Ashford Medical Laboratory

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: Based on Puerto Rico Proficiency Program testing records review (years 2022 and 2023) and laboratory supervisor interview on August 24, 2023, it was determined that the laboratory director and testing personnel failed to sign the proficiency attestation statements. The findings include: 1. Puerto Rico Proficiency testing records from years 2022 and 2023 were reviewed on August 24, 2023 at 1:00 PM 2. On August 24, 2023 at 1:30 pmhe attestation statements (submittion form page 10) instructed the laboratory to print, fill, sing and retain the page for laboratory records and inspection purposes. Review of the attestation statements forms from years 2022 and 2023, showed that none of them were signed by director nor the individual who tested the samples. 3. On August 24, 2023 at 1:40 pm, the supervisor stated that the attestation statements were never signed by the personnel. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records (years 2022 to 2023 ) and interview with the laboratory supervisor on August 24, 2023 n November 15, 2022 , it was determined that laboratory failed to evaluate and monitor the General Laboratory system requirements . The findings include: a. On August 24, 2023 at 2:45 PM, the laboratory supervisor was interviewed regarding the QA program activities. The supervisor stated that the QA activities for year 2022 were not available. For year 2023, she stated that she was recollecting the information for later evaluation, however no evaluation was performed. b. The laboratory did not have any evaluations related to: Patient confidentiality, specimen identification and integrity, compliant investigation, communications and personnel competency. c. At 2:55 pm the QA manual was requested to the laboratory supervisor, she stated that the QA procedure manual was not available at the laboratory. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records (years 2022 to 2023 ) and interview with the laboratory supervisor on August 24, 2023 , it was determined that laboratory failed to evaluate and monitor the Preanalytic Laboratory system requirements . The findings include: a. On August 24, 2023 at 2:45 PM, the laboratory supervisor was interviewed regarding the QA program activities. The supervisor stated that the QA activities for year 2022 were not available. For year 2023, she stated that she was recollecting the information for later evaluation, however no evaluation was performed. b. The laboratory did not have any evaluations related to: test requests, specimen submission, handling and referal. c. At 2:55 pm the QA manual was requested to the laboratory supervisor, she stated that the QA procedure manual was not available at the laboratory. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records (years 2022 to 2023 ) and interview with the laboratory supervisor on August 24, 2023 , it was determined that laboratory failed to evaluate and monitor the Analytic Laboratory system requirements . The findings include: a. On August 24, 2023 at 2:45 PM, the laboratory supervisor was interviewed regarding the QA program activities. The supervisor stated that the QA activities for year 2022 were not available. For year 2023, she stated that she was recollecting the information for later evaluation, however no evaluation was performed. b. The laboratory did not have any evaluations related to: -- 2 of 4 -- test procedures, accurate and reliable test systems, specimen and reagent storage conditions,equipment/instruments/test system mantenance and function checks, calibrationa nd calibration verification, control procedure, comparison of test results,

Summary Statement of Deficiencies D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on Immuno Card Mycoplasma manufacturer's instructions, General Immunology (Mycoplasma pneumoniae) testing record review from June 18, 2021 to July 31, 2021 and interview with the laboratory supervisor on October 28, 2021 at 10: 30 AM, it was determined that the laboratory failed to follow the manufacturer's instruction when 19 out of 19 patients specimens were tested and reported for of Mycoplasma pneumoniae from June 21, 2021 to July 31, 2021. The findings include: 1. The laboratory use the Immuno Card Mycoplasma Test Cassette to perform the Mycoplasma pneumoniae qualitative tests. 2. The manufacturer's instruction establishes to perform the test procedures at room temperature range from 22 to 25 C. 3. On October 28, 2021 at 10:300 AM, review of the Mycoplasma pneumoniae testing records showed that the laboratory did not monitor nor document the room temperature when patient's specimens were tested for Mycoplasma by Immuno Card Meridian method from from June 21, 2021 to July 31, 2021. 4. The laboratory supervisor confirmed on October 28, 2021 at 10:30 AM, that the laboratory did not monitor nor document the room temperature when it processed the patients specimens for Mycoplasma pneumoniae test. 5. The laboratory processed and reported 19 patient samples for Mycoplasma pneumoniae test from June 21, 2021 to July 31, 2021. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) 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 -- 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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on General Immunology (Mycoplasma pneumoniae test) quality control records review from June 18, 2021 to July 31, 2021 and interview with the laboratory supervisor on October 28, 2021 at 10:30 AM, it was determined that the laboratory did not include each day of testing an external positive and negative control material when 19 out of 19 patients specimens were tested and reported for of Mycoplasma pneumoniae patient testing from June 21, 2021 to July 31, 2021. The findings include: 1. The laboratory use the Immuno Card Mycoplasma Test Cassette to perform the Mycoplasma pneumoniae qualitative tests. 2. On October 28, 2021 at 10:300 AM, review of Mycoplasma pneumoniae quality control record showed that the laboratory performs patient testing from June 21, 2021 to July 31, 2021. The laboratory did not include each day of testing the external positive nor the external negative control material. 3. The laboratory supervisor confirmed on October 28, 2021 at 10:30 AM, that the laboratory failed to include each day of testing the external negative and positive control material . She stated that the laboratory run the external controls when it received a new reagent kit. 4. The laboratory processed and reported 19 patient samples for Mycoplasma pneumoniae test from June 21, 2021 to July 31, 2021. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on Immuno Card Mycoplasma manufacturer's instructions, General Immunology (Mycoplasma pneumoniae) testing and quality record review from June 18, 2021 to July 31, 2021 and interview with the laboratory supervisor on October 28, 2021 at 10:30 AM, it was determined that the laboratory director failed to establish the quality control procedures for the Mycoplasma pneumoniae test. Refer to D 5405 (The laboratory did not monitor nor document the room temperature when patient's specimens were tested for Mycoplasma pneumoniae test). Refer to D 5449 (The laboratory did not include every day of testing the external positive and the negative control materials for Mycoplasma pneumoniae test). -- 2 of 2 --

