Pro Health Diagnostic, Llc

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 laboratory policy, patient requisitions and confirmed in interview, the laboratory failed to confirm the specimen source was included on the patient requisitions prior to patient specimen processing for 33 of 35 patients tested in June 2023. Findings Included: 1. Review of laboratory policy, "Criteria for Rejection of Unacceptable Specimens" (Approved by the Laboratory Director on 04/11/2023) revealed the following: "Criteria For Rejections: ...Improper labeling or absence of requisitions 1. Lack of Surgical Pathology Requisition 2. Improperly completed requisition/order" 2. Random review of patient requisitions received in June 2023, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- revealed the following 33 of 35 improperly completed patient requisitions that failed to include a specimen source: June 2023 Patient Accession Numbers: PHD23-0176; PHD23-0177; PHD23-0178; PHD23-0179; PHD23-0219; PHD23-0222; PHD23- 0224; PHD23-0226; PHD23-0227; PHD23-0228; PHD23-0229; PHD23-0230; PHD23-0238; PHD23-0239; PHD23-0240; PHD23-0242; PHD23-0243; PHD23- 0244; PHD23-0248; PHD23-0251; PHD23-0252; PHD23-0253; PHD23-0254; PHD23-0255; PHD23-0256; PHD23-0257; PHD23-0258; PHD23-0259; PHD23- 0260; PHD23-0263; PHD23-0265; PHD23-0268; PHD23-0269 3. During an interview on 08/22/2023 at 01:20 p.m., in the facility break room with the office manager, the office manager confirmed the above findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory policy, validation records, and confirmed in staff interview, the laboratory failed to follow its own written policy for performing a validation study on 1 of 1 tissue processors in 2023. Findings included: 1. Review of the laboratory's policy titled "Tissue Processor" revealed: "QUALITY CONTROL: A validation will be performed any time a new processor is put in place, there is an equipment failure, or if there is a change in a processing program. See Processor Validation." 2. Review of the laboratory's validation records revealed the laboratory did not perform a validation study on the laboratory's Tissue Tek VIP tissue processor Serial number 52150394. The laboratory was asked to provide a validation study, and none was provided. 3. During an interview on 08/22/2023 at 12:32 pm, the Laboratory Consultant after review of records confirmed the laboratory failed to perform a validation study on their tissue processor. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on direct observation, review of manufacturer's instruction, and confirmed in staff interview, the laboratory failed to follow the manufacturer's instructions for covering 1 of 1 microscope when not in use in 2023 (August). Findings included: 1. During a tour of the laboratory's processing room on 08/22/2023 at 12:15 pm, the surveyor observed a Labomed CxL microscope uncovered on a table next to the fume hood. 2. Review of the Labomed CxL microscope user' manual revealed: "2 Maintenance and Storage ... 4. When not using them microscope, ensure the frame is fully cooled and store the unit in a dry locker or cover with a dust cover (provided)." The laboratory failed to follow the manufacturer's instructions for covering the -- 2 of 7 -- microscope when not in use. 3. During an interview on 08/22/2023 at 1:28 pm, the Laboratory Consultant confirmed the above findings. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory's maintenance policy, manufacturer's instructions, maintenance records and confirmed in interview, the laboratory failed to ensure annual maintenance was performed for 1 of 1 Tissue-Tek VIP tissue processor 1 of 1 Leica Autostainer XL, 1 of 1 Leica CV5030 coverslipper, 1 of 1 Leica EG 1150c embedder, 1 of 1 Tissue-Tek TEC embedder, 2 of 2 Bockel ovens, 2 of 2 Reichert-Jung microtomes, 1 of 1 Avantik 630 fume hood, and 1 of 1 Labomed CxL microscope (utilized in histopathology testing) that is necessary for accurate and reliable test results for 2023. Findings included: 1. During a tour of the laboratory on 08/22/2023 at 11:59 am, the following was observed to be stored and ready for use: Staining Room: Tissue-Tek VIP (Serial #52150394) labeled with a preventative maintenance (PM) sticker "Medical Equipment Source - PM (was checked off as completed), Date: 5/17/22, Next Due: 5/17/23" Leica Autostainer XL (Serial #XL01041) labeled with a preventative maintenance (PM) sticker "Medical Equipment Source - PM (was checked off as completed), Date: 4/13/22, Next Due: 4 /13/23" Leica CV5030 cover slipper (Serial #2215107.201) labeled with a preventative maintenance (PM) sticker "Medical Equipment Source - PM (was checked off as completed), Date: 4/13/22, Next Due: 4/13/23" Microtomy Room: Leica EG 1150c embedder (Serial #3346) labeled with a preventative maintenance (PM) sticker "Medical Equipment Source - PM (was checked off as completed), Date: 4/13/22, Next Due: 4/13/023" Tissue-Tek TEC embedder (Serial #51010401) labeled with a preventative maintenance (PM) sticker "Medical Equipment Source - PM (was checked off as completed), Date: 4/13/22, Next Due: 4/13/23" Bockel oven labeled with a preventative (PM) sticker "Orion - electrical safety check and PM were checked off as completed), Date illegible. There was another PM sticker under the first PM sticker labeled: "Electrical Safety Test- Pass Date: 4/13/22; Next Due: 4/13 /23 Reichert-Jung Microtome #1 (Serial #304119) labeled with a preventative maintenance (PM) sticker "Medical Equipment Source - PM (was checked off as completed), Date: 5/18/22, Next Due: 5/18/23" Reichert-Jung Microtome #2 (Serial #152853) labeled with a preventative maintenance (PM) sticker "Medical Equipment Source - PM (was checked off as completed), Date: 4/13/22, Next Due: 4/13/23" Specimen Processing Room: Labomed CxL microscope labeled with a preventative maintenance (PM) sticker "micronix - Date: 10/30/2015, Next Due: 10/30/2016" Avantik 630 fume hood, labeled with a preventative (PM) sticker "Electrical Safety Test- Pass Date: 4/13/22; Next Due: 4/13/23 Bockel oven labeled with a preventative (PM) sticker "Electrical Safety Test- Pass Date: 4/13/22; Next Due: 4/13/23 2. Review of the laboratory's policy titled "Tissue Processor" revealed: "MAINTENANCE ... 4. The annual PM and maintenance are performed. All issues and maintenance -- 3 of 7 -- performed are documented on the Equipment Maintenance History log along with a copy of the invoice." 