Piggott Family Medical Clinic

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: Through review of the Medonic operators' manual, laboratory policies and procedures, and Medonic patient datalogs, as well as interviews with laboratory staff, the laboratory failed to follow manufacturer's instructions for evaluating patient test results when instrument flags are present. Survey findings include: A. Review of the operators' manual for the Medonic hematology analyzer revealed a list of causes for instrument flags and actions the lab must take to resolve the flags. In the section for WBC (White Blood Cell) Differential Abnormalities, it states, "follow laboratory's protocol for verification of results". B. The laboratory "Error Code Policy" states, "Shifts in WBC distribution due to EDTA anticoagulant equilibration will often result in "error" codes next to one of the automated differential values. 1. Check the specimen for clots or agglutination. Recollect if clots are found. 2. If no clots are detected, the specimen will be retested." C. Review of the Medonic CBC (complete blood count) datalog for June and July of 2024 revealed, one of three CBCs with WBC distribution flags failed to be recollected or retested. On 6/11/2024 at 15:16 a CBC was performed on specimen #268591. Flags were present on all differential parameters. The datalog failed to include documentation of retesting of the sample or of recollection and retesting of the patient. D. In an interview, at 1:20 p.m. on 8/13 /2024, the laboratory director confirmed the flags were not addressed as required by the manufacturer and the laboratory policy. 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 D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Through observation, review of manfacturer's package insert and interview it was determined that the laboratory failed to amend the expiration date of nine of nine cartidges for the determination of glycolated hemoglobin (A1c Hgb) when moved from refrigerated storage and placed at room temperature. Findings follow: A) Review of the manufacturer's storage requiements for Afinion A1c Hgb cartridges revealed a storage temperature requirement of 2 degrees C. to 8 degrees C. or 90 days at room temperature, and the date placed at room temperature must be documented. B) During a tour of the laboratory on September 15, 2022 at 11:35 a.m., nine Afinion A1c Hgb cartiridges, lot # 10217313 expiration date 2024-05-11 , were observed in a laboratory drawer without an amended expiration date or date of when the cartridges were placed at room temperature. C) When asked at the time, the testing personnel, ( # seven on the CMS 209 form) stated that the cartridges were currently in use and the date of placing them at room temperature or an amended expiration date was not on the cartridges or a container in which they were kept. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions 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 -- for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Through review of laboratory policy and procedure, observation and interview it was determined that the laboratory failed to label 11 of 58 specimen collection containers with patient name and unique patient identifier. Findings follow: A) During a tour of the laboratory on 9/15/22 at 11:20 a.m. one of eight EDTA blood specimens and one of seven serum specimens in a rack labeled "Monday", and four of nineteen EDTA specimens and seven of fourteen serum specimens in a rack labeled "Tuesday" were observed in the laboratory refrigerator labeled with the patients first and last names only. B) Review of the laboratory policy and procedure revealed that specimen containers are to be labeled with the patient's first and last names and the patient's date of birth or unique identifier. C) In an interview on 9/15/22 at 11:25 a.m. , the laboratory staff members (#1 and #7 on the CMS 209 form) confirmed that the specimens identified above lacked proper patient identification on the containers as required by policy and procedure. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: Through observation, and interview it was determined that the laboratory failed to ensure that approximately 70 supply items available for use had not exceeded their expiration date. Findings follow: A. In a tour of the laboratory on 4/12/18 at approximately 1145, 70 BD Na Citrate 3.5 ml blood collection tubes lot # 7097644 with an expiration date of 2018-01-31 were observed in the laboratory storage room. B. In an interview on 4/12/18 at approximately 1200, the laboratory director identified as number 1 on the CMS 209 form and testing personnel identified as number 3 on the CMS 209 form confirmed that the items identified above had exceeded their expiration dates and were available for use. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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: Through a review of laboratory results in electronic medical records and through interviews with laboratory staff, it was determined the laboratory test report failed to include the name and address of the laboratory where the test was performed. Survey findings follow: A. 100 percent of laboratory reports reviewed as part of the electronic medical record lacked the name and address of the laboratory location where the test was performed. B. In an interview at 1220 on 4/12/18 , the laboratory director identified as number 1 on the CMS 209 report and the testing personnel identified as number 3 on the CMS 209 report confirmed the reports lacked the name and address of the laboratory performing the tests. -- 2 of 2 --