Red Mountain Diagnostics

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 reviews of the Accuracy Comparison documentation, the procedure entitled, "Quality Management Program", and an interview with the Laboratory Director, the laboratory failed to ensure an assessment and comparison of the consulting laboratory's Histopathology results and the laboratory's results was documented. This was noted from the previous survey (03/23/2022) to the current survey (08/29/2023). This is a repeat deficiency. The findings include: 1. A review of the laboratory menu revealed the laboratory performed Histopathology reading and interpretation on-site for patients. In some cases patients then went to the University of Alabama in Birmingham (UAB) for a second opinion. UAB requested the patient's slides from Red Mountain Diagnostics (RMD) and performed a completely new Histopathology assessment. The UAB findings were returned RMD, and utilized as accuracy verification for the specialty of Histopathology. However, upon review of the accuracy verification records, there was no documentation of the laboratory's review (signature and date) and comparison of the results from the two laboratory's. There was no indication of an assessment with documentation of

Summary Statement of Deficiencies D5625 CYTOLOGY CFR(s): 493.1274(c)(3) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (3) For each patient with a current HSIL, adenocarcinoma, or other malignant neoplasm, laboratory review of all normal or negative gynecologic specimens received within the previous 5 years, if available in the laboratory (either on-site or in storage). If significant discrepancies are found that will affect current patient care, the laboratory must notify the patient's physician and issue an amended report. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, microscopic review of gynecologic cytology slide preparations and interview it was determined that the laboratory failed to follow written policies and procedures to review prior gynecologic cases and identify cases with a more significant lesion. The laboratory failed to identify one of two prior negative gynecologic cases as having a more significant lesion than originally reported from January 2021 to December 2021. Findings include: 1. The laboratory failed to follow the procedure FIVE YEAR RETRO REVIEW which stated: "When a GYN case (Pap Smear) is signed out by a Pathologist as HSIL, AIS or Malignant a records search will be done to identify any (which includes unsatisfactory) cases signed out at Red Mountain Pathology in the past five years from the collection date of the current high grade case." 2. The Survey Team reviewed records titled FIVE YEAR GYN PULL LIST from January 2021 to December 2021 that included two current cases of High-grade Intraepithelial Lesion ( HSIL). The Survey Team reviewed two prior negative gynecologic cases from two cases of HSIL and determined that the laboratory failed to identify one of two prior negative gynecologic cases as having a more significant lesion than was originally reported. Prior negative case includes: -CBBO-20-001019 3. During an interview on Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- February 2, 2022 at 11:30 AM the Laboratory Director/Technical Supervisor A confirmed these findings. p D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interviews it was determined that the laboratory failed to follow written policies and procedures for an annual statistical evaluation of six of six required laboratory statistics. The laboratory failed to document the six of six required annual statistics for 2019 and 2020. Findings include: 1. The laboratory failed to follow the procedure CYTOLOGY STATISTICAL RECORDS which stated: "A. Statistics maintained yearly for the entire laboratory are: a). # of specimens by specimen type b). # of specimens by diagnosis c). # of unsatisfactory specimens by diagnosis and client d). # of total cytology cases examined e). # of gyn cases where cytologic and histologic diagnoses are discrepant f). # of cases where rescreen of a normal (WNL) resulted in reclassification as malignant or pre-malignant (LGSIL or greater) result g). # of pre- malignant or malignant cases where histology results are unavailable for comparison." 2. The Survey Team requested and the laboratory failed to provide the six of six required annual statistics for 2019 and 2020. 3. During an interview on February 2, 2022 at 9:30 AM, the Laboratory Manager confirmed these findings. 4. During an interview on February 2, 2022 at 11:30 AM the Laboratory Director/Technical Supervisor A confirmed these findings. D5655 CYTOLOGY CFR(s): 493.1274(e)(4) (e) Slide examination and reporting. The laboratory must establish and follow written policies and procedures that ensure the following: (e)(4) Unsatisfactory specimens or slide preparations are identified and reported as unsatisfactory. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, microscopic review of gynecologic cytology slide preparations and interview it was determined that the laboratory failed to follow written policies and procedures to ensure that unsatisfactory gynecologic cytology slide preparations were identified and reported as unsatisfactory. The laboratory failed to microscopically identify one of -- 2 of 4 -- one gynecologic cytology slide preparation from November 2021 as being "UNSATISFACTORY FOR EVALUATION." Findings include: 1. The laboratory failed to follow the procedure UNSATISFACTORY SPECIMENS which stated: "Specimen adequacy is at least 5000 well visualized and preserved squamous cells when using the ThinPrep method of processing." 2. The laboratory failed to identify and report one of one gynecologic cytology slide preparation from November 2021 as being "UNSATISFACTORY FOR EVALUATION." Case includes: - CBBO-21- 006181 3. During an interview on February 2, 2022 at 11:30 AM the Laboratory Director/Technical Supervisor A confirmed these findings. 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 review of laboratory policies and procedures, lack of laboratory records, microscopic review of gynecologic cytology slide preparations and interviews it was determined that the Laboratory Director failed to ensure that quality assessment programs were followed and maintained to assure the quality of cytology services and identify failures in quality as they occur. Cross refer to D5625 and D5629 Findings include: 1. The Laboratory Director failed to ensure the quality of microscopic examinations as part of a program to review prior negative specimens on current HSIL patients. 2. The Laboratory Director failed to ensure six of six annual statistics were documented and reviewed as part of a program to evaluate and monitor annual laboratory statistics. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on the microscopic review of 403 random negative gynecologic cases/405 slides and the corresponding final test reports from November and December 2021 and confirmation by the Laboratory Director/Technical Supervisor A on February 2, 2022 it was determined that the Technical Supervisor failed to verify the accuracy of three gynecologic tests. 1. CBBO-21-06283 11/10/21 Hologic Imaged ThinPrep Pap Test (I-TPPT) LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM DIAGNOSIS: Low-Grade Squamous Intraepithelial Lesion LABORATORY DIRECTOR/TECHNICAL SUPERVISOR A DIAGNOSIS: Low- Grade Squamous Intraepithelial Lesion 2. CBBO-21-003244 11/05/21 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM DIAGNOSIS: Low-Grade Squamous Intraepithelial Lesion LABORATORY DIRECTOR/TECHNICAL SUPERVISOR A DIAGNOSIS: Low-Grade Squamous Intraepithelial Lesion 3. CBBO-21-006181 11/02/21 I-TPPT LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM DIAGNOSIS: -- 3 of 4 -- Unsatisfactory for Evaluation. Too few epithelial cells LABORATORY DIRECTOR /TECHNICAL SUPERVISOR A DIAGNOSIS: Unsatisfactory for Evaluation. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 4 of 4 --

Summary Statement of Deficiencies D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on telephone interviews with complainants and laboratory staff, a review of policies and procedures, and a lack of documentation of resolution to the clients' concerns, the surveyor determined the laboratory failed to have an effective mechanism in place to ensure valid complaints are investigated and documented. This deficiency is a result of a complaint investigation, with complaint number (AL00039937) and conducted on October 1, 2020. The findings include: 1. The State Survey Agency received a telephone call from a staff member of a long-term-care residence in Alabama on August 26, 2020 at 10:45 AM. The staff member questioned the validity of the results of COVID 19 PCR (Polymerase Chain Reaction) testing by the reference laboratory. The staff member stated, after results were reported as positive, a retest on the following day, indicated the patient was COVID negative. According to the staff member from the long-term-care residence, the laboratory's Account Manager, in a telephone call, said the test media was contaminated; however, in another telephone call, a different staff member said there was no contamination. The occurrence of this, as well as several other questionable results, was in late June and up to August, 2020. During telephone calls on August 26 at 1:47 PM and 3:30 PM, and August 27, 2020 at 3:40 PM, several staff members from different locations of the same long-term-care corporation, reported questionable COVID 19 test results. The long-term-care staff stated the laboratory in question and corporate staff were working on resolving the issue, and would let the State Agency know the out-come. Resolution to the concerns were not communicated to the State Agency, prior to the survey entry on October 1, 2020. 2. Two surveyors entered the laboratory on October Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 1, 2020, to investigate the allegations of concern. The surveyors toured the laboratory, with the Laboratory Director and Account Manager, where COVID testing was being performed, at approximately 10:00 AM. According to the Account Manager, the specimens were received, entered into the database/Laboratory Information System, labeled with a barcode, and tested in this area. The surveyors observed a staff member manually pipetting specimens, some potentially COVID positive, on-top the counter and without a biological hood. The surveyors also observed other instrumentation, including a Thermo Fisher Quant Studio 12. The transport from specimen processing to each instrument, as well as the mapping [orientation of specimen in the well (mapping = electronic scan in the barcode for well placement)] is done by hand. 3. On October 1, 2020 at 10:28 AM, in an interview with the Account Manager, Laboratory Director, and the surveyors, one surveyor asked if there had been any complaints of questionable test results, or of false positive or negatives. The Account Manager stated that from time to time, questions arise; and explained the cut off value for determining positive results. The surveyor inquired of the resolution to complaints, and if the laboratory could provide written documentation for surveyor review. The Account Manager recalled speaking to some long-term care clients, regarding concerns, however had not documented anything. The laboratory had no written record of the problems or documentation of resolution. At this time, the surveyor asked to review the policy and procedure for resolving issues and the quality assurance process. At 10:52 AM, when the Technical Supervisor (TS, also a testing personnel) joined the conversation, he stated he had retained several back-and-forth emails with the clients, but it would take some time (several days) to get them together for review. The TS also stated the laboratory could not provide any documentation of resolution to the problems or any trouble-shooting done to resolve the issues. 4. A review of the Quality Assurance Policy, provided by the Account Manager, revealed the following: "...

