Internal Medicine Associates

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on a review of AAB (American Association of Bioanalysts) proficiency testing records, a review of CMS (Centers for Medicare and Medicaid Services) CASPER reports, and an interview with the Technical Consultant [also Testing Personnel (TP) #1], the surveyor determined the laboratory failed to ensure proficiency testing results were released and reported to HHS (Health and Human Services) to assure CLIA (Clinical Laboratory Improvement Amendments) was able to determine the laboratory's performance with proficiency testing. This affected the survey review period from September 13, 2018 - June 15, 2021. The findings include: 1. The pre- survey offsite review of the CMS CASPER reports revealed no proficiency testing scores for the laboratory were reported to HHS for the review period from September 2018 - June 15, 2021. 2. An on-site review of the AAB proficiency testing records revealed the CLIA number was not listed on the reports sent to the laboratory from AAB, which indicates the proficiency testing provider had not been provided the necessary information to release the laboratory's results to HHS. 3. During an interview on June 15, 2021 at 12:33 PM, the surveyor inquired of the Technical Consultant if AAB had been contacted to release the proficiency testing scores to the national data base for compliance determination. The Technical Consultant stated the proficiency testing was ordered through the McKesson representative, who she assumed had taken care of all the reporting requirements. After reviewing the proficiency testing reports and forms for the CLIA number (not listed), the Technical Consultant confirmed the above noted 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 5 -- 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 a review of AAB (American Association of Bioanalysts) proficiency testing records and an interview with the Technical Consultant (TC), the surveyor determined the laboratory failed to verify the accuracy of "direct bilirubin" testing, at least twice annually. The laboratory routinely participated in organized proficiency testing for Chemistry, specifically "direct bilirubin" testing, which was not offered by the proficiency testing provider used, according to the TC. This affected seven testing events, reviewed by the surveyor. The finding include: 1. A review of the AAB proficiency testing records for 2018 (Event #3) - 2021 (Event #1) revealed the laboratory resulted the "direct bilirubin" for each event, with the following scores: a) Event #3, 2018; Eighty percent (80 %), performed on the Architect (discontinued at the end of 2018). b) Event #1, 2019; 40 % (Chemistry testing now performed on a Vitros 5600) c) Event #3, 2019; 40 % d) Event #1, 2020; 60 % e) Event #2, 2020; 60 % f) Event #3, 2020; 20 % g) Event #1, 2020; 40 % The laboratory did not document

Summary Statement of Deficiencies 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 interviews with the Technical Consultant (TC), and a review of proficiency testing records and an order confirmation sheet, the surveyor determined the laboratory failed to enroll in proficiency testing for Coagulation [Prothrombin and INR (International Normalized Ratio)] for 2018. The laboratory continued to perform Coagulation testing on patient specimens. The laboratory did not establish an alternate method of verifying the accuracy of the testing, although no specimens were available through organized providers for the instrument and methodology used by the laboratory. This affected 2018 enrollment from January to September. The findings include: 1. During the initial tour of the laboratory at 9:44 AM on 9/12/18, the TC [also Testing Personnel #1 (TP #1)] stated the laboratory was performing Coagulation testing on the Hemochron Jr. The TC explained the instrument/methodology was not supported by any proficiency testing provider. Thus, the laboratory was not currently enrolled in proficiency testing for this testing (this same instrument was used for testing during the previous survey period). According to the TC, the laboratory had used AAFP for 2016 and 2017; however this provider no longer provided samples for this instrument-methodology type. The laboratory enrolled with AAB (American Association of Bioanalysts) for 2018; however no Coagulation samples were 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 7 -- for this instrument-methodology. The laboratory had not established an alternate method to verify the accuracy of the Coagulation testing. 2. The AAB proficiency testing records and a 2018 AAB Order Confirmation sheet (dated 4/04/18) failed to include Coagulation testing samples. 