Hospitals Of Providence Transmountain Campus, The

Summary Statement of Deficiencies D0000 Based upon findings made during an onsite validation survey completed December 7, 2023 the laboratory failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493. 1250 Condition: Analytic Systems: 493. 1403 Condition: Laboratories performing moderate complexity testing; laboratory director: 493. 1409 Condition: Laboratories performing moderate complexity testing; technical consultant: 493. 1421 Condition: Laboratories performing Moderate Complexity Testing; testing personnel: D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of laboratory policy, manufacturer instructions for use (IFU), laboratory quality control (QC) records, laboratory worksheets, and confirmed in interview, the laboratory failed to retain the "Spinalscopics Spinal Fluid Cell Count Control/Level 1 & 2" IFU's for the lot-specific QC acceptability criteria for level one and level two body fluid (BF) QC from January 2022 to October 2023. The findings included: 1. Policy titled "Record Retention Policy" included the following information: "Type of Record/Material - Retention Period Quality control records - 2 years (5 years for transfusion medicine)" 2. Review of laboratory policy titled "Body Fluid Analysis", section IV. "Quality Control" stated the following: "A. One level of control is counted in duplicate per 8 hour shift. The level of control used depends on the shift: 1st shift - Level I 2nd and 3rd shift - level II B. ... If results are out of limits, re-mix and load a new Hemocytometer. If expected results are still out of range, open a new vial and start over." 3. Review of the "Spinalscopics Spinal Fluid Cell Count 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 -- Control/Level 1 & 2", section "Limitations" had the following statement: "Any future changes made by the manufacturer of a test system may give different values from the indicated range." 4. Review of the laboratory worksheet titled "Body Fluid Hemocytometer Counts" did not include record of the quality control lot numbers in use on day of testing or the expected acceptability range. The surveyor asked about the acceptable expected ranges for the cell count control. The technical consultant (TC) 1 stated the laboratory used the expected range on the back of the "Spinalscopics Spinal Fluid Cell Count Control/Level 1 & 2" instructions for use. Surveyor queried for the 2022 to October 2023 IFUs, to assess the QC acceptability, and none was provided. 5. In an interview on 12/5/2023 at 14:15, in the conference room, TC 1 stated that the laboratory did not retain the "Spinalscopics Spinal Fluid Cell Count Control/Level 1 & 2", from January 2022 to October 2023. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratories policies and procedures, quality control records, patient test records, and interview of facility personnel, the laboratory failed to meet the applicable analytic systems requirements for Bacteriology, Cytology and Hematology in 2022 and 2023. The laboratory failed to ensure expired media was not used for patient testing in Bacteriology. (See D5417) The laboratory failed to test quality control materials each day of patient testing when using the ImmunoCardSTAT Mono Test. (See D5449) The laboratory failed to test at least one level of quality control each 8 hours when performing manual cell counts using a hemacytometer. (See D5543) The laboratory failed to test quality control materials each time patient specimens were tested using the Stago FDP Plasma kit. (See D5547) The technical Supervisor for Cytology failed to establish a maximum workload limit for five of five testing personnel performing primary screening of Cytology specimens. (See D5633) 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's policies/procedures, random patient sample processing and equipment decontamination logs for 2023, and staff interview, the laboratory failed to document performance of 2 of 4 histology procedures to prevent cross-contamination between cases, as per its own protocols, in 11 months reviewed -- 2 of 15 -- from January to November 2023. Findings included: 1. Review of laboratory procedure "Quality Management Plan" (document PH:01, last reviewed 05/01/2023) revealed: "Prevention of Cross-Contamination ANP.11680 ... ii. The pathologist will clean their forceps and scalpel blades by wiping or rinsing between each case in addition to cleaning their cutting surfaces between each case. ... iv. Cryostat blades will be discarded after use per case." 2. Review of random patient sample processing and equipment decontamination logs for 2023 revealed the laboratory did not have documentation of equipment and cutting surface cleaning or Cryostat blade replacement between cases. 