Cullman Internal Medicine

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to enroll in an approved Proficiency Testing program for 2024. The findings include: Refer to D2001. . D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency 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 3 -- (PT) records and an interview with Testing Personnel #1, the laboratory failed to enroll in an approved Proficiency Testing program for 2024. This was noted for four out of five specialties reviewed in 2024. The findings include: 1. A review of the API PT records revealed the laboratory failed to enroll in the 2024 API program for Event 1 for the following specialties: a. Chemistry b. Immunology c. Hematology d. Microbiology 2. During an interview at 10:35 AM on 5/3/2024, Testing Personnel #1 explained the laboratory enrolled in API's proficiency program in March of 2024, at which time Microbiology Miscellaneous Event 1 was the only event available for shipment. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the QIAstat-Dx Respiratory QC (Quality Control) records, a review of the patient test log, a review of the QIAstat-Dx IQCP (Individualized Quality Control Plan), and an interview with Testing Personnel #1, the Laboratory failed to ensure testing personnel performed the Qiagen QC every 30 days as per the IQCP. The surveyor noted one out of twelve months in 2023 when QC was not performed as required by the IQCP prior to patient testing. The findings include: 1. A review of the QIAstat-Dx Respiratory records revealed the laboratory exceeded the 30- day requirement for external controls QC, as follows: a) 9/28/2023 to 11/27/2023; 30 days over due. 2. A review of the patient test log revealed within those 30 days, three patients were performed on the following dates: a) 10/31/2023. b) 11/17/2023. c) 11 /21/2023. 3. A further review of the QIAstat-Dx Respiratory IQCP revealed on page 3, "Run external controls with positive and negative representation... once a month at a minimum." 4. During an interview on 5/3/2024, at 1:45 PM, Testing Personnel #1 confirmed October 2023 external QC was overlooked. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records, and an interview with Testing Personnel #1, the Laboratory Director -- 2 of 3 -- failed to ensure the laboratory enrolled in an approved PT program for 2024. This was noted for four of five specialties in the first event of 2024. The findings include: Refer to D2001. -- 3 of 3 --

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: Based on a review of the temperature records, a review of the BioRad Liquid Assayed MultiQual Quality Control (QC) package insert, and an interview with Testing Personnel #1, the surveyor determined the laboratory's criteria for Freezer temperatures failed to be consistent with the manufacturer's storage requirements. The laboratory further failed to ensure QC was stored as per manufacturer's requirements for seven out of seven months from January 2022 to July 2022 reviewed by the surveyor. The findings include: 1. A review of temperature records revealed the acceptable range for the Freezer was -17 to -23 degrees Celsius. The temperature records also revealed the following: a) January 2022 - 21 out of 21 days were warmer than -20 degrees Celsius. b) February 2022 - 17 out of 20 days were warmer than -20 degrees Celsius. c) March 2022 - 16 out of 23 days were warmer than -20 degrees Celsius. d) April 2022 - 19 out of 21 days were warmer than -20 degrees Celsius. e) May 2022 - 18 out of 21 days were warmer than -20 degrees Celsius. f) June 2022 - 19 out of 21 days were warmer than -20 degrees Celsius. g) July 2022 - 14 out of 19 days were warmer than -20 degrees Celsius. 2. A review of the BioRad Liquid Assayed MultiQual QC package insert revealed storage requirements of -20 to -70 degrees Celsius. 3. During an interview on 08/02/2022 at 3:30 PM, Testing Personnel #1 confirmed the above findings. 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 -- D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) 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 a review of the QIAstat-Dx Respiratory Panel Quality Control (QC) records and an interview with Testing Personnel #1, the laboratory failed to run controls at least once each day of patient testing or implement an Individualized Quality Control Plan (IQCP) for the QIAstat-Dx Analyzer. From December 2020 through June 2022, the surveyor noted 231 days of patient testing, and only 42 days when QC was performed. The findings include: 1. A review of the QIAstat-Dx Respiratory Panel QC records revealed Pos A, Pos B-1, and Negative QC was performed with each new kit lot number from 12/29/2020 to 06/28/2022. 2. During an interview on 08/02/2022 at 11:45 AM, Testing Personnel #1 confirmed QC was only run with each new lot number, and the laboratory had not implemented an IQCP to allow decreased frequency of QC performance. -- 2 of 2 --