Huntsville Pediatric Associates

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 a review of the Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing (PT) evaluations and an interview with Testing Personnel #1 (TP#1), the laboratory failed to ensure the accuracy of urine sediment examination, a non- regulated test, at least twice a year. The laboratory failed three of four PT surveys from October 2022 through May 2024 with no evidence of any other mechanism to verify the accuracy of the test. The findings include: 1. A record review revealed the laboratory utilized proficiency testing to verify the accuracy of urine sediment examination, however the laboratory failed the following PT surveys: A) 2022-MISC QA POC2; Urine Sediment-50 percent, B) 2023-MISC QA POC1; Urine Sediment-50 percent, C) 2024-MISC QA POC1; Urine Sediment-0 percent. 2. During an interview on 9/12/2024 at 1505 with TP#1, the laboratory provided investigation records and

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of records for the Reichert Unistat Bilirubinometer and the Abbott I-Stat, and interviews with Testing Personnel #1, the laboratory failed to ensure calibration verification (C-V) was performed every six months as required by the manufacturer and laboratory procedure. The surveyor noted the laboratory failed to perform C-V on two of two Chemistry instruments since the previous survey on 12/16 /2020. The findings include: (I) Reichert Unistat Bilirubinometer (Neonatal Bilirubin) 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 -- 1. A review of records for the Reichert Unistat Bilirubinometer revealed the instrument was calibrated with water and the High-Level Check Cuvette (40.6 mg/dL [milligrams/ deciliter]) every six months. Analytes calibrated with less than three calibrators must have a calibration verification every six months, as per CLIA regulation. 2. A review of the operator's manual on page 14 under section "6.4 Calibration Verification" revealed, "Two assayed glass cuvettes are provided with the REICHERT UNISTAT Bilirubinometer: 1. ...Calibration cuvette (assay range from 19 to 23.9 mg/dL) ...[and the] 2. ...High-Level Check Cuvette (assay range approximately 40 mg/dL) ... ...[these] glass cuvettes may be used to check the bilirubinometer at the mid and high points of its 0-40 mg/dL measuring range. A sample cuvette ... filled with distilled water may be used to check zero. ...". 3. During an interview on 10/20 /2022 at 1:10 PM, Testing Personnel #1 stated she did not know about the above requirements in the operator's manual, and confirmed the laboratory had failed to follow the manufacturer's instructions to perform a three-point calibration verification which included the mid-range (21.4 mg/dL) cuvette. (II) Abbott I-Stat (Chem 8 + cartridges for the Basic Metabolic Profile) 1. A review of the Abbott I-Stat procedure revealed the instrument performed an internal calibration on each cartridge upon insertion. Analytes calibrated with less than three calibrators must have a calibration verification every six months, as per CLIA regulation. 2. A review of the Abbott i-Stat records revealed the last calibration verification was performed on 6/25/2020 using the I-Stat Tri-Control Calibration Verification kit. 3. During an interview on 10/20 /2022 at 3:30 PM, Testing Personnel #1 confirmed the laboratory had not performed calibration verification on the I-Stat since 6/25/2020. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on reviews of the installation and validation records and the Procedure manual for the new Beckman Coulter AcT diff 2 Hematology Analyzer, and the hand-written procedure for the Bacteriology "Media QC" (Quality Control), and an interview with Testing Personnel (TP) #1, the laboratory failed to ensure the Laboratory Director documented her review and approval of new procedures with her signature and date before use by the testing personnel. The findings include: 1. A review of the validation and installation records and the Procedure Manual for the AcT diff 2 Hematology analyzer revealed the Laboratory Director's had failed to document her signature and date to indicate her review and approval of the new procedures before patient testing began on 8/31/2016. 2. A review of the hand-written procedure entitled "Media QC" (put in use after the previous survey on 3/30/2016) revealed no review and approval by the Laboratory Director (as indicated by her signature and date). This procedure further failed to specify the acceptable or expected results of the Media QC. 3. During an interview on 4/11/2018 at 2:30 PM, TP #1 was asked if the Laboratory Director had reviewed, dated and signed her approval for the new Hematology analyzer. TP #1 stated the Director looked at the validation documentation, but she did not sign her approval. During a second interview at approximately 4:55 PM, TP #1 was asked if the Laboratory Director had approved the new procedures for the media QC. TP #1 stated she had written the procedure herself (with no education or experience in Microbiology other that plating the Bacteriology cultures) after consultation with the culture media manufacturer. Thus confirming the above noted findings. . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 reviews of the installation and validation records for the Beckman Coulter (B-C) AcT diff 2 Hematology analyzer, patient results, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure a complete validation of the manufacturer's performance specifications, including reportable range, accuracy, and normal reference range verification was performed before patient testing began. The findings include: 1. A review of the installation procedures for the B-C AcT diff 2 Hematology analyzer revealed a calibration, precision (reproducibility) study and three levels of quality controls were performed on 7/11 /2016 and on 8/22/2016. The laboratory also ran samples from a Coulter LIN-C Linearity Control kit on 8/22/2016, however there was no documentation the data was analyzed and evaluated to determine the reportable ranges of the analyzer. 2. A further review of the documentation revealed the laboratory ran a correlation study on thirty patients, however there was no documentation the data was analyzed and evaluated to demonstrate the accuracy of the analyzer as stated in the manufacturer's performance specifications. There was also no documentation of the reference range verification for the laboratory's patient population. 3. The validation and installation records for the AcT diff 2 also failed to include the Laboratory Director's signature and date indicating her review and approval of the new procedures before patient testing began. 