Rheumatology Associates Of Balto Llc

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing provider. The facility was found to be out of compliance with the following conditions of the CLIA program: 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: Based on desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting 0155D report and American 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 3 -- Institute, the laboratory failed to successfully participate in an approved PT program for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of hematology for hematocrit and red blood cell count. Refer to D2130 and D2131. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and the proficiency testing (PT) comparative evaluation report from American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for the same hematology analytes in two out of three consecutive PT events. Findings: 1. Review of the CASPER 0155D report revealed the following results. a. Red blood cell count i. 40% in the 2024 3rd event ii. 60% in the 2025 2nd event b. Hematocrit i. 40% in the 2024 3rd event ii. 0% in the 2025 2nd event 2. Review of the API comparative evaluation report confirmed the CASPER 0155D report results. D2131 HEMATOLOGY CFR(s): 493.851(g) (g) Failure to achieve an overall testing event score of satisfactory performance for 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and the proficiency testing (PT) comparative evaluation report from American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for hematology in two out of three consecutive PT events. Findings: 1. Review of the CASPER 0155D report showed that the laboratory received an overall hematology score of 61% in the 2024 3rd event and 76% in the 2025 2nd event. 2. Review of the API comparative evaluation report confirmed the CASPER 0155D report 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 desk review of proficiency testing (PT) records from the Certification and -- 2 of 3 -- Survey Provider Enhanced Reporting 0155D report and American Proficiency Institute, the laboratory director failed to ensure proficiency testing samples were tested as required. 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; This STANDARD is not met as evidenced by: Based on desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting 0155D report and American Proficiency Institute, the laboratory director failed to ensure proficiency testing (PT) samples were tested as required. The laboratory director failed to ensure successful participation in an approved PT program. Cross-refer to D2130 and D2131. -- 3 of 3 --

Summary Statement of Deficiencies D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on observation in the laboratory, proficiency testing (PT) records, review of the procedures, and interview with the technical consultant (TC) and the laboratory director (LD), the laboratory failed to verify the accuracy of the review for uric acid crystals from synovial fluid collected at the laboratory for review and interpretation. Findings: 1. During the tour of the laboratory the surveyor observed a microscope. The LD was interviewed and he stated that the microscope was used to identify uric acid crystals in the synovial fluid and the results were recorded on the patient's chart. 2. The PT records showed that there were no comparisons performed twice a year to verify accuracy of the testing. The procedure manuals did not have a procedure for how to identify and record the findings of a synovial fluid. 3. During the survey on 06 /12/2025 at 12:15 PM, the TC confirmed that the laboratory was not performing split samples for the verification of uric acid crystals from synovial fluid and there was no procedure for how to identify and record the findings of a synovial fluid. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical 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 -- consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the "Rheumatology Associates of Baltimore Director Responsibility- Delegation of Function" procedure, record review and interview with the technical consultant (TC), the laboratory director (LD) failed to ensure that all records were reviewed in tandem with the LD designee as part of their training. Findings: 1. The delegated responsibilities from the LD to the medical director (MD) in the "Rheumatology Associates of Baltimore Director Responsibility- Delegation of Function" procedure states, "Laboratory Director, I delegate the following to a Medical Director: 6. Review all Laboratory documents and activities at least once a month with the Laboratory Technical Consultant" 2. The Monthly "Lab Director Review of Documents" worksheets from January 2024 through May 2025 were reviewed and three of seventeen months were not reviewed by the LD listed on the CLIA certificate of compliance. Proficiency testing and competency from January 2024 through May 2025 showed that half were not reviewed by the LD listed on the CLIA certificate of compliance. 3. During the survey on 06/12/2025 at 12:15 PM, the TC and LD confirmed that while training the LD designee, all of the laboratory records were not reviewed in tandem to ensure that the LD designee received the continuous training to eventually qualify as a CLIA LD. -- 2 of 2 --

