Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor's review of the previous pathologist/laboratory director histopathology slide quality control records from April 17, 2020 through May 11, 2020, lack of Quality Control (QC) records from October 15, 2020 through survey date and an interview with the current pathologist/laboratory director, the laboratory failed to retain QC records, from October 15, 2020 through survey date. FINDINGS: 1. The current laboratory director confirmed on April 6, 2021, at approximately 2:30 PM, the surveyor's finding that the laboratory failed to retain QC records from October 15, 2020 through survey date. 2. The following Records and Documents for the Quality/reactivity of the histopathology stains were not available for review at this survey: a. The Hematoxylin & Eosin (H &E), Trichrome, Alcian Blue and CD3 for acceptable or unacceptable reactivity 2. Surveyor could not determine if the quality and reactivity of the histopathology slides were acceptable or unacceptable during this survey. a. Approximately 1,015 patient's histopathology slides were interpreted during this above time period. 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 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 -- 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: Based on a surveyor's review of histopathology QC records and an interview with the laboratory director/pathologist at the time of this survey, the laboratory director failed to document the postive and negative reactivity and the staining characteristics of the Hematoxylin & Eosin (H&E) stain, Alcian Blue, Trichrome and CD3 Antibody stains on each day of reading. FINDINGS: 1. The pathologist/laboratory director confirmed on April 6, 2021 at approximately 2:00 PM, findings that the pathologist failed to document the positive and negative reactivity and the staining characteristics of the H&E, Alcian Blue, PAS, Trichrome and CD3 stains on each day of reading from October 15,2020 through survey date. 2. Approximately 1,015 patients' histopathology slides were read and reported during above time frame. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of current laboratory policies and procedures, lack of histopathology QC records and an interview with the current pathologist/laboratory director, the laboratory director failed to provide overall management and fulfill the responsibility for the overall operation of the laboratory and failed to ensure compliance with applicable regulations. Refer to D6093 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 review of laboratory policies and procedures, histopathology QC records and an interview with the current pathologist/laboratory directory, the laboratory director failed to ensure that the established quality control program were maintained to assure the quality of histology testing and identify failures in quality as they occur. Refer to D3031 and D5601 -- 2 of 2 --