3. In an interview on 12/06/2023 at 1510 hours in the laboratory's conference room, the facility's Testing Person number 2 (as indicated on submitted Form CMS 209), confirmed the laboratory did not document cleaning of cutting instruments/surfaces or Cryostat blade replacement. 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 a review of manufacturer's instructions, laboratory documents, and confirmed in interview, the laboratory failed to ensure the selection of normal results were obtained from normal patients used in lot rollover studies for the mean normal patient (MNPT) results for the new lot Innovin Protime (PT) reagents put in use on 3 /12/2023 for two of two analyzers used in coagulation testing: the Sysmex CA660 and the Sysmex CS2500. The findings included: 1. In a tour of the laboratory on 12/5 /2023 at 09:20 hours the hematology department had the following two analyzers in use for coagulation (coag) testing: CA660 - SN13437 CS2500 - SN21437 2. Review of the Sysmex CS2500 System "Installation Guide", section XV "Lot Roll Over Procedure", subsection "Verification of Reference Range" stated the following: "- 20 Normal Individuals - 10 males and 10 females representing reference population. 20 is the minimum requirement for a statistically valid study ... Note: Assess medication history. After review of data, history may be used for excluding aberrant results. - Calculate mean and 2 SD range. - MNPT for INR calculation must be the geometric mean." 3. Review of the Sysmex CA660 Series "Installation Guide", section XIV "Reagent Lot Roll-Over Studies", subsection I "Verification of Reference Range" stated the following: "A. 20 Normal Individuals - 10 males; 10 females spanning age range. 20 is the minimum requirement for a statistically valid study. ... - Note medication history. After review of data, history may be used for excluding questionable results that can be attributed to medications. ... C. Calculate mean and 2 SD range. D. MNPT for INR calculation must be the geometric mean." 4. Review of the laboratory lot rollover documents for the new Innovin PT reagent (Lot#549795, exp 4/29/2024), put in use 3/16/2023 on the Sysmex CS-2500 and the CA-660, did not include the evaluation of patient medication history. In an interview on 12/6/2023 at 11:30 hours, in the hallway, the technical consultant (TC)1 stated the laboratory used normal results for the study and that an evaluation of patient medication history, or health, was not used as a criterion for determining inclusion in the lot rollover MNPT studies. 5. In an interview on 12/6/2023 at 12:00 hours, in the conference room, the -- 3 of 15 -- technical consultant (TC) 1 and the administrative director stated a patient evaluation was not performed to demonstrate that the results obtained for the lot rollover studies were from normal patients. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of manufacturer operating specifications for the Cryostat and microscope instruments in use in the Histology/Cytology department, review of random Histology/Cytology environment monitoring logs for 2023, laboratory test volumes and staff interview, the laboratory failed to document monitoring of room humidity and/or temperature for 3 of 3 rooms where the Cryostat and/or microscope instruments were in use, in 11 months reviewed from January to November 2023. Findings included: 1. Review of manufacturer operating specifications for the Tissue Tek Cryo3 Flex Cryostat (document 0007662-01 Rev. B, revised 25 July 2016) revealed: "Operating Environment: Temperature: 15C [Degrees Celsius] ... to 35C ... Relative Humidity: 30-85%[percent] (non-condensing)" 2. Review of manufacturer operating specifications for the Carl Zeiss Microscope (document Axio Vert. A1) revealed: "Operation: Permissible ambient temperature ... ... ... +5 C to +40 C Maximum permissible humidity ... ... ... .... 75%" 3. Review of random Histology /Cytology environment monitoring logs for 2023 revealed there was no documentation of humidity and/or temperature monitoring for the following rooms where the Cryostat and/or microscope instruments were in use: a. Frozen Room: There was no documentation of humidity monitoring. Frozen Room Equipment: Carl Zeiss Microscope serial number (SN):3135010037 Tissue Tek Cryo3 Flex Cryostat SN: 62010117-0916 b. Pathologist's Office (Room 1): There was no documentation of humidity or temperature monitoring. Room 1 Equipment: "Double headed" Carl Zeiss microscope Serial Number (SN) 3321010047 c. Pathologist's Office (Room 2): There was no documentation of humidity or temperature monitoring. Room 2 Equipment: "Double headed" Carl Zeiss microscope SN 3321003816 "Single headed" Carl Zeiss microscope SN 3135010041 4. Review of laboratory's submitted test volumes revealed the laboratory performed 20,033 histology/cytology examinations annually. 