Clinica Santa Maria

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the laboratory's Cell-Dyn Emerald maintenance records from January 2023 to August 2025, and staff interview, the laboratory failed to have documentation of performing semiannual maintenance for 3 of 5 occurrences. The findings included: 1. A review of the manufacturer's required maintenance for the Cell-Dyn Emerald hematology analyzer from January 2023 to August 2025 determined the laboratory was required to perform semiannual maintenance of lubricating the pistons. Further review determined the laboratory failed to have documentation of performing 3 of 5 occurrences of semiannual maintenance. Maintenance was documented on 4/2023 and 4/2024. The laboratory was missing documentation for 10/2023, 10/2024, and 4/2025. 2. Testing personnel number 1 (as listed on Form CMS 209) confirmed the findings in an interview conducted on 08/26 /2025 at 1015 hours in the laboratory. D5783

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. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing records and confirmed in staff interview, the laboratory failed to provide signed proficiency testing attestation statements for 10 of 10 proficiency testing events in 2023. Findings included: 1. A review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing records revealed the following testing events were submitted in 2023 : a) Chemistry Module b) Endocrinology 1 c) Glycohemoglobin d) Lipid Profile e) Blood Bank 1 f) Chlamydia/GC/Streptococcus B Antigen Screen g) Hematology with 3-Part Differential h) Rubella i) Syphilis Serology j) Viral Markers 2. The laboratory was asked to provide proficiency testing attestation statements signed by the testing personnel and by the laboratory director or designee. No documentation was provided. 3. In an interview on 06/20/2023 at 1030 hours in the laboratory, after review of the proficiency testing records, Technical Consultant 1 (as listed on the CMS Form 209) confirmed the above findings. Word Key: GC = Neisseria gonorrhoeae CMS = Centers for Medicare and Medicaid Services. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 record, a review of BD Max procedure, and confirmed in staff interview, the laboratory failed to provide an approved procedure for 1 of 1 FDA approved, non-modified assays. Findings included: 1. During a tour of the laboratory conducted on 06/20/2023 at 0905 hours, one BD Max (serial number 1599) was observed by the surveyor. 2. A review of laboratory records for the BD Max instrument indicated a new method verification study was performed on 10/21/2022 for the "CT/GC/TV assay". 3. The laboratory was asked to provide an updated procedure for the new method BD Max CT/GC/VT assay. No procedure was provided. 4. In an interview on 06/20/2023 at 1400 in the laboratory, after review of the above records, the Technical Consultant #1 (as listed on the CMS Form 209) confirmed the findings. Word key : BD = Becton Dickinson CT = Chlamydia trachomatis GC = Neisseria gonorrhoeae TV = Trichomonas vaginalis D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the Cobas Folate III assay, surveyor observation, review of patient test records June 15, 2023 - June 19, 2023, and staff interview, it was revealed the laboratory failed to test samples within the manufacturer's required timeframe. The findings include: 1. A review of the manufacturer's instructions for the Cobas Folate III assay (2015-02, V 9.0 English) under the section titled "Specimen collection and preparation" revealed: "Serum: Stable for 2 hours at 20 - 25C, 2 days at 2 - 8C, 4 weeks at -20C." 2. Surveyor observation on 06/20/2023 at 1200 hours identified the following patient serum samples in a test tube rack on the counter in the laboratory awaiting Folate testing to be performed: Specimen ID: 23061513 Specimen ID: 23061608 Specimen ID: 23061614 Specimen ID: 23061904 Specimen ID: 23061915 3. An interview with testing personnel number 1 (as listed on Form CMS 209) on 06/20/2023 at 1400 hours revealed samples for Folate testing were tested twice a week. Samples were stored in the refrigerator at 2 - 8C until testing could be performed. She stated the samples had been on the counter since 11:30 am waiting to warm to room temperature. 4. A review of patient test records for the identified samples revealed the following collection dates: a)Specimen ID: 23061513 Collected 06/15/2023 4 days stored at 2 - 8C. > 2 hours at 20 - 25C the day of testing. b) Specimen ID: 23061608 Collected 06/16/2023 3 days stored at 2 - 8C. > 2 hours at 20 - 25C the day of testing. c) Specimen ID: 23061614 Collected 06/16/2023 4 days stored at 2 - 8C. > 2 hours at 20 - 25C the day of testing. d) Specimen ID: 23061904 Collected 06/19/2023 > 2 hours at 20 - 25C the day of testing. e) Specimen ID: 23061915 Collected 06/19/2023 > 2 hours at 20 - 25C the day of testing. 5. An interview with testing personnel number 1 (as listed on Form -- 2 of 5 -- CMS 209) on 06/20/2023 at 1410 hours in the laboratory - after her review of the records- confirmed the findings. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of the laboratory's test menu, the laboratory's verification studies for the BD Max analyzer performed in 2022, review of the laboratory's test volumes, and confirmed in staff interview, the laboratory failed to provide documentation of performing required studies for 4 of 4 non-modified FDA-approved assays. The findings included: 1. A review of the laboratory's test menu revealed the laboratory performed the following patient testing assays performed on the BD Max (serial number 1599): a) Chlamydia trachomatis b) Neisseria gonorrhoeae c) Trichomonas vaginalis d) Bacterial vaginosis panel 2. The laboratory was asked to provide documentation of performing precision studies as part of the BD Max verification study accepted by the Technical Consultant (as listed on the CMS Form 209) on 10/21 /2022. No documentation was provided. 3. A review of the laboratory's annual test volume for the BD Max revealed 10,788 tests are performed. 4. In an interview on 06 /20/2023 at 1340 hours in the laboratory, after review of the above records, Technical Consultant 1 (as listed on the CMS Form 209) confirmed the above findings. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on direct observation, a review of laboratory procedure, and confirmed in staff interview, the laboratory failed to provide maintenance records for 1 of 1 centrifuges (2021 - 2023). Findings included: 1. During a tour of the laboratory conducted on 06 /20/2023 at 0905 hours, one Sero 12 centrifuge (serial number 210514AA423) was observed by the surveyor. 2. A review of the laboratory procedure titled "Centrifuge Operations and Calibration" (reviewed by the laboratory director on 04-17-2023) stated the following maintenance requirements: "Weekly: External and internal surfaces of each centrifuge must be cleaned using 10% bleach solution. Document on appropriate department disinfection schedule. Semi-annually: 1) Check and record -- 3 of 5 -- RPMs. 2) Check power cord for fraying. 3) Check latch. 4) Omitted from procedure. 5) Check timer (see Timer Calibration SOP). 6) Document on Centrifuge Calibration and Maintenance Schedule." 3. The laboratory was asked to provide documentation of centrifuge maintenance records for 2021 - 2023. No documentation was provided. 4. In an interview on 06/20/2023 at 1440 hours in the laboratory, after review of the above records, Testing Personnel #2 (as listed on the CMS Form 209) confirmed the findings. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of manufacturer's inserts, laboratory records, laboratory test volume and confirmed in staff interview, the laboratory failed to meet the Emerald Cell-Dyn calibration verification acceptability requirements for 4 of 4 events (December 2021 - April 2023). Findings included: 1. A review of Cell-Dyn 18 Plus Calibrator package inserts revealed the following criteria: a) Lot 1319C, Expiration Date 2021-12-29 WBC 109/L Assay Value = 8.5; Tolerance Limits 0.3 RBC 1012/L Assay Value = 4.23; Tolerance Limits 0.10 HGB g/dL Assay Value = 11.5; Tolerance Limits 0.2 PLT 109/L Assay Value = 207; Tolerance Limits 15 b) Lot 2150C, Expiration Date 2022-07-13 RBC 1012/L Assay Value = 4.13; Tolerance Limits 0.10 c) Lot 2262C, Expiration Date 2022-11-02 RBC 1012/L Assay Value = 4.20; Tolerance Limits 0.10 HGB g/dL Assay Value = 11.0; Tolerance Limits 0.2 d) Lot 3093C, Expiration Date 2023-05-17 HGB g/dL Assay Value = 11.1; Tolerance Limits 0.2 2. A review of laboratory records titled "Calibration Verification Worksheet" revealed the following results: a) Date 12/15/2021, Calibrator Lot 1319C, Expiration Date 12/29/2021 Documented WBC Mean Value = 8.5. The provided data's WBC Mean Value = 8.1 (Difference = -0.4) Documented RBC Mean Value = 4.25; The provided data's RBC Mean Value = 4.01 (Difference = -0.22) Documented HGB Mean Value = 11.5; The provided data's HGB Mean Value = 11.1 (Difference = -0.4) Documented PLT Mean Value = 210; The provided data's PLT Mean Value = 181 (Difference = -26) The mean value results exceeded the tolerance limits specified -- 4 of 5 -- in the manufacturer's insert. b) Date 06/27/2022, Calibrator Lot 2150C, Expiration Date 07/13/2022 Documented RBC Mean Value = 4.23; The provided data's RBC Mean Value = 4.24 (Difference = +0.11) The mean value result exceeded the tolerance limit specified in the manufacturer's insert. c) Date 10/11/2022, Calibrator Lot 2262C, Expiration Date 11/02/2022 Documented RBC Mean Value = 4.30; The provided data's RBC Mean Value = 4.39 (Difference = +0.19) Documented HGB Mean Value = 11.3; The provided data's HGB Mean Value = 11.3 (Difference = +0.3) The mean value results exceeded the tolerance limits specified in the manufacturer's insert. d) Date 04/25/2023, Calibrator Lot 3093C, Expiration Date 05/17/2023 Documented HGB Mean Value = 10.9; The provided data's HGB Mean Value = 10.7 (Difference = -0.4) The mean value result exceeded the tolerance limit specified in the manufacturer's insert. 3. A review of the laboratory test volume revealed an annual volume of 16,926 tests. 4. In an interview on 06/20/2023 at 1340 hours in the laboratory, after review of the above records, the Technical Consultant #1 (as listed on the CMS Form 209) confirmed the findings. Word Key: WBC = White blood cell RBC = Red blood cell HGB = Hemoglobin MCV = Mean corpuscular volume PLT = Platelet L = Liter g/dL = grams per deciliter fL = Femtoliters -- 5 of 5 --

