Angelina Pediatrics

Summary Statement of Deficiencies D0000 An onsite survey conducted 12/19/2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and attestation forms, personnel documents, and confirmed in interview, the laboratory failed to include the signatures of testing personnel performing test interpretation for six of six PT testing events in Microbiology in 2022 and 2023. The findings included: 1. Review of the API forms for the events 1st, 2nd, and 3rd events in 2022 and 2023 included the following microbiology PT challenges: Throat Culture Urine Colony Count A review of the API attestation forms had the following personnel listed for person(s) performing the test: 2022 Microbiology 1st Event: TP 15 (see TP crosswalk) TP 16 (see TP crosswalk) TP 1 2022 Microbiology 2nd Event: TP 15 TP 16 TP 21 (see TP crosswalk) TP 20 (see TP crosswalk) 2022 Microbiology 3rd Event: TP 15 TP 1 TP 20 2023 Microbiology 1st Event: TP 3 TP 4 TP 6 TP 33 (see TP crosswalk) TP 32 (see TP crosswalk) 2023 Microbiology 2nd Event: TP 3 TP 1 TP 31 (see TP crosswalk) TP 2 TP 4 2023 Microbiology 3rd Event: TP 3 TP 4 TP 6 TP 33 TP 32 2. The review of laboratory personnel documents, for the above, did not include training and competency evaluations for microbiology test interpretation for throat cultures and urine culture colony counts. In an interview on 12/19/2023 at 11: 35 hours, in the office, the technical consultant (TC) stated that the attestations signatures were for only those testing personnel (TP) preparing the sample for testing and that they did not perform test interpretation for the PT results. The TC stated that 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 -- TP's 8 - 13 were the only ones trained and competent to perform test interpretation. The surveyor queried as to which TP provided the PT results for the 2022 and 2023 microbiology events and none was provided. 3. In an interview on 12/19/2023 at 11: 40 hours, in the office, the TC confirmed that the TP performing the test interpretation for the microbiology 2022 and 2023 PT results had not been documented or attested to. D5783

Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Form CMS 209, laboratory personnel records, and confirmed in interview, the technical consultant failed to perform annual competency assessments on four of nine testing personnel who required one. The findings were: 1. Review of the laboratory's submitted Form CMS 209 (CLIA Laboratory Personnel Report) found the laboratory listed nine testing persons who perform moderate complexity testing. 2. Review of laboratory personnel records found no documentation of an annual competency assessment for the following four of nine testing personnel who required one in 2019 and 2020: Testing Personnel 5 (as listed on Form CMS 209) Testing Personnel 6 (as listed on Form CMS 209) Testing Personnel 8 (as listed on Form CMS 209) Testing Personnel 9 (as listed on Form CMS 209) 3. The laboratory was asked to provide documentation of the technical consultant performing an annual competency assessment for the four of nine testing persons who required one in 2019 and 2020. No documentation was provided. 4. The findings were confirmed in interview with the technical consultant on January 27, 2022 at 10:00 hours in the break room. She stated the providers interpret the zone of hemolysis for Strep testing. Key: CMS - Centers for Medicare and Medicaid Services CLIA - Clinical Laboratory Improvement Amendments 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 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 review of laboratory temperature logs and staff interview, the laboratory failed to maintain bacteriology incubator temperatures within the range specified in policy. Findings: 1. Laboratory quality assurance documentation was reviewed. The temperature chart for the Strep Incubator showed an acceptable range of 33-37 degrees Celsius (C). 2. Review of the temperature charts for 2019 and 2020 revealed the following readings outside the posted range: (Note: readings represent AM/PM temperatures read at beginning and end of shift) DATE TEMP (C) DATE TEMP (C) 04/03/2019 37/38 12/09/2019 37/38 04/25/2019 38/36 12/10/2019 37/38 05/02/2019 38/38 12/12/2019 38/37 05/07/2019 38/38 12/18/2019 39/38 05/29/2019 38/38 12/19 /2019 37/39 05/31/2019 38/36 12/20/2019 37/38 06/19/2019 37/38 12/24/2019 37/38 07/15/2019 36/38 12/26/2019 38/38 07/16/2019 38/35 12/27/2019 38/38 07/17/2019 38/36 01/10/2020 38/37 07/18/2019 36/38 04/10/2020 38/38 08/28/2019 38/38 04/13 /2020 38/38 08/29/2019 37/38 04/14/2020 36/38 08/30/2019 38/37 04/15/2020 38/38 09/04/2019 38/37 04/17/2020 36/38 09/05/2019 38/37 06/01/2020 38/37 09/12/2019 38/37 06/02/2020 37/38 09/26/2019 37/38 06/05/2020 37/38 09/27/2019 37/38 06/09 /2020 38/36 10/02/2019 37/38 06/17/2020 38/38 10/03/2019 37/38 06/19/2020 38/38 10/28/2019 38/37 06/23/2020 38/38 10/29/2019 37/38 06/24/2020 36/38 10/30/2019 37/38 06/26/2020 38/36 10/31/2019 37/38 06/29/2020 37/38 11/05/2019 37/38 07/14 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 -- /2020 37/38 11/26/2019 38/37 07/20/2020 37/38 12/02/2019 37/38 07/21/2020 38/39 12/03/2019 36/38 3. No evidence of