5. In an interview on 12/06/2023 at 1620 hours in the laboratory's conference room the facility's Histology Supervisor (as indicated on submitted Survey Entrance/Exit documents), confirmed the laboratory did not monitor temperature and/or humidity in Frozen section room or pathologists' offices. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. -- 4 of 15 -- This STANDARD is not met as evidenced by: A. Based on surveyor's observations and staff interview, the laboratory failed to ensure expired media was not used in processing samples for two of two microbiology cultures observed requiring liquid Remel THIO (Thioglycolate) media, wound and body fluid cultures. Findings included: 1. Surveyor's observations on 12/06/2023 at 1405 hours in the laboratory revealed the following two patient samples inoculated in expired liquid THIO media incubating in the microbiology 35C (Degrees Celsius) aerobic incubator: Sample:320-MB-23-019854 Patient MRN (Medical Record Number): 5110744 Culture: Wound Collected: 12/06/2023 Inoculated THIO broth lot number: 715713 Inoculated THIO broth expiration date: 2023-10-03 Sample:320-MB- 23-019789 Patient MRN:5138879 Culture: Body Fluid Collected: 12/06/2023 Inoculated THIO broth Lot number: 715713 Inoculated THIO broth expiration date: 2023-10-03 2. In an interview on 12/06/2023 at 1405 hours in the laboratory, the facility's Testing Person number 2 (as indicated on submitted Form CMS 209), after viewing the patient's inoculated samples, confirmed the findings. B. Based on surveyor's observations and staff interview, the laboratory failed to ensure four of four bottles of expired Cytoseal 60 reagent were not used in cytological and histological preparations from October through December 6, 2023. Findings included: 1. Surveyor's observations on 12/06/2023 at 1457 hours in the laboratory revealed four bottles of expired Cytoseal 60 reagent in the Grossing Room's flammables' cabinet. Lot number: 111800 Expiration date: 09/2023 2. In an interview on 12/06/2023 at 1500 hours in the laboratory the facility's Testing Person number 8 (as indicated on submitted Form CMS 209), when asked, stated the laboratory used the expired Cytoseal 60 in slide preparations for approximately 80-90 histology/cytology cases since September 2023. He also stated that no other unexpired Cytoseal 60 reagent was available for use in the laboratory. 3. In an interview on 12/06/2023 at 1505 hours in the laboratory, the facility's Histology Supervisor (as indicated on submitted Survey Entrance/Exit documents), confirmed the 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: A. Based on review of laboratory's stain maintenance protocols, random stain reagent maintenance records for 2022 and 2023 and staff interview, the laboratory failed to follow its own protocols for documenting weekly and daily stain reagent change for two of two stains, Hematoxylin and Eosin (H&E) and Diff Quick stains, used in histology and cytology departments in 2022 and 2023. Findings included: 1. Review of laboratory's stain maintenance protocol/log "H&E STAIN LINE_FROZEN ROOM" (Version 2021A) revealed: "Stain line is changed weekly when in use. Water is changed daily after each use." And: "Changed CH Rotated R Filtered F Checked V (check mark)" 2. Review of laboratory's stain maintenance protocol/log "DIFF -- 5 of 15 -- QUICK STAIN" (Version 2021 A) revealed: "Stain line is changed weekly at minimum. Water is changed daily after each use." And: "Changed CH Rotated R Filtered F Checked V" 3. Review of random stain reagent maintenance records for 2022 and 2023 revealed the following weekly and daily stain reagent changes not being documented: H&E STAIN LINE_FROZEN ROOM January 17-21, 2022: No documentation of stain line weekly change (reagents documented as F or V) No documentation of daily water changes (documented as V) August 15-19, 2022: No documentation of stain line weekly change (reagents documented as F or V) No documentation of daily water changes (documented as V) DIFF QUICK STAIN August 22-26, 2022: No documentation of stain line weekly change (reagents documented as V) No documentation of water daily changes (documented