Internal Medicine Assoc & Arash Tirandaz, Md

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas Health and Human Services Commission, Health Facility Compliance Arlington Group. 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 (Centers for Medicare and Medicaid 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 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: 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 -- Based on a desk review of proficiency testing records, it was determined the laboratory had 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 Routine Chemistry for Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin, Total Calcium, Chloride, Total Cholesterol, Cholesterol, High Density Lipoprotein (HDL), Creatinine, Glucose, Iron, Potassium, Sodium, Total Protein, Triglycerides, Urea Nitrogen, and Uric Acid analytes. 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 Centers for Medicare and Medicaid (CMS) form 0155 and American Proficiency Institute (API) 2020 (1st Event, 2nd Event and 3rd Event) and 2021(1st Event) records, it was revealed the laboratory failed to attain a satisfactory score of at least 80% acceptable responses for Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin, Total Calcium, Chloride, Total Cholesterol, Cholesterol, High Density Lipoprotein (HDL), Creatinine, Glucose, Iron, Potassium, Sodium, Total Protein, Triglycerides, Urea Nitrogen, and Uric Acid analytes in the specialty of Routine Chemistry for 2 of 4 proficiency testing events. Findings included: 1. Review of the CMS 0155 report revealed the following results: Routine Chemistry 2020 - 3rd Event: The laboratory received an unsatisfactory score of 0% for each of the following analytes: Albumin; Alkaline Phosphatase; Alanine Aminotransferase (ALT); Aspartate Aminotransferase (AST); Total Bilirubin; Total Calcium; Chloride; Total Cholesterol; Cholesterol, High Density Lipoprotein (HDL); Creatinine; Glucose; Iron; Potassium; Sodium; Total Protein; Triglycerides; Urea Nitrogen; Uric Acid Routine Chemistry 2021- 1st Event: The laboratory received the following unsatisfactory scores for routine chemistry analytes: Albumin 40% Alkaline Phosphatase 60% ALT 40% AST 40% Total Bilirubin 40% Total Calcium 40% Chloride 40% Total Cholesterol 20% Cholesterol, HDL 40% Creatinine 40% Glucose 40% Iron 40% Potassium 40% Sodium 40% Total Protein 40% Urea Nitrogen 40% Uric Acid 40% 2. A proficiency desk review from American Proficiency Institute (API) 2020 (1st Event, 2nd Event and 3rd Event) and 2021(1st Event) proficiency testing records confirmed the laboratory received the following results: API Chemistry Core 2020 - 3rd Event laboratory received an unsatisfactory score of 0% for each of the following analytes: Albumin; Alkaline Phosphatase; Alanine Aminotransferase (ALT); Aspartate Aminotransferase (AST); Total Bilirubin; Total Calcium; Chloride; Total Cholesterol; Cholesterol, High Density Lipoprotein (HDL); Creatinine; Glucose; Iron; Potassium; Sodium; Total Protein; Triglycerides; Urea Nitrogen; and Uric Acid API Chemistry Core Chemistry 2021- 1st Event laboratory received the following unsatisfactory scores for routine chemistry analytes: Albumin 40% Alkaline Phosphatase 60% ALT 40% AST 40% Total Bilirubin 40% Total Calcium 40% Chloride 40% Total Cholesterol 20% Cholesterol, HDL 40% Creatinine 40% Glucose 40% Iron 40% Potassium 40% Sodium 40% Total Protein 40% Urea Nitrogen 40% Uric Acid 40% -- 2 of 5 -- 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: Based on a proficiency testing desk review of CMS form 0155 and American Proficiency Institute (API) 2020 (1st Event, 2nd Event and 3rd Event) and 2021(1st Event) records, it was revealed that the laboratory failed to attain an overall testing event score of at least 80 % overall score for 2 of 4 Routine Chemistry proficiency testing events which constitutes unsatisfactory performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: Routine Chemistry 2020 - 3rd Event: The laboratory received an overall unsatisfactory score of 0% for Routine Chemistry. Routine Chemistry 2021- 1st Event: The laboratory received an overall unsatisfactory score of 42% for Routine Chemistry 2. A proficiency desk review from American Proficiency Institute (API) 2020 and 2021 proficiency testing records confirmed the laboratory received the following results: API Chemistry Core 2020 - 3rd Event: The laboratory received an overall unsatisfactory score of 0% for Routine Chemistry. API Chemistry Core Chemistry 2021- 1st Event: The laboratory received an overall unsatisfactory score of 42% for Routine Chemistry The laboratory failed to attain an OVERALL testing event score of at least 80 % for 2 of 4 Routine Chemistry events. 