Patricia Mccormack, Md

Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on surveyor review of the Histopathology Slides (HS) and interview with the Office Manager (OM), the laboratory failed to retain HS for 10 years from the date of examination at the time of the survey. The finding includes: 1. Five patient records were reviewed from May 2022 to June 2022. Three of the five patients slides were not available at the time of the survey. 2. The OM confirmed on 9/13/22 at 11:00 am the HS were not retained. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: 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 -- Based on surveyor review of Quality Control (QC) records and interview with the Office Manager (OM), the laboratory failed to document Hematoxylin and Eosin (H&E) control slide reaction from 6/6/22 to the date of survey. The findings include: 1. The laboratory did not document H&E QC reaction for reading of Histopathology slides. 2. The laboratory read and reported approximately 912 patient slides. 3. The OM confirmed on 9/13/22 at 10:40 am that the laboratory did not document H&E QC stain reaction. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of Biannual Assessment (BA) records and interview with the Laboratory Consultant (LC), the laboratory failed to perform BA twice a year in the calendar years 2016 and 2017. The LC confirmed on 2/8/18 at 10:00 am that BA was not performed. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Laboratory Consultant (LC), the laboratory failed to assess and correct problems on the FR from 1 /13/16 to the date of the survey. The finding includes: 1. A review of the FR with an Addendum stated "Deeper levels support the above diagnosis" but the diagnosis was below the Addendum. 2. The LC confirmed on 2/8/18 at 10:30 am the laboratory failed to correct problems on the FR. 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 --