Medcenter Primary Care Pc

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the Laboratory Director (or designee) and laboratory testing analysts failed to sign the attestation statements for ten of twelve events reviewed in 2023 through 2025. The findings include: 1. A review of the MLE PT records revealed the no signature by the previous Laboratory Director (or designee) or the testing analyst on attestation statements for the following surveys: a) 2023 Chemistry M3 and Non-Chemistry M3. b) 2024 Chemistry M1 and Non-Chemistry M1. c) 2024 Chemistry M2 and Non-Chemistry M2. d) 2024 Chemistry M3 and Non-Chemistry M3. e) 2025 Chemistry M1. f) 2025 Chemistry M2. 2. During an interview on 7/29/25, at 1:45 PM, Testing Personnel #1 confirmed the above findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test 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 -- reports. This STANDARD is not met as evidenced by: Based on a review of the temperature records, the Beckman Coulter DxH 520 Hematology analyzer user manual, DxH 500 Series Quality Control package insert, and an interview with Testing Personnel #1, the Laboratory failed to document temperatures for the refrigerator in which Hematology QC was stored and room temperature and humidity in which the DxH 520 Hematology analyzer is stored. This was noted for 23 days of 91 days reviewed in April through June 2025. The findings include: 1. A review of the temperature records revealed the laboratory failed to document temperatures for the refrigerator, room temperature, and humidity for the Beckman Coulter DxH 500 series Controls and Beckman Coulter DxH 520 Hematology analyzer for the following days: a) April 2025: 4/3, 4/6, 4/7, 4/9, 4/10, 4 /18, 4/22, 4/26, and 4/29. b) May 2025: 5/26 - 5/29. c) June 2025: 6/3, 6/10, 6/11, 6 /14, 6/17 - 6/19, 6/23, 6/28, and 6/30. 2. A review of the Beckman Coulter DxH 520 Hematology analyzer user manual revealed, "Optimal requirements: Room temperature 16-30 degrees Celsius, Humidity less than 80%." 3. A review of the Beckman Coulter DxH 500 series Quality Control package insert revealed, "Store at 2- 8 degrees Celsius." 4. During an interview on 7/29/25, at 1:45 PM, Testing Personnel #1 confirmed the above findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Hematology maintenance records, Hematology maintenance procedure, and an interview with Testing Personnel #1, the Laboratory failed to document monthly maintenance on the Beckman Coulter DxH 520 Hematology analyzer as per the manufacturer's requirements. This was noted for 8 months of 18 months reviewed in 2024 and 2025. The findings include: 1. A review of the Beckman Coulter DxH 520 Hematology analyzer records revealed no documentation of monthly maintenance for the following dates: a) 2024: April, May, July, August. b) 2025: March through June. 2. A review of the Beckman Coulter DxH 520 Hematology analyzer maintenance procedure revealed, "Clean WBC bath filter." 3. During an interview on 7/29/2025, at 1:45 PM, Testing Personnel #1 confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The surveyor determined this laboratory is in substantial compliance with the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). 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 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the Beckman Coulter AcT diff 2 Hematology analyzer Operator's Manual and an interview with Testing Personnel #1, the laboratory failed to ensure the Laboratory Director signed, dated and approved the manual for use by the testing personnel. The findings include: 1. A review of the Beckman Coulter AcT diff 2 Operator's Manual revealed no signature and date of the Laboratory Director to indicate review and approval of the manual for use by the testing personnel. 2. During an interview and review of the manual on 8/7/2019 at approximately 10:45 AM, the surveyor asked about the Laboratory Director's review of the Hematology procedures in use. Testing Personnel #1 stated she had forgotten to give the Operator's Manual to the Director for his signature (to indicate his approval). . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 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 installation and validation documentation for the Beckman Coulter AcT diff 2 Hematology analyzer, and interviews with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure the initial installation and verification procedures included documentation of review by the Laboratory Director and Technical Consultant (as indicated by signatures and dates of reviews) before patient testing began on 3/25/2019. The findings include: 1. During the initial tour of the facility on 8/7/2019 from 8:45 to 9:00 AM, TP #1 included CBCs (Complete Blood Counts) on the moderate-complexity test menu for the laboratory. TP #1 stated the laboratory began performing CBCs for patients on 3/25/2019. 2. A review of the personnel records revealed the Laboratory Director had signed a letter designating the duties of the Technical Consultant (TC) to an outside qualified professional TC, who was listed on the Form CMS-209 (Laboratory Personnel Report). 3. A review of the records for the Beckman Coulter AcT diff 2 Hematology analyzer revealed the Coulter technical representative installed the instrument on 3/21/2019. 4. A further review of the installation records revealed Coulter LIN-C Linearity controls (a five level kit) were used to establish accuracy and reportable range on 3/21/2019. Values for each of the five parameters were hand-written on a "Coulter LIN-C Worksheet" by the Coulter technical representative; the instrument printouts of the raw data were retained in the binder. The Laboratory Director had signed on multiple pages, however there was no indication of when his review occurred (no date) to document the data was reviewed/approved before patient testing began. The surveyor further noted there was no signature or date documenting the Technical Consultant's review. 5. In an interview on 8/7/2019 from 10:40 AM, the surveyor asked if the Technical Consultant had reviewed the validation records for the Beckman Coulter AcT diff 2 analyzer. TP #1 stated she previously had a scheduled meeting while the TC was at another facility, however TP#1 had forgotten to include the validation records in the documentation for the TC's review. TP #1 stated the TC had not had a chance to review and approve the verification procedures. The surveyor explained the laboratory also needed the TC's review and approval since the Laboratory Director had delegated this responsibility. 6. As the interviewed continued on 8/7/2019 from 10:45 AM, the surveyor asked when the Laboratory Director had reviewed the Hematology analyzer validation. TP #1 stated "he signed everything on 3/25/2019". The surveyor then asked if the Director had dated his reviews to document the data was reviewed and approved before patient testing began; TP #1 was unable to find any record of the Director signature with a date of approval. Thus, the above noted findings were confirmed. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --