Prithipal S Sethi, Md, 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 on the review of eight (8) Histopathology patient records, lack of personnel competency documentation, and interviews with the office manager (OM) and histology technologist (HT); as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to perform competency assessments for the HT in the years 2022, 2023, 2024 and 2025. The findings include: 1. Surveyor's review of 8 Histopathology records showed that competency assessment for HT was missed to be performed for the years 2022, 2023, 2024, and 2025 2. The OM and HT affirmed by interviews on June 3, 2025, at approximately 10:28 a.m. that no competency records were available for review from 2022 to 2025. Thus, the quality and reliability of patient reports could not be assured. 3. According to the laboratory's annual testing declaration submitted at the time of the survey, the laboratory reported and performed approximately 2.160 tests for Histopathology for which competency assessments of HT were not performed. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) 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; 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 -- This STANDARD is not met as evidenced by: Based on the lack of personnel competency assessment records, review of personnel qualifications, eight patient records for Histopathology, and interviews with the office manager and histology technician, it was determined that the laboratory director is herein cited for failure to ensure that prior to testing patient specimens, all personnel have the appropriate education and experience. 1. No competency records. See D5209. 2. Testing personnel qualifications. See D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) 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 (b)(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(2)(ii) Be qualified under the requirements of 493.1443(b)(3) or 493.1449(c)(4) or (5); or (b)(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or (b)(3)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes (b)(3)(ii) (A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either (b)(3)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(3)(ii)(A)(2) 24 semester hours of science courses that include (b)(3)(ii)(A)(2)(i) 6 semester hours of chemistry; (b)(3)(ii)(A)(2)(ii) 6 semester hours of biology; and (b)(3)(ii)(A)(2)(iii) 12 semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(3)(ii)(B) Have laboratory training that includes: (b)(3)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or (b)(3)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or (b)(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (b)(6) For blood gas analysis (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b) (6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution. (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (f) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on the review of eight (8) Histopathology patient records, lack of personnel competency documentation, and interviews with the office manager (OM) and histology technologist (HT); it was determined that the laboratory failed to meet personnel requirements as specified in subpart M. The findings include: 1. The laboratory performed Histopathology testing, not limited to gross examination and -- 2 of 3 -- technical preparation of all specimens received. Grossing, a high complexity test, was performed without supervision by the HT who was an unqualified personnel under Code of Federal Regulations (CFR) 493.1489. 2. The OM and HT affirmed by interviews on June 3, 2025, at approximately 10:28 a.m. that gross examination is perfomed without supervision of a qualified personnel. 3. According to the testing declaration submitted at the time of survey, the laboratory performed and reported 2,160 Histopathology cases including the period when the HT was missing competency documentation. -- 3 of 3 --

Summary Statement of Deficiencies D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, specimen slides, observation and interviews it was determined that the laboratory failed to provide test requisitions that solicited required patient information (refer to D5305); failed to follow written policies and procedures for the labeling of nongynecologic slide preparations and specimen acceptability (refer to D5311); failed to establish written policies and procedures for two laboratory test processes (refer to D5403); failed to follow manufacturer's instructions for required maintenance for cytocentrifuge (refer to D5429); failed to establish written policies and procedures for the establishment, reassessment and documentation of individual workload limits (refer to D5633, D5637 and D5647); failed to establish written policies and procedures to ensure the laboratory maintained records of the total number of slides examined and the total number of hours spent examining slides per 24-hour period (refer to D5645); failed to establish written policies and procedures to ensure unsatisfactory slide preparations were identified and reported as unsatisfactory (refer to D5655); and failed to ensure test reports indicated the name and address of the laboratory where the test was performed (refer to D5805). 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and phone interview with the Laboratory Director/Technical Supervisor the laboratory failed to establish written policies and procedures to assess the competency of Technical Supervisors. The laboratory failed to provide documentation of a competency assessment for one of one Technical Supervisor in 2020, 2021 and to the date of the survey in 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to assess the competency of Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for one of one Technical Supervisor in 2020, 2021 and to the date of the survey in 2022. Technical Supervisor includes: -Laboratory Director/Technical Supervisor 3. During a phone interview on August 8, 2022 at 3:04 PM these findings were confirmed by Laboratory Director /Technical Supervisor. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews with the Laboratory Director/Technical Supervisor and Lab Assistant the laboratory failed to ensure that a nongynecologic cytology test requisition was provided to physicians to solicit the required patient information for 331 of 331 consecutive nongynecologic cytology specimens from December 1, 2021 to April 12, 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide a nongynecologic cytology test requisition that solicited the required patient information for 331 of 331 consecutive nongynecologic cytology specimens from December 1, 2022 to April 12, 2022. Required information includes: -The name and address or other suitable identifiers of the authorized person requesting the test -The patient's name or unique patient identifier -The sex and age or date of birth of the patient -The test(s) to be performed -The source of the specimen -The date of specimen collection -Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results Specimens include: - U-7214 to U-7544 2. During a phone interview on August 8, 2022 at 3:04 PM these findings were confirmed by Laboratory Director/Technical Supervisor who stated that -- 2 of 15 -- "patient demographic/face sheets" were used in lieu of a test requisition. 3. During an interview on August 9, 2022 at 2:00 PM these findings were confirmed by Lab Assistant who stated that the medical assistants printed "patient demographic/face sheets" and recorded information on the bottom of those. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: A. Based on review of laboratory policies and procedures, cytology slide preparations, observation and interview with the Lab Assistant the laboratory failed to follow written policies and procedures for specimen labeling. The laboratory failed to label ten of 284 cytology slide preparations with the patient name from January 2022 to April 2022. Findings include: 1. The laboratory failed to follow the procedure URINE CYTOLOGY PROCEDURE which stated: -"3.) Slides are properly labeled with two unique patient identifiers: requisition number and patient name." 2. The Survey Team reviewed 284 cytology slide preparations from January 2022 to April 2022. The laboratory failed to label ten of 284 cytology slide preparations with the patient name. Slide preparations include: -U-7290 Slide labeled with patient first name, last initial. and accession number. -U-7320 Slide labeled with patient last name and accession number. -U-7321 Slide labeled with patient last name and accession number. -U-7323 Slide labeled with patient first name, last initial and accession number. -U-7359 Slide labeled with patient last name and accession number. -U-7361 Slide labeled with patient last name and accession number. -U-7367 Slide labeled with patient last name and accession number. -U-7444 Slide labeled with patient last name and accession number. -U-7455 Slide labeled with patient last name and accession number. -U-7496 Slide labeled with patient first name, last initial and accession number. 3. During an interview on August 9, 2022 at 2:00 PM Lab Assistant stated that it is the laboratory's practice to label each slide with accession number, patient first initial and last name. B. Based on review of laboratory policies and procedures, observation and interview with the Lab Assistant the laboratory failed to follow written policies and procedures for specimen acceptability. The laboratory failed to verify the date of birth for one of one nongynecologic cytology specimen during specimen receipt and processing on August 9, 2022. Findings include: 1. The laboratory failed to follow the procedure URINE CYTOLOGY PROCEDURE which stated: -"1.) Urine is collected in vials which have at least 2 unique patient identifiers including patient name and date of birth." 2. The laboratory failed to follow the procedure GROSS EXAMINATION PRACTICES which stated: -"Surgical Pathology and Cytopathology Specimens must be submitted to the gross examination Area in an appropriately labeled, clean container...unacceptable specimens will be re-labeled with verification of the surgeon." 3. During observation of specimen receipt and processing on August 9, 2022 at 2:00 PM the Survey Team identified one of one nongynecologic cytology specimen with a discrepancy between the date of birth on the specimen container and the date of birth on the "patient demographic/face sheet". Lab Assistant proceeded to process the specimen then stain the cytology slide preparation. Specimen includes: -- 3 of 15 -- Accession number: U-7868 Date of birth written on specimen container: 3-28-02 Date of birth typed on "patient demographic/face sheet": 03/28/2000 4. During an interview on August 9, 2022 at 2:00 PM these findings were confirmed by Lab Assistant who stated: -"If the physician who saw this patient was here today, I would ask him to verify the birthdate. Since the month and the day are the same, it's ok." D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory quality assessment records, observation and interview with the Lab Assistant the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the preanalytic systems. The laboratory failed to document preanalytic quality assessment activities in 2020, 2021 and to the date of the survey in 2022. Cross refer to D5305 and D5311 Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an ongoing program to monitor, assess and correct problems identified in the preanalytic laboratory systems. 2. The Survey Team requested and the laboratory failed to provide documentation of preanalytic laboratory quality assessment activities in 2020, 2021 and to the date of the survey in 2022. a. The laboratory failed to have an ongoing mechanism to ensure that cytology test requisitions were provided that solicited the required patient information. (Refer to D5305) b. The laboratory failed to have an ongoing mechanism to monitor, assess and correct problems identified with slide labeling and specimen acceptability. (Refer to D5311) 3. During an interview on August 8, 2022 at 2:00 PM these findings were confirmed by Lab Assistant. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)