Center For Sight Pl

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Center for Sight/Amara on 6/17/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, it was determined the laboratory failed to document the maintenance of one of two microscopes used for patient testing for two of two years (2023-2025) 1. On 6/17/25 at 10:30 a.m., two microscopes were observed in the laboratory, a Leica DM1000 and a Labomed. 2. The Laboratory Procedure Manual was reviewed and approved by the Laboratory Director on 09/19 /11. An Annual Review Sheet dated 5/2/23, included a procedure titled Microscope which listed one of the tasks to be done was to document daily and monthly care. The Review Sheet indicated no changes. 3. Review of microscope maintenance indicated only one microscope maintenance was being documented daily and monthly. 4. Histology Tech A on 6/17/25 at 11:40 a.m., stated only the maintenance for the Labomed microscope was documented daily and monthly. The Lab Director confirmed on 6/17/25 at 11:58 a.m., daily and monthly maintenance for the Leica DM1000 microscope was not documented for 2023-2025. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) 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 -- (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. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory failed to document the Hematoxylin and Eosin (H&E) Histopathology staining materials for intended reactivity for three of three months reviewed (11/2023, 08/2024, and 04/2025). Findings included: 1. The Laboratory Procedure Manual was reviewed and approved by the Laboratory Director on 09/19/11. The Annual Review Sheet dated 5/2/23 with no changes documented, included a Quality Assurance for Routine Stains procedure which stated the Lab Director would determine whether the stain was acceptable for the day and was to be logged on the stain QC (Quality Control) chart. The Lab Director was the only Testing Person for H & E testing performed by the laboratory listed on the CMS-209, which was signed by the Lab Director on 06/12/2025. 2. The Quality Control Staining log for 04/2025, 8/2024, and 11/2023 did not document quality of the H&E staining for any of the testing days at this laboratory by the Lab Director. 3. The Lab Director confirmed on 06/17/2025 at 11:58 a.m., there was no documentation of the H&E Histopathology staining materials for intended reactivity for three, 11/2023, 08/2024, and 04/2025 months reviewed by him. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Center for Sight PL on 02 /09/21. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview with the Director of Operations, the laboratory failed to include the address of where Mycology, Parasitology, and Histopathology testing was performed since 6/2019. Findings Included: A review of 6 patient final reports from 6/5/2019, 12/5/2019, 5/7/2020, 9/17/2020, 11/4/2020, and 01/19/21 revealed that the 6 reports did not contain the address of where the testing was performed. Interview on 02/09/21 at 11:15 AM with the Director of Operations revealed she did not know that the laboratory address needed to be on the test report. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 observations and interview with the Director of Operations, the laboratory failed to ensure the Chlorazol Black E was not expired prior to patient testing since September 15, 2018. Findings Included: A tour of the laboratory on 12/07/2018 at 10: 00 a.m. revealed a bottle of Chlorazol Black E (Lot #6259) which had an expiration date of 09/15/2018. There were 2 more bottles of Chlorazol Black E (Lot#6259) with the expiration date of 09/15/2018 found in examination rooms. During an interview on 12/07/2018 at 10:00 AM, the Director of Operations confirmed that the Chlorazol Black E was expired and had been used for patient testing. The laboratory had ordered a new lot of Chlorazol Black E on 09/10/2018 but had not replaced the expired Chlorazol Black E with the new reagent. D5781