3. Review of Labomed CxL microscope user's manual revealed: "4 Care and Maintenance ... 4. Periodical checking: To maintain the performance of the instrument, we recommend customers have their microscopes serviced periodically by a factory authorized dealer/rep. For details, contact your nearest dealer or Labo America's main office in California." 4. Review of the laboratory's maintenance logs for May 2023 revealed: Leica Autostainer XL log: "Preventative Maintenance (annually due by 4/13)" A handwritten note dated 06/14/2023 by the laboratory director stating: "NEED PM ASAP. Discussed with [XX] & [XX]." Leica CV5030 log: "Preventative Maintenance (annually due by 4/13)" A handwritten note dated 06/14/2023 by the laboratory director stating: "NEED PM ASAP! Discussed with [XX] & [XX]." Leica EG 1150C log: "ANNUAL PREVENTATIVE MAINTENANCE: Due NOW" A handwritten note dated 06/14/2023 by the laboratory director stating: "NEED PM ASAP. Discussed with [XX] & [XX]." Boekel Oven Log: "Annual PM completed: Now Due" Handwritten notes dated 06/14/2023 by the laboratory director stating: "Need PM!" "NEED PM ASAP! Discussed with [XX] & [XX]." Microtome #1/ Water Bath Log: "Annual PM performance date: Now Due" A handwritten note dated 06/14/2023 by the laboratory director stating: "Need PM ASAP! Discussed with [XX] & [XX]." Microtome #2 / Water Bath Log: "Annual PM performance date: 5/18/22" A handwritten note dated 06/14/2023 by the laboratory director stating: "NEED PM ASAP! Discussed with [XX] & [XX]." Avantik Biogroup Fume Hood Log: "Annual PM completed: Now Due" A handwritten note dated 06/14/2023 by the laboratory director stating: "NEED PM ASAP! Discussed with [XX] & [XX]." 5. During an interview on 08/22/2023 at 1:28 pm, the Laboratory Consultant confirmed the above findings. 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 review of laboratory policy manual, CMS (Centers for Medicare and Medicaid Services) form 209, personnel records, and interview with staff, the Technical Supervisor (TS-1) failed to evaluate initial competency of 1 of 3 testing persons (TP-3) responsible for high complexity testing in 2023. Findings Included: 1. Review of laboratory policy manual revealed the following job description signed by TS-1 on 03/03/2020, "Job Category: Technical Supervisor; Department/Group: Pro Health Diagnostics Job Description: Manage periodic activities in lab 1. Identifying training needs and providing in-service training and education 2. Evaluating competency of all testing personnel 3. Evaluating and documenting the performance of individuals responsible for high complexity testing." 2. Review of the CMS 209 form submitted at time of survey, revealed 1 Technical Supervisor (TS-1) and 3 Testing Personnel (TP-1, TP-2, TP-3) performing high complexity testing. 3. Review of TP-3 personnel forms revealed an initial competency performed on 02/17/2023, by TP-2. The Technical Supervisor failed to evaluate initial competency of 1 of 3 testing persons (TP-3) responsible for high complexity testing in 2023. 4. During an interview on 08/22/2023 at 01:20 p.m., in the facility break room with the office manager, the office manager confirmed the above findings. -- 4 of 7 -- 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 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). -- 5 of 7 -- This STANDARD is not met as evidenced by: Based on review of CMS (Center for Medicare & Medicaid Services) 209 form submitted at time of survey, laboratory policy, laboratory specimen grossing review forms, patient requisitions and confirmed in interview, the general supervisor failed to ensure complete gross examinations for patient specimens performed by testing persons, were reviewed within 24 hours for 82 of 82 randomly reviewed patient specimens grossed in May 2023. Findings Included: 1. Review of the CMS 209 form listed the laboratory director as the clinical consultant, technical supervisor (TS), and general supervisor (GS). The 209 included three testing persons (TP-1, TP-2 and TP- 3) who performed the gross examinations of specimens received in the laboratory. The laboratory director/ technical supervisor/ general supervisor was not onsite. TP-2 and TP-3 did not qualify as a technical supervisor or general supervisor, requiring gross review within 24 hours. 2. Review of laboratory policy, "Histotechnologist Training for Macroscopic Evaluation" (Approved by the Laboratory Director on 06/14 /2023) revealed the following: "Specimen Grossing Review: Gross descriptions from the requisitions are reviewed by a pathologist prior to microscopic examination within 24 hours, excluding holidays and weekends. All requisitions are scanned and emailed to the medical director. This is documented by the pathologist on the "Specimen Grossing Review Form"." 3. Review of laboratory specimen grossing review forms, revealed the following statement: "All specimen gross descriptions have been reviewed in 24 hours, excluding weekends and holidays, by the General Supervisor /Technical Supervisor prior to microscopic examination." Also contained on the form was a section for the General Supervisor's acknowledgement/signature to the above statement. The surveyor inquired on 08/22/2023 at 11:55 a.m., in the facility break room with the office manager, as to what information the GS received when reviewing patient specimen grossing. The office manager stated the GS only received the patient requisition with the grossing description, and the grossing review form. No other documentation was provided to the GS for review. The general supervisor failed to ensure complete gross examinations for patient specimens performed by testing persons, were reviewed within 24 hours for 84 of 84 patient specimens grossed in May and June 2023. 