Texas Internal Medicine And Diagnostic Center

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on May 4, 2022, 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute proficiency testing records, the laboratory failed to successfully participate in 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 -- two of three consecutive testing events for the analyte Thyroid Stimulating Hormone (TSH), resulting in unsuccessful performance (refer to D2107). D2098 ENDOCRINOLOGY CFR(s): 493.843(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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of Endocrinology. The findings included: Free T3 (non-regulated analyte) 1. (2021 2nd event) 0% 2. (2021 3rd event) 0% 3. (2022 1st event) 60% PSA (non-regulated analyte) 1. (2021 2nd event) 50% 2. (2022 1st event) 0% Thyroid Stimulating Hormone (TSH) (regulated analyte) 1. (2021 2nd event) 0% 2. (2022 1st event) 60% 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute proficiency testing records, the laboratory failed to successfully participate in two of three consecutive testing events for the analyte Thyroid Stimulating Hormone (TSH), resulting in unsuccessful performance. The findings included: Thyroid Stimulating Hormone (TSH) (regulated analyte) 1. (2021 2nd event) 0% 2. (2022 1st event) 60% 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for analyte Thyroid Stimulating Hormone (TSH) (refer to D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- 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 (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for analyte Thyroid Stimulating Hormone (TSH) in the subspecialty of Endocrinology (refer to D2107). -- 3 of 3 --

