Terrace Pediatric Group, Llc

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records and staff interview, the laboratory failed to test proficiency testing samples the same as patient samples for seven of seven events reviewed for 2021, 2022, and 2023. The findings include: 1. Review of the laboratory's College of American Pathologists (CAP) Hematology Auto Differentials (FH1) proficiency testing records revealed the laboratory tested PT samples in duplicate and submitted the average of the results for the following PT events: - 2021 FH1-C samples FH1-11 through FH1-15 - 2022 FH1- A samples FH1-1 through FH1-5 - 2022 FH1-B samples FH1-6 through FH1-10 - 2022 FH1-C samples FH1-11 through FH1-15 - 2023 FH1-A samples FH1-1 through FH1-5 - 2023 FH1-B samples FH1-6 through FH1-10 - 2023 FH1-C samples FH1-11 through FH1-15 2. An interview with the lead testing person on 12/12/23 at 1:30 p.m. confirmed the laboratory does not routinely test patient samples in duplicate and, therefore, did not test PT samples in the same manner as it tests patient samples when it performed duplicate testing of the PT and reported the average result for seven of seven PT events reviewed in 2021, 2022, and 2023. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- 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 of the laboratory, review of quality control (QC) package inserts, and staff interviews, the laboratory failed to label three of three QC vials with an open date and updated expiration date on the date of the survey. The findings include: 1. Observation of the laboratory on 12/12/23 at 08:45 a.m. revealed an Abbot Cell-Dyn Emerald (SN: 030820-008393) in use for patient CBC testing utilizing three levels of Cell-Dyn 18 Plus QC material (Lot: 3289). The vials were not labeled with either an open date or corrected expiration date. 2. Review of the Cell-Dyne 18 Plus Control assay sheet revealed the control material has an "8 Consecutive-Day Open- Tube Stability". 3. Interview with the lead testing person on 12/12/23 at 1:30 p.m. confirmed that quality control material observed in the laboratory was not labeled with an open date and updated expiration date. D5463 CONTROL PROCEDURES CFR(s): 493.1256(d)(7)(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-- Over time, rotate control material testing among all operators who perform the test. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), review of the laboratory's quality control (QC) logs, and staff interview, the laboratory failed to ensure QC for complete blood count (CBC) patient testing was rotated among all testing personnel (TP) in 2021, 2022 and 2023. The findings include: 1. Observation of the laboratory on 12/12/23 at 08:45 a.m. revealed an Abbot Cell-Dyn Emerald (SN: 030820-008393) in use for patient CBC testing utilizing three levels of Cell-Dyn 18 Plus QC material (Lot: 3289). 3. Review of the Form CMS-209 revealed nine testing persons who perform CBC patient testing. 2. Review of the laboratory's 2021, 2022, and 20223 quality control logs revealed no records of CBC QC being performed by TP1, TP2, and TP7. 4. Interview with the lead testing person on 12/12/23 at 1:30 p.m. confirmed that quality control was performed by designated testing personnel and was not rotated among all personnel who perform patient CBC testing in 2021, 2022 and 2023. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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 -- 2 of 3 -- and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the Clinical Laboratory Improvement Amendments (CLIA) certificate of compliance, CLIA Application for Certification (form CMS-116), Laboratory Personnel Report CLIA (form CMS-209), and staff interview, the laboratory director failed to ensure compliance with regulation 493.51(a)(4) by not notifying the department of Health and Human Services (HHS) state agency within 30 days of when the laboratory director personnel changed on 07/01/22. The findings include: 1. Review of the CLIA certificate of Compliance revealed the laboratory director was not the same as the laboratory director listed on the forms CMS-116 and CMS-209 completed for the survey conducted on 12/12/23. 2. Interview on 12/12/23 at 1:30 p.m. with the Laboratory Director and lead testing person confirmed the laboratory failed to notify the HHS state agency within 30 days of when the laboratory director changed on 07/01/22. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), review of testing personnel (TP) competency assessment records, and staff interview, the technical consultant failed to ensure assessment of blind testing or external proficiency testing was included as part of the competency assessment for three of nine testing personnel in 2021, 2022, and 2023. The finding include: 1. Review of the Form CMS-209 revealed nine testing personnel for moderately complex testing. 2. Review of the competency assessment records revealed neither blind testing nor external proficiency testing was included as part of the annual competency assessments of TP1, TP2, and TP7 in 2021, 2022, and 2023. 3. Interview with the Lab Director and lead testing person on 12/12/23 at 1:30 p. m. confirmed neither internal blind testing nor external proficiency testing was included as part of the competency assessment for TP1, TP2 and TP7 in 2021, 2022, and 2023. -- 3 of 3 --

