Sovereign Medical Group, Llc

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 the lack of an Accession Log (AL), Histopathology Slides (HS) and Cytology Slides (CS) and interview with the Chief Operations Officer (COO), the laboratory failed to retain HS and CS from 5/12/21 to the date of survey. The finding includes: 1. Review of five patient records revealed five out of five patient slides were not available at the time of the survey. 2. The COO confirmed on 4/5/23 at 1:00 pm the slides were not retained. D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on the lack of Quality Control records (QC), Procedure Manual (PM) and interview with the Chief Operations Officer (COO), the laboratory failed to ensure that quality systems for the pre-analytical, analytic and post-analytical phases of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- Histopathology testing were monitored from 5/12/21 to the date of survey. 1. The laboratory failed to verify the accuracy of Histopathology. Cross Refer to D5217. 2. The laboratory failed to establish a detailed procedure for Biannual Assessment (BA) for Histopathology. Cross refer to D5291. 3. The laboratory failed to document Hematoxylin and Eosin (H&E) control slide reactions for Histopathology testing. Cross Refer to D5601. 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 Chief Operation Officer (COO), the laboratory failed to verify the accuracy of Histopathology, Cytology, Cytogenetics and Semen Analysis testing from 5/12/21 to the date of survey. The COO confirmed on 4/5/23 at 1:00 pm that the laboratory did not perform BA for aforementioned sub-specialties. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT 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 the lack of a Procedure Manual and interview with the Chief Operation Officer (COO) the laboratory failed to establish detailed procedures for Biannual Assessment (BA) for Histopathology, Cytology, Cytogenetics and Semen Analysis from 5/12/21 to the date of survey. The COO confirmed on 4/5/23 at 1:15 pm that the laboratory did not have BA procedures. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on the lack of Laboratory Temperature Logs (DLL) and interview with the Chief Operations Officer (COO), the laboratory failed to monitor and document Room temperature, where Histopathology, Cytology, Cytogenetics and Semen Analysis tests -- 2 of 9 -- are performed from 5/12/21 to the date of survey. The COO confirmed on 4/5/23 at 1: 35 pm that Room temperature was not documented . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on lack of maintenance records and interview with the Chief Operations Officer (COO), the laboratory failed to perform and document annual maintenance on microscopes used in Histopathology, Cytology, Cytogenetics and Semen Analysis Testing from 5/12/21 to the date of survey. The COO confirmed on 4/5/23 at 1:00 pm there was no documented evidence maintenance was performed on the microscopes. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the lack of Quality Control (QC) records and interview with the Chief Operations Officer (COO), the laboratory failed to perform and document QC on each day of patient Semen Analysis testing from 5/12/21 to the date of survey. The COO confirmed on 4/5/23 at 1:10 pm that the laboratory did not perform QC on each day of patient Semen Analysis testing. 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 the lack of Quality Control (QC) records and interview with the Chief Operations Officer (COO), the laboratory failed to document Hematoxylin and Eosin (H&E) control slide reactions for Histopathology testing from 5/12/21 to the date of -- 3 of 9 -- the survey. The findings include: 1. The laboratory did not document H&E stain QC reactions during the time period stated above. 2. The laboratory read and reported approximately 2000 patients in the above time period. 3. The COO confirmed on 4/5 /23 at 1:30 pm that the laboratory did not document H&E QC stain reactions. D5603 HISTOPATHOLOGY CFR(s): 493.1273(b)(f) (b) The laboratory must retain stained slides, specimen blocks, and tissue remnants as specified in 493.1105. The remnants of tissue specimens must be maintained in a manner that ensures proper preservation of the tissue specimens until the portions submitted for microscopic examination have been examined and a diagnosis made by an individual qualified under 493.1449(b), (l), or (m). (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the lack of Histopathology slides and interview with the Chief Operations Officer (COO), the laboratory failed to retain Quality Control (QC) Histology Slides (HS) from 5/12/21 to the date of the survey The COO confirmed on 4/5/23 at 1:15 pm that QC HS were not retained. 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 the lack of laboratory policies and procedures, lack of laboratory records and interview with the Chief Operations Officer (COO) the laboratory Director (LD), failed to establish written policies and procedures for the evaluation and comparison of three of three required statistics for nongynecologic cytology from 5/12/21 to the date of the survey. Findings include: 1. The laboratory failed to provide written policies and procedures for an annual statistical evaluation of three required statistics for nongynecologic specimens. 2. The laboratory failed to provide an evaluation of three of three required statistics. Statistics include: a. The number of cytology cases examined; b. The number of specimens processed by specimen type; c. The number of patient cases reported by diagnosis to include unsatisfactory. 3. The COO confirmed on 4/5/23 at 1:50 pm the laboratory did not have the above procedures. D5643 CYTOLOGY -- 4 of 9 -- CFR(s): 493.1274(d)(2)(iii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(2)(iii) Nongynecologic slide preparations made using liquid-based slide preparatory techniques that result in cell dispersion over one-half or less of the total available slide may be counted as one-half slide; and (d)(2) (iv) Technical supervisors who perform primary screening are not required to include tissue pathology slides and previously examined cytology slides (gynecologic and nongynecologic) in the 100 slide workload limit. This STANDARD is not met as evidenced by: Based on the lack of a Procedure Manual (PM), Work Load log and interview with the Chief Operations Officer (COO), the laboratory failed to establish workload limits for personnel reading nongynecology slides from 5/12/21 to the day of the survey. The COO confirmed on 4/5/23 at 1:00 pm that workload limits were not established. D5779