Priority Care, Llc

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory records, review of laboratory policy, and staff interview, the laboratory failed to retain urinalysis quality control (QC) records in 2022, 2023, and 2024. The findings include: 1. Observation of the laboratory on 03/06/2024 at 08:15 am revealed the following equipment in use for patient urinalysis testing: - McKesson Consult Diagnostics 120 Urine Analyzer (Serial Number: 197T10077E1). - Consult Diagnostics 10SG Urine Reagent Strips (Lot: URS3030143) for urine chemistry analysis. - Axiostar Plus Microscope (Serial Number: 3108013850) for urine microscopic analysis. 2. A review of the laboratory's records revealed no documented QC for urinalysis testing in 2022, 2023, and 2024. 3. A review of the laboratory's "Quality Assessment" policy revealed the following statement under item 11. Quality Control: - "We document the results of all controls and will take appropriate actions when the controls do not perform as expected." 4. An interview with the laboratory director and lead testing person on 03/06/2024 at 12: 15 pm confirmed that the laboratory did not maintain QC records in 2022, 2023, and 2024 for urinalysis testing. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or 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 -- examining specimens. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of quality control (QC) records, lack of

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 and interview with Laboratory Supervisor the laboratory failed to rotate all 8 testing persons listed on the Center for Medicare Medicaid (CMS) 209 form performing PT in 2019, 2020 and 2021. The findings include: 1. A review of the PT records for 2019, 2020 and 2021 revealed only three of the eight testing personnel's signature on the attestation sheets. 2. An interview with the Laboratory Supervisor at approximately 10:30A.M. on July 30,2021 confirmed the laboratory failed to rotate 5 of the 8 testing personnel for PT samples for 2019, 2020 and 2021. 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. 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 review of the Proficiency Testing (PT) Records and interview with the Laboratory Supervisor it was determined the laboratory failed to maintain copies of the instrument printouts for PT events for 2019, 2020 and 2021. The findings include: 1. Review of the PT records for 2019, 2020 and 2021 the laboratory failed to maintain copies of instrument printouts. 2. Interview with the Laboratory Supervisor on July 30, 2021 at 10:30A.M. confirmed the laboratory failed to maintain copies from instrument printouts for PT events in 2019, 2020 and 2021. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and upon interview with the Laboratory Supervisor determined the laboratory failed to include procedures and policies for urine microscopic testing, wet preps for KOH, manufacturers package inserts, critical values and specimen rejection criteria for 2019, 2020 and 2021. The findings include: 1. Based on review of laboratory procedure manual revealed no polices or procedures for urine microscopic testing, wet preps for KOH, manufactures package inserts, critical values and specimen rejection criteria. 2. An interview at 10: 00A.M. on July 30, 2021 with the Laboratory Supervisor, confirmed the laboratory procedures and policies failed to include urine microscopic testing, wet preps for KOH, manufacturers package inserts, critical values, and specimen rejection criteria for 2019, 2020 and 2021. 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 the observation, during a laboratory tour, review of the Centers for Medical, Medicare Services (CMS) 116 form, specialties volumes and interview with Laboratory Supervisor, the laboratory failed to discard expired Potassium Hydroxide (KOH) reagent in 2019,2020 and 2021. The findings include: 1. An observation of a bottle of KOH solution currently in use while touring laboratory on survey July 30, 2021 at 9:00am, revealed the solution expired on 11/30/2019. 2. Review CMS 116 form, specialties test volumes revealed 11 patients had KOH tests performed in 2019,2020 through July 30,2021 on KOH reagent expired on 11/30/2019. 3. An interview with the Laboratory Supervisor at 9:00am on July 30, 2021 confirmed the bottle of KOH solution expired on 11/30/2021 had been used for patient testing in 2019,2020 and 2021. -- 2 of 3 -- D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the personnel records and interview with the Laboratory Supervisor the Technical Consultant failed to document 8 out of 8 testing personnel competencies in 2019,2020 and 2021 The findings include: 1. Review of the competency assessment records for testing personnel, eight out of eight testing personnel failed to have a documented review by the Technical Consultant for 2019,2020 and 2021. 2. Interview with the Laboratory Supervisor on July 30, 2021 at 10:00 A.M. confirmed the Technical Consultant failed to document competency assessments on eight out of eight testing personnel in 2019, 2020 and 2021. -- 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 desk review of the Centers for Medicare and Medicaid Services CASPER report 155 & 153 (CMS 153&155) and the proficiency testing agency, American Association of Bioanalysts (AAB) performance summary determined the laboratory failed to maintain satisfactory performance for the specialty of Hematology for Hematocrit (HCT) in event 3 in 2018 and event 1 in 2019 resulting in the first unsuccessful occurrence. (See D2123 & D2130). D2123 HEMATOLOGY CFR(s): 493.851(c) 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 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 Centers for Medicare and Medicaid Services (CMS) 153 & 155 Casper report and the American Association of Bioanalysts( AAB) performance summary the laboratory failed to participate in the 3rd event in 2018 for the specialty Hematology for the analyte Hematocrit (HCT) resulting in a score of zero in 2018. The findings include: 1. Review of the CMS Casper 153 & 155 report revealed the laboratory failed to participate in the 3rd event for the specialty Hematology for the analyte HCT resulting in a score of zero in 2018. 2. Review of the AAB performance summary report the laboratory failed to participate in the 3rd event for the specialty Hematology for the analyte HCT resulting in a score of zero in 2018. 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 review of the CMS Casper 153 & 155 report and the proficiency testing agency American Association of Bioanalysts (AAB) revealed the laboratory failed to achieve successful perfromance for the 3rd event in 2018 and 1st event in 2019 for the specialty Hematology for analyte Hematocrit (HCT). The findings include: 1. Review of the CMS Casper 153 & 155 report revealed the laboratory failed to achieve successful perfromance for the 3rd event 2018 with a score of zero and 1st event 2019 with a score of 40 % for the analyte HCT. 2. Review of the AAB perfromance summary report revealed the laboratory failed to achieve successful performance for the 3rd event 2018 with a score of zero and 1st event 2019 with a score of 40 % for the analyte HCT. -- 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 proficiency testing (PT) record's attestation statements for 2016- 18 and an interview with the lead lab nurse, the laboratory failed to ensure the laboratory director and 8 of 8 testing persons (TP)/ analysts performing the hematology complete blood count (CBC) PT events' specimens signed the attestation statements in 2016-2018. Findings include: 1. There was no laboratory director's signatures on attestation statements for PT events for CBC specimens from 2016-18 available to review. 2. There were no TP/analysts signatures for eight of eight TP analysts for PT events for CBC specimens from 2016-18 available to review. 3. In an interview, August 8, 2018, at 10:30am, the lead lab nurse confirmed the missing laboratory director and 8 of 8 TP analyst's signatures on the attestation statements for the hematology complete blood count (CBC) PT events' specimens for 2016-18. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require