Complete Care De Zavala

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Proficiency Institutes (API). The laboratory was found to be NOT in compliance with the conditions of participation of the CLIA program based on the following CONDITION LEVEL DEFICIENCIES: 493.803 Successful participation [proficiency testing] 493.1403 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 2 -- 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 desk review of the CMS 155 report and proficiency testing records from American Proficiency Institute (API), the laboratory failed to successfully participate for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Hematology for the analyte White Blood Cell Differential resulting in an initial proficiency testing failure. The findings include: 1. A review of the CMS 155 report revealed the laboratory received the following unsatisfactory scores (passing = >80%) for the analyte White Blood Cell Differential: Third testing event 2023 67% First testing event 2024 73% 2. A desk review of the laboratory's American Proficiency Institute (API) results from the third event of 2023 and the first event of 2024 confirmed the proficiency testing scores: Third testing event 2023 67% First testing event 2024 73% 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 a desk review of laboratory proficiency testing performance, the laboratory director failed to provide overall management and direction of the laboratory services (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 a desk review of proficiency testing results, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program (refer to D2130). -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on August 29, 2023. The laboratory was found to be IN compliance with the CLIA regulations found at 42 CFR, with standard level deficiencies cited. 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 personnel records, American Proficiency Institute (API) records for 2022 and 2023, and confirmed in staff interview, the laboratory failed to have all testing personnel participate in proficiency testing for 10 of 15 testing events. Findings included: 1. A review of the submitted Centers for Medicare and Medicaid Services (CMS) form 209 revealed 9 designated testing personnel (TP#1 - TP#9). 2. A review of API proficiency testing records for 2022 and 2023 revealed the following: a) 2023 Hematology/Coagulation 2nd event TP#5 (as listed on the CMS form 209): Samples tested HSY06 - HSY10 b) 2023 Hematology/Coagulation 1st event TP#5: Samples tested HSY01 - HSY05 c) 2023 Microbiology 2nd event TP#8: Samples tested RSP06 - RSP09 TP#5: Samples tested RSP10 d) 2023 Microbiology 1st event TP#1: Samples tested RSP01 TP#8: Samples tested RSP02 - RSP05 e) 2022 Hematology 3rd event TP#7: Samples tested HSY11 TP#5: Samples tested HSY12 - HSY 15 f) 2022 Hematology 2nd event TP#5: Samples tested HSY06 - HSY10 g) 2022 Hematology 1st event TP#1: Samples tested HSY01 TP#5: Samples tested HSY 02 - HSY05 h) 2022 Microbiology 3rd event TP#4: Samples tested RSP11 - RSP15 i) 2022 Microbiology 2nd event TP#8: Samples tested RSP06 - RSP10 j) 2022 Microbiology 1st event TP#8: Samples tested RSP01 - RSP05 Proficiency testing was not performed by TP#2, TP#3, TP#6, TP#7, nor TP#9. 3. During an interview on 08 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 -- /29/2023 at 0930 hours in the conference room, after review of the following records, Technical Consultant #1 (as listed on the CMS form 209) confirmed the findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the submitted CMS form 209, laboratory policy, and confirmed in staff interview, the laboratory failed to establish and follow a policy for assessing the competency for 1 of 1 Technical Consultants. Findings included: 1. A review of the submitted CMS form 209 listed 1 Technical Consultant. 2. A request was made for a policy for assessing the competency of Technical Consultants. No policy was provided. 