Histopath Inc

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 upon review of the policies and procedures, review of personnel files and interview of facility personnel, the laboratory failed to have a written policy to assess the competency of testing personnel performing Histopathology procedures in 2023 and 2024. The findings included: 1. Review of the policies and procedures found in the procedure manual found no policy or procedure for assessing the competency of testing personnel performing histopathology procedures. 2. Review of personnel files found no documentation of competency assessments performed in 2023 or 2024 for five of eight testing personnel performing histopathology procedures in 2023 and 2024. 3. During interview of the practice manager conducted on December 12, 2024 at 12:37 PM, she confirmed there were no competency assessments available for review for the five pathologists performing histopathology procedures. 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 upon review of policies and procedures and interview of facility personnel, 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 -- laboratory failed to ensure 94 of 94 policies and procedures were approved, signed and dated by the current laboratory director. The findings included: 1. Review of the 13 policies and procedures included in the policy and procedure manual found 94 procedures. Review of these procedures found no documentation available for review that the current laboratory director had approved these procedures for use. 2. During interview of the practice manager conducted December 12, 2024 at 12:10 PM, she confirmed the laboratory director had not approved, signed and dated the procedures in use since becoming the laboratory director on October 1, 2024. 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 upon observations, review of manufacturer's instructions and interview of facility personnel, the laboratory failed to follow the manufacturer's instructions for storage for five reagents and stains used in histopathology testing. The findings included: 1. Observations made in the laboratory on December 12, 2024 at 12:27 PM found the laboratory stored the following reagents and stains on open shelving in the laboratory: one gallon Epredia EA-50 two gallons Fisherfinest Clarifier 2 one gallon Harris Hematoxylin one gallon Epredia OG-6 one gallon Eosin Y, Alcoholic with Phloxine B. 2. Review of the manufacturer's storage instructions printed on each of the labels found under the heading STORAGE: "Store locked up." 3. During interview of the Histotechnologist conducted December 12, 2024 at 12:27 PM, she confirmed the laboratory did not store the flammable reagents and stains locked in a flammable cabinet. 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. This STANDARD is not met as evidenced by: Based upon review of patient reports and interview of facility personnel the laboratory failed to include the location of the laboratory where tests were performed in five of five histopathology final reports reviewed. The findings included: 1. Review of five final patient reports found the laboratory used a post office box as the address with no -- 2 of 3 -- location of the laboratory where testing was performed. 2. During interview of the practice manager conducted December 12, 2024 at 1:13 PM, she confirmed that the laboratory did not include the location of the laboratory where testing was performed on the final reports. -- 3 of 3 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) results, and confirmed in interview of laboratory personnel, the laboratory failed to provide documentation of its review of results for 5 of 5 events reviewed from 2021 (event B) and 2022 (events A and B). The findings included: 1. A review of the laboratory's CAP proficiency testing results from 2021 (event B) and 2022 (events A and B) found the laboratory failed to have documentation of its review of results for each of the following 5 events: HER2-B (2021) PM2-B (2021) HER2-A (2022) HER2-B (2022) PM2-A (2022) 2. The laboratory was asked to provide documentation of the missing review of results. No documentation was provided. 3. An interview with testing personnel number #6 (as listed on Form CMS 209) and the Practice Manager on December 12, 2022 at 11:30 hours in the conference room confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services HER2 - Human Epidermal Growth Factor Receptor 2 PM2 Program - CAP proficiency testing program that fulfills Estrogen and Progesterone Receptors D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score 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 -- for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's College of American Pathologists (CAP) proficiency testing records, and confirmed in interview of laboratory personnel, the laboratory failed to have documentation of evaluating ungraded proficiency testing results for 4 of 4 events reviewed from 2021 (event B) and 2022 (events A and B). The findings were: 1. A review of the laboratory's College of American Pathologists (CAP) proficiency testing records from 2021 (event B) and 2022 (events A and B) found the following exception legend codes: [26] = Educational challenge [27] = Lack of consensus For these scores, the laboratory must perform self-evaluation. 