as V) April 10-14, 2023: No documentation of stain line weekly change (reagents documented as V) No documentation of water daily changes (documented as V) 4. In an interview on 12/06/2023 at 1510 hours in the laboratory's conference room, the facility's Histology Supervisor (as indicated on submitted Survey Entrance/Exit documents), confirmed the findings. B. Based on surveyor's observations, review of the manufacturer instructions for use, random microscope maintenance logs for 2023, laboratory's policies/procedures and staff interview, the laboratory failed to document daily maintenance for 3 of 3 pathologists' microscopes used in histologic and cytologic examinations from January to December 2023. Findings included: 1. Surveyor's observations on 12/06/2023 at 1515 hours in Pathologists' offices revealed the following microscopes were being used for histologic and cytologic examinations: Room 1: One "double headed" Carl Zeiss microscope Serial Number (SN) 3321010047 Room 2: One "double headed" Carl Zeiss microscope SN 3321003816 One "single headed" Carl Zeiss microscope SN 3135010041 2. The laboratory was asked for a user manual/instruction for use for the Carl Zeiss microscopes and no such document was available for review prior to survey exit. 3. Review of laboratory's random microscope maintenance logs for 2023 revealed documentation of daily microscope maintenance for the other microscopes used for histologic and cytologic examinations. There was no documentation of daily microscope maintenance for the above microscopes found in Pathologists' offices. 4. Review of laboratory's policy "Instrument and Equipment Maintenance" (document PH:18, last reviewed 05/01 /2023) revealed: "Equipment is assessed daily and corresponding logs filled out to preserve the integrity of the equipment/instrument." 5. In an interview on 12/06/2023 at 1620 hours in the laboratory's conference room, the facility's Histology Supervisor (as indicated on submitted Survey Entrance/Exit documents) confirmed the laboratory did not document daily maintenance for the pathologists' microscopes. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of manufacturer instructions for use, laboratory's policies /procedures, quality control (QC) records for 2023, patient test logs and staff interview, the laboratory failed to document ImmunoCard STAT! Mono Test QC each day of patient testing for six of twenty-four days from February through May 2023. -- 6 of 15 -- Findings included: 1. Review of manufacturer instructions for use for the ImmunoCard STAT Mono Test (document 755725) revealed: "CLIA Complexity: ... Serum or Plasma - Non-waived" And, "External Quality Control ... Quality Control requirements should be established in accordance with local, state, and federal regulations or accreditation requirements." 2. Review of laboratory's policy "Meridian Bioscience ImmunoCard STAT! Mono Test" (document MB 6.8, last reviewed 05/16 /2023) revealed: "External Quality Control Testing Frequency: Two sets of external QC, a positive and a negative control included with the kit are run with each new lot, new shipment, in accordance with the manufacturer, state, local and federal regulations." 3. In an interview on 12/6/2023 at 1330 hours in the laboratory the Testing Person number 2 (as indicated on submitted Form CMS 209) stated the laboratory uses serum for the STAT! Mono Test, making it a non-wiaved test requiring QC each day of testing, and that the laboratory did not perform Individualized Quality Control Plan studies to reduce frequency of QC performance. 4. Review of laboratory's 2023 QC records for the ImmunoCard STAT Mono Test and patient test logs revealed the following six of twenty-four reviewed days patient testing was performed without documentation of QC: Date: Patient tested (MRN): 02 /16/2023 5125011 03/23/2023 5036869 04/04/2023 5038248 04/05/2023 5038247 04 /27/2023 5071684 05/02/2023 5098622 5. In an interview on 12/06/2023 at 1400 hours in the laboratory, the facility's Testing Person number 2 confirmed the findings. Key: MRN = Medical Record Number CMS = Centers for Medicare and Medicaid D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: I. Based on a review of laboratory policy, laboratory quality control records, and patient test results, the laboratory failed to ensure that QC was performed every 8 hours for body fluid cell counts on the C-Chip hemocytometer for nine of nine patients reviewed in random weeks in August, November, December 2022 and February 2023. The findings included: 1. Review of the laboratory policy titled "Body Fluid Analysis", section IV "Quality Control" stated the following: "A. One level of control is counted in duplicate per 8 hour shift." In an interview on 12/16/2023 at 11: 30 hours, in the conference room, the technical consultant (TC) 1 stated that the laboratory did not currently have staff for 8-hour shifts and that testing personnel were staffed in 12-hour shifts. 