.0 Not repeated 11-27- 2019 HSY-12 HGB: 6.1 HCT: 18.1 Not repeated 11-27-2019 HSY-13 HGB: 18.5 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 -- HCT: 57.1 03-26-2020 HSY-03 HGB: 2.1 HCT: 18.3 07-27-2020 HSY-06 HGB: 18.8 HCT: 55.4 11-24-2020 HSY-14 HGB: 6.2 HCT: 17.7 03-31-2021 HSY-02 HGB: 7.1 HCT: 20.8 03-31-2021 HSY-03 HGB: 18.2 HCT: 57.5 08-04-2021 HSY-08 HGB: 6.2 HCT: 18.8 5. An interview with the technical consultant on 09/08/2021 at 09:40 hours in the office after his review of the records confirmed the findings. Key: PT - proficiency testing WBC - white blood cell HGB: hemoglobin HCT: hematocrit PLT - platelets -- 2 of 2 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor observation, review of manufacturer's instructions, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions for storage of Rapid Strep A Consult Diagnostics test kits. The findings were: 1. Surveyor observation at 09:10 hours during a tour of the facility found 1 box of unopened Rapid Strep A Consult Diagnostics test kits (lot #STA8080074, expiration date: 8-31-2020) located in the storage closet. No means of monitoring the temperature of the room was observed. 2. Review of the manufacturer's instructions located on the outside of the kit packing stated the storage temperature of the kit was, "36-86 degrees Fahrenheit or 2-30 degrees Celsius." 3. Interview of testing personnel #2 (as listed on Form CMS-209) on March 6, 2019 at 09:15 hours in the patient exam room confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services 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 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 -- 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 laboratory policy, review of proficiency testing records, and confirmed in interview of facility personnel, the laboratory failed to retain proficiency testing records for 2 years. The findings were: 1. Review of the laboratory's policy titled, "Proficiency Testing" approved by the laboratory director on May 20, 2013, stated, " ...All records and reports will be maintained for two years." 2. Review of the laboratory's American Proficiency Institute (API) proficiency testing records from 2017 (events 1, 2, and 3) and 2018 (events 1, 2, and 3) revealed the laboratory failed to retain the instrument printouts for 2017 (event 2). 3. Review of the laboratory's American Proficiency Institute (API) proficiency testing records from 2017 (events 1, 2, and 3) and 2018 (events 1, 2, and 3) revealed the laboratory failed to retain the Comparative Evaluation for 2017 (event 2). 4. The facility attempted to retrieve the records from the analyzer but the records were no longer available in the instrument. The laboratory was unable to successfully retrieve the instrument print outs on March 6, 2019. 5. Interview with the technical consultant on March 6, 2019 at 10:25 hours in the patient exam room confirmed the findings. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of the laboratory's American Proficiency Institute (API) proficiency testing results from 2017 and 2018, and confirmed in interview of facility personnel, the laboratory failed to have documentation of evaluating proficiency testing results returned by the proficiency testing agency as "Not Graded." The findings were: 1. This is a repeat deficiency from the survey dated January 3, 2017. 2. A review of the laboratory's API proficiency testing records from 2017 (events 1, 2, and 3) and 2018 (events 1, 2, and 3) revealed the following results were returned as "Not Graded (No Consensus)": 2017 - Hematology (event 2) Sample ID: HEM-07 Reported Result (Monocytes): 13.7 Grade: "Not Graded (No Consensus) 2017 - Hematology (event 2) Sample ID: HEM-10 Report Result (Monocytes): 12.1 Grade: "Not Graded (No Consensus) 3. An interview with the technical consultant on March 6, 2019 at 10:30 hours in the patient exam room confirmed the findings. Key: HEM - hematology 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 -- 2 of 6 -- 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 observation, review of the manufacturer's instructions, and confirmed in interview of facility personnel, the laboratory failed to have documentation of monitoring the room temperature where laboratory supplies were stored. The findings were: 1. Surveyor observation made on March 6, 2019 at 09:10 hours during the initial tour of the facility revealed no means to monitor the room temperature of the facility's storage closet. 2. Direct observation of supplies stored in the facility's storage closet revealed the following items: a. BD red top Vacutainer tubes (lot 8226915): quantity of 30 tubes b. BD yellow top Vacutainer tubes (lot 8278849): quantity of 25 tubes c. Boule Cleaning Kit (lot 7508): quantity of 1 opened kit 3. A review of the manufacturer's instructions located on package labeling for the BD Vacutainer blood collection tubes revealed the manufacturer required the tubes to be stored at a temperature range of "4 - 25C". 