4. Review of patient final reports revealed the following patients grossed in May 2023 that did not have review within 24 hours of grossing: May 2023 a. Date Grossed by TP-3: 05/04/2023; Accession Numbers: PHD23-0017; PHD23- 0018; PHD23-0019; PHD23-0020; PHD23-0021; PHD23-0022; PHD23-0023; PHD23-0024; PHD23-0025; PHD23-0026; PHD23-0027; PHD23-0028; PHD23-0029 b. Date Grossed by TP-3: 05/08/2023; Accession Numbers: PHD23-0042; PHD23- 0043; PHD23-0044; PHD23-0045; PHD23-0046; PHD23-0047; PHD23-0048; PHD23-0049; PHD23-0050 c. Date Grossed by TP-3: 05/09/2023; Accession Numbers: PHD23-0053; PHD23-0054; PHD23-0055; PHD23-0056; PHD23-0057; PHD23-0058; PHD23-0060; PHD23-0061; PHD23-0062; PHD23-0063; PHD23-0064 d. Date Grossed by TP-3: 05/11/2023; Accession Numbers: PHD23-0059; PHD23- 0065; PHD23-0066; PHD23-0070; PHD23-0071; PHD23-0072; PHD23-0073; PHD23-0074; PHD23-0075 e. Date Grossed by TP-3: 05/17/2023; Accession Numbers: PHD23-0086; PHD23-0087; PHD23-0088; PHD23-0089; PHD23-0089; PHD23-0090 f. Date Grossed by TP-3: 05/18/2023; Accession Numbers: PHD23- 0095; PHD23-0096; PHD23-0097; PHD23-0098; PHD23-0099; PHD23-0100 g. Date Grossed by TP-3: 05/22/2023; Accession Numbers: PHD23-0108; PHD23-0109; PHD23-0110; PHD23-0111 h. Date Grossed by TP-3: 05/23/2023; Accession Numbers: PHD23-0112; PHD23-0113; PHD23-0114; PHD23-0115; PHD23-0116; PHD23-0117; PHD23-0118; PHD23-0119; PHD23-0120 i. Date Grossed by TP-3: 05 /26/2023; Accession Numbers: PHD23-0121; PHD23-0122; PHD23-0123; PHD23- 0124; PHD23-0125; PHD23-0126 j. Date Grossed by TP-3: 05/31/2023; Accession -- 6 of 7 -- Numbers: PHD23-0127; PHD23-0128; PHD23-0129; PHD23-0130; PHD23-0131; PHD23-0132; PHD23-0133; PHD23-0134; PHD23-0135 5. During a phone interview with the Laboratory Director/GS on 08/22/2023 at 11:58 a.m., the GS stated the only documentation reviewed for grossing were the patient requisitions with gross descriptions. No other information, including digital images, was provided of the grossing. This confirmed the above findings. -- 7 of 7 --

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representative. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in COMPLIANCE with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

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: Revisit 09/04/2018 New Deficiency. Based on review of the laboratory's policy, "QUALITY ASSURANCE PROFICIENCY TESTING PATHOLOGY" records, and confirmed in interview, the laboratory failed to ensure accuracy was verified for histopathology in 08/2018 (not included in subpart I of this part). Findings included: 1. Review of the laboratory's policy "PROFICIENCY TESTING PROGRAM (IN- HOUSE)" stated, "Every 6 months, the histotechnologists will pick a case that has already been reported and will send all slides for review to a Doctor, the histotechnologist needs to put the complete Doctor's name and address. Upon receipt of the pathology report from the Doctor, diagnosis of the slide specimen will be matched to the in-house diagnosis by Laboratory Director. If diagnosis match, the reports are attached and placed in the proficiency testing section of the Quality Control Log." 2. Review of "QUALITY ASSURANCE PROFICIENCY TESTING PATHOLOGY" record dated 08/24/2018 included review for Case #PHD18-3803. The record stated, "Enclosed is a case randomly selected from biopsy case diagnosed during the month of August. I am requesting your professional evaluation to verify diagnosis made by my in-house pathologist as well as the quality of work performed by my lab personnel." Slides (#1, 2, 3, 4) were sent to an outside pathologist for review and included the pathologist documentation of "Diagnosis: Negative/agree..." and at the bottom of the record the comment "Agree with results: Yes" was circled. This included the outside pathologist signature/date (08/30/2018) and above it included the Chief Operating Officer's (COO) signature/date (08/24/2018) ("Dr" beneath the signature was crossed out). This record did not include the laboratory 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 -- director's signature, who is responsible for the QA program [CFR 493.1445(e)(5)] and was the "in-house" pathologist (who was also the technical supervisor, general supervisor and testing person). Note: The COO was not listed on the CMS 209, was not the "in-house" pathologist who made the diagnosis and the COO does not have pathologist credentials. 3. During an interview on 09/04/2018 at 10:55 am, Testing Person - 2 was asked about the process for submitting the slides to an outside pathologist (for QA/PT), she stated, "The slides are submitted to Dr (name), sent with the diagnosis and will document if there is agreement." The laboratory did not ensure slides without the diagnosis (answer to slides) were submitted to ensure verification of accuracy of all histopathology processes performed. D5781

Summary Statement of Deficiencies D0000 Based on the onsite survey conducted 01/09/2018 and review of additional documents provided by drop-off and electronic mail on 01/11/2018, this facility was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493.1219 Histopathology 493.1240 Preanalytic systems 493.1441 Laboratory Director High Complexity 493.1497 Testing Personnel The laboratory's failure to be in compliance with these regulations was found to pose IMMEDIATE JEOPARDY to the patients served by the laboratory. The Chief Operating Officer was informed at the exit conference on 01/09/2018 that the survey results were being sent to CMS Regional Office for evaluation and review, and that the CMS 2567 survey report would be sent by the CMS Regional Office. 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 review of the laboratory's procedure manual, H&E (hematoxylin & eosin) stain worksheets, quality control logs, manufacturer's instructions, temperature charts, test requisitions, receipt logs, special stains quality control sheets, and histology daily quality control logs, the laboratory failed to meet the requirements for the specialty of histopathology, as evidenced by: 1. The laboratory failed to implement a written procedure for the GMS (Grocott's Methenamine Silver) special stain. Refer to D5403, I. 2. The laboratory failed to implement a written procedure that defined the intended reactivity of the H&E stain to ensure predictable characteristics. Refer to D5403, II. 3. The laboratory failed to implement written procedures for the specimen type accepted and processed. Refer to D5403, III. 4. The laboratory failed to define the room Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 32 -- temperature range in accordance with manufacturer's storage requirements; and failed to ensure reagents were stored in accordance with manufacturer's storage requirements for days documented. Refer to D5413, I. 5. The laboratory failed to ensure reagents and solutions were stored in accordance with manufacturer's requirements. Refer to D5413, II. 6. The laboratory failed to have a mechanism in place to monitor the storage conditions of reagents stored in the refrigerator. Refer to D5413, III. 7. The laboratory failed to document room and refrigerator temperatures in which reagents were stored with condition requirements. Refer to D5413, IV. 8. The laboratory failed to document the storage room temperature in which patient samples were stored. Refer to D5413, V. 9. The laboratory failed to ensure the defined temperature range on precision oven charts reflected the range in their own written policy; and failed to ensure the precision oven temperatures were within the range in their policy. Refer to D5413, VI. 10. The laboratory failed to ensure reagents did not exceed their expiration date. Refer D5417. 