2. A review of the laboratory worksheets titled "Body Fluid Hemocytometer Counts" for random weeks in August, November, December 2022 and February 2023 had the following four instances where QC elapsed 8 hours: August 2022 8/8/2022 No QC was documented on 8/8/2022 Patient 005114598, performed at 05:55 hours Patient 005114598, performed at 07:15 hours Patient 005004120, performed at 17:00 hours November 2022 11/1/2022 Level 1 QC performed at 11:05 hours Patent 005119128, performed at 20:20 hours, 1 hour 20 minutes lapse of 8 hour QC. December 2022 12/28/2022 Level 1 QC performed at 11: 15 hours (next QC due 19:15) Patient 005109899, verified in LIS at 19:23 MST, 8 minutes lapse of 8 hour QC Patient 005122564, verified in LIS at 20:00 MST, 45 minutes lapse of 8 hour QC Patient 005122480, verified in LIS at 21:14 MST, 1 hour 59 minutes lapse of 8 hour QC February 2023 2/6/2023 Level 1 QC performed at 00: -- 7 of 15 -- 00 hours Patient 005069769, performed at 14:55 hours, 6 hours 55 minutes lapse of 8 hour QC Patient 005068586, performed at 15:10 hours, 7 hours 10 minutes lapse of 8 hours QC 3. In an interview on 12/16/2023 at 11:50 hours, in the conference room, TC1 confirmed the lapse in the eight-hour QC requirement for manual cell counts on the hemocytometer for the above days. II. Based on review of laboratory worksheets, laboratory patient results, and confirmed in interview, the laboratory failed to document the time of quality control performance for the "Spinalscopics Spinal Fluid Cell Count Control/Level 1 & 2" for four of nine days reviewed in November and December 2022, and February and May 2023. The findings included: 1. Review of the laboratory policy titled "Body Fluid Analysis", section IV "Quality Control" stated the following: "A. One level of control is counted in duplicate per 8 hour shift." 2. A review of the laboratory worksheet titled "Body Fluid Hemocytometer Counts" included a column for the record of date and time of test performance. In an interview on 12/5/2023 at 13:42 hours, in the conference room, technical consultant (TC) 4 stated the laboratory did not document QC for hemocytometer body fluid cell counts anywhere other than the "Body Fluid Hemocytometer Counts" worksheets. 3. Review of random weeks in November and December 2022, and February and May 2023 had the following 4 days where QC time was not documented on the "Body Fluid Hemocytometer Counts" worksheet: November 2022: 11/19/2022 - no documentation of time QC was performed Patient 005005195, verified in the LIS at 14:20 MST Patient 005119028, verified in the LIS at 16:03 MST Patient 005008647, verified in the LIS at 19:51 MST December 2022: 12/20/2022 - no documentation of time QC was performed Patient 005118224, sample one verified in LIS at 15:15 MST Patient 005118224, sample two verified in LIS at 15:19 MST Patient 005058931, verified in LIS at 15:32 MST Patient 005122177, verified in LIS at 15:51 MST February 2023: 2 /3/2023 - no documentation of time QC was performed Patient 005037301, verified in the LIS at 14:52 MST Patient 005002416, verified in the LIS at 14:36 MST Patient 005124215, verified in the LIS at 14:43 MST Patient 005087983, verified in the LIS at 17:06 MST May 2023: 5/31/2023 - no documentation of time QC was performed Patient 005120798, verified in the LIS at 10:07 MST Patient 005119417, verified in the LIS at 11:35 MST Patient 005130307, verified in the LIS at 14:14 MST Patient 005130030, verified in the LIS at 14:28 MST Patient 005125402, verified in the LIS at 19:40 MST 4. In an interview on 12/6/2023 at 11:55 hours, in the conference room, TC1 confirmed that the laboratory failed to ensure documentation of QC time for the hemocytometer body fluid cell counts for the above days. D5547 HEMATOLOGY CFR(s): 493.1269(c)(d) (c) For manual coagulation tests-- (c)(1) Each individual performing tests must test two levels of control materials before testing patient samples and each time a reagent is changed; and (c)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of manufacturer instructions for use, laboratory quality control (QC) worksheets, and patient test results, the laboratory failed to ensure that QC was performed with every patient tested for 8 of 17 patients tested for Fibrin Degradation Products (FDP) in six months reviewed, January, February, April, May, July, and August 2023. The findings included: 1. Review of the "Stago FDP Plasma kit instructions for use for the Qualitative and Semi-Quantitative Determination of FDP -- 8 of 15 -- in Plasma for Latex Agglutination", section 9 "Procedure", subsection "Quality Control" had the following instructions: "Each time the patient's plasma dilutions are tested, include a positive and negative control in the test-run so as to have agglutination patterns for comparison." 