Laboratorio Clinico Doctors Village

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on syphilis serology quality control records, Rapid plasma reagin (RPR) patients reports records review (years 2021 to 2022) and laboratory general supervisor interview on November 9, 2022 at 10:00 a.m., it was determined that the laboratory failed to follow the ASI's manufacturer's instruction when patients 37 out of 411 specimens were tested for syphilis serology tests by the rapid plasma reagin (RPR) method from February 21, 2022 to August 18, 2022. The findings include: 1. Review on the ASI's manufacturer's instructions on November 9, 2022 at 10:00 a.m., requires that the laboratory must perform the needle accuracy check, that should deliver 60 +/- 2 drops of antigen suspension per milliliter when held in vertical position; verify the mechanical rotator set at 100 +/- 5 and circumscribing the 3/4 inch diameter and monitor each day of testing the room temperature in the laboratory that it should be between 20 - 30 C. Also, the manufacturer required to remove and wash the needle at the end of each shift. 2. On November 9, 2022 at 10:05 a.m, the syphilis serology quality control records showed that the laboratory did not perform the needle accuracy check, not verify the rotator rpm, not monitor the room temperature nor wash the needle when they processed and reported 37 out of 411 patients specimens from February 21, 2022 to August 18, 2022. 3. The general supervisor confirmed on November 9, 2022 at 10:20 a.m, that the quality control records showed that the laboratory did not follow the manufacturer's instructions from February 21, 2022 to August 18, 2022. 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 -- 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: Based on observation at the laboratory bleeding (draw blood) area, review of patient records refer test (years 2021 to 2022) and laboratory general supervisor interview on November 9, 2022 at 11:00 a.m., it was determined that the laboratory used sample collection tubes with exceeded expiration date. The findings include: 1. The laboratory bleeding area was evaluated at 11:00 a.m. Fifty Buffered Sodium Citrate pale blue top tubes, lot number B210834P, expiration date August 1, 2022 were found. 2. Review of patient records from August 2, 2022 to November 9, 2022, showed that forty two (42) PT (prothrombin time) and PTT (partial tromboplastin time ) patient sample were collected and referred with the expired tubes during thirty two (32) days. Reviewed at 11:10 a.m. 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 Syphilis Serology (Rapid Plasma Reagin (RPR)) quality control records review (years 2021 to 2022) andlaboratory general supervisor interview on November 9, 2022 at 9:45 a.m., it was determined that the laboratory did not include each day of testing the reactive nor the non-reactive control materials when 37 out of 411 patients specimens were tested and reported for RPR from February 21, 2022 to August 18, 2022. The findings include: 1. The laboratory use ASI RPR Card testing method to perform the Syphilis qualitative test. 2. On November 9, 2022 at 10:00 a.m, review of syphilis quality control record showed that the laboratory did not include each day of testing the reactive nor the non reactive control materials from February 21, 2022 to August 18, 2022. 3. The laboratory general supervisor confirmed on November 9, 2022 at 10:20 a.m, that the laboratory failed to include each day of patient testing the reactive and non-reactive control material the following days 2/21/2022, 7/12/2022, 8 /12/2022, 8/16/2022 and 8/18/2022. 4. The laboratory processed and reported 37 out 411 patient samples for Syphilis (RPR) qualitative tests without controls from February 21, 2022 to August 18, 2022. Reviewed at 10:25 a.m. 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 -- 2 of 3 -- 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 observation at the laboratory bleeding (draw blood) area, syphillis serology quality control records review (years 2021-2022) and laboratory general supervisor interview on November 9, 2022 at 10:30 a.m., it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. The findiings include: 1. The laboratory failed to follow the ASI's manufacturer's instruction when patients 37 out of 411 specimens were tested for syphilis serology tests by the rapid plasma reagin (RPR) method from February 21, 2022 to August 18, 2022. Refer to D5411. . 2. The laboratory used sample collection tubes with exceeded expiration date. Refer to D5417. 3. The laboratory did not include each day of testing the reactive nor the non-reactive control materials when 37 out of 411 patients specimens were tested and reported for RPR from February 21, 2022 to August 18, 2022. Refer to D5449. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on observation at the laboratory bleeding (draw blood) area, syphillis serology quality control records review (years 2021-2022), observation and laboratory general supervisor interview on November 9, 2022 at 11:00 a.m., it was determined that testing personnel failed to follow the ASI's manufacturer's instruction, did not include each day of testing the reactive nor the non-reactive control materials for syphillis serology and used sample collection tubes with exceeded expiration date. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on observation at the laboratory bleeding (draw blood) area, syphillis serology quality control records review (years 2021-2022) and laboratory general supervisor interview on November 9, 2022 at 10:30 a.m., , it was determined that the general supervisor did not assure that quality control procedures were followed by the testing personnel. Refer to D5411, 5417 and D5449. -- 3 of 3 --

Summary Statement of Deficiencies D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, 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 serum Human Chorionic Gonadotropin (hCG) test quality control records (years 2017 to 2018) and interview with the laboratory general supervisor on October 31, 2018 at 10:00 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for serum hCG qualitative tests. The finding includes: 1. The laboratory did not include each day of testing a negative and a positive control material when patients specimens were processed and reported for serum hCG qualitative test. Refer to D 5449 . 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 endocrinology quality control records review and interview with the laboratory general on October 31, 2018 at 10:00 AM , it was determined that 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 3 -- laboratory failed to include a negative and positive control material when performed hCG test. The findings include : 1. The laboratory performed hCG ( human chorionic gonadotropin) by one step method. 2. Endocrinology quality control logs were reviewed from January 2017 to October 2018. 3. The records showed that the laboratory did not include a negative and a positive control material from March 15, 2018 to October 20, 2018. 4. The laboratory performed and reported forty one patient samples during those months. 5. The laboratory general supervisor confirmed on October 31, 2018 at 10:00 A.M, that the laboratory did not include a negative and a positive control material during those months. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on serum Human Chorionic Gonadotropin (hCG) test quality control records (years 2017 to 2018) and interview with the laboratory general supervisor on October 31, 2018 at 10:30 AM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory analytical system for the subspecialty of Endocrinology for hCG qualitative test. The finding includes: 1. The laboratory director did not comply with the requirements in the subspecialty of Endocrinology for hCG qualitative test. Refer to D 5449. 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 endocrinology quality control records review and laboratory general supervisor interview on October 31, 2018 at 10:30 AM, it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. The finding includes: 1. The laboratory director did not ensure that a negative and a positive control material were included when performed hCG test. Refer to D5449. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on endocrinology quality control records review and laboratory general supervisor interview on October 31, 2018 at 10:30 AM, it was determined that laboratory general supervisor failed to ensure compliance with the requirements for analytic systems. The finding includes: 1. The laboratory general supervisor did not ensure that a negative and a positive control material were included when performed hCG test. Refer to D5449. -- 3 of 3 --