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 proficiency testing desk review of CMS form 0155 and American Proficiency Institute (API) 2020 (1st Event, 2nd Event and 3rd Event) and 2021(1st Event) records, it was revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Routine Chemistry for the Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin, Total Calcium, Chloride, Total Cholesterol, Cholesterol, High Density Lipoprotein (HDL), Creatinine, Glucose, Iron, Potassium, Sodium, Total Protein, Urea Nitrogen, and Uric Acid chemistry analytes. Two consecutive unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: Routine Chemistry 2020 - 3rd Event laboratory received an unsatisfactory score of 0% for each of the following analytes: Albumin; Alkaline Phosphatase; Alanine Aminotransferase (ALT); Aspartate Aminotransferase (AST); Total Bilirubin; Total Calcium; Chloride; Total Cholesterol; Cholesterol, High Density Lipoprotein (HDL); Creatinine; Glucose; Iron; Potassium; Sodium; Total Protein; Urea Nitrogen; Uric Acid Routine Chemistry 2021- 1st Event laboratory received the following unsatisfactory scores for routine chemistry analytes: Albumin 40% Alkaline Phosphatase 60% ALT 40% AST 40% Total Bilirubin 40% Total Calcium 40% -- 3 of 5 -- Chloride 40% Total Cholesterol 20% Cholesterol, HDL 40% Creatinine 40% Glucose 40% Iron 40% Potassium 40% Sodium 40% Total Protein 40% Urea Nitrogen 40% Uric Acid 40% 2. A proficiency desk review from American Proficiency Institute (API) 2020 and 2021 proficiency testing records confirmed the laboratory received the following results: API Chemistry Core 2020 - 3rd Event laboratory received an unsatisfactory score of 0% for each of the following analytes: Albumin; Alkaline Phosphatase; Alanine Aminotransferase (ALT); Aspartate Aminotransferase (AST); Total Bilirubin; Total Calcium; Chloride; Total Cholesterol; Cholesterol, High Density Lipoprotein (HDL); Creatinine; Glucose; Iron; Potassium; Sodium; Total Protein; Urea Nitrogen; Uric Acid API Chemistry Core Chemistry 2021- 1st Event laboratory received the following unsatisfactory scores for routine chemistry analytes: Albumin 40% Alkaline Phosphatase 60% ALT 40% AST 40% Total Bilirubin 40% Total Calcium 40% Chloride 40% Total Cholesterol 20% Cholesterol, HDL 40% Creatinine 40% Glucose 40% Iron 40% Potassium 40% Sodium 40% Total Protein 40% Urea Nitrogen 40% Uric Acid 40% D2097 ROUTINE CHEMISTRY CFR(s): 493.841(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 a proficiency testing desk review of CMS form 0155 and American Proficiency Institute (API) 2020 (1st Event, 2nd Event and 3rd Event) and 2021(1st Event) records, it was revealed the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for 2 of 2 consecutive testing events for the specialty of chemistry. Two consecutive unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: Routine Chemistry 2020 - 3rd Event: The laboratory received an overall unsatisfactory score of 0% for Routine Chemistry. Routine Chemistry 2021- 1st Event: The laboratory received an overall unsatisfactory score of 42% for Routine Chemistry 2. A proficiency desk review from American Proficiency Institute (API) 2020 and 2021 proficiency testing records confirmed the laboratory received the following results: API Chemistry Core 2020 - 3rd Event: The laboratory received an overall unsatisfactory score of 0% for Routine Chemistry. API Chemistry Core Chemistry 2021- 1st Event: The laboratory received an overall unsatisfactory score of 42% for Routine Chemistry 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 -- 4 of 5 -- 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. -- 5 of 5 --