Olney Pediatrics

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 proficiency testing (PT) record review and interview with the laboratory director (LD), the laboratory failed to ensure that the individual testing or examining the samples and the LD signed the PT attestation statements, attesting that PT specimens were run in the same manner as patient samples. Findings: 1. The laboratory performs presumptive identification of group A streptococcus on throat cultures. Laboratory staff perform the specimen processing of throat swabs, inoculating the culture media and placing the culture plates in the incubator. The physicians on staff perform the testing, observing any bacterial growth and interpreting the culture plates. 2. A review of microbiology PT records from five events in 2023 and 2024 showed that in five of five events, the attestation statements were signed by the laboratory staff who performed the specimen processing, not by the physicians who performed the PT; and 3. In two of five PT events, the LD did not sign the attestation statements, attesting that PT specimens were run in the same manner as patient samples. 4. During an interview on 02/19/2025 at 1:45 PM, the LD confirmed that all of the attestations statements were not signed by the LD nor by the physicians performing the test. 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. 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 -- This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the laboratory director (LD), the laboratory failed to ensure that microbiology PT results were evaluated and the review documented. Findings: 1. The laboratory performs presumptive identification of group A streptococcus on throat cultures. 2. A review of microbiology PT records from five events in 2023 and 2024 showed that in five of five events, the LD failed to sign the PT results report, documenting that the results had been reviewed and were acceptable. 3. During an interview on 02/19/2025 at 1:45 PM, the LD confirmed that there was no documentation that PT results had been evaluated and reviewed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on procedure manual, manufacturer's package insert, laboratory log, and patient record review and interview with the laboratory director (LD), the laboratory failed to provide written procedures for all aspects of performing bacteriology testing. Findings: 1. The laboratory performs presumptive identification of group A streptococcus on throat cultures using "BBL TSA II 5% SB" media and urine colony counts using "Uricult CLED/EMB" urine "Culture-Paddles." 2. CLIA regulations state that the laboratory must "Check each batch of media for sterility if sterility is required for testing; 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 document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer." 3. Procedure manual review showed that the laboratory did not have a procedure, instructing the laboratory staff on how to perform quality checks on the media shipments received by the laboratory, or stating what it meant if the staff signed the "Strep Plates QC Log" or the "Uricult QC Log." 4. During an interview on 02/19/2025 at 11:00 AM, laboratory staff stated that throat and urine cultures are set up in another office ("Suite 310") and stored in a separate incubator before being transported to the main laboratory's incubator in "Suite 311." There was no written procedure available at the time of the survey for this process. 5. The "Patient Test Management" procedure stated to read throat cultures at "24 and 48 hours of growth"; however this conflicts with the package insert for the "BD BBL Taxo A Discs for Differentiation of Group A Streptococci" which stated that culture plates must be incubated "at 35 to 37C for 18 to 24 hours" before being read or interpreted. 6. During an interview on 02/19/2025 at 1:45 PM, the LD confirmed that the laboratory did not provide a written procedure manual for all tests, assays, and examinations performed by the laboratory. II. Based on procedure manual, manufacturer's package insert, and patient record review and interview with the laboratory director (LD), the laboratory did not follow written procedures for reporting the results of bacteriology testing. Findings: 1. The laboratory performs presumptive identification of group A streptococcus (strep) on throat cultures, using Taxo A discs which are impregnated with low levels of Bacitracin. 2. The package -- 2 of 7 -- insert for the "BD BBL Taxo Discs for Differentiation of Group A Streptococci," under "Results" states, "It is recommended that any zone of inhibition, regardless of diameter, be reported as 'beta-hemolytic Streptococcus, presumptively group A by bacitracin'" and the section, "Limitations of the Procedure" states, "The Taxo A disc test is presumptive, and a positive result should be followed with more specific physiological and/or serological tests." The package insert was included as part of the laboratory's procedure manual. 