Pediatric Center, Pc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Center, PC on June 29, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of initial hematology instrument performance verification documentation, manufacturer's user guide instructions, lack of documentation, patient test logs, and an interview, the laboratory director (LD) failed to evaluate/verify the accuracy, precision, and normal values (reference ranges) for Complete Blood Count (CBC) testing prior to reporting one hundred sixty-eight (168) pediatric patient CBC panels from July 21, 2021 to the date of the survey on June 29, 2023. Findings include: 1. Review of the laboratory's instrument validation records revealed that a Sysmex field service technical representative installed a new hematology PocH-100i analyzer on 7/21/21. The inspector noted there was no LD signature recording an evaluation for the validation data of accuracy/precision/cross over studies performed by the field service representative. Additionally, the inspector noted there was no documentation of CBC pediatric patient normal value studies for the new hematology analyzer (Serial Number G6574). The inspector requested to review documentation 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 -- that the LD established the PocH-100i analyzer pediatric patient normal value ranges and verified the accuracy/precision/cross over data prior to patient testing. No documentation of LD review was available. 2. Review of the Sysmex Users Guide for the new instrument revealed installation instructions for accuracy/precision/cross over studies and statement: "The patient normal values (Reference Range) must be validated by the laboratory". 3. Review of the patient test logs revealed that the lab had assayed/reported 168 CBC panels on the PocH-100i during the timeframe of 7/21 /21 - 6/29/23. 4. An exit interview with the lead laboratory testing personnel on 6/29 /23 at approximately 2:00 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced, off-site CLIA proficiency testing desk review was conducted for Pediatric Center, PC on November 6, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The laboratory was not in compliance with the following Condition under 42 CFR part 493 CLIA Regulations: D2016 - 42 CFR. 493.803 Condition: Successful Participation. Specific deficiencies cited are as follows. 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 an off-site desk review of the laboratory's 2019 and 2020 American Proficiency Institute proficiency testing (PT) records and an interview, the laboratory 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 -- failed to attain a score of at least eighty percent of acceptable responses for urine colony count in two (2) of three testing events reviewed and 2 consecutive throat culture testing events reviewed resulting in unsuccessful Bacteriology PT performance. See D2028. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a desk review of the laboratory's proficiency testing (PT) records and an interview, the laboratory failed to attain a score of at least eighty (80) percent (%) of acceptable responses for throat culture in one (1) out of three (3) Bacteriology testing events reviewed for calendar year 2019. Findings include: 1. Review of the laboratory's American Proficiency Institute PT records (2019 Events 1-3) revealed throat culture scores of less than 80% for the following Bacteriology event: API 2019 1st Event - Throat Culture = 20% (challenges TH -01, TH-03, TH-04, TH-05 scored as unacceptable). 2. In an interview with the lead nurse on 11/6/20 at approximately 10 AM, the above findings were confirmed. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the laboratory's 2019 and 2020 proficiency testing (PT) records (a total of six events) and an interview, the laboratory failed to attain a score of at least eighty (80) percent (%) of acceptable responses for urine colony count in two (2) of three (3) testing events reviewed and 2 consecutive throat culture testing events reviewed resulting in unsuccessful Bacteriology PT performance. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT records (2019 Events 1-3, 2020 Events 1-3) revealed urine colony count scores of less than 80% for the following Bacteriology events: API 2019 3rd Event - Urine Colony Count = 50% (challenge UR -11 scored as unacceptable); API 2020 2nd Event - Urine Colony Count = 50% (challenge UR-7 scored as unacceptable); resulting in unsuccessful PT performance. 2. Review of the laboratory's API PT records (2019 Events 1-3, 2020 Events 1-3) revealed throat culture scores of less than 80% for the following consecutive Bacteriology events: API 2020 2nd Event - Throat Culture = 60% (challenges TH-06 and TH-07 scored as unacceptable); API 2020 3rd Event - Throat Culture = 60% (challenges TH-13 and TH-14 scored as unacceptable); resulting in unsuccessful PT performance. 3. In an interview with the lead nurse on 11 /6/20 at approximately 10 AM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Center, PC on April 17, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of Casper Report 155, proficiency testing (PT) records and interviews, the laboratory failed to enroll in a hematology PT module for Complete Blood Count (CBC) in calendar year 2017. **REPEAT DEFICIENCY Findings include: 1. During a pre-survey review of the laboratory's CLIA Casper Report 155 revealed one (1) hematology event was reported for CBC testing (Cell ID, Hematocrit, Hemoglobin, White Blood Cell, Platelet) in calendar year 2017. The inspector noted scores were available for 2017 Event 2. No scores were reported for inclusion for 2017 Event 1 or 2017 Event 3. 2. Review of the laboratory's retained 2017 PT results revealed American Proficiency Institute (API) scores for Event 2. The inspector called API customer support to inquire about 2017's Event 1 and 3 at approximately 1:30 PM. The API technical specialist stated, "Our records indicate that the laboratory did not enroll for 2017. The notes in our system indicate that the lab called us and 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 -- requested that we send only Event 2 because they were enrolling with American Academy of Family Physicians (AAFP) for 2017". The inspector inquired regarding the laboratory's protocol for PT enrollment in an interview at approximately 3:00 PM, the primary testing personnel stated, "We tried to enroll with AAFP in 2017 but we never received the samples. I did call AAFP and they told us we would receive the samples but we never did. I called API to order the 2nd event when I noticed we had not run PT. The lab director told us to go back to API for 2018'. 3. In an exit interview with the primary testing personnel, at approximately 4:00 PM, the above findings were confirmed. 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 proficiency testing (PT) records and interviews, the laboratory failed to evaluate hematology PT scores of zero (0%) due to non participation on one (1) of four (4) events in the twenty-four (24) months reviewed. Findings include: 1. Review of the laboratory's 2017 and 2018 American Proficiency Institute (API) hematology PT documentation, a total of 4 events, revealed no evaluation or verification of accuracy for: 2018 Event 3: Hematology Score 0% (Cell ID 0%, Hematocrit 0%, Hemoglobin 0%, WBC 0%, Platelets 0%). The inspector requested to review evaluation documentation for the event listed above. No additional documentation was available for review. The primary testing personnel stated, "We sent our results in late because our instrument was down and we failed to report that to API. We ran the samples late and I looked at the results to see if we got the correct results but I did not document it and the lab director did not evaluate it either". 2. In an interview with the primary testing personnel, at approximately 4:00 PM, the above findings were confirmed. 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)