2. Further review of the laboratory's College of American Pathologists (CAP) proficiency testing records from 2021 (event B) and 2022 (events A and B) found the laboratory failed to perform self-evaluation for results ungraded by the proficiency testing agency for the following 4 of 4 events reviewed: Event ID: HER2-B (2021) Test Specimen Score Core 02 HER2-03 27 Core 09 HER2-04 27 Wild Card Her2-04 26 Challenge Event ID: HER2-A (2022) Test Specimen Score Core 08 HER2-01 27 Core 07 HER2-02 27 Event ID: PM2-A (2022) Test Specimen Score ER Core 1 PM2-01 26 Intensity ER Core 2 PM2-01 26 Intensity ER Core 3 PM2-01 26 Intensity ER Core 5 PM2-01 26 Intensity ER Core 7 PM2-01 26 Intensity ER Core 9 PM2-01 26 Intensity ER Core 2 PM2-02 26 Intensity ER Core 3 PM2-02 26 Intensity ER Core 5 PM2-02 26 Intensity ER Core 6 PM2-02 26 Intensity ER Core 7 PM2-02 26 Intensity ER-WC Core 14 PM2-02 26 PgR Core 3 PM2-03 26 Intensity PgR Core 4 PM2-03 26 Intensity PgR Core 6 PM2-03 26 Intensity PgR Core 7 PM2-03 26 Intensity PgR Core 8 PM2-03 26 Intensity PgR Core 1 PM2-04 26 Intensity PgR Core 4 PM2-04 26 Intensity PgR Core 6 PM2-04 26 Intensity PgR Core 8 PM2-04 26 Intensity PgR Core 9 PM2-04 26 Intensity PgR Core 10 PM2-04 26 Intensity Event ID: HER2-B (2022) Test Specimen Score Core 01 HER2-04 27 Core 06 HER2-04 27 Core 09 HER2-04 27 3. The laboratory was asked to provide documentation of performing a self-evaluation of its proficiency testing results to assess their accuracy. No documentation was provided. 4. An interview with the Practice Manager and Testing Personnel #6 (as listed on Form CMS 209) on December 12, 2022 at 11:30 hours in the conference room confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services HER2 - Human Epidermal Growth Factor Receptor 2 PgR - Progesterone Receptor ER - Estrogen Receptor D6143 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 (a) The general supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The general supervisor must be qualified as a-- (b)(1) Laboratory director under 493.1443; or (b)(2) Technical supervisor under 493.1449. (c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of this section are not met, the individual functioning as the general supervisor must-- (c)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; and (c)(1)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing; or (c)(2)(i) Qualify as testing personnel under 493.1489(b)(2); and (c)(2)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or (c)(3)(i) -- 2 of 4 -- Except as specified in paragraph (3)(ii) of this section, have previously qualified as a general supervisor under 493.1462 on or before February 28, 1992. (c)(3)(ii) Exception. An individual who achieved a satisfactory grade in a proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies as a general supervisor if he or she meets the requirements of 493. 1462 on or before January 1, 1994. (c)(4) On or before September 1, 1992, have served as a general supervisor of high complexity testing and as of April 24, 1995-- (c) (4)(i) Meet one of the following requirements: (c)(4)(i)(A) Have graduated from a medical laboratory or clinical laboratory training program approved or accredited by the Accrediting Bureau of Health Education Schools (ABHES), the Commission on Allied Health Education Accreditation (CAHEA), or other organization approved by HHS. (c)(4)(i)(B) Be a high school graduate or equivalent and have successfully completed an official U.S. military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician). (c)(4)(ii) Have at least 2 years of clinical laboratory training, or experience, or both, in high complexity testing; or (c) (5) On or before September 1, 1992, have served as a general supervisor of high complexity testing and-- (c)(5)(i) Be a high school graduate or equivalent; and (c)(5) (ii) Have had at least 10 years of laboratory training or experience, or both, in high complexity testing, including at least 6 years of supervisory experience between September 1, 1982 and September 1, 1992. (d) For blood gas analysis, the individual providing general supervision must-- (d)(1) Be qualified under 493.1461(b)(1) or (2), or 493.1461(c); or (d)(2)(i) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (d)(2)(ii) Have at least one year of laboratory training or experience, or both, in blood gas analysis; or (d)(3) (i) Have earned an associate degree related to pulmonary function from an accredited institution; and (d)(3)(ii) Have at least two years of training or experience, or both in blood gas analysis. (e) The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations, must be performed: (e)(1) In histopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l)(1); (e)(2) In dermatopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l) or (2); (e)(3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(1)(3); and (e)(4) In oral pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(m). This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records, review of patient records, and confirmed in interview, the laboratory failed to review within 24 hours of all physical examinations/descriptions of tissue including color, weight, measurement and other characteristics of the tissue; or other mechanical procedures (grossing) for 9 of 9 samples randomly reviewed from December 2021 and January 2022. The findings included: 1. A review of the laboratory's personnel records for testing personnel #4, testing personnel #5, and testing personnel #6 (as listed on Form CMS 209) found no documentation of records to qualify them as a laboratory director or technical supervisor for high complexity testing in the specialty of histopathology. Therefore, grossing must be reviewed by a technical supervisor within 24 hours. 