3. Random review of patient records showed that two of two patients' throat cultures were reported as "pos at 24 hours" (patient specimen collected 02/12/2025) and "pos at 24 hrs group A" (patient specimen collected 01/17 /2025), not "presumptive positive" as instructed in the "BD BBL Taxo Discs for Differentiation of Group A Streptococci" package insert. 4. During an interview on 02 /19/2025 at 1:45 PM, the LD confirmed that the laboratory reports "presumptive positive" strep test results as "positive" and did not follow written procedures for reporting bacteriology testing. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on procedure manual, laboratory reagent package insert, and patient log record review and interview with the laboratory director (LD), the laboratory failed to follow the manufacturer's instructions for performing bacteriology testing. Findings: 1. The laboratory performs presumptive identification of group A streptococcus on throat cultures, using Taxo A discs which are impregnated with low levels of Bacitracin. 2. The procedure, "Patient Test Management" states that "if the rapid test is negative but the patient is symptomatic, a culture is plated, labelled, documented, and placed in incubator where it will be read at 24 and 48 hours of growth"; however 3. Review of the package insert for the "BD BBL Taxo A Discs for Differentiation of Group A Streptococci" showed that culture plates must be incubated "at 35 to 37C for 18 to 24 hours" before being read or interpreted. 4. Review of "Olney Peds Throat and Urine Culture Logs" from 2024 and 2025 showed that the laboratory evaluated the culture plates at 24 and 48 hours after inoculation and did not follow the manufacturer's instructions for performing throat cultures using the Taxo A disc. 5. During an interview on 02/19/2025 at 1:45 PM the LD confirmed that the laboratory did not follow the manufacturer's instructions for performing throat cultures. 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. -- 3 of 7 -- This STANDARD is not met as evidenced by: Based on manufacturer package insert, procedure manual, and monthly temperature log record review, the laboratory failed to define the acceptable temperature range for room and incubator temperatures which were consistent with the manufacturer's instructions for performing bacteriology testing using purchased growth media. Findings: 1. The laboratory performs presumptive identification of group A streptococcus on throat cultures using "BBL TSA II 5% SB" media and urine colony counts using "Uricult CLED/EMB" urine "Culture-Paddles." 2. Review of the procedure, "Collection, Culture, and Interpretation of Throat Culture Screen for the Presumptive Identification of Group A Streptococci Companion Guide" showed that "BBL TSA II 5% SB" media used for throat cultures should be incubated at "35C- 37C", however the laboratory's monthly temperature log stated that the acceptable incubator temperature range was "34 - 37 C." 3. A review of monthly temperature logs from May through August 2024 showed that the temperature of the incubator in "Suite 311" was out of the acceptable range recommended by the "Group A Streptococci Companion Guide" 14 out of 87 days recorded. 4. Review of the package insert for the "Uricult CLED/EMB" urine "Culture-Paddles" showed that the unopened paddles are to be stored at "7 ...25C", however the laboratory's monthly temperature log stated that the acceptable room temperature range was "20 to 32 C." 5. A review of monthly temperature logs from May through August 2024 showed that the room temperature in "Suite 311" was out of the acceptable range recommended by the "Uricult CLED/EMB" urine "Culture-Paddles" package insert, one out of 87 times recorded. 6. The package insert for the "Culture-Paddles" also states that the inoculated paddles should be incubated at "36C +/- 2C." Record review showed that the incubator in "Suite 311" was out of the manufacturer's acceptable range, two out of 87 days recorded. 7. Four out of four temperature logs for "Suite 311" were signed as having been reviewed by the LD. 8. During an interview on 02/19/2025 at 1:45 PM, the LD confirmed that the laboratory failed to accurately define and monitor room and incubator temperatures to ensure accurate and reliable test system operation and test result reporting. 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 and interview with the laboratory director (LD), the laboratory failed to ensure that the laboratory's Individualized Quality Control Plan (IQCP) for performing quality control (QC) on throat and urine culture media was complete, in order to reduce the frequency of QC testing required. Findings: 1. The laboratory performs presumptive identification of group A streptococcus (strep) on throat cultures as well as colony counts on urine cultures. 2. The laboratory records did not include documentation of two levels of QC each day of testing for throat and -- 4 of 7 -- urine cultures. 