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 proficiency testing (PT) record review and interview with the technical consultant (TC), the laboratory did not ensure that all the testing personnel (TP) who tested patient samples performed the PT. Findings: 1. The laboratory currently has four TP listed on the "Laboratory Personnel Report" (CMS-209) who perform hematology, chemistry, and immunology testing. Three of the four TP have performed laboratory testing since 2021. One TP recently ceased testing in the laboratory and was not included on the current CMS-209, but was employed during the PT testing events reviewed in 2022 and 2023. 2. A review of hematology, chemistry, and immunology PT attestation worksheets from 2022 and 2023 showed that PT was performed by the same TP who recently left the lab for four of four events in hematology, five of five events in chemistry, and four of four events in immunology. 3. During an interview on 07/20/2023 at 1:30 PM, the TC confirmed that PT samples were not tested each year by all the staff who perform patient testing to ensure accurate and reliable patient test results. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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. 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 -- This STANDARD is not met as evidenced by: Based on quality control (QC), instrument, and patient record review and interview with the technical consultant (TC), the laboratory failed to retain analytic systems and patient records for at least two years. Findings: 1. A review of analytic records showed that the laboratory did not have instrument printouts and intermediate records of all QC and patients run in the last two years. During an interview at 1:30 PM on the day of the survey, the TC stated that the laboratory discards the instrument printouts after keeping them for a few weeks. 2. Upon investigation the TC stated that the hematology instrument printouts for patients and QC were available for May 2023 to present. The hematology analyzer maintained an electronic copy of QC and patient runs from January 2023 to present. No record of individual QC and patient runs were available before January 2023. 3. The TC also stated that the chemistry instrument printouts for QC and calibrations performed were available for May 2023 through present, however that the chemistry analyzer did not print out individual patient runs. The TC stated that the chemistry analyzer's internal memory was capable of storing 2000 reports, but did not store patient records for at least two years due to the volume of testing performed in the laboratory. 4. A review of chemistry reagent logs showed that the lab had one "Reagent Log" which documented the lot numbers and expirations dates of reagents used to perform chemistry testing from 07/17/2023 to 07 /20/2023. In an email communication dated 07/28/2023 the TC stated, "I have not yet found out how long the data on the lot numbers of the controls are kept in the Chemistry Analyzer." 5. During an interview on 07/20/2023 at 1:30 PM, the TC confirmed that the laboratory did not retain all analytic systems records for at least 2 years. 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 and interview with the technical consultant (TC), the laboratory did not ensure that hematology controls were labeled with the date that they are put in to use or expire. Findings: 1. During a tour of the laboratory at 9:15 AM, it was observed that the opened and in use "Cell-Dyn 18 Plus" hematology controls in the laboratory refrigerator (lot # L3149, expiration date 09/15/2023) were not labeled with the date that they were put in to use or with the expiration date. A review of manufacturer instructions showed that the hematology controls expire 8 days after opening. 2. During an interview on 07/20/2023 at 1:30 PM, the TC confirmed that the in-use hematology controls were not labeled with the opened or expiration date. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on instrument maintenance record review and interview with the technical consultant (TC), the laboratory did not ensure that monthly maintenance was performed and documented on the hematology and chemistry analyzers as recommended by the manufacturer. Findings: 1. The laboratory uses a Cell-Dyn Emerald hematology analyzer to perform CBC (complete blood cell count) analysis. The monthly "Emerald CBC Maching" maintenance log shows that every month the laboratory should perform "Monthly Bleaching/cleaning." 2. A review of monthly hematology analyzer maintenance records from January through June 2023 showed that monthly instrument cleaning was not documented for four out of six months. 3. The laboratory uses an ACE Axcel chemistry analyzer to perform chemistry testing. The monthly "ACE Axcel Clinical Chemistry System Maintenance Log" shows that every month the laboratory should perform four maintenance tasks. 4. A review of monthly chemistry analyzer maintenance records from January through June 2023 showed that four out of four monthly tasks were not documented for two out of six months. 5. During an interview on 07/20/2023 at 1:30 PM, the TC confirmed that monthly hematology and chemistry analyzer maintenance was not documented as recommended by the manufacturer. -- 3 of 3 --

