Lillie's Lab Solutions

Summary Statement of Deficiencies D0000 An unannounced complaint investigation was conducted on November 28,2023. The laboratory failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780. 493.1403 Condition: Laboratories Performing Moderate Complexity Testing; laboratory director 493.1415 Condition: Laboratories Performing Moderate Complexity Testing; clinical consultant. Complaint TX22087835 was substantiated based upon findings made during this investigation. 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 CMS Report 209 Laboratory Personnel Report, electronic mail submission and staff interview, the laboratory director failed to provide overall management and direction of the laboratory services. The Laboratory Director failed to ensure that the laboratory had a qualified clinical consultant for a laboratory performing moderate complexity testing. ( See D 6065) D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the 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 -- appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based upon review of the CMS report 209 Laboratory Personnel Report, electronic mail submission and interview of facility personnel, the Laboratory director failed to ensure the laboratory had employed a qualified clinical consultant to provide consultation for performing moderately complex chemistry procedures. (See D6065) D6056 CLINICAL CONSULTANT CFR(s): 493.1415 The laboratory must have a clinical consultant who meets the qualification requirements of 493.1417 of this part and provides clinical consultation in accordance with 493.1419 of this part. This CONDITION is not met as evidenced by: Based on review of the CMS 209 Laboratory Personnel Report, electronic mail submissions and interview of facility personnel, the facility failed to employ an individual that met the minimum qualifications for the clinical consultant of a moderate complexity laboratory for thirteen of thirteen months. NOTE: This is a repeat deficiency from the January 2023 initial certification inspection. (See D6057) The findings included: 1. Review of the CMS Laboratory Personnel Report (provided by the laboratory director on November 28, 2023) found the laboratory identified an individual as the Clinical Consultant. (see attached CMS 209) 2. Review of electronic mail submissions dated November 28, 2023 from the individual defined as the Clinical Consultant found the laboratory had not entered into a contractual agreement for employment as the Clinical Consultant. 3. During interview of the Laboratory Director conducted on November 28, 2023 at 10:00 AM (conducted by telephone) she explained that she did not have anything to do with negotiating contracts for employment and that was the responsibility of the owner/operator. D6057 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1417 The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1405(b)(1), (2), or (3)(i); or (b) Be a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine and possess a license to practice medicine, osteopathy or podiatry in the State in which the laboratory is located. This STANDARD is not met as evidenced by: Based on review of the CMS 209 Laboratory Personnel Report, electronic mail submissions and interview of facility personnel, the facility failed to employ an individual that met the minimum qualifications for the clinical consultant of a moderate complexity laboratory for thirteen of thirteen months. NOTE: This is a repeat deficiency from the January 2023 initial certification inspection. (See D6057) The findings included: 1. Review of the CMS Laboratory Personnel Report (provided -- 2 of 3 -- by the laboratory director on November 28, 2023) found the laboratory identified an individual as the Clinical Consultant. (see attached CMS 209) 2. Review of electronic mail submissions dated November 28, 2023 from the individual defined as the Clinical Consultant found the laboratory had not entered into a contractual agreement for employment as the Clinical Consultant. 3. During interview of the Laboratory Director conducted on November 28, 2023 at 10:00 AM (conducted by telephone) she explained that she did not have anything to do with negotiating contracts for employment and that was the responsibility of the owner/operator. NOTE: This is a repeat deficiency from the January 2023 initial certification inspection. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on October 24, 2023, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile 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 evaluation reports, the laboratory failed to achieve satisfactory performance in two of three consecutive testing events for the analyte Thyroid Stimulating Hormone (TSH) and the sub-specialty of Endocrinology, resulting in an initial unsuccessful performance. Refer to D2107 and D2108. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory failed to achieve satisfactory performance for two of three events in 2023 for the analyte Thyroid Stimulating Hormone (TSH), resulting in unsuccessful performance. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for the analyte TSH in two of three events in 2023: 2023 API 1st event 20% 2023 API 3rd event 0% 2. Based on review of the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsatisfactory performances for the analyte TSH in two of three events in 2023: 2023 API 1st event 20% 2023 API 3rd event 0% D2108 ENDOCRINOLOGY CFR(s): 493.843(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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory failed to achieve satisfactory performance for two of three events in 2023 for Endocrinology, resulting in unsuccessful performance. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for the Endocrinology in two of three events in 2023: 2023 API 1st event 73% 2023 API 3rd event 0% 2. Based on review of the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsatisfactory performances for Endocrinology in two of three events in 2023: 2023 API 1st event 73% 2023 API 3rd event 0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 3 -- 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for analyte Thyroid Stimulating Hormone (TSH) and the specialty of Endocrinology for two of three events in 2023. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for analyte Thyroid Stimulating Hormone (TSH) and the subspecialty of Endocrinology for two of three events in 2023, resulting in an initial unsuccessful performance. Refer to D2107 and D2108. -- 3 of 3 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on an unnanounced revisit of the laboratory 05/04/2023 - 04/19/2023, review of the test requisition slip, patient instrument print-outs, and interview, the laboratory failed to retain a test requisition slip for two of two months reviewed for 130 of 130 patients tested from Jan 1, 2023 - Jan 23, 2023, and April 3, 2023 - May 3, 2023. Findings follow. A. Test requisitions were requested on May 4, 2023 at 1320 but not provided. B. Random review of patient instrument print-outs from testing performed from Jan 1, 2023 - Jan 31, 2023 and April 3, 2023 - May 3, 2023 showed the following patients listed by date of testing and patient ID: Date of Testing Patient ID 1. 01/10/23 2301100002 2. 01/10/23 2301100001 3. 01/10/23 000439005 4. 01/11/23 00043890022 5. 01/11/23 0004390017 6. 01/11/23 0004390020 7. 01/11/23 0004389798 8. 01/11/23 2301100001 9. 01/11/23 0004390017 10. 01/11/23 0004389732 11. 01/12/23 0004390034 12. 01/12/23 0004390036 13. 01/13/23 0004390089 14. 01/13/23 0004390041 15. 01/13/23 0004390043 16. 01/13/23 2301120001 17. 01/16/23 0004389902 18. 01/16/23 0004389744 19. 01/16/23 004389770 20. 01/16/23 0004389671 21. 01/17/23 0004389732 22. 01/17/23 0004390034 23. 01/17/23 004389770 24. 01/17/23 0004390130 25. 01/17/23 0004390169 26. 01/17/23 0004390043 27. 01/17/23 0004390134 28. 04/03/23 R0000764633 29. 04/03/23 R0000764629 30. 04/03/23 R0000764647 31. 04/03/23 R0000764646 32. 04/04/23 R0000764629 33. 04/04/23 R0000764635 34. 04/04/23 R0000764650 35. 04/04/23 R0000764649 36. 04/04/23 0004391207 37. 04/04/23 R0000764648 38. 04/05/23 R0000764651 39. 04/05/23 R0000764629 40. 04/06/23 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 -- R0000764652 41. 04/06/23 R0000764629 42. 04/06/23 R0000764640 43. 04/06/23 R0000764639 44. 04/06/23 R0000764641 45. 04/06/23 23012370001 C. Interview with testing personnel, as listed on the CMS form 209 dated 05/04/2023, on May 4, 2023 at 1320 hours confirmed there were no patient requisitions for the testing performed. Interview with the owner on May 4, 2023 at 1325 hours acknowledged they draw the sample, but leave the requisition slips with the provider, and put the patient's name, date of birth, and tests ordered on the tube. She confirmed there was no requisition slip with who ordered the test along with the patient's information [to include name, sex and age, or date of birth, the tests to be performed, and the date and time of collection]. Interview with the owner on May 18, 2023 at 1040 hours acknowledged the phlebotomist was keeping requisitions for a week and then shredding them, and still trying to figure that out. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on an unnanounced revisit of the laboratory 05/04/2023 - 05/19/2023, review of proficiency testing (PT) records, email, and interview, the laboratory failed to retain all PT records for Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, BUN (Blood Urea Nitrogen), Total Bilirubin, Calcium, Protein, Albumin, ALP, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), Cholesterol, HDL (High-Density Lipoprotein), Triglycerides, Uric Acid, and Magnesium performed on the Alfa-Wasserman for 2 out of 3 days of testing reviewed. A. Phone interview with the Laboratory Director on February 6, 2023 at 1440 acknowledged the laboratory had testing issues on 01/27/2023 and had performed Proficiency testing on 01/27/2023 and repeated again on 01/29/2023. B. Review of the Proficiency testing records from the 1st event of 2023 from API (American Proficiency Institute) showed testing was performed on 1/31/2023. Additional records of PT tested from 01/26/2023 - 01/30 /2023 were requested on May 4, 2023 at 1255 but not provided. C. Interview with testing personnel, as listed on the CMS form 209 dated 05/04/2023, on May 4, 2023 at 1305 confirmed Proficiency testing was only performed on 1/31/2023, and all the records of testing were in the binder. D. Email from the former Laboratory Director on May 16, 2023 at 5:08 PM showed instrument print-outs of the Proficiency testing performed on 1/29/2023 for samples CH-01 - CH-05. E. Further interview on May 19, 2023 at 1405 hours with testing personnel acknowledged he didn't remember sending any reports to the Laboratory Director, only screen shots. Further interview on May 19, 2023 at 1424 hours with testing personnel confirmed Proficiency testing was performed on 01/29/2023 after owner viewed instrument print-outs obtained from former laboratory director. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D2000 - 42 C.F.R. 493.801 Condition: Enrollment and testing of [proficiency testing] samples; D5016 - 42 C.F.R. 493.1210 Condition: Routine chemistry; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; D6056 - 42 C.F.R. 493.1415 Condition: Laboratories performing moderate complexity testing; clinical consultant; Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of patient testing records, proficiency testing (PT) records, interview, and email, the laboratory failed to enroll in proficiency testing for Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, BUN (Blood Urea Nitrogen), Total Bilirubin, Calcium, Protein, Albumin, ALP, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), Cholesterol, HDL (High-Density Lipoprotein), Triglycerides, Uric Acid, and Magnesium performed on the Alera Alfa-Wasserman for two of two months reviewed. Findings follow. A. Testing records showed the laboratory started Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- reporting patient testing on the Alera Alfa-Wasserman on November 1, 2022. B. Proficiency testing records were requested on January 3, 2023, at 11:20 but not provided. C. Interview with testing personnel #1 on January 3, 2023, at 1120 was confused as to what PT was and confirmed they were not enrolled. Phone interview with the Laboratory Director on January 3, 2023, at 1125 acknowledged they should have enrolled in PT, and had discussed this with testing personnel #1 in September. D. Email from testing personnel #1 on January 10, 2023, at 0940 showed 2027 tests had been run from 11/01/22 - 01/03/23. 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 review of quality control (QC) records and interview the laboratory failed to retain all QC activities performed for Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, BUN (Blood Urea Nitrogen), Total Bilirubin, Calcium, Protein, Albumin, ALP, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), Cholesterol, HDL (High-Density Lipoprotein), Triglycerides, Uric Acid, and Magnesium performed on the Alera Alfa-Wasserman for 3 out of 30 days reviewed. Findings follow. A. Review of the QC Requisition Reports from 11/01/22 - 11/18/22 and 12/01/22 - 12/14/22 showed missing QC runs on: Testing Date QC Analytes 1. 11 /07/22 Level 1 Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, BUN, Total Bilirubin, Calcium, Protein, Albumin, ALP, ALT, AST, and Uric Acid 2. 11/11/22 Level 1 Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, BUN, Total Bilirubin, Calcium, Protein, Albumin, and Uric Acid 3. 11/12/22 Level 2 Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, BUN, Total Bilirubin, Calcium, Protein, Albumin, and Uric Acid B. Interview with testing personnel #2, as listed on CMS-209, on January 4, 2023, at 1555 hours confirmed the findings. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation, review of the patient testing records, temperature charts, manufacturer's instructions, verification of performance specification records, QC (Quality Control) records, interview and email, the laboratory failed to meet the applicable requirements in the specialty of Chemistry for two of two months reviewed. 1. The laboratory failed to monitor the refrigerator used to store patient specimens located in the lab with the Alera Alfa-Wasserman for two of two months reviewed from 11/01/2022 - 01/04/2023 (refer to D5413 I). 2. The laboratory failed to monitor the room temperature in the lab for two of two months reviewed from 11/01 /2022 - 01/04/2023 (refer to D5413 II). 3. The laboratory failed to perform accuracy and precision for Sodium, Potassium, Chloride, ALP (Alkaline Phosphatase), Uric -- 2 of 12 -- Acid, and Magnesium on the Alera Alfa-Wasserman for six of 18 chemistry analytes reported in the lab from 11/01/2022 - 01/03/2023 (refer to D5421 I). 4. The laboratory failed to verify the precision obtained for Cholesterol on the Alera Alfa-Wasserman during the verification of performance specifications for 1 of 2 levels measured (refer to D5421 II). 5. The laboratory failed to perform a reportable range study for Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, BUN (Blood Urea Nitrogen), Total Bilirubin, Calcium, Protein, Albumin, ALP, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), Cholesterol, HDL (High-Density Lipoprotein), Triglycerides, Uric Acid, and Magnesium on the Alera Alfa-Wasserman for 18 of 18 chemistry analytes reported in the lab from 11/01/2022 - 01/03/2023 (refer to D5421 III). 6. The laboratory failed to verify the normal reference range for Sodium, Potassium, Chloride, Carbon Dioxide, Glucose, BUN, Total Bilirubin, Calcium, Protein, Albumin, ALP, ALT, AST, Cholesterol, HDL, Triglycerides, Uric Acid, and Magnesium on the Alera Alfa-Wasserman for 18 of 18 chemistry analytes reported in the lab from 11/01/2022 - 01/03/2023 (refer to D5421 IV). 7. The laboratory failed to ensure two levels of QC were performed before reporting out patient results for Cholesterol, Triglycerides, and HDL using the Alera Alfa-Wasserman on 2 out of 4 days of testing (refer to D5447). 8. The laboratory failed to ensure two levels of QC were acceptable before reporting out patient results for chemistries using the Alera Alfa-Wasserman on 11 out of 30 days of testing (refer to D5481). 9. The laboratory failed to document