2. Review of laboratory quality control (QC) worksheets and patient reports for January, February, April, May, July, and August 2023 had the following 8 patients with FDP testing performed without documentation of QC. February 2023: 2 patients with no documentation of QC. 2/17/2023, Patient MRN 005097691 2/22/2023, Patient MRN 005104098 April 2023: 1 patient with no documentation of QC. 4/18/2023, Patient MRN 005128158 May 2023: 2 patients with no documentation of QC. 5/19/2023, Patient MRN 005129796 5/23/2023, Patient MRN 005038247 July 2023: 2 patients 2 patients were tested for FDP on 7/10/2023 MRN 005132305, verified at 03:50 MDT MRN 005132298, verified at 09:50 MDT Quality control was performed on same day of testing with no documentation of time to determine QC acceptability for patient test results. August 2023: 1 patient with no documentation of QC. 8/26/2023, Patient MRN 005034080 3. In an interview on 12/6 /2023 at 14:55 hours, in the conference room, technical consultant (TC) 1 confirmed that QC was not documented for the above patients with FDP testing. D5633 CYTOLOGY CFR(s): 493.1274(d)(1) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1) The technical supervisor establishes a maximum workload limit for each individual who performs primary screening. This STANDARD is not met as evidenced by: Based on review of laboratory testing personnel's cytology screening workload records for 2023, policies/procedures and staff interview, the laboratory's Cytology Technical Supervisor failed to establish a maximum workload limit for five of five individuals who performed primary screening. Findings included: 1. Review of laboratory testing personnel's cytology screening workload records for 2023 revealed the laboratory documented daily workload for five of five individuals performing primary screening. 2. Further review of the workload records revealed there were no individual workload limits established for each of the five testing personnel performing primary screening. 3. Review of laboratory's policy "Cytology Screening" (document CYTO:10, last reviewed 05/01/2023) revealed: "Workload Policy ... Individual workload limits for each cytotechnologist will be set by the pathologist according to individual performance capabilities and reassessed at least every six months." There were no protocols in place for establishing individual workload limits. 4. In an interview on 12/07/2023 at 1120 hours in the laboratory's conference room, the facility's Histology Supervisor (as indicated on submitted Survey Entrance/Exit documents) confirmed the findings. D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: -- 9 of 15 -- Based on review of laboratory's policies/procedures, laboratory testing personnel's cytology screening workload records for 2023, submitted Form CMS 116 and staff interview, the laboratory failed to follow its own policy at least every 6 months for documentation of workload limit reassessment and/or adjustment for five of five cytology testing personnel performing primary screening. Findings included: 1. Review of laboratory's policy "Cytology Screening" (document CYTO:10, last reviewed 05/01/2023) section revealed: "Workload Policy ... Individual workload limits for each cytotechnologist will be set by the pathologist according to individual performance capabilities and reassessed at least every six months." 2. Review of laboratory testing personnel's cytology screening workload records for 2023 and submitted Form CMS 116 revealed the laboratory had five cytology testing personnel performing primary screening. 3. The laboratory was asked to provide documentation of 6 months' workload limit reassessment and/or adjustment for five of five cytology testing personnel performing primary screening, and no such documentation was available for review prior to survey exit. 4. In an interview on 12/07/2023 at 1130 hours in the laboratory's conference room, the facility's Histology Supervisor (as indicated on submitted Survey Entrance/Exit documents) confirmed the findings. D5781