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 a review of the installation and validation records for the Hologic Panther [used for the qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae (CT/NG), Trichomonas vaginalis, and Human Papilloma Virus (HPV)] and interviews with the General Supervisor and the Laboratory Director, the surveyor determined the laboratory failed to ensure the APTIMA verification sample set (# 20520) was used for the validation of the instrument before their expiration date on 11/28/2019. The findings include: 1. Refer to D5421. . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of the installation and validation records for the Hologic Panther 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 -- and interviews with the General Supervisor and the Laboratory Director, the surveyor determined the laboratory failed to perform: (1) a valid verification of the manufacturer's performance specifications for precision and accuracy due to the use of expired verification samples, and (2) an evaluation of the data generated during the initial installation procedures for two out of four organisms, before patient testing began on 8/20/2019. The findings include: 1. A review of the installation and validation records for the Hologic Panther, used for the qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae (CT/NG), Trichomonas vaginalis, and Human Papilloma Virus (HPV) revealed the Hologic Service Technician performed validation runs on 1/7, and 2/7 - 2/8/2019 (per instrument printouts) to establish the accuracy and precision of the analyzer. The surveyor reviewed the raw data from runs of positive (+) and negative (-) quality control samples, and "APTIMA Samples for Verification", specimens with known +/- results. However, a review of the manufacturer's assay sheet which specified the expected results, revealed the APTIMA Sample Set # 20520 used in the validation had expired on 11/28/2019 (approximately 6-10 weeks earlier). 2. A further review of the Panther records revealed the laboratory had analyzed and generated a chart of the expected results vs the actual results generated from the studies for CT/NG. However, there was no documentation the results for Trichomonas and HPV were analyzed and evaluated to verify the precision and accuracy as per manufacturer's performance specifications. The surveyor also noted there was no indication the Laboratory Director had reviewed and approved (as indicated by his signature and date) the initial verification procedures. [Refer to D6086.] 3. In an interview on 9/19/2019 at 12:40 PM, the above noted findings were reviewed and confirmed with the General Supervisor who stated they had not noticed the expiration on the APTIMA sample kit. The surveyor then asked if the analyzer had been used for patient testing. The Supervisor printed the records and stated four patients were tested for CT/NG and Trichomonas on 8/20 /2019, and one patient was tested for HPV on 8/29/2019. 4. During the exit summation with the Laboratory Director, the General Supervisor and the Toxicology Technical Supervisor on 9/19/2019 at approximately 3:30 PM, the surveyor reviewed the above noted findings, especially the invalid verification of the manufacturer's performance specifications for precision and accuracy due to the use of expired verification samples. . 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 a review of the installation and validation records for the Hologic Panther [used for the qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae (CT/NG), Trichomonas vaginalis, and Human Papilloma Virus] and interviews with the General Supervisor and the Laboratory Director, the surveyor determined the Laboratory Director failed to ensure the laboratory performed: (1) a valid verification of the manufacturer's performance specifications for precision and accuracy due to the use of expired verification samples, and (2) an evaluation of the data generated during the initial installation procedures for two out of four organisms, before patient testing began on 8/20/2019. The surveyor further noted there was no indication the Laboratory Director had reviewed and approved (as indicated by his signature and -- 2 of 3 -- date) the initial verification procedures for the analyzer. The findings include: 1. Refer to D5421. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 3 of 3 --