Laboratorio Clinico Caimito

Summary Statement of Deficiencies D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on syphilis serology quality control records, patients reports worksheets review (years 2022-2023) and laboratory director interview at 9:45 AM on May 25, 2023, it was determined that the laboratory did not evaluate the new lot of Rapid Plasma reagin (RPR) test by TECO Method for positive and negative reactivity prior to placed it in routine use when reported and performed 98 out of 98 syphilis serology patients samples. The findings include: 1. The laboratory syphilis serology quality control records were review from January 2022 to May 2023. (reviewed on 5/25/2023 at 9:45 a.m. ) 2. The patient reports worksheets ( 2022-2023 ) showed on May 25, 2023 at 9:50 a.m., that the laboratory received the following reagent kit for RPR Method and no evaluation of their reactivity was performed: Test Lot 1- RPR 94381 exp. date: 12/21/23 opened day : 5/3/2022 2.- RPR lot: 87405 exp. date: 4/30/2022 opened day : 1/10/2022 3. The laboratory used the lot -94381 from 1/10/2022 to 4/28 /2022 and reported and processed 36 RPR (Rapid plasma reagin) patient's samples. (reviewed on 5/25/23 at 10:10 a.m. ) 4. The laboratory used the lot -87405 from 5/3 /2022 to 5/2023 and reported and processed 52 RPR (Rapid plasma reagin) patient's samples. (reviewed on 5/25/2023 at 10:10 a.m. ) 5. The laboratory director confirmed on May 25, 2023 at 10:15 a.m. that the laboratory did not evaluate the new lot of 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 -- Rapid Plasma reagin (RPR) test for positive and negative reactivity prior to placed it in routine use. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on syphilis serology quality control records review ( 2022-2023 ) and laboratory director interview on May 25, 2023 at 10:15 A.M., it was determined that laboratory director failed to ensure compliance with the requirements for syphilis serology analytic systems. Refer to D5471. ( The laboratory did not evaluate the new lot of Rapid Plasma reagin (RPR) test by ASI RPR Method for positive and negative reactivity prior to placed it in routine use). -- 2 of 2 --

Summary Statement of Deficiencies D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on complete blood count (CBC) quality control records, Coulter Act 5 diff control plus manufacturer instructions review and laboratory director interview on May 7, 2019 at 9:40 AM, it was determined that the laboratory failed to follow the manufacturer's specifications for using the CBC controls materials when 232 patients specimens were tested and reported by the Coulter Act 5 diff system from January 8, 2019 to March 5, 2019. The findings include: 1. The laboratory analyzed and reported the CBC patient's specimens by the the Coulter Act 5 diff system . 2. The laboratory used the Coulter Act 5 diff control plus control materials. The manufacturer instructed the laboratory to use the control materials with 15 days open-vial stability. One box of this control material includes two vials of each levels (control materials for 30 days). 3. On May 7, 2019 at 9:40 AM, the CBC quality control records showed that the the laboratory opened one box of Coulter Act 5 diff control plus control and verified the following lots of control levels on December 20, 2019: lot 360119, lot 370119 and lot 380119, with the expiration date of March 5, 2019. 4. The CBC quality control records showed that the the laboratory used those lots of control material with exceeded open-vial stability from January 8, 2019 to March 5, 2019. The laboratory used one box of those control material for 62 days. 5. The laboratory director stated on May 7, 2019 at 9:40 AM, that the laboratory used the control materials until the 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 -- expiration date and not considered the open-vial stability. 6. The laboratory processed and reported 232 out of 232 CBC patients specimens from January 8, 2019 to March 5, 2019. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on complete blood count (CBC) quality control records, Coulter Act 5 diff control plus manufacturer instructions review and laboratory director interview on May 7, 2019 at 9:40 AM, it was determined that laboratory director failed to ensure compliance with the requirements for the CBC analytic systems. The finding include: 1. Refer to D 5479 (The laboratory failed to follow the manufacturer's specifications for using the CBC controls materials when 232 patients specimens were tested and reported by the Coulter Act 5 diff system from January 8, 2019 to March 5, 2019). -- 2 of 2 --