3. During an interview on 08/29/2023 at 1030 hours in the conference room, after review of the above records, Technical Consultant #1 confirmed the findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on direct observation, a review of laboratory policy, patient records, and confirmed in staff interview, the laboratory failed to follow laboratory policy for resolving and reporting platelet flags for 3 of 4 CBC Sysmex results (July 2023 through August 2023). Findings included: 1. During a tour of the laboratory on 08/29 /2023 at 0915 hours, one Sysmex XP-300 (Serial number C0564) was observed in use. 2. The laboratory policy titled "Laboratory Procedure CBC Sysmex XP-300" (signed by the Laboratory Director on 09/02/2021) stated "Platelet Flags: Any platelet count >50 with AG flags will be repeated on the original, properly and well mixed sample ... If the AG flag remains, sample will be sent to reference laboratory for confirmatory analysis. The original platelet result should be masked before providing the physician with the CBC results." 3. A review of Sysmex 300-XP patient records tested by the laboratory from July 2023 through August 2023 revealed the following: a) Patient ID 082101 Test date and time: 08/21/2023 at 0243 hours Reported platelet result: "AG* 237" b) Patient ID 073006 Test date and time: 07/30/2023 at 2136 hours Reported platelet result: "AG* 311" c) Patient ID 072805 Test date and time: 07/28 /2023 at 1928 hours Reported platelet result: "AG* 115" The laboratory failed to mask the flagged platelet results prior to reporting to the physician and failed to send samples to the reference laboratory for confirmation. 4. During an interview on 08/29 /2023 at 1315 hours in the conference room, after review of the above records, Technical Consultant #1 confirmed the findings. Word key: CBC = Complete blood count AG = agglutination D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT -- 2 of 3 -- CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on direct observation, review of Sysmex Insight reports, and confirmed in staff interview, the laboratory failed to investigate abnormal results as required by the manufacturer for 3 of 18 months (January 2022 through July 2023). Findings included: 1. During a tour of the laboratory on 08/29/2023 at 0915 hours, 1 Sysmex XP-300 (Serial number C0564) was observed. 2. A review of the Sysmex Insight reports, under the section titled "QC Data Parameter SDI Ranges" revealed: "If your CV is 1.5 times greater than the Group CV, your result is presented in bold type and an investigation is warranted." 3. A review of Sysmex Insight peer Group Comparison reports from January 2022 through July 2023 revealed the following bolded CV results: a) Lot 2278, Cumulative Report 10/5/2022 - 01/11/2023, review date of 02/09 /2023 White Blood Cell count (WBC) Level 1 CV 5.9 White Blood Cell count (WBC) Level 3 CV 8.1 Red Blood Cell count (RBC) Level 3 CV 5.8 Hemoglobin (HGB) Level 3 CV 8.2 Hematocrit (HCT) Level 3 CV 5.7 Mean Corpuscular Hemoglobin (MCH) Level 3 CV 7.4 Mean Corpuscular Hemoglobin Concentration (MCHC) Level 3 CV 7.4 Platelet (PLT) Level 3 CV 6.5 Mixed Blood Cell Count percent (MXD%) Level 1 CV 23.3 Mixed Blood Cell Count percent (MXD%) Level 3 CV 11.5 Neutrophil percent (NEUT%) Level 1 CV 3.9 Neutrophil percent (NEUT%) Level 3 CV 4.6 Lymphocyte count (LYM#) Level 3 CV 8.2 Mixed Blood Cell Count (MXD#) Level 1 CV 33.3 Mixed Blood Cell Count (MXD#) Level 3 CV 10.5 Neutrophil count (NEUT#) Level 1 CV 8.7 Neutrophil count (NEUT#) Level 3 CV 8.3 b) Lot 2278, Period 2, 11/07/2022 - 12/09/2022, review date of 03/30/2023 WBC Level 3 CV 6.4 RBC Level 3 CV 4.5 HGB Level 3 CV 6.3 HCT Level 3 CV 4.4 MCH Level 3 CV 5.7 MCHC Level 3 CV 5.7 PLT Level 3 CV 5.3 MXD% Level 3 CV 10.0 NEUT% Level 3 CV 3.9 LYM# Level 3 CV 6.5 NEUT# Level 3 CV 7.0 c) Lot 2278, Lot-to- date, 10/05/2022 - 12/14/2022, review date of 03/30/2023 WBC Level 1 CV 5.9 WBC Level 3 CV 6.4 RBC Level 3 CV 4.5 HGB Level 3 CV 6.3 HCT Level 3 CV 4.4 MCH Level 3 CV 5.7 MCHC Level 3 CV 5.7 PLT Level 3 CV 5.3 MXD% Level 1 CV 21.2 MXD% Level 3 CV 10.0 NEUT% Level 3 CV 3.9 LYM# Level 3 CV 6.5 MXD# Level 1 CV 33.3 NEUT# Level 1 CV 8.7 NEUT# Level 3 CV 7.0 4. During an interview on 08/29/2023 at 1115 hours in the conference room, Technical Consultant #1 was asked to provide documentation of investigations for the above flagged CV results. None were provided. This confirmed the findings. Word Key: QC = Quality Control SDI = Standard Deviation Index CV = Coefficient of Variation -- 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 representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the