White Oak Pediatrics

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and the procedure manual and interview with the laboratory director (LD), the laboratory did not have written procedures stating that staff who perform the throat culture proficiency testing (interpretation) for reporting to the proficiency test provider, to not discuss their results with other staff who may also have performed the test prior to submission of their test results. Findings: 1. The procedure manual did not include procedures stating that proficiency testing results interpreted by the primary testing person (testing person who is reporting the test results to the proficiency test provider) are not to be discussed with staff who may also be performing the testing, prior to submission of their test results to the proficiency test provider. 2. During the afternoon of the survey on August 14, 2023, the laboratory director confirmed that the laboratory did not have written procedures or documentation to show that the primary testing person did not discuss results with other staff prior to submission of their results to the proficiency test provider. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 -- 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 proficiency testing (PT) records and the procedure manual and interview with the laboratory director (LD), the laboratory did not document the identity of the testing person for each Proficiency test sample that was tested. Findings: 1. The attestation statement from the 2022 1st and 2nd PT event for throat cultures was signed by Testing Person # 1 and Testing Person # 2, but the description of what samples each person tested (Interpreted) was not written on the statement. 2. The attestation statement from the 2022 MLE-M3 PT event for throat cultures was signed by Testing Person # 1 and Testing Person #2 along with four other individuals, but the identification of samples each person tested or processed (prepared cultures for) was not written on the attestation statement. 3. The laboratory did not have the attestation statement for the 1st and 2nd proficiency test event in 2023 for throat culture testing. 4.. During the afternoon of the survey on August 14, 2023, the laboratory director confirmed that the laboratory did not have written procedures or documentation to show who performed the proficiency testing and that the primary did not discuss results with other staff prior to submission to the proficiency test provider. 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 review of proficiency test records (PT), the laboratory did not have documentation that the laboratory director reviewed the results of the proficiency test provider's evaluation of the laboratory's performance for the 1st proficiency test event in 2023 for throat culture testing. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on review of competency check records performed for testing staff (for throat culture testing), the laboratory director did not document if those competency checks were made by observation of throat and urine culture testing or by proficiency testing, or review of urine and throat culture testing records, as needed to show how competency was assessed. -- 3 of 3 --

Summary Statement of Deficiencies 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 proficiency testing (PT) records and interview with the laboratory director (LD), the laboratory failed to attest to the routine integration of throat culture PT samples into the patient workload using the laboratory's routine methods in four out of six PT testing events reviewed. Findings: 1. Throat culture PT records from Medical Laboratory Evaluation (MLE) modules 1-3 (M1-M3) from 2020 and 2021 were reviewed. 2. MLE supplied the laboratory with a "Test Result Form" for each module which included an "Attestation Statement", to be signed by the LD or designee and the testing personnel (TP) that performed the testing, indicating that the PT was performed in the same manner as patient testing. 3. The "Attestation Statement" was not signed by the LD or designee for the 2021 MLE-M2 PT event. 4. The "Attestation Statement" was not signed by the TP who performed the testing for the 2020 MLE-M2, 2020 MLE-M3, and 2021 MLE-M3 PT events. 5. During the survey on 10/27/2021 at 11:30 AM, the LD confirmed that the attestation statements for performing PT in the same manner as patient testing were not consistently signed by laboratory personnel. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. 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 review of proficiency testing (PT) records and the procedure manual and interview with the laboratory director (LD), the laboratory failed to test throat culture PT samples the same number of times that it routinely tested patient samples. Findings: 1. Records from the 2020 3rd PT event for throat cultures included a worksheet documenting that all five PT samples were evaluated by five different testing personnel (TP). 