24/7 Pediatric Care Centers Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at 24/7 Pediatric Care Center on 12/29/25. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Conditions were cited: D5200 493. 1230 Condition: General Laboratory Systems D6000 493.1403 Condition: Moderate Complexity Laboratory Director D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure that instrument printouts for proficiency testing (PT) samples were retained and available for review for two of three testing events in 2025. The findings include: 1. A review of the laboratory's proficiency testing records for 2025 on 12/29/2025 revealed that original instrument printouts were missing for the second and third PT events of the year. 2. During an interview on 12/29/25 at 11:30 AM, the Office Manager confirmed that the laboratory was unable to locate or retrieve the instrument printouts for the second and third events of 2025. . D2128 HEMATOLOGY CFR(s): 493.851(e) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- (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 record review and staff interview, the laboratory failed to ensure that remedial action and training were performed and documented following an unsatisfactory proficiency testing performance for the white blood cell (WBC) differential in the first proficiency testing event of 2024. The findings include: 1. A review of the laboratory's proficiency testing records from the American Proficiency Institute (API) for the first event of 2024 showed that the laboratory received a score of 67% for the white blood cell differential and a score of 0% for Neutrophils. 2. The laboratory lacked documented evidence that any investigation,

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory testing personal, it was determined the laboratory failed to authorize American Proficiency Institute (API) proficiency testing program to release to the agency results for Hematology for 10 events reviewed (2016-2019). Findings included: Review of CASPER Report 0096D CLIA Application and Survey Summary Proficiency Testing Scores for previous 9 testing events showed that no routine proficiency testing scores were found for this provider. Review of API proficiency testing results on 5/29/19 at 9:00 a.m. showed that the laboratory was enrolled in proficiency testing with with successful and unsuccessful scores over the past three years. During an interview with the laboratory testing person #2 at 9:30 a.m. on 5/29/19, she was not aware that results were not being authorized to be released. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. 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 3 -- Based on record review of API (American Proficiency Institute) proficiency test records and interview with testing personal, the laboratory failed to test hematology proficiency samples the same number of times that patient samples are tested for 4 testing events reviewed from 2017-2019. Findings Included: Review of the Complete Blood Count (CBC) Sysmex XP-300 instrument printout records for four API proficiency testing events from December 2017 through March 2019 showed the following: 1. The 2017 Hematology/Coagulation 3rd Event kit had two printouts for each of the five CBC samples tested (HSY-11 - HSY-15). 2. The 2018 Hematology /Coagulation 1st Event kit had two printouts for each of the five CBC samples tested (HSY-01 - HSY-05). 3. The 2018 Hematology/Coagulation 2nd Event kit had two printouts for each of the five CBC samples tested (HSY-06 - HSY-10). 4. The 2019 Hematology/Coagulation 1st Event kit had two printouts for each of the five CBC samples tested (HSY-01 - HSY-05). The tests performed were: White Cell Count, Red Cell Count, Hemoglobin, Hematocrit, Platelet Count, Mean corpuscular volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Red cell distribution width (RDW), Neutrophils, Lymphocytes, Monocytes. . Interview with testing person #2 on 5/29/19 at 9:37am confirmed hematology proficiency testing had been performed in duplicate. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review of American Proficiency Institute (API) Hematology proficiency testing results and interview with laboratory testing personal, the laboratory failed to submit the proficiency testing results in the specified timeframe for the 3rd Hematology Event in 2018, resulting in a score of 0% for all Hematology analytes. Findings included: Review of the API Hematology proficiency testing results showed that the laboratory had obtained a score of 0% "Failure to Participate" for the following analytes: White Cell Count, Red Cell Count, Hemoglobin, Hematocrit, Platelet Count, Mean corpuscular volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Red cell distribution width (RDW), Neutrophils, Lymphocytes, and Monocytes. Interview on 5/29/19 at 9:30am with testing person #2 stated that they forgot to send in the API proficiency test results for the 3rd Hematology Event of 2018. 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 record review and interview with laboratory staff, the facility failed to -- 2 of 3 -- perform Hematology quality control (QC) each time patients were tested for 24 days of 36 patient testing days reviewed in 2019. Findings Included: The review of Hematology QC records on 5/29/19 showed that no QC was performed when patients were tested on the following days: March 1, 2019 - 1 patient , March 5, 2019 - 1 patient, March 8, 2019 - 1 patient, March 11, 2019 - 1 patient, March 17, 2019 - 1 patient, March 18, 2019 - 1 patient, March 20, 2019 - 1 patient, March 27, 2019 - 1 patient, April 10, 2019- 1 patient, April 13, 2019 - 1 patient, April 15, 2019 - 1 patient, April 16, 2019 - 1 patient, April 30, 2019 - 1 patient, May 2, 2019 - 2 patients, May 3, 2019 - 2 patients, May 7, 2019 - 1 patient, May 8, 2019 - 1 patient, May 10, 2019 - 1 patient, May 13, 2019 - 2 patients, May 14, 2019 - 1 patient, May 15, 2019 - 1 patient, May 18, 2019 - 1 patient, May 19, 2019 - 1 patient, and May 20, 2019 - 1 patient. The interview with the laboratory testing person #2 on 5/29/19 at 9:50am confirmed QC was not performed on all day patients were tested in 2019. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory staff, the laboratory failed to perform Hematology quality controls (QC) that were not expired prior to reporting patient results for 1 of 14 days of patient testing in May 2019. Findings Included: Record review of the laboratory's Hematology QC records for May 2019 showed on 5 /9/19 the QC used had lot number 90290710 and expired on 5/8/2019. Two patients were tested. During interview on 5/29/19 at 10:00am the testing personnel #2 confirmed the QC material was expired. 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 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 record review of quarterly Qualtiy Assuarance (QA) documents and interview with testing personel, the laboratory failed to have an effective QA program that identified or corrected problems for quality control for four of four months reviewed (Septermber 2018, March 2019, April 2019 and May 2019). Findings Included: Review of the QA quarterly checklist showed the laboratory did not identify multiple quality control errors 2018-2019. Interview on 5/29/19 at 10:30am with testing person #2 confirmed that the QA checklist did not effectively identify and correct the quality control problems in the laboratory. -- 3 of 3 --