Summit Medical Group Pa

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control Records (QCR) and interview with the Laboratory Managers (LM), the laboratory failed to document all Quality Control (QC) information for Urinalysis tests performed on the Aution Eleven AE-4022 analyzer from 7/20/23 to 9/17/25 . The finding includes: 1. The laboratory did not document the lot numbers and expiration dates of QC material used on the Aution Eleven Daily QC reports. 2. The LM confirmed on 9/17/25 at 2:30 pm, the laboratory did not document all QC information. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of analyzer Quality Control Records (QC), review of the Manufacturer QC Assayed Value Sheet (MQCAVS) and interview with the Laboratory Managers (LM), the laboratory failed to follow the MQCAVS for routine 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 -- chemistry testing performed on the Roach Cobas Integra from June 2025 to 9/17/25. The findings include: 1. The MQCAVS for level 1 did not match the QC records as follows: a) The MQCAVS had Creatinine (CR) listed as .94-1.01 mg/dL the QC records had .79-1.11 mg/dL . b) The MQCAVS had Total Bilirubin (TBIL) listed as . 371-.687 mg/dL the QC records had .371-.69 mg/dL 2. The MQCAVS for level 3 did not match the QC records as follows: a) The MQCAVS had CR listed as 5.25-6.45 mg /dL the QC records had 5.96-7.16 mg/dL 3. The LM confirmed on 9/17/25 at 11:40 am, the laboratory failed to follow the MQCAVS . D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) reagents and interview with the Laboratory Mangers (LM), the laboratory failed to document appropriate expiration dates on the Bio-Rad Liquichek Cardiac Markers Plus Control LT QC reagents in use on the Roach Cobas e411 analyzer from 9/16/25 to 9/17/2025. The findings include: 1. The Manufacturers Package Insert (MPI) stated "open vial stability is 4 days after opening and reconstituting." 2. The laboratory recorded an open and reconstitution date of 9/16/25 on the Bio-Rad Liquichek Cardiac Markers Plus Control LT . 3. Bio-Rad Liquichek Cardiac Markers Plus Control LT were then stable until 9/20/25, but the laboratory had a stability date of 9/26/25 recorded on the QC. 4. The LM confirmed on 9/17/25 at 11:10 am, the laboratory failed to document appropriate expiration dates on opened QC reagents. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 surveyor observation of staining reagents and interview with the Laboratory Managers (LM) the laboratory used expired staining reagents for Hematology tests from 9/12/25 to 9/17/25. The finding includes: 1. The Hema-Tek Stain Pak lot #146520 in use was observed to be expired on 9/12/25. 2. Approximately 27 tests were performed and reported with the expired staining reagents. 3. The LM confirmed on 9/17/25 at 1:35 pm, the laboratory used expired staining reagents. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on December 4, 2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 review of CASPER report 155 and graded results from the College of 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 -- American Pathologists (CAP), the laboratory failed to achieve 80% or more in two out of three events for Endocrinology for the analyte Human Chorionic Gonadotropin (hCG). Refer ro D2107 D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in 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 review of the CASPER 155 report and graded results from College of American Pathologists (CAP), the laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive events in the subspecialty Endocrinology for the analyte Human Chorionic Gonadotropin (hCG). The findings include: 1) A Review of the CASPER 155 report revealed the following: a) The laboratory scored 20% in event 2-2024 b) The laboratory scored 60% in event 3-2024 2. A review of CAP graded results confirmed the aforementioned failed PT events. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CASPER 155 report and graded results from College of American Pathologists (CAP) the Laboratory Director (LD) failed to provide overall management and direction to laboratory personnel to ensure that the Proficiency Testing (PT) surveys are performed satisfactorily and in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations. The findings include: 1. The LD failed to ensure PT surveys are performed satisfactorily and in compliance with CLIA regulations. Cross refer D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from College of American Pathologist (CAP) the Laboratory Director (LD) failed to ensure successful participation in a Department of Health and Human Services (DHHS) approved -- 2 of 3 -- Proficiency Testing (PT) program for two consecutive PT events for the analyte Human Chorionic Gonadotropin (hCG), resulting in initial unsuccessful performance. Refer to D2107. -- 3 of 3 --

Summary Statement of Deficiencies 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)