2. The worksheet did not include a date that each TP evaluated the PT samples or a statement that the PT samples were tested by a single individual and then reviewed by the other TP after the PT results were submitted to the PT provider as part of the TP competency assessments. 3. The procedure manual did not include any procedures stating that routine patient throat cultures were to be reviewed by multiple TP prior to releasing test results. 4. During the survey on 10/27/2021 at 11: 30 AM, the laboratory director confirmed that the PT records indicated that multiple TP evaluated the PT samples prior to results submission to the PT provider. 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 interview with the laboratory director (LD) and review of instrument data, the laboratory failed to report severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) negative test results on 117 of 117 days reviewed from 06/01/2021 through 10 /27/2021. Findings: 1. The laboratory tested patient specimens for SARS-CoV-2 using the Quidel Sofia 2 analyzer. 2. During the survey on 10/27/2021 at 11:30 AM, the LD confirmed that the laboratory was only reporting positive results to the Maryland Department of Health (MDH) and was not reporting negative results. 3. Patient test results from the Quidel Sofia 2 analyzer were electronically transferred to an Excel worksheet that was received via email on 11/09/2021 at 9:32 PM. 4. The Sofia 2 analyzer data was reviewed from 06/01/2021-10/27/2021, during which 689 valid tests were performed. Of 689 valid tests performed, 670 resulted in negative detection. 5. Data review revealed that 65 of 65 tests performed on 22 days in 06/2021 were negative, 79 of 80 tests performed on 23 days in 07/2021 were negative, 98 of 101 tests performed on 24 days in 08/2021 were negative, 243 of 254 tests performed on 26 days in 09/2021 were negative, and 185 of 189 tests performed on the 22 days that were reviewed in 10/2021 were negative. 6. In an email received on 11/09/2021 at 9: 32 PM, the LD stated that staff have been instructed to report all positive and negative SARS-CoV-2 results to MDH. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) -- 2 of 4 -- 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 review of the procedure manual and proficiency testing (PT) records and interview with the laboratory director (LD), the laboratory failed to verify the accuracy of rectal culture testing. Findings: 1. The procedure manual included a procedure titled "Rectal Cultures" that gave instructions for collecting rectal swabs and performing testing to screen for group A streptococcus. 2. Review of PT records showed that the laboratory was only enrolled in PT for throat cultures and not for any additional bacteriology testing. 3. There were no records of any alternative PT or split samples performed twice annually to verify the accuracy of the rectal culture testing. 4. During the survey on 10/27/2021 at 11:30 AM, the LD confirmed that the laboratory did not verify the accuracy of the rectal culture testing twice annually. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of the procedure, personnel report and proficiency testing (PT) records and interview with the laboratory director (LD), testing of the throat culture PT samples was not rotated among all the testing personnel (TP) for evaluation of each individual's competency for evaluating patient throat culture testing results. Findings: 1. The procedure titled "Personnel Assessment" stated that "PT samples will be performed by all employees on a rotating basis." 2. The laboratory personnel report (form CMS-209) listed seven TP that evaluated results for patient throat culture testing. 3. Throat culture PT records from Medical Laboratory Evaluation (MLE) modules 1-3 (M1-M3) from 2020 and 2021 were reviewed. 4. MLE supplied the laboratory with a "Test Result Form" for each module which included an "Attestation Statement", to be signed by the TP that performed the testing. 5. Event 2020 MLE-M1 contained the signatures of five TP. 6. Event 2020 MLE-M3 contained no signatures, but included a worksheet indicating that 5 TP evaluated the PT samples. 7. Events 2020 MLE-M2 and 2021 MLE-M3 contained no signatures and no additional documentation identifying which TP performed the PT. 8. Events 2021 MLE-M1 and 2021 MLE-M2 contained a single signature from the same individual performing the PT for both events. 9. During the survey on 10/27/2021 at 11:30 AM, the LD confirmed that testing of the throat culture PT samples was not documented as being rotated among all TP for evaluation of individual competency. 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. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory personnel report and personnel competency records and interview with the laboratory director (LD), the laboratory failed to provide documentation of annual competency assessments of the testing personnel (TP) evaluating patient throat cultures for 2019 and 2020. Findings: 1. The laboratory personnel report (form CMS-209) listed six TP (other than the LD) that evaluated results for patient throat culture testing. 2. Laboratory records for the competency assessments of the six TP evaluating throat cultures were reviewed for 2021, but were missing for 2019 and 2020. 3. During the survey on 10/27/2021 at 11:30 AM, the LD confirmed that documentation of the annual competency assessments for the six TP performing throat cultures was missing for 2019 and 2020. -- 4 of 4 --

Summary Statement of Deficiencies 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 proficiency testing (PT) records and interview with the laboratory director (LD), the laboratory failed to attest to the routine integration of throat culture PT samples into the patient workload using the laboratory's routine methods in four out of six PT testing events reviewed. Findings: 1. Throat culture PT records from Medical Laboratory Evaluation (MLE) modules 1-3 (M1-M3) from 2020 and 2021 were reviewed. 2. MLE supplied the laboratory with a "Test Result Form" for each module which included an "Attestation Statement", to be signed by the LD or designee and the testing personnel (TP) that performed the testing, indicating that the PT was performed in the same manner as patient testing. 3. The "Attestation Statement" was not signed by the LD or designee for the 2021 MLE-M2 PT event. 4. The "Attestation Statement" was not signed by the TP who performed the testing for the 2020 MLE-M2, 2020 MLE-M3, and 2021 MLE-M3 PT events. 5. During the survey on 10/27/2021 at 11:30 AM, the LD confirmed that the attestation statements for performing PT in the same manner as patient testing were not consistently signed by laboratory personnel. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. 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 review of proficiency testing (PT) records and the procedure manual and interview with the laboratory director (LD), the laboratory failed to test throat culture PT samples the same number of times that it routinely tested patient samples. Findings: 1. Records from the 2020 3rd PT event for throat cultures included a worksheet documenting that all five PT samples were evaluated by five different testing personnel (TP). 2. The worksheet did not include a date that each TP evaluated the PT samples or a statement that the PT samples were tested by a single individual and then reviewed by the other TP after the PT results were submitted to the PT provider as part of the TP competency assessments. 3. The procedure manual did not include any procedures stating that routine patient throat cultures were to be reviewed by multiple TP prior to releasing test results. 4. During the survey on 10/27/2021 at 11: 30 AM, the laboratory director confirmed that the PT records indicated that multiple TP evaluated the PT samples prior to results submission to the PT provider. 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 interview with the laboratory director (LD) and review of instrument data, the laboratory failed to report severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) negative test results on 117 of 117 days reviewed from 06/01/2021 through 10 /27/2021. Findings: 1. The laboratory tested patient specimens for SARS-CoV-2 using the Quidel Sofia 2 analyzer. 2. During the survey on 10/27/2021 at 11:30 AM, the LD confirmed that the laboratory was only reporting positive results to the Maryland Department of Health (MDH) and was not reporting negative results. 3. Patient test results from the Quidel Sofia 2 analyzer were electronically transferred to an Excel worksheet that was received via email on 11/09/2021 at 9:32 PM. 4. The Sofia 2 analyzer data was reviewed from 06/01/2021-10/27/2021, during which 689 valid tests were performed. Of 689 valid tests performed, 670 resulted in negative detection. 5. Data review revealed that 65 of 65 tests performed on 22 days in 06/2021 were negative, 79 of 80 tests performed on 23 days in 07/2021 were negative, 98 of 101 tests performed on 24 days in 08/2021 were negative, 243 of 254 tests performed on 26 days in 09/2021 were negative, and 185 of 189 tests performed on the 22 days that were reviewed in 10/2021 were negative. 6. In an email received on 11/09/2021 at 9: 32 PM, the LD stated that staff have been instructed to report all positive and negative SARS-CoV-2 results to MDH. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) -- 2 of 4 -- 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 review of the procedure manual and proficiency testing (PT) records and interview with the laboratory director (LD), the laboratory failed to verify the accuracy of rectal culture testing. Findings: 1. The procedure manual included a procedure titled "Rectal Cultures" that gave instructions for collecting rectal swabs and performing testing to screen for group A streptococcus. 