Community Clinic Springdale Medical

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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: Review of the proficiency test attestation records for five events in 2023 and 2024, lack of documentation, and interviews with laboratory staff, determined that required signatures to attest to the routine integration of proficiency test samples in the patient workload were not present on two of the five events reviewed. Survey findings follow: A) Review of the attestation forms for American Proficiency Testing Institue (API) Hematology/Coagulation 2023 1st event and API Hematology/Coagulation 2023 2nd event revealed that the attestation form did not have the signatures of the testing personnel. Instead, both attestation forms had the statement "employee resigned" in the space for the testing personel signatures.. B) In an interview, at 11:40 a.m. on 8/1/24, the laboratory staff member (# 1 as listed on the form CMS-209) confirmed the attestation forms identified above were not signed by testing personnel who performed the testing. 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 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 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 two of twelve specimen collection containers with patient name or unique patient identifier. Findings follow: A) During a tour of the laboratory on 10/18/22 at 1:00 pm twelve urine specimen containers were observed in the laboratory testing area; two labeled on the specimen lid only. B) Review of the laboratory policy and procedure revealed that "patient specimen containers must be labeled with the patient's name and unique identifier". . C) In an interview on 10/18/22 at 3:23 pm , the laboratory staff member (#1 on the CMS 209 form) confirmed that the specimens identified above had been analyzed and lacked proper patient identification on the containers as required by policy and procedure. 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: Through observation, review of temperature records, lack of documentation and interview it was determined that the laboratory failed to monitor the temperature in one of three rooms in which supplies with storage temperature requirements were stored on each day of operation. Findings follow: A) During a tour of the laboratory on 10/18/22 at 01:00 p.m.three rooms containing items with a temperature storage requirement (the main laboratory,a storage room and separate area for microscopy) all separated by a closable door, were observed. B) During a review of the laboratory's temperature records it was noted that temperature records for only the main laboratory and storage room were presented. C) During a tour of the laboratory on 10/18/22 at 03: 03 p.m. one container of KOH 10% solution ( lot # 3004-00 expiration date 2024-01- 31) with a storage temperature requirement of 15 degrees C. to 35 degrees C was observed in the microscopy area. D) Upon request, the laboratory could not present the temperature records for the microscopy area in which the supplies identified above were stored,. E) In an interview on 10/18/22 at 03:23 p.m. the laboratory staff member (# 1 on the CMS 209 form) stated that the daily temperature of the microscopy room in which the supplies identified above were stored had not been monitored and recorded.. 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 observations made during a tour of the laboratory and interviews with staff, it was determined the laboratory had supplies available for use when they had exceeded their expiration date. Survey findings follow: A) During a tour of the laboratory on 10/18/22 at 03:00 p.m., the surveyor observed three BD 6.0 ml Red Top blood collection tubes (lot# 1132882, expiration date 2022-9-30) in a plastic bin located in Phlebotomy drawing room. B) In an interview on 10/18/22 at 03.03 p.m., the laboratory staff member (#1 on the CMS 209 Form) confirmed the supplies were available for use when they had exceeded their expiration date. -- 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: Through observation, lack of documentation and interview it was determined that the laboratory failed to document room temperature in two of three rooms surveyed in which supplies with storage temperature requirements were located. Findings follow: A) During a tour of the laboratory on 11/16/20 at approximately 02:30 PM, the surveyor observed two boxes of Quidel Sofia SARS Ag tests, lot # 706189 expiration date 2021-08-12 with a storage temperature requirement of 15 degrees C. to 30 degrees C. in a separate Covid-19 testing room separated from the laboratory by a closable door and 60 boxes of Quidel Sofia SARS Ag tests, lot # 7058987 expiration date 2021-08-12 in a separate storage room separated from the laboratory by a closable door. B) Upon request the laboratory was unable to provide documentation of temperature records for the rooms identified above. C) In an interview on 11/16/20 at approximately 02:30 PM, the laboratory staff member identified as number one on the CMS 209 form confirmed that the laboratory failed to measure and document temperature in the rooms identified above. 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 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: Through review of personnel records, lack of documentation, and interview it was determined that the laboratory failed to perform competency evaluations on two of seven personnel identified on the CMS 209 form. Findings follow: A. Review of personnel records revealed that no competency evaluations were provided for the testing personnel identified as number six on the CMS 209 form, who has been testing since 9/1/16, and number seven on the CMS 209 form, who has been testing since 3/21 /17. B. Upon request, the laboratory could not provide competency evaluations for the personnel identified above. C. In an interview on 4/6/18 at approximately 01:30 pm, the laboratory director identified as number one on the CMS 209 form confirmed that competency evaluations had not been performed on the personnel identified above. 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 assure that supplies were not used when they have exceeded their expiration date. 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 -- Findings follow: A. During a tour of the laboratory on 4/6/18 at approximately 0835, five of five bottles of Potassium Hydroxide Solution ( one bottle Lot # 5315803 with an expiration date of 2016//11/09, and four bottles lot # 1703015 with an expiration date of 2018/01/30) were observed in the microscopy area and no unexpired Potassium Hydroxide was observed in the area at that time . B. In an interview on 4/6 /18 at approximately 0835, the laboratory director identified as number one on the CMS 209 form confirmed that the bottles were available for use, and had exceeded the expiration date. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Through review of personnel records, lack of documentation, and interview it was determined that the laboratory failed to have written authorization to perform testing for three of seven testing personnel listed on the CMS 209 form. Findings follow: A. Upon review of personnel records, no written authorization to test was found for testing personnel identified as numbers six, seven and nine on the CMS 209 form. B. Upon request, the laboratory could not produce a written authorization to test for the personnel mentioned above. C. In an interview on 4/6/18 at approximately 1245 the laboratory director identified as number one on the CMS 209 form confirmed that no written authorization to test was available for the testing personnel identified above and that those personnel did perform moderate complexity testing. -- 2 of 2 --