Kids First Pediatric Specialists Georgetown

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to label open and expiration dates on Quality Control (QC) vials used for five of five analytes (white blood cell count (WBC), red blood cell count (RBC), hemoglobin (HGB), hematocrit (HCT), platelet (PLT), differential blood count (Diff)) tested on the Cell- Dyn Emerald analyzer (serial number 030423-010706). Findings include: 1. During laboratory tour on 9/10/2024 at 10:11 am, the current (opened) QC, lot number 4176, was observed to be missing open date and new expiration date. 2. In an interview on 9 /10/2024 at 10:39 am, SP-4 confirmed that open date and exp date are not being documented on QC vials or in a log. 3. Package insert "Cell-DYN 18 Plus Control" ref 09HG9-01, for QC Lot number 4176, states "8 Consecutive Day Open-Tube Stability". 4. Policy titled "Quality Control for Non-waived testing", revised 9/21 /2023, under Storage and Handling E. reads, "Controls MUST be labeled with the opening date and initialed by TP whom opened." 5.Annual test volume for hematology testing is 1,668. 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 D0000 A proficiency testing desk review survey was completed on 9/13/2023. It was determined that the following condition-level deficiencies existed: 42 Code of Federal Regulation (CFR) 493.803(a)(b)(c) Successful Participation D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to successfully participate in the American Proficiency Institute (API) proficiency testing (PT) program for one (White Blood Cell Differential (WBC Diff)) of six regulated tests in the specialty of Hematology. The laboratory received 73% percent for two consecutive testing events (event 1, 2023 and event 2, 2023) for WBC Diff. (Refer to D2130) 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to achieve a satisfactory performance (80% or greater) for one (White Blood Cell Differential (WBC Diff)) of six regulated tests for two consecutive testing events (event 1, 2023 and event 2, 2023) in the specialty of Hematology. Findings include: 1) Review of "Casper Report 0155D, Individual Laboratory Profile" indicated a score of 73% for event 1 and event 2 in 2023 for White Blood Cell Differential (WBC Diff). 2) Upon request for copies of the Proficiency testing scores from their proficiency testing provider via email on 9 /13/2023 at 8:50 am, SP-1 (Office Manager) provided the scores from the American Proficiency Institute (API) confirming the scores of 73% for event 1 and event 2 in 2023 for White Blood Cell Differential (WBC Diff). 3) Review of API "Performance Summary 2023 Hematology / Coagulation - 2nd Event", not dated, indicated the following scores: a) White Blood Cell Differential 2023 1st = 73% b) White Blood Cell Differential 2023 2nd = 73% c) Lymphocytes 2023 1st = 60% d) Lymphocytes 2023 2nd = 60% e) Monocytes 2023 1st = 60% f) Monocytes 2023 2nd = 60% -- 2 of 2 --

Summary Statement of Deficiencies 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 record review and interview, the laboratory failed to evaluate the zero scores for four of 14 Hematology analytes (Granulocytes, Lymphocytes, Monocytes, and White Blood Cell Differential) received during event 1 2021. Findings Included: 1.) Review of American Proficiency Institute Proficiency Testing (PT) evaluation documentation for Hematology/Coagulation Event 1 in 2021 revealed the following: White Blood cell differential- 0% Granulocytes- 0% Lymphocytes-0% Monocytes-0% The lab did not have the original instrument printouts for the Proficiency Testing failure documentation, nor documentation of an evaluation of the scores. 2.) During an interview on 10/31/2022 at 2:49 PM, SP#1 (Office Manager) confirmed the laboratory did not retain the original instrument printouts or documentation of evaluation of the zero scores for proficiency testing received during event 1 of 2021 for the above analytes. 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 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 -- 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 observation, record review and interview, the laboratory failed to: a) ensure three of three controls (High, Normal, and Low) were not expired. (Refer to D5417); b) perform six-month calibrations for one of one Hematology analyzer (Cell-Dyn Emerald) for twelve of twelve months (January to December) in 2021. (Refer to D5439); and run two levels of controls (Low or normal) for complete blood Count (CBC) testing on 3/17/2021 (Refer to D5445). 