3. The laboratory is required to test two levels of QC materials each day of testing unless they have a written IQCP. Record review showed that the laboratory's IQCP for strep selective agar and urine culture agar included a Risk Assessment, but did not include the Quality Control Plan listing the number, type, frequency of testing & criteria for acceptable results of the QC or the Quality Assessment plan to monitor the effectiveness of the laboratory's IQCP. The IQCP was not approved (signed and dated by the LD). 4. During an interview on 02/19/2025 at 1: 45 PM, the LD confirmed that the laboratory failed to perform an IQCP in order to reduce the frequency with which microbiology QC was required. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on microbiology quality control (QC) record review and interview with the laboratory director (LD), the laboratory failed to perform and document QC on the lot number of "BD BBL Taxo A Discs for Differentiation of Group A Streptococci" (Taxo A discs) currently in use in the laboratory. Findings: 1. The laboratory performs presumptive identification of group A streptococcus on throat cultures, using Taxo A discs which are impregnated with low levels of Bacitracin. 2. The laboratory performs QC on new lot numbers and shipments of Taxo A discs received, using purchased American Type Culture Collection (ATCC) organisms to confirm positive (using Streptococcus pyogenes, ATCC# 19615) and negative (using Streptococcus agalactiae, ATCC# 12386) reactivity. 3. Review of "Bacitracin Disc Quality Control" Logs from 2024 and 2025 showed that the laboratory filled out a "Bacitracin Disc Quality Control" log for the current lot number of Taxo A discs (lot#: 4023684, expiration date: 07/24/2025) on 11/06/2024, however the testing person failed to document the results for the positive and negative controls. The log was signed by the LD on 11/06/2024. 4. During an interview on 02/19/2025 at 1:45 PM, the LD confirmed that the laboratory failed to document the results of QC for the current lot number of Taxo A discs prior to use for patient testing. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (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. (g) The laboratory must document all control procedures performed. -- 5 of 7 -- This STANDARD is not met as evidenced by: Based on procedure manual and microbiology record review, and interview with the laboratory director (LD), the laboratory failed to check each batch of selective streptococcus (strep) throat culture media and urine colony count media for sterility and the ability to support or inhibit growth of specific organisms, and to document the physical characteristics of the media when compromised, prior to use for patient testing. Findings: 1. Review of the "Strep Plates QC Log" worksheets for 2024 and 2025 showed that the laboratory documents the "Lot Number," "Expy Date," "Temp," "Qty Rec'd," and "Staff Initials/Date" and on the "Uricult QC Log" they record the "Lot Number," "Expy Date," "Qty Rec'd," and "Staff Initials/Date." 2. The logs did not document if the laboratory performed quality assurance checks on the condition of the culture media upon receipt. 3. Procedure manual review showed that the laboratory did not have a procedure, instructing the laboratory staff to perform quality checks on the media shipments received by the laboratory, or stating what it meant if the staff signed the QC logs. Cross-refer to D5401, part I 4. The laboratory had not completed an Individualized Quality Control Plan (IQCP) to eliminate the end user quality control requirements. Cross-refer to D5445 5. During an interview on 02/19 /2025 at 1:45 PM, the LD confirmed that the laboratory failed to document quality checks on throat and urine culture media prior to use for patient testing. D5781

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview with laboratory staff, the laboratory did not document staff who performed the testing for each proficiency sample. Findings: 1. Six staff members signed the proficiency testing attestation statement for the third event of 2022, but the proficiency test records and laboratory records did not identify who performed testing for each individual sample; and 2. This was confirmed during interview with laboratory staff on the afternoon of the day of testing. 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 D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of the product insert and laboratory testing logs and interview with the testing person (TP) and laboratory director (LD), the laboratory failed to establish performance specifications for testing specimen types that were not validated by the manufacturer using the McKesson Consult Diagnostics Strep A Dipstick, a FDA- cleared test system. Findings: 1. The laboratory used the McKesson Consult Diagnostics Strep A Dipstick for rapid antigen testing to aid in the diagnosis of Group A Streptococcus (GAS) infection. The testing complexity was categorized as CLIA waived when used with throat swab specimens. 