2. Review of PT records showed that the laboratory was only enrolled in PT for throat cultures and not for any additional bacteriology testing. 3. There were no records of any alternative PT or split samples performed twice annually to verify the accuracy of the rectal culture testing. 4. During the survey on 10/27/2021 at 11:30 AM, the LD confirmed that the laboratory did not verify the accuracy of the rectal culture testing twice annually. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of the procedure, personnel report and proficiency testing (PT) records and interview with the laboratory director (LD), testing of the throat culture PT samples was not rotated among all the testing personnel (TP) for evaluation of each individual's competency for evaluating patient throat culture testing results. Findings: 1. The procedure titled "Personnel Assessment" stated that "PT samples will be performed by all employees on a rotating basis." 2. The laboratory personnel report (form CMS-209) listed seven TP that evaluated results for patient throat culture testing. 3. Throat culture PT records from Medical Laboratory Evaluation (MLE) modules 1-3 (M1-M3) from 2020 and 2021 were reviewed. 4. MLE supplied the laboratory with a "Test Result Form" for each module which included an "Attestation Statement", to be signed by the TP that performed the testing. 5. Event 2020 MLE-M1 contained the signatures of five TP. 6. Event 2020 MLE-M3 contained no signatures, but included a worksheet indicating that 5 TP evaluated the PT samples. 7. Events 2020 MLE-M2 and 2021 MLE-M3 contained no signatures and no additional documentation identifying which TP performed the PT. 8. Events 2021 MLE-M1 and 2021 MLE-M2 contained a single signature from the same individual performing the PT for both events. 9. During the survey on 10/27/2021 at 11:30 AM, the LD confirmed that testing of the throat culture PT samples was not documented as being rotated among all TP for evaluation of individual competency. 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. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory personnel report and personnel competency records and interview with the laboratory director (LD), the laboratory failed to provide documentation of annual competency assessments of the testing personnel (TP) evaluating patient throat cultures for 2019 and 2020. Findings: 1. The laboratory personnel report (form CMS-209) listed six TP (other than the LD) that evaluated results for patient throat culture testing. 2. Laboratory records for the competency assessments of the six TP evaluating throat cultures were reviewed for 2021, but were missing for 2019 and 2020. 3. During the survey on 10/27/2021 at 11:30 AM, the LD confirmed that documentation of the annual competency assessments for the six TP performing throat cultures was missing for 2019 and 2020. -- 4 of 4 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, observation and interview, the lab did not perform quality control procedures for the selective strep agar plates and "Uricult" media used for bacteriology testing. Findings: 1. The laboratory receives bacteriology test media into the lab, and uses quality control checks, performed by the manufacturer to show that the media reacts as expected; 2. In order for the lab to use the manufacturer's quality control checks, the lab is required to document receipt of the culture media, observe the media for physical defects, contamination and drying, and document these activities for each lot and shipment of culture media received; 3. The last quality control check performed by the lab, for the selective strep agar was conducted on April 3, 2018 (lot 1803608) with an assigned expiration date of May 28, 2018, further quality checks have not been recorded as of the date of survey; 4. Prior to the April 3, 2018 media quality control check for the selective strep agar, the last quality control check was performed almost one year ago on March 9, 2017 (lot 7068632) with an assigned expiration date of July 18, 2017; 5. Selective strep agar plates were observed in the lab. The lot number of the plates were 1905830 and 1904500. The quality control checks were not documented on the lab's media check worksheet for these two lots; 6. The last quality control check performed by the lab for the "Uricult" test media 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 -- was on June 3, 2018 for lot number 1810955 that had an assigned expiration date of August 26, 2018, no other receipt was recorded even though it was observed that the lab was using "Uricult" media lot 1875031 (expiration date August 16, 2019) and this media quality control check was not documented; and 7. The lab's records for receipt (quality control) of the "Uricult" media did not include checking the physical characteristics of the media and initials of the person performing the quality control checks in 2018 and 2017. D5781