Cottage Hospital

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 record review, observation, and staff interview the laboratory (lab) failed to follow manufacturer's defined acceptable humidity criteria for operation of the lab's Cobas Pure chemistry test system for 31 out of 45 days reviewed in October and November 2025. Findings include: 1. Review on 11/14/2025 of the operators manual for the Cobas Pure chemistry analyzer revealed on page 231 environmental conditions during operation for ambient (room) humidity must be between 30-85%. 2. Review on 11/14/2025 of the lab's humidity logs from October 1, 2025 through 11/13/2025 revealed the lab's room humidity fell below 30% on 30 out of 44 days reviewed. 3. Observation on 11/14/2025 at 10:00 a.m. of the lab's ambient humidity revealed the humidity was 25%. The lab was performing chemistry testing using the Cobas Pure at the time of observation. 4. Interview on 11/14/2025 at 10:30 a.m. with the Technical Supervisor (TS1) confirmed the above findings and revealed the lab continued to perform chemistry testing using the Cobas Pure analyzer in October and November 2025 on the days identified in the logs when humidity fell outside the manufacturer's acceptable range. 5. Review on 11/14/2025 of the lab's test list revealed the Cobas Pure analyzer is used to test for the following analytes: acetaminophen, albumin, alkaline phosphatase, aspartate aminotransferase, ammonia, amylase, alanine Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- aminotransferase, blood urea nitrogen, calcium, carbon dioxide, chloride, cholesterol, creatine kinase, creatinine, c-reactive protein, protein, digoxin, dilantin, direct bilirubin, direct low density lipoprotein, ethyl alcohol, ferritin, folate, free thyroxine, glucose, human chorionic gonadotropin, high density lipoprotein cholesterol, hemoglobin A1C, iron, lactic acid, lactate dehydrogenase, lipase, lithium, magnesium, microalbumin, phosphorus, potassium, pro-B-type natriuretic peptide, prostate specific antigen, salicylate, sodium, total bilirubin, total protein, unsaturated iron binding capacity, triglycerides, troponin-I high sensitivity, thyroid stimulating hormone, uric acid, valproic acid, vancomycin, vitamin B12, vitamin D (25-hydroxy), and carbamazepine. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on record review, observation, and staff interview; the laboratory (lab) failed to label 3 of 3 opened vials of hematology quality control (QC) material in 2025. Findings include: 1. Review 11/14/2025 of the package insert for complete blood count (CBC) QC material (QC1, QC2, and QC3) revealed "Open vials and vials which have been sampled by cap piercing will retain stability for 15 days if stored at 2- 8 degrees Celsius after being re-capped". QC1, QC2, and QC3 are used for control testing of CBC analytes: white blood cell count, red blood cell count, platelet count, hemoglobin, hematocrit, and white blood cell differential. 2. Observation at 11/14 /2025 at 9:30 a.m. of QC1, QC2, and QC3 vials revealed the caps were pierced and no revised expiration date was documented on the 3 vials. 3. Interview on 11/14/2025 at 9:30 a.m. with the Technical Supervisor (TS1) confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory's frozen blood product storage system failed to include an adequate alarm that activates when temperature falls outside the acceptable range. Findings include: 1. Review on 11/30/2023 of the label for fresh frozen plasma (FFP) revealed the storage temperature must be less than -18 degrees Celsius (C). 2. An alarm test of the blood bank freezer, used to store FFP, was performed at 10:10 a.m. on 11/30/2023. Review of the electronic temperature log (TempTrak) during the alarm test revealed at 10:15 a.m. the temperature recorded was -5.6 C. No alarm was activated at the recording of this temperature. The alarm settings for this freezer were set for outside the range of -39.6 to -18.2 C 3. Interview on 11/30 /2023 at 10:15 a.m. with the Technical Supervisor (TS1) revealed the alarm will be activated on a laboratory computer and another computer located in another unit (Med- Surg staffed 24/7). The laboratory computer received the alarm notification message at 10:30 a.m. 4. Interview with staff located at Med-Surg on 11/30/2023 at 10:30 a.m. revealed they had not received an alarm notification message on their computer. The alarm notification was later reported to have been received in Med-Surg at 10:37 a.m. 5. Interview on 11/30/2023 at 10:45 with Maintenance revealed the alarm notification was set to a 15 minute delay and the temperatures were set to record every 15 minutes. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D6175 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(1) Each individual performing high complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on record review and staff interview, laboratory personnel failed to follow the laboratory's procedures for 1 of 5 manual cell counts performed in 2023. Findings include: 1. Review on 11/30/2023 of the laboratory's procedure titled "Synovial Fluid Analysis" revealed instruction to count all 9 squares of the Hemacytometer (with or without specimen dilution). 2. Review on 11/30/2023 of manual cell counts performed between June and November 2023 revealed for 1 of 5 records reviewed only 20% of 1 square had been counted and results reported. 3. Interview on 11/30/2023 with the Technical Supervisor (TS2) confirmed the above findings. 4. The laboratory's combined annual volume for manual white blood cell and red blood cell counts is 40. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing (PT) record review and and staff interview, the laboratory failed to successfully participate for blood gas analyte pH testing in PT events 2 and 3 of 2021. Refer to tag D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and and staff interview, the laboratory failed to successfully participate for blood gas analyte pH testing in PT events 2 and 3 of 2021. Findings include: 1. Review of Wisconsin State Laboratory of Hygene (WSLH) PT evalauation reports for 2021 revealed the laboratory obtained usatisfactory PT scores for blood gas pH testing in event 2 (60%) and 3 (60%). 2. Interview with the Chemistry Technical Supervisor (TS) confirmed the laboratory obtained a score of 60% for pH in events 2 and 3 in 2021. -- 2 of 2 --

Summary Statement of Deficiencies D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: A. Based on record review and staff interview, the laboratory failed to monitor refrigerated storage temperatures for red blood cell units on 2 days in May 2018. Findings include: 1) Review of Immunohematology refrigerator temperature logs on 12/17/2019 from January 2018 through November 2019 revealed no temperature (digital or internal) was documented on 5/26/18 and 5/27/18 for the refrigerator used to store red blood cell units. 2) Interview on 12/17/2019 at 10:15 a.m. with the Technical Supervisor (TS1) confirmed temperatures were not recorded on the Immunohematology refrigerator temperature logs for 5/26/18 and 5/27/18. B. Based on record review and staff interview, the laboratory and failed to ensure room temperature storage conditions were within acceptable limits for 11 of 12 plateletpheresis (platelet) units in 2018 and 2019. Findings include: 1) Review of the laboratory's policy titled "Apheresis Platelets" on 12/17/2019 revealed the acceptable storage temperature for platelet units is 20-24 degrees Celsius. 2) Review of "Plateletpheresis Temperature Log" on 12/17/2019 from January 2018 through December 17, 2019 revealed the laboratory received and stored 12 platelet units during this period. Further review revealed temperatures recorded on days the laboratory stored platelets fell below 20 degrees Celsius for 11 of 12 platelet units. 3) Interview on 12/17/2019 at 10:15 a.m. with the Technical Supervisor (TS1) confirmed the above findings. D3041 RETENTION REQUIREMENTS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on review of patient test reports for the period of March 2018 through December 2019 and staff interview, the laboratory failed to maintain copies of original patient test reports for at least two years after the reports were issued from the Merge Laboratory Information System (LIS). Findings include: 1. Record review conducted on 12/16/2019 of patient test reports for the period of 03/27/2018 through 12/16/2019 revealed copies of the original patient test reports issued from the MERGE LIS between the period of 03/27/2018 through 01/29/2019 were not maintained for at least 2 years after the reports were issued. 2. Record review conducted on 12/17/2019 of the Quality Management Program, version 4.0, effective 05/31/2017, stated the following on page 7 under Section Records H, "test reports - retain or be able to retrieve a copy of the original report (including preliminary, final, and corrected) for a minimum of two years." 3. The General Supervisor (GS1) stated during an interview on 12/17/2019 at 1:00 p.m. that copies of the original test reports that were issued from the Merge LIS and faxed to outside clients were not maintained by the laboratory. The interview further revealed that the Merge LIS went "live" on 03 /27/2018 and was then replaced with a new HARVEST LIS on 01/29/2019. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory's calibration verification procedures for blood gases in November 2019 failed to cover the laboratory's -- 2 of 8 -- reportable range. Findings include: 1) Review on 12/17/2019 of calibration verification for blood gases performed in November 2019 revealed the following ranges had been verified: Hydrogen concentration (pH) = 6.529-7.895 Oxygen partial pressure (pO2) = 17 - 428 mmHg Carbon dioxide partial pressure (pCO2) = 19.4 - 93.4 mmHg 2) Review on 12/27/2019 of the laboratory's procedure titled 'iSTAT Cartridge and Test Information" revealed the following reportable ranges: pH = 6.5 - 8.2 pO2 = 5 - 800 mmHg pCO2 = 5 - 130 mmHg 3) Interview on 12/17/2019 at 11:25 a.m. with the Technical Consultant (TS1) confirmed the calibration verification performed in November 2019 for pH, pO2, and pCO2 did not fully verify the laboratory's reportable ranges. 4) This is a repeat deficiency from the initial survey completed 6/14/2018. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview with the Testing Personnel (TP1) and the General Supervisor (GS1), the laboratory failed to check each batch of media for sterility, ability to support and/or inhibit growth, and produce a biochemical response in 2019. Findings include: 1. Review conducted on 12/17/2019 of quality control (QC) records from September 2019 through December 2019 of Columbia CAN w/5% Sheep Blood, MH Agar w/ 5% Sheep Blood, Blood Agar 5% Sheep Blood, Haemophilus ID Quad, Thio Med w/Dex, Hemin, Vit K, and MacConkey agar plates, revealed that media batches were not checked for sterility, ability to support and/or inhibit growth or produce a biochemical response. 2. Record review conducted on 12 /17/2019 of the Quality Control and Quality Assurance Program, effective 03/29 /2017, stated the following on page 2: "Before, or concurrent with initial use: Check each batch of media for sterility if sterility is required for testing, Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response, Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer." 3. TP1 and GS1 stated during interview on 12/17/2019 at 11:45 a.m. that certain commercially prepared media were only visually inspected and the manufacturer's quality control certificate was kept on file when each batch was received. D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. This STANDARD is not met as evidenced by: -- 3 of 8 -- Based on record review and staff interview with the General Supervisor (GS1) and Technical Supervisor (TS1), the laboratory failed to document quality control of Gram stain each week of use in 2019. Findings include: 1. Record review conducted on 12 /17/2019 of Bacteriology quality control records for the period of October 2019 through December 2019 revealed that the laboratory failed to document checking Gram stain reagents with positive and negative reference organisms with each new batch of stains and each week of patient testing. 2. Interview with the TS1 at 12/17 /2019 at 12:10 p.m. and with the GS1 at 12/17/2019 at 1:15 p.m. confirmed the findings above. 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: Based on record review and staff interview, the laboratory failed to perform control testing for 3 manual cell counts performed in 2018 and 2019. Findings include: 1) Review on 12/16/2019 of manual body fluid cell count proficiency testing (PT) records from 2018 and 2019 revealed no quality control (QC) testing was documented for 2 of 3 PT samples (BFM-1 and BFM-3) in event 2018-Chem&HemeQA1. The attestation was signed in April and May 2018 for these PT samples. 2) Review on 12 /17/2019 of records titled "Body Fluid Patient QC Form" from January 2018 through December 17, 2019 revealed 1 patient cerebral spinal fluid (CSF) cell count performed on 9/14/19. No QC testing was documented on the QC form. The laboratory was unable to provide quality control testing performed on 9/14/19 at the time of survey. 3) Interview on 12/17/2019 at 12:30 p.m. with the Technical Supervisor (TS1) confirmed the manual cell count control testing for the 2 PT samples and 1 patient sample were not documented. 4) This is a repeat deficiency cited on the initial survey completed on 6/14/2016 and again on the recertification survey completed 1/10/2018. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to follow their established procedures to monitor, assess and correct problems identified for testing performed in the specialties of bacteriology, chemistry and hematology. Findings include: 1) The laboratory's calibration verification procedures failed to cover the laboratory's reportable ranges for blood gases. Refer to tag D5439. 2) The laboratory failed to check each batch of media for sterility and its ability to support and/or inhibit growth. Refer to tag D5477. 3) The laboratory failed to ensure gram stain control -- 4 of 8 -- testing was documented. Refer to tag D5503 4) The laboratory director failed to ensure control testing was performed for manual cell counts. This is a repeat deficiency from the initial survey completed on 6/14/2016 and the recertification survey completed 1/10/2018. Refer to tag D5543. 