Laboratorio Clinico Bayamon

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio Clinico Bayamon on May 14, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the recertification CLIA survey ending on May 14, 2025. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 manufacturer's specifications, hematology preventive maintenance records review (years 2024 - 2025) and laboratory director interview on May 14, 2025 at 11: 30 AM, it was determined that the laboratory failed to perform and document the preventive maintenance as required by the manufacturer of the Cell Dyn 3200 hematology instrument, when they processed and reported 246 Complete Blood Count (CBC) tests from January 1, 2024 to February 29, 2024. The findings include: 1. The laboratory uses Cell Dyn 3200 hematology instrument to perform CBC patient tests. 2. The manufacturer's specifications establishes that the monthly maintenance of the Cell Dyn 3200 hematology instrument are the following: clean fan filter, run extended auto clean and replace diluent/sheath filter. 3. On May 14, 2025 at 11:25 AM, review of preventive maintenance records from January 1, 2024 to February 29, 2024, showed that the laboratory did not perform nor document the monthly preventive maintenance of the hematology instrument. 4. The laboratory processed and reported 246 CBC tests from January 1, 2024 to February 29, 2024. 5. The laboratory director 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 -- confirmed on May 14, 2025, at 11:30 AM, that the laboratory failed to follow the manufacturer's specifications for the preventive maintenance of the Cell Dyn 3200 hematology instrument. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: A. Based on urinalysis quality control records review (years 2024 - 2025) and laboratory director interview on May 14, 2025 at 12:19 PM, it was determined that the laboratory failed to verify the stated value of the new lot of control materials (normal and abnormal controls), when the laboratory processed and reported 137 patient urinalysis samples from April 1, 2024 to July 1, 2024. The findings include: 1. The laboratory performs urinalysis tests with the AimStrip Urine Analyzer 2 instrument and uses Thermo Scientific MAS UA control material. 2. The urinalysis quality control records reviewed (years 2024 - 2025) on May 14, 2025 at 12:19 PM, from April 1, 2024 to July 1, 2024, showed that there was no evaluation of the manufacturer's stated values for the normal control lot number 326201 and abnormal control lot number 326202 prior to placing them in routine use on April 1, 2024. 3. The laboratory director confirmed on May 14, 2025 at 12:24 PM, that the laboratory failed to evaluate the stated value of the new lot of control materials prior to placing them in routine use for urinalysis tests, performed by the AimStrip Urine Analyzer 2 instrument, when they processed and reported 137 patient samples from April 1, 2024 to July 1, 2024. B. Based on Rapid Reagin Plasma (RPR) quality control records review (years 2024 - 2025) and laboratory director interview on May 14, 2025 at 12: 51 PM, it was determined that the laboratory failed to evaluate the reactivity of the new lot of RPR reagent prior to placing it in routine use, when the laboratory processed and reported 51 RPR patient samples from December 4, 2024 to April 23, 2025. The findings include: 1. The laboratory performs RPR tests with the ASI RPR Card Test For Syphilis reagent kit. 2. The RPR quality control records reviewed (years 2024 - 2025) on May 14, 2025 at 12:51 PM, from December 4, 2024 to April 23, 2025, showed that there was no evaluation of the reactivity of the RPR reagent, lot number CA3E26RH, prior to placing it in routine use on December 4, 2024. 3. The laboratory director confirmed on May 14, 2025 at 12:55 PM, that the laboratory failed to evaluate the reactivity of the new lot of RPR reagent prior to placing it in routine use, when they processed and reported 51 RPR patient samples from December 4, 2024 to April 23, 2025. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established -- 2 of 3 -- 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 hematology instrument monthly maintenance quality control records, syphilis serology Rapid Reagin Plasma (RPR) quality control records, and urinalysis quality control records and interview with the laboratory director on May 14, 2025 at 1:10 PM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the manufacturer's instructions and laboratory quality control requirements. Refer to D5429 and D5469. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) (b)(3) Adhere to the laboratorys 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 hematology instrument monthly maintenance quality control records, syphilis serology Rapid Reagin Plasma (RPR) quality control records, and urinalysis quality control records and interview with the laboratory director and testing personnel on May 14, 2025 at 1:10 PM, it was determined that the laboratory testing personnel failed to follow the manufacturer's instructions and quality control procedures for hematology, syphilis serology, and urinalysis tests. Refer to D5429 and D5469. -- 3 of 3 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency testing records review ( 2018-2019 ) and laboratory general supervisor interview on July 30, 2019 at 9:20 A.M., it was determined that the laboratory director and testing personnel failed to sign the attestation statements. The findings include: 1. Puerto Rico Proficiency testing records were review from February 2018 to June 2019. 