Imrl Clinical Lab

Summary Statement of Deficiencies D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) records review (years 2020 and 2021) and laboratory director interview by telephone call, during the onsite survey on February 3, 2023 at 12:10 PM, it was determined that the laboratory failed to retain the Quality Assessment records (annual evaluations for the following systems: pre-analytic, analytic and post-analytic systems since November 2020. The findings include: 1. On February 3, 2023 at 12:10 PM, the QA records showed that the laboratory did not maintain the annual evaluations of the Quality Assessment Program Program (pre- analytic, analytic and post-analytic systems) since November 2020. 2. On February 3, 2023 at 12:20 PM, the laboratory director confirmed that the annual evaluations of the QA program were not available in the laboratory since November 2020. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are 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 -- properly performed. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) records review (years 2020 and 2021) and laboratory director interview by telephone call on February 3, 2023 at 12:10 PM, it was determined that the laboratory director failed to ensure that the laboratory retain the QA records for at least 2 years since November 2020. Refer to D 3039 (The laboratory failed to retain the Quality Assessment records (annual evaluations for the following systems: pre-analytic, analytic and post-analytic systems since November 2020). -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on lack of Puerto Rico Proficiency Testing Program (PRPTP) records review from February 2017 to February 2019 and laboratory director interview on March 5, 2019 at 9:38 AM, it was determined that the laboratory failed to maintain the proficiency testing event records. The findings include: 1. Puerto Rico Proficiency Testing Program (PRPTP) records were reviewed from February 2017 to February 2018. 2. Review of proficiency testing records from February 2017 to February 2019, showed that the laboratory did not maintain the following proficiency testing event records: March 2019, April 2019, June 2019, July 2019, August 2019, August 2019, October 2019, November 2019 and December 2019. 3. The laboratory director confirmed on March 5, 2019, that the laboratory did not maintain these proficiency testing event records. 4. This deficiency was cited on February 07, 2017. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) 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 -- Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records from February 2017 to February 2019 and laboratory director interview on March 5, 2019 at 9:38 AM, it was determined that the laboratory failed to retain all proficiency testing records for at least 2 years. The findings include: 1. Puerto Rico Proficiency Testing Program (PRPTP) records were reviewed from February 2017 to February 2019. 2. The laboratory did not have the proficiency testing scores from March 2018, April 2018, June 2018, July 2018, August 2018, October 2018, November 2018 and December 2018. 3. The laboratory director confirmed on March 5, 2019 at 9:38 AM, that the laboratory did not have these PRPTP testing scores records. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on lack of quality control records, written procedures review and laboratory director interview on March 5, 2019 at 11:15 AM, it was determined that the laboratory failed to follow written instructions for the preventive maintenance of the centrifuges, rotator and microscope instrument each day of use. The findings include: 1. The laboratory did not perform and document the preventive maintenance of the centrifuges (ALC 4218, Clay Adams), rotator (American Rotator 100) and microscope (Nikon) each day of use from January 2017 to March 5, 2019. 2. The testing personnel confirmed on March 5, 2019, that those preventive maintenance were not perform and document from January 1, 2018 to March 5, 2019. 3. The 2019's annual volume records showed that the laboratory processed the following patients specimens: a. urinalysis (microscopic examination) - 4570 specimens b. pregnancy tests - 60 specimens c. syphilis serology - 177 specimens d. complete blood count - 13955 4. This deficiency was cited on February 7, 2017. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of hematology stain quality control records review and laboratory director and testing personnel interview on March 5, 2019 at 11:36 AM, it was determined that the laboratory failed to check, each day of use, the Wright's stain used in hematology for intended reactivity to ensure predictable staining characteristics. The findings include: 1. The laboratory establish in the procedures manual, that the -- 2 of 4 -- laboratory check, each day of use, the Wright's stain (Wright's ONE Step Satin) used in hematology for intended reactivity to ensure predictable staining characteristics. 2. Review of hematology quality control records showed that the laboratory did not check nor document the reactivity of Wright's stain reagent, each day of use, from January 1, 2018 to March 5, 2019. 3. The laboratory director and general supervisor confirmed on March 5, 2019, that the laboratory did not check nor document the reactivity of Wright's stain reagent from January 1, 2018 to March 5, 2018. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on hematology quality control records review and laboratory director and general supervisor interview on March 5, 2019 at 11:32 AM, it was determined that the laboratory failed to follow the written policies to evaluate twice a year the relationship of the WBC differential examination results performed by the manual method and Coulter AcT 5 Diff AL system. The findings include: 1. The laboratory performed automatic cell differential by Coulter AcT 5 Diff AL hematology system. 2. Quality controls records were reviewed from January 2017 to March 5, 2019. 3. The laboratory director stated on March 5, 2019, that the laboratory did not evaluate twice a year a relationship between the manual cell differential and automatic cell differential by hematology system since February 2017. 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 quality assessment (QA) records review and laboratory director interview on March 5, 2019 at 11:48 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for analytic systems. The findings include: 1. Review of the laboratory quality assessment manual showed that for each analytic process a log sheet was designate to keep track of the laboratory performance. 2. The laboratory did not evaluate aspects regarding the analytic systems: a. to follow written instructions for the preventive maintenance of the centrifuges, rotator and microscope instrument each day of use. Refer to D5429. b. to check, each day of use, the Wright's stain used in hematology for intended reactivity to ensure predictable staining characteristics. Refer to D5473. c. to follow the written policies to evaluate twice a year the relationship of the WBC differential examination results performed by the manual method and Coulter AcT 5 Diff AL system. -- 3 of 4 -- 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 urinalysis and hematology procedures manual, quality control records review from January 2017 to March 5, 2019 and laboratory director and general supervisor interview on March 5, 2019 at 11:55 AM, it was determined that the laboratory director failed to ensure compliance with the requirements for analytic systems. Refer to D5429, D5473 and D5775. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment 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 Quality Assessment (QA) records review from January 2017 to March 5, 2019 and laboratory director interview on March 5, 2019 at 11:48 AM, it was determined that laboratory director failed to ensure compliance with quality assessment (QA) requierements. The finding includes: 1. The laboratory did not evaluate the established Quality Asessment Program to monitor and evaluate the requirement for analytic systems. Refer to D5791. -- 4 of 4 --