Laboratorio De Patologia Dr Noy Inc

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Laboratorio de Patologa Dr. Noy Inc. on September 17, 2024. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the unannounced routine CLIA recertification survey ending on September 17, 2024. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) records review (year 2023-2024) and laboratory testing personnel interview on September 17,2024 at 12:00 PM, it was determined that the laboratory failed to follow the established Quality Assessment Program to evaluate the requirement for pre- analytic system: test request. The findings include: 1. On September 17, 2024 at 12:00 P.M., the QA records was requested. 2. The Pre- analytic system QA record showed that evaluations to test request must be performed quaterly. The laboratory did not evaluate the test request since of year 2023. (Reviewed on September 17,2024 at 12:10 PM) 3. The QA record was reviewed with the laboratory testing personnel (#9) and confirmed, during interview on Septiembre 17,2024 at 12:15 PM, that the Pre-analytic system QA records were not evaluated since of year 2023. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) 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 -- 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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) records review (year 2023-2024) and laboratory testing personnel interview on September 17,2024 at 12:45 PM, it was determined that the laboratory failed to follow the established Quality Assessment Program to evaluate the requirement for Post- Analytic system: Turn around times (TAT). The findings include: 1. On September 17, 2024 at 12:00 P.M., the QA records was requested. 2. The Post- analytic system QA record showed that evaluations to TAT must be performed annually. The laboratory did not evaluate the TAT in the year 2023. (Reviewed on September 17,2024 at 12:45 PM) 3. The QA record was reviewed with the laboratory testing personnel (#9) and confirmed, during interview on Septiembre 17,2024 at 12:56 PM, that the Post- analytic system QA records were not evaluated in the year 2023 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 the QA records and interview with the laboratory testing personnel (#9) on September 17, 2024, at 1: 00 PM., it was determined that the laboratory director failed to ensure the compliance with QA requirements (years 2023 - 2024): test request and TAT. Refer to D5391 and D5891. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the Ventana HE 600 preventive maintenance and interview with the Histotechnologist #1, it was found that the laboratory did not perform the monthly nor the trimester preventive maintenance as required by the manufacturer's. The findings include: a. The laboratory used the Ventana HE 600 to perform histopathology special stains. b. The manufacturer's instructed the laboratory to perform a monthly and a trimester preventive maintenance's. c. Review of the monthly and trimester preventive maintenance (years 2017 to 2018) on October 12, 2018 at 9:40 am, showed the following: i. The laboratory did not perform the monthly preventive maintenance in: February 2017, April 2017, June 2017, July 2017, September 2017, October 2017, January 2018, February 2018, March 2018, April 2018, May 218, June 2018, July 2018, August 2018 and September 2018. ii. The laboratory only performed the trimester preventive maintenance in the first trimester of 2017. d. The Histotechnologist # 1 stated that preventive maintenance were not performed. e. The laboratory processed 6,219 special stain slides since January 2017. D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. 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 -- This STANDARD is not met as evidenced by: Based on review of cytotechnologists workload reassessment records and interview with the supervisor on October 12, 2018 at 11:00 am, it was found that the laboratory did not perform the every 6 months reassessment evaluations of the cytotechnologists (CT) for year 2018. The findings include: a. The supervisor stated that the reassessment evaluations must be done in January and July of each year. b. Review if the personnel records showed that the laboratory did not perform the reassessment work load evaluations during the year 2018 of the following cytotechnologists: CT 1, CT2, CT3, CT4, CT5, CT6, CT7, CT8,CT9, CT10 AND CT12. D6130 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(c)(2)(3) (c) In cytology, the technical supervisor or the individual qualified under 493.1449(k) (2)-- (c)(2) Must establish the workload limit for each individual examining slides and (c)(3) Must reassess the workload limit for each individual examining slides at least every 6 months and adjust as necessary. This STANDARD is not met as evidenced by: Based on review of cytotechnologists records and interview with the laboratory supervisor on October 12, 2018 at 11:00 AM, it was found that the technical supervisor did not reassess the workload limits during year 2018. Refer to D5637 -- 2 of 2 --