2. The laboratory director and testing personnel did not sign the attestation statements of the Proficiency testing records since February 2018. 3. The laboratory general supervisor confirmed on July 29, 2019 at 9:20 A.M that the laboratory director and testing personnel failed to sign the attestation statements since 2018. D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on reviewed of quality assessment records ( year 2018-2019 ) and laboratory general supervisor interview on July 30, 2019 at 9:30 A.M, it was determined that the laboratory failed to follow written procedures to ensure confidentiality of patient 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 -- information throughout all phases of the testing process that are under the laboratory control. The findings include: 1. The laboratory did not perform in 2018 and 2019 an evaluation to ensure confidentiality of patient information throughout all phases of the testing process that are under the laboratory control. 2. The laboratory general supervisor confirmed on July 30, 2019 at 9:30 A.M., that in from January 2018 to June 2019 the laboratory did follow written procedures to ensure confidentiality of patient information and failed to perform an evaluation to ensure confidentiality of patient information. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) written procedures review ( year 2018-2019) and laboratory general supervisor interview on July 30, 2019 at 9:40 AM, it was determined that the laboratory failed to follow written procedures to document and evaluate any complaint submitted and problems reported. The findings include: 1. Quality Assessment (QA) written procedures were reviewed from 2018-2019. 2. Since January 2018 the laboratory did not document or evaluate any complaint submitted to the laboratory. 3. The laboratory general supervisor confirmed on July 30, 2019 at 9: 40 A.M., that the laboratory did not document or evaluate any complaint submitted to the laboratory since 2018. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on reviewed of quality assessment records ( year 2018-2019 ) , and laboratory general supervisor interview on July 30, 2019 at 9:45 AM, it was determined that the laboratory failed to follow Quality Assessment Program to monitor and evaluate the following requirements for general laboratory systems: confidentiality of patient information and complaint. The findings include: 1. The laboratory failed to follow written procedures to ensure confidentiality of patient information . Refer to D 5201. 2. The laboratory failed to follow written procedures in order to evaluate and document any complaint. Refer to D 5205. 3. The laboratory general supervisor confirmed on July 30, 2019 at 9:45 A.M., that evaluations to confidentiality of patient information and complaint were not performed since 2018. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an -- 2 of 3 -- ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on reviewed of Quality Assessment (QA) written procedures (year 2018-2019) and laboratory general supervisor interview on July 30, 2019 at 9:45 AM, it was determined that the laboratory failed to follow Quality Assessment Program to monitor and evaluate the requirement for pre- analytic systems. The findings include: 1. Quality Assessment (QA) written procedures were reviewed from 2018-2019. 2. The laboratory did not evaluate the following QA assessment for pre- analytic systems. since 2018: test requests 3. The laboratory general supervisor confirmed on July 30, 2019 at 9:45 A.M., that the pre analytic system was not evaluated since 2018. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on proficiency testing records review ( year 2018-2019) and laboratory general supervisor interview on July 30, 2019 at 10:30 A.M., it was determined that the laboratory director failed to ensure that proficiency testing samples were tested as required under Subpart H requirements. Refer to D2009. 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 ( year 2018-2019) and laboratory general supervisor interview on July 30, 2019 at 10:00 A.M. it was determined that laboratory failed to ensure compliance with quality assessment (QA) requirements. The findings include: 1. Quality Assessment records showed that the laboratory did not evaluate the established Quality Assessment Program to monitor and evaluate the requirements for laboratory general systems and preanalytic systems. 2. The laboratory general supervisor confirmed on July 30, 2019 at 10:00 A.M., that the laboratory failed to evaluate the requirements for laboratory general systems and preanalytic systems. Refer to D5291 and D5391. -- 3 of 3 --