Andrzej Janecki Md Pa

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5028 - 42 C.F.R. 493.1219 Condition: Histopathology; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director; The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. 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 laboratory policies, quality control, and personnel files, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1273, and 493. 1281 through 493.1299. Refer to D5217, D5601, D5805 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 review of the laboratory records and confirmed in an interview, the laboratory failed to document at least twice annually the accuracy of 1 of 1 tests in 2018 and 2019. (grossing) Findings were: 1. A review of laboratory testing records 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 -- from 2018 and 2019 revealed no documentation of the laboratory verifying the accuracy for grossing. 2. An interview with the testing person #1 on 11/14/19 at 1040 hours confirmed the above findings. He was unaware the laboratory should perform the accuracy assessment for this laboratory. 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 laboratory records and confirmed in interview, the laboratory failed to document the stain quality with each patient slide or group of patient slides for H/E, Diff Quik and AB/PAS stain. Findings were: 1. Review of the laboratory records available revealed the laboratory performed the technical component of the following stains: H/E, Diff Quik and AB/PAS stains. 2. Review of laboratory records available revealed no documentation of quality control of stain quality for Diff Quick and AB/PAS special stain. 3. An interview of the testing person #1 on 11/14/19 at 1015 hours in the laboratory confirmed the above findings. He stated that the laboratory sent the slides and paperwork for quality control to the laboratory performing the professional component of the slides. He acknowledged that the documentation should be kept at both locations. key: AB/PAS - Alcian Blue/Periodic Acid Schiff stain Stain Kit H/E - Hematoxylin and eosin stain Diff Quik - Romanowsky stain variant 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 on review of patient test reports and confirmed in interview, the laboratory failed to document the name and address of the testing facility where the technical component (grossing) were performed for the histopathology specimens. Findings were: 1. A random review of the patient reports from January 2019 and September 2019 revealed 10 of 10 test reports with no documentation of the name and address of the testing facility where the grossing was performed for the histopathology specimens. Date Accession # 1/02/19 AJ19-0017 4/11/19 AJ19-0406 4/25/19 AJ19- 0472 5/08/19 AJ19-0518 5/22/19 AJ19-0553 7/01/19 AJ19-0730 7/30/19 AJ19-0785 8 -- 2 of 5 -- /19/19 AJ19-0860 8/19/19 AJ19-0925 9/04/19 AJ19-1020 2. An interview with the testing person #1 on 11/14/19 at 1030 hours in the laboratory confirmed the above findings. He acknowledged that the reports should be updated to reflect the laboratory that performed the technical component. 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 a review of the laboratory's quality control records, facility procedures, record review and staff interview, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services (refer to D6079, D6084, D6094) D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory's personnel records and confirmed in interview, the technical supervisor failed to have documentation of performing competency assessments twice within the first year for 5 of 5 testing personnel (TP) in 2018. Findings were: 1. A review of the facility's personnel files, revealed no documentation at the time of the survey of an initial or a second competency evaluation relating to histopathology laboratory testing for 5 of 5 TP in 2018. 2. An interview with the testing person #1 on 11/14/19 at 1040 hours in the laboratory confirmed the above findings. He was unaware the competencies should only be performed by the technical supervisor of this laboratory, not another laboratory. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on a review of the laboratory's personnel records and confirmed in interview, the technical supervisor failed to have documentation of performing an annual competency assessments for 5 of 7 testing personnel (TP) in 2019. Findings were: 1. A review of the facility's personnel files, revealed no documentation at the time of the -- 3 of 5 -- survey of an annual competency evaluation relating to histopathology laboratory testing for 5 of 7 TP in 2019. 2. An interview with the testing person #1 on 11/14/19 at 1040 hours in the laboratory confirmed the above findings. He was unaware the competencies should only be performed by the technical supervisor of this laboratory, not another laboratory. 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) 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 -- 4 of 5 -- 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 patient test reports 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. Finding were: 1. A random review of the patient reports, whose grossing was performed by a testing person (not qualified as a technical supervisor) from January 2019 and September 2019 revealed 10 of 10 test reports which did not document review of the grossing by the technical supervisor (TS) within 24 hours. Date Accession # 1/02/19 AJ19-0017 4/11/19 AJ19-0406 4/25/19 AJ19-0472 5/08/19 AJ19-0518 5/22/19 AJ19-0553 7/1/19 AJ19-0730 7/30/19 AJ19- 0785 8/19/19 AJ19-0860 8/19/19 AJ19-0925 9/04/19 AJ19-1020 2. An interview with the laboratory manager on 11/14/19 at 1040 hours in the office confirmed that there is no review of the grossing. He was unaware the grossing required 24 hour review by the TS. -- 5 of 5 --