5) Interview on 12/17/2019 at 12:30 p.m. with Testing Personnel (TP3) revealed TP3 reviewed the patient manual cell count mentioned above for accuracy of the calculation and manual entry into the reporting system. TP3 confirmed control testing was not part of the review of the "Body Fluid Patient QC Form". D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory director failed to ensure 1 of 7 new testing personnel met educational qualifications and received appropriate training prior to testing patients' specimens in 2018. Findings include: 1) Review on 12 /16/2019 of personnel records revealed 1 of 7 (TP1) new testing personnel failed to include educational qualifications for performing high complexity testing. Cross reference D6171. Further review of TP1's record on 12/16/2019 revealed incomplete training for blood gas testing and cell identification; there was no documentation of training for all other specialties and testing performed by TP1 who worked on third shift. 2) Interview on 12/16/2019 at 12:30 p.m. with TS1 confirmed the above finding and revealed testing personnel on third shift perform all testing in all specialties except bacteriology culture workups using the Vitek2. 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 record review and staff interview, the technical supervisor failed to perform competency assessments semiannually within the first year for 4 new testing personnel in 2018 and 2019. Findings include: 1) Review of 7 new testing personnel records on 12/16/2019 revealed 4 of 7 have performed testing for 1 year or more. Further review of of the 4 personnel records revealed semiannual competency assessments were not documented within the first year for the following: TP2: 1 competency assessment for Immunohematology procedures and 2 competency assessments for Chemistry, Hematology, and Microbiology test systems were not documented. TP3: 1 competency assessment for all Immunohematology procedures, manual body fluid cell counts, complete blood counts (CBC) coagulation testing on the CA 600 analyzer, chemistry procedures on the Dimension EXL, and Vitek2 analyzer. TP4: 1 competency assessment for manual body fluid counts, CBC, manual -- 5 of 8 -- cell differentials, coagulation testing on the CA 600 analyzer, chemistry procedures on the Dimension EXL; and 2 competency assessments for gram stains, urine sediment, and Vitek2 analyzer. TS1: 1 competency assessment for procedures for Alere analyzer (d-dimer and brain natriuretic peptide), chemistry procedures on the Dimension EXL; and 2 competency assessments for Vitek2 analyzer. 2) Interview on 12/16/2019 at 12:30 p.m. with the Technical Supervisor (TS1) revealed the missing semiannual competency assessments listed above had not been performed. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interview, 1 of 12 laboratory personnel performing high complexity testing from January 2018 to June 2018 failed to meet educational qualification requirements. Refer to tag D6171. Based on record review and staff interview, 1 of 12 testing personnel failed to follow control procedures for blood gas testing. Refer to tag D6177. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or 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; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory -- 6 of 8 -- Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on record review and staff interview, 1 of 7 new laboratory personnel performing high complexity testing from January 2018 to June 2018 failed to meet educational qualification requirements. Findings include: 1) Review of the laboratory personnel form (CMS-209) on 12/16/2019 revealed 7 of 12 testing personnel were hired since the previous recertification survey. 2) Review of 7 new testing personnel records on 12/16/2019 revealed 1 (TP1) of 7 records failed to include educational qualifications. 3) Interview on 12/17/2019 at 9:00 a.m. with the Director of Radiation and Laboratory Services revealed TP1 was employed by the laboratory from January 2018 to June 7, 2018. 4) Interview on 12/16/2019 at with Technical Supervisor (TS1) confirmed TP1's record did not include education qualifications. TS1 revealed TP1 was performing patient testing on 3rd shift in all specialties. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the testing personnel failed to follow the laboratory's quality control (QC) policies for routine chemistry testing in October 2019. Findings include: 1) Review of the laboratory's policy titled "Quality Control and Quality Assurance Program" on 12/17/2019 revealed on page 3 "