Summary Statement of Deficiencies 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 record review and interview with the technical consultant (TC), the laboratory failed to perform linearity/calibration verification every six months for the routine chemistry analyzer. Findings: 1. Laboratory records documented that the linearity/calibration verification for the chemistry analyzer was performed on 01/26 /2020. The laboratory suspended patient testing from 03/17/2020 through 11/12/2020. The next linearity/calibration verification was documented as performed on 09/11 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 -- /2021. 2. During the exit interview on 11/18/2021 at 1:30 PM, the TC confirmed that linearity/calibration verification was not performed every six months for the chemistry analyzer as was required. D5783

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 review of the federal proficiency testing (PT) data report and review of the comparative evaluation summary from the American Proficiency Institute (API) PT program, the laboratory failed to successfully participate in the API PT program for hematology testing, in which the laboratory is certified under CLIA (D2130 and D2131). 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 3 -- 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 review of the federal proficiency testing (PT) data report and review of the comparative evaluation summary from the American Proficiency Institute (API) PT program, the laboratory failed to achieve satisfactory performance for the same analyte in 2 consecutive hematology testing events. The following analyte was noted as failed in the API 2020 3rd and 2021 1st events. Findings: 1. API 2020 3rd event platelet count 60% 2. API 2021 1st event platelet count 60% D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for 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 review of the federal proficiency testing (PT) data report and review of the comparative evaluation summary from the American Proficiency Institute (API) PT program, the laboratory failed to achieve an overall testing event score of satisfactory performance for 2 consecutive hematology testing events. Findings: 1. API 2020 3rd event overall hematology 75% 2. API 2021 1st event overall hematology 78% 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 review of the federal proficiency testing (PT) data report and review of the comparative evaluation summary from the American Proficiency Institute (API) PT program, the laboratory director failed to ensure that the laboratory successfully participated in the API PT program for hematology testing, in which the laboratory is certified under CLIA (D6019). D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for chemistry testing, in which the laboratory is certified under CLIA. (Refer to D2093 and D2096) D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) 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 -- Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the performance summery from American Proficiency Institute (API), the laboratory failed to return proficiency testing results to the proficiency testing program within the time frame. The following analyte was noted as failed in the 2020 2nd and 3rd event routine chemistry. Findings: 1. American Proficiency Institute 2020 2nd event routine chemistry overall score 0% 2. American Proficiency Institute 2020 3rd event routine chemistry overall score 0% D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 review of the federal proficiency testing data report and review of the performance summery from the American Proficiency Institute proficiency testing program, the laboratory failed to successfully participate in the API PT program for routine chemistry. The following analyte was noted as failed in the 2nd and 3rd event of 2020. Findings: 1. American Proficiency Institute 2020 2nd event routine chemistry 0% 2. American Proficiency Institute 2020 3rd event routine chemistry 0% 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 review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory director failed to ensure the laboratory successfully participated in the API PT program for routine chemistry testing, in which the laboratory is certified under CLIA. (Refer to D2093 and 2096) D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies 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 review of the calibration records and interview with the technical consultant, the laboratory did not ensure that calibration verification was performed and documented every six month for the hematology analyzer and the chemistry analyzer. Findings: 1. The manufacturer of the hematology analyzer requires calibration verification to be performed every six months. The laboratory records show that the calibration verification was performed on 05/04/17 and then on 06/12/18 showing an 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 -- 11 month gape between calibrations. Additional records show that the calibration verification was performed on 07/27/18 and then on 03/21/19 showing an 8.5 month gape between calibrations. 2. The chemistry records show that the last time linearity was performed was in 2017 verifying the reportable range of the analyzer. 3. During the survey on 04/26/19 at 11:00 AM the technical consultant confirmed that the calibration verification for the hematology and chemistry analyzers were not being performed every six months as required. -- 2 of 2 --