11. The laboratory failed to perform and document maintenance for the Tissue Processor at the frequency defined in the logs. Refer to D5429, I. 12. The laboratory failed to perform and document microscope maintenance in 2017. Refer to D5429, II. 13. The laboratory failed to document H&E intended reactivity to ensure predictable staining characteristics each day of use. Refer to D5473. 14. The laboratory failed to document the reactions of control slides with PAS (Periodic Acid Schiff) and GMS (Grocott's Methenamine Silver) stains. Refer to D5601. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's procedure manual, patient requisitions, final test reports, and receipt log, the laboratory failed to meet the requirements for preanalytic systems, as evidenced by: 1. The laboratory failed to ensure patient test requisitions solicited the name and address of the authorized person requesting the test for patients. Refer to D5305. 2. The laboratory failed to establish written policies for storage, stability and preservation requirements for the specimen type (toenails) accepted and processed. Refer to D5311, I. 3. The laboratory failed to ensure specimen containers were labeled with the patient's name or a unique patient identifier to ensure integrity for specimens. Refer to D5311, II. 4. The laboratory failed to ensure clients followed instructions for filling out all patient and insurance information, as required by their policy for patients. Refer to D5311, III. 5. The laboratory failed to follow their own written policy for labeling patient slides with all components for patients. Refer to D5311, IV. 6. The laboratory failed to document the time 2,087 patient specimens were received into the laboratory for processing and testing. Refer to D5313. 7. The laboratory failed to ensure complete written instructions were available to clients sending specimens for testing. Refer to D5317. D5305 TEST REQUEST CFR(s): 493.1241(c) -- 2 of 32 -- 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 direct observation, review of the laboratory's procedure manual, patient requisitions, and confirmed in interview, the laboratory failed to ensure patient test requisitions solicited the name and address of the authorized person requesting the test for 11 out of 20 patients in 2017 and 2018 (random sampling from 09/2017, 12/2017 and 01/2018). Findings included: 1. Review of the laboratory's procedure manual included a "Specimen Receiving" policy and stated, "4. Then each patient's biopsy bottle and requisitions are QA to assure that each label affixed matches the requisition and that the following information is correct: a. patient name, b. patient account number, c. patient sex, d. patient date of birth, e. patient biopsy site, f. patient accession number." The procedure did not include ensuring the test requisition solicited the name and address of the authorized person requesting the test. 2. During a tour of the facility on 01/09/2018 at 4:50 pm, the COO provided UPS (united parcel service) bags of specimens that were being held for testing. The requisitions of the following patient specimens observed did not include the name and address of the authorized person requesting the test (this was a random sampling): UPS bag #1 - Patient #2 requisition collection date was 09/12/17 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09 /20/2017. Patient #3 requisition collection date was 09/13/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. Patient #5 requisition collection date was 09/18/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. UPS bag #2 - Patient #6 requisition collection date was 12/21/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #7 requisition collection date was 12/20/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #8 requisition collection date was 12/15/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #10 requisition collection date was 01/03/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #12 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #13 requisition -- 3 of 32 -- collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #14 requisition collection date was 01/03/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #17 requisition collection date was 01/03/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Received dates for the above mentioned specimens in UPS bag #2 were not documented in the receipt log. All requisitions for patients mentioned above (UPS bag #1 and #2) included a section "Ordering Physician" and were all blank. During an interview on 01 /09/2018 at 4:55 pm, the COO (chief operating officer) was asked how the laboratory knew the name of the authorized person ordering the above tests, she stated, "By the signature (physician) on the requisition." The laboratory did not ensure the requisitions solicited the name and address of the authorized person ordering the tests, as required. Word Key: PAS - Periodic Acid Schiff GMS - Grocott's Methenamine Silver H&E - Haematoxylin & Eosin 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: I. Based on direct observation, review of laboratory's procedure manual, patient requisitions, final test reports, receipt log and confirmed in interview, the laboratory failed to establish written policies for storage, stability and preservation requirements for the specimen type (toenails) accepted and processed. Findings included: 1. Review of the laboratory's procedure manual included a "Specimen Receiving" policy and stated, "The biopsies are submitted in 10% formalin fixative specimen bottles." Review of the policy distributed to clients stated, "Place biopsy inside pre-filled 10% NBF bottles with patient's name, date, location, for specimen preservation." The laboratory received and processed toenails that were not submitted in formalin. The procedure was not applicable to the specimen type. The laboratory did not establish written policies of toenail storage, preservation, acceptability, rejection, and processing. During an interview on 01/09/2018 at 4:50 pm, the Chief Operating Officer (COO) confirmed the 10% formalin policy was not applicable to the toenails received. Procedures applicable to the toenails were not provided. 