4. A review of the manufacturer's instructions for Boule Cleaning Kit located on package labeling revealed the manufacturer required the kit to be stored at "15-30 degrees Celsius." 5. Interview with testing person #2 (as listed on Form CMS-209) on March 6, 2019 at 09:15 hours in the patient exam room confirmed the findings. Key BD - Becton Dickinson CMS - Centers for Medicare and Medicaid Services 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 laboratory policy, review of manufacturer's instructions, review of maintenance records, and confirmed in interview of facility personnel, the laboratory failed to ensure reagents were not used after their expiration date. The findings were: 1. Review of the laboratory's policy titled, "Instrument Operation and Maintenance" approved by the laboratory director on May 20, 2003, it stated, " ...Maintenance of each piece of laboratory instrumentation shall be in accordance with the manufacturer's recommendations ..." 2. Review of the manufacturer's instructions for the Boule Cleaning Kit (11452-1, 2009-03-10) under, "Contents" it stated, "The contents can be used for three full and complete cleaning cycles. Remaining cleaning solution should be disposed of." 3. Review of maintenance records from January 2018 to March 2019 revealed the laboratory performed maintenance on the Medonic hematology analyzer using Boule Cleaning Kit opened on 02-29-2018 as follows: April 24, 2018 June 29, 2018 November 2, 2018 March 5, 2019 4. The maintenance procedure performed on March 5, 2019 was performed using expired reagents. 5. An interview with testing personnel #1 (as listed on Form CMS-209) on March 6, 2019 at 09:30 hours in the patient exam room confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) -- 3 of 6 -- Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of manufacturer's instructions, review of calibration records, and confirmed in interview of facility personnel, the laboratory failed to perform complete calibration procedures. The findings were: 1. Review of laboratory policy titled, "Instrument Operation and Maintenance" approved by the laboratory director on May 20, 2003, it stated, "Calibration of all laboratory instruments will be every six months, every time there is a complete change in lot numbers, or when controls don't give desired results. Calibrations have to be done more frequently if the manufacturer indicates it. 2. Review of the manufacturer's instructions for the Medonic M-series hematology analyzer (Article No. 1504248, May 2009) under, "Section 7: Calibration" it stated, "This section describes the step- by-step procedure for calibration of the Medonic M-Series." 3. Review of the laboratory's calibration records from January 2017 to December 2018 revealed the laboratory perform instrument calibrations as follows: January 24, 2017 April 14, 2017 July 25, 2017 October 11, 2017 January 17, 2018 April 25, 2018 August 1, 2018 December 31, 2018 4. Review of post-calibration records revealed that calibrations for the following dates were incomplete: October 11, 2017 The laboratory failed to calibrate all analytes: MCV (previous calibration 07/25/2017) PLT (previous calibration 07/25/2017) MPV (previous calibration 07/25/2017) HGB (previous calibration 07/25/2017) WBC (previous calibration 07/25/2017) January 17, 2018 The laboratory failed to calibrate all analytes: MCV (previous calibration 07/25/2017) PLT (previous calibration 07/25/2017) MPV (previous calibration 07/25/2017) HGB (previous calibration 07/25/2017) WBC (previous calibration 07/25/2017) December 31, 2018 The laboratory failed to calibrate all analytes: MCV (previous calibration 08 /01/2018) MPV (previous calibration 08/01/2018) HGB (previous calibration 08/01 /2018) WBC (previous calibration 08/02/2018) 5. Interview of the technical consultant on March 6, 2019 at 11:30 hours in the patient exam room confirmed the findings. He agreed the calibrations were incomplete. D6012 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(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)(3) Ensure that-- (e)(3)(ii) The test methodologies selected have the capability of providing the quality of results required for patient care; -- 4 of 6 -- This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of the Medonic Patient Sample Summary Report, review of patient final reports, and confirmed in interview of facility personnel, the laboratory director failed to ensure the laboratory's methodologies provide quality results. The findings were: 1. Review of the laboratory's policy titled, "