Summary:
Summary Statement of Deficiencies D5018 URINALYSIS CFR(s): 493.1211 If the laboratory provides services in the subspecialty of Urinalysis, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Urinalysis quality control records review and interview with the laboratory supervisor on March 16, 2022 at 12:00 PM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements of Urinalysis. Refer to D 5449 (3) 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, Mycoplasma testing records and laboratory general supervisor, it was determined that the laboratory failed to follow the manufacturer's instruction when 9 out of 9 patient specimen were tested for Mycoplasma by Immuno Card Meridian method from February 16, 2022 to March 16, 2022. The findings include: 1. The manufacturer's instruction establishes to perform the test procedures at room temperature from 22 to 25 C. 2. On March 16, 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 -- 2022 at 11:30 AM, the Mycoplasma testing records showed that the laboratory did not follow the manufacturer instruction when it processed the following patients specimens: Testing Sample ID Temperature Date processed 1. 02/16/2022 465500 21 C. 2. 02/16/2022 465561 21 C. 3. 02/16/2022 465563 21 C. 4. 03/04/2022 467334 21 C. 5. 03/08/2022 No ID 21 C. 6. 03/08/2022 No ID 21 C. 7. 03/09/2022 No ID 21 C. 8. 03/16/2022 467916 21 C. 9. 03/16/2022 467944 21 C. 3. The laboratory supervisor confirmed on March 16, 2022 at 11:45 AM, that the laboratory did not follow the manufacture's instructions for the temperature of processing. 4. The laboratory processed and reported 9 out of 9 patient specimen for mycoplasma test out of the manufacturer's temperature range from February 16, 2022 to March 16, 2022. 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: 1. Based on General Immunology (COVID-19 Ab IgG/IgM) quality control records review from January 5, 2021 to March 16, 2022 and interview the laboratory director, it was determined that the laboratory did not include an external positive and negative control material each day of COVID-19 Ab IgG/IgM patient testing. The findings include: a. Review of COVID-19 Ab IgG/IgM the laboratory used Right Sign Kit. b. The quality control review on March 16, 2022 at 11:01 AM, showed that the laboratory performs patient testing from February 22, 2022 to March 16, 2022. Before February 22, 2022 the laboratory worksheet showed that a positive and negative control material were included. However since February 22, 2022 the laboratory changed their worksheet and the fields for control material was not included. c. From February 22, 2021 to March 16, 2022 the laboratory processed and reported 7 patient samples, and no external control material was included. d. The laboratory Supervisor confirmed on March 16, 2022 at 11:08 AM, that the laboratory failed to include a external negative and positive control material since February 22, 2022. Instead they run the external control only with a new open box or new lot. 2. Based on General Immunology (Mycoplasma pneumoniae test) quality control records review from January 5, 2021 to March 16, 2022 and interview with the laboratory supervisor, it was determined that the laboratory did not include each day of patient testing an external positive and negative control material. The findings include: a. The laboratory use the Immuno Card Mycoplasma Test Cassette to perform the Mycoplasma pneumoniae qualitative tests. b. The quality control review on March 16, 2022 at 11:12 AM, showed that the laboratory performs patient testing from February 22, 2022 to March 16, 2022, the laboratory did not include any control material each day of patient testing. c. The laboratory supervisor confirmed on March 16, 2022 at 11: 22 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 control when it received a new reagent kit. d. The laboratory processed and reported 9 patient samples for Mycoplasma pneumoniae from February 16, 2022 to March 16, 2022. 3. Based on Urinalysis microscopic control record review from January 2021 to March 2022 and interview with the laboratory supervisor, it was determined that the laboratory did not include each day of patient testing any microscopic control -- 2 of 4 -- material. The Findings include: a. The urinalysis microscopic quality control review on March 16, 2022 at 11:43 AM showed that the laboratory did not include any control material when 4,319 out of 4,319 patient samples was processed and reported, since January 2021. b. During interview with the laboratory supervisor on March 16, 2022 at 11:50 AM she stated that she was not aware that microscopic positive and negative control materdial were nedded. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Review of syphilis serology qualitative and quantitative control and patient records from January 2021 to March 2022 and interview with the laboratory supervisor, it was determined that the laboratory did not include any control material with tittered reactivity when the laboratory processed and reported patients with tittered results. The findings include: a. The laboratory processed syphilis serology patient tests by RPR (Rapid Plasma Reagin) method. b. Review of quality control on March 16, 2022 at 12:38 pm and patient log book records showed that from February 17, 2022 to March 2, 2022 the laboratory reported four patients with tittered test results: Patient # Date Result VCR 2/17/2022 1:2 dils WRN 2/19/2022 1:16 dils VRR 2/25/2022 1:4 dils CLC 3/02/2022 1:4 dils No tittered control material were included. c. The laboratory supervisor confirmed on March 16, 2022 at 12:45 pm that the tittered control material was not included when patient tests were performed. Instead she said that a qualitative control was processed. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on quality control records review and laboratory supervisor interview on March 16, 2022 at 12:10 PM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control and quality assessment requirements. Refer to D 5449 (3) and D 5018. 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. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on General Immunology, Syphilis Serology and Urinalysis test quality control records and interview with the laboratory supervisor on March 16, 2022 at 1:00 PM, it was determined that the laboratory did not assure that the established quality control program for General Immunology, Syphilis Serology and Urinalysis tests were followed. The findings include: a. The Mycoplasma IgM quality control records showed that no positive neither negative control material were included each day of patient testing. b. The COVID Ab IgG/IgM quality control records showed that no positive neither negative control material were included each day of patient testing. c. The Urinalysis quality control record showed that no microscopic control was performed each day of patient testing. d. The Syphilis Serology quantitative record showed that no control for tittered was run every day of patient testing. Refer to D5405, D5449, D5451. -- 4 of 4 --