2. Review of patient requisitions, final test reports, and receipt log from 04/2017 and 06/2017 revealed the laboratory received, processed and reported patient specimens/results without established written policies of specimen handling: Requisition for Patient #PHD17-01712 collection date was 06/19/2017; receipt log for the patient included received date 06/27/2017; the final test report included collection date 06/19/2017, received date 12/20/2017 and report date was 12/29/2017 at 1:36 pm. Requisition for Patient #PHD17-01479 collection date was 04/12/2017; receipt log for the patient included received date 04/17/2017; final test report included collection date 04/12 /2017, received date 12/20/2017 and report date was 01/02/2018 at 10:12 pm. Requisition for Patient #PHD17-01366 collection date was 06/22/2017; receipt log for -- 4 of 32 -- the patient included received date 06/23/2017; final report included collection date 06 /22/2017, received date 12/202/107 and report date was 01/02/2018 at 9:39 pm. Requisition for Patient #PHD17-01474 collection date was 04/10/2017; receipt log for the patient included received date 04/17/2017; final report included collection date 04 /10/2017, received date 12/20/2017 and report date was 01/02/2018 at 10:08 pm. PAS, GMS and H&E stains were used for above patient specimens. During an interview on 01/09/2018 at 4:50 pm, the COO was asked about the specimens collected from 04 /2017 and 06/2017 and processing occurring in 12/2017, she stated, "The specimens were still being received even though we were not testing. We held on to the specimens until we were able to test. Doctors (clients) were notified that the toenails would be processed later due to no testing. They were held in their UPS bags and we document the received date in a spreadsheet. We had specimens from 04/2017 through 12/2017. Right now we are processing 08/2017 specimens." During an interview on 01/09/2018 at 4:50 pm, the COO was asked if there was documentation of notifying their clients of the delay in testing, she stated, "No, I went to them in person and let them know and they said that was ok." During an interview on 01/09 /2018 at 4:50 pm, the COO was asked if the laboratory had established written policies defining the storage, stability, handling and inclusion of pertinent clinical literature references of the toenails, she stated, "No." The laboratory did not have written established policies and procedures of the toenail preanalytical requirements to ensure integrity of the specimens from the time of collection to report date. 3. During a tour of the facility on 01/09/2018 at 4:50 pm, the COO provided UPS (united parcel service) bags of the following specimens that were being held for testing (this was a random sampling): UPS bag #1 - Patient #1 requisition collection date was 09/12/17 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. Patient #2 requisition collection date was 09/12/17 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. Patient #3 requisition collection date was 09/13/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. Patient #4 requisition collection date was 09/12/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. Patient #5 requisition collection date was 09/18/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. The specimen containers mentioned above were not labeled with a patient name or a unique patient identifier, as required. Patient requisitions mentioned above included "Precise Diagnostics" on the top part of the page and at the bottom "Precise Diagnostics 1510 Randolph St. #603, Carrollton, TX 75006, Phone: (214) 619-5632, Fax: (888) 548-2767." (Precise Diagnostics is the sister laboratory of Pro Health Diagnostics) UPS bag #2 - Patient #6 requisition collection date was 12/21/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #7 requisition collection date was 12/20/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #8 requisition collection date was 12/15/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #9 requisition collection date was 12/15/2017 and order was for PAS and GMS stain. The biohazard bag contained -- 5 of 32 -- 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #10 requisition collection date was 01/03/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #11 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #12 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #13 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #14 requisition collection date was 01/03/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #15 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #16 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #17 requisition collection date was 01/03/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #18 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #19 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #20 requisition collection date was 01/03/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The specimen containers mentioned above were not labeled with a patient name or a unique patient identifier, as required and received dates were not documented in the receipt log. Patient requisitions mentioned above included "Precise Diagnostics" on top part of page and at the bottom "Precise Diagnostics 1510 Randolph St. #603, Carrollton, TX 75006, Phone: (214) 619-5632, Fax: (888) 548- 2767." (Precise Diagnostics is the sister laboratory of Pro Health Diagnostics) During an interview on 01/09/2018 at 4:55 pm, the COO was asked why there was a different laboratory name (Precise Diagnostics) on the patient requisitions, she stated, "Precise is not testing at this time, so the specimens are sent here and we are processing and testing the specimens." 