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 out of three proficiency testing (PT) events for Hematocrit (HCT) and hemaglobin (HGB) analytes resulting in the 1st unsuccessful PT performance in 2021. Refer to(D2130). 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. 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 review of the Centers for Medicare and Medicaid Services Casper report 155D (CMS 155) and the College of Amerian Pathologist (CAP) evaluation reports, the laboratory failed to acheive satisfactory performance for Hemoglobin (HGB) and Hematocrit(HCT) analytes in two out of three testing events resulting in the 1st unsuccessful PT performance in 2021. The findings include: 1. Review of the CMS 155D revealed the following scores: Event 1-2021 HGB and HCT score of 0% Event 2-2021 HGB and HCT score of 0% 2. Review of the laboratory's CAP evaluation report revealed the following scores. Event 1-2021 HGB and HCT score of 0%. Event 2- 2021 HGB and HCT score of 0%. -- 2 of 2 --

Summary Statement of Deficiencies 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. (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 lack of room temperature and humidity records available for review and interview with the lead testing person, the laboratory failed to document the room temperature and humidity in 2018 and 2019. The findings include: 1. There were no room temperature and humidity records available for review from January 1, 2018 through August 22, 2019. 2. Interview with the lead testing person on August 22, 2019 at 2:00 p.m. confirmed the laboratory did not monitor the room temperature and the humidity January 1, 2018 through August 22, 2019. 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 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 -- 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 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 a review of calibration records from December 28 2017 to August 22, 2019 and an interview with the lead testing person, the laboratory failed to calibrate the hematology analyzer at least once every six months during the two year period. Findings include: 1. Review of calibration records for 2017 through 2019 disclosed a nine to ten month period between calibrations, from 12-28-17 to 9-7-18 to 7-3-19. 2. An interview with the lead testing person at 2:00 p.m. on August 22, 2019 confirmed calibrations were not done at least at a six month interval during the two year period. D6044 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(6) (b) The technical consultant is responsible for-- (b)(6) Ensuring that patient test results are not reported until all

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 a review of 2017 Proficiency Testing (PT) attestation records and interview with testing personnel number one, the laboratory did not involve all nine testing personnel in rotating PT complete blood count (CBC) samples, in 2017. The findings include: 1) Review of the 2017 PT records revealed testing personnel number one performed all PT sample CBC testing for 2017 events one, two, and three. 2) Interview on January 17, 2018 at 11:00 a.m. with testing personnel number one confirmed the PT CBC samples were not rotated among the 9 testing personnel in 2017. 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: Based on review of the 2016 and 2017 proficiency testing (PT) records and interview with testing personnel number one, the laboratory failed to test the PT samples the same number of times that it routinely test patient samples, during the two year period. The findings include: 1) Review of the 2016 and 2017 events one, two and three PT records revealed each PT sample was tested twice. 2) Interview on January 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 -- 17, 2018 at 11:40 a.m. with testing personnel number one confirmed each PT sample is tested twice and the average is reported to the PT agency. The patient CBC samples are routinely tested once. 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 observation of the laboratory, review of nine testing personnel training and competency assessment forms and interview with testing personnel number one, the laboratory failed to include all required competency assessment elements for the performance of the complete blood count (CBC) in 2016 and 2017. The findings include: 1. Observation of the laboratory on January 17, 2018 at 9:40 a.m. revealed the Beckman Coulter AcT diff instrument in use for patient CBC testing. 2. Review of the forms in use for nine testing personnel training and competency assessment documentation revealed that all six required competency assessment methods were not included in the competency assessment. The required elements include: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results, quality control records, proficiency testing results and preventative maintenance records; direct observation of instrument maintenance and function checks; assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and problem solving skills. 3. Interview with testing personnel number one on January 17, 2018 at 12: 15 p.m. confirmed that competency assessment methods used did not include all six required elements as specified in subpart M for the nine testing personnel in 2016 and 2017. 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 review of the Quality Assurance (QA) Plan stating "The Laboratory Director will complete a monthly QA checklist", lack of monthly QA documentations and interview with the Laboratory Director, the Director failed to follow written policy for documenting monthly QA reviews for 2016 and 2017. The findings include: 1. Review of the QA Plan states "The Laboratory Director will complete a monthly QA checklist" (copy attached). 2. Lack of monthly QA documentations for 2016 and 2017. 3. Interview at approximately 3:00 p.m. January 17, 2018 with the Laboratory Director confirmed there was no monthly QA documentation for the two year period. ______________________________________ -- 2 of 5 -- 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)