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview, laboratory personnel failed to attest to the routine integration of chemistry, microbiology, immunohematology, and hematology proficiency testing (PT) samples using the laboratory's routine methods for PT in 2017. Findings include: 1) Review on 1/9/18 of PT records from 2017 revealed laboratory personnel failed to attest to the routine integration of PT samples following American Proficiency Institute PT events: 6 out of 7 testing personnel failed to sign the attestation form for the "2017 Chemistry Miscellaneous 2nd Event;" 2 out of 6 testing personnel failed to sign the attestation form for "2017 Chemistry Core 1st Event;" 2 out of 6 testing personnel failed to sign the attestation form for " 2017 Chemistry Core 3rd Event;" 4 out of 6 testing personnel failed to sign the attestation form for "2017 Hematology/Coagulation 2nd Event;" 4 out of 6 testing personnel failed to sign the attestation form for "2017 Hematology/Coagulation 3rd Event;" 3 out of 6 testing personnel failed to sign the attestation form for "2017 Microbiology 3rd Event;" 2 out of 5 testing personnel and the laboratory director failed to sign the attestation form for "2017 Immunology/Immunohematology 1st Event;" 2 out of 5 testing personnel and the laboratory director failed to sign the attestation form for "2017 Immunology/Immunohematology 2nd Event;" and, 1 out of 5 testing personnel and the laboratory director failed to sign the attestation form for "2017 Immunology /Immunohematology 3rd Event." 2) Interview on 1/9/18 at 11:30 a.m. with the Technical Supervisor and Laboratory Director confirmed the above finding. D5543 HEMATOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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: Based on record review and staff interview, the laboratory failed to document duplicate test counts for two levels of control materials used for manual cell counts. Findings include: 1) Review on 1/10/2018 of the Body Fluid Control Log from October 4, 2016 through December 31, 2017, revealed the laboratory documented one test count for each level of control material used for manual cell counts performed on the hemocytometer. 2) Review on 1/10/2018 of the laboratory procedure "Synovial Fluid Analysis" last revised 6/25/2008, revealed when the laboratory uses a hemocytometer to perform manual cell counts it will perform two counts, one on each side of the hemocytometer, and document both counts on the Body Fluid Control Log. 3) Interview on 1/10/2018 at 12:30 p.m. with the Technical Supervisor (TS) revealed testing personnel were performing cell counts for both control materials in duplicate. TS confirmed that two separate counts were not documented on the Body Fluid Control Log from October 4, 2016 through December 31, 2017. 4) Review 1/10/2018 of patient records from 10/4/2016 to 12/31/2017 revealed the laboratory performed and reported a total of 39 manual patient cell counts. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document notification of corrected chemistry and hematology results when errors in patient tests results were detected. Findings include: 1) Review on 1/10/2018 of corrected reports from June 2017 through November 2017 revealed prompt notification was not documented when corrections were made to 38 patient test results. 2) Review on 1/10 /2018 of the laboratory's procedure titled "Detection and Documentation of Clerical Errors, Analytical Errors and Unusual Results," effective 8/7/2017, revealed no instruction to notify and document notification of correction of patient test results. 3) Interview on 1/10/2018 at 11:00 a.m. with the Technical Supervisor confirmed the above findings. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument -- 2 of 3 -- and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, testing personnel performing moderately complex hematology testing failed to adhere to the laboratory's quality control policies for complete blood cell counts (CBC). Findings include: 1) Review on 1/10 /2018 of the laboratory's procedure titled "Complete Blood Count CBC (xs1000i)" effective 10/2012 revealed instruction to check expiration dates of control material, remix the control vials, and rerun CBC controls when results are not acceptable. If repeat CBC control testing is still out of acceptable range, open new CBC control material vials. 2) Review on 1/10/2018 of CBC control records from November 2017 to January 10, 2018 revealed on 12/16/2017 the platelet count was unacceptable for CBC control level three and was not repeated. 3) Review on 1/10/2018 of patient records revealed 16 patient CBC results had been reported on 12/16/2017. 4) Interview on 1/10/2018 at 10:30 a.m. with the Technical Supervisor confirmed the above findings. -- 3 of 3 --