Summary Statement of Deficiencies D0000 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: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing records and confirmed in interview of facility personnel, it was determined that the laboratory has not successfully participated in a proficiency testing program 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 -- 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 subspecialty of endocrinology for analyte Free Thyroxine (refer to D2098). D2098 ENDOCRINOLOGY CFR(s): 493.843(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 review of the laboratory's American Proficiency Institute (API) proficiency testing records and confirmed in interview of facility personnel, it was determined that the laboratory failed to attain a score of 80% or greater for Free Thyroxine and Thyroid Stimulating Hormone (TSH) resulting in unsuccessful analyte performance. The findings included: 1. Review of the laboratory's API proficiency testing records found the following unsuccessful scores for Free Thyroxine and TSH: API 2021 - 2nd event the laboratory scored 20% for Free Thyroxine API 2021 - 3rd event the laboratory scored 0% for Free Thyroxine API 2021 - 2nd event the laboratory scored 0% for TSH 2. An interview with the technical consultant on November 4, 2021 at 10: 00 hours in the break room confirmed the findings. It was confirmed he was aware of the regulated analyte failures and is in the process of performing the follow up. He stated that the laboratory is currently not testing Free T3 and Free Thyroxine. 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 laboratory's American Proficiency Institute (API) proficiency testing records and confirmed in interview of facility personnel, it was determined that the laboratory failed to achieve satisfactory performance (80 % or greater) for the same analyte in the specialty of endocrinology in two consecutive testing events or two out of three consecutive testing events. Two out of three unsatisfactory scores results in unsuccessful PT performance. The findings included: 1. Review of the laboratory's API proficiency testing records found the following unsuccessful scores for Free Thyroxine: API 2021 - 2nd event the laboratory scored 20% for Free Thyroxine API 2021 - 3rd event the laboratory scored 0% for Free Thyroxine 2. An interview with the technical consultant on November 4, 2021 at 10:00 hours in the break room confirmed the findings. It was confirmed he was aware of the regulated analyte failures and is in the process of performing the follow up. He stated that the laboratory is currently not testing Free T3 and Free Thyroxine. 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 -- 2 of 5 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing records and confirmed in interview of facility personnel, it was determined that the laboratory failed to achieve a satisfactory score of at least 80% for the overall endocrinology testing event score. The findings included: 1. Review of the laboratory's API proficiency testing records found the following unsuccessful overall scores in the subspecialty of Endocrinology: API 2021 - 2nd event laboratory received an unsatisfactory event score of 10%. API 2021 - 3rd event laboratory received an unsatisfactory event score of 50%. 2. An interview with the technical consultant on November 4, 2021 at 10:00 hours in the break room confirmed the findings. It was confirmed he was aware of the regulated analyte failures and is in the process of performing the follow up. He stated that the laboratory is currently not testing Free T3 and Free Thyroxine. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records from American Proficiency Institute (API), and confirmed in interview of facility personnel, the laboratory failed to perform twice annual accuracy for the unregulated analyte of Free T3. The findings included: 1. Review of the laboratory's API proficiency testing records found that the laboratory participated in three of three events in 2021 for the subspecialty of endocrinology. 2021 - 1st event laboratory scored 100% 2021 - 2nd event laboratory scored 0% 2021 - 3rd event laboratory scored 0% 2. The laboratory failed two of three events and therefore did not perform twice annual accuracy assessments for the analyte Free T3. 3. An interview with the technical consultant on November 4, 2021 at 10:00 hours in the break room confirmed the findings. It was confirmed he was aware of the regulated analyte failures and is in the process of performing the follow up. He stated that the laboratory is currently not testing Free T3 and Free Thyroxine. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor observations, review of manufacturer's instructions, review of the -- 3 of 5 -- laboratory's environmental records, and confirmed in interview with facility personnel, the laboratory failed to establish an accurate room temperature range for 200 of 200 blood collection tubes stored in the laboratory. The findings included: 1. Surveyor observation made on November 4, 2021 at 13:15 hours in the laboratory found the following blood collection tubes stored in the laboratory: 200 Vacuette red top tubes 200 Vacutainer red top tubes 2. Review of the manufacturer's instructions found on the package labeling stated to store the blood collection tubes at, "4-25 degrees Celsius" or 39.2 to 77.0 degrees Fahrenheit. 3. Review of the laboratory's environmental logs from November 2020 to September 2021 found the laboratory monitored the room humidity at a range of 68 to 86 degrees Fahrenheit. The laboratory's upper limit temperature range was set too high for monitoring of the blood collection tubes. 4. An interview with the technical consultant on November 4, 2021 at 13:15 hours in the laboratory confirmed the findings. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on random review of patient reports from September 2021 and October 2021, and confirmed in interview of facility personnel, the laboratory failed to include the testing facility's address on 10 of 10 patient reports reviewed. The findings were: 1. A random review of patient reports from September and October 2021 found the laboratory failed to include the testing facility's address on 10 of 10 patient test reports. 2. The laboratory was asked to provide documentation of patient reports which included the laboratory's address. No documentation was provided. 3. An interview with the technical consultant and the testing person on November 4, 2021 at 14:30 hours in the break room confirmed the findings. 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 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) -- 4 of 5 -- 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 an HHS approved proficiency testing program (refer to D2098). D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on review of instrument verification records, review of the laboratory's personnel records, and confirmed in interview of facility personnel, 1 of 1 testing persons failed to have documentation of training when the laboratory implemented a new hematology analyzer. The findings included: 1. Review of instrument verification records found the laboratory installed a new Horiba hematology analyzer in January 2020. 2. Review of personnel records for testing personnel #1 (as listed on Form CMS- 209) found no documentation of training for the newly installed Horiba hematology analyzer. 3. The laboratory was asked to provide documentation of the required training. No documentation was provided. 4. An interview with the technical consultant on November 4, 2021 at 14:30 hours in the break room confirmed the findings. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the Casper 155 Report and verified with the proficiency testing company, American Proficiency Institute (API). 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; lab 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 proficiency testing records, it was determined that 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 5 -- 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 Sodium (Na) (refer to D2096). 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 Casper Report 155 and American Proficiency Institute (API) proficiency testing (PT) records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry. Findings: 1. API 2020 - 1st event the laboratory received an unsatisfactory score of 60% for Sodium. 2. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Sodium. 3. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for ALT. 4. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Albumin. 5. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Alkaline Phosphatase. 6. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Amylase. 7. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for AST. 8. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Total Bilirubin. 9. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Total Calcium. 10. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Chloride. 11. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Total Cholesterol. 12. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for HDL Cholesterol. 13. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Creatine. 14. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Glucose. 15. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Potassium. 16. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Total Protein. 17. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Triglycerides. 18. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for BUN. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(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: Review of the Casper 155 Report and American Proficiency Institute (API) proficiency testing (PT) records found that the laboratory failed to achieve a satisfactory score of at least 80% for the overall chemistry testing event score. Findings: 1. API 2020 - 2nd event reported an event chemistry score of 0%. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) -- 2 of 5 -- 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: Review of the Casper 155 Report and American Proficiency Institute (API) proficiency testing (PT) records found that the laboratory failed to participate in 2020 (2nd Event) resulting in a score of 0% for the all analytes in the specialty of Chemistry, constituting unsatisfactory performance. Findings: 1. API 2020 - 2nd event reported No Data Received resulting in the following unsatisfactory scores: Alanine aminotransferase ALT 0% Albumin 0% Alkaline Phosphatase 0% Amylase 0% Aspartate aminotransferase AST 0% Bilirubin, Total 0% Calcium, Total 0% Chloride 0% Total Cholesterol 0% Cholesterol HDL (high density lipoprotein) 0% Creatinine 0% Glucose 0% Potassium 0% Sodium 0% Total Protein 0% Triglycerides 0% Blood Urea Nitrogen BUN 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 a desk review of American Proficiency Institute (API) proficiency testing (PT) 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 Sodium. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. API 2020 - 1st event the laboratory received an unsatisfactory score of 60% for Sodium. 2. API 2020- 2nd event the laboratory received an unsatisfactory score of 0% for Sodium. D2099 ENDOCRINOLOGY CFR(s): 493.843(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: Review of the Casper Report 155 and American Proficiency Institute (API) proficiency testing (PT) records found that the laboratory failed to achieve a satisfactory score of at least 80% for the overall endocrinology testing event score. -- 3 of 5 -- Findings: 1. API 2020 - 2nd event lab received an unsatisfactory event score of 0% for Endocrinology. D2100 ENDOCRINOLOGY CFR(s): 493.843(c) 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: Review of the Casper 155 Report and American Proficiency Institute (API) proficiency testing (PT) records found that the laboratory failed to participate in 2020 (2nd Event) resulting in a score of 0% for the all analytes in the specialty of Endocrinology, constituting unsatisfactory performance. Findings: 1. API 2020 - 2nd event reported No Data Received resulting in the following unsatisfactory scores: Thyroxine, Free 0% Thyroid Stimulating Hormone 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 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 -- 4 of 5 -- 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 -- 5 of 5 --

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 No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 A follow-up visit for the proficiency test desk review survey was performed onsite on February 8, 2018. The laboratory failed to cease testing for the analytes of Hematocrit and Red Blood Cell according to the enforcement letter dated July 5, 2017. The laboratory performed 319 CBC (complete blood count) patient tests that included the analytes of Hematocrit and Red Blood Cell from the period of July 20, 2017 to February 8, 2018. The laboratory has not demonstrated two consecutive sustained satisfactory performance (>80%) on two consecutive testing events for reinstatement. The laboratory continued to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: 493.803 successful participation in a proficiency testing program 493.807 (a) Reinstatement after Failure 493.1403 laboratories performing moderate complexity testing; laboratory director ******************** 30468 The following deficiencies are a result of two desk reviews performed on October 3, 2017 and November 16, 2017 of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). 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 493.807 (a) reinstatement after failure These are repeat deficiencies noted on the 6/17/17 CMS 2567. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --