Pediatrics In Brevard Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatrics in Brevard PA on November 5, 2025 to December 5, 2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D5300 493.1250 Condition: Preanalytic Systems D5400 493.1250 Condition: Analytic Systems D6000 493.1403 - Condition: Moderate Complexity Laboratory Director D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, and interview, the laboratory failed to follow manufacturer's instructions for interpreting Dermatophyte Test Medium (DTM) test results within 14 days for 54 (#1- 5, 7 - 12, 14 - 16, 20, 26 - 54, 56 - 64) of 64 (#1 - 64) patients from 06 /06/2024 to 10/31/2025. (See D5311) D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to follow manufacturer's instructions for interpreting Dermatophyte Test Medium (DTM) test results within 14 days for 54 (#1- 5, 7 - 12, 14 - 16, 20, 26 - 54, 56 - 64) of 64 (#1 - 64) patients from 06 /06/2024 to 10/31/2025. Findings: 1. Review of the Instructions for Use for Dermatophyte Test Medium noted, "Media should be examined daily for up to fourteen (14) days." The Instructions for Use for the Dermatophyte Test Medium also noted, "False-positive reactions may result, if interpretations are made beyond 14 days of incubation." 2. Review of the DTM Culture Results Log showed the following patient results were reported after 14 days: Patient #1 - date received 03/06/2024, date completed 04/05/2024 Patient #2 - date received 03/14/2024, date completed 04/15 /2024 Patient #3 - date received 04/16/2024, date completed 05/16/2024 Patient #4 - date received 04/17/2024, date completed 05/17/2024 Patient #5 - date received 05/01 /2024, date completed 05/31/2024 Patient #7 - date received 05/20/2024, date completed 06/21/2024 Patient #8 - date received 05/23/2024, date completed 06/25 /2024 Patient #9 - date received 06/11/2024, date completed 07/11/2024 Patient #10 - date received 07/30/2024, date completed 08/21/2024 Patient #11 - date received 07 /30/2024, date completed 08/26/2024 Patient #12 - date received 08/09/2024, date completed 08/26/2024 Patient #14 - date received 08/26/2024, date completed 09/11 /2024 Patient #15 - date received 08/29/2024, date completed 09/20/2024 Patient #16 - date received 08/29/2024, date completed 09/20/2024 Patient #20 - date received 09 /05/2024, date completed 09/24/2024 Patient #21 - date received 09/12/2024, date completed 09/30/2024 Patient #26 - date received 09/26/2024, date completed 10/11 /2024 Patient #27 - date received 10/07/2024, date completed 10/23/2024 Patient #28 - date received 10/25/2024, date completed 11/11/2024 Patient #29 - date received 11 /01/2024, date completed 11/21/2024 Patient #30 - date received 11/15/2024, date completed 12/04/2024 Patient #31 - date received 11/15/2024, date completed 12/04 /2024 Patient #32 - date received 11/19/2024, date completed 12/04/2024 Patient #33 - date received 12/03/2024, date completed 12/26/2024 Patient #34 - date received 12 /03/2024, date completed 12/26/2024 Patient #35 - date received 12/10/2024, date completed 12/31/2024 Patient #36 - date received 12/13/2024, date completed 01/03 /2025 Patient #37 - date received 12/16/2024, date completed 01/10/2025 Patient #38 - date received 01/10/2025, date completed 02/10/2025 Patient #39 - date received 01 /30/2025, date completed 03/03/2025 Patient #40 - date received 01/30/2025, date completed 03/03/2025 Patient #41 - date received 02/05/2025, date completed 03/06 /2025 Patient #42 - date received 02/05/2025, date completed 03/06/2025 Patient #43 - date received 02/07/2025, date completed 03/10/2025 Patient #44 - date received 02 /19/2025, date completed 03/21/2025 Patient #45 - date received 02/19/2025, date completed 03/21/2025 Patient #46 - date received 02/19/2025, date completed 03/21 /2025 Patient #47 - date received 02/19/2025, date completed 03/21/2025 Patient #48 - date received 02/20/2025, date completed 03/21/2025 Patient #49 - date received 03 /13/2025, date completed 04/14/2025 Patient #50 - date received 03/27/2025, date completed 04/29/2025 Patient #51 - date received 03/27/2025, date completed 04/29 /2025 Patient #52 - date received 04/01/2025, date completed 04/21/2025 Patient #53 - date received 04/09/2025, date completed 05/06/2025 Patient #54 - date received 04 /27/2025, date