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. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory's verification studies, review of patient test records and staff interview, it was revealed the laboratory failed to have documentation of verifying patient normal ranges for 1 of 1 patient normal range used for testing CBCs (complete blood count). The findings included: 1. A review of the laboratory's verification studies revealed the laboratory failed to have documentation of verifying patient normal ranges for females on CBCs: WBC 4.6 - 10.8 Lymphocytes (% and absolute) 10.0 - 50.0 0.6 - 3.4 Mids (% and absolute) 0.1 -24.0 0.0 - 1.8 Granulocytes (% and absolute) 37.0 - 80.0 2.0 - 6.9 RBC 4.04 - 5.48 HGB 12.2 - 16.2 HCT 36.0 - 46.0 MCV 80.0 - 97.0 MCH 26.0 - 32.0 MCHC 32.0 - 36.0 RDW 11.5 - 14.5 Platelets 140 - 440 MPV 0.0 - 99.8 2. Review of patient records revealed the listed CBC ranges were in use for females. 3. The laboratory was asked to provide documentation of verifying the patient normal ranges currently in use. No documentation was provided. 4. An interview with the technical consultant on 09/22/2021 at 14:30 hours in the laboratory - after her review of the records- confirmed the findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of patient records and confirmed in interview of facility personnel, the laboratory failed to ensure patient normal ranges were available to the ordering provider. The findings included: 1. Review of patient records for the following tests revealed patient normal values were listed as follows: Antibody Screen Positive /Negative RPR Reactive/Non-Reactive Rubella Reactive/Non-Reactive HIV 1/HIV2 Antibody Negative/Positive Chlamydia Trachomitis Positive/Negative Neisseria Gonorrhoeae Positive/Negative 2. In an interview with the Technical Consultant on 09-23-2021 at 14:30 hours in the laboratory, she was asked if a positive HIV and a reactive RPR was normal. She stated, "No." This confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was 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

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 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 4 -- Based on a desk review of proficiency testing records, it was determined that the laboratory has not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of chemistry for the analyte Uric Acid (refer to D2096) and speciality General Immunology for the analyte Hepatitis B Antigen (refer to D2084). D2072 SYPHILIS SEROLOGY CFR(s): 493.835(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and AAB records found the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the speciality of serology. Findings: 1. AAB 2017 - 3rd event laboratory received an un satisfactory score of 0 % for Syphilis Serology. D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based upon a review of the CMS 155 report and AAB proficiency testing records, it was revealed that the laboratory failed to attain a score of 80% for Rubella resulting in unsatisfactory analyte performance. Findings: 1. AAB 2017 - 2nd event, laboratory received a score of 0 % for HBS AG (hepatitis B surface antigen). 2. AAB 2017 - 2nd event laboratory received a score 60 % for HBE AG (hepatitis B antigen). 3. AAB 2017 - 3rd event laboratory received a score 0 % for HBE AG (hepatitis B antigen). D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and AAB records found that the laboratory failed to attain an overall score of at least 80% for each testing event in the specialty of general immunology. Findings: 1. API 2017 - 2nd event lab received a score of 65% for the general immunology testing event. 2. API 2017 - 3rd event lab received a score of 70% for the general immunology testing event. -- 2 of 4 -- D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80 % or greater) for the same analyte in the specialty of immunology in two consecutive testing events or two out of three consecutive testing events. Two out of three unsatisfactory scores results in unsuccessful PT performance. 1. AAB 2017 - 2nd event laboratory received an unsatisfactory score 60 % for HBE AG (hepatitis B antigen). 2. AAB 2017 - 3rd event laboratory received an unsatisfactory score 0 % for HBE AG (hepatitis B antigen). D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and AAB records found that the laboratory failed to attain a score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry for the analyte uric acid. Findings: 1. API 2017-1st event the laboratory received an unsatisfactory score of 0% for uric acid. 2. API 2017-2nd event the laboratory received an unsatisfactory score of 0% for uric acid. 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 a desk review of AAB proficiency testing records, it was determined that laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance in the specialty of chemistry for the analyte uric acid. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. API 2017-1st event the laboratory received an unsatisfactory score of 0% for uric acid. 2. API 2017-2nd event the laboratory received an unsatisfactory score of 0% for uric acid. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 3 of 4 -- 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 it was revealed that 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 it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program (refer to D2096 and D2084). -- 4 of 4 --