4. Review of the receipt log revealed the laboratory had received 2,087 patient specimens from 04/03/2017 through 12/20/2017. Note: The laboratory had ceased testing on 02/13/2017 and began testing 11/17/2017. Specimens continued to be received and held until testing began. Word Key: PAS - Periodic Acid Schiff GMS - Grocott's Methenamine Silver H&E - Haematoxylin & Eosin II. Based on direct observation, review of the laboratory's policies, requisitions, and confirmed in interview, the laboratory failed to ensure specimen containers were labeled with the patient's name or a unique patient identifier to ensure integrity for 20 of 20 specimens collected in 09/2017, 12/2017 and 01/2018. Findings included: 1. Review of the laboratory's procedure manual included a "Specimen Receiving" policy and stated, "5. The person receiving the specimen verifies that the specimen is indeed inside the container and that the patient's name, date of birth and biopsy site is written clearly on the bottle. 6. The name on the bottle is compared to the name on the patient requisition. The requisition must be completely and accurately filled out." Review of the "Requirement for Specimen Collection to all offices" for clients stated, "Place patient biopsy inside pre-filled 10% NBF bottles with patient's name, date, location, for specimen preservation." 2. During a tour of the facility on 01/09/2018 at 4:50 pm, -- 6 of 32 -- the COO provided UPS (united parcel service) bags of the following specimens that were being held for testing and containers were not labeled with the patient's name or a unique patient identifier (this was a random sampling): UPS bag #1 - Patient #1 requisition collection date was 09/12/17 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. Patient #2 requisition collection date was 09/12/17 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09 /20/2017. Patient #3 requisition collection date was 09/13/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. Patient #4 requisition collection date was 09/12/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. Patient #5 requisition collection date was 09/18/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. UPS bag #2 - Patient #6 requisition collection date was 12/21/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #7 requisition collection date was 12/20/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #8 requisition collection date was 12/15/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #9 requisition collection date was 12/15/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #10 requisition collection date was 01/03/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #11 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #12 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #13 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #14 requisition collection date was 01/03/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #15 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #16 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #17 requisition collection date was 01/03/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #18 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #19 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Patient #20 requisition collection date was 01/03/2018 and -- 7 of 32 -- order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The date and time of receipt into the laboratory for the specimens mentioned above was not documented. 3. During an interview on 01/09/2018 at 4:55 pm, the COO (chief operating officer) confirmed the above findings. Word Key: PAS - Periodic Acid Schiff GMS - Grocott's Methenamine Silver H&E - Haematoxylin & Eosin III. Based on direct observation, review of the laboratory's procedure manual, patient requisitions, and confirmed in interview, the laboratory failed to ensure clients followed instructions for filling out all patient and insurance information, as required by their policy for 24 of 24 patients from 04/2017. 06/2017, 09/2017, 12/2017 and 01/2018. Findings included: 1. Review of the laboratory's procedure manual included a "Specimen Receiving" policy and stated, "4. Then each patient's biopsy bottle and requisitions are QA to assure that each label affixed matches the requisition and that the following information is correct: a. patient name, b. patient account number, c. patient sex, d. patient date of birth, e. patient biopsy site, f. patient accession number." Review of the "Requirement for Specimen Collection to all offices" for clients stated, "1. Fill out patient requisition form with all patient and insurance information." 2. Review of patient requisitions, final test reports, and receipt log from 04/2017 through 06/2017 revealed the laboratory received, processed and reported patient specimens/results without ensuring all patient and insurance information was filled out on requisitions: Requisition for Patient #PHD17-01712 collection date was 06/19/2017; receipt log for the patient included received date 06/27/2017; the final test report included collection date 06/19/2017, received date 12/20/2017 and report date was 12/29/2017 at 1:36 pm. The requisition included a "Patient Information" section and street address, city, state, zip were blank. "Billing Information" section that was blank. Requisition for Patient #PHD17-01479 collection date was 04/12/2017; receipt log for the patient included received date 04/17/2017; final test report included collection date 04/12 /2017, received date 12/20/2017 and report date was 01/02/2018 at 10:12 pm. The requisition included a "Patient Information" section and street address, city, state, zip were blank. "Billing Information" section that was blank. Requisition for Patient #PHD17-01366 collection date was 06/22/2017; receipt log for the patient included received date 06/23/2017; final report included collection date 06/22/2017, received date 12/202/107 and report date was 01/02/2018 at 9:39 pm. The requisition included a "Patient Information" section and street address, city, state, zip were blank. "Billing Information" section that was blank. Requisition for Patient #PHD17-01474 collection date was 04/10/2017; receipt log for the patient included received date 04/17/2017; final report included collection date 04/10/2017, received date 12/20/2017 and report date was 01/02/2018 at 10:08 pm. The requisition included a "Patient Information" section and street address, city, state, zip were blank. "Billing Information" section that was blank. During a tour of the facility on 01/09/2018 at 4:50 pm, the COO provided UPS (united parcel service) bags of the following specimens that were being held for testing (this was a random sampling): UPS bag #1 - Patient #1 requisition collection date was 09/12/17 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #2 requisition collection date was 09/12/17 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #3 requisition collection date -- 8 of 32 -- was 09/13/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #4 requisition collection date was 09/12/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #5 requisition collection date was 09/18/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. Receipt log for the patient included received date was 09/20/2017. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. UPS bag #2 - Patient #6 requisition collection date was 12/21/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #7 requisition collection date was 12/20/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #8 requisition collection date was 12/15/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #9 requisition collection date was 12/15/2017 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #10 requisition collection date was 01/03/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #11 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #12 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #13 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #14 requisition collection date was 01/03/2018 and order was for PAS and GMS stain. The biohazard -- 9 of 32 -- bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #15 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #16 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #17 requisition collection date was 01/03/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #18 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #19 requisition collection date was 01/02/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. Patient #20 requisition collection date was 01/03/2018 and order was for PAS and GMS stain. The biohazard bag contained 4 small plastic containers (no preservatives) that each had a piece of toenail. The requisition included a "Patient Information" section and social security, phone number, street address, city, state, zip were blank. "Billing Information" section that was blank. 3. During an interview on 01/09/2018 at 4:55 pm, the COO (chief operating officer) confirmed the above findings. Word Key: PAS - Periodic Acid Schiff GMS - Grocott's Methenamine Silver H&E - Haematoxylin & Eosin IV. Based on direct observation, review of the laboratory's policy, and confirmed in interview, the laboratory failed to follow their own written policy for labeling patient slides with all components for 13 of 13 patients in 2017. Findings included: 1. Review of the laboratory's policy "Slide Preparation" stated, "Slides are labeled as follows: Patient's accession number across the very top of the white portion of the slide at the end of the accession number the site letter is to be written, directly underneath the patients last name is to be written and finally the name of the stain being done is to be written on the far right bottom corner of the white portion of the slide with a slide labeler or labeling marker." 2. During a tour of the laboratory on 01/09/2018 at 3:44 pm, the following labeled patient slides were observed: Last name was not included - PHD17- 2330 A GMS PHD17-2330 B GMS PHD17-2330 C GMS PHD17-2330 D GMS PHD17-2328 D GMS PHD17-2329 A GMS PHD17-2329 B GMS PHD17-2331 A GMS PHD17-2331 B GMS PHD17-2324 A GMS PHD17-2324 B GMS PHD17-2325 A GMS PHD17-2325 B GMS PHD17-2325 C GMS PHD17-2325 D GMS PHD17- 2327 A GMS PHD17-2327 B GMS PHD17-2328 A GMS PHD17-2328 C GMS PHD17-1675 B PAS PHD17-1653 A PAS Stain and last name was not included - PHD17-1650 A PHD17-1651 B PHD17-1652 B The laboratory did not follow their own written policy for labeling patient slides. 3. During an interview on 01/09/2018 at 4:50 pm, the Chief Operating Officer confirmed the above findings. Word Key: PAS - Periodic Acid Schiff GMS - Grocott's Methenamine Silver -- 10 of 32 -- D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on review of patient specimen receipt log, final test reports, and confirmed in interview, the laboratory failed to document the time 2,087 patient specimens were received into the laboratory for processing and testing from 04/03/2017 through 12/20 /2017. Findings included: 1. The laboratory provided the patient specimen receipt log via electronic mail on 01/10/2018 and final test reports via drop-off on 01/12/2018. Review of the receipt log revealed the laboratory had received 2,087 patient specimens from 04/03/2017 through 12/20/2017 and had not documented the receipt time. The following is a random sampling of patients from the receipt log and their corresponding final test reports: Specimens collected 03/2017 - Receipt log for Patient #PHD17-01213 included a documented received date of 04/05/2017; the final patient test report received date was 12/18/2017. Receipt log for Patient #PHD17-01272 included a documented received date of 04/11/2017; the final patient test report received date was 12/18/2017. Receipt log for Patient #PHD17-01104 included a documented received date of 04/24/2017; the final patient test report received date was 12/18/2017. Receipt log for Patient #PHD17-01249 included a documented received date of 04/05/2017; the final patient test report received date was 12/18 /2017. Receipt log for Patient #PHD17-01229 included a documented received date of 04/15/2017; the final patient test report received date was 12/18/2017. Specimens collected 04/2017 - Receipt log for Patient #PHD17-01511 included a documented received date of 05/25/2017; the final patient test report received date was 12/20 /2017. Receipt log for Patient #PHD17-01483 included a documented received date of 04/17/2017; the final patient test report received date was 12/20/2017. Receipt log for Patient #PHD17-01596 included a documented received date of 05/25/2017; the final patient test report received date was 12/20/2017. Receipt log for Patient #PHD17- 01505 included a documented received date of 04/17/2017; the final patient test report received date was 12/20/2017. Receipt log for Patient #PHD17-01639 included a documented received date of 04/20/2017; the final patient test report received date was 12/20/2017. Specimens collected 05/2017 - Receipt log for Patient #PHD17- 01336 included a documented received date of 05/22/2017; the final patient test report received date was 12/20/2017. Receipt log for Patient #PHD17-01563 included a documented received date of 05/09/2017; the final patient test report received date was 12/20/2017. Receipt log for Patient #PHD17-01657 included a documented received date of 05/09/2017; the final patient test report received date was 12/20 /2017. Receipt log for Patient #PHD17-01703 included a documented received date of 06/05/2017; the final patient test report received date was 12/20/2017. Receipt log for Patient #PHD17-01655 included a documented received date of 05/09/2017; the final patient test report received date was 12/20/2017. Specimens collected 06/2017 - Receipt log for Patient #PHD17-02047 included a documented received date of 06/27 /2017; the final patient test report received date was 01/05/2018. Receipt log for Patient #PHD17-01875 included a documented received date of 07/03/2017; the final patient test report received date was 01/03/2018. Receipt log for Patient #PHD17- 01358 included a documented received date of 06/07/2017; the final patient test report received date was 12/20/2017. Receipt log for Patient #PHD17-01378 included a documented received date of 06/29/2017; the final patient test report received date was 12/20/2017. Receipt log for Patient #PHD17-02058 included a documented received date of 06/27/2017; the final patient test report received date was 01/05 -- 11 of 32 -- /2018. Specimens collected 07/2017 - Receipt log for Patient #PHD17-01831 included a documented received date of 07/12/2017; the final patient test report received date was 01/03/2018. Receipt log for Patient #PHD17-02286 included a documented received date of 08/03/2017; the final patient test report received date was 01/03 /2018. Receipt log for Patient #PHD17-02289 included a documented received date of 08/03/2017; the final patient test report received date was 01/03/2018. Receipt log for Patient #PHD17-02294 included a documented received date of 08/03/2017; the final patient test report received date was 01/03/2018. Receipt log for Patient #PHD17- 01847 included a documented received date of 07/12/2017; the final patient test report received date was 01/03/2018. PAS, GMS and H&E stains were used for above patient specimens. The laboratory failed to ensure the actual received date was transcribed accurately to the final test reports. Refer to D5801. 3. During an interview on 01/09/2018 at 4:50 pm, the COO (chief operating officer) had confirmed the laboratory documented the received date for specimens in a spreadsheet. The laboratory did not document the time. Word Key: PAS - Periodic Acid Schiff GMS - Grocott's Methenamine Silver H&E - Haematoxylin & Eosin D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory's procedure manual, patient test requisitions, final test reports and confirmed in interview, the laboratory failed to ensure complete written instructions were available to clients sending specimens for testing. Findings included: 1. Review of the laboratory's procedure manual included a "Requirement for Specimen Collection to all offices" and did not include the following components: a) Specimen storage and preservation for toenails b) Conditions for specimen transportation c) Specimen processing d) Specimen acceptability and rejection e) Specimen referral 2. Review of the "Requirement for Specimen Collection to all offices"policy distributed to clients stated, "Place biopsy inside pre-filled 10% NBF bottles with patient's name, date, location, for specimen preservation." The laboratory received and processed toenails that were not submitted in formalin. The procedure was not applicable to the specimen type. The laboratory did not provide a client services manual that was applicable to the specimen type received. During an interview on 01/09/2018 at 4:50 pm, the Chief Operating Officer (COO) confirmed the 10% formalin policy was not applicable to the toenails received. Procedures applicable to the toenails were not provided. 3. Review of patient requisitions, final test reports, and receipt log from 04/2017 and 06/2017 revealed the laboratory received, processed and reported patient specimens/results: Requisition for Patient #PHD17-01712 collection date was 06/19/2017; receipt log for the patient included received date 06/27/2017; the final test report included collection date 06/19 /2017, received date 12/20/2017 and report date was 12/29/2017 at 1:36 pm. . Requisition for Patient #PHD17-01479 collection date was 04/12/2017; receipt log for the patient included received date 04/17/2017; final test report included collection date 04/12/2017, received date 12/20/2017 and report date was 01/02/2018 at 10:12 pm. Requisition for Patient #PHD17-01366 collection date was 06/22/2017; receipt log for the patient included received date 06/23/2017; final report included collection date 06/22/2017, received date 12/202/107 and report date was 01/02/2018 at 9:39 -- 12 of 32 -- pm. Requisition for Patient #PHD17-01474 collection date was 04/10/2017; receipt log for the patient included received date 04/17/2017; final report included collection date 04/10/2017, received date 12/20/2017 and report date was 01/02/2018 at 10:08 pm. PAS, GMS and H&E stains were used for above patient specimens. The laboratory did not provide their clients with a services manual that included specimen storage and preservation for toenails and specimen acceptability and rejection. During an interview on 01/09/2018 at 4:50 pm, the COO was asked about the specimens collected from 04/2017 and 06/2017 and processing occurring in 12/2017, she stated, "The specimens were still being received even though we were not testing. We held on to the specimens until we were able to test. Doctors (clients) were notified that the toenails would be processed later due to no testing. They were held in their UPS bags and we document the received date in a spreadsheet. We had specimens from 04/2017 through 12/2017. Right now we are processing 08/2017 specimens." The laboratory did not have written established policies and procedures of the toenail preanalytical requirements to ensure integrity of the specimens from the time of collection to report date. Refer to D5311, I. 4. During a tour of the facility on 01/09/2018 at 4:50 pm, the COO provided UPS (united parcel service) bags of the following specimens with requisitions that were being held for testing (this was a random sampling) (Refer to D5311, I, II): UPS bag #1 contained patient toenails in plastic containers in biohazard bags. There was a total of 5 patient specimens and the containers were not labeled with the patient's name or