completed 05/27/2025 Patient #56 - date received 05/29/2025, date completed 06/27/2025 Patient #57 - date received 05/29/2025, date completed 06/30 /2025 Patient #58 - date received 07/14/2025, date completed 08/16/2025 Patient #59 - date received 07/17/2025, date completed 08/18/2025 Patient #60 - date received 07 -- 2 of 6 -- /31/2025, date completed 09/03/2025 Patient #61 - date received 07/31/2025, date completed 09/03/2025 Patient #62 - date received 08/25/2025, date completed 09/25 /2025 Patient #63 - date received 09/23/2025, date completed 10/27/2025 Patient #64 - date received 09/30/2025, date completed 10/31/2025 3. During an interview on 11 /17/2025 at 11:55 AM, Technical Consultant B stated the received date was the date the cultures were set up. 4. During an interview on 11/17/2025 at 12:20 PM, Technical Consultant B acknowledged patients' DTM test results were reported after 14 days. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to complete performance specification verification (installation procedure) for the Cell-Dyn Emerald hematology analyzer before testing patients on 01/27/2025 after moving the hematology analyzer to its new location (See D5421); the laboratory failed to perform quality control (QC) measures on the Dermatophyte Test Medium (DTM) agar used to test patients from 05/17/2024 to 05/05/2025 (See D5477); and the laboratory failed to document the quality controls for the Dermatophyte Test Medium (DTM) testing done from 03/16/2024 to 04/27/2025 (See D5481). D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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 record review and interview, the laboratory failed to complete the performance specification verification (installation procedure) for the Cell-Dyn Emerald hematology analyzer before testing patients on 01/27/2025 after moving the hematology analyzer to its new location. Findings: 1. Review of the Cell-Dyn Emerald Operator's Manual noted, "Installation procedures must be repeated if the instrument is moved from the original installation site." 2. Review of the calibration documentation showed the analyzer was calibrated on 11/24/2024 and then on 04/15 /2025. No documentation of the performance specification verification which would have included a calibration was found. 3. During an interview on 11/05/2025 at 3:15 PM, Technical Consultant B stated the first day of patient testing after moving -- 3 of 6 -- locations was 01/27/2025. 4. During an interview on 11/05/2025 at 4:03 PM, Technical Consultant B acknowledged she did not perform the installation procedure after moving to the new location. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e)(4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform quality control (QC) measures on the Dermatophyte Test Medium (DTM) agar used to test patients from 05/17/2024 to 05/05/2025. Findings: 1. Review of the Instructions for Use for the Dermatophyte Test Medium noted "End users of commercially prepared culture media should perform QC testing in accordance with applicable government regulatory agencies, and in compliance with accreditation requirements." 2. Review of the procedure titled DTM Microbiological Media Quality Control included instruction on performing the visual check and performing a positive control, a negative control and a control with no growth. The procedure did not include instructions on performing a sterility check. 3. Review of the order invoices showed DTM culture media agar was ordered on 05/17/2024, 08/26/2024, 10/17/2024, and 05/05/2025. 4. Review of the Test Kit Quality Control Log showed the QC passed for Hardy DTM agar received on 05/17/2024 and 09/03/2025. No results of a sterility check performed on the agar was documented. 5. Review of the Test Kit Quality Control Log showed the orders from 10/17/2024, and 05/05/2025 were not documented in the log. 6. Review of the Test Kit Quality Control Log revealed sterility of the DTM agar was not recorded for the media on 05/17/2024, 08/26/2024, 10/17/2024, and 05/05/2025. 7. During an interview on 11/17/2025 at 11:45 AM, Technical Consultant B acknowledged the visual check and QC was not documented for the last two shipments and that she did not do sterility checks on the 4 shipments of DTM agar. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the quality controls (QC) for the Dermatophyte Test Medium (DTM) testing done from 03/16 /2024 to 04/27/2025. Findings: 1. Review of the procedure titled, Laboratory Quality Assurance and Assessment Policy noted, "The laboratory will document all instrument maintenance and quality control. Quality control is run according to, or greater than CLIA (Clinical Laboratory Improvement Amendments) requirements." 2. Review of the Instructions for Use for the Dermatophyte Test Medium noted, "End -- 4 of 6 -- users of commercially prepared culture media should perform QC testing in accordance with applicable government regulatory agencies, and in compliance with accreditation requirements." 3. Review of the Instructions for Use for the Dermatophyte Test Medium noted, "if dictated by laboratory quality control procedures or regulations, perform quality control testing to demonstrate growth or a positive reaction and to demonstrate inhibition or negative reaction." 4. Review of the procedure manual revealed the laboratory did not have a policy on how the laboratory performed their daily controls on days of patient testing for DTM. 5. Review of the DTM Culture Results Log showed there was no documentation of the controls from 03 /16/2024 to 04/27/2025. 6. During an interview on 11/17/2025 at 11:50 AM, Technical Consultant B acknowledged they did not have a policy on performing daily QC and that she started to record the daily QC results on 05/08/2025. 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 record review and interview, the Laboratory Director failed to ensure quality laboratory services for all aspects of tests performed. (See D6007); the Laboratory Director failed to ensure testing was performed as required for accurate and reliable results for 54 (#1- 5, 7 - 12, 14 - 16, 20, 26 - 54, 56 - 64) of 64 (#1 - #64) patients from 06/06/2024 to 10/31/2025. (See D6014) D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure quality laboratory services for all aspects of tests performed. Findings: A1. Review of the Instructions for Use for the Dermatophyte Test Medium (DTM), the procedure titled DTM Microbiological Media Quality Control, the order invoices, and the Test Kit Quality Control Log, showed the laboratory failed to perform quality control (QC) measures on the Dermatophyte Test Medium (DTM) agar used to test patients from 05 /17/2024 to 05/05/2025. (See D5477) A2. During an interview on 11/17/2025 at 11:45 AM, Technical Consultant B acknowledged the visual check and QC was not documented for the last two shipments and that she did not do sterility checks on the 4 shipments of DTM agar. B1. Review of the procedure titled, Laboratory Quality Assurance and Assessment Policy, the Instructions for Use for the Dermatophyte Test Medium, the procedure manual, and the DTM Culture Results Log showed the laboratory failed to document the quality controls for the Dermatophyte Test Medium (DTM) testing done from 03/16/2024 to 04/27/2025. (See D5481) B2. During an interview on 11/17/2025 at 11:50 AM, Technical Consultant B acknowledged they did -- 5 of 6 -- not have a policy on performing daily QC and that she started to record the daily QC results on 05/08/2025. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure testing was performed as required for accurate and reliable results for 54 (#1- 5, 7 - 12, 14 - 16, 20, 26 - 54, 56 - 64) of 64 (#1 - #64) patients from 06/06/2024 to 10/31/2025. Findings: 1. Review of the Instructions for Use for the Dermatophyte Test Medium and the DTM Culture Results Log showed the laboratory failed to follow manufactures instructions for interpreting the Dermatophyte Test Medium (DTM) test results within 14 days for 54 (#1- 5, 7 - 12, 14 - 16, 20, 26 - 54, 56 - 64) of 64 (#1 - 64) patients from 06/06/2024 to 10/31/2025. (See D5311) 2. During an interview on 11 /17/2025 at 11:55 AM, Technical Consultant B stated the received date was the date the cultures were set up. 3. During an interview on 11/17/2025 at 12:20 PM, Technical Consultant B acknowledged patients' DTM test results were reported after 14 days. -- 6 of 6 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on June 7, 2021. Pediatrics in Brevard PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and interview, the laboratory failed to record the humidity of the rooms where testing was performed from 07/07/2019 to 07/07/2021. Findings: Review of quality control documents showed there were no logs recording the humidity of the room where testing was performed in the laboratory. Review of the Cell- Dyn Emerald Operator's Manual for the hematology instrument noted the maximum humidity of the room should be 80% (percent). On 07/07/21 at 2:40 PM, the Technical Consultant B stated they did not record the humidity in the laboratory. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where 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 test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the procedure notes failed to provide all required information for laboratory test reports for 6 out of 6 patients, (#1, #2, #3, #4, #5, #6). Findings: Review of the patient test reports showed 6 of 6 patients' reports failed to have the correct name of the laboratory listed on the report. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification the laboratory annual estimated hematology test volume was 2,980 tests. On 07/07/21 at 4:25 PM, Technical Consultant B stated the patient test reports did not have the correct name of the laboratory. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and interview, the technical consultant failed to evaluate and document at least semiannually (six month) the performance of 3 (D, E, H) of 10 (A, B, C, D, E, F G, H, I, J) Testing Personnel during the first year of employment and then annually thereafter. Findings: Review of training and competency forms for Testing Personnel D showed her initial training was dated 04/10/2019 and the annual competency was dated 02/10/2021. Testing Personnel D did not have a six month competency evaluation in 2019 or an annual competency evaluation in 2020. Review of training and competency forms for Testing Personnel E showed her initial training was dated 03/12/2019 and her annual competency was dated 06/15/2021. Testing Personnel E did not have a six month competency evaluation in 2019 or an annual competency evaluation in 2020. Review of training and competency forms for Testing Personnel G showed her initial training was dated 04/05/2019 and her annual competency was dated 06/15/2021. Testing Personnel H did not have a six month competency evaluation in 2019 or an annual competency evaluation in 2020. On 7/07 /2021 at 2:20 PM, Technical Consultant B stated the six month competency evaluations and annual competency evaluation in 2020 for Testing Personnel D, E, and H were not done. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: -- 2 of 3 -- Based on record review and interview, the laboratory failed to verify the educational qualifications (degrees) of 9 (C -K) of 11 (A - K) Testing Personnel. Findings: Cross Reference D6065. Based on record review and interview, the laboratory failed to verify the educational qualifications (degrees) for 9 (C -K) of 11 (A - K) Testing Personnel. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to verify the educational qualifications (degrees) for 9 (C -K) of 11 (A - K) Testing Personnel. Findings: Review of the CMS 209 Laboratory Personnel Report, signed by the Laboratory Director on 07/08/2021, showed there were 11 employees listed as moderate complexity testing personnel. Review of the laboratory records showed there was no documentation of the degrees for Testing Personnel C, D, E, F, G, H, I, J, and K available for review. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 07/08/2021, the laboratory had an estimated annual test volume of 2,980. On 07/07 /2021 at 3:35 PM, Technical Consultant B stated she did not have the degrees for the Testing Personnel. -- 3 of 3 --

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to receive a score of at least 80% in the proficiency testing (PT) for bacteriology for the 3rd testing event in 2018. Findings: Review of the laboratory's proficiency testing with American Association of Bioanalysts (AAB) results showed that the laboratory received a score of 70% for bacteriology for the 3rd testing event in 2018. During an interview on 4/17 /19 at 10 AM, Testing Personnel A acknowledged that they had not received at least 80% for bacteriology for the 3rd testing event in 2018. 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 --