Ascent Surgery Center

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and an interview with the Clinical Director (CD), the laboratory failed to establish and follow written policies and procedures to assess the competency of the General Supervisors (GS), based on the responsibilities of the position and at a frequency determined by the laboratory. The laboratory also failed to establish and follow written policies and procedures to assess the competency of testing personnel (TP) as specified in the personnel requirements in subpart M for the high complexity tissue biopsy grossing and slide interpretation testing procedures for frozen sections in the subspecialty of Histopathology. This deficient practice had the potential to affect 41 out of 41 frozen section cases performed since the implementation of testing on 08/11/2022 through 02/06/2023. Findings Include: 1. Review of the laboratory's "Pathology Policies" manual, provided on the date of the inspection, did not find any mention of competency assessment procedures for the GS based on the responsibilities of the position, at a frequency determined by the laboratory and TP utilizing the six required components. 2. Review of the laboratory's Form CMS-209, approved by the Laboratory Director on 02/03/2023, revealed four individuals listed and qualified by the Laboratory Director to function as a GS and TP. 3. The Inspector requested the laboratory's policy and procedure for the competency assessment of the GS's and TP's and the competency assessment documentation for GS#1, GS#2, GS#3, GS#4 based on the responsibilities of the position and for TP#1, TP#2, TP#3 and TP#4 from the CD. The CD confirmed the laboratory did not establish a policy and procedure for the assessment of the GS's and TP's, did not assess the competency of the GS's based on the responsibilities of the position, at 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 14 -- frequency determined by the laboratory, did not assess the competency of the TP's and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 02/06/2023 at 8:00 AM. 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 record review and an interview with the Clinical Director (CD), the laboratory failed to establish and conduct blind test accuracy verification (TAV) activities, at least twice annually, for the high complexity tissue biopsy grossing and slide interpretation testing procedures for frozen sections in the subspecialty of Histopathology. This deficient practice had the potential to affect 41 out of 41 frozen section cases performed since the implementation of testing on 08/11/2022 through 02 /06/2023. Findings Include: 1. Review of the laboratory's "Pathology Policies" policy and procedure, provided on the date of the inspection, did not find any instructions to conduct blind TAV activities for the high complexity tissue biopsy grossing and slide interpretation testing procedures for frozen sections performed, at least twice annually. 2. The Inspector requested the laboratory's TAV policy and procedure and documentation of blind TAV from the CD. The CD confirmed the laboratory did not establish and follow a policy and procedure for blind TAV activities at least twice annually for the high complexity tissue biopsy grossing and slide interpretation testing procedures for frozen sections performed and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 02/06/2023 at 11:09 AM. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and an interview with the Clinical Director (CD), the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems with the high complexity tissue biopsy grossing and slide interpretation testing procedures for frozen sections in the subspecialty of Histopathology. This deficient practice had the potential to affect 41 out of 41 frozen section cases performed since the implementation of testing on 08/11/2022 through 02 /06/2023. Findings Include: 1. The Laboratory Director failed to ensure that policies and procedures for high complexity tissue biopsy grossing and slide interpretation testing procedures for frozen sections in the subspecialty of Histopathology were approved via signature and date before implementation. (Refer to D5407) 2. The laboratory failed to label the secondary containers of reagents, solutions and stains in -- 2 of 14 -- the slide stain station with their contents, lot numbers and expiration dates which were utilized for high complexity tissue biopsy grossing and slide interpretation testing procedures for frozen sections in the subspecialty of Histopathology. (Refer to D5415) 3. The laboratory failed to establish and demonstrate, before reporting patient test results, performance specifications for the cryostat, slide staining station and microscope to include accuracy, precision and any other performance characteristics required for accurate and reliable high complexity tissue biopsy grossing and slide interpretation testing procedures for frozen sections in the subspecialty of Histopathology. (Refer to D5423) 4. The laboratory failed to establish a maintenance policy and procedure that ensures temperature, humidity and microscope test system performance necessary for accurate and reliable high complexity tissue biopsy grossing and slide interpretation testing procedures for frozen sections in the subspecialty of Histopathology. (Refer to D5435) 5. The laboratory failed to establish a hematoxylin and eosin (H&E) quality control (QC) policy and procedure, including the criteria of acceptability, and document H&E stain quality control (QC) activities corresponding to the intended stain reactivity to ensure predictable staining characteristics each day of use for the high complexity tissue biopsy grossing and slide interpretation testing procedures for frozen sections in the subspecialty of Histopathology. (Refer to D5469) 6. The laboratory failed to perform and document hematoxylin and eosin (H&E) stain quality control (QC) for the intended reactivity to ensure predictable staining characteristics each day of use for the high complexity tissue biopsy grossing and slide interpretation testing procedures for frozen sections in the subspecialty of Histopathology. (Refer to D5473) D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and an interview with the Clinical Director (CD), the Laboratory Director failed to ensure that policies and procedures for high complexity tissue biopsy grossing and slide interpretation testing procedures for frozen sections in the subspecialty of Histopathology were approved via signature and date before implementation. This deficient practice had the potential to affect 41 out of 41 frozen section cases performed since the implementation of testing on 08/11/2022 through 02 /06/2023. Findings Include: 1. Review of the laboratory's "Pathology Policies" manual, provided on the date of the inspection, revealed the following procedures were approved by the Laboratory Director on 11/01/2022, after the testing was implemented on 08/11/2022. "Section 1.0 Frozen Section" "Section 1.2 Labeling /Expiration Dates/Storage of Reagents and Stains" "Section 1.3 Storage of Flammable Liquids" "Section 1.5 Cryostat Decontamination" "Section 1.6 Xylene Safety Program" "Section 1.7 Formaldehyde and Xylene Environmental Monitoring" "Section 1.8 Recommended Precautions for Mycobacterium Tuberculosis" "Section 1.9 Daily Logs" "Section 1.10 Use of Flammable Freezing Spray Inside the Cryostat" 2. Further review of the laboratory's "Pathology Policies" manual, revealed the following policies and procedures were on a hospital laboratory's letterhead and had not been approved by the Laboratory Director. "Transcription of Pathology Reports" "QAP Reports" "Frozen Sections" "Reporting Frozen Sections" 3. The CD confirmed the Laboratory Director did not approve the laboratory's policies and procedures prior to implementing the high complexity tissue biopsy grossing and slide interpretation -- 3 of 14 -- testing procedures for frozen sections. The interview occurred on 02/06/2023 at 8:30 AM. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on record review, direct observation and an interview with the Clinical Director (CD), the laboratory failed to label the secondary containers of reagents, solutions and stains in the slide stain station with their contents, lot numbers and expiration dates, which were utilized for high complexity tissue biopsy grossing and slide interpretation testing procedures for frozen sections in the subspecialty of Histopathology. This deficient practice had the potential to affect 41 out of 41 frozen section cases performed since the implementation of testing on 08/11/2022 through 02/06/2023. Findings Include: 1. Review of the laboratory's "Section 1.2 Labeling/Expiration Dates /Storage of Reagents and Stains" policy and procedure, approved by the Laboratory Director via signature and date on 11/01/2022 and provided on the date of the inspection, revealed the following information: "Policy Reagents, stains, chemicals, and solutions are properly labeled in the Pathology Frozen Section room. If any container is missing a label or required information,