Beverly Hills Pediatrics

Summary Statement of Deficiencies 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 record review and interview with Testing Personnel #6, the laboratory failed to verify the accuracy of its nasal smear examinations at least twice annually for 2 (October 2021 to October 2023) of 2 years. Findings include: 1. A review of the laboratory's "Wright Staining Proficiency" policy revealed a section stating, "This testing shall take place on an annual basis for all providers who analyze smears for nasal cytology." 2. A review of the laboratory's competency assessment records revealed documentation of verification of accuracy was performed annually rather than twice annually. 3. An interview on 10/18/23 at 9:29 am with Testing Personnel #6 confirmed the laboratory had not verified the accuracy of its nasal smear testing at least twice annually from October 2021 to October 2023. **This is a repeated deficiency from the 11/9/17 recertification survey** D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #6, the laboratory failed to ensure patients with nasal smear testing had test requests from an authorized person for 3 (Patients 5, 8, and 11) of 4 nasal smear patient test records reviewed. 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 -- Findings include: 1. A review of patient test records revealed the following patients had documented test reports for nasal smear testing without a test request from an authorized person: a. Patient #5 had testing performed on 10/4/22. b. Patient #8 had testing performed on 3/14/23. c. Patient #11 had testing performed on 9/7/23. 2. A review of the laboratory's "Quality Assurance Program" policy revealed a section stating, "Test tracking (requisitions)- Ensure the folowing are correct in EMR: a. Patient Name b. Date of collection c. Patient date of birth d. Name of provider ordering test" 3. An interview on 10/18/23 at 10:17 am with Testing Personnel #6 confirmed the patients listed above did not have test requests from an authorized person for the testing performed. **This is a repeated deficiency from the 3/2/2020 recertification survey** D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review and interview with Testing Personnel #6 (TP6), the laboratory failed to report all SARS-CoV-2 test results every day of patient testing for 4 (patients 2, 5, 14, and 15) of 4 patient test records for SARS-CoV-2 testing reviewed. Findings include: 1. The surveyor observed the laboratory's Abbott ID NOW SARS-CoV-2 test system on 3/9/22 at 9:06 am. 2. A review of the laboratory's test records revealed only positive patients tested using the Abbott ID NOW SARS- CoV-2 test system had been reported to the health department. 3. The surveyor requested documentation of the submission of test results to the health department for patients 2, 5, 14, and 15 receiving testing on 11/22/21, 9/21/21, 2/28/22, and 1/14/22 respectively on 3/9/22 at 11:05 am and they were not made available. 4. An interview on 3/9/22 at 11:05 am with TP6 confirmed the laboratory had not reported all SARS- CoV-2 patient test results to the health department. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) 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 -- (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #6 (TP6), the laboratory failed to test the Wright Stain used in the nasal smear procedure to ensure predictable staining characteristics for 2 (March 2020 to March 2022) of 2 years. Findings include: 1. A review of patient test records revealed the following patients had nasal smears performed: a. Patient 3 had testing performed on 10/27/21 b. Patient 7 had testing performed on 7/30/21 c. Patient 9 had testing performed on 4/23/21 d. Patient 10 had testing performed on 3/11/21 e. Patient 11 had testing performed on 11 /12/20 f. Patient 13 had testing performed on 6/12/20 g. Patient 15 had testing performed on 1/14/22 2. The surveyor requested documentation of the assessment of staining characteristics for the dates listed above on 3/9/22 at 11:08 am and it was not made available. 3. An interview on 3/9/22 at 11:08 am with TP6 revealed the laboratory had not performed and documented staining characteristics each day of patient testing. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review and interview with Testing Personnel #6 (TP6), the laboratory failed to report all SARS-CoV-2 test results every day of patient testing for 4 (patients 2, 5, 14, and 15) of 4 patient test records for SARS-CoV-2 testing reviewed. Findings include: 1. The surveyor observed the laboratory's Abbott ID NOW SARS-CoV-2 test system on 3/9/22 at 9:06 am. 2. A review of the laboratory's test records revealed only positive patients tested using the Abbott ID NOW SARS- CoV-2 test system had been reported to the health department. 3. The surveyor requested documentation of the submission of test results to the health department for patients 2, 5, 14, and 15 receiving testing on 11/22/21, 9/21/21, 2/28/22, and 1/14/22 respectively on 3/9/22 at 11:05 am and they were not made available. 4. An interview on 3/9/22 at 11:05 am with TP6 confirmed the laboratory had not reported all SARS- CoV-2 patient test results to the health department. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) 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 -- (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #6 (TP6), the laboratory failed to test the Wright Stain used in the nasal smear procedure to ensure predictable staining characteristics for 2 (March 2020 to March 2022) of 2 years. Findings include: 1. A review of patient test records revealed the following patients had nasal smears performed: a. Patient 3 had testing performed on 10/27/21 b. Patient 7 had testing performed on 7/30/21 c. Patient 9 had testing performed on 4/23/21 d. Patient 10 had testing performed on 3/11/21 e. Patient 11 had testing performed on 11 /12/20 f. Patient 13 had testing performed on 6/12/20 g. Patient 15 had testing performed on 1/14/22 2. The surveyor requested documentation of the assessment of staining characteristics for the dates listed above on 3/9/22 at 11:08 am and it was not made available. 3. An interview on 3/9/22 at 11:08 am with TP6 revealed the laboratory had not performed and documented staining characteristics each day of patient testing. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #9 (TP9), the laboratory failed to have a written and/or electronic request for patient testing from an authorized person for the routine hematology testing for 2 (#2 and #12) of 20 patient charts audited. Findings include: 1. Record review revealed for 2 of 20 patient charts audited the laboratory did not have a written and/or electronic request for laboratory testing by an authorized person as follows: a. Patient #2 complete blood cell count (CBC) performed on 6/27/2018 b. Patient #12 CBC performed on 11/01/2019 2. During the interview on 3/02/2020 at 11:10 am, TP9 confirmed the patient testing did not have a written and/or electronic request. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on document review and interview with Testing Personnel #9 (TP9), the laboratory failed to have the final hematology report maintained as part of the patient's chart or medical record for 2 (#14 and #20) of 20 patient charts audited. Findings include: 1. Record review revealed the final hematology nasal smear for eosinophils was not maintained as part of the patient's electronic medical record (EMR) as 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 -- follows: a. Patient #14 testing performed on 2/05/2018 b. Patient #20 testing performed on 2/12/2020 2. On 3/02/2020 at 11:24 am when queried, TP9 was not able to provide the surveyor the final reports requested. 3. During the interview on 3/02 /2020 at 11:24 am, TP9 confirmed the final nasal smear for eosinophils was not part of the patient's EMR report. -- 2 of 2 --

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 --