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 observation, record review and interview, the laboratory failed to ensure three of three controls (High, Normal, and Low) in use for ten of ten patients tested from 10/27/2022 to 10/31/2022 on one of one hematology machine (Cell-Dyn Emerald) were not expired. Findings Included: 1.) During a tour of the lab on 10/31 /2022 at 10:00AM, revealed a refrigerator containing the following controls: a.) High control lot H 2234 was opened on 10/17/2022 b.) Normal control lot N2234 opened on 10/17/2022. c.) Low control lot L2234 opened on 10/17/2022 There were no other open controls in the refrigerator. Cell Dyn controls are used in the Cell-Dyn Emerald system. 2.) Review of "Cell-DYN 18 Plus Control" package insert, not dated, read "Storage and Stability ... Unopened containers are stable until the expiration date indicated. Once opened, containers can be used only for the number of days stated on the assay sheet." 3.) Review of the assay sheet for the Cell-Dyne 18 Plus control, dated August 5, 2018, read "8 consecutive-day Open Tube Stability." 4.) Review of October CBC "Lab Log" revealed ten patients were tested for complete blood count (CBC) from 10/24/2022 to 10/31/2022. This was past the eight consecutive day "open tube stability" date of 10/24/2022. 5.) The annual test volume for Hematology is 285. 6.) During an interview on 10/31/2022 at 4:29 PM, SP#1 (Office Manager) confirmed the laboratory failed to use High, Normal and Low controls that were not expired in for ten out of ten patients tested. 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 -- 2 of 4 -- 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 observation, record review and interview, the laboratory failed to perform six-month calibrations for one of one Hematology analyzer (Cell-Dyn Emerald) for twelve of twelve months (January to December) in 2021. Findings included: 1.) During a tour of the lab on 10/31/2022 at 10:00 AM, revealed a Cell-Dyn Emerald used in Hematology testing for complete blood count (CBC). 2.) Review of the "Cell- DYN Emerald Operator's Manual" page 6-1 states, "calibration is a procedure that confirms the accuracy of the Cell-DYN Emerald." 3.) Review of "Services and Maintenance Log" for Cell-Dyn Emerald indicated the frequency for calibration is semi-annually. 4.) Review of 2021 "Service and Maintenance Logs" for Cell-DYN Emerald revealed for January-December in 2021 no calibrations were performed on the Cell-DYN Emerald. 5.) During interview on 10/31/2022 at 4:29 pm, SP#1 (Office Manager) confirmed the laboratory failed to perform six-month calibration as required for the Cell-Dyn Emerald during 2021. 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, record review and interview, the laboratory failed to run two levels of controls (Low or Normal) for PT#4 tested for complete blood count (CBC) testing on 3/17/2021. Findings included: 1.) During a tour of the lab on 10/31/2022 at 10:00 AM revealed a Cell-Dyn Emerald used in Hematology testing for CBC testing. 2.) Review of Cell DYN Emerald Control printouts revealed a high control was run on 3/17/2021 at 9:48 AM. There was no documentation of a normal and low control run for 3/17/2021. 3.) Review of "CELL-DYN 18 Plus Control" manufacturer's instructions read, "Summary and Principle ... It is an established laboratory procedure to use stable quality control material to monitor the performance of diagnostic tests. CELL-DYN 18 Plus Control is composed of stable materials that provide a means of verifying the accuracy and precision of CELL-DYN hematology results. It is handled and run in the same manner as patient specimens, and it is available in three levels -- 3 of 4 -- representing low, normal, and high results." 4.) Review "CELL-DYN Emerald Operator's Manual" on page 11-9 stated, "before running patient specimens, run a minimum of two levels of control." 5.) Review of patient reports revealed that PT#4 was tested for CBC on 3/17/2021. 6.) During interview on 10/31/2022 at 4:29 pm, SP#1 confirmed the laboratory failed to run two levels of control (Low or Normal) for PT#4 tested for CBC on 3/17/2021. -- 4 of 4 --