Ethel Diagnostic Laboratory

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 surveyor review of the Procedure Manual (PM), lack of Biannual Assessment (BA) records and interview with the Testing Personnel (TP), the laboratory failed to verify the accuracy and reliability of Histopathology testing twice a year in the calendar year 2021. The finding includes: 1. There was no evidence that a BA was performed in 2021. 2. The TP confirmed on 3/15/23 at 1:00 pm that the laboratory did not verify the accuracy of Histopathology testing twice a year. 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 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 surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP) the laboratory failed to follow its policies and procedures for assessing the competency of TP who perform Histopathology testing from 1/9/19 to the date of survey. The findings include: 1. The CA was not performed on two out of two TP in the calendar years 2019, 2020, and 2021. 2. The laboratory CA policy stated that testing personnel are evaluated annually. 3. The TP confirmed on 1/25/22 at 1:20 pm the laboratory did not follow the CA procedure. 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 the lack of Biannual Assessment (BA) records and interview with the Testing Personnel (TP), the laboratory failed to verify the accuracy of Histopathology tests testing twice annually from 1/9/19 to the date of survey. The TP confirmed on 1 /25/22 at 1:45 pm the laboratory did not perform BA twice annually. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT 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 -- CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Testing Personnel (TP), the laboratory failed to establish a written procedure for Biannual Assessment (BA) from 1/9/19 to the date of survey. The TP confirmed on 1/25/22 at 1: 45 pm that a BA procedure was not established. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of Personnel Records (PR) and interview with the Testing Personnel (TP), the Laboratory Director failed to ensure that the education records were available on the date of the survey. The finding includes: 1. Education records were not available for one of two TP. 2. The TP confirmed on 1/25/22 at 1:30 pm that education records were not available. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Final Reports (FR) and interview with the owner, the laboratory failed to follow Document # HIS-004 procedure from March 2019 to the date of a revisit survey. The finding includes: 1. Procedure section, step # 3 stated 'The benchmark measure for routine specimens is 24-72 hours from receipt of specimen' but the review of 30 out of 30 FR revealed that the laboratory reported after 100 hours. 2. The owner confirmed on 3/25/19 at 11:00 am that the laboratory did not follow HIS-004 procedure. b) Based on surveyor review of the PM, observation of flammable cabinet and interview with the owner, the laboratory failed to follow Document # HIS-040 procedure from March 2019 to the date of a revisit survey. The finding includes: 1. Section # III, step # 3 stated 'All reagents are labeled with the date received' but the observation of Eosin-Y, Harris Hematoxylin and Rapid Pap counter stain did not have receive date on them. 2. The owner confirmed on 3/25/19 at 12:15 pm that reagents were not labeled. c) Based on surveyor review of the PM and interview with the owner, the laboratory failed to follow Document # HIS-034 procedure on 3/9/19 and 3/18/19. The finding includes: 1. Section III, step # 4 stated 'the driver logs are documented on the Daily Delivery Log Sheet' but there was no evidence of log sheets for 3/9/19 and 3/18/19. d) Based on surveyor review of the PM and interview with the owner, the laboratory failed to have a detail Document # HIS-025 procedure on the date of a revisit survey. The Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- finding includes: 1. The procedure did not mention the use of tools to assess competency assessment. 2. The owner confirmed on 3/25/19 at 10:30 am that the procedure was not complete. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must 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. The laboratory must 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 surveyor review of the laboratory records, procedure manual and interview with the owner, the laboratory failed to establish a maintenance protocol for Microscope when protocols were not provided by the manufacturer from March 2019 to the date of a revisit survey. The owner confirmed on 3/25/19 at 10:30 am that the laboratory did not establish maintenance protocol. 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: Based on surveyor review of Quality Control (QC) records and interview with the owner, the laboratory failed to perform Hematoxylin and Eosin (H&E) stain Quality Control (QC) slide on March 9 and 18 of 2019. The owner confirmed on 3/25/19 at 11: 25 am that the laboratory did not prepare H&E stain QC slide. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the owner,the laboratory failed to ensure that the FR included the name of the laboratory where testing was performed from March 2019 to the date of a revisit survey. The owner confirmed on 3/25/19 at 11:50 pm that FR did not have all the required information. 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 surveyor review of the Procedure Manual and interview with the owner, the Laboratory Director (LD) failed to ensure a Quality Assurance (QA) program was established to assure quality of laboratory services provided from October 2018 to the date of a revisit survey. The owner confirmed on 3/25/19 at 10:45 am the LD did not establish a QA program. -- 3 of 3 --

Summary Statement of Deficiencies 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 surveyor observation of the manual Staining Station and interview with the owner, the laboratory failed to label all staining jars used for manual Hematoxylin and Eosin staining from October 2018 to the date of the survey. The owner confirmed on 1 /9/19 at 11:15 am that the staining jars were not labeled. 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 the Procedure Manual (PM), the laboratory records, tour of the laboratory and interview with the owner, the Laboratory Director (LD) failed to provide overall management, oversight and direction to the owner for laboratory testing. The findings include: 1. The LD failed to ensure that performance verifiation was performed on laboratory information system. Cross refer to D6086. 2. The LD failed to ensure that personnel had education and experience to perform patient 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 -- testing. Cross Refer to D6102. 3. The LD failed to ensure that PM was approved. Cross Refer to D6106. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the owner, the Laboratory Director (LD) failed to ensure that Laboratory Information System (LIS) was verified from October 2018 to the day of survey. The owner confirmed on 1/9/19 at 10:40 am that the LD did not ensure LIS was verified. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on lack of Personnel Records (PR) and interview with the owner, the laboratory director failed to ensure that education and experience records of each personnel were available from October 2018 to the date of survey. The owner confirmed on 1/9/19 at 10:20 am that education and experience was not documented for personnel performing testing. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the owner, the current laboratory director failed to have an approved procedure manual from July 2018 to the date of the survey. The findings include: 1. On the day of survey the owner stated that the laboratory director was changed in July 2018 but there was no update sent to CLIA program. 2. The PM included procedures not performed in the laboartory such as Cytology procedures, proficiency testing guidelines. 3. The owner confirmed on 1/9/19 at 10:00 am that the current director did not approve PM. -- 2 of 2 --