4. In an interview on 4/11/2018 at 12:10 PM, when asked if the Laboratory Director reviewed, approved and dated the new AcT diff 2 procedures, TP #1 stated the Director looked at the validation documentation, but she did not sign her approval. The surveyor then asked if reference ranges were verified, and whether the reportable range and correlation data had been analyzed and evaluated as verification of the manufacturer's performance specifications; TP #1 stated the records on file were all they had been given by the installation technician. When asked when patient testing began on the new instrument, TP #1 referred to her patient testing records and stated 8 /31/2016. Thus the above noted findings were confirmed. . D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on reviews of the quality control (QC) logs and patient results for the Reichert -- 2 of 5 -- Bilirubinometer (used for newborn Bilirubin testing), and an interview with Testing Personnel (TP) #1, the laboratory failed to ensure two levels of Bilirubin QC were performed and documented for two days of patient testing in August 2016. The findings include: 1. A review of the poorly organized Reichert Bilirubinometer QC records revealed testing personnel were required to perform two levels of external Pediatric Bilirubin QC each day of patient testing. However on 8/6 and 8/7/2016 only the Level 1 QC was performed. [Note: The QC sheets in use by the laboratory were divided in half with space at the top of both columns for the QC Levels, lot numbers and expected ranges. However, instead of using the sheets as intended, the laboratory chose to record the values for Level 1 QC on one sheet, and values for Level 2 on another sheet in another section of the binder, which made QC review difficult.] 2. During an interview on 4/11/2018 at 2:30 PM, TP #1 reviewed the QC records and was unable to find results for the Level 2 Bilirubin QC for the above dates. After reviewing the patient results, TP #1 stated one Neonatal Bilirubin was performed on each of these dates. Thus the above noted findings were confirmed. . D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of the Bacteriology Quality Control (QC) records and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure zone sizes or minimum inhibitory concentration (MIC) for control organisms were within established limits for culture media and antimicrobial discs each day of patient testing in 2016-2018, in the absence of an Individualized Quality Control Plan (IQCP). The findings include: 1. A review of the 2016-2018 Bacteriology QC records revealed the laboratory performed antimicrobial susceptibility (zone sizes or MIC) testing on one gram positive (Staphylococcus aureas) and one gram negative (Escherichia coli) and occasionally on Pseudomonas aeruginosa control organisms, once a week, not every day of patient testing in the absence of an IQCP. 2. During the exit summation and review of the records on 4/11/2018 at 5:20 PM, TP #1 confirmed the laboratory did not have an optional IQCP for tests performed in the Bacteriology specialty. The surveyor explained the previous Equivalent Quality Control (EQC) regulation which allowed weekly MIC QC testing was replaced on 1/1/2016, and the laboratory needed to implement an IQCP if they wished to continue decreased frequency of the antimicrobial susceptibility QC testing (QC performance only once a week instead of each day of patient testing). . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems -- 3 of 5 -- identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of quality assurance (QA) records and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to implement effective quality assessment reviews to identify and correct problems identified in the analytical systems. The findings include: 1. A review of quality assurance documentation revealed the laboratory routinely performed monthly QA activities, however the reviews were inadequate to discover and correct problems noted in the following areas: A.) Ensure the Laboratory Director documented her review and approval of all new procedures with her signature and date before use by the testing personnel. (Refer to D5407.) B.) Ensure an analysis of the data generated during the Beckman Coulter AcT diff 2 Hematology analyzer installation was performed and documented to prove the accuracy and reportable ranges of the parameters as stated in the manufacturer's performance specifications; and ensure the Laboratory Director documented and dated her review and approval of the initial procedures verifying performance specifications before patient testing began. (Refer to D5421.) C.) Ensure two levels of QC were performed each day of patient testing. (Refer to D5447.) [Note: The laboratory's mechanism for documenting the QC results for Neonatal Bilirubin, and Mycoplasma made review of the QC records difficult.] D) Ensure the implementation of an optional Individualized Quality Control Plan (IQCP) to allow decreased QC frequency of once a week, or ensure zone sizes or minimum inhibitory concentration (MIC) for control organisms were within established limits for culture media and antimicrobial discs each day of patient testing. (Refer to D5507.) 2. During the exit summation on 4 /11/2018 at approximately 5:20 PM, these concerns were reviewed and confirmed with Testing Personnel #1. . D6055 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 whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with Testing Personnel (TP) #1, the surveyor determined the Technical Consultant (also the Laboratory Director) failed to ensure training and competency on the new Beckman Coulter AcT diff 2 was documented for five of five testing personnel before they began patient testing. The findings include: 1. A review of the personnel files revealed TP #1 thru #5 were employed when the new Beckman Coulter AcT diff 2 Hematology analyzer was installed in July 2016. Patient testing on the new instrument began 8/31/2016, however there was no documentation of training and competency available for any of the testing personnel during the survey. 2. In an interview on 4/11/2018 at 12:10 PM, TP #1 was asked if there were any records of training and competency for the testing personnel on the AcT diff 2 before they began patient testing. TP #1 reviewed her records and stated the Beckman Coulter technician had instructed the staff in the operation, however he had not left the laboratory a copy of the training. Thus the -- 4 of 5 -- above noted findings were confirmed. SURVEYOR: Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor -- 5 of 5 --