Galen North Pediatrics

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual and staff interview, the laboratory failed to establish a written policy or procedure defining the quality activities used to monitor, assess, and correct problems in the laboratory's testing systems for 2023 and 2024. The findings include: 1. A review of the laboratory procedure manual revealed no policy or procedure defining the laboratory's quality assessment activities used to monitor, assess, and correct problems in the laboratory's testing systems on the survey date (11/04/2024). 2. An interview with the office manager and laboratory consultant on 11/04/2024 at 1:30 p.m. confirmed that the laboratory did not have written quality assessment policies for monitoring and evaluating the pre-analytical, analytical, and post-analytical phases of the testing process. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual, environmental monitoring records, and staff interview, the laboratory failed to follow its temperature and humidity monitoring procedure for 23 of 24 months in 2022, 2023, and 2024. The findings include: 1. A review of the laboratory's "Temperature and Humidity Monitoring" policy revealed the following: - The laboratory is "to monitor room, incubator, refrigerator, and freezer temperature to assure reagent stability and room humidity of testing environment for quality instrument operation." - "In the event of a temperature or humidity that is found outside of acceptable range, steps must be taken to evaluate the contents of the storage container." - "Quality control logs containing temperature checks and eye wash station flush will be reviewed monthly." 2. A review of the laboratory's 2022, 2023, and 2024 "Monthly Temperature Checks" logs revealed the following: - The laboratory's acceptable room temperature range is 20 - 23 degrees Celsius(C). - The laboratory recorded the following room temperatures outside their established acceptable ranges: 23.2C on 11/03/2022, 23.4C on 11/11 /2022, 18.5C on 11/14/2022, 19.7C on 12/16/2022, 23.9C on 02/06/2023, 23.4C on 02 /23/2023, 23.5C on 03/02/2023, 23.4C on 03/31/2023, 23.4C on 08/09/2023, 19.7C on 11/13/2023, 19.7C on 11/27/2023, 19.9C on 12/19/2023, 19.7C on 12/21/2023, 19.9C on 12/22/2023, 19.1C on 01/29/2024, 23.2C on 04/08/2024, 23.4C on 04/11/2024, 23.2C on 04/30/2024, 23.4C on 06/03/2024, 23.4C on 06/05/2024, 23.4C on 06/19 /2024, 23.4C on 07/17/2024, and 23.4C on 07/31/2024. - The laboratory did not document any

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's American Proficiency Institute (API) proficiency testing (PT) records, the Centers for Medicare and Medicaid Services Form 209 Laboratory Personnel Report (CMS-209) and interview with the laboratory technical consultant and lead testing person, determined that PT samples were not tested by all testing personnel listed on the CMS-209 in 2020, 2021, and 2022. The findings include: 1. Review of the laboratory's API Proficiency Testing Attestation records revealed only two of six testing personnel's signatures as testing PT samples (2020 Event 1, 2 and 3; 2021 Event 1 and 3; 2022 Event 1 and 2). 2. Review of the CMS-209 revealed six personnel who perform patient testing. 3. Interview with the technical consultant and lead testing person on September 22, 2022 at 11:30 am in the laboratory breakroom confirmed that PT samples were not tested by all testing personnel listed on the CMS-209 for 7 events in 2020, 2021, and 2022. ==================================== D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. 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 -- (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: ================================== Based on direct observation, review of laboratory environmental logs, review of laboratory's Beckman Coulter DxH 520 Operator's Manual, and interview with the technical consultant and lead testing person, determined the laboratory failed to document laboratory room temperature and humidity for 32 of 32 months (01/2020 through 08/2022). The findings include: 1. During a tour of the laboratory on 09.22.2022 at 9:15 A.M., the surveyor observed a Beckman Coulter DxH 520 CBC analyzer on the laboratory counter. 2. Review of laboratory environmental logs revealed laboratory failed to document laboratory room temperature and room humidity for 32 of 32 months (01/2020 through 08/2022). 3. Review of the laboratory's Beckman Coulter DxH520 Operator's Manual, stated, "The instrument configured with DxH 520 consumables meets performance specifications when operated at a temperature of +18 to 32 degrees Celsius (64.4 to 89.6 degrees F). The instrument meets performance claims when operated at a maximum of 80% relative humidity (non-condensing) at 32 degrees Celsius (89.6 degrees F)." 4. Interview with laboratory technical consultant and lead testing person at 11:45 am on 09.22.2022 in the laboratory brekroom confirmed the above findings. ================================= -- 2 of 2 --

Summary Statement of Deficiencies 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: =================================== Hematology: The laboratory failed to maintain satisfactory participation in two consecutive events for the Hemoglobin (HGB) and White Blood Cell (WBC) analytes resulting in the initial unsuccessful proficiency testing (PT) occurrence for HGB and WBC. (Refer to D2130) =================================== D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 a desk review of the CMS CASPER Report 0155D and the laboratory's 2021 Proficiency Testing (PT) performance summary records from the American Proficiency Institute (API) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the Hemoglobin (HGB) and White Blood Cell (WBC) analytes in the 1st event 2021 and 2nd event 2021, resulting in the initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed an unsatisfactory HGB analyte score of 40% and unsatisfactory WBC analyte score of 60% for the 1st event of 2021 and unsatisfactory HGB and WBC analyte scores of 0% for the 2nd event of 2021. 2. A review of the laboratory's API Proficiency Testing records revealed an unsatisfactory HGB analyte score of 40% and unsatisfactory WBC analyte score of 60% for the 1st event of 2021 and unsatisfactory HGB and WBC analyte scores of 0% for the 2nd event of 2021. =================================== -- 2 of 2 --

Summary Statement of Deficiencies 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 review of Complete Blood Count (CBC) quality control (QC) on 4/13/18, patient reports and interview with Technical Consultant, the laboratory failed to meet QC criteria prior to reporting patients. The findings include: 1. Review of CBC quality controls on 4/13/18 revealed normal and high controls (lot#'s: 079200 and 089200) for platelets failed to meet acceptable QC criteria. 2. Review of patient CBC's on 4/13/18 revealed 11 patients reported. 3. Interview with the Technical Consultant at 12:30 p.m. April 9, 2019 confirmed that 2 levels of CBC quality controls failed to meet acceptable criteria for platelets and 11 patients were reported. ===================================== 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 --