Internal Medicine Associates, Pa

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), and interview with the Testing Personnel (TP), the laboratory failed to have a procedure for Quality control verification (QVC) for Endocrinology, Hematology and Routine Chemistry testing from 6/24/21 to the date of survey. The TP confirmed on 8/15/23 at 11:30 am that the laboratory failed to have the above mentioned procedure. 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 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 an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% or more for Hematology tests performed with the American Association of Bioanalysts (AAB). The findings include: 1) The laboratory scored a 60% for Hemoglobin (Hgb) in event 3-21 and 40% in event 2-21 with the AAB. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an office review of the proficecny testing provider reports and CASPER reports 153 and 155 and Proficiency Testing (PT), the laboratory failed to achieve a score of 80% or more in two out of three event for for Hematology tests performed with American Association of Bioanalysts (AAB). The findings include: 1) The laboratory scored a 60% for Hemoglobin (Hgb) in event 3-21 and 40% in event 2-21 with the AAB. 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 an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the Laboratory Director (LD) failed to provide appropriate direction to laboratory personnel to ensure that the PT surveys are performed satisfactorily and that the laboratory is in compliance with the CLIA regulations. -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to evaluate coded results obtained from the American Association of Bioanalysts (AAB) for Chemistry and Nonchemistry events from May 2019 to the date of survey. The findings include: 1. The laboratory did not evaluate Code # (This method was not graded due to an insufficient number of peer respondents. No appropriate default grouping was available. The listed range should provide a reasonable guild to your performance. However, exercise caution in evaluating your results) response from AAB for the following: a) Triiodothyronine Total (TT3) in Chemistry events Q2 and Q3 2019, and 2020, and Q1 2021. b) Leukocyte, Hemoglobin, Hematocrit, Platelets, Neutrophil, and Lymphocyte % in Nonchemistry event Q3 2020. 2. The LD confirmed on 6/24/21 at 10:00 am that the laboratory failed to evaluate the above mentioned coded results. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to verify the accuracy of Endocrinology and Hematology tests performed the American Association of Bioanalysts (AAB) form May 2019 to the date of survey. The findings include: 1. The laboratory did not evaluate Code # (This method was not graded due to an insufficient number of peer respondents. No appropriate default grouping was available. The listed range should provide a reasonable guild to your performance. However, exercise caution in evaluating your results). The analyte's below received Code #: a) Triiodothyronine Total (TT3) in Chemistry events Q2 and Q3 2019, and 2020, and Q1 2021 but received a score of 100 %. b) Leukocyte (LEU), Hemoglobin (Hgb), Hematocrit, Platelets, Neutrophil, and Lymphocyte % in Nonchemistry event Q3 2020 but received a score of 100%. 2. Upon evaluation analytes scored as below: 2a. Event Q2 Chemistry 2019 the laboratory scored 0% for TT3 a) Challenge 1 result 2.73 Grading Range (GR) 0-2.09. b) Challenge 2 result 4.71 GR .06-3.29. c) Challenge 3 result 5.35 GR 0-3.94. d) Challenge 4 result 5.59 GR 0-4.11. e) Challenge 5 result 3.9 GR .04-3.02. 2b. Event Q3 Chemistry 2019 the laboratory scored 20% for TT3. a) Challenge 11 result 6.06 GR 0-4.08. b) Challenge 13 result 3.27 GR 0-2.7. c) Challenge 14 result 5.8 GR 0-3.81. d) Challenge 15 result 6.97 GR 0-4.6. 2c. Event Q2 Chemistry 2020 the laboratory scored 20% for TT3. a) Challenge 6 result 5.75 GR 0-4.44. b) Challenge 7 result 5.27 GR 0-3.89. c) Challenge 8 result 5.74 GR 0-4.13. d) Challenge 10 result 4.27 GR 0-3.39. 2d. Event Q3 Chemistry 2020 the laboratory scored 0% for TT3. a) Challenge 11 result 5.97 GR 0-4.56. b) Challenge 12 result 4.23 GR 0-3.94. c) Challenge 13 result 3.87 GR 0-3.57. d) Challenge 14 result 6.13 GR 0-4.57 e) Challenge 15 result 4.27 GR 0-4.1. 2e. Event Q3 Nonchemistry 2020 the laboratory scored 40% for LUE. a) Challenge 11 result 6.1 GR 6.3-8.6. b) Challenge 13 result 2.1 GR 2.6-3.5. c) Challenge 15 result 2.2 GR 2.7-3.6. 2f. Event Q3 Nonchemistry 2020 the laboratory scored 40% for Hgb. a) Challenge 11 result 12.2 GR 13.1-15. b) Challenge 13 result 4.9 GR 5.6-6.5. c) Challenge 15 result 4.8 GR 5.7- 6.5. 2g. Event Q3 Nonchemistry 2020 the laboratory scored 0% for Lymph%. a) Challenge 11 result 12.6 GR 16-31.3. b) Challenge 12 result 11.1 GR 12.3-20.1. c) Challenge 13 result 17.6 GR 28.7-44.2. d) Challenge 14 result 10.7 GR 12.2-19.9. e) Challenge 15 result 17.6 GR 29.9-43.7. 3. All analytes above revied a score of 100% from AAB 4. There was no documented evidence

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on lack of the Competency Assessment (CA) records, review of the procedure manual and interview with the Testing Personnel (TP), the laboratory failed to perform a CA on one out of one testing personnel in the calandar year 2017. The TP confirmed on 11/20/18 at 10:25 am that CA procedure was not followed. 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 Performance Specification records and interview with the Testing Personnel (TP), the laboratory failed to verify Reference Interval (RI) for Thyroxine, Thyroid-Stimulating Hormone, Total Thyroxine, Prostate-Specific Antigen performed on the Tosoh AIA-360 analyzer from August 2017 to the date of 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 -- survey. The TP confirmed on 11/20/18 at 12:00 pm that the laboratory did not perform RI verification. -- 2 of 2 --