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: Based on testing personnel records (Medical Technologist #1 and Medical Technologist #2) from years 2017 to 2019, personnel competence written procedures and policies and laboratory general supervisor interview on August 27, 2019 at 1:00 PM, it was determined that the laboratory failed to follow written policies to assess the testing personnel competency. The findings include: 1. The laboratory written policies showed that the testing personnel competence's must include the following criteria's: i. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. ii. Monitoring, recording and reporting of test results. iii. Review of intermediate test results or worksheets, quality control records, proficiency testing results and preventive maintenance records. iiii. Direct observation of performance of instrument maintenance and function checks. iiiii. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 2. Review of the testing personnel competence (Medical technologist #1 and Medical technologist #2) evaluation on August 27, 2019 at 1:00 PM, showed that the above criteria's were not included. 3 . The laboratory general supervisor stated that personnel competence evaluations must be performed every year. The laboratory did not evaluate the competence of the testing personnel (Medical technologist #1 and Medical technologist #2) since year 2018. D5421 ESTABLISHMENT AND VERIFICATION OF 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 -- 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. This STANDARD is not met as evidenced by: A. Based on hematology performance specifications records review and laboratory general supervisor interview at 12:30 PM on August 27, 2019, it was determined that the laboratory did not verify the manufacturer's reference intervals of the Act 5 diff AL hematology system when they verified the instrument performance verification in December 2017. The findings include: 1. The laboratory verified the performance specifications of the Act 5 diff AL hematology system in December 2017. 2. The verification of the performance specifications records showed that the laboratory did not verify that the manufacturer's reference intervals (normal values) were appropriate for the laboratory's patient population. 3. The laboratory general supervisor confirmed on August 27, 2019, that the laboratory did not verify if the manufacturer's reference intervals (normal values) were appropriate for the laboratory's patient population prior to begin to test patient's samples. 4. The laboratory processed and reported approximately 6,012 (Six thousand twelve) Complete Blood Count (CBC) by Act 5 diff AL hematology system since January 2018. B. Based on hematology performance specifications records review and laboratory general supervisor interview at 12:30 PM on August 27, 2019, it was determined that the laboratory did not include the verification of the performance specifications of the WBC (White Blood Cells) differential parameters for the Act 5 diff AL hematology system. The findings include: 1. The laboratory verified of the performance specification of the Act 5 diff AL hematology system in December 2017. 2. The performance specifications records showed that laboratory did not include the verification of the WBC differential parameters prior to begin to test patient's samples. 3. The laboratory general supervisor confirmed on August 27, 2019, that the laboratory did not verify the automatized differential vs manual method comparison prior to begin to test patient's samples. 4. The laboratory processed and reported approximately 6,012 (Six thousand twelve) Complete Blood Count (CBC) by Act 5 diff AL hematology system since January 2018. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on hematology performance specifications records review (December 2017) and laboratory general supervisor interview at 11:30 AM on August 27, 2019, it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. Refer to D5421. -- 2 of 2 --