3. At 11:22 AM on 9/12/18, the TC stated the laboratory changed PT (Proficiency Testing) providers for 2018 from AAFP to AAB. According to the TC, the laboratory's enrollment should have been submitted through the McKesson representative in December of 2017. It was not until March of 2018, did the TC realize she had not received any PT specimens. Upon contacting AAB in March, the TC realized the laboratory had not been enrolled in any proficiency testing. On April 18, 2018, the laboratory received a late shipment of testing specimens for Chemistry (only 4 specimens) and CBCs (Complete Blood Counts). No PT samples were received for Coagulation. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the test menu, a review of proficiency testing records (attestation statements and instrument printouts), a review of personnel competency evaluations, and an interview with the Technical Consultant [also Testing Personnel (TP) #1], the surveyor determined the laboratory failed to rotate the testing of proficiency specimens among all testing personnel, who routinely perform moderate-complexity testing of patient specimens. This affected seven of seven testing events reviewed by the surveyor. The findings include: 1. The surveyor reviewed the testing menu with the Technical Consultant, upon initial tour of the laboratory on 9/12/18 at 9:44 AM. The testing menu included Hematology (Emerald Cell-Dyn, Complete Blood Count), Streck Auto Plus (Erythrocyte Sedimentation Rate), Coagulation (Hemochron Jr, PT /INR), and Chemistry/Endocrinology (Architect Plus), all moderate-complexity testing. 2. A review of the attestation statements retained with proficiency testing records revealed the testing personnel as TP #1 [also the Technical Consultant (TC)] for Events: AAFP 2016 B and C; and AAFP 2017 A, B and C. 3. There were no attestation statements retained for AAB Events for 2018 Quarters 1 and 2. However, the instrument printouts for Quarter 1 indicated TP #1 (TC) was the testing personnel. 4. In an interview on 9/12/18 at 11:45 AM, TP #1 stated she was the testing personnel for proficiency testing for Quarter 2. At 2:37 PM, TP #1 (TC) stated she understood proficiency testing should be rotated among the testing personnel. The TC also stated she usually performed all of the proficiency testing. The TC further stated TP #2 was trained and qualified to test all moderate-complexity testing as listed, and routinely tested patient specimens. 5. The CMS form 209 included TP #2 as a qualified testing personnel of moderate complexity testing. 6. TP #2's personnel competency assessments were last documented on 9/30/17 and 1/28/16, which indicated her competency to perform moderate complexity testing. 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, -- 2 of 7 -- consultant competency. This STANDARD is not met as evidenced by: Based on a review of personnel competency evaluations and an interview with the Technical Consultant (TC), [also Testing Personnel (TP) #1], the surveyor determined the laboratory failed to assess the competency of the TC for the CLIA survey review period of August 18, 2016 - September 12, 2018. This affected 1 of 2 testing personnel, who performed moderate complexity testing, and the only technical consultant, listed on the form CMS 209. The findings include: 1. A review of competency evaluations for the laboratory staff revealed no laboratory competency evaluation for TP #1, also the Technical Consultant. TP #1 was one of two testing personnel with greater than one year employment with the laboratory. 2. At the time of this review, at 10:05 AM on 9/12/18, the Technical Consultant stated the Laboratory Director had performed a Performance Evaluation (reviewed by the surveyor) on her (TP #1/TC); however confirmed this evaluation did not include laboratory responsibilities nor competency. At this time, the surveyor discussed with the TC ways to achieve this assessment with the Laboratory Director's involvement. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of 2016 and 2017 proficiency testing (PT) records and an interview with the Technical Consultant (TC), the surveyor determined the laboratory failed to ensure the accuracy of the Coagulation testing [Prothrombin and INR (International Normalized Ratio)], as evidenced by the laboratory failing to review and evaluate proficiency testing results, which were not graded by the PT provider. This affected five of five events (2016 - 2017), reviewed by the surveyor. The findings include: 1. A review of the AAFP (American Academy of Family Physicians) proficiency testing records for 2016 - 2017 revealed the results of the following events were not graded by AAFP, due to having no comparison group: AAFP 2016 B and C events; and AAFP 2017 A, B and C events. 2. On 9/12/18 at 2:08 PM, the TC confirmed the results were not graded by AAFP. Also, the TC did not provide documentation the laboratory staff reviewed the results for reporting accuracy. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of AAFP (American Academy of Family Physicians) proficiency testing records for 2017 and AAB (American Association of Bioanalysts) records for 2018, and an interview with the Technical Consultant (also Testing Personnel #1), the surveyor determined the laboratory failed to implement and document