2. The "Limitations" section of the Strep A Dipstick product insert stated that "The test should be used for the detection of Strep A antigen in throat swab specimens only." 3. Review of the patient logs for GAS rapid and culture testing from 01/02/2020-06/30/2021 identified that penile specimens were tested on 06/26/2020 and 07/16/2020 and rectal specimens were tested on 02/07/2020 and 03/21/2021 using the Strep A Dipstick rapid antigen test kit. 4. The laboratory modified a FDA-cleared test system by testing specimen types that were not validated or approved by the manufacturer. A modified FDA-cleared or 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 -- approved test system becomes a high complexity test. The laboratory did not establish performance specifications for accuracy, precision, analytical sensitivity and analytical specificity for testing the unapproved specimen types, penile and rectal, using the McKesson Consult Diagnostics Strep A Dipstick. 5. During the exit interview on 09/27/2021 at 11:45 AM, the TP and LD confirmed that the laboratory tested penile and rectal specimens using the McKesson Consult Diagnostics Strep A Dipstick, which was approved for use with throat swab specimens only. 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 laboratory personnel report and proficiency testing (PT) records and interview with the laboratory director (LD), testing of the microbiology 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 laboratory personnel report (form CMS-209) listed five TP that evaluated results for patient throat culture testing. 2. Review of eight microbiology PT events from 2019-2021 showed that only a single TP was performing all the throat culture PT. 3. During the exit interview on 09/27/2021 at 11:50 AM, the LD confirmed that testing of the throat culture PT samples was not 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. 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 technical consultant (TC) failed to perform annual competency assessments of the testing personnel (TP) evaluating patient throat culture testing results. Findings: 1. The laboratory personnel report (form CMS-209) listed four TP (other than the LD) that evaluated results for patient throat culture testing. 2. The personnel files for these four TP did not include annual competency assessments of evaluating patient throat culture testing results. 3. During the exit interview on 09/27/2021 at 11:50 AM, the LD confirmed that annual competency assessments of the four TP evaluating throat culture testing results was not being performed. -- 2 of 2 --

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 record review and interview, the laboratory (lab) did not ensure that testing personnel attested that proficiency testing was performed in the same manner as patient samples. Findings: 1. The laboratory is enrolled in a proficiency test program. Unknown samples are shipped to the lab by the proficiency test provider for testing. The test results are reported to the provider and the provider then evaluates and scores the labs performance; 2. The proficiency test records for 2018 and 2017 bacteriology proficiency test events 1, 2 and 3 (for both years) did not include signed statements attesting to the routine integration of the samples into the patient workload using the laboratory's routine methods (either by pen or electronic signature); and 3. These findings were confirmed with lab staff during interview with staff on the day of survey. 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 record review and interview, the laboratory (lab) did not ensure that the proficiency test results evaluated by the proficiency test provider are reviewed by the 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 -- lab director and that the reviews are documented. Findings: 1. The laboratory is enrolled in a proficiency test program. Unknown samples are shipped to the lab by the proficiency test provider for testing. The test results are reported to the provider and the provider then evaluates and scores the labs performance; 2. The results of the 2018 bacteriology proficiency test events 1, 2 and 3 were not reviewed, signed and dated by the lab director; and 3. These findings were confirmed with lab staff during interview with staff on the day of survey. 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 observation of the written procedure manual and interview with lab staff, the lab did not have an Individualized Quality Control Plan (IQCP) for The Uricult and Selective Strep Agar plates (SSA) the laboratory (lab) uses for patient testing. Findings: 1. The laboratory uses commercially prepared test media (Uricult and SSA) to test for harmful bacteria in patient specimens. The sources of these specimens are throat for SSA and urine for Uricult; 2. The lab documents the conditions of the media upon arrival in the lab for quality control purposes; and 3. It was observed during review that the lab did not have an IQCP showing that the documentation made during receipt was as effective as checking each shipment of media with quality control organisms to demonstrate growth and chemical reactivity; 4. On the day of survey this was confirmed during interview of lab staff. -- 2 of 2 --