2. A random review of 9 of 9 patient reports whose grossing was performed from December 2021 and January 2022 did not document review of the grossing by the technical supervisor (TS) within 24 hours. Pathology Number Date of Final Diagnosis CY-21-01596 01- 03-2022 CY-21-01597 01-03-2022 HP-21-05135 01-03-2022 HP-21-05134 01-03- -- 3 of 4 -- 2022 ST-22-00001 01-04-2022 ST-22-00002 01-04-2022 ST-21-04415 01-03-2022 ST-22-00003 01-04-2022 ER-22-00005 01-12-2022 3. An interview with the Practice Manager on December 12, 2022 at 12:15 hours in the conference room confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services -- 4 of 4 --

Summary Statement of Deficiencies 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 review of the laboratory's slide quality control records from June 2020 and September 2020 (as of the day of the survey), review of patient test records and staff interview, it was revealed the laboratory failed to have documentation of evaluating immunohistochemical stains for positive and negative reactivity each time of use for 4 of 4 events. The findings were: 1. Random review of quality control records from June 2020 and September 2020 found the following dates when patients were tested and a positive and negative quality control reactivity was not documented: June 2, 2020 June 22, 2020 September 2, 2020 September 18, 2020 2. A review of patient test records revealed the following patients were tested on the identified days: Pathology No: ST-20-01488 June 2, 2020 CD56 Chromogranin Ki67 Synaptophysin Pathology No: HP-20-02343 June 22, 2020 ER PR HER2 P53 Ki67 Pathology No: HP-20-03359 September 2, 2020 P16 Pathology No: ST-20-02804 September 18, 2020 Pankeratin 3. An interview with the laboratory director at the exit conference on May 6, 2021 confirmed the findings. 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 a review of the Form CMS-209 (CLIA Personnel Form), review of laboratory policy, review of personnel records and interview of facility personnel the laboratory did not have a written policy to assess the competency of each of its technical supervisors. The findings included: 1. A review of the laboratory's submitted Form CMS-209, signed by the laboratory director on February 5, 2019, revealed the laboratory identified 5 technical supervisors in addition to himself. 2. A review of the Laboratory Policy and Procedure manual revealed that the manual did not include a policy and procedure to evaluate the competency of each of its technical supervisors. 3. A review of the facility's personnel files, revealed that the technical supervisors did not include evidence that the competency of the technical supervisor had been evaluated. 4. An interview with the Laboratory Director, Laboratory Supervisor, and Administrator on February 5, 2019 at 14:00 hours in the conference room confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services CLIA - Clinical Laboratory Improvement Amendments 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 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 -- 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 review of patient results, review of quality control records, and confirmed in interview with facility personnel, the laboratory failed to provide documentation of staining materials for intended reactivity to ensure predictable staining characteristics each time of use for 1 of 5 randomly selected patient charts reviewed. The findings included: 1. Review of patient results found the following patient had results reported for IHC studies. The report (Pathology No. HP-18-04223) stated, " ... Immunohistochemical studies are performed, and these nests stain strongly for p40 and negative for CD 68 ..." 2. Based on review of patient records, the laboratory did not have quality control records for assessing stain acceptability for positive and negative reactivity, when appropriate, for 1 of 5 randomly reviewed patient specimens: Pathology No.: HP-18-04223 Date of Procedure: 09-11/2018 Date Reported: 09-21-2018 IHC stains: p40, CD 68 3. On February 5, 2019 at 13:30 hours the facility attempted to retrieve a scanned copy of the quality control documentation. No documentation was provided. 4. On February 5, 2019 at 13:30 hours the facility attempted to retrieve a paper copy of the quality control documentation. No documentation was provided. 5. According to the CLIA 116 signed by the laboratory director on February 5, 2019, the laboratory reports an estimated annual volume in histopathology of 25,000 tests per year. 6. An interview with the Laboratory Director, Laboratory Supervisor, and Administrator on February 5, 2019 at 14:00 hours in the conference room confirmed the findings. Key: CLIA - Clinical Laboratory Improvement Amendments -- 2 of 2 --