West End Pediatrics

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting System (CASPER 0155D) and American Proficiency Institute (API) PT summary reports as well as interviews with the Practice Manager (PM) and Testing Personnel (TP), the laboratory failed to perform, document, and retain remedial action for unacceptable specialty and analyte testing event scores. FINDINGS: a. A review of the CASPER 0155 report revealed the following unsatisfactory scores: 1. Hematology Specialty: 2024 First Event = 64% 2. Red Blood Cell (RBC) Test Analyte: 2024 First Event = 60% 3. Hematocrit (HCT) (Non-Waived) Test Analyte: 2024 First Event = 60% 4. Hemoglobin (HGB) (Non-Waived) Test Analyte: 2024 First Event = 60% 5. White Blood Cell (WBC) Count Test Analyte: 2024 First Event = 60% 6. Platelets Test Analyte: 2024 First Event = 60% b. A review of the proficiency testing scores from API (2024) confirmed the above findings. c. There was no documentation of

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor's review of laboratory personnel records and an interview with the practice manager, the laboratory failed to follow their establish written competency policy that included the six required components that assess testing person's competency,twice annually during the first year of testing and annually thereafter. Refer to D6029 and D6053. FINDINGS: The laboratory failed to perform the training and six month competency evaluation for the two new testing personnel , who perform moderate complexity testing. a. Confirmed by the practice manager on 8-22- 22 at approximately 11:00 AM. This is a repeat deficiency from the survey conducted on May 30, 2019. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: 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 -- Based on review of the laboratory's "Specimen & Handling" procedure, surveyor' direct observation of the hematology tube & microctainer in the laboratory and an interview with practice manager, the laboratory personnel failed to follow the established laboratory's procedure for labeling patient specimens. FINDINGS: 1. The laboratory's establish written procedure requires the patient's full name, and/or date of birth (DOB) or medical records number (MR), date of collection on the specimen container. 2. Surveyor observed a EDTA tube in a cup and a EDTA microctainer on the counter next to Coulter DXH 520 Hematology analyzer at 10:30 AM were unlabeled. 3. Surveyor observed a hematology report sequence # 48187 on the DXH 520 screen but could not determine which sample it was used to report the Complete Blood count (CBC) results. a.. The practice manager confirmed at 11:47 that the laboratory staff failed to follow the established "Specimen & Handling Procedure. b. All laboratory manuals are in the laboratory, for personnel to access the material when needed. 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 review of the Coulter DXH 520 operations manual at the time of survey and interview with the practice manager, the current laboratory director failed to approve (sign and date) the manufacturer's operations manual for automated CBC testing. Refer to D6031 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor's observation of the Select Strep Agar (SSA), patient sample in the incubator and an interview with the practice manager, the laboratory failed to discontinue the use of the expired SSA. Refer to D6020. FINDINGS: 1. The surveyor observed a throat culture in the incubator labeled with DOB 1/9/06 and date of service 8/22/22, initials HAJ at approximately 11:30 AM with an expired SSA media on 8/18 /22 lot# 145058P. a. Observed 3 SSA plates in the refrigerator same lot # and expiration date b. Observed 5 vials of 0.04 bacitracin disc lot # 9182592 expiration date 7/31/22 2. A new lot of 0.04 bacitracin disc Lot # 145480P expiration date 4/30 /23 was opened and used on the patient SSA plate. 3. Confirmed by practice manager at 11:30 AM 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 -- 2 of 4 -- 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 the review of the laboratory's Quality Control (QC) records for the bacitracin disc and an interview with the practice manager, the laboratory failed to check the new lot number of 0.04 bacitracin disk for positive and negative reactivity. Refer to D6020 FINDINGS: 1. The laboratory failed to check new lot # 1297972 expiration date 4/30/22 of 0.04 bacitracin disks for positive and negative reactivity. a. One disc was used for a patient throat culture plate labeled HAJ, DOB 1/9/06 and date of service 8/22/22.. b. Confirmed by the practice manager at 11:30 AM. 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 review of Horiba operations manual, laboratory records and direct observation and an interview with the laboratory testing person, the laboratory director failed to provide overall management of the laboratory. FINDINGS: The laboratory director failed to ensure that the laboratory: 1. Implemented and maintained the

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of laboratory competency records and an interview with the laboratory testing person, the laboratory failed to follow their written policies and procedures to assess the competency of the laboratory testing personnel semi-annually for the first year of patient testing. Findings Include: It was confirmed by the laboratory testing person on May 30, 2019, at approximately 10:15 am, that the laboratory director acting as the technical consultant failed to have documentation of semi-annual competency for two of two new testing personnel who perform bacteriology and hematology testing. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of PT records from the API PT program and an interview with the testing person, the laboratory failed to successfully participate in a PT program 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 -- approved by the Centers for Medicare and Medicaid Services (CMS) for the specialty of Bacteriology. The following scores were assigned: 2019 1st event: urine colony count = 50% 2018 1st event: urine colony count = 50% These results are all considered unsatisfactory PT performance. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)