West End Pediatrics Pc

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the laboratory testing logs, American Proficiency Institute (API) Proficiency Test (PT) reports, as well as interviews with the Testing Personnel (TP) and Practice Manager (PM), the laboratory failed to test PT samples by TP who routinely perform patient testing. FINDINGS: 1. Laboratory testing logs indicated eight TP who routinely perform hematology and bacteriology patient testing yet 2022, 2023, and 2024 API PT reports documented only one TP performing hematology and bacteriology PT. 2. Confirmed findings by interview with the TP and PM on November 18, 2024, at approximately 2:00 P.M. 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 review of personnel competency records, standard operating procedures (SOPs), as well as interview with the PM, the laboratory failed to perform and document TP six-month competency evaluations. FINDINGS: 1. There was no documentation of TP six-month competency performance. 2. The current, approved 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 -- SOPs did not include instructions for performing such activity. 3. Confirmed findings by interview with the PM on November 18, 2024, at approximately 2:00 P.M. 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 direct observations, review of SOPs, as well as interview with the Testing Personnel (TP), the laboratory failed to remove from inventory expired reagents in the patient specimen processing laboratory. FINDINGS: 1. The surveyor's observations in the patient specimen processing laboratory confirmed on November 18, 2024, at approximately 2:00 P.M. that two bottles of Hemoccult developer, lot number: 75009H, expiration: September 2023 were not removed from inventory. 2. The current, approved SOPs did not include instructions for removal of expired reagents and calibration materials from inventory. 3. The TP confirmed that the respective reagents were not utilized for patient specimen testing. 4. The TP confirmed the findings on November 18, 2024, at approximately 2:00 P.M. -- 2 of 2 --

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 2:00 PM. 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: Based on review of the laboratory's "Specimen & Handling" procedure, surveyor' 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 -- 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 with a first name only on the counter next to Coulter DXH 520 Hematology analyzer at 2:20 PM. a.. The practice manager confirmed at 2:30 P 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 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. Testing personnel had appropriated education & training prior to patient testing, Refer to D6029, 2. Performed initial training and six-month competency evaluation for four of the two testing personnel, Refer to D6053. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the lack of training records for the two of the five testing personnel and an interview with the practice manager and confirmed at the time of this survey, the laboratory director failed to ensure that two new testing personnel had appropriated education and training was documented for the perform moderate complexity bacteriology and hematology testing. Refer to D5209 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 lack of the training & competency evaluation records for the two new testing personnel and confirmed in an interview with the practice manager, the laboratory director, failed to perform the six month competency evaluation for the two new testing personnel during the first year of patient testing. Refer to D5209. -- 3 of 3 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on the surveyor's review of hematology calibration records and an interview with a testing person and the laboratory director, the laboratory failed to calibrate the Coulter AcT Diff hematology analyzer every six months as per manufacturer's requirement. Calibrations were performed on 10/14/16, 07/07/17, and 04/27/18. Findings Include: It was confirmed with a testing person and the laboratory director at approximately 11:00 AM on the date of survey that the Coulter AcT Diff hematology analyzer was out of calibration from April 14, 2017 until July 7, 2017, and from January 7, 2018 until April 27, 2018. Approximately 160 patient specimens were tested and reported for hematology testing during each of the three month periods when the Coulter AcT Diff analyzer was out of calibration. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- 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 the surveyor's review of the laboratory's Quality Control Plan (QCP) and Quality Assessment (QA) procedures and an interview with a testing person and the laboratory director, the laboratory failed to establish a Risk Assessment (RA) plan as part of the Individual Quality Control Plan (IQCP) for the urine colony count testing. Findings: The testing person and the laboratory director confirmed during the May 3, 2018 onsite survey that the laboratory director had failed to establish a Risk Assessment (RA) plan to identify and evaluate potential failures and sources of error in the urine colony count testing process, to include the five Risk Assessment Components: Specimen, Test System, Reagent, Environment, and Testing Personnel. PLEASE NOTE: THIS IS A RECITED DEFICIENCY FROM THE SURVEY CONDUCTED ON 5/19/2016. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on the surveyor's review of Quality Control (QC) records and confirmed, during this onsite survey, with a testing person and the laboratory director, the laboratory director failed to ensure that the QC program for bacteriology testing was maintained to assure quality of laboratory services. Refer to: D5445 PLEASE NOTE: THIS IS A RECITED DEFICIENCY FROM THE SURVEY CONDUCTED ON 5/19 /2016. D6024 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(7) 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)(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of hematology calibration records and confirmed in an interview with a testing person and the laboratory director, the laboratory director failed to ensure that remedial action was taken and documented when problems were identified. Refer to D5437. -- 3 of 3 --